A compounding dilemma

Presented by Express Scripts by Evernorth: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Sep 27, 2024 View in browser   By Lauren Gardner and David Lim Presented by  With Ruth Reader Driving the day Novo Nordisk's Wegovy is one of the brand-name GLP-1 drugs that compounders are copying due to the shortage. | Scott Olson/Getty Images THE FUTURE OF BESPOKE WEIGHT-LOSS PRODUCTS — The shortage of popular diabetes and weight-loss drugs known as GLP-1s — and insurers’ uneven coverage of them — is putting an unprecedented supply of compounded drugs in consumers' medicine cabinets. Now, some telehealth companies are looking ahead to the end of a shortage for the FDA-approved drugs to ensure they can continue to sell non-branded alternatives, prompting some experts to call for more oversight of compounders, Lauren and POLITICO’s Ruth Reader report. The psychology-based weight-management app Noom has urged the FDA and Congress to give large compounders more than 60 days, as is required, to wind down production of their GLP-1 copies once the shortage ends. The FDA allows those outsourcing facilities to make “essentially a copy” of a drug if it’s in shortage, which Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound are. Another avenue: But the law also allows compounders to make personalized drug formulations if a provider determines such tweaks would benefit a patient — say, if someone is allergic to a dye in a brand-name medicine or can’t swallow pills. For GLP-1s, some compounders will combine the active ingredient in the branded products with vitamin B12 for people who complain of side effects from the FDA-approved products. Dr. Pat Carroll, chief medical officer for telehealth platform Hims, said his company is focusing on specialized dosing — products whose doses fall between two FDA-approved dosage levels — as a way to appeal to patients who want to slowly increase the amount of the drug they take. More regulation? Some health experts and former regulators want more oversight of telehealth providers they say too freely write scripts for less-regulated compounded drugs and don’t adequately monitor patients. Both Noom and Hims say their platforms encourage behavioral change in GLP-1 users by promoting diet and exercise alongside medication adherence. “The misconception is that providers are not making clinical decisions,” Carroll said. “It is not a log-on-and-get-a-medication provider review. That’s not how our platform works.” Price pressure: Some providers told Lauren and Ruth that’s exactly how easy it can be to access compounded GLP-1s from telehealth sites. They worry that high prices for the branded drugs — which aren’t uniformly covered by insurance plans — are driving more Americans to products that haven’t been reviewed by the FDA for safety and efficacy. Novo and Lilly have sued dozens of compounders and wellness centers, claiming they’ve illegally marketed GLP-1 products. Those who are following the phenomenon say they expect courts to ultimately decide where to draw the line on post-shortage compounding. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Now that Congress is gone for several weeks, what should we focus on in the pharma world? Reach out with tips and ideas to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).   A message from Express Scripts by Evernorth: Nearly two-thirds of Express Scripts by Evernorth customers spend less than $100 a year out-of-pocket for all their medications. Yes, despite the median annual price of new drugs to market soaring to an average of $300K in 2023. Yes, despite the median of all drug prices going up by 5% last year. That's not a middleman. That's an advocate. Express Scripts is fighting to make medications more affordable. Learn more here.   Eye on the FDA NOVEL SCHIZOPHRENIA TREATMENT — The FDA on Thursday approved Bristol Myers Squibb’s Cobenfy, the first new antipsychotic drug to treat schizophrenia in decades. The drug represents a new mechanism of action for the antipsychotic class that experts hope will translate into fewer side effects for patients. The approval reflects the pharma industry's renewed interest in the drug development of neuroscience products following several new Alzheimer's disease treatments in recent years. “Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person’s quality of life,” said Dr. Tiffany Farchione, director of the psychiatry division in the FDA’s neuroscience office. “This drug takes the first new approach to schizophrenia treatment in decades.” The Institute for Clinical and Economic Review, a nonprofit that assesses drugs’ value relative to their effectiveness, estimated a price benchmark of between $16,000 and $20,000 annually. The drug must be taken twice daily. In Congress KEEPING THE LIGHTS ON — Congress passed a continuing resolution Wednesday night, keeping the FDA and other federal agencies open for business through Dec. 20 and setting up a pre-Christmas spending showdown, POLITICO’s Jennifer Scholtes writes. The stopgap includes an extension of the rare pediatric disease priority review voucher program until the same date. The House passed legislation Monday to reauthorize it for five years. The Senate HELP Committee was scheduled to mark up a six-year reauthorization bill on Thursday before Congress’ pre-election hiatus, but the meeting was postponed as members left town early to beat Hurricane Helene in the Southeast. ON THE SHELF — Both HELP and the Senate Judiciary Committee delayed action this week on bills addressing drug competition and patent issues. It’s unclear whether they’ll reschedule the markups for when lawmakers return to Washington after Election Day, the results of which will determine what end-of-year priorities make it to the president’s desk. Here’s a quick rundown of the pending business before HELP: — A bill by Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) would require drug developer applicants to submit consistent information to the FDA and the U.S. Patent and Trademark Office to discourage patent thickets, which extend a drug’s exclusivity; — A bill by Sens. Mike Lee (R-Utah) and Ben Ray Lujan (D-N.M.) to deem all FDA-approved biosimilars “interchangeable” with their reference product. The Biden administration has sought the change to ensure cheaper biologics can be more easily substituted for brand-name products. And, as we recently reported in Prescription Pulse, two measures before Judiciary would affect pharma interests. Rep. Diana DeGette (D-Colo.) is next in line to become the top Democrat on the House Energy and Commerce Health Subcommittee. | Susan Walsh/AP GETTING DEGETTE — POLITICO’s Ben Leonard sat down with Colorado Rep. Diana DeGette, who’s in line to be the top Democrat on the House Energy and Commerce Health Subcommittee next Congress, to chat about her priorities. Some pharma highlights include: The future of lab-developed test legislation: “We’re continuing to work to overcome some of the resistance. But if we don’t, that will be a top priority next year.” Expanding Medicare drug price negotiations: “I would work to expand that. But we also need to look at the way our insurance system is working in drug pricing and what we can do for pharmacy benefit manager reform.” The future of the CURES 2.0 effort: “We’re working on having a white paper or something like that later this fall. The concept of that is not that we’re trying to do legislation this year, but that in the next year, we can hit the ground running, irrespective of who is in charge.”   A message from Express Scripts by Evernorth:   Industry Intel PFIZER WITHDRAWS SICKLE CELL DRUG — The drugmaker is withdrawing from the market a drug granted accelerated approval in 2019 to treat sickle cell disease because of data that indicates the benefit of the drug to patients “no longer outweighs the risk.” “The data suggest an imbalance in vaso-occlusive crises and fatal events which require further assessment,” the company said in a press release. “Pfizer has notified regulatory authorities about these findings and its decision to voluntarily withdraw OXBRYTA from the market and discontinue distribution and clinical studies while further reviewing the available data and investigating the findings.” Pharma in the States KENTUCKY SUES PBM OVER OPIOIDS — Kentucky sued Express Scripts Thursday, claiming that the pharmacy benefit manager colluded with opioid makers to boost sales of the addictive drugs and failed to manage suspicious volumes of the products. “Express Scripts resisted efforts to limit access to prescription opioids due to the revenue generated from the dispensing of opioids and concerns about the impact on the rebates it received from opioid manufacturers,” state Attorney General Russell Coleman argued in the complaint. A spokesperson for Cigna, the insurer that owns Express Scripts, didn’t respond to a request for comment. Pharma Worldwide ANOTHER MPOX SHOT COMMITMENT — Bavarian Nordic announced a deal with UNICEF Thursday to supply 1 million mpox vaccine doses for African countries affected by this year’s outbreak. The agreement includes the 500,000 doses committed by the public-private vaccine partnership Gavi earlier this month, the company said. Bavarian Nordic will make all doses available before the end of the year and will work with partners to quickly deliver them, it said. Pharma Moves John Murphy is the new CEO of the Association for Accessible Medicines. The former Biotechnology Innovation Organization chief policy officer discussed his new gig with David here. Document Drawer The FDA published a glossary of digital health and artificial intelligence terms the agency says will be updated as appropriate. what we're reading Reps. Anna Eshoo (D-Calif.) and Rosa DeLauro (D-Conn.) are asking HHS Inspector General Christi Grimm to investigate whether former FDA medical device regulator Jeff Shuren maintained his ethics responsibilities in work that overlapped with his wife Allison Shuren — an FDA lawyer at Arnold & Porter, The New York Times’ Christina Jewett reports. POLITICO’s Ruth Reader spoke with Tala Fakhouri, the FDA’s associate director for data science and AI policy, about the agency’s work developing new guidance on the use of artificial intelligence in pharmaceutical research.   A message from Express Scripts by Evernorth: Want to know something unhealthy? The median annual price of a new drug reached $300K in 2023. Yes, $300,000. Yet millions of Americans pay less than $100 a year out-of-pocket for all their medications combined. How? Express Scripts by Evernorth. Express Scripts by Evernorth is the last line of defense for millions of Americans against rising health costs – fighting every day to make their medications more affordable and accessible. And they’re not stopping anytime soon. That’s not a middleman. That’s an advocate. See how Express Scripts is fighting to make medication more affordable for millions. Learn more here.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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