MMIT Reality Check on Non-Small Cell Lung Cancer ALK+ or ROS1+

Payer Coverage:

A review of market access for non-small cell lung cancer ALK+ or ROS1+ treatments shows that under the pharmacy benefit, about 77% of the lives under commercial formularies are covered with utilization management restrictions. Only 2% of the lives under Medicare formularies are not covered for at least one of the drugs.

For about 96% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 30% require multiple steps. Around 85% of payer-controlled pharmacy benefit covered lives require prior authorization, with 3% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Expands Lorbrena’s Label

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.

FDA Expands FoundationOne CDx’s Label

In July 2021, the FDA expanded the label of Roche Group subsidiary Foundation Medicine, Inc.’s FoundationOne CDx as a companion diagnostic for Takeda’s Alunbrig (brigatinib), which is FDA approved for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC as detected by an FDA-approved test. The tissue-based, next-generation sequencing test now has 28 companion diagnostic claims and is clinically and analytically validated for solid tumors.

Biomarker Testing Is Not Keeping Up With Drug Innovations

Despite the tremendous progress made over the past decade in developing targeted oncolytic therapies, testing for specific mutations — or biomarkers — to determine the proper candidates for those treatments lags behind. A few states have passed or are considering legislation requiring insurers to cover biomarker testing, with California becoming the most recent state to pass such a law.

Non-small cell lung cancer is one area that has undergone the most development. There are now more than two dozen drugs that target nine different changes in NSCLC cells that help them grow. But an article published July 7 in Cancer Therapy Advisor — which summarized a presentation at the 2021 American Society of Clinical Oncology Annual Meeting — revealed that less than half of people with metastatic NSCLC received a test for five analyzed biomarkers before starting first-line treatment.

Key Findings:

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, Medical 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:

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