Pharmaceutical Firms Consider Action as HIRA Calls for Re-Evaluation of Reimbursement and Cost-Effectiveness Criteria
A potential legal battle is brewing over the re-evaluation of reimbursement rates for "Sarpogrelate Hydrochloride" drugs, sparking industry-wide concern about the adequacy of these reimbursements under impending price cuts. Should pharmaceutical companies pursue litigation, the dispute is likely to be addressed within the framework of the drug reimbursement and rebate program.
According to industry insiders, several pharmaceutical companies with sarpogrelate-based products are contemplating lawsuits in response to the price reductions required for continued coverage. The Health Insurance Review & Assessment Service (HIRA), following an initial evaluation, previously ruled that reimbursement for sarpogrelate lacked justification. Although certain clinical studies and guidelines suggest some efficacy, HIRA ultimately found the drug’s clinical utility to be uncertain and insufficiently cost-effective.
In a subsequent communication, HIRA informed approximately 80 companies producing sarpogrelate-based drugs that a 3.9% maximum price cut could enable them to retain reimbursement, pending a full review of cost-effectiveness and clinical utility. These firms now face a choice: accept the price cut based on sales performance or risk losing reimbursement due to the product's lack of cost-effectiveness.
Some pharmaceutical companies have filed appeals seeking the exclusion of aspirin from reimbursement ceiling calculations, which would impact the 3.9% reduction. While several companies have agreed to the rate and opted for the price cut, others continue to weigh the option of legal action.
The industry’s legal approach varies, with some companies considering either a direct challenge to the price reduction or a selective dispute over the assessment method. Those who accepted the cut might inadvertently weaken the legal stance of those seeking to reverse or adjust it. Additionally, firms must evaluate potential implications under the drug reimbursement and rebate program, which has been active since November 20 last year. This program allows the government to recover any economic benefits or losses resulting from court orders suspending administrative actions like price reductions or reimbursement suspensions.
Meanwhile, a separate review mandates a 7.7–7.8% price cut for Levodropropizine products to retain reimbursement, although no legal opposition has been reported. HIRA's second review on this matter is set for October 10, with implementation planned for December.
