MMIT Reality Check on Diffuse Large B-Cell Lymphoma (October 2022)

Payer Coverage:

A review of market access for diffuse large B-cell lymphoma treatments shows that under the pharmacy benefit, about 42% of the lives under commercial formularies are covered with utilization management restrictions. Around 31% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 65% of the lives under commercial policies are covered with utilization management restrictions. Almost 63% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 93% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 64% of the lives require multiple steps. Around 79% of payer-controlled pharmacy benefit covered lives require prior authorization, with 5% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Expands Breyanzi Label

In June 2022, the FDA expanded the label of Bristol Myers Squibb company Juno Therapeutics, Inc.’s Breyanzi (lisocabtagene maraleucel) for the treatment of adults with large B-cell lymphoma, including diffuse LBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal LBCL and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation due to comorbidities or age. The agency first approved the CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy on Feb. 5, 2021. The price for the one-time treatment is $410,300.

FDA Expands Rituxan Label

In December 2021, the FDA expanded the label of Roche Group subsidiary Genentech USA, Inc. and Biogen’s Rituxan (rituximab) in combination with chemotherapy to include the treatment of pediatric patients between the ages of 6 months to 18 years with previously untreated, advanced-stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma or mature B-cell acute leukemia. The review used the Assessment Aid, and the application had priority review. The recommended dose is 375 mg/m2 via intravenous infusion in combination with systemic Lymphome Malin B (LMB) chemotherapy for a total of six infusions. Drugs.com lists the price of a 500 mg/50 mL (10 mg/mL) vial as more than $4,913.

FDA Gives Zynlonta Accelerated Approval

In April 2021, the FDA gave accelerated approval to ADC Therapeutics SA’s Zynlonta (loncastuximab tesirine-lpyl) for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least two lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, DLBCL from low-grade lymphoma and high-grade B-cell lymphoma. The wholesale acquisition cost for a 10 mg vial is $23,500.

Key Findings:

Market Events Drive Changes

In June 2022, the FDA expanded the label of Bristol Myers Squibb company Juno Therapeutics, Inc.’s Breyanzi (lisocabtagene maraleucel) for the treatment of adults with large B-cell lymphoma. In December 2021, the agency expanded the label of Roche Group subsidiary Genentech USA, Inc. and Biogen’s Rituxan (rituximab) in combination with chemotherapy to include the treatment of pediatric patients between the ages of 6 months to 18 years with previously untreated, advanced-stage, CD20-positive DLBCL, Burkitt lymphoma or mature B-cell acute leukemia.

Competitive Market Landscape

With the increasing incidence of DLBCL in the U.S., the market has become more crowded with available therapies. However, several of the newer agents are high-cost treatments and require specialized centers for administration. The positive is that there are several options along the treatment journey for patients to try.

Pharmacy, Medical Benefit Implications

Coverage for treatment of DLBCL is good, and many payers have written policies for the agents in this class, including the newer chimeric antigen receptor T-cell (CAR-T) options. Coverage for the physician-administered drugs typically goes through the medical benefit, while the oral products will be available through retail and specialty pharmacies.

Key Players in Market:

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