ICER Weekly View 12-07-18

From the desk of Mitchell Stein

 

Good morning. My crystal ball is cloudy! On the one hand, news this week that Grassley and Wyden (the incoming chairman and ranking member of the Senate Finance Committee) introduced a drug pricing bill together makes one think there is a chance of movement on the issue in the next Congress. On the other hand, conservative groups are mobilizing against the Administration’s most recent proposals. I’ve seen pundits come down on both sides, some saying we’ll see movement and some saying it’s just beltway drama and at the end of the day nothing will change. Stay tuned, because no one knows how this is going to play out or to put it another way, “that’s why we play the game.”  This week, we’ll look at these issues along with the rest of the line-up:

ICER in the News – ICER’s policy recommendations for extended-release medications for the treatment of opioid use disorder and nominations open for ICER voting panels

Inside the Beltway – Bipartisan drug bill introduced, GAO critiques orphan drug program, drug patent discussions, real-world evidence framework released, BIO sees industry threat and 340B drug program ceiling price finally set to begin

Industry Trends – CVS to offer an option where all rebated go to plan sponsor, CVS-Aetna merger update, mini-exodus from biosimilar space, biosimilar manufacturers want action on misleading marketing, CAR-T misses, ASH summary, generic drug prices predictive of shortages, GSK busy Tearo, and AbbVie’s Rova-T looks destined for the trash heap

Now, on to the news.


ICER in the News

ICER released a Final Evidence Report and Report-at-a-Glance assessing the comparative clinical effectiveness and value of extended-release medications for the treatment of opioid use disorder. The report focuses on a buprenorphine implant (Probuphine, Titan), an extended-release naltrexone injection (Vivitrol, Alkermes), and two extended-release buprenorphine injections: Sublocade (Indivior) and CAM2038 (Braeburn), an investigational agent with an expected FDA approval decision later this month. ICER’s report was reviewed at the November 2018 public meeting of the New England Comparative Effectiveness Public Advisory Council. During the meeting, a majority of the panel found that the evidence is not adequate to demonstrate that any of these extended-release treatments provides superior net health benefit over buprenorphine/naloxone, nor is the evidence adequate to distinguish between the four extended-release treatments. The release was covered by ThePharmaLetter.

Institute for Clinical and Economic Review Provides Policy Recommendations for Extended-Release Treatments for Opioid Use Disorder

ICER is seeking nominations for new members to join its independent evidence review groups:

These bodies are composed of leading clinicians, patient, and public representatives, methodologists, and health economists. Each group convenes three times per year at public meetings to discuss ICER evidence reports, hear input from stakeholders, and vote on the strength of evidence on the effectiveness and value of new drugs, devices, and delivery system innovations. Prospective nominees should have familiarity with the interpretation and application of medical evidence in health care delivery. This may include (but is not limited to) training in fields such as clinical epidemiology, health services research, or health economics, or experience in public health administration, consumer/patient engagement, or policy efforts to improve access to health care.

ICER Opens Nominations for New Members of Its Voting Panels


Pharmaceutical News

Inside the Beltway/State Regulatory Developments

Is a new bill from the incoming chairman and ranking member of the Senate Finance Committee a sign of things to come regarding bipartisan action on drug prices? (The Hill)

Bipartisan senators introduce new drug pricing bill

A bill introduced by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) will seek to crack down on the tactics used by drug companies like Mylan to overcharge taxpayers for Medicaid rebates.

Kaiser Health News reports on the GAO finding problems with how the FDA administers the Orphan Drug Program. In response, the FDA says they agree with the report recommendations and that they will be updating their process.

Government Investigation Finds Flaws In the FDA’s Orphan Drug Program

This story also ran on This story can be republished for free ( NPR. details). The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report Friday.

Are drug patents up for discussion? This in-depth STAT piece looks at how Democrats may have patents in their sites as they look for bolder measures to control drug prices. Probably not something we’ll see in a split Congress, but the discussions could lay the groundwork for action after the 2020 elections (depending on their outcome).

Democrats are eyeing a valuable pharma asset: its patents – STAT

W ASHINGTON – Forget the push to bring more generics to market or to tweak Medicare’s arcane payment system. Democrats, newly empowered in D.C. and on the hunt for bigger and bolder ways to lower drug prices, are suddenly taking aim at a far more central part of pharma’s monopoly power: the patents the industry holds on its drugs.

The era of real-world evidence is coming as the FDA releases their framework for how it will be used (BioCentury).

FDA releases real-world evidence framework

FDA is creating a roadmap that will facilitate the integration of real-world evidence into drug development. FDA’s framework for real-world evidence envisions using data from electronic health records (EHRs), observational and pragmatic studies, and mobile or wearable devices to generate effectiveness data that would support approvals of new indications for approved drugs, and for satisfying postapproval study requirements.

The Hill reports that the CEO of BIO (PhRMA’s trade group cousin) says “…the industry is under a greater threat than it’s ever been before.”

Top biotech lobbyist: Industry under ‘greater threat’ than ever before

The top biotech industry lobbyist said his industry is “under a greater threat than it’s ever been before” as the Trump administration and Democrats in Congress set their sights on drug companies.

After five delays, implementation of the 340B drug program ceiling price will begin on January 1 (HealthCare Dive).

340B drug program ceiling price, penalties start Jan. 1

After years of delay, HHS finalized a rule Thursday that will impose a ceiling price to limit how much drug manufacturers can charge hospitals participating in the 340B drug discount program for their products, as well as civil monetary penalties for manufacturers charging above the ceiling. The rule will take effect Jan.

Industry Trends

The term game-changer is often overused. However, in this case, it may be accurate as CVS is set to offer a program through which all manufacturer rebates and fees will be passed on to participating plan sponsors.

CVS offers ‘guaranteed net cost’ for pharmacy benefit clients

Pharmacy chain and benefits manager CVS Health Corp on Wednesday said as of Jan. 1 it will offer a new prescription benefit option guaranteeing its health plan clients 100 percent of any rebates, discounts or other fees paid by drugmakers.

As we discussed last week, the judge with oversight over the CVS-Aetna merger has raised his voice to slow down the process. CNBC reports on what he can and can’t do concerning stopping the merger (tl:dr — he can’t stop it).

What a judge can – and can’t – do in ruling on the Justice Department’s deal with CVS and Aetna

Michael Nagle | Bloomberg | Getty Images A federal judge is considering halting the integration of CVS Health and Aetna – even though the two companies closed their merger last week. Judge Richard Leon of the U.S.

What’s a week without a biosimilar story, so we’ll have two — First RAPSlooks at the exits of three companies from the biosimilar space and how the US continues to have a very different biosimilar landscape than Europe.

Mini-Exodus From Biosimilar Space Stirs Questions

In just the past month, three companies have all exited the biosimilar space in one way or another, which has some questioning whether expectations for the biosimilars markets need to be adjusted. The slide began early last month when Sandoz halted its submission for biosimilar rituximab in the US after the Food and Drug Administration (FDA) requested additional information.

Second, as reported in BioCentury, Pfizer and other biosimilar manufacturers urged the FDA to act on misleading brand marketing related to the safety and efficacy of biosimilars.

Biosimilar makers back Pfizer in call to end misleading brand marketing

A group of biosimilar manufacturers including Pfizer Inc. (NYSE:PFE) urged FDA to produce supplemental guidance clarifying how to comply with existing law when communicating about biosimilars. The Biosimilars Forum sent its plea in a letter supporting an August Citizen’s Petition from Pfizer asking FDA to take action against branded drugmakers that the pharma said have misled the public about the safety or efficacy of biosimilars.

CAR-T therapies only work for a subset of patients, and among the group they help, the help only lasts for a subset of that subset. (Bloomberg — subscription required after a quota of free articles)

There Is a Magic Bullet for Some Cancers. What If It Misses?

The American Society of Hematologists (ASH) held their annual meeting in San Diego this week. BioPharma Dive has a summary of developments.

No Title

Some key takeaways: First generation CAR-T therapies demonstrated lasting efficacy for some, while a newer wave offered impressive responses in hard-to-treat cancers. Durability will be a focus with these therapies moving forward, and a potential differentiator as the market matures.

Is there such a thing as too low a price for a drug? As reported by Zachary Brennan in RAPS, a new report finds that the lower the price, the more likely the drug is to experience a shortage.

Generic Drug Prices ‘Strongly Predictive’ of Shortages, Study Finds

How a generic drug is priced may be the difference between whether it experiences a shortage or not, a new study published in Value in Health found. The study of commonly used outpatient generic drugs from 2008 to 2014 found that the prevalence of shortages decreased from a peak in 2011-2012 to less than 4% of the overall sample by the end of 2014.

As reported in BioCentury, Pfizer and other biosimilar manufacturers urged the FDA to act on misleading brand marketing related to the safety and efficacy of biosimilars.

Biosimilar makers back Pfizer in call to end misleading brand marketing

A group of biosimilar manufacturers including Pfizer Inc. (NYSE:PFE) urged FDA to produce supplemental guidance clarifying how to comply with existing law when communicating about biosimilars. The Biosimilars Forum sent its plea in a letter supporting an August Citizen’s Petition from Pfizer asking FDA to take action against branded drugmakers that the pharma said have misled the public about the safety or efficacy of biosimilars.

Forbes’ Matthew Herper reports on GSK’s $5 billion acquisition of Tesaro.

GSK Buys Tesaro For $5 Billion In Dramatic Bet On Cancer Genetics

The deal is a dramatic bet that the London-based drug giant can see opportunities connected to the genetics of cancer drugs better than the stock market. It fits into a framework outlined in July by Hal Barron, the widely respected pharma veteran who took over as GSK’s head of R&D last year.

John Carroll of Endpoints News reports on an earlier $6 billion acquisition that seems destined to go down in flames.

AbbVie’s troubled $10B Rova-T cancer drug program takes a sudden turn toward the cliff

The Rova-T problem at AbbVie $ABBV may be headed toward a full-fledged disaster. Researchers slammed the brakes on one of their Phase III studies of the $10 billion drug after an independent group of monitors determined that their drug was linked to a shorter overall survival rate than the chemo

 

www.icer-review.org 
@icer_review
@mhstein  |  https://www.linkedin.com/in/mitchellhstein/


Sign-up to have the Weekly View delivered to your inbox every Friday morning.

SIGN UP