Timeline set for negotiating Medicare drug prices

Presented by The Campaign for Sustainable Rx Pricing

Programming note: We’ll be off Monday for Martin Luther King Jr. Day but will be back in your inboxes on Wednesday.

With Krista Mahr

Driving The Day

CMS RELEASES KEY DATES FOR MEDICARE NEGOTIATION — CMS Administrator Chiquita Brooks-LaSure announced Wednesday that the first 10 Medicare Part D drugs selected for price negotiations will be made public by Sept. 1 — a key step toward implementation of the Inflation Reduction Act.

The 2022 law empowers the federal government to negotiate prices for a subset of high-cost, name-brand drugs covered by Medicare that do not have generic or biosimilar competition.

Once the list of 10 drugs is published, Medicare will go through the negotiation process with drug manufacturers in 2024, Brooks-LaSure said. CMS expects to publish the established maximum fair price for the drugs in September 2024, which will take effect in January 2026.

CMS laid out additional details in a memo, outlining the agency’s plan to issue draft implementation guidance for initial price applicability year 2026 and to request comment on topics, including the offer and counteroffer process, and how maximum fair prices will be applied across dosage forms.

“While we remain profoundly concerned about the impact the IRA’s drug pricing provisions will have on patients, [the] announcement represents a useful step that will enable stakeholders to provide feedback as CMS begins implementation,” PhRMA spokesperson Nicole Longo said.

IT’S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Send tips, feedback and compliments to David Lim ([email protected] or @davidalim), Lauren Gardner ([email protected] or @Gardner_LM) or Katherine Ellen Foley ([email protected] or @katherineefoley).

TODAY ON OUR PULSE CHECK PODCAST, Ben Leonard talks with Ruth Reader about the impact the end of the Covid-19 public health emergency might have on access to drugs used to treat substance use disorders and mental illnesses.

Eye on the FDA

ANTI-ABORTION GROUPS TO TAKE PROTESTS TO PHARMACIES — Abortion-rights opponents are targeting pharmacy chains for pickets now that the FDA allows brick-and-mortar stores to get certified to dispense the abortion drug mifepristone. Advocates are organizing protests outside CVS and Walgreens stores in early February in more than eight cities, including Washington, D.C., as well as a call-in campaign and a national boycott of the chains.

Pharmacy groups tell Lauren it will take a few weeks to get a better understanding of how many storefronts, including independent pharmacies, decide to get certified to dispense. They’ve been working with the drug’s manufacturers to understand how to comply with the updated FDA risk management strategy rules.

Another issue raised: It’s unclear how long it will take for insurers to cover mifepristone under their pharmacy benefits. If a doctor directs a patient to pick up the pill at a pharmacy, it won’t be covered under the medical benefit as it is when doctors distribute the drug, meaning consumers must pay out-of-pocket at the pharmacy counter.

CALIFF: CAN’T HAVE SEPARATE CLINICAL TRIAL RESPONSE FOR EMERGENCIES — FDA Commissioner Robert Califf on Thursday called for the U.S. to consider setting up a governance structure for clinical trials — which does not yet exist — that can help identify the “most important questions for public health and make sure that those questions get answered.”

“Any notion that we can have an entirely separate response to emergencies vs. having standing capability, I think is just flat-out wrong,” Califf said at the White House’s roundtable discussion on how to prepare the U.S. clinical trial infrastructure for emergencies.

In Congress

NEW GOP E&C MEMBERS — The House Republican Steering Committee selected nine new members to serve on the House Energy and Commerce Committee: Reps. Randy Weber (Texas), Rick Allen (Ga.), Troy Balderson (Ohio), Russ Fulcher (Idaho), August Pfluger (Texas), Diana Harshbarger (Tenn.), Mariannette Miller-Meeks (Iowa), Kat Cammack (Fla.) and Jay Obernolte (R-Calif.).

Another notable for FDA watchers: House Appropriations Chair Kay Granger (R-Texas) tentatively selected Rep. Andy Harris (R-Md.) to head the appropriations subcommittee for agriculture, rural development and the FDA, POLITICO’s Olivia Beavers and Sarah Ferris report. The appointment, which still needs to be ratified by the GOP steering committee, could change before it is presented to the full conference.

Coronavirus

HHS EXTENDS COVID PUBLIC HEALTH EMERGENCY — On Wednesday, HHS Secretary Xavier Becerra extended the Covid-19 public health emergency for the 11th time since it was first declared in January 2020. It could be the last time the administration extends the emergency, as federal health officials eye a potential spring end date, POLITICO’s Adam Cancryn writes.

House E&C Committee Chair Cathy McMorris Rodgers (R-Wash.) lamented the decision in a statement, arguing “there should be no further extension.”

FDA ADVISER ARGUES MOST PEOPLE DON’T NEED BIVALENT BOOSTERS — Paul Offit, a leading immunologist and member of the FDA’s vaccine advisory committee, wrote in The New England Journal of Medicine on Wednesday that current data show that young, healthy, previously vaccinated individuals don’t benefit from bivalent boosters because they are already protected from severe disease.

The piece appeared to ruffle some feathers, and Califf tweeted that CDC data show that bivalent vaccines have been associated with significantly fewer hospitalizations and death and that not all younger individuals may be aware of their comorbidities.

Offit responds: “According to CDC data, three groups benefit from booster dosing with regard to protection from hospitalization,” Offit told Katherine. Those three groups include the elderly, the immunocompromised and those with multiple comorbidities that put them at risk of severe disease. “Healthy young people are not in those three groups. … That’s the CDC data.”

Around the Agencies

KINDERGARTEN VACCINATION RATES PLUMMET — Vaccination coverage among kindergarteners fell to a 10-year low last school year, CDC officials said Thursday.

In the 2021–2022 school year, national vaccination coverage among kindergarteners dropped to approximately 93 percent, down from around 94 percent the previous year, the CDC reported. Coverage for MMR, DTaP, polio and varicella vaccines declined in most states, and about 3.9 percent of children — or 250,000 — had not been vaccinated against measles.

Why it’s happening: CDC officials attributed the continuing drop to a variety of factors, ranging from missed routine pediatrician visits during the pandemic, lockdowns, schools having to focus on remote learning instead of enforcing vaccination requirements and misinformation and vaccine hesitancy about the Covid-19 vaccine spilling over into other immunizations.

In the Courts

CALIFORNIA AG SUES INSULIN MAKERS, PBMS — California Attorney General Rob Bonta filed a lawsuit Thursday against the country’s largest insulin makers and pharmacy benefit managers, alleging they “unacceptably and artificially inflate the cost of life-saving medication at the expense of vulnerable patients.”

The lawsuit accuses drugmakers Eli Lilly, Novo Nordisk and Sanofi and pharmacy benefit managers CVS Caremark, Express Scripts and OptumRx of leveraging their market power to overcharge patients for insulin. CVS told POLITICO California’s Ramon Castanos that the defendants “plan to vigorously defend against this complaint.”

STERIGENICS AGREES TO $408M SETTLEMENT — Medical device sterilizer Sterigenics agreed Monday to settle more than 870 ethylene oxide lawsuits in Illinois.

“Sterigenics maintains that its Willowbrook operations did not pose a safety risk to the community in which it operated,” parent company Sotera Health said in a statement.

Pharma Moves

Nirav Shah will become the principal deputy director of the U.S. CDC in March, Maine Gov. Janet Mills announced Thursday.

Quick Hits

Two new studies published in JAMA raise concern that some devices that use the FDA’s 510(k) pathway may be associated with an increased risk of recalls, STAT’s Matthew Herper reports.

Hospitals are disappointed with a federal court decision that allows HHS to decide how to repay 340B hospitals for underpayment for certain drugs, Healthcare Dive’s Rebecca Pifer reports.

A monthly $35 cap on out-of-pocket costs for insulin kicked into effect for Medicare beneficiaries on Jan. 1, The Wall Street Journal’s Peter Loftus reports.

Document Drawer

The FDA recently issued two warning letters to Olympus Medical Systems Corp. and subsidiary Aizu Olympus, raising concerns about medical device reporting requirement violations for endoscopes and accessories.

The National Academies will hold a two-day virtual workshop on the FDA’s accelerated approval program on Jan. 30 and 31.