Revising the PE exemption system… focuses on 'deferral'

defers rather than waives the required data submission

HIRA completes research service...will require evidence submission post-listing

The ‘Pharmacoeconomic Evaluation Exemption System', which was first implemented in 2015, will be completely transformed in the new year.

 

In the future, the system will defer rather than exempt companies from submitting required data, increasing the possibility of drugs being evaluated after listing.

 

According to the industry on December 29th, the study on 'Preparation of a plan to improve the pharmacoeconomic evaluation data submission waiver system’ that was conducted as the Health Insurance Review and Assessment Service’s research service in February, has been completed.

 

The results of the study, which mention the need to redesign the system to defer data submission rather than omit it, are expected to be used to make systemic improvements.

 

As a result, drugs subject to deferral of pharmacoeconomic evaluation data submission will also prepare evidence for the agreements it had made when it was listed through prior assessments.

 

The system, which was implemented in 2015, is applied to rare disease drugs and anticancer drugs for which no alternatives exist.

 

This year, it was also applied to pediatric drugs that have proven to improve quality of life.

 

However, the HIRA believes that these drugs need to undergo a post-marketing cost-effectiveness evaluation, given how expensive these drugs are.

 

The need for post-marketing evaluation of PE exemption drugs was also mentioned at the public hearing for the ‘Performance-based reimbursement management plan for drugs using RWD/RWE’ that was held last November.

 

At the time, Mi-Young Yoo, Director-General of the Pharmaceutical Benefits at HIRA, said, “Since the introduction of the positive listing system in 2006, many drugs have been listed for reimbursement through various systems including the PE exemption system to enable better patient access.

 

So this is now the time a post-listing measure needs to be implemented.

 

Although social consensus should be made on its need, such a management system can be a way to ensure an appropriate level of financial soundness within limited insurance.” This implied that RWD (Real-World Data) can be used to post-evaluate drugs that have omitted pharmacoeconomic evaluations.

 

At the ‘2023 Korean Association of Health Technology Assessment Winter Conference' that was held on the 1st of the previous month, experts raised voices that the system should be redesigned so that the exemptions are switched to deferrals.

 

Accordingly, HIRA is expected to improve the overall system to introduce post-evaluation of PE exemption drugs this year, based on the results of the research service.