The combination therapy of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor and fulvestrant for advanced or metastatic breast cancer is likely to receive insurance coverage in the first half of next year, industry sources said.
The government’s push for a revision of the risk-sharing agreement as part of the amendment in drug pricing could accelerate reimbursement of the combo therapy as patients have wished, the sources said.
All three CDK4/6 inhibitors for the treatment of hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) metastatic breast cancer have arrived in the Korean market. Pfizer rolled out Ibrance (ingredient: palbociclib) in August 2016, and Lilly, Verzenio (abemaciclib) in May, and Novartis, Kisqali (ribociclib) in October.
Local breast cancer patients can get the insurance benefit only through Ibrance. Ibrance is reimbursable for the combo with an aromatase inhibitor (letrozole) as the first-line endocrine therapy in postmenopausal patients with HR+/HER2- advanced and metastatic breast cancer.
Pfizer had failed to win an insurance benefit for Ibrance’s combo with fulvestrant in patients whose disease progressed after the endocrine therapy because the government refused to review it with the non-reimbursable fulvestrant.
However, the situation changed as fulvestrant obtained the insurance benefit in April, over 10 years after the local market launch.
Pfizer immediately applied for the Ibrance benefit, and it passed the cancer drug review committee in October. The company is waiting for an assessment by the subcommittee of the risk-sharing agreement.
The government is reviewing not only Ibrance but Verzenio for reimbursement.
Novartis also applied for reimbursement for Kisqali in late October. Thus, the three drugmakers are all hoping to get reimbursement for their CDK4/6 inhibitors to be used with fulvestrant in patients whose disease progressed after the endocrine therapy.
Their attempts to get reimbursement are likely to be supported by the government’s revision of the risk-sharing agreement, which could be expanded for late-comer drugs.
The Ministry of Health and Welfare said it would complete the revision in December, put to notice the administrative measure, and implement it in the first half of next year. Therefore, local breast cancer patients could get the insurance benefit from the combo therapy of CDK4/6 inhibitor plus fulvestrant, observers said.
The combo of CDK4/6 plus fulvestrant has proved benefit through various overall survival (OS) data in trials. The latest MONALEESA-3 study on Kisqali plus fulvestrant showed that the combo therapy reduced death risk by 28 percent at 42 months, compared to fulvestrant alone.
Sohn Joo-hyuk, a professor at the Oncology Department of Severance Hospital, said not only Kisqali but all the three CDK4/6 inhibitors need insurance benefit for premenopausal and postmenopausal women with HR+/HER2- advanced and metastatic breast cancer.
“The number may be small, but the patients who could not use CDK4/6 inhibitor in the first-line treatment must use CDK4/6 plus fulvestrant. So, the combo needs reimbursement in the second-line treatment,” Sohn emphasized.