MMIT Reality Check on Breast Cancer HR+/HER2- (September 2022)

Payer Coverage:

A review of market access for treatments of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer shows that under the pharmacy benefit, about 44% of the lives under commercial formularies are covered with utilization management restrictions. Around 33% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 49% of the lives under commercial policies are covered with utilization management restrictions. Almost 72% of the lives under Medicare 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, about 42% of the lives require multiple steps. Around 72% 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.

Trends:

FDA Approves Additional Indication for Verzenio

In October 2021, the FDA expanded the indication of Eli Lilly and Co.’s Verzenio (abemaciclib) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of >20% as determined by an FDA-approved test. The tablet is the only CDK4/6 inhibitor approved for this indication. The FDA initially approved the drug on Sept. 28, 2017. Recommended dosing for this use is 150 mg twice daily. The monthly list price is $13,058.08.

FDA Approves Everolimus

In December 2019, the FDA approved Teva Pharmaceuticals USA, Inc.’s and Endo International plc unit Par Pharmaceuticals’ everolimus for the treatment of advanced hormone receptor-positive, HER2-negative breast cancer in postmenopausal women; advanced renal cell carcinoma; renal angiomyolipoma and tuberous sclerosis complex; progressive neuroendocrine tumors of pancreatic origin; and progressive, well-differentiated, non-functional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable. The tablets were the first generics of Novartis’ Afinitor. Both companies had 2.5 mg, 5 mg and 7.5 mg versions approved, and Teva also had a 10 mg tablet approved. Dosing is based on the indication. GoodRx lists the price of 28 5 mg tablets of everolimus as more than $4,000, compared with more than $15,500 for Afinitor.

People on CDK 4/6 Inhibitors Show High Adherence

Since 2015, three cyclin-dependent kinase (CDK) 4/6 inhibitors have come onto the U.S. market as treatments for hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. A recently released poster from AllianceRx Walgreens Prime in collaboration with Duquesne University School of Pharmacy shows that people taking the therapies have high adherence, low rates of stopping treatment and low side effects.

Key Findings:

Market Events Drive Changes

In October 2021, the FDA expanded the indication of Eli Lilly and Co.’s Verzenio (abemaciclib) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of >20% as determined by an FDA-approved test. In December 2019, the agency approved Teva Pharmaceuticals USA, Inc.’s and Endo International plc unit Par Pharmaceuticals’ everolimus, the first generics of Novartis International AG’s Afinitor, for the treatment of advanced HR+/HER2- breast cancer in postmenopausal women, among other indications.

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:

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