MMIT Reality Check on Breast Cancer (HR+/HER2+) (4Q2022)

Payer Coverage:

A review of market access for hormone receptor-positive/human epidermal growth factor receptor 2-positive (HR+/HER2+) breast cancer treatments shows that under the pharmacy benefit, about 39% of the lives under commercial formularies are covered with utilization management restrictions. Around 59% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 68% of the lives under commercial policies are covered with utilization management restrictions. Almost 71% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

For about 96% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 61% require multiple steps. Around 73% of payer-controlled pharmacy benefit covered lives require prior authorization, with 14% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Expands Enhertu Label

In May 2022, the FDA expanded the label of AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) to include the treatment of people with unresectable or metastatic human epidermal growth factor receptor 2-positive breast cancer who have received an anti-HER2 treatment in the metastatic, neoadjuvant or adjuvant setting followed by disease recurrence during treatment or within six months of completing therapy. The approval went through the FDA’s Real-Time Oncology Review program and was reviewed under Project Orbis. It converts the Dec. 20, 2019, accelerated approval of Enhertu in later line HER2-positive metastatic breast cancer to standard approval. Use in the earlier setting for the antibody-drug conjugate (ADC) had priority review and breakthrough therapy designation. Dosing for breast cancer is 5.4 mg/kg via an intravenous infusion once every three weeks. Drugs.com lists the price of one 100 mg vial of lyophilized powder as more than $2,562.

FDA Expands Use of Roche’s Companion Diagnostic

In October 2022, the FDA expanded the use of Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify people with metastatic breast cancer with low human epidermal growth factor receptor 2 expression who may be candidates for treatment with AstraZeneca and Daiichi Sankyo, Inc.’s Enhertu (fam-trastuzumab deruxtecan-nxki). The company says the test is the first FDA-approved companion diagnostic for this indication. The agency initially granted the test premarket approval on Nov. 28, 2000.

FDA Approves Margenza

In December 2020, the FDA approved MacroGenics, Inc.’s Margenza (margetuximab-cmkb) in combination with chemotherapy for the treatment of adults with metastatic human epidermal growth factor receptor 2-positive breast cancer who have received at least two anti-HER2 regimens, with at least one of them for metastatic disease. Dosing is via a 120-minute intravenous infusion at 15 mg/kg for the first dose and then over a minimum of 30 minutes every three weeks.

Key Findings:

Market Events Drive Changes

The disruptive market events in this class will be the biosimilars. Several are commercially available while others are in the drug pipeline. In December 2020, the FDA approved MacroGenics, Inc.’s Margenza (margetuximab-cmkb) in combination with chemotherapy for the treatment of adults with metastatic human epidermal growth factor receptor 2-positive breast cancer who have received at least two anti-HER2 regimens, with at least one of them for metastatic disease. In June 2020, the agency approved Roche Group unit Genentech Inc.’s Phesgo (pertuzumab, trastuzumab and hyaluronidase-zzxf) to treat early and metastatic HER2+ breast cancer.

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. 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. Since many combinations of products are used, no preference is given to one combination over another.

Pharmacy, Medical Benefit Implications

We typically see treatment 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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