ICER Weekly View 07-13-18

From the desk of Mitchell Stein


Good morning. I’m trying to make this newsletter more streamlined – but, between taking a week off and so much drug pricing news, I fear I may have backslid a bit this week. I hope you can find it in your heart to forgive me. With so much to cover, let’s get right to it. This week we’ll look at:

ICER in the news – Dan Ollendorf departs ICER, Draft Evidence Report on antiandrogen therapies for prostate cancer, Final Evidence Report on CGRP inhibitors for migraines, and Vertex/NICE battle

Inside the Beltway – Pfizer price increases and rollbacks, change coming to 340B, new CMS fee schedule cuts WAC add-on for physician administered drugs, Pentagon gets FDA exception, CMS quits value-based payment agreement, six gene therapy draft guidances, CA transparancy law, and MA medicaid waiver denied

Industry Trends – copay accumulators, will the CVS-Aetna deal get a green light, new PBM player, regional drug price differences, 2 COI stories, ER drug shortages, Alzheimer’s reconsideration, and research “breakthroughs”

Now, on to the news.

ICER In The News

Last week, ICER announced that Chief Scientific Officer Dan Ollendorf, PhD, will be leaving his current role at ICER. Dan will take up a position as the Director of Value Assessment and Global Health Initiatives at the Center for the Evaluation of Value and Risk in Health (CEVR) at Tufts Medical Center.

“Dan has been an extraordinary colleague and has been an integral part of every step of ICER’s evolution since we first launched over 10 years ago,” said Steve Pearson, MD, MSc, ICER’s President.

With the announcement of Dan’s departure, ICER has launched a nationwide search for a new Chief Scientific Officer. To learn more about the position, please visit ICER’s website. Dan’s departure was covered in Politico’s Prescription Pulse newsletter.

Institute for Clinical and Economic Review Announces Departure of Dan Ollendorf; Launches Search for New Chief Scientific Officer

ICER released a Draft Evidence Report assessing the comparative clinical effectiveness of three antiandrogen therapies for high-risk, nonmetastatic castration-resistant prostate cancer. The report, which reviews abiraterone acetate (Zytiga, Janssen and Yonsa, Sun Pharmaceuticals), apalutamide (Erleada, Janssen), and enzalutamide (Xtandi, Astellas and Pfizer), also assesses the value of enzalutamide and apalutamide. The report and accompanying draft voting questions will be open to public comment until August 9, 2018.

Institute for Clinical and Economic Review Releases Draft Evidence Report on Antiandrogen Therapies for Nonmetastatic Castration-Resistant Prostate Cancer

ICER released a Final Evidence Report and Report-at-a-Glance on three calcitonin gene-related peptide (CGRP) inhibitors for prevention of migraine attacks: erenumab (Aimovig, Amgen/Novartis), fremanezumab (Teva), and galcanezumab (Eli Lilly). Erenumab was approved in May of 2018, while the other two agents remain under FDA review. The report notes the significant remaining uncertainty about the long-term safety of CGRP inhibitors given their new mechanism of action, highlights that their clinical and economic value hinges on use among patients for whom other available treatments have not been successful.

The release of the final report was covered in the following publications: BioPharmaDive  FiercePharma  PMLive  ManagedCare  

Institute for Clinical and Economic Review’s Final Report on CGRP Inhibitors for Migraine Prevention Explores Specific Coverage Policy Options in Light of Responsible Manufacturer Pricing

This FiercePharma report on Vertex’s battle with the UK’s NICE over an adverse coverage decision references ICER’s work.

Vertex chief, thwarted by NICE, pressures England’s PM to play ball on drug prices

Vertex was already playing hardball with England’s cost-effectiveness watchdogs as price talks for its CF drugs hit yet another impasse last week-and this after its “most innovative and best” offer yet. But CEO Jeffrey Leiden took it to a new level Friday with a letter to U.K. Prime Minister Theresa May.

Pharmaceutical News

Inside the Beltway/State Developments

Where to begin…  First, let me attempt to summarize the situation, then we’ll get to some of the coverage. 

While we were attempting to vacation, Pfizer announced it was raising the price of about 100 drugs as of July 1. These increases came in the wake of the Administration saying companies were going to lower their prices. Needless to say, the President was not pleased and tweeted his displeasure. Then, after a call with Pfizer’s CEO, the President announced the company had changed their mind and was rolling back its price increases. What Pfizer fully said is they would return prices to the level they were on June 30 – but that the price increases were only deferred to either January 1 or when the Administration’s Blueprint is enacted, whichever comes first. (Keep in mind that it is doubtful the Blueprint will be implemented this year. The document contains several open questions, and many of the steps would require congressional action.) 

Now to some of the coverage:

Secretary Azar said “change is coming” for the 340B program – but as Healthcare Dive reported, he neglected to mention what that change would be.

Azar says ‘change is coming’ for 340B

HHS Secretary Alex Azar warned hospitals and drugmakers both on Monday that “change is coming” to the 340B program, stressing the “need to disrupt the entire system of rebates.” He emphasized the administration’s plans to reduce the gap between drug discounts and reimbursements.

Yesterday CMS released their proposed physician fee schedule for 2019. It included a reduction in the wholesale acquisition cost add-on from 6% to 3%. A similar proposal by the Obama Administration ended up being withdrawn. We’ll see if this one sticks.

Physician Fee Schedule: CMS to Trim Part B Add-On for New Drugs | HealthLeaders Media

The Centers for Medicare & Medicaid Services announced a series of proposed changes Thursday to Medicare’s physician fee schedule for 2019 promising, among other things, to advance the Trump administration’s commitment to lowering prescription drug prices. Included in the proposal is a significant reduction in the amount Medicare pays physicians for new prescription drugs.

Remember last year (no, not that) when the Pentagon wanted to do an end-run around the FDA and approve stuff on their own? Well, the compromise that emerged has yielded its first EUA (emergency use authorization) as The Hill reports the military will use freeze-dried plasma from France – a product that has not been approved for sale in the US.

FDA approves freeze-dried blood plasma for troops in combat

The Food and Drug Administration (FDA) on Tuesday approved freeze-dried blood plasma for use to treat combat injuries from U.S. troops, after a dispute over whether access would be allowed.

This one almost slipped by… Politico reports that earlier this year, CMS quietly pulled back from a value-based payment agreement over concerns the manufacturer was exerting too much influence in how the deal was structured.

CMS quit test of pricey cancer treatment amid concerns over industry role

Medicare and Medicaid administrators earlier this year quietly killed a plan to pay for a breakthrough, half-million-dollar cancer treatment based on how well it worked, scuttling one of the Trump’s administration’s first and most highly touted attempts to lower the cost of drugs.

The FDA released six gene therapy draft guidances. RAPS provides summaries and links to the original documents.

FDA Unveils 6 New Draft Guidances on Gene Therapy

As first announced in January, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Wednesday offered a swath of new draft guidance documents on human gene therapies – offering a look at what it expects from an industry that’s beginning to take off.

Is California’s price transparency law having an impact? The answer seems to be… wait for it… it’s complicated. While several announced price hikes have been rolled back (no not Pfizer, we deal with that one elsewhere), one industry observer told Bloomberg he thinks there is less there than meets the eye:

“What seems like transparency or falling prices forced by the new law may not actually be so, said Richard Evans, an health and pharmaceutical analyst at SSR in Montclair, New Jersey.

Pharmaceutical companies are likely “throwing up a smokescreen” to conceal the timing and magnitude of their actual price increases from competitors, or from purchasers who might then stock up in advance of an increase, said Evans. He predicted that the law won’t slow the actual rate of actual price increases.”

Drugmakers Cancel Price Hikes After California Law Takes Effect

Massachusetts wanted a Medicaid waiver so they could institute a drug formulary (to save money). FiercePharma reports on the rejection of the waiver application by the Feds.

No, Massachusetts, you can’t run a PBM-style Medicaid formulary, feds say

As drug pricing moves at the federal level have floundered, state officials have taken matters into their own hands. But Massachusetts is discovering there’s a limit to drug-pricing innovation. Last year, the state asked for permission to manage its Medicaid drug coverage using a formulary, just as private insurers and pharmacy benefits managers do.

Industry Trends

So about those “copay accumulator” programs – you remember, the ones designed to exclude manufacturer copay assistance from deductible calculations – Reuters reports it looks like they’re having an impact and worrying manufacturers about their increasing prevalence.

Drugmakers try evasion, tougher negotiations to fight new U.S….

NEW YORK (Reuters) – In the escalating battle over U.S. prescription drug prices, major pharmaceutical companies are scrambling to limit the economic damage from a new U.S. insurer tactic that coaxes patients away from expensive drugs. The latest move by insurers – which effectively forces drug companies to pay more to assist patients with their copays – is causing a decline in real U.S.

In Axios Vitals Newsletter this morning, Sam Baker reports that the Department of Justice may not challenge the CVS-Aetna merger.  (Am I the only one who, when reading about the Department of Justice, pictures the Justice League headquarters building in Super Friends?)

1 big thing: CVS-Aetna may get the green light

Bloomberg reports a new PBM is announced, but can it make any headway in the market?

After Feuding With Drug Middlemen, Startup Fields a Competitor

Regional differences in drug prices – why some of these differences exist is anybody’s guess. Here’s the average price for Metformin for select cities: Birmingham — $43.00, Boston — $28.57, Columbus — $11.16, New York — $66.23, San Francisco — $49.36. (A NY Times report of the study is below, the original GoodRx report can be found here.

What Does a Drug Cost? It Depends on Where You Live

What you pay at the pharmacy for generic drugs can vary widely based on where you live, according to a new analysis by the consumer website GoodRx. The study, which looked at 500 commonly used drugs in 30 American cities, highlights just how unpredictable drug prices can be.

When is a conflict of interest a conflict of interest…  and when should it be disclosed? Both Kaiser Health News and Science investigated the topic – both stories below.

Top Policy Expert’s Ties To Giant Drugmaker Often Go Unstated

When Dr. Mark McClellan sat for an in-depth 30-minute question-and-answer session at an April health policy forum, the audience was filled with top researchers, advocates and Capitol Hill staffers eager to hear what insight the former head of the Food and Drug Administration would dispense. He did not disappoint.

Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns

On a sweltering July day in 2010, seven medical researchers and one patient advocate gathered in a plush Marriott hotel in College Park, Maryland, to review a promising drug designed to prevent heart attacks and strokes by limiting blood clotting.

Along with warm weather, summer also brings drug shortages reports the NY Times.

Emergency Rooms Run Out of Vital Drugs, and Patients Are Feeling It

Summer is “trauma season,” when emergency rooms see a rise in injuries, but a drug supply crisis has doctors scrambling to find alternatives to needed medications. CHICAGO – George Vander Linde tapped a code into the emergency room’s automated medicine cabinet. A drawer slid open and he flipped the lid, but found nothing inside.

Several months ago, Biogen/Eisai reported on the failure of their PhII trial for their Alzheimer’s drug BAN2401. Now, Endpoints reports on their press release that says they spoke too soon – using different statistical methods, they see positive results. It is unclear if there is something there or not, as the press release did not give many details (they will be presented later). Initially, the stock market was pleased, but upon reflection the market (and others not affiliated with the study) have questions. In fact, one analyst downgraded Biogen. My bottom line, until the actual results are reviewed, it’s too soon to break out the champagne.

That Alzheimer’s drug that flunked a PhII? On second look, Biogen/Eisai say it’s a winner

Seven months ago, Biogen and Eisai were forced to abandon their plans for a quick pivot into Phase III as their Alzheimer’s drug BAN2401 failed a decisive Phase II. Now, with the full 18-month analysis in hand, the partners are saying they were right to persist. Biogen’s stock $BIIB surged

Research breakthroughs mean mice are now immortal – OK, not really. However, given some headlines, I wouldn’t blame you if that’s what you believed. However, while developments may be overhyped, sometimes they are significant. Here are three stories on developments that may be in the significant category, although it’s too soon to tell.

Experimental Drugs Boost Elderly Immune Systems, Raising Hopes For Anti-Aging Effects (NPR)

CRISPR makes cancer cells turncoats that attack their tumor, mouse study finds (STAT)

Parker Institute scientists herald a cell therapy breakthrough in the lab, using next-gen CRISPR tech to engineer T cells (EndPoints) 
@mhstein  |

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