Drugmakers and the government will start talks this week to negotiate prices of breast cancer medicines that combined cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor with fulvestrant.
Pfizer has the first developed CDK4/6 inhibitor Ibrance (ingredient: palbociclib) and Lilly, Verzenio (abemaciclib), which recently passed the regulatory review for reimbursement after winning approval in May.
The two companies will have price negotiations with the National Health Insurance Service for 60 days.
Ibrance will be an item for the “expansion of reimbursement” under the risk-sharing agreement (RSA), and Verzenio, an item for “new reimbursement.”
Pfizer obtained the license for Ibrance in August 2016. Pressured by breast cancer patients’ demand for the reimbursement of Ibrance, the drug got the health insurance benefit in the following year for the combo with letrozole as the first-line endocrine therapy in postmenopausal patients with HR+/HER2- advanced and metastatic breast cancer.
However, calls were mounting among patients and physicians for a more comprehensive insurance benefit amid the increase of younger patients who had to pay the full medical bill because they were premenopausal.
Pfizer has also strived to earn reimbursement for Ibrance’s combination with fulvestrant for the past three years.
As fulvestrant was not reimbursable, however, the Health Insurance Review and Assessment Service (HIRA) had refused to grant an insurance benefit. The situation started to change in April last year when fulvestrant got the reimbursement, more than a decade after its arrival in the Korean market.
Pfizer immediately applied for the benefit of the Ibrance plus fulvestrant combo, and it passed the drug reimbursement review committee in February.
In comparison, it took Lily less than one year to get the local permit for Verzenio and the passage of the drug reimbursement review. As soon as the company grabbed the nod for Verzenio in May, it applied for the drug reimbursement.
As Pfizer’s Ibrance secured the indication of the first-line endocrine therapy, Lilly went after the new reimbursement for the combo of Verzenio with fulvestrant. The strategy worked to pass the drug reimbursement review earlier this month. Now, the company is in the final stage to get the benefit through price negotiations with the NHIS.
Both Ibrance and Verzenio proved the benefit of progress-free survival in phase-3 trials, PALOMA-3 and MONARCH-2, respectively.
“Metastatic breast cancer is a refractory disease, detrimental to the health of many women. CDK4/6 inhibitors are essential for them,” said Park Yeon-hee, a professor at the Hematology-Oncology Department of Samsung Medical Center.