MMIT Reality Check on Non-Small Cell Lung Cancer EGFR-Mutated

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 55% 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.

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Under the medical benefit, about 74% 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.

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For about 95% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 7% require multiple steps. Around 81% of payer-controlled pharmacy benefit covered lives require prior authorization.

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Trends:

FDA Gives Exkivity Accelerated Approval

In September 2021, the FDA gave accelerated approval to Takeda Pharmaceutical Company Ltd.’s Exkivity (mobocertinib) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test whose disease has progressed on or after platinum-based chemotherapy. Dosing is 160 mg via four 40 mg capsules once daily. The price of 120 40 mg capsules is $25,000.00.

FDA Gives Rybrevant Accelerated Approval

In May 2021, the FDA gave accelerated approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Rybrevant (amivantamab-vmjw) for the treatment of adults with locally advanced or nonmetastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The bispecific antibody was the first approved treatment for this use. The agency gave the intravenous infusion priority review and breakthrough therapy designation. The review was conducted under Project Orbis. Dosing for patients weighing less than 80 kg is 1,050 mg (three vials); for those weighing at least 80 kg, it is 1,400 mg (four vials). The drug is administered weekly for four weeks, with the initial dose as a split infusion in week one on days one and two, and then is administered every two weeks.

FDA Grants Oncomine Dx Target Test Premarket Approval

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 FDA gave accelerated approval to Takeda Pharmaceutical Company Ltd.’s Exkivity (mobocertinib) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (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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AIS Health Staff

AIS Health Staff

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