[Reporter’s View] On HIRA's price cuts for PE waiver drugs

HIRA's unilateral formulation of price cuts for PE exempted drugs leave regrets

HIRA’s unilateral notice of its decision leaves a lingering question on whether this really was the best way to conclude the discussions.

 

Couldn't the government have included its favorite words - "in discussion" or "in coordination" - that it uses best?

 

The Health Insurance Review and Assessment Service responded that the criteria for evaluating the cost-effectiveness of drugs that are waived submission of pharmacoeconomic evaluation data was set at ‘80% of the lowest A7 adjusted price’ rather than the lowest A7 adjusted price to a written QA submitted by NA member Miae Kim of the People Power Party during the NA audit.

 

This is a sort of forced conclusion and a line drawn to the persistent resistance and controversy raised by the industry.

 

On the news, the Korean Research-based Pharma Industry Association immediately issued its criticism, expressing strong regrets.

 

KRPIA said, “During discussions with HIRA, we have continuously expressed that the uncertainties caused by the application of the risk-sharing system in A8 countries should be flexibly evaluated according to characteristics of each drug.

 

A blanket application of the 80% standard without clear grounds on its calculation will seriously undermine access to drugs that are subject to pharmacoeconomic evaluation exemptions that are being allowed limited use in rare and severe disease patients.” The association added that such a standard would invalidate the system in itself.

 

Some may consider the industry’s sullen response as a natural course of making transitions.

 

However, the response provided for the NA audit was a blow in the back from the industry’s view as the issue had not been discussed after the Ministry of Health and Welfare’s Division of Pharmaceutical Benefits had said it will continue to collect stakeholder opinions following the serious concerns that were raised in the two meetings the HIRA held with the industry (industry roundtable in June and the private consultative body in July).

 

The pharmacoeconomic evaluation exemption system is the only way for drugs that cannot undergo economic evaluations but is necessary to receive reimbursement.

 

Various fiscal management systems are included in the scheme, and the ‘Expenditure Cap’ design has been embraced ever since the system was implemented.

 

With the increasing number of drugs being eligible for the system, the government could have deemed some improvement is necessary.

 

However, the way how they implemented the system is regrettable.

 

“We will continue discussions with stakeholders.

 

We will review the issue.” Why HIRA was unable to implement the caution and ambiguity that it had so often implemented in the written response to the NA remains in question.