[Reporter’s View] The key to the ‘PE Exemption’ issue

that arose during the NA audit

The cries that the improvement reduces rather than expand benefits have reached the National Assembly.

 

The government’s improvement plan for the special pharmacoeconomic evaluation (PE) exemption system was brought onto the chopping block at the NA audit.

 

During the NA audit for the Health Insurance Review and Assessment Service that was held on the 13th, Rep.

 

Sun-Woo Kang of the Democratic Party of Korea raised an issue on the PE exemption system improvement plan that had been submitted by the Ministry of Health and Welfare and HIRA.

 

The “Measure to improve patient access and reinforce reimbursement management for high-priced severe disease treatments” that was recently presented by the government includes a measure to improve the PE exemption standards.

 

According to Rep.

 

Kang, unlike the authorities’ explanation, the drugs subject to PE Exemptions will be rather reduced if the improvement plan is applied.

 

The “small number of eligible patients” which had previously been an “OR” clause for PE exemptions became a prerequisite in the proposed amendment, reducing the scope of eligible drugs.

 

This issue has been raised continuously across the industry, including by the Korean Research-based Pharmaceutical Industry Association (KRPIA), since the government announced the amendment.

 

In other words, the concern is that all drugs that wish to take the PE exemption track will have to have a “small number of eligible patients (less than 200 patients)” if the amendment is applied.

 

On this, HIRA President Sun-Min Kim replied that “The 200 people limit is not absolute.

 

All drugs that do not have enough patients to prepare evidence for PE evaluations are applied the PE evaluation exemption track.” In other words, the authorities will show some flexibility in the “small number” standard.

 

However, the impact of this amendment is not only due to the changed premise.

 

If the amendment is applied in the current state, all drugs that wish to take the PE exemption track have to have a small number of patients (as defined as 200 in the current criteria) and receive recognition from the committee for its difficulty in producing evidence to satisfy Article 2.c of the regulation.

 

In other words, the companies will not be able to know if their drugs are eligible for the PE exemption track until HIRA’s Drug Reimbursement Review and Assessment Committee make a decision.

 

This will inevitably have a significant impact on the predictability of reimbursement listings for companies that wish to use the PE exemption system.

 

Considering how the new administration promised rapid listing of anticancer and rare disease drugs immediately upon its inauguration and the non-reimbursed blind spots still remain for drugs that are applied special exemptions, the government needs to seriously consider whether this amendment is achieving its original purpose.