MMIT Reality Check on Diffuse Large B-Cell Lymphoma (4Q2023)
Payer Coverage:
A review of market access for diffuse large B-cell lymphoma treatments shows that under the pharmacy benefit, about 43% of the lives under commercial formularies are covered with utilization management restrictions. Around 50% of the lives under Medicare formularies are not covered for at least one of the drugs.
Under the medical benefit, almost 59% of the lives under commercial policies are covered with utilization management restrictions. About 56% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.
For about 94% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 56% of the lives require multiple steps. Around 80% 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 Accelerated Approval to Columvi
In June 2023, the FDA gave accelerated approval to Roche Group unit Genentech USA, Inc.’s Columvi (glofitamab-gxbm) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma arising from follicular lymphoma after at least two lines of systemic therapy. The drug, a bispecific CD20-directed CD3 T-cell engager, is the first bispecific antibody with a fixed-duration treatment for people with relapsed or refractory DLBCL, says the company. For the first treatment cycle, patients are dosed with 1,000 mg of obinutuzumab — currently available as Genentech’s Gazyva — via intravenous infusion seven days before starting Columvi. On day eight, patients receive 2.5 mg of Columvi via intravenous infusion, then 10 mg on day 15. For cycles two through 12, dosing is 30 mg on day one. The cost for a full course of treatment is approximately $350,000.
FDA Gives Accelerated Approval to Epkinly
In May 2023, the FDA granted accelerated approval to AbbVie Inc. and Genmab A/S’s Epkinly (epcoritamab-bysp) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after at least two lines of systemic therapies. It was the first and only T-cell engaging bispecific antibody for this indication. Dosing for the bispecific CD20-directed CD3 T-cell engager is administered by a health care professional via subcutaneous injection in 28-day cycles. For the first cycle, dosing is 0.16 mg on day one, 0.8 mg on day eight, then 48 mg on days 15 and 22. For cycles two and three, dosing is 48 mg on days one, eight, 15 and 22; for cycles four to nine, dosing is 48 mg on days one and 15; and then for cycles 10 and beyond, dosing is 48 mg on day one. The drug’s monthly list price is $37,500 based on an average treatment duration of nine months, after which the price should decrease due to less-frequent dosing.
FDA Gives Additional Indication to Polivy
In April 2023, the FDA granted an additional indication to Roche Group company Genentech USA, Inc.’s Polivy (polatuzumab vedotin-piiq) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adults who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified or high-grade B-cell lymphoma and who have an International Prognostic Index score of at least two. The agency also converted the accelerated approval of the CD79b-directed antibody-drug conjugate in combination with bendamustine and rituximab to treat adults with relapsed or refractory DLBCL after at least two prior therapies to regular approval. The FDA first approved the agent on June 10, 2019. Recommended dosing is 1.8 mg/kg via intravenous infusion every 21 days for six cycles. The initial dose should be a 90-minute infusion; if that is tolerated, subsequent infusions can be administered over 30 minutes. Drugs.com lists the price of a 30 mg vial as more than $3,635 and that of a 140 mg vial as more than $16,929.
Key Findings:
Market Events Drive Changes
In June 2023, the FDA gave accelerated approval to Roche Group unit Genentech USA, Inc.’s Columvi (glofitamab-gxbm) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma arising from follicular lymphoma after at least two lines of systemic therapy. In May, the agency granted accelerated approval to AbbVie Inc. and Genmab A/S’s Epkinly (epcoritamab-bysp) for the treatment of adults with relapsed or refractory DLBCL, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after at least two lines of systemic therapies.
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 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:
