dailypharmkorea

Opinion
[Reporter’s View] Postponing clinical reevaluations by 1 yr
by Lee, Tak-Sun Jul 18, 2022 06:05am
The National Health Insurance Service’s Drug Reimbursement Evaluation Committee conducted its first reevaluation to assess the reimbursement adequacy on the anti-inflammatory streptokinase/streptodornase combo and decided that the combination is inadequate for insurance benefit. The drug has been used to ▲relieve acute inflammatory edema exacerbation due to ankle surgery or trauma, and ▲ to address the expectoration of sputum difficulties that accompany respiratory disorders. However, as the drug is not listed for reimbursement in any of the A8 reference countries (the US, the UK, France, Italy, Japan, Germany, Switzerland, and Canada), the combination was highly likely to receive negative results during reevaluation. The issue that arises here is that Korean pharmaceutical companies are conducting domestic clinical trials to supplement the lacking evidence on its use overseas. The Ministry of Food and Drug Safety ordered companies to conduct a clinical reevaluation for the drug, under which companies have been investing their own resourcesinceom 2017 to demonstrate the efficacy of the combination. SK Chemical, which owns the original Varidase Tab, is taking lead in demonstrating the drug’s efficacy in the first indication, and Hanmi Pharmaceutical, which has made the highest performance in the market with its Mucolase Tab, is leading the clinical trials for the second indication. With patient recruitment complete for both trials, the companies only have final analysis reports left. The companies are required to submit the final result report to the MFDS in 1H next year. In line with this progress, the companies subject to reimbursement cancellation requested that the reimbursement reevaluation be pushed back one year, to after the final report for the clinical reevaluation is submitted. However, on the 7th, DREC turned down the companies’ requests. It could seem harsh, as the companies were only asking for a 1-year grace period rather than avoiding the reevaluation in its entirety. However, HIRA’s reasons for the refusal, such as maintaining equity with other ingredients and the differences that exist in their purpose and method was also reasonable. However still, the streptokinase/streptodornase combination is the only drug that will submit clinical reevaluation results next year among drugs subject to reimbursement reevaluations this year. The result report for drugs such as acetyl L carnitine and oxiracetam that will receive reimbursement reevaluations next year are scheduled to submit results this year. Also, the differences in purpose and method that HIRA pointed out can be addressed by HIRA’s postponement of the reimbursement reevaluations. If streptokinase/streptodornase receives a non-reimbursement decision during reimbursement reevaluations, the drive and momentum to conduct its clinical re-evaluations will dissolve into thin air. The company would see no reason to verify the efficacy of a drug that lost marketability due to non-reimbursement. If its efficacy is demonstrated through the clinical trial next year, this would then bring more serious problems, as it would be difficult to reverse the non-reimbursement judgment even though there is evidence to prove reimbursement adequacy. HIRA needs to stop drawing a line between clinical re-evaluations and reimbursement re-evaluations and rationally adjust the order of drugs subject to reevaluations by period. Then no objections will arise regarding the procedure or results. The drugs that had received non-reimbursement decisions last year are still being sold in the market after 1 year. The companies had filed a suspension of execution to the court to suspend the disposition. In this sense, 1 year is not that long a delay. The companies will be proposing 1-year grace period again in the 30-day objection submission period. Upon receiving the request, I ask HIRA and DREC to seriously consider what s more reasonable.