MMIT Reality Check on Multiple Myeloma (Oct 2021)

Payer Coverage:

A review of market access for multiple myeloma treatments shows that under the pharmacy benefit, about half of the lives under commercial formularies are covered with utilization management restrictions. About 29% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 60% of the lives under commercial policies are covered with utilization management restrictions. Meanwhile, more than 78% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

For about 99% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, 62% require multiple steps. Around 76% 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 Darzalex Faspro Another Indication

In July 2021, the FDA granted another indication to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who have received at least one line of therapy, including lenalidomide and a proteasome inhibitor. Drugs.com lists the price of an 1,800 mg/30,000 per 15 mL vial as more than $8,290.

Multiple Myeloma Poses Management Challenges

Multiple myeloma has an array of products available to treat it, and new agents — including the first gene therapy for the disease — continue to gain FDA approval. However, as the therapies are different types of drugs, management of the space can be challenging. “While induction regimens have remained rather consistent over the years, the majority of the recently approved treatment options are in the maintenance and resistant/relapsing stages of treatment,” says Winston Wong, Pharm.D., president of W-Squared Group.

FDA Approves Abecma

In March 2021, the FDA approved Bristol Myers Squibb and bluebird bio, Inc.’s Abecma (idecabtagene vicleucel) for the treatment of adults with relapsed or refractory multiple myeloma after at least four lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. It is the first B-cell maturation antigen (BCMA)-directed CAR-T therapy for the indication.
The monthly price of the drug is $10,417, with a net price of about $8,000 for many payers.

Key Findings:

Market Events Drive Changes

In July 2021, the FDA granted another indication to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who have received at least one line of therapy, including lenalidomide and a proteasome inhibitor. In March 2021, the agency approved Bristol Myers Squibb and bluebird bio, Inc.’s Abecma (idecabtagene vicleucel) for the treatment of adults with relapsed or refractory multiple myeloma after at least four lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.

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 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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AIS Health Staff

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