A review of market access for nonmetastatic prostate cancer treatments shows that under the pharmacy benefit, about 53% 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 55% of the lives under commercial policies are covered with utilization management restrictions. Almost 63% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.
For about 97% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 27% require multiple steps. Around 72% of payer-controlled pharmacy benefit covered lives require prior authorization, with 4% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
When the FDA approved Johnson & Johnson unit Janssen Biotech, Inc.’s Erleada (apalutamide) for the treatment of nonmetastatic castration-resistant prostate cancer on Feb. 14, 2018, it was the first therapy that the agency had approved for that indication. Following the July 30, 2019, approval of Bayer’s Nubeqa (darolutamide), three FDA-approved agents, all oral androgen receptor inhibitors, are available to treat the condition, offering a choice of treatment options. All three drugs are similar in price, coming in around $12,000 for a 30-day supply.
In July 2019, the FDA approved Bayer’s Nubeqa (darolutamide) for the treatment of nonmetastatic castration-resistant prostate cancer. Dosing for the androgen receptor inhibitor is 600 mg via two 300 mg tablets twice daily.
In June 2019, the FDA granted an additional approval to Xtandi (enzalutamide) for the treatment of nonmetastatic castration-resistant prostate cancer. The agency initially approved the capsule from Astellas Pharma Inc. and Pfizer Inc. in 2012. Dosing is 160 mg once daily. GoodRx lists the price of 120 40 mg capsules as more than $12,100.
Market Events Drive Changes
In July 2019, the FDA approved Bayer’s Nubeqa (darolutamide) for the treatment of nonmetastatic castration-resistant prostate cancer. In June of that year, the agency granted an additional approval to Xtandi (enzalutamide) from Astellas Pharma US, Inc. and Pfizer Inc. for the treatment of nonmetastatic castration-resistant prostate cancer.
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: