'No other country has a PE exemption system'

should reduce the use of the PE exemption system to only when necessary

Professor Eun-Young Bae, “If the system allows drugs to be listed in a non-cost-effective manner, this has a negative impact on latecomer drugs”

Professor Eun-Young Bae

“Korea is the only country that has introduced the use of the pharmacoeconomic evaluation exemption system.

 

As an academic, I do not understand the logic of the PE exemption system.

 

It is also difficult to explain to other countries.

 

If a particular drug has received reimbursement at a non-cost effective price due to the system, it will continue to affect latecomers in the indication." An expert has pointed out that the use of the PE exemption system in place for the reimbursement of drugs approved in Korea should be reduced to a minimum.

 

The analysis is that if a drug has demonstrated a significant level of clinical benefit or is an ultra-rare disease, the specificity of the drug, such as its impact on health insurance finances, should be closely reviewed to determine whether to apply for PE exemptions.

 

Also, suggestions that the current standard, which allows drugs that should not be subject to PE exemptions to receive exemptions, should be reformed and a separate reimbursement standard should be set for National Essential Medicines were raised.

 

Eun-Young Bae, Professor of Pharmacy at Gyeongsang National University expressed her opinion at a forum that was held on the 23rd to seek ways to improve the PE data waiver system (PE exemption system) of pharmaceutical economic evaluation data.

 

The PE exemption system, which was introduced in 2015, reviews the listing status and listed prices of a drug in A8 countries (that the government uses to calculate the foreign adjusted average price of drugs) during the reimbursement review process rather than its cost-effectiveness.

 

As of July 2022, 26 drugs have been reimbursed under the PE exemption system.

 

Professor Bae pointed out that it is necessary to review how to resolve the uncertainties that arise due to the cost-effectiveness of PE exemption drugs.

 

Bae explained that the issue should be resolved because high uncertainties remain about the clinical grounds of drugs that were reimbursed through the PE exemption system, and affects the evaluation of its latecomers.

 

Bae stressed, “An initial evaluation should be made on PE exemption drugs.

 

The effectiveness of the reevaluations that are conducted after the application of the PE exemption system is low because of the lack of initial evaluation.

 

If a drug has been reimbursed through the system at a high price and is not cost-effective, this will continue to affect latecomers.” She added, "We also need to look at whether to keep the initial registration conditions during the 5 years until reevaluations said.

 

"We need to check how to evaluate the latecomers of PE exemption drugs and what the appropriate price level should be for the PE exemption drugs." "The justification for the use of the system is weak.

 

If the government seeks to maintain the system nevertheless, its use should be minimized to the extent necessary.

 

The PE exemption drugs should submit pharmacoeconomic evaluation plans in advance and receive deliberations that can be used as the basis for price reevaluation or readjustments in the future.” The forum was cohosted by NA Rep.

 

Hye-Young Choi of the Democratic Party of Korea and the Korea Alliance of Patients Organization