Friday, July 29, 2016

Orange Co. safe syringe program looks to decrease Hepatitis C cases

HILLSBOROUGH, N.C. (WNCN) — A large increase in the cases of Hepatitis C has helped spur a safe syringe program.

North Carolina’s Hepatitis C rates have gone up 200 percent between 2007 and 2011, Robin Gasparini of the Orange County Health Department reports.

As a result, local police and health officials have teamed up to start the health department’s program.

Under the program, anyone who wants them can get new, sterile syringes. So far a handful of people have taken up the offer.

Gasparini, a nurse, says it’s a safe resource for those who need syringes for prescribed medication, and have trouble getting them from a pharmacy.

“It’s at the pharmacists’ discretion who they sell syringes to,” Gasparini said. “So individuals that may have chronic diseases or individuals of low socioeconomic status may have difficulty obtaining syringes.”

In addition to the 20 syringes provided, users also get a needle disposal can and several fliers.

“Information on local resources including referrals on where to seek help or where to seek treatment if needed,” Gasparini said.

There are two safe disposal sites for used syringes in Orange County but Sheriff Charles Blackwood said he’d like to see more.

“That prevents a child from running into a needle at a playground, a bus stop, and those are calls we’ve responded to in the years,” Sheriff Blackwood said.

He added that his deputies encounter used syringes on the job. “If you arrest someone and they may be an illegal user and they may have them in their pocket,” he said.

The N.C. Harm Reduction Coalition reports that one in three officers will be stuck with a syringe during their careers, and that safe syringe programs can reduce exposure by 60 percent.

Roy Misses the Value Proposition

During a Presidential election cycle, facts are often the first casualty.
Avik Roy argues that the GOP needs a “clear plan to tackle the high and rising price of branded prescription drugs.” He calls it a Republican “blind spot.” And he’s right – but for the wrong reasons.
According to Roy, “Even 66 percent of Republican voters said high drug prices should be a top policy priority, compared to 60 percent who said the same of repealing Obamacare.” What he doesn’t share (or more likely doesn’t know) is that for most Americans, “the price of drugs” means the co-pay they hand over at the pharmacy when they pick up their prescriptions. That’s not a drug-pricing problem; it’s an insurance industry problem. It’s so easy to blame Big Pharma. That’s the real blind spot.
Mr. Roy quotes from a recent Kaiser Family Foundation poll which says 72 percent of their sample find “drug prices” generally unreasonable. But he doesn’t share that the same exact percentage (72 percent) said they find their drugs affordable. If Mr. Roy is reporting one he should report the other. It’s an issue of probability versus reality
Mr. Roy discusses consumer purchasing of iPhones and compares it to healthcare. His assumption that consumers can make choices through transparent pricing is false since, in healthcare, there are pesky things called therapeutic outcomes. Even if consumers have pricing information its not good enough to make an appropriate “purchasing  decision” since they don’t necessarily have or understand the information which drives positive outcomes. This is despite pharmaceuticals being the only segment of healthcare (compared to physician and hospital services ) where pricing and outcomes are the most transparent.
Also, Mr. Roy fails to mention that pharmaceuticals are the only segment of healthcare where the costs plummet after a period of time (brand vs. generics). Today’s expensive medicines are tomorrow’s very inexpensive generics. Today’s hospitalizations, alas, are tomorrow’s even more expensive hospitalizations. Modern medicines continue to provide value in perpetuity – what value does a site of care, like a hospital or an insurer or PBM provide?
Mr. Roy fails to mention that hospitals actually manipulate and increase drug costs by buying up physician practices and shifting site of care. According to Sloane Kettering data, a medicine administered in a hospital setting is 150 percent more costly that one administered in physician offices.  Hospitals make more money by shifting site of care while vilifying drug companies! They also artificially pad their bottom lines by taking advantage of the 340B program – but he fails to mention that as well.
Of course, drug pricing is a complicated matter — which is why the pharmaceutical industry should focus on a few basic points when making its case.
Roy argues there’s no relevant connection between the pharmaceutical industry’s investments in R&D and pricing. That’s intuitively and factually wrong.
Since 2000, drugs firms have spent over half a trillion dollars developing new medicines. And research costs for the last year alone totaled more than $51 billion. That’s up from $15.2 billion in 1995.
These are extraordinary spending levels, even compared to other research-intensive industries. In fact, the pharmaceutical sector spends five times more on R&D than aerospace, and 2 ½ times more than the software and computer industry. This is the kind of investment that pharmaceutical innovation demands, and it’s reflected in the economics of advanced drugs.
Big Pharma also needs to do a better job explaining just how many failures firms endure searching for the next breakthrough medicine. Drug companies must develop hundreds of compounds until they find one suitable for testing on humans. Of those rare compounds that make it to phase-1 human trials, fewer than 12 percent win approval from the FDA.
That’s why bringing just one drug to market costs an average of nearly $2.6 billion and takes more than 10 years, according to researchers at Tufts.
If drug companies were open and honest about their frequent and expensive failures, they could quash the myth that pharmaceutical research is obscenely lucrative.
Consider the controversy surrounding the hepatitis C drug Sovaldi. When the medicine came on the market, it quickly became known in the press as “the $1,000 pill.” This may be a great sound bite, but it’s hardly accurate.
In reality, insurers and benefit managers negotiated discounts that reduced the price of Sovaldi by 20 to 50 percent. But they didn’t pass the full discount on to the consumer. Instead, insurers and pharmacy benefit managers pocketed the money to pad their bottom lines and executives’ wallets. Last year, CVS Caremark Corporation, one of the biggest benefit managers, paid its CEO over $32 million.
For many patients, particularly those without insurance coverage, Sovaldi’s manufacturer supplied a coupon ensuring that co-pays for the drug wouldn’t exceed $5.
But Mr. Roy’s key error is focusing on price as the denominator of the conversation. That’s wrong too, in fact it the fundamental error that allows people like Hillary Clinton and Donald Trump to blame for the biopharmaceutical industry for rising health care costs. The true denominator is value.
Consider one pre-Sovaldi “best practice” treatment for Hepatitis C, the drug Pegasys. This requires one injection a week for 48 weeks — and very few patients see the treatment through to completion, so much of that treatment, both physician time and drug cost, is wasted. Nor is it that much cheaper: At about $7,000/month, the full course of treatment is over $70,000 — barely less than cost of the three months needed for Sovaldi to work a cure.
And the price of not using Sovaldi is very high. One in three patients with the Hepatitis C virus eventually develops liver cirrhosis, and managing these patients is costly. A “routine” liver transplant (where the liver is from a cadaver) costs close to $300,000; a “living donor” transplant is even more expensive.
Thanks to Sovaldi, a pill that cures the disease when taken once a day over 12 weeks will eradicate the need, the risks and the costs of liver transplantation. Such radical innovation deserves to be both lauded and rewarded.
But it’s so much easier to place blame than say thank you. When it comes to pharmaceuticals, we have to learn to understand the value proposition. It’s not just the price of the product –it’s the price relative to the value the product provides to individuals and society.
In short, drugs aren’t the cause of rising health-care costs — they’re the solution. Demonizing new treatments distracts from the real problem in the US biopharmaceutical industry: top-down cost-centric policies that focus on the near-term, short-changing long-term patient outcomes, and so endanger “sustainable innovation” by denying fair reimbursement for high-risk investment in R&D.
But it’s so much easier to just place blame. Easy and wrong.  Avik Roy should know better.

EU clears Gilead’s pan-genotypic hepatitis C therapy

Gilead's Sovaldi-based combination therapy for hepatitis C has been cleared for use by European reglators to treat all six types of the virus, potentially eliminating the need for genotype testing.

Epclusa - a once-daily, fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF/VEL; approved as Sovaldi) and the pan-genotypic NS5A inhibitor velpatasvir - is the first all-oral, pan-genotypic, single tablet regimen cleared for the treatment of adults with genotype 1-6 chronic HCV.

The combination of SOF/VEL for 12 weeks was authorised for use in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C).

It is also the first single tablet regimen licensed for the treatment of patients with HCV genotype 2 and 3, without the need for RBV, said Gilead, noting that physicians may consider the addition of RBV for genotype 3 infected patients with compensated cirrhosis.

The therapy's green light follows an accelerated review procedure by the European Medicines Agency, and comes on the back for data from the Phase III ASTRAL trials, which showed that, of the 1,035 patients treated with the combination for 12 weeks - 21 percent of which had compensated cirrhosis and 28 percent of which had failed prior treatments - 98 percent achieved the primary efficacy endpoint of a sustained virologic response.

"SOF/VEL offers an effective and generally tolerable choice which is ribavirin free for the majority of patients. For the first time we have a once-daily single tablet treatment option which works across all genotypes including genotype 3, which is often the least responsive to treatment," said Professor William Rosenberg, clinical lead for Viral Hepatitis, UCL Institute for Liver and Digestive Health, London.







Mitchell Mcleod Pugh Williams Inc Lowers stake in Gilead Sciences (GILD)

Gilead Sciences (GILD) : Mitchell Mcleod Pugh Williams Inc reduced its stake in Gilead Sciences by 14.73% during the most recent quarter end. The investment management company now holds a total of 12,850 shares of Gilead Sciences which is valued at $1,117,051 after selling 2,220 shares in Gilead Sciences , the firm said in a disclosure report filed with the SEC on Jul 15, 2016.Gilead Sciences makes up approximately 0.83% of Mitchell Mcleod Pugh Williams Inc’s portfolio.

Other Hedge Funds, Including , Piershale Financial Group added GILD to its portfolio by purchasing 201 company shares during the most recent quarter which is valued at $17,473. Gilead Sciences makes up approx 0.01% of Piershale Financial Group’s portfolio.First Manhattan Co boosted its stake in GILD in the latest quarter, The investment management firm added 359,484 additional shares and now holds a total of 2,031,292 shares of Gilead Sciences which is valued at $176,580,214. Gilead Sciences makes up approx 1.06% of First Manhattan Co’s portfolio.Raymond James Trust N.a. boosted its stake in GILD in the latest quarter, The investment management firm added 744 additional shares and now holds a total of 16,033 shares of Gilead Sciences which is valued at $1,387,656. Gilead Sciences makes up approx 0.12% of Raymond James Trust N.a.’s portfolio.Nadler Financial Group reduced its stake in GILD by selling 42 shares or 1.08% in the most recent quarter. The Hedge Fund company now holds 3,835 shares of GILD which is valued at $331,919. Gilead Sciences makes up approx 0.14% of Nadler Financial Group’s portfolio.

Gilead Sciences opened for trading at $86.94 and hit $87.34 on the upside on Monday, eventually ending the session at $86.93, with a gain of 0.30% or 0.26 points. The heightened volatility saw the trading volume jump to 67,88,252 shares. Company has a market cap of $115,775 M.

On the company’s financial health, Gilead Sciences reported $3.03 EPS for the quarter, missing the analyst consensus estimate by $ -0.10 based on the information available during the earnings call on Apr 28, 2016. Analyst had a consensus of $3.13. The company had revenue of $7794.00 million for the quarter, compared to analysts expectations of $8065.42 million. The company’s revenue was up 2.6% compared to the same quarter last year. During the same quarter in the previous year, the company posted $2.94 EPS.

Many Wall Street Analysts have commented on Gilead Sciences. Gabelli & Co Initiated Gilead Sciences on Jun 1, 2016 to “Buy”, Price Target of the shares are set at $109.Gilead Sciences was Downgraded by Maxim Group to ” Hold” on Apr 29, 2016. Shares were Reiterated by UBS on Apr 29, 2016 to “Buy” and Lowered the Price Target to $ 118 from a previous price target of $130 .

Gilead Sciences Inc. (Gilead) is a research-based biopharmaceutical company that discovers develops and commercializes innovative medicines. The Company’s primary areas of focus include human immunodeficiency virus (HIV) liver diseases such as chronic hepatitis C virus (HCV) infection and chronic hepatitis B virus (HBV) infection oncology and inflammation and serious cardiovascular and respiratory conditions. The Company’s HIV products include Stribild Complera/Eviplera Atripla Truvada Viread Emtriva Tybost and Vitekta. Its Liver Diseases products include Harvoni Sovaldi Viread and Hepsera. Zydelig is the Company’s oncology product. Its Cardiovascular products include Letairis Ranexa and Lexiscan/Rapiscan. Its Respiratory products include Cayston and Tamiflu. Its other products include AmBisome and Macugen.

Drug maker Gilead the target of activists’ ire at AIDS conference

DURBAN — Chants of "Gilead kills" and "Shame shame" filled the air of the exhibition hall at the 21st International AIDS Conference as activists protested against the price of Gilead Sciences’ HIV and hepatitis drugs earlier on Wednesday.

The cost of Gilead’s hepatitis C drug Solvadi was in the spotlight because its high price tag puts it out of reach of all but the wealthiest patients.

While it is not very common in SA, hepatitis C is prevalent among injecting drug users and is widespread in many other middle-income countries.

A 12-week course of Solvadi costs $84,000 in the US. In SA it costs about R158,000 for the three-month course.

Gilead came under fire from the activists, including local lobbyists Section 27 and the Treatment Action Campaign, not only for the price of Solvadi, but also for tax avoidance.

The US-based pharmaceutical company moved some of its assets to Ireland in order to shift some US drug sales revenue offshore to benefit from lower tax rates, according to a report by Americans for Tax Fairness published last week.

By not repatriating its foreign profits, Gilead avoided nearly $10bn in taxes, the group said.

The activists also protested against what they said was Gilead’s patent abuse.

They said Gilead it was issuing voluntary licences for other companies to make its HIV drugs in countries in which it did not have patent protection.

The most expensive drugs

US report highlights the expensive new medications that may be heading our way

A lot of attention has recently been given to the economic impact on pharmacy’s stocking expensive new hepatitis C medicines.

However, if the United States provides an example of what may be heading our way, the pharmacy sector in Australia may have to prepare for many other such scenarios in the near future.

According to a US Medicaid report, “the launch of several expensive hepatitis C drugs over the past few years has ushered the topic of high cost prescription drugs back into the public’s and policymakers’ attention”.

Among the most commonly prescribed outpatient prescription drugs in Medicaid, the top five drugs are used for pain relief (hydrocodone-acetaminophen and ibuprofen), management of chronic illness (lisinopril and omeprazole), and antibiotics (amoxicillin). However, these drugs are not necessarily among the most costly used by Medicaid as many are inexpensive at the per prescription level.

Nearly three quarters of the 50 most costly drugs fall into five drug groups, the report reveals, of which the most prevalent is antivirals, which includes drugs used to treat HIV as well as hepatitis C drugs.

Many of the most costly drugs have some form of regulatory and consequently market exclusivity, thus enabling the manufacturers to charge a premium price for the drug at the prescription level. Twenty two of the fifty most costly drugs are particularly expensive at the prescription level, including the most costly drug before rebates used by Medicaid over this period, Abilify (an atypical antipsychotic).

45 of the 50 most costly drugs fall into the high-cost category in part or primarily because they are frequently prescribed. Hydrocodone-acetaminophen and Suboxone, both opioids, a drug group which has garnered much public attention recently, fall into this category, as do several drugs used to treat ADHD.

The twelve costliest, in terms of total spend, are:

1 Abilify Antipsychotics/Antimanic Agent

2 Sovaldi Antiviral

3 Vyvanse ADHD/Anti-Narcolepsy/AntiObesity/Anorexiant

4 Harvoni Antiviral

5 Truvada Antivirals

6 Lantus Antidiabetic

7 Methylphenidate HCI ER  ADHD/Anti-Narcolepsy/AntiObesity/Anorexiants

8 Atripla Antivirals

9 Advair Diskus Antiasthmatic and Bronchodilator Agent

10 Lantus SoloStar Antidiabetics

11 Seroquel Antipsychotics/Antimanic Agents

12 Latuda Antipsychotics/Antimanic Agents

Prisons around the world are reservoirs of infectious disease

Prisoners around the world and people who were formerly incarcerated have a higher burden of HIV and other infectious diseases than the general population, worsening the spread of diseases inside and outside of prison, according to new research.

In a series of six papers in medical journal the Lancet, researchers from the Johns Hopkins Bloomberg School of Public Health analyzed the prevalence of infectious diseases including HIV, hepatitis C, hepatitis B and tuberculosis between 2005 and 2015.

They broke down how many of the 10.2 million people incarcerated worldwide had which illnesses. Based on the most recent data, from 2014, they estimate that 3.8 percent had HIV, 15.1 percent had hepatitis C, 4.8 percent had chronic hepatitis B and 2.8 percent had active tuberculosis.

The series noted that the spread of disease is usually low while someone is incarcerated, and people typically have access to treatment while incarcerated. However, it is difficult for them to continue their treatment once they are released.

Chris Beyrer, one of the researchers and a professor of public health and human rights, said the lack of resources is often a reason for a person becoming more infectious.

“What you have is treatment interruptions and gaps in care, and that’s because it’s very hard for people to access services,” he said.

Newly released prisoners with HIV often see their viral loads spike, which makes them more infectious to sexual partners and to people with whom they share drug needles.

[A cure for AIDS is no longer unthinkable]

Beyrer points out that criminal-justice policies that affect certain groups can have a big impact on how infectious diseases spread. He said that in much of the world, a substantial number of people are jailed because of drugs or drug-related offenses. In 27 countries, according to the analysis, drug users often don't receive treatment and are kept in unsanitary areas that can promote the spread of disease.

In the United States, researchers estimated that 1.3 percent of prisoners have HIV and 16.4 percent of prisoners have hepatitis C.

Drug use across America is pretty much the same for many demographics, Beyrer said, but who is actually punished for drug use or drug-related offenses varies greatly by race.

The series notes that black men are nine times more likely to be incarcerated for drug offenses than white men are, and they represent a disproportionate share of the U.S. prison population. Moreover, the high rates of black men in prison could be contributing to the high rate of HIV among all black Americans, according to one of the papers.

Researchers recommend reforming police practices, changing health-care management in prisons and decriminalizing drug use and the possession of drug across all nations. Doing so, they say, will mean compliance with the global standards of health care for prisoners.

William Schaffner, medical director at the National Foundation for Infectious Disease and professor of preventive medicine at Vanderbilt University School of Medicine, agrees with many of the findings and recommendations of the series. He suggests improving treatment after incarceration. “I should like to see prisoners [screened] when they enter prison and then the problems identified,” he said. “As they’re discharged, I’d like to see an actual link to post-discharge care.”

Brad Brockmann, executive director of the Center for Prisoner Health and Human Rights, supports many of the points leading to incarceration in the study. However, he thinks one of the studies doesn't emphasize enough just how rampant hepatitis C is among prisoners and the rest of the population, especially in the U.S.

[Hepatitis C-related deaths hit a record high in the U.S.]

“The hep C epidemic has been woefully under-addressed,” he said. “The funding for HIV in this country dwarfs the funding that is available for hep C.”

Brockmann said 90 percent of prisons and jails in the United States offered antiretroviral therapy for prisoners with HIV.

Like Schaffner and Beyrer, Brockmann said the public should be concerned about the health of its prisoners.

“The population in the country with the highest health burden is our prison population,” he said. “Over 90 percent of that population is going to be released.”

Medical Advisor Tuberculosis, HIV and Hepatitis C, MSF Access Campaign

Médecins Sans Frontières (MSF) is an international, independent, medical humanitarian organisation that delivers emergency aid to people affected by armed conflict, epidemics, healthcare exclusion and natural disasters. MSF offers assistance to people based only on need and irrespective of race, religion, gender or political affiliation.

Médecins Sans Frontières set up the MSF Access Campaign (AC) in 1999 to address systemic challenges and improve access to existing medical tools (medicines, diagnostics and vaccines) and to stimulate the development of urgently needed better tools for people in countries where MSF works and beyond. The priorities of the Access Campaign are guided by the medical challenges faced by MSF and its patients in its operational settings. The primary objectives of the Access Campaign include identifying, analysing and advocating for changes around the legal and regulatory systems and practices that hinder access to medical tools and innovation suitable for people in need especially in resource limited settings.
PLACE IN THE ORGANISATION

The TB/HIV/HCV Medical Advisor reports directly to the Medical Coordinator of the Access Campaign. The advisor is the point of contact within MSF AC for the MSF movement and external actors on issues related to TB/HIV and HCV within the objectives defined in the Terms of Reference (ToR).
OBJECTIVES OF THE POSITION

The MSF Access Campaign’s TB/HIV/HCV Medical Advisor works on access and advocacy issues pertaining to access for treatment and development of new tools (treatments and diagnostics) for drug sensitive and resistant TB, HIV and HCV disease.

The TB/HIV/HCV medical advisor is the focal point within the Access Campaign, working with a cross disciplinary team of specialists (pharmacists, diagnostics, policy, advocacy and communications that are based in a number of bases across Europe and the US). The medical advisor also plays a role in strategy development, reporting and representation.
MAIN RESPONSIBILITIES

The core responsibilities of the current position are defined by these priority dossiers: tuberculosis (TB), human immunodeficiency virus (HIV) and hepatitis C virus (HCV). The main activities in each dossier are summarized below:
TB (approx. 50%)

The TB dossier is an ongoing dossier. The medical advisor will work closely with the campaign team, key individuals within MSF headquarter and operations, and external experts to develop and implement the core priorities of the TB Dossier.

These include:

    Improving the diagnosis and management of TB in HIV co-infection and other key populations
    Increasing access and affordability to new medicines and ensuring early access to pipeline drugs and promising phase 2 drugs for regime trials.
    Increasing access to medicines  paediatric TB care, and
    Increasing access to effective medicines and diagnostics to improve drug-resistant TB management.
    Support and advocacy on the adoption of optimal tools, models of care and policies and there inclusion in the national guidelines of countries where MSF operates.
    Supporting the ongoing policy and advocacy priorities within the TB dossier in collaboration with the MSF technical working groups and operations.

HIV/HCV dossier (40-50%)

The HIV dossier within the Access Campaign is managed by a core interdisciplinary team of pharmacists, medical doctor, policy advocate, diagnostics expert and a communications officer. The Geneva based team works closely with the India, China and Brazil based Access Campaign teams.

Much has changed in recent years in the external environment, new actors, challenges and threats have impacted on the access to medicines arena within countries and at international level. There have been trends towards tighter legal restrictions on access to medicines produced in middle income countries. As such the HIV strategy focuses on the following areas:

    Access to and development of adapted formulations and new drugs in ARV pipeline
    Co-infections prioritizing TB and hepatitis and integration of care as well as the identification/treatment of mono infected Hepatitis patients where pertinent to MSF operations.
    PMTCT and paediatric access to formulations
    Diagnostics

The Access Campaign works closely with the MSF international HIV AIDS working group, the HCV contact group, operational and medical departments in this regard.
Priorities for the medical advisor include:

    Follow and implement the new Access Campaign HIV dossier objectives to ensure continuity and communication with internal (AIDS Working Group, Laboratory Working Group) and external contacts. (note these strategic priorities will be reset for the period 2017-20 in the coming months)
    Work closely with the policy team, pharmacist and the diagnostic advisor to define and implement objectives related to diagnosis and ARV pipeline and provide technical support. Vigilance on emerging resistance in both disease areas and the rational use of new agents.
    Identify external and internal opportunities within the context of the action plan objectives to move forward on the HIV/HCV agenda
    Represent MSF Access Campaign at specific external technical meetings or conferences where medical input is required.

REQUIREMENTS OF THE POSITION

The ideal candidate will possess the following skills and experience:

    Medical doctor
    Experience working in resource-limited settings, ideally with MSF
    TB/HIV program experience at international or national level
    Strong knowledge synthesis skills (including literature reviews)
    Understanding of access to medicines priorities for TB/HIV in the developing world
    Excellent communication and team working skills
    Willingness to speak at public events when required on behalf of MSF
    Available for overseas travel most likely to international conferences, internal meetings and/or field trips depending on requests.

Pharmacologic Considerations in the Treatment of Hepatitis C Virus in Persons With HIV

An error occurred in a 15 July 2016 supplement article [MacBrayne CE and Kiser JJ. Pharmacologic Considerations in the Treatment of Hepatitis C Virus in Persons With HIV. Clin Infect Dis 2016; 63(S1):12–23]. In the second paragraph under the Velpatasvir section, the second sentence should state that the agents should be taken 4 hours before food, and not simultaneously. The online version of the article has been corrected but the print version has the original wording.
The authors apologize for this error.

Four Doctors Referred to Investigation for Promoting Egyptian Military’s ‘Hepatitis Cure Device’

Egypt’s Doctor’s Syndicate has referred four doctors to a disciplinary committee for promoting a device touted by the Egyptian military as a “cure” for Hepatitis C and HIV/AIDS, the syndicate announced in a statement.
According to the statement, the four doctors – Ahmed Ali Moenes, Sally Mostafa Mahmoud, Ahmed Abdallah Sabry and Wael Ahmed Mohamed Attia – will be investigated for their involvement in announcing and promoting the device before the necessary scientific steps were taken to verify the device’s efficacy. The promotion of the device therefore led to the “intentional harming of millions of Egyptian citizens who waited for treatment by said device,” the syndicate’s statement reads.
Meanwhile, five other doctors have been cleared of involvement in the same case.
In 2014, the Egyptian military unveiled a “breakthrough” device that was said to be able to diagnose and treat Hepatitis C and HIV/AIDS, in addition to other diseases. The “Complete Cure Device,” or CCD, was said to draw blood from the inflicted patients, eliminate the disease and return the disease-free blood to the body.
Major-General Ibrahim Abdel Atti, who led the unveiling of the device, refused to explain the mechanism behind the device and said that the device simply “takes diseases and turns them into Kofta.”
At the time of the unveiling, many people, including the Egyptian president’s Scientific Advisor, criticized the presentation of the device without adequate scientific testing and review, and said it was a sham. Abdel Atti was also the subject of a long-running joke from many comedians and satirists, many of whom now refer to the discredited devices as “Kofta-Gate” – a reference to former US President Nixon’s Watergate scandal.
Egyptians currently have one of the highest number of cases of Hepatitis C in the world, with the World Health Organization saying in 2015 that approximately 22 percent of Egyptian blood donors tested positive for the deadly disease.
The epidemic began decades ago, when the government carried out a mass vaccination campaign for Egyptians against the Belharzia disease but medical professionals administering the vaccinations failed to adequately sterilize the syringes between uses, causing the Hepatitis virus to spread rapidly.
Lacking in infrastructure to deal with the virus, Egypt suffers from a particularly high morbidity and mortality rate, with 40,000 dying from the disease each year. It is estimated that roughly 15 million Egyptians currently suffer from Hepatitis C and there are 170,000 to 200,000 new cases each year.
In response to the epidemic, Egypt opened its first factory for the local production of “Sofosbuvir” – a drug that contains the active ingredient in “Sovaldi,” the US-approved medication commonly used to cure the virus.

Hep C's Growth: ConsultantLive & Rheumatology Network

Hepatitis C is on the rise in North America, according to a recent study. One expert explains why that may be in this video.

New research suggests that patients with lupus are more likely to develop dementia.

Children with severe asthma may face a greater risk of chronic obstructive pulmonary disease as adults, according to a study published in the New England Journal of Medicine.

Rheumatologists are starting to face a new challenge: how to treat an aging RA population that is more prone to a range of comorbidities.

One rheumatologist explains treatment strategies for subclinical thyroid disease.

Yale expert advances AIDS research at global conference in Durban, South Africa

At the AIDS 2016 international conference in Durban, South Africa, Frederick L. Altice, professor of medicine, epidemiology, and public health, presented research published in a special theme issue of The Lancet. Altice’s work focused on incarceration as a key contributor to rising rates of HIV, hepatitis C virus, and tuberculosis in Eastern Europe and Central Asia.

Incarceration rates in Eastern Europe and Central Asia (EECA) are among the highest in the world, in part due to criminal justice policies targeting people who use drugs. These policies markedly contribute to heightened levels of HIV, as well as Hepatitis C and tuberculosis, in the region, according to the research.

For the paper presented on Tuesday, July 19 — titled “The perfect storm” — Altice collaborated with an international team of investigators. The research team reviewed and analyzed published reports on the treatment and prevention of addiction, HIV, hepatitis C, and tuberculosis in the criminal justice systems of 15 EECA nations. They found that in the Ukraine alone, incarceration may contribute to up to half of all new HIV infections and 75% of all new tuberculosis infections among people who inject drugs (PWID). HIV infections in PWID could be reduced by over 50%, however, if prisons scaled up treatment with methadone or buprenorphine (which curb cravings for opioids) and maintained patients on treatment after release, the team reported.

"The HIV epidemic in EECA in people who inject drugs is volatile, and a large percentage PWID eventually becoming incarcerated,” said Altice. The lack of HIV prevention strategies — such as opioid agonist therapies with methadone or buprenorphine to treat addiction, and needle and syringe programs — undermines HIV prevention efforts, he noted. “For such interventions to be most effective, they would need to be scaled up within prison and continued post release."

To address the issue, the Lancet paper described strategies such as scaling up treatment for opioid addiction in prisons and communities; reducing incarceration of drug users; and improving screening, treatment, and care for prisoners with tuberculosis.

Altice is also senior author on three other papers presented in this series, which can be read in full here. A podcast interview featuring Altice is available on the upper-righthand side of this page.

A Path Forward for Lowering Prescription Drug Prices

It’s no secret that prescription drug prices are the fastest rising part of our health care system. That’s especially true in the cases of specialty and life-saving medications used to treat cancer, hepatitis C, and other rare diseases and ailments. But price increases are also prevalent among more common prescription medicines used by millions of Americans. The totality of these unsustainable, across-the-board price increases is impacting patients and those seeking access to such medications; it is also weighing down our health care system and the U.S. economy.

A recent Morning Consult opinion piece appears to miss this point, and moreover includes several citations that merit further clarification.

For example, the author cited a controversial figure that pegs the average cost of developing a new prescription drug at $2.6 billion. But that number is far from accepted within the medical community. When the figure was initially floated in 2014, the director of policy and analysis for Doctors Without Borders put it plainly, “If you believe that, you probably also believe the earth is flat.” 

Transparency about what is spent and how prices are set would improve the quality of the debate over drug pricing and actual value.

But the larger problem with arguments about the cost of developing drugs is a misunderstanding about the nature of “sunk costs.”  Simply put, sunk costs do not affect optimal price decisions.  Drug company cash flow today finances today’s R&D and marketing and profits.  Yesterday’s R&D was financed with yesterday’s cash flow.  Today’s prices are set to maximize profits given today’s competitive conditions, regardless of how much or little any specific drug cost to develop.  Let’s be clear: the reason to avoid draconian price controls is to keep innovation flowing.  But we do not need to allow drug companies to make as much as they are making to keep today’s R&D flowing, since so much of their current cash flow – more than they spend on R&D according to Global Data is spent on marketing.  Clearly they could cut marketing, which rarely improves clinical quality for any patient, without harming today’s investment in the drugs of the future.

The core complaint about today’s competitive conditions is that we’ve allowed an unbalanced situation to develop.

We have lately over-incentivized innovation with very long extra periods of monopoly called “exclusivity” during which developers can keep their clinical trial data secret and force competitors to perform expensive and redundant trials.  This is the main problem with new incredibly expensive biologics and the biosimilars we are unnecessarily delaying from providing market competition.  We have also allowed FDA backlogs for approving new generic drugs to lengthen due to lack of resources, and this has prevented lower cost generic drugs from getting to market.

Even established companies like Pfizer have piled on, increasing prices twice this year. The first increase came in January when prices for 133 of its medications rose by an average of 10.4 percent. It happened again just last month with another price hike averaging nearly 9 percent.  These hikes have nothing to do with past drug development costs.

This is not to debate the importance of developing life-saving drugs. The research and innovation of new treatments is critical to healing countless illnesses and diseases. Yet affordability and long-term health system sustainability must also be part of the equation.

Data from the Institute for Healthcare Informatics shows that over the last five years, prices for specialty drugs that require careful handling or administration have increased by a staggering $54 billion. These price increases accounted for 73 percent of increased U.S. spending on medications.

Such budget-busting prices from prescription drugs pose an impossible situation for many patients and for essential taxpayer-funded health care programs like Medicare and Medicaid. What’s clear is it’s unsustainable. Americans are also taking notice. In a recent Kaiser Family Foundation poll, almost three-quarters – 73 percent – of the public say that prescription drug costs are unreasonable.

Ideas like adding more transparency, competition and value to the prescription drug market are gaining broad support from important players in our health care system, including physicians, pharmacists, and nurses. These concepts would drive down prices and help reverse some of the damage these high prices have done to our entire health care system.

It’s time for action to put America’s prescription drug market on a more sustainable path forward.

Kentucky needs more needle exchanges to stem spread of infectious disease



A member of the board that oversees his county’s health department, Carter County Judge-Executive Mike Malone had worries when health department officials brought up the idea of giving clean needles to IV drug users.

Like many people, especially politicians, he worried that handing out needles might appear to be encouraging illicit drug use. But now he supports the program. “The more you learn about it, the more you’ll understand it’s the right thing to do,” Malone, a Republican, told reporter Bill Estep.

Carter County is one of 13 locations in Kentucky that have either approved or begun operating needle exchanges since they were legalized last year by the General Assembly in a wide-ranging effort to address heroin abuse in the state.

That’s a lot of progress in a short time but as Estep’s story Sunday explained, to avoid an epidemic of HIV and hepatitis C more Kentucky communities need to get on board, quickly.

The way exchanges work is that drug users bring in used needles and get clean ones in exchange. This gets dirty needles out of circulation where they are a danger to anyone who encounters them, including police searching subjects and children on playgrounds. At exchanges drug users can also be tested for and educated about infectious diseases. And, of course, it’s a way to reach out to those who want to get into treatment.

But the most fundamental motivation for the exchanges is to fight the spread of dreadful and costly blood-borne diseases, like HIV and hepatitis C, through needle sharing. Kentucky has the nation’s highest incidence of hepatitis C, a dreadful disease that can lead to liver failure and liver cancer. The drugs alone for treating one case of hepatitis C cost $86,000, Jennifer Hunter, the director of clinical services at Northern Kentucky District Health Department, told Estep. As much as 7 percent of Kentucky’s total annual Medicaid budget, $50 million, is spent on two drugs used to treat hepatitis C.

Needle exchanges have operated in other countries and in major cities of the United States for decades. Researchers have found over and over that not only do they not encourage drug abuse but that users who participate in the programs are much more likely to seek treatment. Still, the politics for allowing them in more rural areas only recently began to shift.

In this region the change happened quickly after Scott County, Ind., close by Louisville, gained national attention when the HIV infection rate there soared. Between November 2014 and October 2015, 181 new cases of HIV were diagnosed in the county of 24,000 which had reported only five new cases in the previous decade.

Researchers from the Centers for Disease Control drilled deep to find out what was going on. They found that some drug users there injected themselves as often as 15 times a day and shared needles with as many as six other people, a recipe for spreading disease. CDC also looked at the demographic profile and found a county that matched so many in Kentucky: rural and poor, with a high incidence of unemployment, prescription painkiller sales and overdose deaths. In fact, the analysis found 54 counties in Kentucky that were vulnerable to a disease outbreak among IV drug users, 18 of them more vulnerable than Scott County, Ind.

“I think a lot of health departments in Eastern Kentucky looked at it and said, ‘That easily could have been us,’” Kristy Bolen, an epidemiologist at the Ashland-Boyd County Health Department told Estep.

But Boyd and neighboring Carter counties are among only a handful of the at-risk Kentucky counties that have needle exchange programs.

That has to change or soon Scott County will be us.

UPDATED: J&J hikes forecast as standouts Imbruvica, Xarelto crank up pharma growth

Once again, Johnson & Johnson’s pharma engine powered top-line growth, with top performers Imbruvica, Xarelto and Daklinza all racking up impressive gains. Thanks to that “notable strength,” the healthcare giant hiked its sales and earnings forecasts for the year.

J&J’s pharmaceuticals sales vaulted ahead by almost 9% to $8.7 billion--even after currency effects--which helped jack up overall sales by 3.9%. Meanwhile, consumer sales slipped (down 1.8%) and devices squeaked out a tiny increase (0.8%).

In pharma, "the strong performance was generally across the board, with almost all of the key growth drivers delivering good quarters," Credit Suisse analyst Vamil Divan said in a Tuesday note, calling out the anti-inflammatory meds Simponi and Stelara among the meds beating his expectations.
Standout products? Though it fell short of some anlayst estimates, Imbruvica, the blood cancer drug, racked up global gains and now leads the market in second-line leukemia treatment, J&J said in a Tuesday investor presentation. The drug, shared with AbbVie, brought in $295 million for the quarter, more than half of that overseas.

Then there’s Xarelto, a reliable growth driver, with $594 million in sales, up more than 25%. J&J likes to brag about its market share among oral anticoagulants: Now 16.9% of the overall market, despite blockbuster rivals from Bristol-Myers Squibb and Pfizer, and Boehringer Ingelheim.

Some other big percentage increases--on the prostate cancer med Zytiga and anti-inflammatory Stelara, for instance--were fueled partly by adjustments to the funds J&J had set aside to cover gross-to-net charges. Apparently, the drugs haven’t been hit as hard as expected by discounts and rebates, which surface only after initial sales are booked.

Zytiga’s sales line amounted to $601 million worldwide, and Stelara’s stood at $804 million, a global hike of 41.1%.

J&J will need all the help it can get from these fast-growing products, what with biosimilar competition to its top seller, Remicade, coming down the pike. Pfizer and partner Celltrion say they’re raring to go with their biosim version, but as of last quarter’s earnings call, J&J CFO Dominic Caruso was insisting that Remicade won’t face copycats in the U.S. this year.
Leerink Partners analyst Danielle Antalffy also has a sanguine view, if for a different reason. Though investors have been worried about Remicade knockoffs, the blockbuster med "was not a meaningful contributor to outperformance relative to us and more importantly was not additive to pharma growth overall," Antalffy wrote in a Tuesday note.

Meanwhile, on the flip side of J&J’s pharma growth, the company’s hepatitis C drugs continued to drag down overall pharma growth. To be expected, now that Olysio faces formidable competition from Gilead Sciences’ Sovaldi and Harvoni, AbbVie’s Viekira Pak and Merck & Co.’s new entrant Zepatier, which carries a much lower list price than its predecessors. Gilead’s latest approval for an all-genotype hep C fighter, Epclusa, poses yet another threat.

On the consumer side, J&J saw increases in its over-the-counter meds, which accounted for $1 billion in sales. Pain relievers such as Tylenol pitched in the most--worldwide growth amounted to 13%--while allergy meds, including Zyrtec, faltered on seasonal weakness. J&J’s oral care line also grew strongly, mostly thanks to its Listerine brand, which has added some new products and launched marketing campaigns.

CEO Alex Gorsky touted J&J’s “good momentum” for the first half of the year, citing “notable strength in our pharmaceuticals business” thanks to “continued success of new products.” And Gorsky pointed out that more new meds are on the horizon: Pharma R&D “achieved significant clinical milestones” in the quarter, he said.

Haskayne and Cumming School bring scientist-entrepreneur behind hepatitis C cure to campus



The Haskayne School of Business and the Cumming School of Medicine recently teamed up to bring Michael J. Sofia, PhD, chief scientific officer at Arbutus Biopharma Inc., to campus. He gave two talks on how he led a team of scientists in discovering a cure for hepatitis C and how he became a successful scientist-entrepreneur.

Sofia was the first speaker to be jointly hosted by both faculties. He has introduced numerous drugs into clinical development for the treatment of infectious and inflammatory diseases. He has also authored more than 100 publications, 10 book chapters and numerous abstracts, and is an inventor on more than 51 United States patents and numerous patent applications.

Drug for hepatitis C patients is important backbone therapy

At the Cumming event, Sofia provided fascinating insights into how his love of science, training as a chemist, and dedication to research led to the breakthrough of Sofosbuvir, named in his honour.

Until Sofosbuvir was invented, patients had to endure months of injections with interferon therapy that often did not work and had severe side-effects. Sofosbuvir was the first drug to use pro-drug technology in the treatment of hepatitis C, which allows delivery of the active drug to where it is needed — in the infected liver cell. There have since been many new advances in hepatitis C therapy, but Sofosbuvir remains an important backbone therapy in the fight against the disease.

'A small company needs innovation to survive'

At the Haskayne event, Sofia provided a glimpse into the key factors that led to his success in the biotechnology industry and the challenges he faced along the way. He gave insight into how, no matter what your background, the fundamental rules of running a successful startup apply across industries.

“During your career, you are going to get told that your idea won’t work by key opinion leaders, colleagues and friends. Your belief in your idea makes a difference,” Sofia told the audience.

“A small company needs innovation to survive. We had to innovate in order to always be a step ahead of our much larger competitors. This was only an organization that never maxed higher than seven individuals, it is possible to beat multinational companies by being innovative, focused and creative with your objectives.”

Sofia strongly believes that what drives him is his passion to help others. He says, “success is not just dollars and cents, it is also measured in the patients’ success rates.”

Joint talks enabled greater learning for both medicine and business

“By working together with the Cumming School of Medicine, we were able to maximize Sofia’s visit to the University of Calgary and provide meaningful opportunities for students, staff and faculty to engage with a world-renowned leader,” says Elizabeth Allen, associate director of the Hunter Centre for Entrepreneurship and Innovation.

“[His] career has included the discovery and development of multiple therapies and treatments; our joint efforts enabled greater learning, value and impact for both Sofia and the guests in attendance at his events.”

Sofia’s talks were co-hosted by the Hunter Centre’s Wayne Henuset Speakers Series and the Cumming School of Medicine’s Cal Wenzel Family Foundation Chair in Hepatology, Division of Gastroenterology and Hepatology.

Sofosbuvir Shows Anti-Zika Activity In Vitro

he World Health Organization (WHO) in February declared Zika virus infection a public health emergency of international concern. In Brazil, one of the areas hardest hit by the ongoing outbreak, perhaps the most threatening aspect of Zika virus transmission has been its association with microcephaly and other abnormalities of the central nervous system in fetuses whose mothers were infected during pregnancy.

Because there is not yet an available vaccine, researchers have been looking for drugs presenting anti-Zika proprieties that are safe to give to pregnant women who live in high-risk areas. In a May preprint, a team led by researchers at Federal University of Rio de Janeiro showed that the antimalarial drug chloroquine reduced Zika virus infection of human cells in vitro. Now, in a study led by Caroline Sacramento and colleagues at the Rio-based Oswaldo Cruz Foundation, researchers have reported that the urudine nucleotide analogue sofosbuvir showed anti-Zika activity in three cell lines—a neuroblastoma cell line (SH-SY5Y), and two nonhuman kidney cell lines (BHK-21 and Vero). Sofosbuvir is approved for the treatment of hepatitis C and is not considered to be teratogenic. The team’s results were published in a July 6 bioRxiv preprint.

Aware that the aminoacids of the hepatitis C virus RNA polymerase that interact with sofosbuvir are highly conserved among members of the Flaviviridae family, the group built a 3-D model of Zika virus based on a hepatitis C ortholog molecule. According to 3-D modeling, sofosbuvir is found in an area of the molecule critical for nucleotide incorporation in the new strand, affecting the RNA-directed RNA polymerase (RDRP) domain.

The group next isolated a clinical Zika virus strain and inoculated BHK-21, Vero, and SH-SY5Y cell lines with different multiplicities of infection. All three cell lines were treated with different concentrations of sofosbuvir.

Sofosbuvir trisphosphate, the drug’s bioactive compound, inhibited Zika virus RDRP activity in certain infected cell fractions, the researchers reported.

For Ludek Eyer and Daniel Ruzek of the Veterinary Research Institute in the Czech Republic, who were not involved in the work, these in vitro results are encouraging.

Eyer and Ruzek told The Scientist they had previously tested sofosbuvir against Zika virus but found no effects. “We did also test sofosbuvir against Zika virus, but these tests were performed in Vero cells only and this is the reason for the fact that we did not see any antiviral effect,” they explained in an email.

Sacramento and colleagues observed the anti-Zika effects of sofosbuvir in BHK-21 and SH-SY5Y cells, but not in Vero cells. (Previous studies have shown that Vero cells express glycoprotein-P, a multidrug resistant ATP-binding cassette transporter that most likely pumps the drug out of the cell.)

Matthew Aliota at University of Wisconsin agreed that the results, though preliminary, are promising. But the arthropod-borne pathogen researcher, who was not involved with the study, noted in an email that, of course, “in vitro efficacy does not necessarily translate to in vivo efficacy.”

“I do believe this provides the basis to do additional testing with this compound,” Aliota added, “preferably in an animal model.”

An important question is whether sofosbuvir, a drug metabolized largely in the liver, can cross the placenta or the blood-brain barrier and have an effect in other organs. “So far, the pharmacological properties of the drug were tested mainly with respect to hepatitis and its targeting into liver, and . . . very little [is] known about the activity of the drug in other organs” noted Eyer and Ruzek.

Although Zika virus appears to preferentially target certain brain cells, studies have shown that the virus is often found in peripheral organs before it reaches the brain. To Aliota’s mind, that sofosbuvir metabolism takes place in the liver is not necessarily problematic.

“It is not clear how Zika virus makes its way to the brain but if the drug can impair the initial replication of the virus, preventing migration to the brain then it would be successful,” he wrote. “Because many of the mouse models available for ZIKV [Zika virus] have demonstrated ZIKV tropism for the brain, this could be easily tested.”

Federal University of Rio de Janeiro’s Amilcar Tanuri, a coauthor on the chloroquine study who was not involved in the present work, agreed that the next step is to test sofosbuvir in animal models of Zika infection.

If preclinical studies confirm the apparent anti-Zika effects of sofosbuvir, then “it might represent an ideal future therapy,” noted Eyer and Ruzek. “The fact that sofosbuvir is not teratogenic could reduce the time frame in preclinical testing and highly increases the chances for possible future application of this drug in therapy of Zika virus–infected women,” they wrote.

Cambridge startup Jounce gets $225m in Celgene deal to develop cancer drug

On the prowl for new drug candidates, drug maker Celgene Corp.’s favorite hunting ground is the Cambridge biotech cluster.
Celgene’s latest deal, unveiled Tuesday, will hand a $225 million upfront payment to Jounce Therapeutics Inc., a three-year-old Cambridge startup that is developing cancer drugs. The agreement, potentially worth as much as $2.3 billion, will help Jounce fund development of a new generation of drugs that stimulate the immune system to fight tumors.
It comes three months after Celgene, which embraces a “distributed” research and development strategy, fronted $200 million to another Cambridge cancer drug developer, Agios Pharmaceuticals Inc. Celgene, based in Summit, N.J., is also collaborating with Bluebird Bio Inc., Epizyme Inc., and Acceleron Pharma Inc., all in Cambridge, and has options to buy two other Massachusetts companies.
Celgene will take a $36 million equity stake in Jounce, and received options to share profits and losses from its lead experimental drug, JTX-2011, which seeks to treat head and neck cancer and non-small cell lung cancer. The deal also includes options on four other cancer immunotherapies in Jounce’s research pipeline.
“We had a number of business discussions, and in the end we felt that Celgene was the right strategic partner,” Jounce chief executive Richard Murray said in an interview. “This agreement really validates our approach, and substantial capital and resources will now be available to us.”
The Jounce-Celgene alliance is one of the largest unveiled in recent months between early-stage biotechs seeking cash and development expertise and larger drug makers looking for promising new treatments. Such deals allow the parties to share the escalating costs and risks of drug development.
With a market value of $79.6 billion, Celgene is the third-largest US biotech company, after Amgen Inc. and Gilead Sciences Inc. Its senior vice president of business development, George Golumbeski, is known as one of the most aggressive executives in working with partners, establishing alliances with more than a half dozen Massachusetts biotechs in the past five years.
Jounce, launched in 2013 by Boston venture capital firm Third Rock Ventures, has raised more than $100 million in private capital. Its name, derived partly from a physics term and partly from a synonym for jolt, is meant to signal the dramatic change the company and its financial backers expect from their cancer-fighting approach, which it calls immuno-oncology 2.0.
Most of the first generation of cancer immumotherapies — such as the melanoma drug Keytruda, which Murray worked on at Merck & Co. — are so-called PD-1 inhibitors that empower a specific T cell to kill tumors. While they can be effective for up to a third of patients, the majority fail to respond.
“There’s been a kind of a gold rush in the oncology business over the past six or seven years,” Murray said. “We’re locking in the correct way of using the immune system against tumors. But we’re also seeing that not all patients respond to this approach. Our immuno-oncology 2.0 approach looks at the entire immune system and provokes different immune cell types to target the 70 to 80 percent of patients that aren’t responding” to current drugs.
Murray said the Jounce lead drug, JTX-2011, which targets solid tumors, “steps on the gas” of T cells to generate more robust anti-tumor activity. He said Celgene, a leader in hematology treatments, could help Jounce also develop blood cancer drugs.
Celgene’s other recent partner, Agios, is also a cancer drug company but not a direct competitor to Jounce. Agios scientists take a different approach, seeking to treat tumors by fixing metabolic irregularities.
Under their collaboration deal, Jounce and Celgene will share profits and losses for all programs on which Celgene opts in. Jounce would retain a 60 percent US profit share of JTX-2011, with Celgene getting 40 percent. Celgene would be allocated 75 percent of the US profits, and Jounce 25 percent, on the first additional drug program, and the partners would share US profits equally on any of the next three programs. Outside of the United States, Celgene will have exclusive rights to market the drugs, but Jounce will receive royalties from foreign sales.
The eventual value of the deal for Jounce will depend on how many options Celgene exercises and the success of any drugs developed.
Jounce currently has about 60 employees at its office and lab complex near Harvard Square. Murray said it expects to hire about 20 additional employees by the end of the year.

Otsuka's Abilify leads Medicaid spending, report finds, with Gilead's hep C meds close behind

Amid a period of intense drug pricing scrutiny, data are out on the costliest drugs to Medicaid, with some of pharma's biggest names among the highest-ranking brands. It's a tale of the Medicaid population--more likely to be treated for hep C and HIV, plus mental health disorders--and the sometimes pricey drugs they're prescribed.
A new report by the Kaiser Commission on Medicaid and the Uninsured shows that, of the top 19 costliest medicines to Medicaid, all cost more per prescription than at least three-fourths of other meds. The program put up $27.4 billion in outpatient drug spending in 2014.
Sitting at the top was Otsuka's antipsychotic drug Abilify, priced higher per prescription than 90% of all drugs used by Medicaid patients, and among the most-prescribed meds in the program. The report covers January 2014 to June 2016, so timing may have played a factor in the results; Abilify lost patent protection in mid-2015 and Otsuka raised the prices as the med neared the patent cliff, "a strategy often seen before a brand drug’s patent expires," Kaiser Commission points out.
While Abilify's per-prescription cost and prescription frequency propelled it to the top of the list, its price wasn't nearly as high as some drugs covered by Medicaid. It failed to make Kaiser Commission's top 50 list of priciest drugs on a per-prescription basis.
Behind Abilify in total Medicaid spending were Gilead Sciences’ ($GILD) hepatitis C treatment Sovaldi--costing more than 99% of other meds while prescribed more frequently than 90%. Rounding out the top were Shire’s ($SHPG) ADHD med Vyvanse, Gilead’s hep C combo Harvoni and HIV fighter Truvada, and Sanofi’s ($SNY) basal insulin for diabetics, Lantus.
Many of the drugs on the most-costly list treat behavioral health conditions for which Medicaid is a major provider, Kaiser Commission pointed out. Medicaid provides access to more than 70 million people.
On a per-prescription basis, Novo Nordisk’s ($NVO) rare disease drug for hemophilia, NovoSeven RT, topped the list at a price of $58,843 before rebates; fellow hemophilia treatment Koate-DVI followed closely behind at $57,162. Many of the drugs at the top of the per-prescription cost list are those for serious health conditions such as hemophilia, multiple sclerosis or rare infant diseases. Baxalta ($BXLT) hemophilia med Feiba landed at third at a per-prescription cost of $48,366 before rebates and Sigma-Tau's rare disease med Adagen, costing $44,551, was fourth.
Mallinckrodt's ($MNK) H.P Acthar Gel--which has had a history of pricing controversy dating back to previous owner Questcor--ended up near the top of the list at No. 5, costing Medicaid $43,877 before rebates.
Sovaldi and Harvoni, with their infamous list prices of $84,000 and $94,500 respectively, ranked outside of the top 15 in per-prescription costs to Medicaid. Harvoni ended up at No. 16 and Sovaldi at No. 24, with their per-prescription costs to the program at $28,977 and $26,612 before rebates, according to the report.
The most frequently prescribed drug over the period was hydrocodone-acetaminophen, information that could play a role in an effort by federal authorities to rein in opioid prescriptions and tackle an epidemic of addiction.
Only a handful of generics made the top 50 costliest meds list. Ninety-four percent of the top 50 were brands, while brands accounted for just 45% of all Medicaid drugs.

Big Pharma Feels the Bern

Ever since Reagan, conservatives have been telling us about "welfare queens."
The way they put it, there are thousands of undeserving poor people in this country right now bilking taxpayers for all they're worth, all while you and I are sweating out a hard day's work.
And here's the thing: conservatives are right.
There are a lot of undeserving people getting rich off the commons and the working class.
But they don't fit the racist and classist stereotypes of popular conservative mythology -- far from it.
See more news and opinion from Thom Hartmann at Truthout here.
The entities that are really getting rich off the commons are the corporations and corporate executives who, with the help of sellout Republicans, have turned our economy and tax system into their very own get-rich-quick scheme.
Case in point: Big Pharma.
While big drug companies like to talk about how cutting-edge they are, they really don't do very much innovation at all.
They leave that to taxpayer-funded government scientists.
As a recent piece in the Los Angeles Times pointed out,  "75% of so-called new molecular entities with priority rating (the most innovative drugs) trace their existence to NIH funding [the National Institutes of Health], while companies spend more on 'me too' drugs (slight variations of existing ones.)"
And, while there is a strong argument to be made against private corporations getting a free ride off taxpayer-funded research, there's nothing inherently wrong with this situation.
This is what governments do and have been doing for much of the last century -- they fill in the holes in the marketplace and create incentive structures that wouldn't otherwise exist.
But what makes Big Pharma's dependence on public research so offensive is the fact it uses that public research to manufacture drugs that it then sells at absurdly high and often unaffordable prices.
And that's not even the worst part.
After these giant drug companies make all that money from selling drugs invented by taxpayer-funded research, they then stash that money overseas to avoid paying taxes on it.
In other words, instead of paying taxpayers back for helping them get rich, pharmaceutical companies rip them off.
According to Senator Bernie Sanders, one of the worst offenders is Gilead Sciences, which sells a drug called Sovaldi.
Developed in large part through taxpayer subsidies to a much smaller drug company that Gilead later bought out, Sovaldi treats Hepatitis C.
It's also one of the most expensive drugs around. One pill costs an eye-popping $1,000 and a full treatment costs around $84,000.
Although this is great news for Gilead's profits, it's very, very bad news for Hepatitis C patients -- the people who actually need Sovaldi to survive.
As Senators Sanders points out in a new editorial about this very issue, "Patients with hepatitis C are often low-income and a disproportionate number of them are veterans. Yet many Medicaid programs have had to limit access to the drug, and despite spending literally billions of dollars on the new hepatitis C drugs, the Department of Veterans Affairs initially struggled to provide the medication to every veteran who needed it."
The fact that people are struggling to get the medicine they need because some Big Pharma executive wants to buy a new yacht is bad enough, but as Sanders goes on to point out, what's really obnoxious about Gilead is that, like many other pharmaceutical companies, it's a serial tax dodger.
Sanders notes that new studies show that Gilead has skipped out on paying as much as $10 billion in taxes.
How is that possible!?
It's possible because the American tax system is one big Swiss cheese wedge of loopholes and carve-outs, especially if you're a big corporation.
The big picture here is outrageous.

State council rules for free treatment of Hepatitis C patients

The state council has on Monday decreed that the state shall treat those who suffer from chronic renal illnesses, like Hepatitis C, free of charge─even if they do not have health insurance.
The court maintained that the right to healthcare is constitutionally guaranteed to Egyptian citizens, and thus, they should be treated at the state’s expense.
The court also decreed that the state should allocate no less than 3% of its annual budget towards healthcare and maintaining public hospitals and medical facilities─a rate that should increase annually, until international healthcare standards are met.
This came as part of a ruling on a case brought before the court by a man who was reportedly refused treatment for Hepatitis C. He will be given a court-ordered compensation of EGP 20,000.
He had reportedly contracted the virus when being treated for Bilharzia, after using contaminated syringes at a public hospital.

What Is Hepatitis B and C? Nearly 300 In Canada 'At Risk' Of Infection From Edmonton Clinic

Nearly 300 patients in Edmonton, Canada have been put 'at risk of infection' of Hepatitis B and C as a result of the unsanitary practices of a single health clinic, according to an investigation by Alberta Health Services (AHS) and the College of Physicians & Surgeons of Alberta. The heightened risk of infection comes as a result of the Northtown Medical Clinic, located at 94 Street and 137 Avenue, which was inadequately sterilizing medical devices.

Though the risk of infection is considered low, at-risk patients identified through the investigation process will be advised to seek simple blood testing for Hepatitis B and C," AHS said, according to the Edmonton Journal.

Hepatitis is a disease that affects the liver and causes serious inflammation in the organ's tissue, often leading to jaundice, poor appetite, and fatigue. In some cases it can result in liver failure and even death. The two strains of the disease patients are at risk from here, Hepatitis B and Hepatitis C, can both be spread virally via infected needles. However, there are some important distinctions.

People can vaccinate themselves against Hepatitis B, which can also be spread through unprotected sex, while Hepatitis C has no vaccination. It is also much more common for Hepatitis C to progress to a chronic condition from an acute one, meaning that the infected patient could suffer from the disease long term — most who only suffer from acute Hepatitis recover with no long term liver damage. There is no medical treatment for Hepatitis, but patients should avoid alcohol, which can worsen their conditions, and get evaluated for liver disease regularly.

AHS says that the possibly infected patients have been sent notification letters warning them that they might be at risk. Patients identified in the investigation have been advised to receive blood testing for Hepatitis B and C.

VA reports see Hepatitis C spike in baby boomers

JACKSON, MS (Mississippi News Now) -
Jackson's VA Center is seeing an increase in Hepatitis C cases among Baby Boomers.
Infectious Disease specialists began offering HIV and Hepatitis C screenings in December of 2014, and so far 280 patients have tested positive for Hepatitis C. The HIV/HEP C tests are offered in conjunction with patients receiving treatment for substance use disorders.
Doctors attribute the spike is linked to opioid use.
When opioids are not available, some users turn to injecting heroin. Physicians said not all cases come from needle injections.  
"We discovered about one in five had Hepatitis C and 25% of the cases that we discovered were brand new cases," said Jackson VA Infectious Disease Specialist Dr. Mary Jane Burton. "Meaning the day they walked into substance use disorder treatment they did not know they were infected."
VA physicians said the spike in Hepatitis C is among those born from 1945 to 1965 and screenings are recommended for all patients in that age range.

Despite promising treatments, hepatitis C continues to rise

About twice the number of Wisconsinites are living with hepatitis C than have been diagnosed.

About 38,000 Wisconsinites have confirmed cases of the virus, according to the state Department of Health Services' most recent figures from December 2013, though an estimated 74,000 Wisconsin residents are projected to be infected.

And that number is going up, fueled by drug users who contract the virus by sharing infected needles, according to preliminary figures to be released by the Department of Health Services later this month.

Despite the June 28 U.S. Food and Drug Administration approval of Epclusa, a drug certified to treat all strains of the hepatitis C virus, and research out of Spain that calls a combined HIV and hepatitis C vaccine "a possibility," some experts in the field aren't confident the medical changes will lower the number of cases statewide.

Though hepatitis C is highly treatable in its early stages, most people don't know they're infected because the disease is highly asymptomatic, said Rob Striker, a researcher and associate professor of infectious diseases in the University of Wisconsin-Madison School of Medicine and Public Health.

"This is a real problem, not only in the country, but in the state of Wisconsin," he said.
Deadly toll

In May, the Centers for Disease Control and Prevention announced hepatitis C causes more deaths in the U.S. than any other infectious disease. The total number killed from complications with hepatitis C nationwide in 2013 was greater than the number of deaths from 60 other infectious diseases combined.

Baby boomers — born between 1946 and 1964 — who became infected often contracted the disease through tainted blood transfusions before tighter regulations kicked in during the '90s. Now, younger generations make up a new wave of people who contract the disease by sharing infected needles during intravenous drug use.

The number of hepatitis C reports and the rate of heroin overdoses both increased between 2009 and 2014, according to state health department data. While hepatitis C reports in people under 30 — who are most likely to contract it through injection drug use — made up 5% of all state reports in 2003, that number rose to 27% in 2013.

"There's been a lot of misuse and lax prescribing of opiates for pain management," Striker said. "This has led to a resurgence in needle use and hepatitis C transmission."
ADVERTISEMENT


Acute symptoms of hepatitis C can include fatigue, abdominal pain, poor appetite or jaundice, according to the CDC. But most people are asymptomatic for decades, until their infection progresses to chronic liver disease, such as cirrhosis and liver cancer.

Because it's largely silent, Ajay Sahajpal started a screening program in 2014 through Aurora Health Care to pinpoint patients whose medical records showed signs the person could have hepatitis C. So far, 73,000 people have been screened, out of which doctors have found about 600 cases of hepatitis C.

And the more patients tested for hepatitis C while they're still asymptomatic, the quicker they can be cured of the infection.
Costly treatment

Before new drugs infiltrated the market in 2013, the cost of a one-year treatment plan for hepatitis C was about $100,000, Sahajpal said.

Now, the cost is about $75,000 for treatment that lasts 12 weeks. Though it's not always covered by insurance, he said, the cost of a liver transplant down the road is greater than that of the drug.

Still, cost acts as a major barrier to treatment, Striker said.

"If insurance and Medicaid allows widespread treatment, for sure we could drive the prevalence of hepatitis C down — and possibly, within a decade or so, largely eradicate hepatitis C," he said, adding that patients need to be willing to get tested and treated, too.

Though a vaccine to prevent the transmission of hepatitis C is in its early stages and isn't expected to make a clinical appearance anytime soon, experts say the newest FDA-approved drug, Epclusa, is highly effective in treating all strains of hepatitis C.

To Sahajpal, Epclusa's approval is just another addition to the drugs introduced after 2013 that were already working well to treat infected patients.

Providing treatment services for heroin and opioid addictions, prescribing fewer opioid medications and upping the number of needle exchange and hepatitis C testing programs in the state are all part of reducing the prevalence of the disease, said Sheila Guilfoyle, the viral hepatitis prevention coordinator in the state health department's Division of Public Health.

Striker doesn't think adding Epclusa to the market will change the outlook for hepatitis C in Wisconsin as much as increased testing and insurance coverage would.

"Right now, I'm not sure that there's enough will among the health care organizations to really test everybody that needs to be tested and then pay for treatment," Striker said.

Calls for needle exchange program in jails

THE spread of blood-borne diseases such as hepatitis B and C among Australia's prison population has prompted a call for jails to establish needle exchange programs.
There are currently no syringe programs active in any Australian prison despite infections becoming more frequent.
Up to two-thirds of female inmates and one-third of males in prison are infected with hepatitis C, according to the Department of Health's Fourth National Hepatitis C Strategy 2014-2017.
Meanwhile 43% of Aboriginal and Torres Strait Islander people in Australian jails have contracted the potentially fatal virus.
A 2013 Corrective Services NSW study found 37% of the state's prison population said they had used drugs while behind bars.
And despite calls from the World Health Organization and the United Nations Office on Drugs and Crime, Australia still does not have any needle exchange programs operating in prisons.
UNSW National Drug and Alcohol Research Centre Professor Kate Dolan wrote an online opinion piece calling for the state governments to revisit the issue.
"In the West, more than one third of inmates have a history of drug injection. In NSW, it's about half of inmates," she said.
"This is in stark contrast with levels of drug injecting in the general population, which are less than 0.5% in Europe and Australia.
"While those in the community may not feel at risk, most inmates are released back to their communities.
"Many prisoners serve short sentences of about six months or less. And sentences served by women tend to be shorter, three months or so."
Professor Dolan said the NDARC reviewed prevention programs for prisoners including education, voluntary testing and counselling, needle and syringe programs, methadone, condom provision and antiretroviral therapy for HIV.
"Only seven countries - Moldova, Kyrgyzstan, Germany, Luxembourg, Portugal, Spain and Switzerland - provide all six interventions in their prisons," she said.
"However, the actual level of coverage in these countries remains unknown."
She said ice had overtaken heroin as the main drug injected in Australian jails, and years of research had proven syringe programs to be safe and effective at reducing infection.
"While we are still grappling with how we can best treat these people, users should be provided with cognitive behavioural therapy to manage their addiction and the underlying problems that led them to use," Professor Dolan said.
"While Australia has led the way in the control of HIV in prison, it still has to control hepatitis B and hepatitis C.
"For every 100 people in prison who has ever injected drugs, 14 will become infected with hepatitis C each year.
"Treatment is available and has been provided in NSW for several years now, but most other states have not yet introduced this costly but effective treatment.
"If other states follow suit, we could virtually eliminate hepatitis C infection from the prison population."

Medicaid's 50 costliest drugs: 6 things to know

With more than 70 million beneficiaries nationwide, many of whom have complicated health needs, Medicaid is one of the largest providers of prescription drugs in the United States.

Overall, individuals who enroll in Medicaid programs have poorer health than enrollees who purchase private coverage, and they are more likely to require prescription drugs to manage their medical conditions. A recent study from Kaiser Family Foundation identified the 50 most costly drugs before rebates paid for by Medicaid between January 2014 and June 2015.

To determine the 50 costliest drugs in terms of aggregate spending, researchers examined drug utilization data by state (available through CMS) and Wolters Kluwer Clinical Drug Information data.

Below are six findings on Medicaid's costliest drugs.

1. Forty-five of the top 50 drugs were considered high-cost, in part, because they were the most frequently prescribed.

2. More than half (28) were frequently prescribed but not expensive at the prescription level. Among those were hydrocodone-acetaminophen, which was the most frequently prescribed drug in Medicaid during the period studied, and treatments for ADHD.

3. The top five most commonly prescribed drugs in Medicaid were used for pain relief, management of chronic illness and antibiotics.

4. Only five of the top 50 drugs were high-cost drugs with low prescription rates. These included drugs to treat hepatitis C and HIV.

5. Antivirals accounted for 20 percent of the top 50 drugs used by Medicaid.

6. Overall, the most costly drugs used by Medicaid included those to treat behavioral health conditions (Abilify and Vyvanse), hepatitis C (Sovaldi and Harvoni) and HIV (Truvada).

Calls for needle exchange programs in jail



THE spread of blood-borne diseases such as hepatitis B and C among Australia's prison population has prompted a call for jails to establish needle exchange programs.

There are currently no syringe programs active in any Australian prison despite infections becoming more frequent.

Up to two-thirds of female inmates and one-third of males in prison are infected with hepatitis C, according to the Department of Health's Fourth National Hepatitis C Strategy 2014-2017.

Meanwhile 43% of Aboriginal and Torres Strait Islander people in Australian jails have contracted the potentially fatal virus.

A 2013 Corrective Services NSW study found 37% of the state's prison population said they had used drugs while behind bars.

And despite calls from the World Health Organization and the United Nations Office on Drugs and Crime, Australia still does not have any needle exchange programs operating in prisons.
ADVERTISING
inRead invented by Teads

UNSW National Drug and Alcohol Research Centre Professor Kate Dolan wrote an online opinion piece calling for the state governments to revisit the issue.

"In the West, more than one third of inmates have a history of drug injection. In NSW, it's about half of inmates," she said.

"This is in stark contrast with levels of drug injecting in the general population, which are less than 0.5% in Europe and Australia.

"While those in the community may not feel at risk, most inmates are released back to their communities.

"Many prisoners serve short sentences of about six months or less. And sentences served by women tend to be shorter, three months or so."

Professor Dolan said the NDARC reviewed prevention programs for prisoners including education, voluntary testing and counselling, needle and syringe programs, methadone, condom provision and antiretroviral therapy for HIV.

"Only seven countries - Moldova, Kyrgyzstan, Germany, Luxembourg, Portugal, Spain and Switzerland - provide all six interventions in their prisons," she said.

"However, the actual level of coverage in these countries remains unknown."

She said ice had overtaken heroin as the main drug injected in Australian jails, and years of research had proven syringe programs to be safe and effective at reducing infection.

"While we are still grappling with how we can best treat these people, users should be provided with cognitive behavioural therapy to manage their addiction and the underlying problems that led them to use," Professor Dolan said.

"While Australia has led the way in the control of HIV in prison, it still has to control hepatitis B and hepatitis C.

"For every 100 people in prison who has ever injected drugs, 14 will become infected with hepatitis C each year.

"Treatment is available and has been provided in NSW for several years now, but most other states have not yet introduced this costly but effective treatment.

"If other states follow suit, we could virtually eliminate hepatitis C infection from the prison population."

See you in September, funding fights

THE MONEY CHASE — When Congress comes back in September, its main challenge will be to keep the government’s lights on, but more wrangling over money for 21st Century Cures, Zika and opioids is a certainty. Here’s where things stood as lawmakers left for seven weeks.

Cures — Senate HELP Committee Chairman Lamar Alexander is now looking at September as the target for advancing the biomedical innovation bill. That’s music to the ears of Cures cheerleader-in-chief Fred Upton, chairman of the House Energy in Commerce Committee, who has worked up a new list of pay-fors that he says is “pretty close” to providing the NIH funding needed to seal a deal with Democrats.

But Upton said he won’t unveil the list until after recess. A Senate Democratic aide said it hadn’t been shared with Democrats and the two sides haven’t even agreed on a firm number for the NIH. In other words, there’s enthusiasm aplenty but no concrete progress to report.

… Ahead of the break, the National Organization for Rare Disorders said it was “disappointed” at the latest delay but will keep pushing for Cures over recess. And some critics of Cures re-upped their concerns in Health Affairs last week.

Zika — The blame game over Congress’s failure to fund a response to the virus will vault to a whole new level if Zika starts to transmit locally in the U.S. this summer, Pro’s Jen Haberkorn reports. On Thursday, Democrats for a second time voted down Republicans’ $1.1 billion proposal, citing partisan GOP riders and controversial offsets, including Ebola funds. Republican appropriators asked the White House to “aggressively use funds that are already available to mount a strong defense” against Zika.

CARA — The Senate last week overwhelmingly passed the first major overhaul of substance abuse prevention and treatment policy in decades. But it didn’t include any money. Senate Democrats on Thursday introduced their latest proposal to spend $920 million to battle the opioid epidemic and the White House pledged to press Republicans for money (though it has said President Barack Obama will sign CARA.). Physician groups and addiction advocates praised the bill’s passage – and immediately began calling for funding to back it up. Brett’s story on how deferring to appropriators for money – potentially until next March, under one temporary spending bill scenario – will delay the impact the bill will have on the ground as the epidemic claims lives: http://politico.pro/29TciWv

…Said an aide to HELP ranking member Patty Murray: “Unfortunately, the case for additional funding is only going to get stronger.”

… Nonetheless, CARA was a HUGE legislative victory for GOP Sen. Rob Portman and fellow co-sponsor Kelly Ayotte, both of whom are running on their opioid work in their tough reelection bids. Many down-ballot Republicans incumbents are embracing a broader and more positive health care agenda – on opioids and medical research, for instance – than the single-issue anti-Obamacare platform that dominated the last few cycles, Brett reports with our Pro colleague Nancy Cook. But Obamacare’s hardly going away. That story: http://politico.pro/29Wd19q

Good Monday to you and welcome to Prescription PULSE — and summer recess! The physician and novelist A.J. Cronin was born in Scotland this week in 1896. His international best seller "The Citadel," published in 1937, describes the struggles of an idealistic doctor working in 1920s and 1930s in a corrupt and ineffective health care system, and is thought to have directly influenced the founding of the National Health Service in 1948. http://bit.ly/29OgRCy

Brett is taking off a few weeks of delayed paternity leave (Baby #2 you’ll recall was born in April). Sarah is here so send her news and tips to get us through August. SKarlin-Smith@politico.com and @sarahkarlin.

PDUFA VI AGREEMENT DROPS — FDA outlined Friday the agreement it reached with the drug industry covering the agency’s performance goals and industry user fees from fiscal years 2018 to 2022. It’s the culmination of months of closed door negotiations and represents an important step toward the reauthorization of user fee legislation that Congress must pass by October 2017. FDA is requesting more than $110 million in new user fees, much of which will go to support 230 new staff. Overall, FDA will collect billions over the five-year fee cycle. In return it commits to reviewing drugs under particular time frames. The deal also offers a roadmap of how the agency will modify drug review and approval, and prioritize resources and staffing. Patient-reported data, real-world evidence and combination drug and device products are all set to get more attention and resources. The popular “breakthrough” therapy program will receive additional funding and FDA plans to expand the Sentinel System, which pulls from large amounts of EHRs, insurance claims and registries to monitor the safety of approved drugs. A 30-day clock now starts ticking on public input. The agreement: http://bit.ly/29ARF3j. The FR notice: http://bit.ly/29XmOzh. More details from Sarah.

…If you’re keeping score — we are still waiting on user fee agreements on biosimilars, generic drugs and medical devices that will be incorporated into the same legislation.

MEDICAID’S COSTLIEST DRUGS — The antipsychotic Abilify tops the list of a new Kaiser Family Foundation analysis that looked at the 50 most costly outpatient drugs to Medicaid from January 2014 through June 2015. The list takes into account how frequently the drugs are prescribed as well as how expensive they are at the prescription level. Abilify beat out Gilead’s hepatitis C drug Sovaldi, which took the number two slot. Gilead’s other pricey hepatitis C drug Harvoni is number four on the list. Antiviral drugs for the treatment of HIV/AIDS accounted for 20 percent of the 50 most costly drugs, asthmatics and bronchodilators 16 percent.

… The often pricey biologics accounted for 12 percent, or six of the 50 mostly costly drugs, including Humira Pen and Enbrel Sure Click, both used for some types of arthritis and psoriasis. Nearly one-quarter (11) of the most costly drugs had an orphan designation meaning they are approved for use in a rare disease.

Not all drugs made the KFF list because they were pricey – 28 of the drugs were deemed not expensive at the prescription level, but were listed because of the high volumes prescribed. And 17 were both frequently prescribed --and expensive. One drug that made the list due to high utilization-only was hydrocodone-acetaminophen -- an opioid, and Medicaid’s most prescribed drug during this time period.

The analysis also has a list of the most expensive drugs by spending per prescription, too. It offers hints into the discounts Medicaid programs are receiving off the list prices of drugs before additional rebates they might receive. For example, average Medicaid spending before rebates for Harvoni is less than $29,000, about one-third the list price for 12-week treatment with the drug. This indicates hepatis C treatments may be becoming more affordable for Medicaid programs.

REPORTS: DRUG SPENDING GROWTH MODERATES — CMS projects prescription drug spending will grow by 6.7 percent per year through 2025, according to the National Health Expenditures report released last week. That’s down from a record spike of 12.2 percent in 2014 and 8.1 percent in 2015, but still higher than overall health care spending, which is projected to grow at 5.8 percent through 2025 on average. The NHE report: http://go.cms.gov/1J3iyc9

… Altarum meanwhile reported that year-over-year prescription drug spending growth fell to 5.2 percent in May. More: http://bit.ly/1Ujrn4G

TEVA JOINS PhRMA — ICYMI, the world's largest generic drug company is officially one of the newest members of the brand-drug lobbying powerhouse PhRMA. The lobby’s board approved Teva’s membership last week, despite opposition from some members to admitting a company that often takes opposing policy positions to those drug companies that primarily make branded medications. But Teva’s joining PhRMA at a time when the lines between generic and brand drug companies are increasingly blurring, with many companies known for their innovative products, pursuing biosimilars. PhRMA also approved membership for Alexion Pharmaceuticals and Jazz Pharmaceuticals, and it elevated Horizon Pharma and AMAG Pharmaceuticals from research associates to full members. PhRMA CEO Stephen Ubl said that the new members will help as the lobby strives to “address costs holistically.” More from Sarah.

CMS WEIGHS IN ON VALUE-BASED DRUG PURCHASING AGREEMENTS … KIND OF — In guidance released late last week CMS said that value-based purchasing arrangements developed between drug companies and payers could affect the calculation of a drug’s “best price” for Medicaid. Drug companies are required to offer Medicaid the lowest price on a drug offered on the private market. Companies, have been worried value or outcomes-based purchasing agreements could lower their best price and serve as a disincentive to create these arrangements with private payers.

CMS didn’t offer specifics on what kind of agreements would affect the calculations but said companies can submit questions on a particular arrangement to its CMCS Division of Pharmacy. Based on these inquiries it plans to generalize lessons learned and produce additional guidance. CMS is also encouraging state Medicaid programs to use value-based purchasing.. http://bit.ly/29ZuX2F

E&C APPROVES NEW PRIORITY REVIEW VOUCHER PROGRAM — The House Energy and Commerce Committee approved a bill last week that would reward companies that get a “medical countermeasure” approved with a priority review voucher for a six-month review of a future drug application. Medical countermeasures are drugs that would treat or prevent harm from biological, chemical, radiological or nuclear threats. That could include treatments for Zika or pandemic flu, for instance. Drug companies can sell their vouchers. To refresh your memory, vouchers rewarded as part of other priority review programs, such as for rare pediatric disease, have sold for hundreds of millions of dollars -- the chance to get a drug to market just a few months faster is extremely valuable for companies. The bill also sets up a user fee program for companies that use a priority review voucher. http://bit.ly/29HUdrS

…BIO applauded the bill’s advancement through committee. Similar legislation has been passed out of Senate HELP. The FDA, however, hasn’t been a huge fan of priority review voucher programs, saying they often force the agency to prioritize drugs that don’t necessarily deserve a faster review. BIO’s statement: http://bit.ly/29ADVpw

ICER LOOKS FOR INPUT; PLANS NEW REPORT — The Institute of Clinical and Economic Review, which has been giving drug makers heart burn with its frequently unflattering estimates of their products economic value, is accepting public input before a planned update next year on how it can improve value assessments. How to submit your two cents here.

… ICER also announced that it will report on the comparative effectiveness and value of new drug treatments for rheumatoid arthritis, and possibly psoriatic arthritis. More here.

Quick hits

— PhRMA and doctor groups appear to be working together to push back on CMS’s Medicare Part B demo, USA Today reports. http://usat.ly/29WqttY

— Scott Gottlieb and Kavita Patel propose an approach to drug prices including indication and outcomes-based pricing and reducing regulatory burdens. http://bit.ly/29WquhS

— Avik Roy at Forbes criticizes the GOP for not taking on high drug prices. The conservative writer briefly outlines several policy options for market-based reforms, including equal tax treatment of health insurance, expanded accelerated approvals and more. http://bit.ly/2a4C78X

— Former Republican Majority Leader Bill Frist and Democratic Rep. Bart Gordon argue for the use of “real-world data” to accelerate drug and device approvals at US News & World Report. http://bit.ly/29Jp7lv

— Gilead, in the spotlight for its high cost breakthrough hepatitis C treatments, avoided paying $10 billion in U.S. taxes by moving some of its assets to Ireland, according to a new report by Americans for Tax Fairness, detailed in the Washington Post. http://wapo.st/29J9FKn

… Rep. Lloyd Doggett blasted the company in a statement: “Gilead excels at tax dodging and price gouging. While a chief exporter of drug patents and profits to Ireland, it refuses to charge Americans the much lower drug prices of Ireland.”

— Insurers could reduce drug prices, but policymakers are making it harder to them to do so, according to an op-ed in Health Affairs. http://bit.ly/29UFSMY

— A new survey finds two-thirds of chronic pain sufferers say getting opioid prescriptions has become more difficult in the past year, the Boston Globe reports.

— Race is the most significant factor influencing NIH grant awards, and new policies are need to address the gap, a new study out of the University of Kansas finds. http://bit.ly/2ag9Qsi

CHOOSING WISELY CAMPAIGN SAYS: USE CHEAPER EFFECTIVE DRUGS — The American College of Preventive Medicine issued several new recommendations last week, including that doctors should use the cheaper alternative among equally effective medications. They also advised against taking a multivitamin, vitamin E or beta carotene to prevent heart disease or cancer. The new recommendations.

AHRQ FUNDS OPIOID ABUSE TREATMENT IN RURAL PRACTICES — AHRQ is making about $9 million in grants over three years to help rural primary care practices provide medication-assisted treatment to more than 20,000 patients. Details here.

CIGAR TRADE GROUPS SUE FDA OVER DEEMING REG — A lawsuit filed Friday by cigar interests is the latest legal challenge to FDA’s deeming rule released in May which asserts the agency’s authority to regulate e-cigarettes, hookahs, cigars, pipe tobacco and other products under the Tobacco Control Act. The premium cigar industry had lobbied hard but did not get an exemption from pre-market review to which new tobacco products will be subjected. The lawsuit was brought by Cigar Rights of America, the International Premium Cigars & Pipe Retailers Association and the Cigar Association of America, and alleges that FDA incorrectly subjects new products to stricter regulation that those that were already on the market and effectively imposes a tax on cigars by charging user fees for FDA review, among other complaints. Some companies in the vaping industry have already sued.

PHARMA TRANSITIONS

— Francis de Souza is taking the helm as the new CEO at Illumina after serving as president. http://bit.ly/29IXgG7

— From POLITICO Influence: James Stansel, former acting HHS general council, will become PhRMA’s general counsel after serving as co-head of Sidley Austin’s global life sciences team.

… Michael Spira, former chief of staff for Rep. Carolyn McCarthy (D-N.Y.), joins the American Pharmacists Association as vice president.

… Joseph Devaney was named VP of government affairs and policy, Americas, for Astellas.

— From Playbook: Caitlin Carroll joins the communications team at PhRMA from the Republican Study Committee.

— Cybele Bjorklund joins Sanofi as head of policy where she’ll focus on pricing, affordability, access, science policy and other issues. She spent 14 years a staffer on the House Ways & Means Committee and nearly four years as a health policy adviser for Sen. Ted Kennedy.

CATCHING OUR ATTENTION: PUSHBACK ON DRUG PRICES HASN’T KEPT PHARMA COMPANIES DOWN — Most of the largest drug companies said that increasing prices boosted sales of some or most of their top products in the first quarter of this year, the Wall Street Journal reports based on a review of corporate filings and conference call transcripts. Despite slow economic growth, pharma is proving more able than most other industries to boost prices and the increases have grown in “magnitude and frequency” in recent years. From May 2015 to May 2016, pharmaceutical prices received by manufacturers grew 9.8 percent – the second biggest increase tracked by the Bureau of Labor Statistics’ Producer Price index in the largest products and services category, behind investment services. While drug makers often divert attention away from list prices, citing negotiated discounts, their financial disclosures show how prices continue to rise. “The industry sort of hiding behind that is really a diversionary tactic,” said Geoffrey Porges, a Leerink Partners LLC biotech analyst.