ICER Weekly View 12-14-18

From the desk of Mitchell Stein


Good morning. It is with mixed feelings that I write that this will be my final issue of Weekly View. In 2011 I became a member of New England CEPAC, then in May of 2015 I joined the staff of ICER and started sharing a few articles each morning with a few staff members. That email evolved first into Morning View and then into Weekly View. Now in December of 2018, it is time for me to bid farewell. I have seen ICER grow in scope and influence, and could not be more proud of any small role I played in its success. But all good things must come to an end, and it’s time for me to move on. A big thank you to the staff at ICER, particularly Steve and Sarah who worked closely with me as my role evolved. 

Most importantly, a big thank you to all of you readers. Without you, I was just a crazy person talking to myself… If you’d like to continue our conversation, please follow me on Twitter and/or connect with me on LinkedIn. I hope to have some news about my next adventure at the beginning of the New Year.

ICER management asked me to share this following note about the past, present, and future of Weekly View:

“From everyone at ICER, we thank Mitchell for his knowledge, his heart, and his wit, all of which were evident in each week’s edition of this newsletter. We value the connection that Weekly View brings us with a broad community of leaders across different fields. We may not be able to match Mitchell’s smile-per-line ratio, but going forward we hope that our future Weekly Views will continue to provide a distinctive insight into ICER’s activities and the evolution of the drug innovation, pricing, and payment landscape in the US. This will be the final edition of 2018, but stay tuned for when we start back up in the New Year.”

But for today, for one last time, let’s do this. This week we’ll look at:

ICER in the News – New assessment on Duchenne Muscular Dystrophy, Washington Examiner profile of ICER, and Frakt talks drug pricing with references to ICER

Inside the Beltway – New FDA staff, what a partial shutdown means for the FDA, PhRMA getting nervous, and a (minor) drug pricing bill moves forward

Industry Trends – Generic drug collusion story even bigger than we thought, Kaleo to offer their own generic, US has higher drug costs but no better outcomes, insulin market changes coming, lessons from blockbuster launches, Lilly in new Alzheimer’s deal

Now, on to the news.

ICER in the News

ICER announced that it plans to assess the comparative clinical effectiveness and value of treatments for Duchenne muscular dystrophy (DMD). The report will be reviewed during a public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) in July of 2019. ICER’s assessment will focus on eteplirsen (Exondys 51, Sarepta Therapeutics) and golodirsen (Sarepta Therapeutics). Eteplirsen was approved by the FDA in September of 2016, and golodirsen has an anticipated FDA approval decision expected in the middle of 2019.

ICER to Publish Upcoming Assessment on Treatments for Duchenne Muscular Dystrophy

The Washington Examiner profiles ICER and interviews ICER’s President Dr. Steven Pearson.

Big Pharma’s biggest threat in Washington? It may be this obscure research firm

The U.S. pharmaceutical industry’s greatest worry in Washington, D.C., might not be President Trump’s drug-pricing blueprint or Democrats’ retaking control of the U.S. House of Representatives, but a little-known, non-partisan research firm. The Institute for Clinical and Economic Review, or ICER, evaluates prescription drugs to determine whether list prices align with the clinical and economic value for patients.

Austin Frakt, health systems researcher, blogger, and member of New England CEPAC, writes in the New York Times about potential solutions to the drug price issue.

How to Cut U.S. Drug Prices: Experts Weigh In

The New Health Care A look at policies and possible trade-offs, including the risk of hampering innovation. Americans are generally uncomfortable with pharmaceutical prices – which are the highest for brand drugs among wealthy nations – and with drug companies’ profits. But if policies were adopted to reduce drug prices, could there be negative consequences?

Pharmaceutical News

Inside the Beltway/State Regulatory Developments

In this week’s Capitol Checkup, S&P Global’s Donna Young reports on the new drug pricing czar and the FDA’s new director of the Office of New Drugs.

Capitol Checkup: ACA sign-ups lag; drug pricing czar named; NIH flies to space

The Democratic heads of four House committees last week again demanded answers from top U.S. health officials about why the Trump administration is not defending the Affordable Care Act in a lawsuit being fought in Texas.

As the prospect of a partial government shutdown looms, BioCentury takes a look at how it would impact the FDA.

Government shutdown could hobble FDA

Political stalemate in Washington is raising the possibility of a partial government shutdown that could limit FDA’s ability to review NDAs. While the agency would be able to continue ongoing drug reviews during a shutdown, FDA could be barred from accepting new applications.

Is PhRMA’s ability to work with Democrats in the House diminishing? STAT takes a look (and thinks the answer is yes).

Will Democrats in Congress keep the door open for pharma – or slam it?

W ASHINGTON – With annual revenues of roughly $450 million and an army of some 160 lobbyists, PhRMA has long been described in near mythological terms by both awed opponents and reverent allies: It’s untouchable, it never loses, it can kill a bill before the ink is dry on the first draft.

The bipartisan bill introduced by Grassley and Wyden and aimed at the misclassification of Medicaid drugs hitched a ride on other legislation and was passed by the House on Tuesday (The Hill).

House passes bill to keep drug companies from overcharging Medicaid

The House approved a proposal Tuesday cracking down on the tactics drug companies use to charge Medicaid. The bipartisan bill, from Sens.

Industry Trends

So about that generic drug collusion investigation – as the Washington Post reports, it’s much bigger than we suspected.

Investigation of generic ‘cartel’ expands to 300 drugs

December 9 Executives at more than a dozen generic-drug companies had a form of shorthand to describe how they conducted business, insider lingo worked out over steak dinners, cocktail receptions and rounds of golf. The “sandbox,” according to investigators, was the market for generic prescription drugs, where everyone was expected to play nice.

And speaking of generics – Kaleo will offer their own $178 generic alternative to their $4,100 overdose antidote injector (STAT).

Kaleo, maker of $4,100 overdose antidote, to offer generic for $178 – STAT

W ASHINGTON – A month after the drug maker Kaleo came under fire from lawmakers and public-health advocates for charging $4,100 for a device that reverses overdoses, the company has announced it will introduce a generic version for a small fraction of the price.

Caitlin Owens reports in Axios that we pay more and get some drugs faster in the US than other countries – but the data doesn’t show the speed resulting in better health outcomes.

The U.S. pays more for prescription drugs but doesn’t get better health outcomes

The big picture: There’s no question that the U.S. is paying more for drugs than other countries, that we approve drugs faster here than Europe and Canada do, or that the development of new, expensive drugs has had medical value. The questions are whether we get better health outcomes in return for what we’re paying, and whether making U.S.

Change is (finally) coming to the insulin market. But as STAT reports, no immediate relief is on the horizon.

FDA chief blasts insulin prices, touts far-off new rules for the market – STAT

W ASHINGTON – FDA Commissioner Scott Gottlieb blasted insulin makers Tuesday for what he called unacceptably high prices for a decades-old drug. And he rolled out a slate of new guidances for the industry he says will spur competition in the insulin market and bring down the drug’s cost when they take effect in 2020.

John LaMattina, writing in Forbes, distills lessons from a review of blockbuster drug launches.

Lessons From The Biggest Pharma Drug Launches Of All Time

One way to measure the importance of a new drug is how fast the drug is taken up by the market. Furthermore, this is a key metric as a strong commercial launch usually predicts that the drug will become a major revenue generator.

It seems fitting that my last story of my last edition covers the continued search for an Alzheimer’s treatment (we’ve covered so many…). BioPharma Dive reports on Lilly sealing a deal with AC Immune as the search continues.

Lilly bets on AC Immune’s tech to target Alzheimer’s

Eli Lilly and Swiss biotech AC Immune are teaming up to develop drugs that inhibit aggregation of a protein many believe to be integral to one of the most elusive targets in pharma: Alzheimer’s disease. 
@mhstein  |

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