MMIT Reality Check on Melanoma (2Q2023)

Payer Coverage:

A review of market access for melanoma treatments shows that under the pharmacy benefit, about 59% of the lives under commercial formularies are covered with utilization management restrictions. Around 30% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 78% of the lives under commercial policies are covered with utilization management restrictions. Almost 59% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 97% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 77% require multiple steps. Around 78% of payer-controlled pharmacy benefit covered lives require prior authorization, with 4% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Broadens Opdivo’s Patient Population

In February 2023, the FDA broadened the patient population of Bristol Myers Squibb’s Opdivo (nivolumab) in two indications to include the treatment of (1) people at least 12 years old with unresectable or metastatic melanoma as a single agent or in combination with the company’s Yervoy (ipilimumab) and (2) people at least 12 years old with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting. The FDA first approved the PD-1 blocking antibody on Dec. 22, 2014. Dosing is based on weight and indication. Treatment with Opdivo plus Yervoy is done in two phases. The cost for the first phase — which has a maximum of four infusions — ranges from $24,196 to $43,404 depending on the dose. The second phase is treatment with Opdivo alone. For people receiving 240 mg every two weeks, the list price is $7,194 per infusion, and for every-four-weeks dosing of 480 mg, the price per infusion is $14,389. These are also Opdivo’s prices as a monotherapy.

FDA Approves Opdualag

In March 2022, the FDA approved Bristol Myers Squibb’s Opdualag (nivolumab and relatlimab-rmbw) for the treatment of people at least 12 years old with unresectable or metastatic melanoma. The first-in-class agent targets two different immune checkpoints: programmed death receptor-1 (PD-1) and lymphocyte activation gene-3 (LAG-3). Dosing for people at least 12 who weigh at least 40 kg is 480 mg nivolumab and 160 mg relatlimab intravenously every four weeks. The price per infusion is $27,389.

FDA Gives FoundationOne CDx Additional Approval

In December 2021, the FDA gave another approval to Foundation Medicine, Inc.’s FoundationOne CDx as a companion diagnostic for current and future BRAF inhibitors used to treat melanoma, including monotherapies targeting BRAF V600E and BRAF/MEK inhibitor combination therapies targeting BRAF V600E or V600K mutations. The agency first approved the test on Nov. 30, 2017.

Key Findings:

Market Events Drive Changes

In February 2023, the FDA broadened the patient population of Bristol Myers Squibb’s Opdivo (nivolumab) in two indications to include the treatment of (1) people at least 12 years old with unresectable or metastatic melanoma as a single agent or in combination with the company’s Yervoy (ipilimumab) and (2) people at least 12 years old with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting. In March 2022, the agency approved Bristol Myers Squibb’s Opdualag (nivolumab and relatlimab-rmbw) for the treatment of people at least 12 years old with unresectable or metastatic melanoma. In December 2021, the agency granted another indication to Merck & Co., Inc.’s Keytruda (pembrolizumab) for the treatment of people at least 12 years old with stage IIB or IIC melanoma following complete resection. The agency also expanded the indication for the agent as adjuvant treatment for stage III melanoma following complete resection in include pediatric patients at least 12 years old.

Competitive Market Landscape

The market is witnessing substantial growth owing to development and approval of new biologics as well as their growing demand, which has drawn several local and international companies to invest in developing these therapeutics. With a shift toward combination therapy, doublet and triplet therapy, and the introduction of novel agents for later lines, the malignant melanoma treatment algorithm will continue to evolve.

Pharmacy, Medical Benefit Implications

BRAF kinase inhibitors are covered by most plans with prior authorization (PA). Monoclonal antibodies and Bristol Myers Squibb’s Yervoy (ipilimumab) are covered by most plans either unrestricted or with PA. Many drugs in this indication have both medical and pharmacy coverage.

Key Players in Market:

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