MMIT Reality Check on Diffuse Large B-Cell Lymphoma (Oct 2021)

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 40% of the lives under Medicare Part D formularies are not covered for at least one of the drugs.

Under the medical benefit, about 55% of the lives under commercial policies are covered with utilization management restrictions. Almost 67% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

For about 92% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, 65% require multiple steps. Around 78% 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 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.

Payers Create CAR-T Approval Systems

Spurred by CMS’s decision to cover chimeric antigen receptor T-cell therapies under Medicare, commercial payers are beginning to systematize approvals for CAR-T treatment as use of these breakthrough cancer therapies is beginning to ramp up, experts say. Five CAR-T therapies currently hold FDA approval for treating forms of lymphoma, leukemia and multiple myeloma. In addition, the CAR-T pipeline is rich, with drugs in dozens of clinical trials targeting multiple different types of both blood cancers and solid tumors.

FDA Approves Breyanzi

In February 2021, the FDA approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B. The list price for the one-time treatment is $410,300.

Key Findings:

Market Events Drive Changes

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. In February 2021, the agency approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B.

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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AIS Health Staff

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