Insurance price ceiling reeval results to be notified soon

within the week...30-day objection period will follow, allowing companies to file objections

DREC deliberations were completed on the 4th...a month behind the original schedule

Results disclosed after 2nd DREC deliberations...list to be amended after negotiations

The Health Insurance Review and Assessment Service completed its first review on drugs subject to primary pricing ceiling reevaluations and will be notifying companies of the results soon.

 

A 30-day objection period will follow HIRA’s result notification.

 

According to HIRA on the 8th, HIRA’s Drug Reimbursement Evaluation Committee completed its first review of drugs subject to pricing ceiling reevaluations and will notify companies of the results within the week.

 

About 14,000 items from about 200 companies were subject to primary evaluations.

 

According to the original schedule, HIRA was supposed to complete the first evaluation and DREC review in April, but the period was delayed by a month due to the large amount of data the companies submitted in February, the last month of the data submission deadline.

 

As a result, the plan for the results to be applied to the reimbursement list in July after negotiations is also likely to be delayed by a month.

 

The re-evaluation of the upper limit amount of drugs includes the decision of whether to maintain or lower the upper limit after examining whether listed drugs met the self-bioequivalence testing and DMF listing requirements.

 

Drugs that satisfy both the self-bioequivalence testing and DMF listing requirements are allowed to maintain their previous upper limit, and the price ceiling for drugs that satisfy only one of the two requirements is reduced to 85%, and those that satisfy none are reduced to 72.25%.

 

In July 2020, the government applied the differentiated drug pricing system based on the standard requirements such as self-bioequivalence testing and DMF to new drugs and then started to reevaluate existing drugs (items listed as of August 1, 2020) after a grace period.

 

The reevaluations were conducted in two groups in consideration of the pharmaceutical companies’ schedules.

 

Companies that were subject to submit bioequivalence test results last year for their items (5,905 items) submitted data by July 31, and for other drugs, the standard requirements data were submitted from October of last year to February of this year.

 

The items that will be notified of the first results are those whose data has been submitted by February.

 

Once the first results are notified to each pharmaceutical company, a 30-day objection period will be available for the companies’ appeal.

 

After the appeal process is concluded, the final result will be announced through DREC’s second review.

 

According to the current schedule, it is highly likely that the final evaluation results will be deliberated at the second DREC meeting held at the end of June.

 

Then, the results are expected to be reflected in the reimbursement list in August after the companies undergo main negotiations with the NHIS in July.

 

The NHIS is currently forging preliminary discussions with pharmaceutical companies to complete the main negotiations in one month.