Zitter Pulse Check: Breast Cancer (June 2023)

Coverage

Breast cancer is a high-cost category with an increasing number of therapies, including biosimilars, that treat different subtypes of the condition. To help stakeholders absorb datapoints and perceptions from all directions and synthesize those insights into a tangible strategy for breast cancer, Zitter Insights surveys a leading panel of pharmacy and therapeutics (P&T) decision makers at payers and integrated delivery networks. The Managed Care Oncology Index: Breast Cancer combines deep payer insights with the industry standard in market access information to produce quarterly reports and insights summaries on leading oncology brands.

Payer Management

Commercial payers with approximately three-fourths of covered lives and Medicare payers representing more than two-thirds of beneficiaries said managing branded breast cancer agents is a high priority. Payers covering almost half of commercial lives and nearly three-fifths of Medicare ones said they are somewhat aggressive in their management of those drugs, preferring some products over others. Almost three-fifths of oncologists and Medicare payers with more than two-thirds of lives said there is moderate unmet need in treating breast cancer, while commercial payers with almost two-thirds of lives classified that need as high.

Almost half of oncologists and payers with almost half of Medicare lives said that people with breast cancer have an average level of disease burden, while payers with more than two-thirds of commercial lives perceived it as high. Commercial payers with four-fifths of beneficiaries and Medicare payers with more than half said that drugs to treat breast cancer have a high impact on their budget.

Key Findings

Many breast cancer medications target specific subtypes of the disease, so physicians may choose to run tests to identify genes, proteins and other markers in a tumor. Payers with about three-fourths of commercial lives and almost all Medicare lives said that they cover companion diagnostics for breast cancer. Two-thirds of oncologists said that insurers require test results for specific agents only, while almost a quarter reported that they are required for all breast cancer drugs. Among payers that cover the tests, those with more than three-fourths of commercial beneficiaries and almost all Medicare lives said they do not have a limit on the number of times a patient can be tested for a specific mutation. Among payers requiring test results for all breast cancer medications, those with more than two-thirds of commercial beneficiaries mandate that members wait at least 12 months between tests.

Orserdu

On Jan. 27, 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 selective estrogen receptor degrader 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. At the time of the survey, payers with almost two-thirds of commercial lives and ones with almost all Medicare lives had not conducted a P&T review of the agent, and of those payers, ones with more than half of commercial lives and more than two-thirds of Medicare beneficiaries said they expect the drug will have a moderate impact on other breast cancer medications. But among payers that had conducted a P&T review, those with more than half of commercial beneficiaries and almost three-fourths of Medicare ones said that Orserdu would not have an impact on their management of other products for breast cancer.

Social Determinants of Health

Among payers covering commercial lives, the top social determinants of health initiative for disadvantaged members with breast cancer was offering greater access to telehealth — which is done by payers with almost three-fourths of lives — followed by providing services to assist in health/medicine language barriers, as well as services to support health/medicine literacy. For Medicare payers, the top programs were providing free or low-cost mental health services and greater access to telehealth. Oncologists identified a person’s socioeconomic status as the top nonmedical factor impacting breast cancer patients’ access to therapy, as well as education and health literacy, and occupation and job security.

Trends

Efficacy

Message: “Discussion and product overview regarding the use of Herceptin Hylecta in the treatment and management of HER2+mBC. Herceptin Hylecta provides for a SC [subcutaneous] injection option vs. IV infusion of Herceptin. Clinical efficacy studies demonstrated a non-inferiority in efficacy and pharmacokinetics in comparison to infusing the drug IV. Additionally, the Hylecta formulation permits a fixed dosing option, no loading dosing requirement or weight-based dosing and a faster infusion time (2-5 minutes), dosed every 21 days. Utilization of the hyaluronidase within the formulation permits an increase in the drug’s dispersion and absorption.”

Payer Thoughts: “Overall, the SC formulation permits improved patient satisfaction (faster infusion time/less clinic time) with the same efficacy to that on an IV infusion.”

As Breast Cancer Treatments Continue to Evolve, a Few Stand Out

Breast cancer is the most common cancer diagnosed in American women and the most common cancer globally. Estimates show that more than 300,000 people in the U.S. are expected to be diagnosed this year alone, almost 3,000 of them men.

When the FDA first approved Genentech, Inc.’s Herceptin (trastuzumab) on Sept. 25, 1998, for the treatment of people with breast cancer whose tumors overexpress the human epidermal growth factor receptor-2 (HER2) protein, the drug offered a new targeted approach to treating the disease. In the years since, researchers have identified other subtypes of the cancer and developed newer agents indicated for specific types and stages of the disease.

Subscribers to AIS’s RADAR on Specialty Pharmacy may read the in-depth article online

FDA Expands Patient Population for Ibrance

On Dec. 13, 2022, the FDA expanded the patient population for Pfizer Inc.’s Ibrance (palbociclib) to include pre-/perimenopausal women in the indication for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy. The agency first approved the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor on Feb. 3, 2015. The drug is available in both capsule and tablet formulations, and the recommended starting dose for both is 125 mg once daily for 21 days, followed by seven days off treatment. The list price for 21 capsules in 125 mg, 100 mg and 75 mg formulations is $13,973.80.

Subscribers to AIS’s RADAR on Specialty Pharmacy may read the in-depth article online

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