ICER Weekly View 10-26-18

From the desk of Mitchell Stein

 

Good morning. Presidential speeches, Wall Street Journal profiles, price changes, drug approvals, PBM developments… So much news, so little time so let’s get right to it. This week we’ll look at:

ICER in the News – WSJ profile of John Arnold, evidence report on extended-release opioid use disorder treatments, ICER won’t proceed with the assessment of Canakinumab, 60% price cut for Repatha, and expanded approval for Dupixent

Inside the Beltway – President’s speech on drug prices (lots of coverage), PhRMA spends big on lobbying, the President may work with Democrats on drug pricing, and Maryland appeals to SCOTUS on drug pricing law

Industry Trends – Express Scripts opens network, Avik Roy on PBMS, CVS-Aetna update, Centene-RxAdvance update, Xofluza approval, ESMO recap, immune therapy breakthrough for breast cancer – not so fast, interview with Dr. Prasad, Humira biosimilar update, and probiotic review.

Now, on to the news.


ICER in the News

Peter Loftus of the Wall Street Journal (subscription required) took an in-depth look at the drug pricing work of John Arnold and the Arnold Foundation. In discussing why the drug industry is different, Mr. Arnold said: “In any other industry where you have some type of monopoly, where the good that’s being sold is viewed as a necessity, and there aren’t close substitutes, there has to be a strong regulatory environment on how to ensure access and ensure affordability…”

The Foundation has funded several groups (including ICER) working on the issue, and the WSJ profile includes interviews with many of the principals. ICER’s President Steven Pearson noted: “…patients deserve access to the medicines they need, and ICER’s methods help reveal what fair prices would be for those medicines.”

Biospace posted a follow-up piece that looked at the groups funded by the Foundation: Billionaire Activist Has Invested Over $100 Million for Cheaper Meds.

A Billionaire Pledges to Fight High Drug Prices, and the Industry Is Rattled

Ex-energy trader John Arnold has put millions behind efforts to curb prices. Drugmakers say his view is flawed and oversimplified, and will restrict patients’ access to important medicines.

ICER released an Evidence Report 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: CAM2038 (Braeburn), an investigational agent currently under FDA review, and Sublocade (Indivior).

“Opioid use disorder is devastating families and communities in the US,” said David Rind, MD, ICER’s Chief Medical Officer. “Extended-release medications have generated clinical interest because of their potential to improve individuals’ ability to remain in treatment. It is helpful to have multiple formulations available to be able to tailor treatment for each individual’s needs, but the findings of our analysis suggest that these extended-release formulations achieve at most marginal clinical benefits over generic buprenorphine/naloxone, and at far higher costs.”

Institute for Clinical and Economic Review Report Finds Extended-Release Treatments for Opioid Use Disorder Provide Only Marginal Benefits Over Generic Alternatives, at Significantly Higher Prices

 

ICER announced that it would not proceed with its comparative clinical effectiveness and value assessment of canakinumab. This decision is the result of the Food and Drug Administration recently issuing a Complete Response Letter to Novartis Pharmaceuticals, declining to approve canakinumab’s expanded indication for atherosclerotic cardiovascular disease. The news was reported on by the PharmaLetter

Institute for Clinical and Economic Review Ends Assessment of Canakinumab for Atherosclerosis

 

Amgen announced a 60% price cut for Repatha. Many of the articles included reference to ICER’s work on the topic including that the revised price is still above the level set for cost-effectiveness in ICER’s updated work that was done after the FOURIER trial. In addition to the MedPage Today story below, ICER’s work was referenced in the STATAJMC, and TCTMD articles.

Amgen Plans 60% Price Cut for Evolocumab

 

Dupixent received expanded approval from the FDA in asthma. BioPharma Dive reported on the approval along with ICER’s work on the topic. The approval and ICER’s work was also reported in Evaluate.

Regeneron and Sanofi’s Dupixent gains asthma approval

Sanofi and Regneron have won an expanded U.S. approval for Dupixent in asthma, securing another indication for the biologic drug which the companies are counting on to deliver blockbuster sales. On Friday, the Food and Drug Administration OK’d the drug for moderate-to-severe asthma patients with an eosinophilic phenotype, or with oral corticosteroid-dependent asthma regardless of phenotype, the companies said.

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: Chief Scientific Officer

The role of the CSO includes oversight of a skilled research team at ICER and the overall production of ICER reports, management of ICER’s engagement with outside academic researchers, and leadership in the evolution of ICER’s methods of value assessment and report development. The CSO will be a key member of ICER’s Senior Management Team and a central figure in ICER’s strategic planning and all other high-level activities.


Pharmaceutical News

Inside the Beltway/State Regulatory Developments

The President’s speech on drug pricing

The proposal:

The President gave a speech yesterday on drug pricing while HHS released an Advance Notice of Proposed Rulemaking. The main proposal was a pilot program (under a feature of the ACA): International pricing Index Model for Medicare Part B Drugs. The pilot would be defined in a proposed rule that might be issued next spring (with the pilot potentially beginning in early 2020). It would eliminate the AWP + 6% reimbursement for Medicare Part B (physician’s office) drugs and replace it with a system where the reimbursement level was set relative to drug prices in certain other countries. This stems from the President’s position that other countries are taking advantage of the US by paying half of what the US pays for some drugs (as outlined in a report issued by HHS earlier in the day). The proposal is similar to one made by the Obama administration that was ultimately killed. 

Here, from Donna Young of S&P Global, is one of the best pieces of the many (many many) I read about the proposal.

Trump mulls testing international pricing model for Medicare injectable drugs

The reactions:

The overall reaction was muted, as reported by Politico.

Trump’s drug plan falls flat in health care messaging war

President Donald Trump tried Thursday to make good on a campaign vow to lower drug prices – attacking “foreign freeloaders” and proposing significant changes to how Medicare pays for many drugs. But his populist proposal didn’t appear likely to budge the national debate around health care, just days ahead of the midterm elections.

Not surprisingly, manufacturers were not happy, as reported by Bloomberg.

Drug Lobby Compares Trump Drug Price Plan to ‘Socialized’ System

Some reporting noted certain inconsistencies in the approach, as reported by Business Insider.

Trump’s newest plan to drive down drug prices to fight ‘global freeloaders’ sounds exactly like what a lot of those ‘freeloaders’ are already doing

President Donald Trump on Thursday is giving a speech on ways to curb drug pricing. The speech will focus on spending in the part of Medicare that pays for seniors who get drugs administered in a doctor’s office.

Conservative economist Craig Garthwaite had observations on Twitter including this question: “It seems like we are not negotiating but tying ourselves to the mast of European price controls? ”  

And finally, Margot Sanger-Katz of the New York Times had several insightful observations on Twitter.

Now on to the rest of the news.

PhRMA continues to spend big on lobbying according to this report from FiercePharma.

As elections near, PhRMA’s lobbying spend on track for potential record-breaking year

Pharma has come under political pressure in Washington, D.C., and lobbying spend shows the industry is taking the threat seriously-and shelling out accordingly. In fact, it just might approach-or even break-the $27.1 million spent in 2009 as the Obama administration came into power.

While I’m not sure that this will ever come to pass, the New York Times speculates on the President working with Democrats on drug pricing.

What Big Pharma Fears Most: A Trump Alliance With Democrats to Cut Drug Prices

WASHINGTON – The pharmaceutical industry, pilloried by President Trump for the last two years, is war-gaming for the possibility that its worst fear is realized: that Democrats, if they flip control of the House, find common ground with the president to rein in drug prices.

Maryland asks the Supreme Court to overturn a appeals court decision that struck down Maryland’s drug pricing law (AP).

Maryland asks Supreme Court to uphold law on drug pricing

ANNAPOLIS, Md. (AP) – Maryland Attorney General Brian Frosh petitioned the U.S. Supreme Court on Friday to uphold a first-in-the-nation law against pharmaceutical price gouging. The Maryland law, which was struck down by a federal appeals court panel this year, enabled the state’s attorney general to sue makers of off-patent or generic drugs for price increases that state officials considered “unconscionable.”

Industry Trends

The PBM industry continues to evolve at a breakneck pace. Bob Herman of Axios reports on Express Scripts opening their network to other mail-order pharmacies.

Express Scripts is opening up its mail-order pharmacy network

Express Scripts sent a notification this month to pharmacies saying its networks will expand to include “pharmacies predominantly engaged in mail-order practice” by the first quarter of 2019.

Avik Roy, writing in Forbes, suggests that it’s manufacturers, not PBMs, who are responsible for high drug prices.

Drug Companies, Not ‘Middlemen’, Are Responsible For High Drug Prices

As pharmaceutical companies have faced more heat for their pricing practices, they’ve found someone else to blame: “middlemen” who extract discounts from drugmakers. But in fact, if it weren’t for middlemen like wholesalers and pharmacy benefit managers, drug prices would be even higher.

Speaking of PBMs, despite concerns earlier in the week, FierceHealthcare reports that the CVS-Aetna merger is expected to be approved by NY regulators. Their approval is the last step needed before the merger can proceed.

Confidence remains in CVS-Aetna deal despite pushback from New York regulators

Sharp rhetoric from New York regulators isn’t expected to derail the $69 billion CVS-Aetna deal, according to one financial analyst. Getting approval from New York is the merger’s last big regulatory hurdle, after receiving approval from the Department of Justice earlier this month.

While the attention is focused on the bigger insurer/PBM combinations, Centene is busy crafting a new relationship with RxAdvance. Forbes Bruce Japsen reports on Centene’s plan to roll out the integration which they promise will be a game-changer: “We will be moving to a different operating model, which is built around transparency and more focused on cost-sharing for total cost of care, so integration of pharmacy cost with the more comprehensive total medical costs…”

Centene Rolls Out RxAdvance PBM Promising Drug Cost Transparency

Health insurer Centene has begun rolling out its new relationship with the pharmacy benefit manager, RxAdvance, a cloud-based PBM trying to tap into the rapidly changing business of controlling drug costs. Run by executives that include former Apple chief executive John Sculley, RxAdvance bills itself as a full-service PBM that Centene took a financial stake in earlier this year.

Xofluza was approved by the FDA. This one will be interesting to watch as the new drug has the convenience factor of only requiring one dose, but it is no more effective than Tamiflu. How much is convenience worth? Stay tuned (AP).

US approves first new type of flu drug in 2 decades

TRENTON, N.J. (AP) – U.S. health regulators have approved the first new type of flu drug in two decades. Wednesday’s approval of Xofluza for people age 12 and older comes ahead of the brunt of this winter’s flu season. Xofluza is a pill that can reduce severity and shorten duration of flu symptoms after one just dose.

In case you’ve been otherwise occupied, BioPharma Dive provides a review of the European Society for Medical Oncology conference.

ESMO 2018: What you missed over the weekend

Researchers, investors and analysts continue to pore over clinical results reported over the weekend at the annual meeting of the European Society for Medical Oncology, which kicked off Friday and runs through Tuesday. Europe’s answer to the American Society of Clinical Oncology’s yearly conference, ESMO brought notable updates from immunotherapy leaders like Merck & Co.

Elaine Schattner, writing in Forbes, discusses that reports of an Immune Therapy breakthrough for Breast Cancer have been greatly exaggerated.

Not So Fast With Immune Therapy For Breast Cancer

Since I began writing here at Forbes, it’s become harder to keep up with new oncology drugs. So many medicines are being tested, who can keep track of them all? Days ago, investigators reported results of a multinational trial of an immune drug, combined with chemotherapy, in patients with advanced triple negative breast cancer (TNBC), an aggressive form.

MIT Technology Review interviewed Dr. Vinay Prasad (who, like ICER received funding from the Laura and John Arnold Foundation – see first item above). He discusses his concern about overhyping precision medicine: “I’m very optimistic about science, that we will improve outcomes. I just think that we would benefit from a lot more empiricism and impartiality in the process. That’s what I feel is missing—empiricism, impartiality, and more modest rhetoric. I think those three things would go like 90% of the way.”

The skeptic: What precision medicine revolution?

Vinay Prasad is relatively young (35) and still climbing the academic ladder (he’s an associate professor of medicine at Oregon Health & Sciences University in Portland), but he has already established an outsize reputation as a “professional scold” for his sharp critiques of contemporary biomedical research, including personalized medicine.

We’ve discussed the continued absence of (much) biosimilar competition in this country before. I found this article (and accompanying chart) helpful in driving home the point that Europe will get competition to the multi-billion dollar drug Humira at least five years before the US does.

Battle Over Humira Begins in Europe as 5-Year Wait Begins in US

Posted 22 October 2018 | By Zachary Brennan The world’s best-selling biologic, AbbVie’s Humira (adalimumab), is now facing competition in Europe from at least four companies, although the US will have to wait until 2023 for competition.

EndPoints reports that the latest update on the Alzheimer’s drug BAN2401 seems to be a replay of last month, with new data resulting in more market skepticism instead of less. 

Biogen, Eisai fight back against accusations their big BAN2401 study was skewed — but this fight isn’t over yet

After getting slapped hard by critics for the way it handled their recent trial summary for their Alzheimer’s drug BAN2401, Eisai and their partners at Biogen $BIIB turned up at an Alzheimer’s conference in Barcelona to present their defense of the data after crunching the numbers again. But it’s not

“For too long we’ve assumed that probiotics are doing some good and little harm. That might be true for some, but it’s not assured in the current environment.” So reports Dr. Aaron Carroll in an NY Times Upshot column.

The Problem With Probiotics

The New Health Care There are potential harms as well as benefits, and a lot of wishful thinking and imprecision in the marketing of products containing them. Even before the microbiome craze – the hope that the bacteria in your gut holds the key to good health – people were ingesting cultures of living micro-organisms to treat a host of conditions.

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