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Presented by the Pharmaceutical Care Management Association: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Katherine Ellen Foley, David Lim and Lauren Gardner | Presented by the Pharmaceutical Care Management Association | | | | — HHS Secretary Xavier Becerra wants CMS to reevaluate 2022 Medicare Part B premiums days before CMS decides whether it will propose to cover Biogen’s Alzheimer’s treatment. — The Biden administration Monday outlined how private insurers must reimburse at least some of the cost of at-home Covid-19 tests. — Walensky, Fauci, Woodcock and O’Connell head to Capitol Hill to testify on the federal response to Covid-19 variants. It’s Tuesday. Welcome back to Prescription Pulse. Our editor asks if a Mean Girls reference is too young for our readers. We hope not. Send tips and feedback to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM ) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). | | | | A message from the Pharmaceutical Care Management Association: With Congress poised to fully repeal the rebate rule and prevent significant increases in both Medicare beneficiary premiums and Medicare Part D program costs, pharmaceutical industry representatives are once again attempting to divert attention by suggesting so-called point of sale rebate policies that would undo this progress. We urge Congressional negotiators to continue to resist the latest attempts to shift the blame that puts profits over patients. | | | | | | | 
Xavier Becerra, nominee for Secretary of Health and Human Services, answers questions during his confirmation hearing before the Senate Finance Committee on Capitol Hill on February 24, 2021 in Washington, DC. | Greg Nash, Pool/Getty Images | HHS ASKS MEDICARE TO RETHINK 2022 PART B PREMIUMS, CITING ALZHEIMER’S DRUG COST — Secretary Xavier Becerra on Monday called for a reevaluation of 2022 Medicare Part B premiums, citing the price of a controversial Alzheimer’s treatment the Food and Drug Administration approved last year, Katherine reports. Aduhelm, manufactured by Biogen, was priced at roughly $56,000 annually. Medicare administrators in November announced a nearly 15 percent increase in beneficiaries’ Part B premiums for 2022, citing Aduhelm’s potential cost to the program. Biogen has since reduced the drug’s yearly cost to about $28,000. Crucial timing: Sec. Becerra’s directive came two days before CMS is set to release its draft guidance on whether Medicare will cover Aduhelm. Though CMS isn’t required to follow its draft guidance, it usually does. Ripple effects: Patients, providers and payers are closely eying the CMS’ draft decision and bracing for the waves it will make. Estimates suggest that roughly 1.5 million Americans are eligible for the drug. As we’ve reported, Medicare costs would balloon should the agency elect to cover it. In addition to the costly monthly infusions, Aduhelm recipients also need to receive expensive brain imaging needed to spot brain swelling and bleeding, both potentially dangerous side effects from the drug. CMS’ decision also isn’t limited to just Aduhelm — it’s a decision that would affect antibody therapies in the pipeline that target protein clumps in the brain thought to cause Alzheimer’s. Currently, three such therapies are in development, including another one from Biogen and Eisai. If CMS rejects covering Aduhelm, those therapies would likely be quashed. Coverage denial would also create even more scrutiny for the accelerated approval process the FDA used for Aduhelm. “If the decision is not to cover the drug, then it means that Medicare beneficiaries won’t have access to a drug that the FDA has approved,” James Chambers, an associate professor of medicine at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, told POLITICO. And that, he said, could set a precedent for CMS not covering other therapies that go through the accelerated approval process. The HHS inspector general has already launched a probe into the pathway in light of Aduhelm’s approval. The potential middle ground: CMS may decide an alternative to blanket coverage or denial: Either cover the drug for patients who meet a narrow range of clinical criteria or provide coverage conditional on additional evidence, much like the FDA’s accelerated approval process. The bottom line: Any draft guidance CMS issues will likely get pushback. “No one’s gonna be happy with this,” said Chambers. “[CMS] is in a very unenviable position to say the least.” | | | | DON’T MISS CONGRESS MINUTES: Need to follow the action on Capitol Hill blow-by-blow? Check out Minutes, POLITICO’s new platform that delivers the latest exclusives, twists and much more in real time. Get it on your desktop or download the POLITICO mobile app for iOS or Android. CHECK OUT CONGRESS MINUTES HERE. | | | | | | | | BIDEN ADMIN LAYS OUT HOME TESTING REIMBURSEMENT RULES — People with private insurance can be reimbursed for up to eight over-the-counter at-home Covid-19 tests each month starting Saturday, the Biden administration announced Monday. Under the plan, private insurers can set up programs at preferred pharmacies or retailers where the upfront cost of home tests is covered for beneficiaries. Individuals who purchase home tests outside of their insurers’ preferred network must be reimbursed up to $12 a test, but plans can “provide more generous reimbursement up to the actual price of” more pricey tests, according to the guidance. America’s Health Insurance Plans CEO Matt Eyles said that while there “will likely be some hiccups” implementing the new guidance, insurers plan to work with the Biden administration to address issues as they pop up. “We recognize that the administration’s guidance takes steps to mitigate the real risks of price gouging, fraud, and abuse, which would limit access and reduce affordability for everyone,” Eyles said in a statement. MODERNA CEO: COMPANY WILL PICK SITE FOR AFRICA HUB SOON — Moderna CEO Stéphane Bancel said Monday the vaccine manufacturer is close to selecting a country to host its mRNA facility in Africa. The company has spoken to a few nations and has two or three more to consult alongside the U.S. government and expects to decide in about a month, he said. As Pros know, Moderna has come under fire worldwide for not widely sharing its vaccine recipe to help other manufacturers make shots that can get into more arms faster. Omicron-specific boosters: Bancel said Moderna needs a few more weeks of real-world data before deciding whether to proceed with an Omicron-specific booster dose for a fall 2022 rollout. “We have all of the options on the table,” he said, including a multivalent one. Meanwhile, Pfizer CEO Albert Bourla said Monday the company’s Omicron-specific vaccine will be available by March, with human trials beginning later this month. ICYMI: FDA shortened the time frame for Moderna vaccine recipients to receive a booster after their primary series from six months to five, aligning it with the current Pfizer-BioNTech vaccine schedule. CDC quickly endorsed the change. MORE PEDIATRIC TRIAL QUESTIONS — A local news report in Wisconsin quoting the lead doctor on the University of Wisconsin Health’s Moderna vaccine trial for children 6 months to 4 years old caused a stir on Covid and science Twitter over the weekend. That’s because he said FDA had again asked vaccine manufacturers to add a few hundred more kids to their trials. (Pros may recall this first happened over the summer.) FDA wouldn’t comment (as is standard for interactions with drugmakers working on new products), and a Moderna spokesperson could not respond to questions about the pediatric trial before Prescription Pulse’s deadline. A check of the federal government’s clinical trial database shows the projected participant number, 13,275, has remained unchanged since the summer, at least as of the last update on Dec. 18. | | | | A message from the Pharmaceutical Care Management Association:   | | | | | | BIDEN OFFICIALS HEAD TO HILL AS OMICRON RAGES — The White House’s Covid core four (maybe we can make this happen, like “fetch”) heads to the Senate HELP Committee this morning to give a pandemic response update as Omicron sweeps across the country — and the Capitol complex . A committee aide shared that Chair Patty Murray (D-Wash.) “will express the anxiety she’s hearing from families in Washington state amid the surge of Omicron,” including frustration with the CDC’s new isolation and quarantine guidance and the scarcity of tests. “What I hope to hear from the Administration at this hearing is: What are you doing — right now — to make sure every American can make use of the progress they’ve worked so hard for? What can my constituents expect to see improve this week and the week after?” Murray will say. | | | DEMOCRATS AREN’T PUSHING FOR SHUTDOWNS IN THE WAKE OF OMICRON SURGES — From New York to California, Democratic mayors and governors are fighting to keep schools and businesses open with an urgency they haven’t flexed before in the pandemic, POLITICO’s Lisa Kashinsky and Susannah Luthi report. Previously, Democratic leaders went further than most Republicans in shutting down businesses, enforcing social distancing and requiring masks to tame the virus’ spread — and were initially rewarded politically for their caution. But, now, they’re urging people to get vaccinated and carry on. | | | UK COMPANY PULLS RAPID COVID-19 TEST OVER OMICRON DETECTION CONCERNS — British biotech Avacta is withdrawing its rapid antigen test from the market over concerns the test isn’t sensitive enough to detect cases of the Omicron variant that now make up most infections in the U.K., POLITICO Europe’s Carlo Martuscelli reports. The decision comes amid concerns that antigen tests developed before the Omicron variant’s arrival aren’t accurate enough with the new strain, which contains a large number of mutations. | | | | BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now. | | | | | | | | Tamra Moore has joined King & Spalding as a partner on the health care team in Washington. She was most recently corporate counsel for litigation at Northrop Grumman and is a DOJ Civil Division alumna. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. Proposed medical device quality rule heads to OMB — A long-planned proposed rule that would overhaul how the FDA oversees medical device quality was sent this week to the Office of Management and Budget for review. The rule, which has been in development since at least 2018, seeks to harmonize the way the FDA regulates device quality (known as the Quality System Regulation, or QSR) with a highly similar international standard known as ISO 13485:2016. The ISO standard is recognized by most major global regulators and is highly similar to the FDA’s QSR. By harmonizing the QSR with ISO 13485, the FDA hopes to make it easier and efficient for companies to comply with a single global standard instead of differing ones. However, key issues remain to be resolved, including how much effort it will take for companies (and in particular smaller, U.S.-based companies) to comply with the new requirements and for how long. | | | Hospitals and long-term care facilities are so short-staffed that many are compelling Covid-positive doctors and nurses to return to work, Rachael Levy reports for POLITICO. Illumina and Boehringer Ingelheim announced Monday they are partnering to develop companion diagnostics for several products in Boehringer Ingelheim’s oncology pipeline. | | | | A message from the Pharmaceutical Care Management Association: With Congress poised to fully repeal the rebate rule and prevent significant increases in both Medicare beneficiary premiums and Medicare Part D program costs, pharmaceutical industry representatives are once again attempting to divert attention by suggesting so-called point of sale rebate policies that would undo this progress. We urge Congressional negotiators to continue to resist the latest attempts to shift the blame that puts profits over patients. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
