HUMIRA RAISES ATTENTION ON BIOSIMILAR MARKET — The first copycat alternatives to a blockbuster anti-inflammatory drug will hit the U.S. market next year, marking an important moment for the drug and insurance industries as they determine how biosimilar products for one of the top-selling brand names will be priced, Lauren reports.
Biosimilars to Humira will roll out gradually during 2023, thanks to the settlement terms companies made with AbbVie, determining when their marketing licenses will kick in. Biosimilars to the drug became available in Europe in 2018 and, by 2019, had captured more than a third of the continent’s market, according to University of Michigan researchers.
How doctors, patients, pharmacy benefit managers and insurers handle competition to Humira — which generated $20.7 billion in sales in 2021 — could set the tone for the domestic biosimilar industry for years to come.
Two of the three biggest PBMs charged with negotiating prescription drug benefits in the U.S. have announced plans to add Humira biosimilars to their prescription drug coverage lists, known as formularies, next year — but with different approaches.
Optum Rx will add up to three products on formulary while keeping Humira available in the same position. Express Scripts said it will start adding the biosimilars to its largest formularies as “preferred” products — a placement PBMs use to nudge patients to a cheaper alternative than a brand-name drug.
“This moment, this Humira moment, will tell us whether or not the stakeholders other than our industry will support this marketplace,” said Juliana Reed, executive director of the Biosimilars Forum, a trade group that represents several U.S. biosimilars manufacturers.
IT’S TUESDAY. WELCOME TO PRESCRIPTION PULSE. ICYMI, the CDC endorsed bivalent shots for very young kids last week.
Send tips, feedback and holiday party gossip to David Lim (firstname.lastname@example.org or @davidalim), Lauren Gardner (email@example.com or @Gardner_LM) or Katherine Ellen Foley (firstname.lastname@example.org or @katherineefoley).
TODAY ON OUR PULSE CHECK PODCAST, Katherine talks with Megan Messerly about the situation inside hospitals as Covid, RSV and flu cases spike. Nearly 30,000 people in U.S. hospitals have tested positive for Covid-19, according to the CDC, up 30 percent since Thanksgiving.
CONGRESS INCHES TOWARD OMNIBUS DEAL — Congressional spending leaders are nearing agreement on a massive government funding deal, but one powerful skeptic remains: Rosa DeLauro (D-Conn.), the House Appropriations Committee chair, POLITICO’s Caitlin Emma, Sarah Ferris and Burgess Everett report.
At the same time, the House and Senate must pass a stopgap spending patch this week to avert a government shutdown on Friday at midnight, buying more time for negotiations on the omnibus spending bill that would keep federal agencies open through this fiscal year’s end on Sept. 30.
The House is expected to move first on the short-term funding bill, according to aides. That measure may come with its own risks in the upper chamber, as any one senator can hold up the vote on a bill to request amendment votes or other concessions.
WARREN, WELCH PRESS PFIZER TO REVERSE COVID SHOT PRICE HIKES — Sen. Elizabeth Warren (D-Mass.) and incoming senator Peter Welch (D-Vt.) are demanding answers from Pfizer CEO Albert Bourla about reported plans to quadruple the price of its Covid-19 vaccine in 2023 and pushing the company to change course.
The senators want the company to answer several questions by Jan. 9 — including how much it expects to make as a result of the price hike in 2023, how much it would make without the increase, how many patients have so far used the company’s patient assistance program and how much Pfizer plans to charge Medicare, Medicaid and the VA for the Covid vaccine.
“Everyone deserves easy and affordable access to these lifesaving vaccines, and I’m urging Pfizer to reverse this planned price hike and put public health ahead of corporate greed,” Warren told POLITICO.
Pfizer spokesperson Sharon Castillo said the company disagreed with the characterization in the letter that it is displaying “pure and deadly greed” and is “unseemly profiteering.”
“We will not get ahead of an official response in the media,” Castillo said in an email.
Big picture: The letter comes as Congress appears unlikely to meet the Biden administration’s request for $10 billion to continue combating Covid as part of an end-of-year spending bill, funding the White House says is needed to continue bulk-buying vaccines and make them available to the public for free. As the pandemic response shifts to the private sector, Democratic lawmakers fear progress on racial and economic disparities in Covid infections and deaths will backslide.
FIRST IN RxP: CAP, ADVAMED, PEW LOBBY FOR VALID ACT — A group of organizations, including Friends of Cancer Research, Association for Clinical Oncology, AdvaMed, The Pew Charitable Trusts and the College of American Pathologists, urged in a Monday letter that the Democrat and Republican leaders of the Senate HELP Committee and House Energy and Commerce Committee advance legislation that would overhaul how diagnostics and laboratory developed tests are regulated before the end of the current Congress.
SCOTUS DENIES REYNOLDS’ REQUEST FOR EMERGENCY STAY IN CALIF. — On Monday, the Supreme Court denied a request from R.J. Reynolds and other tobacco industry players to issue an emergency stay that would have delayed implementation of California’s ban on flavored tobacco products, Katherine reports.
Reynolds, which makes Newport menthol cigarettes, and other industry players asked the high court to grant an emergency stay after two lower courts, including the 9th U.S. Circuit Court of Appeals, denied the companies’ emergency stay request. This request was tied to a preliminary injunction request the industry group had filed in the District Court of the Southern District of California in November, right after voters in the state resoundingly upheld a ban in midterm election voting on the sale of flavored tobacco products.
Supreme Court Justice Elena Kagan had been expected to issue a ruling on the stay request, but instead, she asked the full court to weigh in, and a majority of the justices agreed to deny the request. There were no dissenters.
The court’s denial means that the state ban will go into effect no later than Dec. 21, although the industry can continue to litigate the issues it cited in its stay request.
ARPA-H TO CHOOSE ITS HEADQUARTERS WITHOUT REQUESTING PROPOSALS — The Advanced Research Projects Agency for Health doesn’t plan to release a request for proposal for its highly sought-after headquarters location, an agency spokesperson told POLITICO’s Ben Leonard. Jared Adams, ARPA-H’s chief of engagement and communications, declined to provide a timeline on the decision but gave some insight into the process, saying the agency is taking a number of factors into consideration and wants to allow “open competition.”
At least 10 states, including California, Texas and Massachusetts, have indicated they want to host the agency. Lobbyists have said it is unclear how the agency will choose a winner.
ROUND TWO: FTC TAKES ON ILLUMINA-GRAIL — Commissioners at the Federal Trade Commission are set to hear oral arguments today from FTC staff in a case challenging genetic sequencing company Illumina’s vertical acquisition of Grail. The commissioners will be tasked with deciding whether to reverse a decision from Administrative Law Judge D. Michael Chappell that the deal would not negatively impact the developing multicancer diagnostics market.
If the FTC staff prevails, Illumina and Grail will be able to appeal to a federal appeals court of their choice.
Amgen said Monday it agreed to buy Horizon Therapeutics for $27.8 billion, The Wall Street Journal’s Ben Dummett, Dana Cimilluca and Laura Cooper report.
Darbi Gottlieb is the new director of state government and regional affairs at AdvaMed. She previously worked for Arizona Gov. Doug Ducey (R) as director of policy. Susan Askew is AdvaMed’s new political action committee director.
The FDA renewed the Cardiovascular and Renal Drugs Advisory Committee for two years. The new charter remains in effect until Aug. 27, 2024.