From the desk of Mitchell Stein
Good morning. I’m old enough to remember when policy proposals in DC slowed down during the summer. It was way back, like two or three years ago… Whenever it was, it’s certainly not the case now with today’s 24/7 news cycle. The point was driven home this week when during a 36-hour period, HHS and the FDA announced significant proposals in five areas, any one of which would have been a major announcement:
- Safe harbor rules (limit/eliminate rebates)
- Allowing limited drug importation
- Fostering biosimilar competition
- Eliminating the need for prescriptions for some medications
- Formation of a task force to combat drug shortages
We’ll have full coverage on all of them below. Here’s this week’s full line-up:
ICER in the news – ICER’s Migraine work and careers at ICER
Inside the Beltway – Safe harbor rules changes, allowing limited drug importation, fostering biosimilar competition, eliminating the need for prescriptions for some medications, formation of a task force to combat drug shortages, President meets with Pfizer CEO, cutting 340B discounts, comments on President’s drug price plan, and industry influencing Medicaid coverage
Industry Trends – Novartis joins Pfizer in price freeze, Merck lowers some prices, Engelberg talks prices, Bloomberg drug price index, CRISPR may not be as safe as some thought, smallpox drug approved, rigor (or lack thereof) in breakthrough drug studies, Amazon news, and urgent care centers overprescribing antibiotics
Now, on to the news.
ICER In The News
ICER’s migraine work continues to be in the news with mentions by AJMC and BioPharma Dive.
The Institute for Clinical and Economic Review (ICER) has released their final evidence evaluating the effectiveness and value of calcitonin gene-related peptide (CGRP) inhibitors as preventive treatments for patients who suffer from episodic or chronic migraine. In order to assess the clinical effectiveness, the report compared the tolerability and safety of CGRP inhibitors-erenumab, fremanezumab, and galcanezumab-to no preventive treatment or commonly-used preventive therapies.
The second quarter is traditionally a strong sales period for biotechs. Leerink expects that trend to hold true as earnings read out in the coming weeks, yet a handful of recently launched products may bring some surprises. The investment bank highlighted five such products in a report Monday: Amgen and Novartis’ Aimovig, Gilead’s Biktarvy, Vertex’s Symdeko, Alexion’s Soliris and Biogen’s Spinraza.
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.
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.
Inside the Beltway/State Regulatory Developments
HHS was busy this week with new proposals to elaborate on and add to the Administration’s plans to rein in drug prices. The next five stories cover the range of proposals.
1) Safe harbor rules (limit/eliminate rebates) – few details are available other than that there would be changes to the safe harbor regulations that permit rebates paid by manufacturers to PBMs. While it is unquestionable that there have been abuses in the current rebate system (and changes are needed), it is unclear what impact these changes would have on the overall cost issue (Modern Healthcare – paywall after a limited number of free articles).
The Trump administration looks like it’s making good on its promise to tweak drug rebate laws that favor pharmacy benefit managers. On Wednesday, HHS’ Office of Inspector General sent a new rule to the White House Office of Management and Budget for review related to legal protections for drug rebates.
2) Allowing limited importation – While many (including both the Administration and your humble author) are skeptical of the ability of drug importation to have a significant impact on overall pricing issues, the FDA proposal focuses on specific cases where it could help (RAPS). Gottlieb described the criteria this way: “For certain critical medicines, where there are no blocking patents or exclusivities associated with the drugs, but where there is only a single manufacturer; conditions may develop that create significant barriers to, and ultimately threaten patient access.”
At the direction of Department Health and Human Services (HHS) Secretary Alex Azar, the US Food and Drug Administration (FDA) on Thursday announced it will work to develop a policy to facilitate the importation of certain sole-source drugs in response to dramatic price hikes and supply disruptions.
3) Fostering biosimilar competition – Gottlieb wants more biosimilar uptake and is trying to figure out how he can make that happen (RAPS).
FDA Commissioner Scott Gottlieb unveiled the agency’s 11-part biosimilar action plan at the Brookings Institution on Wednesday, explaining the “anemic” growth the market has seen so far. “I’m worried that the market for these products still isn’t established,” Gottlieb said, noting 11 biosimilars have been approved but just three have gained market share.
4) Eliminating the need for prescriptions for some medications – The FDA is considering making it easier for individuals to access certain drugs without a prescription. However, as Bloomberg reports, when this has been considered in the past, concerns were raised that it could actually increase individual’s costs since non-prescription drugs are often not covered by health insurance.
5) Task force to combat drug shortages – Biopharma Dive reports on their creation of a new task force to combat drug shortages.
Food and Drug Administration head Scott Gottlieb has formed a new task force to try to minimize the impact of drug shortages on patients and physicians. This will focus on creating long-term solutions to the “underlying structural concerns that give rise to these recurring challenges.”
While all the above was going on, the President met with Pfizer’s CEO.
The CEO of drug giant Pfizer met with President Donald Trump at the White House today as the administration pressures drugmakers to voluntarily rein in prices, according to multiple industry sources. Ian Read’s appearance followed a Trump tweet this morning that thanked Pfizer and the Swiss manufacturer Novartis for pledging not to raise drug prices further this year.
Azar proposed cutting the 340B discount rate at a meeting with GOP lawmakers. Modern Healthcare reports the proposal received a chilly reception (Subscription required after a limited number of free articles).
HHS Secretary Alex Azar in a private meeting with GOP House lawmakers Thursday floated standardizing the 340B drug discounts offered to providers, cutting it to 20% of the list price, a lawmaker who attended the meeting told Modern Healthcare.
Now that the comment period has closed for the President’s drug price plan, Fiercehealthcare reports on some of the comments.
Organizations from across the healthcare industry weighed in on the Trump administration’s drug price blueprint in time for a Monday deadline. In May, the Department of Health and Human Services issued a request for information shortly after President Donald Trump unveiled his administration’s “American Patients First” plan to lower drug prices.
NPR reports that drug companies are working in a myriad of ways to influence Medicaid drug spending in their favor.
Eight months pregnant, the drug sales representative wore a wire for the FBI around her bulging belly as she recorded conversations with colleagues at a conference in Chicago. Her code name? Pampers. Her company, drugmaker Warner Chilcott, was using payments and perks to get doctors to prescribe its drugs.
Shortly after putting in place price increases, Novartis joined Pfizer in announcing they would refrain from additional increases this year (Endpoints News).
UPDATED: Novartis CEO Vas Narasimhan hits the brakes on US drug price hikes — right after tapping the gas
President Donald Trump may not be getting the cascading drug prices he promised, but he is holding the line against any increases – at least for this year. Novartis CEO Vas Narasimhan today joined Pfizer CEO Ian Read in promising to put the brake on US drug price hikes. And
Merck also joined the party with an announcement that it was lowering some prices. Details are important – it is lowering the price of Zepatier by 60%, but as the NY Times reports “sales have dipped so low that, after paying after-the-fact rebates to insurers, the company recorded no sales in the United States for the product in the first quarter of this year.” The other six drugs where prices were rolled back all have generic competition, and according to GoodRx, the average cash price ranges from $4 to $21 (for comparison, Merck’s blockbuster Keytruda which can cost $150,000 for a year’s treatment).
The drugmaker Merck said Thursday that it would lower prices on several drugs by 10 percent or more, but its rollback affects minor products and would not lower the cost of its top-selling, expensive cancer and diabetes products.
Alfred B. Engelberg writes in Modern Healthcare (paywall after a limited number of free articles) about high prices and the role of Federal funding in drug development.
Engelberg: By whatever means, the current system-allowing new medicines discovered with public funds to be sold at prices that make pharmaceuticals America’s most profitable industry-must end.
The large price increases on brand name drugs and the high prices of new specialty drugs are driven by a desire for greater profits and not by the cost of research. The pharmaceutical industry no longer makes significant investments in drug discovery. Its pipeline depends on discoveries made in academic medical centers with federal funding.
Bloomberg has created drug price indexes to track prescription drug price changes. To no one’s surprise, they find the several categories they reviewed have all risen greater than inflation.
So this is disturbing. STAT reports that CRISPR may not be as safe as we thought. In a follow-up article, STAT Plus (subscription required) reported on the reaction to the study (That CRISPR study, in the cold, clear light of morning: why it’s raising concerns).
rom the earliest days of the CRISPR-Cas9 era, scientists have known that the first step in how it edits genomes – snipping DNA – creates an unholy mess: Cellular repairmen frantically try to fix the cuts by throwing random chunks of DNA into the breach and deleting other random bits.
In a victory for preparedness (now and then there are victories), the FDA approved a medication to treat smallpox. As the NY Times reports, since the virus has been eradicated in nature (there is the prospect of an intentional release), routine vaccine administration was halted in 1980, meaning those under 40 are not protected.
The Food and Drug Administration on Friday approved the first drug intended to treat smallpox – a move that could halt a lethal pandemic if the virus were to be released as a terrorist bioweapon or through a laboratory accident.
A new study published in JAMA calls into question the rigor used in breakthrough drug approval studies (Washington Post).
When federal regulators started giving certain drugs “breakthrough” status in 2012, pharmaceutical company interest exploded. The goal was to speed up the approval of drugs for serious diseases when there was preliminary evidence the new drugs were better than existing treatment options. Giving these drugs “breakthrough” status comes with a side benefit: an evocative name.
Believe it or not, we have some real news about Amazon selling medical supplies (Healthcare Dive).
Amazon is in talks with digital prescription platform Xealth and at least two hospital systems to launch a pilot that would have doctors prescribe products to patients before they’re discharged, with the retail giant or other ecommerce companies handling fulfillment, according to a report from CNBC. Prime members would be eligible for discounts.
There will come a day when there is a spectrum of locations, from drug stores to doctors’ offices to urgent care centers to ERs, each providing appropriate quality health care based on their capabilities and the patients’ needs. That day is not today as a new study reveals urgent care clinics are overprescribing antibiotics.
Nearly half of patients who go to urgent care clinics seeking treatment for a flu, cold or other conditions that do not require antibiotics received a prescription for one anyway. That is three times as often as antibiotics are prescribed to patients with the same illnesses in traditional doctors’ offices, according to a study published Monday.