A review of market access for metastatic prostate cancer treatments shows that under the pharmacy benefit, about 52% of the lives under commercial formularies are covered with utilization management restrictions. Around 28% of the lives under Medicare formularies are not covered for at least one of the drugs.
Under the medical benefit, about 62% of the lives under commercial policies are covered with utilization management restrictions. Almost 69% 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, about 13% require multiple steps. Around 74% 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 November 2020, the FDA expanded the label of Foundation Medicine, Inc.’s FoundationOne Liquid CDx to identify people with BRCA1, BRCA2 and/or ATM alterations in metastatic castration-resistant prostate cancer who may be appropriate for treatment with AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib). The agency initially approved the liquid biopsy test in August; it’s now approved as a companion diagnostic for seven targeted therapies across four tumor types. The manufacturer says it is the only FDA-approved blood-based test that can analyze more than 300 genes.
Although poly (ADP-ribose) polymerase (PARP) inhibitors are not new to the market, two of them — AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) and Clovis Oncology, Inc.’s Rubraca (rucaparib) — gained approval for use in prostate cancer for the first time in 2020. The therapies will bring a new option for the treatment of certain subpopulations of patients.
AstraZeneca and Merck & Co., Inc. released positive results of Lynparza’s Phase III PROfound trial in August 2019. Shortly thereafter, from Sept. 3, 2019, to Oct. 7, 2019, Zitter Insights polled 51 commercial payers with 158.4 million covered lives about how they were likely to manage the therapy. Commercial payers with 60% of covered lives said they were more likely than unlikely and significantly likely to manage Lynparza at parity with other drugs in the second-line treatment of metastatic castration-resistant prostate cancer.
Market Events Drive Changes
In May 2020, the FDA gave accelerated approval to Clovis Oncology, Inc.’s Rubraca (rucaparib) for the treatment of adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Within a week, the agency also expanded the label of AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) to include the treatment of people with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer who have progressed following treatment with enzalutamide or abiraterone.
Competitive Market Landscape
Products in this drug class represent several different mechanisms of action, treating prostate cancer in different stages of the disease. Mechanisms of action include estrogen/nitrogen mustard, microtubule inhibitors, gonadotropin-releasing hormone (GnRH) analogs, autologous cellular immunotherapy, a radiopharmaceutical and androgen receptor inhibitors.
Pharmacy, Medical Benefit Implications
The products in this indication are well-reimbursed by payers. Pharmacy and medical policies may require procurement of a drug through a specialty pharmacy by either the patient or the administering doctor. On the medical benefit, providers are more often allowed to buy and bill than are required to obtain the drugs through a specialty pharmacy. For the patient, however, the oncology drugs that process through the pharmacy benefit are more often required to be obtained through a specialty pharmacy.
Key Players in Market: