ICER Weekly View 09-28-18

From the desk of Mitchell Stein

Good morning. Last week I opened by discussing personal angst and the solace of superheroes. This week, I’d like to remind you that you can be a superhero yourself with one simple step – get a flu shot! As we head into October and the official start of flu season, there’s no better time to protect yourself and those around you by getting vaccinated. It’s easy, and if you have health insurance, it’s probably free (I get mine at the supermarket pharmacy, it takes about 6 minutes). Last year, 80,000 died of influenza and related complications – higher than any year in the past 40. I’m constantly surprised that people who will defend vaccines with their last breath (as we all should) find themselves too busy to get their flu shot. Thanks for coming to my Ted Talk – now let’s get to the pharma news where this week we’ll look at:

ICER in the news – Draft report on asthma, Luxturna coverage, and the stage set for migraine battle,

Inside the Beltway – Gag clause bill moves forward, Opioid bill moves forward but without certain provisions, and Oklahoma’s Medicaid value-based contracts

Industry Trends – Drug prices continue to rise, biosimilar wars continue, benefits consultants (2 stories), drug shortages cost impact, Hep C, the need to publish negative results, the cost of accessing published results, CVS-Aetna (3 stories), and Amarin’s fish oil

Now, on to the news.

ICER In The News

ICER released a Draft Evidence Report assessing the clinical effectiveness and value of biologic treatments for asthma associated with Type 2 inflammation and/or allergic asthma. The draft report will be open to public comment until October 22, 2018. ICER’s report assesses the effectiveness and value of dupilumab (Dupixent, Sanofi/Regeneron), omalizumab (Xolair, Genentech/Novartis), mepolizumab (Nucala, GlaxoSmithKline), reslizumab (Cinqair, Teva), and benralizumab (Fasenra, AstraZeneca). The report will be subject to deliberation during a public meeting of the Midwest Comparative Effectiveness Public Advisory Council. The release was covered in AJMC,  ThePharmaLetter, Evaluate, and FiercePharma,

Institute for Clinical and Economic Review Releases Draft Evidence Report on Biologic Treatments for Asthma

The Wall Street Journal looks at Luxturna – the gene therapy treatment for those with a rare eye condition. The article mentions ICER’s work on the topic and includes a quote from ICER’s CMO, David Rind.

High Hopes for a Gene Therapy Come With Fears Over Cost

Luxturna can improve sight for children and others with a rare eye condition, but costs nearly $1 million-the industry is reckoning with how to pay for such treatments as more become available.

With the announcement on Thursday that the FDA approved Eli Lilly’s new migraine drug, the stage is set for the three entrants in this new class of drugs to compete. ICER’s work on the topic continues to be part of the discussion, as evidenced by the MarketWatch article below. There were also migraine stories mentioning ICER this week in Healthline and Infosurhoy.

Three new drugs will compete fiercely to revolutionize migraine treatment – with identical $6,900 price tags

By For millions of Americans with chronic, debilitating migraines – often replete with head pain along with vomiting, dizziness and light, sound and smell sensitivity – a new, emerging drug class that aims to prevent migraines could be a game-changer. Drug companies in the space, meanwhile, have a new and lucrative market opening up.

Careers at ICER

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:

Research Lead

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.

Pharmaceutical News

Inside the Beltway/State Regulatory Developments

The House passed the two gag clause bills previously passed by the Senate – As Donna Young of S&P Global reports, both now head to the White House for the President’s signature.

House adopts bills to ban pharmacy ‘gag clauses,’ promote biodefense enterprise

The Democrats and Republicans from both the House and Senate reached agreement on the text of the final, massive (600 page) opioid bill. I will leave it to others to debate elsewhere the bill’s impact. For our purposes, a significant part of the final legislative package is what it does not contain: changes to the Donut hole closure and a version of the CREATES Act that would incentivize more competition from generic drugs were both left out of the bill. The final text still needs to be passed by both houses before going to the President for his signature. 

Lawmakers unveil massive bipartisan bill aimed at fighting opioid crisis

Bipartisan congressional leaders in both chambers on Tuesday night unveiled a massive bill aimed at fighting the epidemic of opioid abuse in the United States, capping months of work. Fighting the crisis has been an area of bipartisan cooperation this year amid many fierce partisan battles raging with more publicity.

NASHP’s Jennifer Reck writes about that hotbed of drug price innovation, Oklahoma Medicaid (wait, what?).

Oklahoma Signs the Nation’s First State Medicaid Value-Based Contracts for Rx Drugs – NASHP

On the heels of Oklahoma’s first-in-the-nation, value-based purchasing deal to improve adherence to an antipsychotic drug, the state’s Medicaid agency just signed its second value-based contract for a prescription drug used to treat serious bacterial skin infections. While several private insurers have initiated value-based contracting, which links payments to a drug’s effectiveness and outcome, Oklahoma …

Industry Trends

So, are we seeing those much-heralded price cuts? Not so much. In its investigation, the Associated Press found that “Over the first seven months of the year, there were 96 price hikes for every price cut.”

AP investigation: Drug prices going up despite Trump promise

NEW YORK (AP) – President Donald Trump made reducing drug prices a key promise during his election campaign, repeatedly accusing drugmakers of “getting away with murder.” At the end of May, he promised that drug companies would be announcing “massive” voluntary drug price cuts within two weeks.

Speaking of things we’re not seeing, we’re still not seeing much competition based on biosimilars. Pfizer says that’s the fault of some of their peers, and the company is taking its argument to the FDA, the courts, and the public square. Bloomberg takes an in-depth look at the conflict.

Brand-Name Drugmakers Turn on Each Other in Fight for New Market

So what’s a large employer to do about their drug spend? Hire a consultant! Axios’s Bob Herman takes a look at the role of benefits consultants work on PBMs (below) and in a companion piece looks at the role of drug purchasing coalitions.

How consultants and pharmacy middlemen work the drug pricing system

How it works: Employers pay consultants, who are supposed to act as disinterested third parties, to help them pick a pharmacy benefit manager to negotiate with drug companies. Consulting firms solicit bids from PBMs, compare their prices and pharmacy networks, and then present the options to employers.

A new study concludes that $230 million of the US drug spend is due to drug shortages (Reuters).

Drug shortages may add $230 million to annual U.S. drug costs

(Reuters Health) – Prescription drug shortages may drive up prices twice as much as they would rise with medicines in abundant supply, adding $230 million a year to U.S. drug costs, a new study estimates. Researchers examined data on 90 medications involved in shortages between December 2015 and December 2016.

Histories will be written about hep C drugs, both for their significance medically (a cure) and economically (bringing general awareness to the drug pricing issue). While posing significant budget implications when first launched, the growing list of substitutable drugs made by different manufacturers now makes this therapy class the closest thing to a free market we see in the drug space. Keep all that in mind as you read this FiercePharma story about Gilead introducing generic versions of its hep C brands.

With its hepatitis C franchise tumbling, Gilead plots knockoffs of its own drugs

More than a decade before Gilead’s patents expire for blockbuster hep C drugs Epclusa and Harvoni, the company is actually launching authorized generics at one-third the list price-or less. To say this is an unusual step would be an understatement-drugmakers usually fight generics for as long as possible.

Writing in the New York Times, Dr. Aaron Carroll (Midwest CEPAC member) talks about the need to publish negative results – and to publish them accurately and without spin.

Congratulations. Your Study Went Nowhere.

The New Health Care Researchers should embrace negative results instead of accentuating the positive, which is one of several biases that can lead to bad science. When we think of biases in research, the one that most often makes the news is a researcher’s financial conflict of interest.

Of course, published results – positive or negative – aren’t any use if you can’t access them. Funders in 11 European countries are working to get research out from behind paywalls. 

Europe has a plan to force academic publishers to make research free to read

If you’ve ever done academic research, you know the frustration: You find the perfect study or analysis, only it’ll cost you around $30 to access it. Universities spend millions every year on academic journal subscriptions for their students and faculty.

The CVS-Aetna deal is in the news this week. HealthcareDive has the coverage, first with a report on Aetna’s sale of its stand-alone Part D business (it is transferring 2.2 million covered lives to WellCare), then with a point-counterpoint with reports on the NY Attorney General voicing objections and CVS promoting the positives.

Aetna sells Medicare Part D business to WellCare subsidiary

A subsidiary of WellCare agreed Wednesday to purchase Aetna’s entire standalone Medicare Part D prescription drug coverage, representing 2.2 million covered lives, according to an SEC filing. The deal – meant to grease the wheels for approval of the pending CVS-Aetna deal – does not affect individual or group Medicare Advantage plans or Medicare supplement plans or products.

New York regulator warns CVS-Aetna merger could raise prices, reduce consumer choice

Maria Vullo, New York’s top financial watchdog, is sounding the alarm over the proposed $69 billion marriage between CVS and Aetna. She warns that the merger could lessen competition and raise prices for consumers. Her concerns were contained in a letter sent to the commissioner of Connecticut’s insurance department, intended to arrive before the state’s Oct.

CVS execs promote proposed Aetna merger as cost saver

CVS’ CEO and CFO laid out examples for how consumers and shareholders could benefit from the proposed merger with Aetna during a recent investor meeting hosted by Mizuho Securities. Mizuho analysts said investors have been interested in the “long-term merits” of the deal, which is expected to achieve $750 million in cost savings in the second full year after closing.

Finally, this week Amarin released top-line results for its fish oil drug, and those results were stunning, showing a 25% reduction in cardiovascular problems. As this Forbes story notes, only topline results have been released so far, but if the full results are robust, this could be a multi-billion dollar drug.


In Blowout, Amarin’s Fish-Oil-Derived Drug Dramatically Cuts Heart Risk In Study

A drug derived from fish oil cut the rate of cardiovascular problems, including heart attacks and strokes, by 25%, a result that will likely transform the fortunes of its maker, Amarin Pharmaceuticals, and upend decades of thinking about cardiovascular disease. “What??!!! Fantastic! Wow!” 
@mhstein  |

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