From the desk of Mitchell Stein
Good morning. I hope everyone subject to the coastal storms stays safe. Here in Maine, I’m marveling at the fact that I’m not supposed to get any snow. There was lots of non-pharmacy news coming out of Washington this week (as always). But don’t worry, I’ve found a few things to discuss. This week we’ll look at:
ICER In The News – Dr. Pearson quoted on insurer/manufacturer conflict
Inside the Beltway – some want the Creates Act to be part of the Omnibus, FDA issues fewer regulations, limiting the tax deductibility of drug advertising, Medicaid drug rebate changes and Arkansas pushes to require PBM licenses
Industry Trends – PBM gag clauses, call for greater action on drug prices, review of big data uses by drug companies, review of AI uses by drug companies, Pew looks at drug spend estimates, PhRMA promotes value pricing, a not so cheap generic, biosimilars (2 articles), rethinking the flu vaccine, and about that new antidepressant study.
Company/Drug Specific – Allergan, Celgene, Novartis, and Teva
Weekly View In-depth – The patient perspective
Now, on to the news.
ICER In The News
ICER’s President Dr. Steve Pearson is quoted in this article about the conflict between health insurers and drug manufacturers.
Bankrolled by the insurance industry, California’s newest cartoon mascot masks a nasty healthcare feud
SACRAMENTO – In the age of Black Panther, Thor and Captain America, California’s health insurance plans bring you … A giant, androgynous red heart. The health insurers debuted their bubbly superhero Tuesday in front of California’s stately Capitol building. The heart, who wore black booties and white, Michael Jackson-esque gloves, had no name.
Inside the Beltway/State Regulatory Developments
Inside the Beltway
The Creates Act, which has some bipartisan support, may be added to the Omnibus spending bill due in March.
Lawmakers are trying to add a provision to a long-term budget bill that would ban a way that drug makers keep monopolies on their brand-name products. The lawmakers want to add the CREATES Act to the omnibus two-year spending bill that Congress is set to vote on next month.
2017 saw significantly fewer new drug regulations than previous years.
The Trump effect: PwC report says the FDA has slammed the brakes on significant new drug regulations
Donald Trump launched his presidency breathing fire on federal regulations. And the top officials at the FDA heard that call loud and clear. A new report out from PricewaterhouseCoopers shows that the agency reined in its issuance of new federal regulations to a 20-year low in 2017, as the Scott
A bill is introduced in the Senate to limit the tax deductibility of expenses for pharmaceutical advertising.
Sen. Claire McCaskill, D-Mo., wants to kill the tax break drug companies get on money they spend on TV and magazine advertising. The senator introduced a bill Thursday that would eliminate the ability of drug manufacturers to fully deduct the cost of advertising their products from taxes.
A look at Medicaid drug rebate changes and possible next steps on drug pricing.
Bipartisan Deal Includes Important Step to Control Medicaid Drug Prices, But More Efforts Are Needed
Push in Arkansas to have PBMs be licensed by their insurance department.
PBM gag clauses again in the spotlight.
Alex M. Azar II, the new secretary of health and human services, who was a top executive at the drugmaker Eli Lilly for nearly 10 years, echoed that concern. “That shouldn’t be happening,” he said. Pharmacy benefit managers say they hold down costs for consumers by negotiating prices with drug manufacturers and retail drugstores, but their practices have come under intense scrutiny.
The Editorial Board of Bloomberg calls for greater action on drug prices.
President Donald Trump has complained that U.S. drug companies are “getting away with murder.” For once the hyperbole is forgivable: It suggests he takes the problem of drug costs seriously and might be willing to do something about it. Unfortunately, his administration’s efforts up to now suggest the opposite.
A review of the use of big data by pharmaceutical companies.
The ability to capture the experience of real-world patients, who represent a wider sample of society than the relatively narrow selection enrolled into traditional trials, is increasingly useful as medicine becomes more personalised.
A review of the use of AI in drug development.
Developing new medicines isn’t for the faint of heart. On average, it takes about a decade of research – and an expenditure of $2.6 billion – to shepherd an experimental drug from lab to market. And because of concerns over safety and effectiveness, only about 5 percent of experimental drugs make it to market at all.
Pew Charitable Trust puts various drug spend estimates side-by-side.
PhRMA promotes value-based pricing, but there are questions.
Industry lobbying group PhRMA, in conjunction with Avalere Health, released a report this week contending patient copays in commercial plans using value-based contracts were 28% lower for drugs for certain conditions – including diabetes, HIV, and high cholesterol – compared to copays for these medications in similar plans that did not use risk-sharing arrangements.
Tell me if you’ve heard this one before… A drug is priced at $652 in 2010, five years later the same drug is now $21,267. A generic version comes along to save the day, but the hoped for savings do not materialize as the generic is priced at $18,375.
Despite efforts by the Food and Drug Administration to encourage more competition for drugs that have no generic alternatives, companies like Teva will still charge as much as the market will bear as long as there is no significant competition.
Richard Frank wrote a Perspective on biosimilars in the New England Journal of Medicine. While observers found some salient points made in the piece, as Zach Brennan points out, the piece has several factual errors.
Echoing others who have lamented the slow uptake of biosimilars in the US, Richard Frank of the Department of Health Care Policy at Harvard Medical School took his perspective on biosimilar adoption to the New England Journal of Medicine on Thursday.
We know we need to do better with the flu vaccine. All it will take is time and money.
A reminder that headlines can be misleading. That recent meta-analysis of antidepressants didn’t really have much new to say.
Maybe Allergan wasn’t so clever after all as the courts rule against the Mohawk tribe patent deal.
After months of criticism that even spilled into a judge’s opinion in a separate case, Allergan’s Restasis patent deal with the Saint Regis Mohawk Tribe just didn’t work. Thanks to a Friday ruling, the blockbuster eye drug has to face the very patent challenge Allergan sought to prevent.
Problems for Celgene. (History shows the problems could be significant: How Bad Is Celgene’s FDA Foul-Up? Two Decades Of Biotech History Say It Can’t Be Good.)
nother embarrassing and costly blunder has befallen Celgene. The Food and Drug Administration is refusing to review ozanimod, an experimental treatment for multiple sclerosis and Celgene’s most important pipeline product, the company said Tuesday. Celgene said the FDA issued the so-called refuse to file letter because “nonclinical and clinical pharmacology” sections of the ozanimod application were insufficient.
For Novartis, it’s now about more than the pill – using prescription apps to aid treatment.
Putting digital into Novartis’ DNA is one of new CEO Vas Narasimhan’s goals, and it has just inked another deal that does just that. The drugmaker has teamed with Pear Therapeutics on new software apps in schizophrenia and multiple sclerosis that could eventually be prescribed along with its drugs.
Teva continues to cut expenses.
Teva is working to consolidate seven U.S. offices under one roof, and that means saying bye-bye to its New York and Washington, D.C., locations. The Israeli drugmaker has already shuttered office sites in the two East Coast hubs, CEO Kåre Schultz-the architect of Teva’s restructuring- told Israeli newspaper Calcalist.
Weekly View In-depth
The Patient Perspective.
Over the past several years, the patient perspective has appropriately been given increasing importance. (ICER has created their own Patient Participation Guide to help patients participate in their process.) Below we look at several recent developments.
FDA moves forward, and industry comments on incorporating patient voices into clinical research.
Posted 27 February 2018 | By Zachary Brennan The idea of incorporating patients’ voices into drug development has been around for more than a decade, but now the US Food and Drug Administration (FDA) is weighing how to provide practical guidance for industry on incorporating such voices.
Should patients be compensated for their expertise?
hanks to a surprising and devastating diagnosis, I know more than most physicians about what it’s like to live with the brain cancer known as glioblastoma, everything from self-titrating my anti-epileptic medications to making sure the right ICD-10 code appears on my MRI referrals.
Should patients be compensated for participating in clinical trials?
Posted 27 February 2018 | By Michael Mezher A group of researchers are proposing a framework for evaluating payments to reimburse, compensate and incentivize volunteers to participate in clinical trials and other studies involving human subjects.
There can be a downside to too much patient independence – in this era of “fake news” there can be a desire to do one’s own research, regardless of if it comes from questionable sources.
The availability of health data on the internet has its benefits. Online, for example, we can find explanations and solutions for symptoms we might be too embarrassed, or afraid, to discuss with another person, in person. Or, for life-threatening diseases, we can locate clinical trials our doctors may not be aware of.