MMIT Reality Check on Non-Small Cell Lung Cancer Systemic Therapy (August 2022)

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 38% 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 68% of the lives under commercial policies are covered with utilization management restrictions. Almost 66% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

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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% of the lives require multiple steps. Around 73% 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.

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Trends:

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 programmed death-ligand 1 (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.

FDA Gives Libtayo Additional Indication

In February 2021, the FDA 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. Patients must have either metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK or ROS1 aberrations.

FDA Gives Imfinzi Additional Dosing Option

In November 2020, the FDA approved AstraZeneca’s Imfinzi (durvalumab) for an additional dosing option of 1,500 mg every four weeks for unresectable Stage III non-small cell lung cancer after chemoradiation therapy and for previously treated advanced bladder cancer. The new dose is available to people weighing more than 30 kg and is an alternative to the approved 10 mg/kg every two weeks. The agency granted priority review to the application. The agency initially approved the programmed death-ligand 1 inhibitor on May 1, 2017. Dosing is via a 60-minute intravenous infusion. Website GoodRx lists the price of four 500 mg/10 mL vials as more than $14,600.

Key Findings:

Market Events Drive Changes

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 NSCLC whose tumors express programmed death-ligand 1 (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:

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AIS Health Staff

AIS Health Staff

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