MMIT Reality Check on Chronic Lymphocytic Leukemia (4Q2023)

Payer Coverage:

A review of market access for chronic lymphocytic leukemia treatments shows that under the pharmacy benefit, about 54% of the lives under commercial formularies are covered with utilization management restrictions. Around 29% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 69% of the lives under commercial policies are covered with utilization management restrictions. Almost 55% of the lives under Medicare Part B 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, 24% 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 Expands Brukinsa Label

In January 2023, the FDA expanded the label of BeiGene, Ltd.’s Brukinsa (zanubrutinib) to include the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. The agency initially approved the Bruton’s tyrosine kinase (BTK) inhibitor on Nov. 14, 2019. The agency granted the application orphan drug designation, and its review used the Assessment Aid. The recommended dose of the capsule is 160 mg twice daily or 320 mg once daily. Drugs.com lists the price of 120 80 mg capsules as more than $15,264.

Brukinsa Gains Another Approval in Non-Hodgkin Lymphoma

The FDA expanded the use of BeiGene, Ltd.’s Brukinsa (zanubrutinib) to include its use in the treatment of a hematologic cancer. The agent is already approved for three other rare types of non-Hodgkin lymphoma. Respondents to a Zitter Insights survey said that while its availability will result in a lower level of unmet need in the treatment of chronic lymphocytic leukemia (CLL), there is still moderate or high unmet need for the condition.

FDA Approves Calquence

In August 2022, the FDA approved a new tablet formulation for AstraZeneca’s Calquence (acalabrutinib) for all of its current indications: the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma and for people with relapsed or refractory mantle cell lymphoma who have received at least one prior therapy, which is approved under accelerated approval. The agency initially approved the drug as a capsule on Oct. 31, 2017. The recommended dose for both formulations is 100 mg every 12 hours. Drugs.com lists the price of 60 100 mg capsules as more than $15,263.

Key Findings:

Market Events Drive Changes

In January 2023, the FDA expanded the label of BeiGene, Ltd.’s Brukinsa (zanubrutinib) to include the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In August 2022, the FDA approved a new tablet formulation for AstraZeneca’s Calquence (acalabrutinib) for all of its current indications: the treatment of adults with CLL or SLL and for people with relapsed or refractory mantle cell lymphoma who have received at least one prior therapy, which is approved under accelerated approval. In April 2022, TG Therapeutics, Inc. said that it voluntarily withdrew its pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and Ukoniq (umbralisib) for the treatment of adults with CLL and SLL.

Competitive Market Landscape

The FDA has approved three biosimilars for Genentech USA, Inc., a member of the Roche Group, and Biogen’s Rituxan (rituximab), and all are indicated for CLL. Teva Pharmaceuticals USA, Inc. and Celltrion, Inc.’s Truxima (rituximab-abbs) launched in November 2019, Pfizer Inc.’s Ruxience (rituximab-pvvr) launched in January 2020, and Amgen Inc.’s Riabni (rituximab-arrx) became available in January 2021. There have been multiple clinical trials that have proven beneficial results in CLL using nonchemotherapy combinations, some of which have been approved by the FDA. Eli Lilly and Co. submitted an NDA for Jaypirca (pirtobrutinib) in 2023 seeking accelerated approval for its use in the treatment of CLL after treatment with a Bruton’s tyrosine kinase (BTK) inhibitor and B-cell lymphoma-2 (BCL2) inhibitor, and an FDA decision is expected by the end of the year. Otherwise, the late-stage pipeline is minimal.

Pharmacy, Medical Benefit Implications

Coverage is through both the pharmacy and medical benefits. There is good coverage for products treating CLL, although many plans do not have drug-specific policies for the older chemotherapy agents. Payers have written or are in the process of writing policies for the newer, more targeted agents. In the medical benefit, providers are more often allowed to buy and bill than are required to obtain the drugs through a specialty pharmacy. However, the drugs that process through the pharmacy benefit are more often required to be obtained through a specialty pharmacy.

Key Players in Market:

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