A petition has been posted to call for providing insurance benefits for Lilly's CDK 4&6 inhibitor Verzenio (abemaciclib) for early-stage breast cancer.

Verzenio is the first CDK 4&6 inhibitor to have its indication expanded to include HR+ (hormone receptor positive)/HER2- (human epidermal growth factor receptor 2 negative), lymph node positive, recurrent high-risk early breast cancer.

Last year, the Ministry of Food and Drug Safety approved Verzenio combined with endocrine therapy for the adjuvant treatment of adult patients with HR+/HER2-, lymph node-positive, high-risk recurrent early breast cancer.

Lilly immediately set about to expand reimbursement for Verzenio.

In May, however, it drug failed to cross the threshold of the Health Insurance Review and Assessment Service (HIRA)’s Cancer Disease Review Committee, because of insufficient evidence of clinical utility. The company resubmitted its application for coverage in October.

Verzenio recently received a spotlight at the European Society for Medical Oncology Annual Meeting (ESMO 2023) in Madrid, Spain, where long-term data from the phase 3 monarchE study, which evaluated the drug as adjuvant therapy after surgery in high-risk early-stage breast cancer patients, confirmed its recurrence prevention effect.

More recently, a petition that calls for providing insurance coverage for early breast cancer targeted therapy Verzenio has been posted on the National Assembly Citizen's Petition Board. Currently, 7,327 people have agreed to the petition, which will run until Nov. 30.

"My wife is in hormone receptor-positive breast cancer stage 3. Tamoxifen had long been the only treatment until targeted therapy drug Verzenio was launched in November last year. I saw a ray of hope in my depressed and frustrated heart," the petitioner said. "The problem is that it is a non-reimbursable drug that must be taken for two years, and the treatment cost is about 50 million won ($38,370)."

The petitioner noted that in 2019, early stage breast cancer accounts for 92.2 percent of all breast cancers in Korea, adding that breast cancer has a high recurrence rate, and the recurrence rate after endocrine therapy was 14-23 percent, with the highest risk of recurrence in the first one to two years after diagnosis.

"The five-year survival rate can be as low as 21 percent if lymph node metastasis occurs," the petitioner said.

The key to treating early breast cancer is post-operative adjuvant therapy rather than surgery, and while Verzenio is emerging as one of the options for post-operative adjuvant therapy for early breast cancer patients, it is too expensive for many patients to afford, he added.

“I hope that it will receive insurance benefits as soon as possible and become a light for patients who are struggling with recurrence," the petitioner said.