MMIT Reality Check on Chronic Lymphocytic Leukemia (4Q2022)

Payer Coverage:

A review of market access for chronic lymphocytic leukemia treatments shows that under the pharmacy benefit, about 51% of the lives under commercial formularies are covered with utilization management restrictions. Around 33% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 70% of the lives under commercial policies are covered with utilization management restrictions. Almost 59% of the lives under Medicare Part B 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, 21% 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 Approves New Calquence Formulation

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.

TG Therapeutics Withdraws Pending Applications for Ublituximab/Ukoniq Combo

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 chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma. The company said it made the decision based on updated overall survival data from the UNITY-CLL Phase III trial. The company also said that it voluntarily withdrew Ukoniq from sale for two indications: (1) for adults with marginal zone lymphoma who have received at least one anti-CD20-based regimen, and (2) for adults with follicular lymphoma who have received at least three prior systemic therapies. The FDA gave the drug accelerated approval for those indications on Feb. 5, 2021.

FDA Approves Riabni

In December 2020, the FDA approved Amgen Inc.’s Riabni (rituximab-arrx) to treat adults with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis. It is the third approved biosimilar of Rituxan (rituximab), from Biogen and the Roche Group’s Genentech USA, Inc., and the fifth approved biosimilar from Amgen. Riabni’s wholesale acquisition cost is 23.7% lower than that of Rituxan; 15.2% less than the WAC of biosimilar Truxima (rituximab-abbs), from Celltrion Inc. and commercialized by Teva Pharmaceuticals USA, Inc.; and equal to the WAC of Pfizer Inc.’s Ruxience (rituximab-pvvr), another biosimilar. Riabni’s WAC for a 100 mg vial is $716.80, and the WAC of a 500 mg vial is $3,584.00. Dosing for the intravenous infusion is weight-based and varies by indication. The drug became available on Jan. 4, 2021.

Key Findings:

Market Events Drive Changes

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 (CLL) or small lymphocytic lymphoma (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 Rituxan, and all are indicated for CLL. Teva Pharmaceuticals USA, Inc. and Celltrion, Inc.’s Truxima (rituximab-abbs) launched in November 2019, and Pfizer Inc.’s Ruxience (rituximab-pvvr), approved in July 2019, launched in January 2020. Most recently, Amgen Inc.’s Riabni was approved in December 2020 and became available in January 2021. There have been multiple clinical trials that have proven beneficial results using nonchemotherapy combinations, some of which have been approved by the FDA. There are several targeted drugs currently being evaluated in the pipeline, as well as research in chimeric antigen receptor T-cell (CAR T) therapy.

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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