From the desk of Mitchell Stein
Good morning. Before we get started, I’d like to talk about civic engagement. In as non-partisan a way as possible, I encourage you to engage in the following three ways: First, get your flu shot. If you’re reading this newsletter, I have to believe that you know they work and are safe, so just do it. You are not only helping yourself, but you are helping those who for valid reasons can’t get immunized. Second, vote! I’m not telling you who to vote for; I’m just reminding you that if you don’t vote, you don’t get to complain for the next two years. Third, enroll in health insurance and/or remind those you know to do so. Open enrollment on the ACA marketplace started this week and only lasts for six weeks. Many of you get your insurance from your employer, so the marketplace open-enrollment doesn’t apply. However, you probably know someone who doesn’t; a child, niece/nephew, friend, or the guy you get your coffee from – make sure they know now is the time to enroll. For those of you who, like me, are independent contractors and do buy your insurance on your own, now is the time. Due to changes in outreach, there won’t be as many reminders this year from the government, so it’s up to all of us. OK, that’s it, thanks for coming to my Ted Talk, now let’s get to the pharmacy news where this week we’ll look at:
ICER in the News – draft scoping document on siponimod, draft scoping document on esketamine, upcoming assessment on treatments for peanut allergy, HTA works with ICER, and patient-centric metrics
Inside the Beltway – More on the President’s proposed Part B changes, manufacturers nervous about a Democratic House, Senate pharma allies may increase, 340B ceiling price to be effective 1/1, Pfizer returns to business as usual, and industry campaigns against drug importation
Industry Trends – Hep C subscription payment model, insulin pricing, prescription tourism, Humira price drop in Europe, genetic tests for drug efficacy, flu vaccine step forward, clinical trial data, Novartis cleans house, and Merck pulls back from rotavirus agreement in West Africa
Now, on to the news.
ICER in the News
ICER has posted a Draft Scoping Document outlining a planned review of the comparative clinical effectiveness and value of siponimod (Novartis), which is currently undergoing FDA review as a potential treatment for secondary progressive multiple sclerosis (SPMS), with an approval decision expected in March 2019. ICER’s report on siponimod will be the subject of a May 2019 meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC). All interested stakeholders are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered.
Institute for Clinical and Economic Review Posts Draft Scoping Document for the Assessment of Siponimod for the Treatment of Secondary Progressive Multiple Sclerosis
ICER has posted a Draft Scoping Document outlining a planned review of the comparative clinical effectiveness and value of esketamine (Janssen), which is currently undergoing FDA review for treatment-resistant depression with an approval decision expected in May 2019. ICER’s report on esketamine will be the subject of a May 2019 meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC). All interested stakeholders are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered.
Institute for Clinical and Economic Review Posts Draft Scoping Document for the Assessment of Esketamine for Treatment-Resistant Depression
ICER announced that it plans to assess the comparative clinical effectiveness and value of potential new treatments for peanut allergy. The report will be reviewed during a public meeting of the California Technology Assessment Forum (CTAF) in June of 2019. ICER’s assessment will focus on Viaskin Peanut (DBV Technologies) and AR101 (Aimmune Therapeutics). Viaskin Peanut is currently undergoing FDA review with an approval decision expected in the middle of 2019. For AR101, Aimmune has announced its intention to submit a biologics license application with the FDA by the end of 2018.
Institute for Clinical and Economic Review to Publish Upcoming Assessment on Treatments for Peanut Allergy
Health Transformation Alliance, a group of major employers, announced a new agreement with Rx Savings Solutions and highlighted the consortium’s ongoing interest in applying ICER’s work to help their employees save on pharmacy costs.
Clinical Leader published a discussion of patient-centric outcome metrics in clinical trial design. The discussion included ICER’s work on the topic and possible future role in reviewing trial design early in the process.
Commercial viability of pharmaceuticals depends on getting medicines to patients, which requires developers to evaluate investigative therapies using …
ICER is growing! Interested in joining the ICER team? Check out our open positions in research, health economics, program management, and more on ICER’s Careers Page. This week’s job spotlight: The Research Lead, Evidence Synthesis will participate in multiple scientific activities, including developing strategy for and performing literature searches, critically evaluating the research methods and statistical findings of health outcome studies from the medical literature, and conducting qualitative and quantitative synthesis of evidence from literature and other sources.
ICER is growing! Interested in joining the ICER team? Check out our open positions in research, health economics, program management, and more on ICER’s Careers Page.
This week’s job spotlight:
The Research Lead, Evidence Synthesis will participate in multiple scientific activities, including developing strategy for and performing literature searches, critically evaluating the research methods and statistical findings of health outcome studies from the medical literature, and conducting qualitative and quantitative synthesis of evidence from literature and other sources.
Inside the Beltway/State Regulatory Developments
Last week’s Part B price proposal from the President continues to generate discussion. Here are a few highlights:
Republicans and the pharmaceutical industry grow apart (Sam Baker, Axios)
Amgen, Roche, and Regeneron set to suffer biggest hits from Trump pricing plan: report (Eric Sagonowsky, FiercePharma)
US health chief Azar confronts criticism of Medicare international pricing model (Donna Young, S&P Global)
HHS also published an additional FAQ: Answering Your Questions about the IPI Drug Pricing Model
As the midterms approach, STAT reports that drug manufacturers may have reason to be nervous of a Democratic majority in the House.
A number of top Democrats – led by Minority Leader Nancy Pelosi – are positioning themselves to take on drug makers if their party takes the House.
On the other hand, as STAT reports, their ranks of allies in the Senate may grow.
If Patrick Morrisey prevails in West Virginia and Bob Hugin wins in New Jersey, they’ll join Sen. Jon Kyl of Arizona as the Senate’s key pharma allies.
Long-delayed 340B regulations regarding ceiling prices now slated to take effect January 1 (Healthcare Dive).
After temporarily freezing prices this year, Pfizer’s CEO says it’s back to business as usual next year regarding potential price increases (The Hill).
Trump has touted the company holding off on price increases.
Industry (both manufacturers and payers) continues to campaign against drug importation, according to this The Hill report. (Although there are exceptions as seen in the story below about Utah’s state employee plan.)
A coalition of insurers and drug manufacturers wants the Trump administration to stop its research into importing certain prescription drugs from foreign countries.
Is a subscription payment model the future for Hep C drugs? Donna Young of S&P Global reports Senator Bill Cassidy, Peter Bach, and Mark Trusheim think it could be.
The uproar over insulin pricing continues. The AMA urges action (The Hill – Physicians group urges FTC to monitor insulin pricing), and a bipartisan Congressional report makes policy recommendations (RAPS).
As the price of insulin has doubled since 2012, Congressional Diabetes Caucus co-chairs Tom Reed (R-NY) and Diana DeGette (D-CO) on Thursday outlined 11 policy recommendations that they believe will help lower prices.
The Salt Lake Tribune reports that Utah will pay public employees (160,000 are covered by the plan) $500 plus expenses to travel to Mexico to fill certain prescriptions.
Amid a flurry of national proposals to bring exorbitant U.S. drug prices in line with other countries’ charges, one Utah insurer has a different option for patients:
Wondering what will happen when Humira biosimilars are available in the US? Well, in Europe, AbbVie just cut the price by 80% because of the threat of competition (several biosimilars are already available there). But don’t get too excited. Despite the FDA approving the third Humira biosimilar this week, it will still be five years before any are available (Fiercepharma).
How far is AbbVie willing to go to fend off the new Humira biosimilars in Europe? Quite far, apparently, judging by the enormous discount it offered to win a government contract.
The FDA approved a genetic test to help individuals determine how well a drug would work for them – but as STAT reports, there are many caveats: “The agency cautioned that the test cannot assess whether a drug is appropriate, or gauge a patient’s ability to respond to any specific medication. The FDA also said that patients should not look to the test for medical advice or to make treatment decisions on their own; instead, they should only use the information to guide discussions with their health care provider.” The day after the approval: FDA Warns Against Use of Unapproved Genetic Tests (RAPS).
The genetic test is the first of its kind authorized by the Food and Drug Administration for direct-to-consumer marketing.
A step forward in creating a universal flu vaccine (NY TImes).
A giant antibody created in the laboratory protected mice against dozens of flu strains, offering hope for better protection in humans.
Publication of clinical trial data is in the news on both sides of the pond this week. The FDA has published draft guidelines regarding penalties for failing to report clinical trial results. The organization All Trials has posted a blog including a discussion and of the proposal and their comments. Meanwhile, in the UK a government report shows that half of the clinical trials there fail to publish (RAPS reports below).
Despite UK and EU rules aimed at boosting clinical trials reporting and transparency, a new report by the UK House of Commons’ Science and Technology Committee finds that nearly half of clinical trials fail to publish results.
Novartis is scrapping 90 drug development programs as part of its global restructuring (Endpoints News).
Novartis has scrapped a fifth of its programs in pursuit of ‘truly impactful’ drugs, Bradner reveals
It turns out the wave of global restructuring at Novartis has claimed more than just jobs – it’s also taken a sizable chunk of its research pipeline. In an interview with Bloomberg, Jay Bradner, president of the Novartis Institutes for Biomedical Research, revealed that the pharma giant has scrapped 90
NPR reports on Merck phasing out its agreement to supply its rotavirus vaccine to four West African countries. Sadly, this decision will likely cost lives in those countries.
The pharmaceutical giant will stop delivering its rotavirus vaccine to four West African countries – and will begin to sell it in China for likely more than 10 times the cost.