FDA approves game-changing regimen for urothelial cancer, but will cost pose issue?

February 20, 2024

Reprinted with AIS Health permission from the Feb. 15, 2024, issue of Spotlight on Market Access.

By Angela Maas

In late 2023, the FDA approved a new treatment regimen for urothelial cancer that represents a “paradigm change,” according to one industry expert. The cost of the therapy, however, 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.

The Phase III EV-302/KEYNOTE-A39 clinical trial found that Padcev in combination with Keytruda almost doubled median overall survival and median progression-free survival in people who had previously untreated la/mUC compared with platinum-containing chemotherapy.

Dosing for Padcev, a Nectin-4-directed antibody and microtubule inhibitor conjugate, is 1.25 mg/kg via a 30-minute infusion on days one and eight of a 21-day cycle, and for Keytruda, a programmed death receptor-1 (PD-1) inhibitor, dosing is 200 mg via a 30-minute infusion every three weeks or 400 mg every six weeks. Drugs.com lists the price of one single-dose 20 mg vial of Padcev as $2,909. The list price of every-three-weeks Keytruda is $11,115; for every-six-weeks dosing, it is $22,230.

Assuming treatment lasts one year, the annual per-person cost could be more than half a million dollars, according to one estimate.

Urothelial carcinoma is the most common form of bladder cancer, accounting for about 90% of cases.

“Almost 50% of patients with metastatic bladder cancer are cisplatin-ineligible,” explains Haita Makanji, Pharm.D., vice president of clinical strategy and innovation for Prime/Magellan Rx. The December approval, she says, marks “the first time a nonplatinum-based combination therapy received approval as a first-line therapy. Due to the high price of these two agents, the cost of therapy increases significantly, as does the projected budget impact.”

The approval, remarked Ahsan Arozullah, M.D., M.P.H., senior vice president and head of oncology development at Astellas, “represents a paradigm change in the treatment of advanced bladder cancer and provides hope to the thousands of Americans impacted by this aggressive disease. This achievement is notable, as it is the first regimen approved in advanced urothelial cancer that has demonstrated superiority to platinum chemotherapy, the gold standard of care for decades.”

For the Managed Care Oncology Index: Q1 2023, from March 2, 2023, to March 30, 2023, Zitter Insights polled 35 commercial payers covering 116.7 million lives, 26 Medicare payers covering 42.3 million lives, 50 oncologists and 52 practice managers about their management of and prescribing for bladder cancer. Payers said that an annualized net price for Padcev + Keytruda between $189,000 and $204,000 would be appropriately priced, while a price more than $281,000 would be too expensive, leading to their not covering or highly restricting the regimen.

More than half — 58% — of payers said that managing branded bladder cancer treatments is an average priority for them. Those with 71% of commercial lives reported that they are somewhat aggressive in their management of the therapies, meaning that while all products are covered, some may be preferred over others through tiering, step edits and/or prior authorization.

The survey, which was conducted before the Padcev/Keytruda approvals, revealed that 81% of payers and 56% of oncologists expressed average satisfaction with available treatments for bladder cancer. Respondents also expressed a variety of perceptions about the level of unmet need for the treatment of the condition.

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