MMIT Reality Check on Multiple Myeloma (October 2022)

Payer Coverage:

A review of market access for multiple myeloma treatments shows that under the pharmacy benefit, about 49% of the lives under commercial formularies are covered with utilization management restrictions. Around 27% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 69% 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, about 36% of the lives require multiple steps. Around 77% of payer-controlled pharmacy benefit covered lives require prior authorization, with 7% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Gives Kyprolis Additional Indication

In June 2022, the FDA granted another indication to Amgen Inc. subsidiary Onyx Pharmaceuticals, Inc.’s Kyprolis (carfilzomib) in combination with Sanofi’s Sarclisa (isatuximab-irfc) and dexamethasone (Isa-Kd) for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three lines of therapy.

Carvykti Approval Brings Second CAR-T to Multiple Myeloma Treatment

With its Feb. 28, 2022, approval, the Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA, Inc.’s Carvykti (ciltacabtagene autoleucel; cilta-cel) becomes the second chimeric antigen receptor T-cell (CAR-T) therapy to treat multiple myeloma. Payers report being less likely to prefer it over some or all other multiple myeloma treatments with a similar indication, but oncologists are showing more enthusiasm for prescribing the new agent, according to Zitter Insights.

Teva Launches First Generic Version of Revlimid

In March 2022, Teva Pharmaceuticals Ltd. launched the first generic version of Bristol Myers Squibb unit Celgene Corp.’s Revlimid (lenalidomide) in 5 mg, 10 mg, 15 mg and 25 mg strengths in the United States on March 7. The FDA approved the drug from Teva U.S. affiliate Arrow International Ltd. and Natco Pharma Ltd. on May 21, 2021. The companies have tentative approval for the 2.5 mg and 20 mg strengths due to an exclusivity issue: The FDA has approved Dr. Reddy’s Laboratories Ltd.’s lenalidomide for those dosages. (Editor’s note: Dr. Reddy’s launched its generic in September.) The product is approved for three indications: (1) multiple myeloma in combination with dexamethasone, (2) transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenic abnormalities and (3) mantle cell lymphoma that has relapsed or progressed after at least two treatments, including bortezomib. The launch is limited, and through an agreement with Celgene, the companies are allowed to sell “mid-single-digit percentages” of Revlimid’s total volume this month, a figure that gradually will increase to one-third of the volume. Beginning Jan. 31, 2026, Teva can sell the drug without volume limitation. Multiple companies are expected to launch Revlimid generics in the U.S. in 2022.

Key Findings:

Market Events Drive Changes

In June 2022, the FDA granted another indication to Amgen Inc. subsidiary Onyx Pharmaceuticals, Inc.’s Kyprolis (carfilzomib) in combination with Sanofi’s Sarclisa (isatuximab-irfc) and dexamethasone (Isa-Kd) for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three lines of therapy. In February, the FDA approved the Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA, Inc.’s Carvykti (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma after at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. The product is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy.

Competitive Market Landscape

Many different drugs to treat multiple myeloma are available. The choice and dose of drug therapy depend on many factors, including the stage of the cancer, the age of the patient, kidney function of the patient and if a stem cell transplant is planned. A variety of novel drugs are being studied for the treatment of relapsed myeloma and relapsed/refractory myeloma.

Pharmacy, Medical Benefit Implications

Drugs for this class receive excellent coverage by payers, and it is under both the pharmacy and medical benefit. Most myeloma cells will eventually become resistant to standard chemotherapy, a condition called multidrug resistance. New drugs and combinations of approved drugs are being researched to provide more options for patients with myeloma. Most payers will include these FDA-approved and off-label combination therapies in their payment policies.

Key Players in Market:

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