Industry requests re-revision of the PE exemption standards

KRPIA and KPBMA submit an official written opinion to the government

Regulation on the ‘few subject patients’ and ‘pediatric patient’ needs improvement

The pharmaceutical industry raised opposition to the government’s proposed amendment to the insurance reimbursement system.

 

According to industry sources, the Korea-Research Based Pharmaceutical Industry Association (KRPIA) submitted an opinion statement to the government regarding the pre-announced ‘Proposal for Partial Amendment to the Regulations on the Evaluation Standards and Procedures to Determine Eligibility for Reimbursement Benefits.’ In the statement, KRPIA requested revisions to the special exemption of pharmacoeconomic evaluations exemption system’s ▲‘few patient’ requirement ▲benefits for pediatric patients, etc.

 

Korea Pharmaceutical and Bio-Pharma Manufacturers Association is also expected to submit a written opinion by the deadline, which is today (30th) to relay the same opinion as KRPIA.

 

The two associations, which usually had different positions on government policies, seem to agree on this case.

 

First, the KRPIA clearly expressed its opposition to the improvement plan that includes the "few subject patients" as a prerequisite.

 

The improvement plan brought concern in the industry due to the fact that a major premise for the PE exemptions has also been changed.

 

The condition had previously been an “OR” clause included in Article 2(c) of eligibility for PE exemption regulations, along with other clauses such as ‘if a single-arm study was conducted,’ etc.

 

The association requested the government to maintain the regulation in its current state.

 

KRPIA said, “Drugs that fall under Item 2(a) and 2(b) that have difficulty generating evidence were eligible for PE exemptions even if they were not used to treat ‘few’ patients.

 

However, the revision mandates the ‘few’ condition to be met.

 

This will only reduce the scope of eligible subjects.” The association also added that expanding the scope of PE exemption to pediatric patients, which the government had heralded as the purpose of the revision, also needs additional improvements.

 

The government added a clause allowing PE exemption for ‘drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option; and demonstrates improvement in quality of life or is otherwise approved by the committee.’ In essence, the added clause excluded the “life-threatening disease” condition for PE exemptions just for pediatric patients.

 

In other words, if drugs used for pediatric patients satisfy the remaining conditions, the PE exemption may be applied even if the condition is not life-threatening.

 

However, the industry’s opinion is that the application of the standard should be extended.

 

Through the written opinion, the KRPIA stated, “The government had first discussed expanding coverage to diseases that affect a small number of patients and bring a very poor quality of life even if they are not life-threatening in consideration of the characteristics of rare diseases.

 

However, the benefit expansions made to pediatric patients or just main indications is limited and does not align with the government’s initial purpose.” To what extent the KRPIA and KPBMA’s opinions will be reflected remains to be seen.

 

The Ministry of Health and Welfare and other subordinate institutions have been cautious about expanding the scope of the PE exemption system.