FDA

New FDA Approvals: FDA Approves BeiGene’s Tevimbra

March 13: The FDA approved BeiGene, Ltd.’s Tevimbra (tislelizumab-jsgr) for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a programmed death receptor-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor. Recommended dosing for the PD-1 inhibitor is 200 mg via intravenous infusion once every three weeks. The initial dose is administered over 60 minutes; if it is tolerated, subsequent doses can be administered over 30 minutes. The drug will be available in the second half of 2024.

March 13: The FDA gave an additional indication to Mirum Pharmaceuticals, Inc.’s Livmarli (maralixibat) for the treatment of cholestatic pruritus in people at least 5 years old with progressive familial intrahepatic cholestasis (PFIC). The agency first approved the ileal bile acid transporter inhibitor on Sept. 29, 2021. The new indication has orphan drug designation, as well as breakthrough therapy designation for PFIC type 2. The starting dose for the newest use of the oral solution is 285 mcg/kg once daily in the morning, increasing to 285 mcg/kg twice daily, then 428 mcg/kg twice daily and then 570 mcg/kg twice daily. Drugs.com lists the price of 9.5 mg/mL for 30 milliliters as more than $56,239.

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‘Significant Milestone’ Brings New Weapon to Advanced Melanoma Fight

The FDA recently approved a first-in-class agent to treat a particularly deadly cancer. The therapy, Iovance Biotherapeutics, Inc.’s Amtagvi (lifileucel), signifies a promising new development in the treatment of solid tumors, which represent about 90% of all cancers in the U.S. While the drug comes with a price tag of more than $500,000, as well as additional costs, payers’ experience with chimeric antigen receptor T cells (CAR-T) therapies should be helpful in their coverage of the new agent, say industry sources.

On Feb. 16, the FDA gave accelerated approval to Amtagvi for the treatment of adults with unresectable or metastatic melanoma previously treated with a programmed death receptor-1 (PD-1) inhibitor and, if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor. The agency gave the therapy orphan drug, regenerative medicine advanced therapy, fast track and priority review designations.

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News Briefs: Startup PBM Closes $100m Funding Round

Startup PBM Rightway on March 30 closed a $100 million Series C financing round, the firm said. According to Rightway, that means the startup is now valued at $1.1 billion. A press release discussing the funding round claims that the firm now serves more than 500,000 members and 850 clients. Rightway, which touts its transparency to prospective clients, also claimed that it generates “an average of 20% reduction in year 1 pharmacy cost savings.”

Payers doubt that state prescription drug affordability boards (PDABs) will have an effect on prescription costs any time soon, according to a survey by Avalere Health. As part of its survey, Avalere conducted “six double-blinded interviews with health plan representatives.” Among the states that have established PDABs, Colorado, Maryland, Minnesota and Washington granted their boards the authority to set upper payment limits (UPLs.) According to Avalere, “all interviewees agreed that UPL-affected drugs or their competitors in the therapeutic class could see greater utilization management…depending on how manufacturers respond to supply chain changes, rebating, and UPL implementation.” In addition, five of six interviewees said they “expect formulary adjustments.” Colorado’s was the first PDAB to propose a UPL, but that has been challenged by the affected drug manufacturer. As a result, interviewed Colorado payers “are not yet actively preparing for a UPL,” expecting that the actual UPL won’t come into effect for “more than a year.”

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Califf: AI, Drug Shortages, Cell and Gene Therapies Are Among FDA Priorities

Artificial intelligence (AI), drug shortages and cell and gene therapies are just a few of the areas on which the FDA is focusing during a major reorganization. Those were some of the topics that FDA Commissioner Robert Califf, M.D., discussed with Mike Tuffin, president and CEO of AHIP, at the insurer trade group’s 2024 Medicare, Medicaid, Duals & Commercial Markets Forum, held March 12 through 14 in Baltimore.

When asked his vision for the FDA in 2024 and beyond, Califf responded that 2024 priorities were different because it’s an election year, and the agency’s priorities are “tied to the administration that’s in place.”

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Wegovy Coverage Question Puts Part D Plans in Tricky Position

In newly released guidance, CMS told Medicare Part D plans that they’re allowed to cover weight-loss drugs if they’ve been approved for another medical use — a description fitting Novo Nordisk’s Wegovy (semaglutide) after it recently received an FDA nod for preventing major heart problems.

So far, CVS Health Corp., Elevance Health, Inc. and Kaiser Permanente have said their Part D plans will cover Wegovy for its newest approved use: reducing the risk of heart attacks and strokes in people who have cardiovascular disease and who meet body-weight criteria, the Wall Street Journal reported on March 28.

For other insurers that sell Part D plans, the decision about whether to cover Wegovy represents an additional challenge to grapple with, as they’re also facing significant regulatory changes.

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‘Landmark Approval’ Brings New Weapon to Advanced Melanoma Fight

The FDA recently approved a first-in-class agent to treat a particularly deadly cancer. The therapy signifies a promising new development in the treatment of solid tumors, which represent about 90% of all cancers in the U.S.

On Feb. 16, the FDA gave accelerated approval to Iovance Biotherapeutics, Inc.’s Amtagvi (lifileucel) for the treatment of adults with unresectable or metastatic melanoma previously treated with a programmed death receptor-1 (PD-1) inhibitor and, if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor. The agency gave the therapy orphan drug, regenerative medicine advanced therapy, fast track and priority review designations.

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News Briefs: Wegovy Gains Another Indication

The FDA on March 8 granted Novo Nordisk A/S’s Wegovy (semaglutide) yet another indication — for cardiovascular risk reduction — that could further boost staggering GLP-1 sales. Wegovy is now approved to reduce risk of “major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke” in adults who are either overweight or obese and have established cardiovascular disease, per a Novo press release. FDA official John Sharretts, M.D., described Wegovy as the first weight loss medication “to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight.” As the FDA noted in a press release, approximately 70% of U.S. adults are obese or overweight. The new indication was approved after a priority review.

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Cardinal Health Report Highlights ‘Pivotal Year’ for Biosimilars

The FDA approved the first biosimilar in 2015, and since then, almost 50 more have been greenlighted. Last year saw the biggest influx of these competitors onto the U.S. market, and a recent Cardinal Health report, titled 2024 Biosimilars Report: Insights on a pivotal year of evolution and expansion, highlights this burgeoning market.

Since 2015, biosimilars have saved $23.6 billion, with $9.4 billion of that total coming in 2023 alone. Last year saw the long-awaited competition to the top-selling Humira (adalimumab) from AbbVie Inc., with nine biosimilars launching, two of them with interchangeable status, an important differentiator to providers. “As the top-selling drug in the world with annual sales of $20 billion in 2022, the potential monetary impact of increased market competition cannot be overstated,” says the report.

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AHIP Panelists: Accelerated Approval, IRA Uncertainty Worry Health Plans

For health plans, managing prescription drug coverage has become a highly complex task for myriad reasons, including never-ending regulatory changes and ever-rising prices. And that task is made even more difficult by the fact that an increasing number of drugs are coming to market with limited evidence that they are effective, panelists said during a March 13 session of the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum in Baltimore.

“One of the challenges for insurers going forward will be the increasing need to manage uncertainty,” said Daniel Ollendorf, Ph.D., chief scientific officer at the Institute for Clinical and Economic Review (ICER). Many drug launch prices, he said, “are being driven by approvals that happen on an accelerated basis with very limited evidence.”

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FDA Grants Full Approval to Game-Changing Regimen for Urothelial Cancer

Late last year, the FDA approved a new regimen for urothelial cancer that could transform the treatment of the condition, according to industry experts. However, the cost of the combination — which is estimated to be more than half a million dollars annually — could pose a barrier to its uptake.

On Dec. 15, 2023, the FDA approved Pfizer Inc. and Astellas Pharma Inc.’s Padcev (enfortumab vedotin-ejfv) in combination with Merck & Co., Inc.’s Keytruda (pembrolizumab) for the treatment of people with locally advanced or metastatic urothelial cancer (la/mUC). The agency gave accelerated approval to this combination for people with la/mUC who are not eligible for cisplatin-containing chemotherapy on April 3, 2023. The newest approval converts that accelerated approval to full and expands the labeled indication to include the treatment of people eligible for cisplatin chemotherapy. The application had priority review and breakthrough therapy designation.

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