The Health Insurance Review and Assessment Service (HIRA) held a closed-door meeting with patients with severe atopic dermatitis to calm their anger over the lack of access to Sanofi’s new biologic agent Dupixent (ingredient: dupilumab).
The government emphasized that Dupixent is the first drug to be applied to an extended risk-sharing agreement (RSA) and that the government was fully aware of the patients’ despair.
HIRA had the non-disclosure meeting with the Association of Patients with Severe Atopic Dermatitis at the Seoul office of HIRA on Wednesday.
After HIRA’s drug reimbursement review board did not discuss any issue involving Dupixent last week, the patients originally planned to protest the delay at a rally in front of HIRA’s Seoul office. However, HIRA proposed to have a closed meeting instead, and the group accepted the idea and canceled the rally.
According to people who attended the meeting, HIRA reportedly said Dupixent was the first drug being mentioned for the expansion of RSA and that the government was well aware of severe atopic dermatitis patients’ situation. The government used to apply RSA only to treating severe and rare diseases, including cancer, but plans to have an RSA for Dupixent so that the treatment could become reimbursable, sources said.
HIRA repeatedly asked the patients’ group to “trust the government and wait,” but declined to provide a detailed timeline when Dupixent will get insurance benefit.
The patients’ group asked HIRA what parts of negotiations with Sanofi were problematic, but HIRA did not answer only saying that it was classified information of the company's business.
HIRA’s Pharmaceutical Reimbursement Evaluation Committee is likely to put the Dupixent issue on the agenda at a meeting in October. HIRA said the government and Sanofi are doing their best to make it happen next month.
Even if the review board rules that Dupixent can get insurance benefit, however, the drugmaker should go through drug pricing negotiations with the National Health Insurance Service and the voting of the Health Insurance Policy Review Committee. Thus, it is almost impossible to predict the timing of Dupixent’s winning reimbursement.
Dupixent is the only biologic drug to treat patients with severe atopic dermatitis whose symptoms do not improve with conventional systemic therapies. It costs about 20 million won ($16,515) a year for patients to use Dupixent.
Since the beginning of this year, the patients’ association has staged one-person protests in front of the National Assembly, visited offices of the members of the National Assembly's Health and Welfare Committee, filed complaints with the health and welfare ministry and HIRA, and visited Sanofi’s office to push for the Dupixent reimbursement.