MMIT Reality Check on Melanoma

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 16% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 75% of the lives under commercial policies are covered with utilization management restrictions. Almost 60% 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, about 88% require multiple steps. Around 81% of payer-controlled pharmacy benefit covered lives require prior authorization, with 2% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

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.

Many Melanoma Therapies Exist, but Treatment Remains Challenging

Since 2011, the FDA has approved multiple therapies for advanced or late-stage melanoma. Recently, the agency granted an additional approval to one of those drugs for the earlier stage melanoma setting, filling an unmet need, industry experts note. However, the condition is complex to treat and may be challenging for health plans to manage.

On Dec. 3, 2021, the FDA approved Merck & Co., Inc.’s programmed death receptor-1 (PD-1) inhibitor Keytruda (pembrolizumab) for the adjuvant treatment of people at least 12 years old with stage IIB or IIC melanoma following complete resection.

Key Findings:

Market Events Drive Changes

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. 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 to 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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