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 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: Metastatic Melanoma combines deep payer insights with the industry standard in market access information to produce quarterly reports and insights summaries on leading oncology brands.
Payers covering almost three-fourths of Medicare lives said that managing branded treatments for metastatic melanoma was an average priority, while those with one-fifth of lives rated it very high. Payers with almost all commercial lives reported that it was an average or high priority to manage these therapies. Payers with more than half of commercial beneficiaries and those with one-quarter of Medicare lives said they were somewhat aggressive in their management of the drugs.
Payers representing more than four-fifths of commercial lives, those with almost half of Medicare lives and more than one-third of oncologists said that high unmet need in treating metastatic melanoma exists. Medicare and commercial payers with less than half of beneficiaries said there is an average level of contracting for agents in the class.
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). The price per infusion is more than $27,000, and payers covering more than two-thirds of Medicare lives said that’s about what they expected it to be. Almost half of oncologists said they expect the new product will have a moderate impact on their treatment approach for metastatic melanoma. Payers covering approximately one-third of commercial and Medicare lives said they do not expect the agent will impact other drugs for the condition.
Oncologists frequently prescribe combination therapies to treat metastatic melanoma. Payers with more than half of both commercial and Medicare covered lives said they manage each agent independently as opposed to managing all the drugs together as one combined product. Commercial payers representing more than half of lives do not take measures to control the use of combination treatments, while Medicare payers with four-fifths of beneficiaries responded similarly. Among respondents who were taking steps to regulate those therapies’ use, payers with all beneficiaries had increased their use of prior authorization. Medicare payers with four-fifths of lives said they were strictly adhering to clinical treatment pathways compared with those representing slightly more than one-quarter of commercial lives who said the same.
Social Determinants of Health
Among payers covering commercial lives, the top social determinants of health initiative for disadvantaged members with metastatic melanoma was offering greater access to telehealth — which is done by payers with almost three-fourths of lives — followed by providing services to support health/medicine literacy, as well as services to assist in health/medicine language barriers. For Medicare payers, the top programs were providing educational content about healthy living, transportation to and from medical appointments and services to support health/medicine literacy. Oncologists identified a person’s socioeconomic status as the top nonmedical factor impacting metastatic melanoma patients’ access to therapy, as well as education and health literacy, occupation and job security, and familial/other support.
Message: “We had a routine visit with Merck to discuss our current Keytruda utilization. From a specialty pharmacy dispensing perspective, Keytruda is one of our largest volume and revenue medications we dispensed (roughly $2,500,000 per month in revenue and 230 dispenses per month). We also discussed our utilization on the medical benefit. Our annual cost spend for Keytruda in 2021 was $2,700,000, with 20% of the spend being infused at physician’s office. Our payor segment has been focused on site of care and trying to shift patients from the hospital to the physician’s office or home infusion if applicable.”
Payer Thoughts: “The meeting went well. We continue to partner with Merck, as Keytruda is one of our largest oncology revenue drivers. We are looking for ways to further partner with enhanced or value-based contracting. It is harder to obtain enhanced/value-based contracting with medications that are infused vs. oral formulations.”
FDA Gives Additional Indications to Opdivo
On Feb. 15, 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.
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.