[Reporter’s View] Industry sullen over revised PE exemption

The pharmaceutical industry is sullen despite the government's announcement of a measure to expand drug coverage, as the so-called measures for expanded coverage are closer to reductions from the industry’s point of view.

 

The main issue lies in the improvement of the pharmacoeconomic evaluation (PE) exemption system that was included in the “Measure to improve patient access and reinforce reimbursement management for high-priced severe disease treatments” that was recently presented by the government.

 

The goal of the improvement is to expand coverage for the pediatric patients.

 

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." The added clause excluded the “life-threatening disease” condition required for PE exemptions in 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.

 

On the surface, it seems like an encouraging improvement.

 

Many multinational pharmaceutical companies and the Korean Research-based Pharmaceutical Industry Association have been requesting the ‘life-threatening’ condition be removed from the eligibility criteria for PE exemptions.

 

In this sense, this exclusion, although limited to pediatric patients, is a valuable step forward.

 

However, a major premise for PE exemptions had also been revised.

 

The government had added the phrase “a small number of eligible patients ” in the revision.

 

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

 

In other words, if the amendment is applied in the current state, all drugs that wish to take the PE exemption track would 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 2c of the regulation.

 

Multinational pharmaceutical companies have been criticizing that this has narrowed the pathway for PE exemptions rather than expanding it.

 

In fact, the KRPIA had issued a statement immediately after the government announced the revision, criticizing that the amended measure “overlooks the fact that it can demotivate companies from developing innovative new drugs and impede access to severe rare disease treatments.” Although such industry complaints are common following government policy announcements, considering the fact that the new government promised prompt listing of anticancer and rare disease drugs upon inauguration, and the non-reimbursed blind spots still exist for drugs that apply for special exemptions, the government needs to consider whether this revision is achieving its original purpose.