A review of market access for chronic lymphocytic leukemia treatments shows that under the pharmacy benefit, about 49% of the lives under commercial formularies are covered with utilization management restrictions. Around 32% 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 64% 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, 20% require multiple steps. Around 77% 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.
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. The drug became available on Jan. 4, 2021.
In April 2020, the FDA expanded the label for Pharmacyclics LLC, an AbbVie Inc. company, and Janssen Biotech, Inc.’s Imbruvica (ibrutinib) in combination with rituximab for the treatment of adults newly diagnosed with chronic lymphocytic leukemia or small lymphocytic leukemia. The agency initially approved the Bruton’s tyrosine kinase inhibitor in 2013; this newest approval is its 11th across six disease areas.
Among the different forms of leukemia, chronic lymphocytic leukemia (CLL) is one of the most common in adults. The FDA has approved multiple treatments for the condition, making it a potential target of value-based contracts — assuming manufacturers would be amenable to such deals. The CLL pipeline “appears to be really strong,…ranging from new and improved medications in current targeted classes, as well as research in new novel medications in pathways that have been recently discovered,” says Winston Wong, Pharm.D., president of W-Squared Group.
Market Events Drive Changes
In December 2020, the FDA approved Amgen Inc.’s Riabni (rituximab-arrx) to treat adults with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis and microscopic polyangiitis. It was the third approved biosimilar of Rituxan (rituximab) from Biogen and the Roche Group’s Genentech USA, Inc. and the fifth approved biosimilar from Amgen. In April 2020, the FDA expanded the label for Pharmacyclics LLC, an AbbVie Inc. company, and Janssen Biotech, Inc.’s Imbruvica (ibrutinib) in combination with rituximab for the treatment of adults newly diagnosed with CLL or small lymphocytic leukemia.
Competitive Market Landscape
The FDA has approved three biosimilars of 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’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: