[Reporter’s View] New govnt signals expanded PE exemptions

The inauguration of a new government brings hope and anticipation to each and every industry.

 

The same goes for multinational pharmaceutical companies.

 

In the pharmaceutical industry, hopes are rising for the expanded eligibility of the pharmacoeconomic evaluation exemption scheme.

 

Although many agendas remain in need of resolution, such as improvement of drug prices for each indication and the pre-listing post-evaluation scheme, etc., the industry believes the improvement of the PE exemption system is most realistic.

 

This seems plausible from the third person's perspective as well.

 

In fact, Yoon Suk-Yeol’s administration plans to promote the accelerated listing of anticancer drugs and treatments for severe and rare diseases that have no alternatives to improve patient access to such treatments.

 

However, due to the conservative stance held by the relevant ministries such as the Ministry of Health and Welfare, Health Insurance Review and Assessment Service, and the National Health Insurance Service in improving drug prices for each indication and the application of the pre-listing post-evaluation system, no drastic change may be possible even with the administration change.

 

But there still lies hope for improvement in the PE exemption system, as this special system that was introduced as an exception by the Korean government is still being well utilized, and the request for its improvement has been continuously raised for some time.

 

Strangely enough, new drugs with low profitability due to a small number of eligible patients and drugs that have difficulty demonstrating cost-effectiveness even after overcoming developmental difficulties are becoming a trend and being actively introduced to the market.

 

It may be due on one part because drugs for almost all other diseases have already been released, but still, the addition of these new treatment options cannot be bad for mankind.

 

The industry has been requesting expanding eligibility of the pharmacoeconomic evaluation exemption scheme.

 

The industry requested a more flexible application of the system, under which the PE exemption system is applied to drugs with no alternatives that have been approved with placebo-controlled data or be applied the same eligibility standards for the patients, etc.

 

However, from the government’s perspective, it is difficult to open up its pockets upon every request as it has to pay the expenses from a limited budget.

 

This is why the rumor that the PE exempted drug’s price will be set at ‘80% of the lowest A7-adjusted price’ had turned the industry upside down last year.

 

PE exemptions are the only option for necessary drugs deemed difficult to receive pharmacoeconomic evaluations.

 

It contains various fiscal management devices and has incorporated the ‘expenditure cap’ design ever since its implementation to protect fiscal sustainability.

 

It’s just that with more drugs introduced to the market, more flexible management of the system may now be required for the right treatment to be prescribed to patients at the right time.

 

In this context, on what picture the new administration has prepared to address this issue remains a focus of attention.