MMIT Reality Check on Non-Small Cell Lung Cancer Systemic Therapy (3Q2023)

Payer Coverage:

A review of market access for non-small cell lung cancer systemic therapy treatments shows that under the pharmacy benefit, about 38% of the lives under commercial formularies are covered with utilization management restrictions. Around 67% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 67% of the lives under commercial policies are covered with utilization management restrictions. Almost 62% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 95% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 26% of the lives require multiple steps. Around 74% of payer-controlled pharmacy benefit covered lives require prior authorization, with 5% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

Celltrion Launches Vegzelma

Celltrion Healthcare Co. launched Vegzelma (bevacizumab-adcd), the company said on April 17. The FDA approved the injectable last September for multiple types of cancer, including colorectal and non-small cell lung cancer. It is the fourth FDA-approved biosimilar of Avastin (bevacizumab) from Genentech USA, Inc., a member of the Roche Group, to launch in the U.S. While the company has partnered with other companies in marketing biosimilars in the U.S., its Celltrion USA unit is taking full responsibility for this launch.

FDA Gives Additional Indication to Libtayo

In November 2022, the FDA gave another indication to Regeneron Pharmaceuticals, Inc.’s Libtayo (cemiplimab-rwlc) for use as a first-line treatment, in combination with platinum-based chemotherapy, of adults with locally advanced or metastatic non-small cell lung cancer who do not have epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) aberrations and who have tumors that are not candidates for surgical resection or definitive chemoradiation. The agency initially approved the programmed death receptor-1 (PD-1) inhibitor on Sept. 28, 2018. The recommended dose is 350 mg via a 30-minute intravenous infusion every three weeks. Drugs.com lists the price of one 350 mg/7 mL vial as more than $10,128.

FDA Approves Additional Indication for Tecentriq

In October 2021, the FDA gave another approval to Roche Group company Genentech USA, Inc.’s Tecentriq (atezolizumab) for the adjuvant treatment, following surgery and platinum-based chemotherapy, of adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1 ≥ 1%, as determined by an FDA-approved test. The review was conducted under the FDA’s Project Orbis initiative and the Real-Time Oncology Review pilot program. The FDA initially approved the PD-L1 inhibitor on May 18, 2016. Following resection and up to four cycles of platinum-based chemotherapy, dosing is 840 mg every two weeks, 1,200 mg every three weeks or 1,680 mg every four weeks for up to one year. The initial dose of the intravenous infusion is 60 minutes; if that is tolerated, subsequent doses may be decreased to 30 minutes. According to Drugs.com, treatment is around $13,860.00 per month depending on the dosing schedule.

Key Findings:

Market Events Drive Changes

In November 2022, the FDA gave another indication to Regeneron Pharmaceuticals, Inc.’s Libtayo (cemiplimab-rwlc) for use as a first-line treatment, in combination with platinum-based chemotherapy, of adults with locally advanced or metastatic NSCLC who do not have epidermal growth factor receptor, anaplastic lymphoma kinase or ROS proto-oncogene 1, receptor tyrosine kinase aberrations and who have tumors that are not candidates for surgical resection or definitive chemoradiation. In October 2021, the agency gave another approval to Roche Group company Genentech USA, Inc.’s Tecentriq (atezolizumab) for the adjuvant treatment, following surgery and platinum-based chemotherapy, of adults with Stage II-IIIA NSCLC whose tumors express PD-L1 ≥ 1%, as determined by an FDA-approved test. In February 2021, the agency gave an additional indication to Regeneron Pharmaceuticals, Inc. and Sanofi’s Libtayo (cemiplimab-rwlc) for the first-line treatment of people with advanced NSCLC whose tumors have high PD-L1 expression of tumor proportion score ≥ 50%, as determined by an FDA-approved test.

Competitive Market Landscape

There are multiple drugs on the market today that are FDA approved for the treatment of NSCLC not otherwise specified as having a targeted mutation, and more than 10 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.

Key Players in Market:

reality-check-nscls-systemic-therapy-player-3q2023

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AIS Health Staff

AIS Health Staff

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