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 40% of the lives under commercial formularies are covered with utilization management restrictions. Around 47% of the lives under Medicare formularies are not covered for at least one of the drugs.
Under the medical benefit, about 64% of the lives under commercial policies are covered with utilization management restrictions. Almost 75% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.
For about 97% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 25% require multiple steps. Around 73% of payer-controlled pharmacy benefit covered lives require prior authorization, with 13% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
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.
In June 2020, the FDA approved Roche Group unit Genentech Inc.’s Phesgo (pertuzumab, trastuzumab and hyaluronidase-zzxf) to treat early and metastatic HER2-positive breast cancer. Administration of the subcutaneous injection may be done at home or in a treatment center. Dosing varies depending on neoadjuvant or adjuvant setting. The initial loading dose is $12,707, and the monthly maintenance cost is $12,300.
In April 2020, the FDA approved Seattle Genetics, Inc.’s (now known as Seagen Inc.) Tukysa (tucatinib) in combination with trastuzumab and capecitabine for adults with advanced unresectable or metastatic HER2-positive breast cancer, including people with brain metastases, who have received at least one prior HER2-based regimen in the metastatic setting. The agency gave the tyrosine kinase inhibitor breakthrough therapy designation and priority review. Recommended dosing of the tablet is 300 mg twice daily. The drug’s 30-day list price is $18,500.
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-positive 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: