MMIT Reality Check on Non-Small Cell Lung Cancer EGFR-Mutated (1Q2023)

Payer Coverage:

A review of market access for non-small cell lung cancer epidermal growth factor receptor (EGFR)-mutated treatments shows that under the pharmacy benefit, about 59% of the lives under commercial formularies are covered with utilization management restrictions. Around 40% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 74% 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 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 82% of payer-controlled pharmacy benefit covered lives require prior authorization.

Trends:

FDA Broadens Use of Foundation Medicine, Inc.’s FoundationOne Liquid CDx

In December 2022, the FDA granted another indication to Foundation Medicine, Inc.’s FoundationOne Liquid CDx as a companion diagnostic to identify people with non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R substitutions and are appropriate for treatment with a group of current and future EGFR tyrosine kinase inhibitors approved by the FDA for this indication. The agency initially approved the test on Aug. 26, 2020. Current therapies for which the product is a companion diagnostic are Tagrisso (osimertinib) and Iressa (gefitinib), both from AstraZeneca, and Tarceva (erlotinib) from Genentech USA, Inc., a member of the Roche Group.

FDA Expands Foundation Medicine, Inc.’s FoundationOne CDx

In March 2022, the FDA expanded the label of Foundation Medicine, Inc.’s FoundationOne CDx to be used as a companion diagnostic to identify people with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) alterations and are appropriate for treatment with EGFR tyrosine kinase inhibitors approved for this indication. These deletions and substitutions account for about 85% of observed EGFR mutations in NSCLC, which themselves are the second most common oncogenic drivers in NSCLC. The agency first approved the test on Nov. 30, 2017.

FDA Grants Premarket Approval to Thermo Fisher Scientific’s Oncomine Dx Target Test

In December 2021, the FDA granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to help identify people with non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 20-insertion mutations who may be candidates for treatment with Rybrevant (amivantamab-vmjw) from Janssen Biotech, Inc., a Johnson & Johnson company. The agency initially approved the test on June 22, 2017.

Key Findings:

Market Events Drive Changes

In September 2021, the agency gave accelerated approval to Takeda Pharmaceutical Company Ltd.’s Exkivity (mobocertinib) for the treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations as detected by an FDA-approved test whose disease has progressed on or after platinum-based chemotherapy. In May 2021, the agency gave accelerated approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Rybrevant (amivantamab-vmjw) for the same indication.

Competitive Market Landscape

Many drugs to treat NSCLC are on the market today, and multiple ones are in Phase III trials. The discovery of genetic alterations that drive tumor growth has changed the clinical management of the disease and produced specific targeted therapies to treat the various genetic mutations.

Pharmacy, Medical Benefit Implications

The products in this indication are well-reimbursed by payers. There are medical and pharmacy policies written for most products in the class. 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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