MMIT Reality Check on Breast Cancer HR+/HER2- (3Q2023)
Payer Coverage:
A review of market access for treatments of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) shows that under the pharmacy benefit, about 48% 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.
Under the medical benefit, about 56% of the lives under commercial policies are covered with utilization management restrictions. Almost 71% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.
For about 94% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 38% of the lives require multiple steps. Around 76% of payer-controlled pharmacy benefit covered lives require prior authorization, with 9% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
Trends:
FDA Broadens Verzenio Indications
In March 2023, the FDA broadened the indications for Eli Lilly and Co.’s Verzenio (abemaciclib) to include, in combination with endocrine therapy, the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor-2 negative (HER2-), node-positive early breast cancer at a high risk of recurrence. High-risk patients now can be identified by nodal status, tumor size and tumor grade, regardless of Ki-67 score. The FDA initially approved the CDK4/6 inhibitor on Sept. 28, 2017. The recommended starting dose of the tablet is 200 mg twice daily. The monthly list price is $14,533.68.
FDA Grants Another Approval to Trodelvy
In February 2023, the FDA granted another indication to Gilead Sciences, Inc.’s antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy) for the treatment of adults with unresectable locally advanced or metastatic hormone receptor-positive (HR+), HER2- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. The agency initially approved the Trop-2 directed antibody and topoisomerase inhibitor conjugate on April 22, 2020. The review was conducted under Project Orbis, and the FDA gave it priority review. Dosing is 10 mg/kg once weekly via intravenous infusion on days one and eight of continuous 21-day treatment cycles. Drugs.com lists the price for one 180 mg vial of lyophilized powder as more than $2,418.
FDA Approves Orserdu
In January 2023, the FDA approved Menarini Group subsidiary Stemline Therapeutics, Inc.’s Orserdu (elacestrant) for the treatment of postmenopausal women or adult men with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. The agency gave the selective estrogen receptor degrader (SERD) priority review and fast track designation; the review used the Assessment Aid. The agent is the first to gain FDA approval for ER+, HER2- advanced or metastatic breast cancer patients with ESR1 mutations, as well as the first oral SERD for breast cancer. Dosing is one 345 mg tablet once daily. The wholesale acquisition cost of a 30-day supply is $21,369.
Key Findings:
Market Events Drive Changes
In March 2023, the FDA broadened the indications for Eli Lilly and Co.’s Verzenio (abemaciclib) to include, in combination with endocrine therapy, the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor-2 negative (HER2-), node-positive early breast cancer at a high risk of recurrence. In February 2023, the FDA granted another indication to Gilead Sciences, Inc.’s antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy) for the treatment of adults with unresectable locally advanced or metastatic HR+, HER2- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. In January 2023, the FDA approved Menarini Group subsidiary Stemline Therapeutics, Inc.’s Orserdu (elacestrant) for the treatment of postmenopausal women or adult men with estrogen receptor-positive (ER+), HER2-, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Competitive Market Landscape
In most cases, especially when used before or after surgery, chemotherapy is most effective when combinations of drugs are used. Today, doctors use many different combinations, and it’s not clear that any single one is the best, so no preference is given to one over another. It is rare to see a payer place branded products for breast cancer on a preferred tier in the pharmacy benefit, mainly because the majority of products process through the medical benefit.
Pharmacy, Medical Benefit Implications
Typically treatment is through standard-of-care chemotherapy, and combinations follow more targeted therapy. Many policies require HER2 testing. Reimbursement via buy and bill and specialty pharmacy requirements are common. Most policies follow national guidelines in cancer treatment.
Key Players in Market:
