ICER Weekly View 05-18-18

From the desk of Mitchell Stein


Good morning. Drinking water from a fire hose – that’s the only way to describe trying to follow drug industry news this week. The President’s speech and elaboration from Azar and Gottlieb, approval of Aimovig, Ebola, biohacking and much more. I’m trying to keep this newsletter streamlined, but the world isn’t cooperating! By the way, how are things going? Am I bringing you the right mix of stories? Too many? Too few? The only way I’ll get it right is if you help. So drop me a note by emailing and let me know how I’m doing. This week’s lineup includes:

ICER in the news – Aimovig’s approval, draft scoping document on biologics for Asthma, how ICER’s work can help lower prices, more on ICER and lowering drug prices (2 articles), and Health Affairs drug pricing collection

Inside the Beltway – The President’s speech and follow-up (7 articles), 340B program scrutiny, “right-to-try” moves forward, changes at the FDA, and VT importation law

Industry Trends – PBM contracts (OptumRx and NJ), Ebola outbreak, biosimilar approval, ASCO abstract night, every drug ever developed, DTC advertising for oncology and biohacking

Now, on to the news.

ICER In The News

Late Thursday (5/17/18) the FDA approved Aimovig (erenumab, from Amgen and Novartis) for the prevention of migraines. This is the first in a new class of drugs (CGRP inhibitors) approved to prevent migraines. ICER is working on the topic and has to date issued a draft report. The ICER draft used industry analyst consensus for pricing, however, the manufacturers announced an initial price that was below expectations – $6,900 a year vs. $8,500 a year. The FDA approval and ICER’s work were covered this morning by Endpoints (link below), Xconomy (New Drug Offers Hope to Millions With Severe Migraines), and the New York Times (Amgen Migraine Drug Gets FDA Nod, First in New Class of Medicines).

It’s unclear why the launch price came in below expectations, but this excerpt from the Endpoints article thinks it may be connected to the initial reaction to the higher price: 

“Significantly, the heavyweight partners — who will share the US marketing rights — are launching this CGRP pioneer with a list price of $6,900 a year. That number comes in well below the $8,000 to $10,000 spread that Express Scripts had already warned would be unacceptable to them. It’s also well under the $8,500 figure the Institute for Clinical and Economic Review penciled in for their review, which they considered too costly for all but the most seriously afflicted. That message clearly got through to the manufacturers. Amgen in particular has had to work out some deals on its PCSK9 drug to get that past steep payer hurdles.”

Amgen, Novartis ready to roll as FDA green lights blockbuster campaign for migraine drug – priced at $6,900

Amgen and Novartis have brought home the big Aimovig (erenumab) approval they’ve been hunting, scoring first-mover advantage for a blockbuster contender that will now look to start changing the standard of care for debilitating migraines.

ICER has posted a Draft Scoping Document outlining a planned review of the comparative clinical effectiveness and value of biologic treatments for asthma. The release of the document was covered by AJMC: ICER Releases Draft Scoping Document on Biologics for Asthma.

Institute for Clinical and Economic Review Posts Draft Scoping Document on Biologic Treatments for Asthma


Austin Frakt writes about high drug prices and how ICER’s work can help get them lower.

High Drug Prices Can Be Lowered Without Government Controls

This deal sounds great – why pay for a drug if it doesn’t work? – but there’s less to it than meets the eye. About 7 percent of patients taking the drug are expected to have a heart attack or stroke, so Amgen won’t be on the hook for many rebates.

Bloomberg radio piece on drug prices and the President’s speech includes comments from ICER’s President Steve Pearson.

Bloomberg Baystate Business: Drug Prices

Bloomberg Boston Bureau Chief Tom Moroney and Radio News Anchors Peter Barnes, Pat Carroll, Anne Mostue and Janet Wu are joined by top names from local business and finance to medicine and politics, along with Bloomberg reporters covering the latest stories in Boston, the Bay State and beyond.

NY Times opinion piece on high drug prices discusses how low foreign prices are not the cause of high US prices; the article includes discussion of ICER’s work.

Opinion | What Trump Should Actually Do About the High Cost of Drugs

By Thomas J. Bollyky, Aaron S. Kesselheim and Joshua M. Sharfstein Mr. Bollyky, Mr. Kesselheim and Mr. Sharfstein have worked separately on many aspects of the drug pricing problem.

Health Affairs has made available a primer on prescription drug pricing. It includes twelve health policy briefs and three policy options papers that review the prescription drug market. One of the papers is co-written by ICER’s President, Dr. Steve Pearson.

HEALTH AFFAIRS COLLECTION: Prescription Drug Pricing

Pharmaceutical News

Inside the Beltway/State Regulatory Developments

Last Friday (was that only a week ago?), the President gave his highly anticipated speech on drug prices. The initial response was muted as many did not think there was much new in his remarks. Pharmaceutical stocks rose after he finished, indicating investors did not think the actions would have much impact. Then, starting on Monday, HHS Secretary Azar provided more information; specifically, he started discussing moving some drugs from Medicare Part B to Medicare Part D so that they would be subject to private plan negotiation (while at the same time defending the fact that HHS would not negotiate directly). This caused more of a stir than the President’s speech. Additionally, FDA Commissioner Gottlieb discussed details of the measures focused on generic drugs and the obstacles brand name manufacturers created to generics being approved.

ICER’s President Dr. Steve Pearson released this comment:

“While encouraged to see both political parties evaluating new options to reform drug reimbursement, we continue to believe the fundamental challenge in the US pharmaceutical system is that – particularly in areas with little competition – a drug’s price rarely reflects the drug’s benefit for patients. There are times when our country receives tremendous value from medicine and other times when we’re getting ripped off, and our health care system struggles to tell the difference.

Outcomes-based and indication-specific contracting offer promise, as long as these novel arrangements are not positioned as a substitute for ensuring the drug’s underlying price is fairly aligned to its value.

We will continue to monitor these proposed federal reforms, as well as the accelerating efforts to better manage drug pricing by individual states and within the private market.”

Below I’ve lined up seven articles reviewing this eventful week; starting last Friday and working through Thursday’s launch of the FDA website  (and if you think limiting it to seven was easy, think again).

We’ll start with a summary of the speech and the initial reaction.

Trump’s ‘sweeping action’ to lower drug prices mocked by analysts as relieved investors trigger rally in Big Pharma stocks

President Donald Trump took to the bully pulpit today to steer a package of proposals into existence that he claimed is “the most sweeping action in history to lower the price of prescription drugs for the American people.” But if that was his aim, his shot hit so far from

Weekly View favorite (and Midwest CEPAC member) Rachel Sachs reviews the specific proposals in the speech in this Health Affairs blog.

Trump’s Drug Pricing Speech Breaks Little New Ground, Largely Spares Industry

NASHP looks at the impact of the plan on states’ efforts to rein in prices.

What does the Trump Administration Drug Cost Initiative Mean for States? – NASHP

On Friday, May 11, the Trump Administration announced a series of potential policy options that, if implemented, aim to reduce the cost of prescription drugs. The initiative, called American Patients First, is described in the nearly 40-page document that lacks many specifics for the policy options.

Azar discusses moving drugs from Medicare Part B to Part D and other changes to help lower prices. (Note these changes may impact individuals’ out-of-pocket costs which are handled differently in the two parts of Medicare and will vary depending on what coverage individuals have. In 2017 only 42 million of the 59 million (71%) eligible for Part D were enrolled in coverage.) 

Azar plans to reshape Medicare drug coverage

HHS Secretary Alex Azar brought the Trump administration’s drug pricing plan into sharper focus Monday, making it clear that he is considering administrative steps that could reshape the Medicare drug marketplace.

The Medicare changes evoked a reaction from manufacturers.

PhRMA expresses ‘serious concerns’ with Trump drug pricing proposals

The main drug industry lobbying group on Tuesday said that it had “serious concerns” with major elements of President Trump Donald John Trump Giuliani says FBI may have placed spy in Trump campaign Giuliani: There is ‘nothing illegal about looking for dirt on political opponents’ Giuliani: If Mueller subpoenas us, we will challenge it MORE ‘s new plan to bring down drug prices.

Personal comment: I thought the President’s initial remarks indicated the most significant actions would revolve around generic drugs. While the Medicare coverage changes could prove me wrong in the future, the naming names, revival of the Creates Act, and other activities already begun backs up that initial impression. 

F.D.A. Names and Shames Drug Makers to Encourage Generic Competition

While Celgene tops the list, other companies that the F.D.A. named as the subject of complaints included GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, and BioMarin Pharmaceutical. Celgene, which makes drugs to treat cancer and immune-inflammatory diseases, was named as the subject of 31 inquiries from companies seeking access to Revlimid (lenalidomide), its treatment for multiple myeloma and related diseases; Pomalyst (pomalidomide); and Thalomid (thalidomide).

While no timetable for a vote was provided, it seems the Creates Act has new life.

Ryan: ‘Compromise’ in the works for controversial drug pricing bill

Speaker Paul Ryan Paul Davis Ryan Lighthizer says NAFTA countries are ‘nowhere’ near reaching a deal Dem introduces bill to prohibit lawmakers from sleeping in their offices Trump hears ‘covfefe’ as White House aides weigh in on ‘Yanny’ and ‘Laurel’ MORE (R-Wis.)

Now on to other news.

The 340B program continues to garner attention. (For those not familiar with the issues, this Vox piece might be helpful.)

340B scrutinized in Senate, targeted by Trump

First Published on The Senate HELP Committee again turned its attention toward the 340B Drug Pricing Program on Tuesday, calling into question the program’s vague intent, lack of transparency surrounding its rules and “inadequate” level of oversight by the Health Resources and Services Administration.

The Senate version of the “right-to-try” bill will be voted on by the House next week.

Right-to-try bill headed for vote puts bigger burden on FDA, Gottlieb says

HITE OAK, Md. – The House is set to take up a controversial ” right-to-try ” bill next week – and if it passes, the Food and Drug Administration will have to work harder to protect patients than it would if a different version of the legislation were advancing, Commissioner Scott Gottlieb told STAT in an interview.

Changes coming to the FDA.

FDA is reorganizing the Office of New Drugs to stay ahead of drug development

FDA is reorganizing the Office of New Drugs in its Center for Drug Evaluation and Research, seeking to make review oversight more consistent while encouraging senior staff to become thought leaders. The changes at OND are being implemented as CDER ramps up hiring and personnel policies in anticipation of a staffing cliff that will dramatically change the face of the agency over the next few years (see “CDER’s Cliff”).

Vermont’s Republican governor signed the Canadian drug importation bill. However, several steps remain before the program begins, including cooperation from HHS. At this point, it is unclear if that cooperation will be forthcoming as importation is not part of the Administration’s plan. In addition to the piece below describing passage of the law, Kaiser looks at what happens next: Vermont Legislators Pass A Drug Importation Law. So What?.

Vermont becomes first state to permit drug imports from Canada

Vermont Republican Gov. Phil Scott Wednesday signed legislation making his state the first to legalize importing prescription drugs from Canada, an idea President Donald Trump’s top health officials oppose that’s also drawn fierce opposition from the pharmaceutical industry. A spokeswoman for Scott said he signed the bill Wednesday morning.

Industry Trends

Bob Herman continues his exploration of PBMs and their business model with this close-up view of a contract between OptumRx and New Jersey, and the resulting court case.

What New Jersey’s drug plan do-over says about the industry

Last year, New Jersey awarded pharmacy benefit manager OptumRx a $6.7 billion contract to oversee prescription drug benefits for the state’s 835,000 public employees, retirees and dependents. But now New Jersey has to redo the process after a court said OptumRx “improperly hedged” its contract.

Will we do better this time? The response has been quicker, and the vaccine (despite logistical problems) will help – but the situation is far from contained.

Ebola Spreads to Major City in Congo, Raising Threat of Contagion

GENEVA – An outbreak of the deadly Ebola virus in rural Democratic Republic of Congo has spread for the first time to a major city there, the World Health Organization reported on Thursday, raising the threat of a far larger contagion.

The FDA approves the 10th biosimilar here in the US. As a point of reference, this biosimilar was approved 11 years ago in Europe.

Pfizer’s Epoetin Alfa Biosimilar Approved by FDA

Posted 15 May 2018 | By Michael Mezher The US Food and Drug Administration (FDA) on Tuesday approved the first biosimilar to Amgen’s blockbuster Epogen/Procrit (epoetin alfa), bringing the total number of biosimilars approved by the agency to 10.

While the ASCO conference hasn’t started yet, we did have “abstract night” this week where some of the results to be presented at the conference were shared in advance. Below Endpoints takes a look at some of the highlights. It’s also worth noting that there are some who feel this pre-release of conference abstracts can be a mixed blessing: ASCO 2018: How a major medical meeting uses embargoes to shape the news, and what the consequences may be.

UPDATED: The top winners and losers on ASCO abstract night: Loxo, Blueprint, Jounce, Merck KGaA and more

Let the jousting begin. The big abstract drop ahead of ASCO – the annual Olympics of cancer R&D – provided some early, quick snapshots that helped drive stocks up or down, or simply provided a chance to tout some potential in a hotly contested field. As more and more biopharma

Does anyone besides me remember the Robert Klein routine about buying “every record ever recorded?” Well, the Broad Institute is trying to do the same thing, only with drug compounds as they try and build a library of every drug ever made in their quest to find new uses for them.

This Cambridge nonprofit is seeking every drug ever developed – The Boston Globe

Sajni Chakrabarti’s parents were staggered when doctors at Boston Children’s Hospital told them that the 7-year-old girl’s puzzling symptoms – several falls, trouble moving her pinky finger while playing the violin – were caused by a rare and malignant brain tumor. And there was little anyone could do to help.

DTC advertising for oncology is increasing. Some think that’s a good idea, but many aren’t so sure.

Oncology boom spurs DTC advertising, and with it controversy

Mary Jennings-Smith spent more than three decades working at a California community college. Her career would have gone longer too, had metastatic breast cancer not gotten in the way. She recalls crying at the last graduation ceremony she attended in 2009. The diagnosis led Jennings-Smith on a winding road of treatment, marked by chemotherapy, infusions and potent enzyme inhibitors.

Finally, in case you don’t have enough to worry about, the age of do-it-yourself biohacking (and perhaps bioweapons development) is here.

As D.I.Y. Gene Editing Gains Popularity, ‘Someone Is Going to Get Hurt’

WASHINGTON – As a teenager, Keoni Gandall already was operating a cutting-edge research laboratory in his bedroom in Huntington Beach, Calif. While his friends were buying video games, he acquired more than a dozen pieces of equipment – a transilluminator, a centrifuge, two thermocyclers – in pursuit of a hobby that once was the province of white-coated Ph.D.’s in institutional labs. 
@mhstein  | 

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