Jul 13, 2021, 9:05 AM (1 day ago)
|Jul 13, 2021View in browser BY ADAM CANCRYN AND SARAH OWERMOHLEPresented byWith Rachel Roubein and Lauren GardnerEditor’s Note: POLITICO Pulse is a free version of POLITICO Pro Health Care’s morning newsletter, which is delivered to our subscribers each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day’s biggest stories. Act on the news with POLITICO Pro.|
QUICK FIX— Biden health officials believe it’s highly likely vulnerable Americans will need coronavirus booster shots, but haven’t yet decided when.— Medicare is reviewing Biogen’s Aduhelm to determine whether to limit coverage of the pricey Alzheimer’s drug.— The FDA is appending a new warning to Johnson & Johnson’s Covid-19 vaccine, after linking it to cases of Guillain-Barré syndrome.WELCOME TO TUESDAY PULSE — and here’s the latest intel on what might make it into Democrats’ partisan spending package , culled from POLITICO reporting across every policy area. Tell us what’s important in your world; send tips to firstname.lastname@example.org and email@example.com. A message from PhRMA:The way insurance covers your medicine is too complicated. See how we can make the system work for patients. Not the other way around. DRIVING THE DAYTO BOOST OR NOT TO BOOST — For weeks, top Biden officials have repeatedly downplayed the need for vaccinated people to get Covid-19 booster shots, wary of undermining confidence in the vaccines and getting ahead of formal procedures.But within the administration, there’s growing belief that boosters for the most vulnerable Americans are no longer an “if” — but simply a matter of when, your authors and Erin Banco report.Officials across the health department have spent months laying the groundwork for another round of shots, poring over data and coordinating with vaccine makers in an effort to pinpoint exactly who should get them and on what timeline.So far, they’ve reached one concrete conclusion: The initial recipients will likely be the highest-risk people, such as nursing home residents who were among the first to be vaccinated or those who are immunocompromised. But little else is decided, and there’s reluctance to lay out any booster plan without hard evidence the extra shot will provide a meaningful benefit.That’s forced Biden’s team to walk a tightrope, both denying that boosters are needed now while leaving their options open down the road. “Fully vaccinated people do not need a shot at this time,” one senior administration official told us, putting extra emphasis on the last three words.It’s a position that’s getting harder to maintain: After a rush of public health experts advised recipients of the Johnson & Johnson vaccine to consider an additional dose of Moderna or Pfizer, even Andy Slavitt — a former senior adviser to the White House Covid-19 team — said on his podcast that it couldn’t hurt.Pfizer then caused a stir last week by going public with its plans for a booster – a move that blindsided and irritated officials not because the company said anything different than it had communicated privately, but because it jumped the gun on what had otherwise been a carefully managed and critical process.Still, the episodes aren’t likely to change the administration’s conservative approach. Officials have gone by the book on every big decision, waiting for the health agencies to formally weigh in despite criticism at times for moving too slow.With more than 30 percent of the U.S. still unvaccinated, the White House is eager to keep the focus on getting people their first round of shots — especially since those they’ve yet to reach are unlikely to be the high-risk individuals who’d be eligible for a booster.And then there’s the optics, as the U.S. vaccinates its way out of crisis while much of the rest of the world still struggles to find shots.“We’re in the midst of a growing two-track pandemic where the haves and have-nots, within and between countries, are increasingly divergent,” World Health Organization chief Tedros Adhanom Ghebreyesus said Monday, blasting drug makers’ rush to develop boosters for the U.S. when many others still need their first shots.
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MEDICARE WILL REVIEW COVERAGE OF ALZHEIMER’s DRUG — The administration is launching a months-long review of Biogen’s Aduhelm to determine how Medicare should cover the pricey new treatment — a decision that comes amid rising scrutiny of its approval and $56,000 price tag.The review process known as a national coverage determination is relatively uncommon, POLITICO’s Rachel Roubein reports, and raises the prospect that CMS could limit payment for the treatment to certain patients. A 30-day comment period opened Monday, which will be followed by an analysis to determine whether the drug meets Medicare’s requirements of being “reasonable and necessary” for treating Alzheimer’s. CMS is expected to propose a coverage policy within six months and finalize it within nine months.Controversy has swirled around Aduhelm since its June approval by the FDA, which came despite thin evidence that the treatment actually worked.In the face of heavy criticism, the FDA has since agreed to narrow its recommended use to only those with early stages of the disease. Most recently, FDA Commissioner Janet Woodcock requested an independent HHS investigation of Aduhelm’s approval process.Congressional committees are also probing the FDA’s decisionmaking. The chairs of the House Energy and Commerce and Oversight and Reform committees launched a formal investigation in late June, and on Monday demanded that Biogen turn over documents related to the approval, marketing and pricing of the drug.VACCINESJ&J VACCINE HIT WITH ANOTHER WARNING — The FDA is adding a warning to the single-shot Covid-19 vaccine amid preliminary reports linking it to the development of Guillain-Barré syndrome, POLITICO’s Lauren Gardner and Erin Banco report.The cases are rare — just 100 patients are suspected to have the neurological condition out of 12.8 million who’ve been given the J&J shot. And the benefits of the vaccine still outweigh the risks of contracting Covid-19. In its letter to J&J, the FDA wrote that the fact sheet given to vaccine recipients would caution that GBS has occurred in some patients, but also that “the chance of having this occur is very low.”But the FDA caution marks yet another setback for J&J’s vaccine, which was paused earlier this year to investigate cases of severe blood clots. Production of the shot has also been hampered by contamination issues at a plan run by contract manufacturer Emergent BioSolutions.Most of the GBS cases tied to the J&J vaccine were reported roughly two weeks after vaccination, and seen predominantly in males ages 50 and older. Officials haven’t established any similar pattern with the Pfizer and Moderna vaccines.