Daiichi Sankyo's Enhertu passes cancer drug benefit review after patients’ petition
Daiichi Sankyo Korea’s Enhertu (ingredient: trastuzumab druxtecan), a treatment for breast and gastric cancer, has passed the first gateway for winning insurance coverage, after garnering more than 50,000 votes of patients and guardians in a national online petition to push for reimbursement.
The treatment showed remarkable therapeutic benefits in metastatic HER2-positive breast cancer and gastric cancer.
The Health Insurance and Review Service’s (HIRA) Cancer Drug Review Committee passed the second review of Enhertu on Wednesday.
Also up for review on the same day were Megval, a melphalan-based injection, Meslpal, a pre-treatment for hematopoietic stem cell transplantation, and Yondelis (trabectedin) for soft tissue sarcoma.
In addition, the hematologic cancer drugs Darzalex (daratumumab) and Xospata (gilteritinib) also became eligible for insurance coverage expansion.
HIRA announced the results of the Cancer Disease Review Committee deliberations on Wednesday.
Daiichi Sankyo's Enhertu was granted coverage for the treatment of patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based therapies, and for the treatment of locally advanced or metastatic HER2-positive adenocarcinoma of the stomach or gastroesophageal junction who have received two or more prior therapies, including anti-HER2 therapy.
Enhertu received approval from the Ministry of Food and Drug Safety in September last year. Demonstrating an unprecedented improvement in survival rates, particularly in breast cancer, the treatment prompted Korean patients to file a national petition to introduce it to Korea.
In June 2021, Enhertu was designated as a fast-track drug by the MFDS, but as the pharmaceutical company's license application was delayed, patients continued to petition for Enhertu’s approval.
After the drug won regulatory approval in late 2022, patients who were unable to receive treatment due to the high cost of the drug petitioned the National Assembly's Health and Welfare Committee for insurance coverage.
On the back of the efforts of these patients, the proposal to create a new reimbursement for Enhertu quickly made it to the Cancer Drug Review Committee’s review in late March. However, the panel decided to reconsider. Then, Daiichi Sankyo Korea submitted an additional financial contribution plan, and the committee finally passed the review.
Now, Enhertu will be assessed for reimbursement appropriateness by the Pharmaceutical Benefit Evaluation Committee. Then, the drugmaker has to negotiate the drug price with the Korea Health Insurance Service. If the drug passes the deliberation of the Ministry of Health and Welfare’s Health Insurance Policy Review Committee, it will be finally covered by national health insurance.
On the same day, the HIRA’s cancer drug review committee also allowed to set new reimbursement for Megval, Melspal, and Yondelis.
Megval and Melspal, sold by Ace Pharma and Korea HO Pharm, are injectable versions of melphalan. The original drug is Alkeran, which was introduced by Samil Pharmaceutical in late 1999. Melphalan is a cytotoxic anticancer drug belonging to the class of typical alkylating agents, and is mainly used to treat multiple myeloma or as a pretreatment before hematopoietic stem cell transplantation.
The committee decided that Megval and Melspal could be reimbursed to treat multiple myeloma including rhabdomyosarcoma as “pre-treatment for hematopoietic stem cell transplantation.”
Yondelis, which Meditip relaunched after its domestic sales were suspended in April 2008, also became reimbursable to treat liposarcoma and leiomyosarcoma in the cancer drug benefit review.
Darzalex, a treatment for multiple myeloma, and Xospata, a treatment for acute myeloid leukemia, received expanded coverage.
The indication for Darzalex reimbursement sought by Janssen Korea is "combination therapy with bortezomib, thalidomide and dexamethasone in newly diagnosed multiple myeloma patients suitable for hematopoietic stem cell transplantation (D-VTd).”
Currently, D-VTd 4-drug induction therapy is covered (5 percent patient co-pay) for the remaining 3 VTd drugs except for Darzalex. Patients are paying 100 percent of Darzalex's cost.
Xospata gets insurance benefits for the treatment of patients with relapsed or refractory acute myeloid leukemia who are FLT3 mutation-positive, but the coverage has been limited to a maximum of four cycles in transplant-eligible patients.
Astellas Korea sought expanded coverage for all patients within the indication, regardless of the patient's transplantability and dosing frequency, and the review panel gave the green light.
However, HIRA’s review panel rejected the proposed reimbursement for Novartis' Piqray (alpelisib) and the proposed reimbursement expansion for Lilly's Verzenio (abemaciclib) and Roche's Tecentriq (atezolizumab).