From the desk of Mitchell Stein
Good morning. There was a lot of non-pharma news this week. While that’s beyond the scope of our little newsletter, humor me as I share a mantra I learned from comedian Patton Oswalt: It’s chaos, be kind. You can’t go wrong following that advice. Now, back to the reason you’re here, pharma news where this week we’ll look at:
ICER in the news – Evidence report on elagolix, topic announcement on canakinumub, and coverage of Midwest CEPAC’s CF meeting
Inside the Beltway – It’s rocket science, 340B hearings, possible Part D changes, and a plan to modify the FDA (that may not get very far in Congress)
Industry Trends – Some patients can’t afford diabetes treatments (and some new treatments are tried), a suggestion of prizes instead of patents, the threat of 1498 to spur negotiation, two sides of the right-to-try coin (2 stories), video on drug pricing, nonprofit gets PRV, IV Tylenol may not be all that, Alzehiemer’s news, and a look at a good Gardasil ad campaign
Now, on to the news.
ICER In The News
ICER released an Evidence Report assessing the comparative clinical effectiveness and value of elagolix (AbbVie/Neurocrine Biosciences) for the management of endometriosis and associated pain. Elagolix is currently under review by the FDA, with an approval decision expected in mid-2018.”Elagolix shows promise in reducing the pain women with endometriosis experience, but more research is needed to determine the drug’s long-term effectiveness and safety profile, particularly in comparison to alternative agents,” noted Dan Ollendorf, PhD, ICER’s Chief Scientific Officer. “While elagolix may be cost-effective in the long-term if priced in line with analyst expectations, the treatment will potentially challenge short-term budgets given the large number of women affected by endometriosis. During our meeting on July 12th, stakeholders will convene to discuss strategies to ensure appropriate patient access while managing system-wide affordability.” ThePharmaLetter and Endometriosis News reported on the release.
Institute for Clinical and Economic Review Report Questions the Adequacy of Evidence on Overall Health Benefit of Elagolix Given Limitations of Information on Safety and Limited Evidence Comparing to Other Treatment Options
ICER announced plans to develop a report assessing the comparative clinical effectiveness and value of canakinumab (Novartis) for cardiovascular risk reduction in people with atherosclerosis. The report is set to be reviewed during a January 2019 public meeting of the Midwest Comparative Effectiveness Public Advisory Council. ThePharmaLetter reported on the release.
Cystic Fibrosis News Today reported on the Midwest CEPAC meeting where ICER’s report was reviewed. Video of the meeting is available on ICER’s website including the Evidence Presentation, Public Comments, Panel Voting, and Policy Roundtable.
Read about the results of a Midwest CEPAC meeting, part of ICER, where a clear majority of members judged Vertex’s 3 CF therapies of solid benefit to patients in combo with supportive care, but of “low” value because of prices that “exceed cost-effectiveness thresholds.”
Inside the Beltway/State Regulatory Developments
The Administration’s drug pricing plan is so complex it’s beyond the grasp of stock analysts, according to Secretary Azar as reported by S&P Global. You know, stock analysts, those really poorly paid uneducated people who have nothing riding on their work.
Biopharma Dive reports on the 340B Senate hearing.
First Published on The 340B Drug Pricing Program took center stage at the Senate’s HELP panel for the third time in several months on Tuesday, this time turning the focus to audits of hospitals and drug manufacturers conducted by the Health Resources and Services Administration.
The Kaiser Family Foundation takes a detailed look at the Administration’s Part D plan.
What’s in the Administration’s 5-Part Plan for Medicare Part D and What Would it Mean for Beneficiaries and Program Savings?
Today more than 43 million older adults and people with disabilities have prescription drug coverage under Medicare Part D. Part D helps people with Medicare afford their medications by subsidizing the purchase of drug coverage from private stand-alone prescription drug plans (PDPs) and Medicare Advantage drug plans (MA-PDs), and offering additional financial help to people with low-incomes.
Is the FDA getting a new name and modified responsibilities? Probably not, but the idea is part of the Administration’s plan to reorganize the federal government (STAT).
ASHINGTON – The Trump administration has proposed a fundamental change to the mission of the Food and Drug Administration, one that would transfer most of the responsibility for regulating food safety to the Department of Agriculture and rename the FDA the “Federal Drug Administration.”
Cost continues to be an issue for many as we see in this CBS report on people with diabetes forgoing treatment. Meanwhile, some are looking at unorthodox treatments for diabetes including farmacies (I love that word): Diabetes defeated by diet: How new fresh-food prescriptions are beating pricey drugs and this experimental treatment (long dismissed) that may be starting to show positive results: Controversial researcher’s diabetes vaccine causes improvement in small study.
Almost half of diabetics are cutting back on treatment because of costs, according to a new survey that comes as the skyrocketing price of insulin is prompting lawmakers and physicians to call for more oversight. The American Medical Association, the largest association of physicians in the U.S., last week called for federal intervention to protect diabetics from being exploited by price gouging on insulin products.
Two writers from the CATO Institute offer their plan (prizes instead of patents) for lowering drug costs in this VOX piece.
Outside contributors’ opinions and analysis of the most important issues in politics, science, and culture. President Donald Trump and Secretary of Health and Human Services Alex Azar recently introduced American Patients First, a complicated plan intended to make prescription drugs more affordable.
The NY Times has a more immediate solution; they want the government to march in and use Section 1498 to draw drug manufacturers to the negotiating table.
The editorial board represents the opinions of the board, its editor and the publisher. It is separate from the newsroom and the Op-Ed section. In Baltimore, the health commissioner, Dr. Leana Wen, uses a need-based algorithm to decide which emergency rooms, needle-exchange vans, E.M.T.s and opioid outreach workers receive the city’s limited supply of naloxone – and which don’t.
Well, that didn’t take long… Derek Lowe writes about a firm that wants to sell their unproven (and unapproved) therapy under the auspices of the right-to-try law.
On the other hand, as Donna Young of S&P Global reports, some firms (like Sarepta who this week reported encouraging results) have said sorry, but no.
Bob Herman and Sam Baker (with Axios) are two of my favorite health care reporters. They’ve made a video explaining the drug price conundrum. As a regular reader of this newsletter, it may not have much new info for you, but then again it might. Alternatively, if you struggle to explain to family and friends what you work on, this might help.
A complicated system with complicated solutions.
Call me crazy (you’re crazy), but this seems to be why the PRV program was designed. BiopharmaDive reports on a nonprofit receiving one and how it might be used to generate an influx of funds to the organization.
The Food and Drug Administration has approved Medicines Development for Global Health’s oral antiparasitic drug moxidectin for the treatment of river blindness in adults and adolescents. MDGH is the first nonprofit to be handed a priority review voucher (PRV) under the tropical disease PRV program.
The Washington Post takes a look at IV Tylenol – much more expensive and little or no benefit (beyond perhaps a placebo effect from the IV) above the pill version.
In the midst of the opioid crisis, Boston Medical Center added an intravenous version of Tylenol to its arsenal of drugs for pain management. But IV Tylenol was expensive, and after drugmaker Mallinckrodt Pharmaceuticals increased the price, the hospital projected it was on track to spend $750,000 in 2015 on acetaminophen (the active ingredient in Tylenol) in injectable form.
I report a lot of bad news when it comes to Alzheimer’s. For a change, NPR reports that we are gaining new understanding of the role that viruses might play in the disease.
Two common herpes viruses appear to play a role in Alzheimer’s disease. The viruses, best known for causing a distinctive skin rash in young children, are abundant in brain tissue from people with Alzheimer’s, a team of scientists reports in the June 21 issue of Neuron.
Sometimes we do learn from our mistakes. STAT reviews what went wrong when Gardasil was introduced and what is going right with the latest ad campaign.
hile clicking through Snapchat the other day, an ad for Merck’s new Versed campaign for Gardasil, its vaccine against the human papillomavirus (HPV), stopped my thumb in its tracks. As a researcher interested in how gender and science interact in the realm of health policy, I knew what a controversial blunder its earlier marketing had been.