A review of market access for non-small cell lung cancer ALK+ or ROS1+ treatments shows that under the pharmacy benefit, about 72% of the lives under commercial formularies are covered with utilization management restrictions. Only 4% of the lives under Medicare formularies have access to at least one of the drugs without utilization management restrictions.
For about 96% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 8% require multiple steps. Around 83% of payer-controlled pharmacy benefit covered lives require prior authorization, with 2% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
In January 2023, the FDA granted another use to Foundation Medicine, Inc.’s FoundationOne Liquid CDx as a companion diagnostic to identify people with ROS proto-oncogene 1, receptor tyrosine kinase (ROS1)-positive non-small cell lung cancer or people with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumors who do not have a tissue sample available and may be appropriate for treatment with Rozlytrek (entrectinib) from Genentech USA, Inc., a member of the Roche Group. The agency initially approved the assay on Nov. 30, 2017. The test is the first blood-based companion diagnostic approved for the drug. It analyzes more than 300 cancer-related genes and is approved as a companion diagnostic for nine targeted therapies.
In March 2021, the FDA expanded the label for Pfizer Inc.’s Lorbrena (lorlatinib) to include the first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. The agency also converted the 2018 accelerated approval for people with ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least one other ALK inhibitor or those whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor for metastatic disease to full approval. Recommended dosing for the tablet is 100 mg once daily. Website Drugs.com lists the price of 30 100 mg tablets as more than $18,480.
The FDA has approved around 100 targeted therapies for different types of cancer, with many more in the pipeline. Current agents for non-small cell lung cancer (NSCLC), for example, target about 10 different biomarkers, and more than 70% of people with the condition have alterations in their tumors that are tied to available treatments. But a recent study found that due to practice gaps in the precision oncology pathway, just more than one-third of patients with biomarkers that could be treated with an FDA-approved therapy are actually benefiting from those drugs.
Market Events Drive Changes
In March 2021, the FDA expanded the label for Pfizer Inc.’s Lorbrena (lorlatinib) to include the first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. In May 2020, the agency expanded the label of Takeda Pharmaceutical Company Limited’s Alunbrig (brigatinib) to include the treatment of newly diagnosed adults with ALK-positive NSCLC as detected by an FDA-approved test.
Competitive Market Landscape
Competition is growing, with several drugs from different manufacturers targeting these gene mutations in patients with NSCLC.
Pharmacy Benefit Implications
The products in this indication are well-reimbursed by payers and covered under the pharmacy benefit. Payer policies for lung cancer typically follow National Comprehensive Cancer Network (NCCN) guidelines. Payers usually have some type of decision support tool in place, which translates NCCN guidelines into an algorithm and walks the provider through what the next best treatment option would be. However, most payers often allow the final decision to rest with the provider and the patient.
Key Players in Market: