From the desk of Mitchell Stein
Good morning. So yesterday I innocently go out to walk my dog, and it starts snowing! Yes, it’s Maine, but it’s only October – way too soon for snow. This little story has nothing to do with this week’s news; I am just still not over the shock. OK, even though winter is coming, let’s get to the news where this week we’ll look at:
ICER in the News – ICER considers biopharma request for early advice, Express Scripts new migraine drug program, cost-effectiveness and Shire’s Takhzyro, and Dupixent discussion
Inside the Beltway – Administration’s plan to include prices in ads (lots of coverage), pediatric trials, Democrats question drug makers, and Minnesota AG sues over insulin prices
Industry Trends – Kaiser looks at drug manufacturers political contributions, Eyles responds to Carrier, United Heath to use step-therapy in Medicare plans, Novartis goes shopping, antibiotics need a new compensation model, Merck ending insulin development, and a universal cure for snake bites
Now, on to the news.
ICER in the News
ICER is considering working with life sciences companies on early reviews of their clinical trial designs. Below is a statement from ICER’s David Whitrap, Vice President of Communications and Outreach:
“For some time, ICER has been receiving requests from life sciences companies to help them rethink clinical trial design so that the trials more adequately measure the types of outcomes that matter most to patients and their families. Some international health technology organizations, such as NICE and CADTH, have offered this ‘early scientific advice’ to industry for many years with general success. We are therefore evaluating the options to provide a similar service but have not made any definitive plans. If we do pursue such a program, we would only do so in a manner that would preserve ICER’s independence and integrity, and only if offering the early advice to manufacturers would further our core mission of helping all patients achieve access to high-value care.”
Below is coverage from FierceBiotech. There was also coverage in RAPS “ICER Plots Early Scientific Advice Program for Biopharma” (the same article was reposted by EndPoints News), STAT Plus “A cost-effectiveness watchdog may charge drug makers for ‘early scientific advice’” (behind a paywall), and BioCentury “ICER WEIGHING ISSUING ADVICE ON TRIAL DESIGN“.
The Institute for Clinical and Economic Review (ICER)-an independent source for information on the cost-effectiveness of new, cutting-edge drugs and big-ticket therapies-is considering offering biotech companies early scientific advice and direct guidance in clinical trial design, for a fee.
Express Scripts announced a new program to cover some of the new class of migraine drugs. The company’s announcement, as well as much of the media coverage, included discussion of ICER’s work on the topic. In addition to the Reuters story below, there was coverage in BioPharma Dive, Xconomy, the PharmaLetter (subscription required) and StreetInsider.
Express Scripts Holding Co, one of the largest U.S. prescription benefits managers, will cover new migraine drugs from Eli Lilly and Amgen Inc, but exclude a rival medication from Teva Pharmaceutical Industries Ltd after price negotiations with all three manufacturers.
Evaluate/Vantage reports on ICER’s report on treatments for hereditary angioedema, focusing on the discount needed for the Shire drugs to reach commonly cited thresholds for cost-effectiveness. Importantly, ICER noted in its press release last week that these cost-effectiveness results are highly sensitive to patients’ baseline frequency of attacks.
A damning report by the US pricing watchdog Icer could bode ill for the uptake of Shire’s big hereditary angioedema hope.
FiercePharma’s article on Dupixent includes discussion of ICER’s work on the drug’s potential use for asthma.
Analysts expect Dupixent to be a $3 billion-plus blockbuster for Sanofi and Regeneron, but to get there, the drug needs to move beyond atopic dermatitis. An asthma nod could come soon, and now the companies can tout strong sinusitis data, too. But challenges abound, including payer pushback.
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: The Research Lead, Evidence Synthesis will participate in multiple scientific activities, including developing strategy for and performing literature searches, critically evaluating the research methods and statistical findings of health outcome studies from the medical literature, and conducting qualitative and quantitative synthesis of evidence from literature and other sources.
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:
The Research Lead, Evidence Synthesis will participate in multiple scientific activities, including developing strategy for and performing literature searches, critically evaluating the research methods and statistical findings of health outcome studies from the medical literature, and conducting qualitative and quantitative synthesis of evidence from literature and other sources.
Inside the Beltway/State Regulatory Developments
The Administration issued a proposed rule that requires pharmaceutical manufacturers to include the list price of a drug in television advertising to consumers. The industry tried to preempt the announcement by announcing that their advertising would include information on where consumers could find out more about pricing (such as sending them to a website) without the ad including the actual list price. The Administration said the industry’s proposal was insufficient. You can read about the dueling proposals in Politico: Trump issues rule to require drug prices in TV ads, rejecting industry plan.
As a reminder of why this matters, FiercePharma reports about TV ad spending: “The top 10 brands dropped $1.19 billion through Sept. 30“.
Law Professor, drug pricing expert, and member of Midwest CEPAC Rachel Sachs shared her reaction on Twitter. Among her concerns are that CMS may not have the authority to issue the rule (as opposed to the FDA), that the rule has a lack of enforcement provisions, and like many, she questions the impact of the proposed rule. Also questioning the impact of the proposed rule in a thoughtful piece is STAT’s Ed Silverman: “The list price is not right: Trump’s plan to force pharma to advertise prices is misguided“. Some have wondered why the Administration picked this issue to go head-to-head with industry. The Hill looks at that question here: “Trump officials ratchet up drug pricing fight“.
And finally, BioPharma Dive attempts to sum up the issue with their five questions (apparently this is more complicated than Passover, which only gets four questions).
Pharma, which spends billions each year to advertise its products on television, is expected to fiercely oppose the proposal.
In response to regulatory requirements, the FDA published a list of 200 cancer targets requiring pediatric trials.
In a move to spur development of drugs for pediatric populations and require more studies of pediatric cancers, FDA published Tuesday a list of 200 molecular targets for which companies developing directed compounds must conduct pediatric clinical studies.
The political battles over this year’s tax cut spill over into the pharmaceutical world as five drugmakers are questioned by Democrats in Congress.
In letters to the CEOs of five top US drugmakers, 16 House Democrats question the companies’ actions on pricing, investment in research and development, employment, stock buybacks and executive compensation in light of tax savings as a result of the 2017 Tax Cuts and Jobs Act (TCJA) .
The Minnesota Attorney General filed suit against three drug companies over insulin prices. Many across the country will be keeping a close eye on this one (The Hill).
The Minnesota attorney general on Tuesday filed a lawsuit against three major pharmaceutical companies for “deceptive and misleading” price increases for insulin to treat diabetes. “Insulin is a life-or-death drug for people with diabetes,” Minnesota Attorney General Lori Swanson (D) said in a statement.
Kaiser Health News created a database and took an in-depth look at drug manufacturers’ political contributions. The article is below, and you can access the database directly here.
Drugmakers’ contributions to lawmakers have peaked as surging drug prices emerge as a hot-button political issue. In the past decade, Congress has received nearly $79 million from 68 pharma PACs, run by employees of companies that make drugs treating everything from cancer to erectile dysfunction.
Matthew Eyles, President and CEO of America’s Health Insurance Plans, responds to a previous Health Affairs post from Michael Carrier.
It isn’t surprising that drug manufacturers want to weaken the leverage of the negotiators who are lowering their prices. However, weakening PBM and health plan leverage will make the drug-pricing problem worse, not better. Instead, policy makers should consider the following solutions, which specifically target the tools that manufacturers use to prevent competition and keep prices high.
UnitedHealthcare will use step-therapy in its Medicare plans (per new government guidance), which may increase use of biosimilars (FiercePharma).
Armed with new rules from CMS, UnitedHealthcare is making some moves in its Medicare plans that could hit Johnson & Johnson’s Remicade and jump-start biosims from Pfizer, Merck & Co. and more. The insurance behemoth will roll out step therapy to control costs on pricey biologics, including Remicade, which has managed to hang on to market share despite the multiple biosims now on the market.
Novartis makes a $2.1 billion acquisition – and Bloomberg reports they may not be done.
We talk periodically about the antibiotic crisis. In case you’re not frightened enough, Wired has you covered. But after scaring you, the piece discusses a possible solution: treat antibiotics as infrastructure (or to put it another way, as a public good) and change the compensation model for those developing and manufacturing them.
In early October, the Food and Drug Administration approved a new antibiotic: Nuzyra, generic name omadacycline. Omadacycline is a tweaked version of a tetracycline, a class of drugs that have been around since the very beginning of the antibiotic era; it works against skin infections and cases of pneumonia.
Given the continuing concern over insulin prices (see the MN AG lawsuit article above), it is a testament to the complexity of manufacturing biologics that Merck is backing away from entering the market (BioPharma Dive).
Merck & Co. and Samsung Bioepis jointly bailed on bringing a diabetes insulin treatment to market that would have mimicked Sanofi’s Lantus, both drugmakers confirmed to BioPharma Dive on Friday. According to a Korean stock exchange disclosure form, Merck will pay Samsung Bioepis a termination fee of roughly $155 million.
Imagine a universal shot for all snake bites instead of species-specific anti-venom. The New York Times reports on one chemist who thinks it may be possible.
Global health Snakes kill or cripple 500,000 people a year, but antivenins are costly and rare in poor countries. Now scientists are testing injectable nanoparticles that neutralize venom. An Epi-Pen to treat a snakebit e?