Metastatic melanoma is a high-cost category with an increasing number of therapies that treat the condition. To help stakeholders absorb datapoints and perceptions from all directions and synthesize those insights into a tangible strategy for metastatic melanoma, Zitter Insights surveys a leading panel of pharmacy and therapeutics (P&T) decision makers at payers and integrated delivery networks. The Managed Care Oncology Index combines deep payer insights with the industry standard in market access information to produce quarterly reports and insights summaries on leading oncology brands.
Combination therapies often are used to treat metastatic melanoma. Commercial payers with about one-third of covered lives said they anticipate taking measures to control the use of these regimens (see chart). The top actions include stricter enforcement of prior authorizations and requiring prior authorizations for the individual drugs in a combination. Payers with more than three-quarters of lives will prefer monotherapies over combination therapies.
Payers said that a significant increase in progression-free survival and a substantial improvement in overall survival are the two most influential factors influencing their coverage of combination therapies. On the opposite end, a regimen’s route of administration and a biomarker testing requirement were the least influential issues.
On March 18, 2022, the FDA approved Bristol Myers Squibb’s Opdualag — a combination of the company’s Opdivo (nivolumab) and relatlimab-rmbw — for the treatment of people at least 12 years old with unresectable or metastatic melanoma. Payers covering more than three-quarters of lives said they expect to manage the therapy to label, and most said they expect to manage the new agent at parity with all other combination therapies for metastatic melanoma. Approximately three-fourths of oncologists said they anticipate prescribing the therapy for some patients.
Opdivo was the drug prescribed most often in the 12 months prior to the survey, with more than four-fifths of oncologists writing a script for it. Also commonly prescribed were Yervoy (ipilimumab) from Bristol Myers Squibb and Merck & Co., Inc.’s Keytruda (pembrolizumab), with approximately three-quarters of oncologists prescribing them. Least prescribed was Imlygic (talimogene laherparepvec) from Amgen Inc. subsidiary BioVex, Inc.
Payers, oncologists and practice managers rated manufacturers of metastatic melanoma treatments across a range of performance metrics: overall commitment to the disease, account representative support, patient and family support programs and resources, patient copay assistance, physician education and support, and hub services. Payers said that Bristol Myers Squibb was the top metastatic melanoma therapy manufacturer in overall commitment to the disease, account representative support, and patient and family support programs and resources. They ranked Roche No. 1 in patient copay assistance, Merck the top company for physician education and support and Pfizer the best in hub services. Oncologists rated Merck the top company in four of the six categories and deemed Roche the best in overall commitment to the disease and patient/family support programs and resources. Practice managers gave Merck top marks across all six metrics.
Message: “Discussion regarding the use of Opdualag in the treatment and management of metastatic melanoma. The drug combination consists of a fixed dose combination of the PD-1 Opdivo and the LAG-3 inhibitor relatlimab for the treatment of unresectable metastatic melanoma. Clinical efficacy studies demonstrated in the Phase II/III RELATIVITY-047 trial a significant improvement in mPFS [i.e., modified progression-free survival] to 10 months, almost double to that of Opdivo monotherapy. While dose interruption can be used to address adverse effects, the drug demonstrated a significant reduction in grade 3/4 adverse effects as compared to combination Opdivo/Yervoy. Additionally, of interest, the drug is also underdoing additional clinical studies for…the treatment of NSCLC and hepatic carcinoma. Additional information with be forthcoming.”
Payer Thoughts: “Overall, this fixed dose combination has the potential of changing the dynamic landscape for treatment. With a doubling in efficacy, Opdualag has the potential of shifting utilization towards this approach vs. monotherapy.”
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 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, filling an unmet need in early-stage disease, industry experts note. The agency also expanded the indication for the agent’s use as an adjuvant treatment of stage III melanoma following complete resection to include pediatric patients at least 12 years old. However, the condition is complex to treat and may be challenging for health plans to manage.
FDA Approves Opdualag
On March 18, 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.