From the desk of Mitchell Stein
Good morning. Thankfully, we’ve almost made it through another week. Thankful, because this week the non-pharma news was as bad as it’s been, to the point where I was (once again) questioning the time I spend on Twitter (no really, I do it for you, my loyal readers). However, in the midst of this existential crisis, a female hero emerged, reminding me the Internet can bring good news as well as bad. So here, in case you somehow missed it, is the first trailer for Captain Marvel (what, you didn’t think I was going to talk politics, did you?). Although that would have been enough to restore my faith in humanity, there was more! On Thursday, because sometimes the universe is kind, the new Doctor Who trailer brought us another hero for these dark time. So reinvigorated, let’s proceed to the pharma news; this week we’ll look at:
ICER in the news – Discussion of the new CVS formulary offering using ICER results continues (several stories), ICER’s impact on drug spend, more on migraine drugs, and Dr. Pearson to appear on a panel
Inside the Beltway – Gag clause bill moves forward (2 stories), step-therapy in MA (2 stories), donut hole changes rollback (2 stories), failure to report penalties, and 340B transparency
Industry Trends – Cigna/Express Scripts get Justice Dept. go-ahead, CA sues AbbVie over Humira (2 stories), clinical trials fail to represent drug target populations, Florence’s minimal impact on drug manufacturing, what to think about aspirin, new approach to Alzheimer’s, and a look back at the Tylenol scare that changed how we package drugs
Now, on to the news.
ICER In The News
The CVS announcement that it will use ICER reports to help structure a new plan design offering received additional attention this week. Health Affairs published two blogs providing a point/counter-point on the topic: “Why CVS Is Giving Plans A New Tool To Target High Launch Prices” from two executives at CVS, and “CVS To Restrict Patient Access Using Cost-Effectiveness: Too Much, Too Soon” from an executive with the National Pharmaceutical Council.
Vox reports on the debate:
Can a prescription drug simply cost too much for health insurance to cover? That idea is implicit in a new program by CVS Health, one of the largest pharmacy benefits managers (PBMs) in the country. The pros and the cons of the proposal were debated on Monday in Health Affairs, with pharmaceutical interests coming out with a critique and CVS defending itself .
Managed Care Magazine published the results of work by ICON plc looking at the potential dollar impact of ICER on drug spend: “From the payer point of view, expenditures on the drugs included in our analysis would decrease $9.8 billion a year.” ICON also looked at ICER’s potential role: “We expect contracting negotiations to be significantly affected by ICER assessments in the coming years. Manufacturers need to be prepared to reconcile their economic evaluations with ICER’s.”
A few years ago, if you had mentioned ICER, even pharma industry insiders wouldn’t know what you were talking about-or would have confused it with confirmation of naval orders (aye, sir!). Now ICER-the acronym for the Institute for Clinical and Economic Review-has become familiar to anyone involved in the business side of the pharmaceutical industry and a major force in payer-manufacturer price negotiations.
Teva received FDA approval for its migraine treatment Ajovy, one of the new class of migraine drugs reviewed by ICER this year. The Biopharma Dive article below as well as this PMLive article mention ICER’s work on the topic.
Teva Pharmaceutical on Friday secured a crucial U.S. approval for its preventive migraine treatment Ajovy, overcoming manufacturing problems at the drug’s South Korean supplier which had threatened to further delay regulatory review. Ajovy arrives on the market four months after a similar drug from Amgen and Novartis won a first-in-class OK from the Food and Drug Administration in May.
Next week, ICER’s President Dr. Steven Pearson will appear at a Harvard/Reuters forum on U.S. drug pricing:
THE DR. LAWRENCE H. AND ROBERTA COHN FORUMS U.S. DRUG PRICES: Why Are They So High? Presented jointly with Reuters Americans pay more money – sometimes much more money – for prescriptions than consumers in many other wealthy countries. Why? The drivers are many and complicated.
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: Research Lead 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
This week the Senate passes a bill (98-2) banning “gag clauses.” The Washington Post’s Paulina Firozi reviews the law and its potential (limited) impact. The bill also contains a section regarding the “pay-for-delay” deals that have been slowing the launch of biosimilars, an issue that BioPharma Dive covers in the second article below.
Analysis | The Health 202: Senate passage of ‘gag clause’ ban is just a tiny step to lowering drug prices
Lowering the price of prescription drugs is a popular talking point for both sides of the aisle, and a mantra for President Trump. The Senate last night took a step in that direction by voting to eliminate “gag clauses” that pharmacists say prevent them from disclosing when there’s a cheaper way to buy prescription drugs.
The U.S. Senate passed a bill Monday that would require disclosure of settlements reached between biologic and biosimilar developers to the Federal Trade Commission, revising an existing law that governs generic drugs to include biosimilars.
There is increased focus on step therapy, with its use in Medicare Advantage plans set to begin in 2019. This week we have two articles on the topic – first Kaiser Health News takes a look at the new regulations, then Health Affairs reviews the current use of step therapy in employer plans.
This story also ran on This story can be republished for free ( NPR. details). Starting next year, Medicare Advantage plans will be able to add restrictions on expensive, injectable drugs administered by doctors to treat cancer, rheumatoid arthritis, macular degeneration and other serious diseases.
Because plans independently judge the strength of a product’s evidence and value, and tailor drug coverage decisions to their own enrollees and situations, some variation in plan behavior is expected. Moreover, how aggressively plans manage specialty drugs is presumably influenced by negotiated prices, available financial resources, the degree of competition within a plan’s operating region, and local practice patterns.
Pharma ad wars, begun they have. This week a patient advocacy group began an ad campaign to counteract industry ads that support the rollback of changes to the Medicare Donut Hole (The Hill).
Drug-pricing advocates are launching a six-figure ad campaign to try to stop Congress from rolling back a move targeting drug companies. The ads from Patients for Affordable Drugs Now seek to counteract an aggressive lobbying push by drug companies to undo a change from February that shifted billions of dollars in new costs onto them.
In addition to the ad wars, pressure is being applied by industry to add a “fix” to the opioid bill. The manufacturers want a roll-back of the change that will push more of the costs of closing the donut hole onto them (Axios). As of Friday morning, observers were skeptical the lobbyists would be successful.
Democrats may not go along.
In a little-noticed but significant move for data transparancy, RAPS reports the FDA released draft guidance that included monetary penalties for failing to report clinical trials to the Federal website (clinicaltrials.gov).
Posted 20 September 2018 | By Zachary Brennan Failing to submit trial data to ClinicalTrials.gov may start to cost drug and device makers, the US Food and Drug Administration (FDA) said Thursday in draft guidance.
Hospitals offer methods for improving transparency in the 340B program (Healthcare Dive).
The American Hospital Association released Tuesday in an effort to improve transparency and highlight the program’s value as the industry faces contentious 340B stewardship principles legaland political headwinds.
The Justice Department approved the Cigna/Express Scripts merger. The New York Times Reed Abelson looks at the approval and changes in the landscape that led to it and other PBM mergers.
Federal officials on Monday gave the go-ahead to the proposed merger between Cigna, one of the nation’s largest health insurers, and Express Scripts, a major pharmacy benefit manager. The $52 billion deal, announced last March, is one of two proposed transactions involving pharmacy companies before the Justice Department.
The California Insurance Commissioner filed suit against AbbVie accusing the firm of illegal efforts to keep patients on the drug (BioPharma Dive).
California’s insurance commissioner on Tuesday sued AbbVie alleging a kickback scheme designed to convince doctors to prescribe the biopharma’s top-selling biologic drug Humira over competing medicines. According to the lawsuit, AbbVie’s efforts to keep patients on Humira included both illegal cash payments and gifts to prescribers as well as more the “sophisticated” provision of services like insurance processing to doctors who wrote prescriptions for Humira.
If you’re wondering why AbbVie has been (allegedly) so aggressive in keeping Humira customers, the presence of biosimilar competitors in Europe (and their eventual introduction in the US) may hold part of the answer (Reuters).
LONDON (Reuters) – Europe has approved a fifth copy of AbbVie’s $18-billion-a-year biologic drug Humira – the world’s best-selling prescription medicine – ramping up competition among makers of less-expensive biotech drugs. Mylan and Fujifilm Kyowa Kirin Biologics said on Thursday they had won a European Commission green light to market their version of the injectable medicine, known as Hulio.
We are failing segments of the population by underrepresenting them in clinical trials (reported by ProPublica and STAT).
It’s a promising new drug for multiple myeloma, one of the most savage blood cancers. Called Ninlaro, it can be taken as a pill, sparing patients painful injections or cumbersome IV treatments. In a video sponsored by the manufacturer, Takeda Pharmaceutical Co., one patient even hailed Ninlaro as “my savior.”
Most drug manufacturers avoided damage to facilities from Florence (FiercePharma).
Drug manufacturers were shaking off the remnants of Hurricane Florence on Monday after the dangers from the “monstrous” storm morphed into hazardous flooding. GlaxoSmithKline, Pfizer and Novartis and Novo Nordisk all confirmed their manufacturing operations were back online. GSK said it has reopened and resumed production at its inhaler plant.
A cardiologist, writing in Forbes, reflects on the recent study of aspirin for older adults says he will rethink his answer to the question, “should I start taking aspirin?”
As a cardiologist, I get this question all the time: “Should I take a baby aspirin?” People ask me whether aspirin would be good for their heart. In fact, the question often comes from older people, those more than 70 years old, who are otherwise healthy and wondering whether there is anything they can do to protect their heart.
We’ve been fooled by mice before – but the potential upside if this approach works means that no matter how preliminary the data, it is a line of research to keep our eyes on (Endpoints News).
Mayo team spotlights the role of senescent cells in neurodegeneration, starting down a pathway that may lead to Alzheimer’s
As anti-aging research grows around the world, there’s been a big focus on clearing away the “senescent” cells that clutter bodies as people grow older. These aging cells lose the ability to divide and mouse studies have offered a preclinical theory that sweeping them away with new drugs can offer
Sherman, fire up the WABAC machine. Let’s take a look at why it’s so hard to open pill bottles (New York Times).
Retro report The origins of tamper-resistant packaging – exasperating yet reassuring – lie in a deadly episode in 1982, when cyanide-laced Tylenol killed seven people. Odds are that you have had moments of frustration trying to open new bottles of aspirin or other over-the-counter medications.