A review of market access for colorectal cancer treatments shows that under the pharmacy benefit, about 53% of the lives under commercial formularies are covered with utilization management restrictions. Around 28% of the lives under Medicare formularies are not covered for at least one of the drugs.
Under the medical benefit, about 77% of the lives under commercial policies are covered with utilization management restrictions. Almost 55% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.
For about 93% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, 34% require multiple steps. Around 74% of payer-controlled pharmacy benefit covered lives require prior authorization, with 8% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
In July 2021, the FDA granted premarket approval to Pillar Biosciences, Inc.’s ONCO/Reveal Dx Lung and Colon Cancer Assay as a companion diagnostic for all FDA-approved epidermal growth factor receptor tyrosine kinase inhibitor (TKI) therapies for non-small cell lung cancer (NSCLC) targeting EGFR and KRAS wild-type tumor tissue for metastatic colorectal cancer patients. The in vitro diagnostic kit is intended to be used on the Illumina MiSeq Dx instrument.
In April 2021, the FDA approved a new dosing regimen for Eli Lilly and Co.’s Erbitux (cetuximab) of 500 mg/m2 as a 120-minute infusion every two weeks as a single agent or in combination with chemotherapy for people with K-ras wild-type epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck. The previously approved 250 mg/m2 per-week regimen remains an option. The drug’s monthly list price is $13,596.20.
In April 2020, the FDA granted an additional approval to Pfizer Inc. subsidiary Array BioPharma Inc.’s Braftovi (encorafenib) in combination with Lilly USA, LLC’s Erbitux (cetuximab) for the treatment of adults with metastatic colorectal cancer with the BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy. The agency initially approved the capsule in June 2018. The recommended dose for the new use is 300 mg once daily in combination with Erbitux. Website GoodRx lists the price of two bottles, each with 90 75 mg capsules, as more than $12,400.
Market Events Drive Changes
In April 2021, the FDA approved a new dosing regimen for Eli Lilly and Co.’s Erbitux (cetuximab) of 500 mg/m2 as a 120-minute infusion every two weeks as a single agent or in combination with chemotherapy for people with K-ras wild-type epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck. In April 2020, the agency granted an additional approval to Pfizer Inc. subsidiary Array BioPharma Inc.’s Braftovi (encorafenib) in combination with Erbitux for the treatment of adults with metastatic colorectal cancer with the BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy.
Competitive Market Landscape
Combinations of chemotherapy and bevacizumab, either as branded Avastin or in biosimilar form, have managed to remain a standard of care (SoC) in the highly crowded first- and second-line settings. Uptake also remains high for Erbitux, which is a SoC for first- and second-line RAF/KRAS WT and EGFR+ tumors (approximately 40% of colorectal cancers (CRCs)). Subsequently approved anti-angiogenic competitors to Avastin and Erbitux, such as Zaltrap and Vectibix, respectively, have had only limited impacts. All branded drugs are approved solely in metastatic, unresectable disease. Most treatment regimens in metastatic CRC (mCRC) consist of a chemotherapy and angiogenesis inhibitor combination. Anti PD-1 immune checkpoint inhibitors Opdivo and Keytruda have seen initial success in MSI-H/dMMR CRCs, which comprise approximately 15% of patients. Herceptin, Tykerb and Perjeta are recommended for off-label use in HER2+ tumors (approximately 3.5% of CRCs in the U.S.).
Pharmacy, Medical Benefit Implications
Although colorectal cancer drugs primarily are covered under the medical benefit, payers and PBMs have included injectable cancer medications in their formularies since oncology is a Medicare-protected class, and therefore coverage is surfacing under the pharmacy benefit as well for B vs. D determination. Most policies require the use of generic regimens FOLFOX, FOLFOXIRI or CapeOx before newer targeted agents. Genetic testing is required for most targeted agents. Primarily covered under the medical benefit, systemic therapy is administered in local disease, typically as adjuvant therapy, mostly consisting of generic chemotherapies. Most branded agents are confined to metastatic, unresectable CRC. Treatment for mCRC is heavily dependent on gene expression, with many drugs being prescribed only for specific tumor profiles. Some of these agents, like Braftovi, will process through the pharmacy benefit. First- and second-line metastatic CRC have become very crowded treatment settings, with multiple combinations of chemotherapies and targeted agents competing for the same disease mutation.
Key Players in Market: