MMIT Reality Check on Follicular Lymphoma (4Q2023)
Payer Coverage:
A review of market access for follicular lymphoma treatments shows that under the pharmacy benefit, about 42% of the lives under commercial formularies are covered with utilization management restrictions. Around 44% 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 57% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.
For about 95% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, 37% 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:
Bayer Will Voluntarily Withdraw NDA for Aliqopa
Bayer will work with the FDA to voluntarily withdraw the New Drug Application (NDA) for Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma (FL) who have received at least two systemic therapies, the company said Nov. 13, 2023. The agency gave the PI3K inhibitor accelerated approval on Sept. 14, 2017.
FDA Gives Lunsumio Accelerated Approval
In December 2022, the FDA gave accelerated approval to Roche Group member Genentech USA, Inc.’s Lunsumio (mosunetuzumab-axgb) for the treatment of adults with relapsed or refractory follicular lymphoma after at least two lines of systemic therapy. Dosing via intravenous infusion is 1 mg on day one of cycle one, 2 mg on day eight of cycle one and 60 mg on day 15 of cycle one, each over a minimum of four hours. On day one of cycle two, dosing is 60 mg, and then in cycle three and following cycles, dosing is 30 mg on day one; administration can be two hours if cycle one infusions were tolerated. Dosing for eight cycles is recommended. If people have a partial response or stable disease after eight cycles, an additional nine cycles may be administered. The drug’s price for eight cycles of the first-in-class CD20xCD3 T-cell engaging bispecific antibody is about $180,000.
Dr. Reddy’s Launched Six Strengths of Lenalidomide
Dr. Reddy’s Laboratories Ltd. launched six strengths of lenalidomide, and two of them — 2.5 mg and 20 mg — are eligible for first-to-market 180-day exclusivity, the company said Sept. 7, 2022. The FDA approved those two strengths and gave tentative approval to the others on Oct. 14, 2021. Teva Pharmaceuticals Ltd. launched the first generics of the other four strengths of the generic of Bristol Myers Squibb’s Revlimid — 5 mg, 10 mg, 15 mg and 25 mg — on March 7, 2022. Lenalidomide is approved for six indications for the treatment of adults with (1) multiple myeloma in combination with dexamethasone; (2) MM as maintenance treatment following autologous hematopoietic stem cell transplantation; (3) transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenic abnormalities; (4) mantle cell lymphoma that has relapsed or progressed after at least two treatments, including bortezomib; (5) previously treated follicular lymphoma in combination with a rituximab product; and (6) previously treated marginal zone lymphoma in combination with a rituximab product. On Sept. 17, 2020, Dr. Reddy’s said that it had settled patent litigation with Bristol Myers subsidiary Celgene Corp. that would allow it to sell volume-limited amounts of the generic as of a confidential date after March 2022. As of Jan. 31, 2026, Dr. Reddy’s can sell lenalidomide without limitation.
Key Findings:
Market Events Drive Changes
In November 2023, Bayer said it will work with the FDA to voluntarily withdraw the New Drug Application for Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma (FL) who have received at least two systemic therapies. In December 2022, the FDA gave accelerated approval to Roche Group member Genentech USA, Inc.’s Lunsumio (mosunetuzumab-axgb) for the treatment of adults with relapsed or refractory follicular lymphoma after at least two lines of systemic therapy. In June 2022, the agency 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 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.
Competitive Market Landscape
Despite new treatments that improve overall survival, follicular lymphoma is regarded as an incurable malignancy with a relapsing and remitting pattern. The treatment of the disease has shifted from use of chemotherapy alone to chemotherapy in combination with immunotherapy. In recent years, several new products have been introduced into the market for hard-to-treat relapsed refractory disease. Several biosimilars for rituximab have entered this market as well. Although patients in third or later line treatment for follicular lymphoma have multiple systemic therapies available, the efficacy of these regimens drops off rapidly in later lines. Throughout the lifetime of a relapsing patient, they may be exposed to a median of five lines of prior treatment, with an upper range of 12 lines. There also is an unmet need in people who are refractory to treatment or quickly relapse, who may exhaust treatment options while they are still healthy enough to receive active treatment.
Pharmacy, Medical Benefit Implications
Most medications, with the exception of Bayer AG’s Aliqopa (copanlisib) and Gilead Sciences, Inc. subsidiary Kite Pharma, Inc.’s Yescarta (axicabtagene ciloleucel), are covered with either no restrictions or with a prior authorization. Coverage of follicular lymphoma treatments is under both the pharmacy and the medical benefit.
Key Players in Market:
