MMIT Reality Check on Urothelial/Bladder Cancer (June 2022)

Payer Coverage:

A review of market access for urothelial/bladder cancer shows that under the pharmacy benefit, about 46% of the lives under commercial formularies are covered with utilization management restrictions. Around 38% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 76% of the lives under commercial policies are covered with utilization management restrictions. Almost 65% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 98% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, all require a single step. Around 77% of payer-controlled pharmacy benefit covered lives require prior authorization.

Trends:

FDA Expands Opdivo’s Label

In August 2021, the FDA expanded the label of Bristol-Myers Squibb Co.’s Opdivo (nivolumab) to include the adjuvant treatment of people with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection. It is the first therapy that the agency has approved for this use. The FDA initially approved the PD-1 inhibitor on Dec. 22, 2014. The most recent approval was under the Real-Time Oncology Review pilot program. Dosing is 240 mg every two weeks or 480 mg every four weeks via intravenous infusion. The price of every-two-weeks dosing is $6,779.00; for every four weeks, it’s $13,559.00.

Padcev Approval Gives Another Option to Treat Bladder Cancer

The FDA recently expanded the indication of a drug for certain types of urothelial cancer, the most common form of bladder cancer. Payers and oncologists appear to be divided, however, on the drug’s place in a treatment regimen. But in a therapeutic class with limited therapeutic options, the approvals are a welcome addition, particularly in the second-line setting.

On July 9, 2021, the FDA gave an additional approval to Astellas Pharma US, Inc. and Seagen Inc.’s Padcev (enfortumab vedotin-ejfv) for the treatment of adults with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have received at least one line of therapy. The agency also converted the Nectin-4-directed antibody and microtubule inhibitor conjugate’s accelerated approval, granted Dec. 18, 2019, to regular approval for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before or after surgery or in a locally advanced or metastatic urothelial cancer setting.

FDA Approves Trodelvy

In April 2021, the FDA gave accelerated approval to Gilead Sciences, Inc.’s Trodelvy (sacituzumab govitecan-hziy) for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. The recommended dose of the intravenous infusion is 10 mg/kg once weekly on days one and eight of a continuous 21-day treatment cycle.

Key Findings:

Market Events Drive Changes

In August 2021, the FDA expanded the label of Bristol-Myers Squibb Co.’s Opdivo (nivolumab) to include the adjuvant treatment of people with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection. It is the first therapy that the agency approved for this use. In July 2021, the FDA gave an additional approval to Astellas Pharma US, Inc. and Seagen Inc.’s Padcev (enfortumab vedotin-ejfv) for the treatment of adults with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have received at least one line of therapy. The agency also converted the drug’s accelerated approval, granted in December 2019, to regular approval for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before or after surgery or in a locally advanced or metastatic urothelial cancer setting. In April 2021, the agency gave accelerated approval to Gilead Sciences, Inc.’s Trodelvy (sacituzumab govitecan-hziy) for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. Several new drugs for bladder cancer of all stages have been approved in recent years, and more treatments are on the horizon.

Competitive Market Landscape

Several anti-PD-L1 monoclonal antibodies are currently FDA approved for urothelial cancer. There is only one Nectin-4-directed antibody and microtubule inhibitor conjugate and one gel form of mitomycin. Many payers have policies written to manage the use of these agents in the treatment of urothelial cancer and their place in the treatment pathway.

Pharmacy, Medical Benefit Implications

Balversa (erdafitinib), a tablet from Janssen Biotech, Inc., a Johnson & Johnson unit, is processed through the pharmacy benefit, while the rest of the products currently approved for urothelial cancer are primarily processed through the medical benefit since they are required to be administered by a physician or authorized health care provider. In general, for provider-administered products, there are policies covering an entire class for an oncology indication when two or more products in a class carry an FDA approval.

Key Players in Market:

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