The revaluation of Streptokinase could be maintained for 1yr

It is difficult to maintain benefits for some indications of Godex & Eperisone

The pharmaceutical industry expects some components to be suspended in this year's benefit revaluation.

 

The benefit revaluation of Streptokinase and Streptodornase, which are scheduled to submit a report on clinical revaluation results next year, could be suspended for one year.

 

However, the final plan is expected to be decided through deliberation by the Drug Benefit Evaluation Committee of the HIRA, which will be held on the 7th.

 

An official from the pharmaceutical industry said on the 4th, "Streptokinase and Streptodornase, which are components subject to benefit reevaluation this year, are also discussing a one-year grace period." "However, I understand that it is not a confirmed issue," he explained.

 

Streptokinase and Streptodornase are enzyme drugs such as Hanmi Pharmaceutical's Mucolase and SK Chemical's Varidase.

 

Since 2017, the drug has been conducting clinical re-evaluation by the MFDS, and the previous indications of sinusitis and thrombosis have been deleted.

 

Next year, it is scheduled to submit a report on the results of clinical re-evaluation of the difficulty of ventilation accompanied by respiratory diseases.

 

Accordingly, the industry suggested that the re-evaluation of the drug should be suspended until the clinical re-evaluation of the drug is completed.

 

This is because the cost of clinical trials that were in progress cannot be compensated.

 

However, the HIRA said that benefit revaluation and clinical revaluation are different.

 

On the 14th of last month, Kim Ae-ryeon, head of the HIRA's Pharmaceutical Price Benefit Division, explained, "The review of benefit adequacy may include the target of clinical revaluation by the MFDS by selecting the target according to the selection criteria." She said, "It is difficult to consider arbitrarily delaying the evaluation of benefit adequacy only for components subject to clinical revaluation in terms of equity with other components." It remains to be seen whether the re-evaluation of Streptokinase and Streptodronase salary will be postponed as the industry suggests.

 

Industries are also predicting some re-evaluation results.

 

In the case of Celltrion's liver disease solvent Godex, which has the highest benefit claim among the ingredients this year, it is uncertain whether it will be maintained, and on the contrary, the antacid Almagate is likely to be maintained.

 

In the case of Eperisone HCl, pain muscle contraction accompanied by musculoskeletal disease, which is the first indication, is likely to maintain, but it is uncertain about stiffness paralysis due to nervous system disease, which is the second indication.

 

However, another industry official said, "The HIRA maintains strict security this time, so little has been confirmed in the industry." "It is said that only two of the six target ingredients will be maintained," he said.

 

Since the announcement of the benefit adequacy revaluation plan in March, The HIRA received data from the pharmaceutical company and conducted a practical review on whether each ingredient meets the evaluation criteria.

 

Therefore, on the 7th, the results will be announced after the first deliberation by the Pharmaceutical Benefit Evaluation Committee with the results.

 

After that, during the fourth quarter, the Post-Pharmaceutical Evaluation Committee and the Pharmaceutical Benefit Evaluation Committee will be held once more to deliberate on the final plan.