Conflict rise over the need of the PE exemption system

Fix vs Abolish

Those in opposition “Only increases the price of new drugs and increase pharmaceutical company profits”

Those in favor “Will impede access to new drugs if abolished...strengthening reevaluations will be enough”

NA Rep. Hye-Young Choi holds a roundtable discussion to improve Korea's PE exemption system

Experts are showing a sharp conflict of opinion over the effectiveness and need for the existence of Korea's system that exempts new drugs from receiving pharmacoeconomic evaluations.

 

The PE exemption system, which was introduced in 2015, was implemented to improve access to new drugs for patients with severe and rare diseases.

 

However, conflict has been rising on whether to abolish/reduce or continue the operation of the system after making improvements.

 

Those who are in favor of the PE exemption system argue that the system should be more actively implemented but the process strengthened to increase patient access to treatments, while opponents argue that the system makes overseas drug prices be reflected as they are, wasting health insurance finances and only benefitting the pharmaceutical companies.

 

On the 22nd, the pros and cons of the PE system were discussed by medical and pharmaceutical experts at a forum hosted by NA Rep.

 

Hye-Young Choi of the Democratic Party of Korea to improve the PE exemption system that allows drugs to waive submission of pharmacoeconomic evaluation data during the reimbursement review process.

 

Borami Kim, Co-chair of the Market Access Committee at KRPIA (Korea Research based Pharmaceutical Industry Association), which represents the global pharmaceutical industry, said that the PE exemption system has many advantages in expanding patient access to drugs within the limited health insurance budget.

 

In other words, Kim’s point is that abolishment of the system is out of the question as it would impede patient access to new drugs.

 

Kim said, “It is much more beneficial to operate the current system well according to its purpose, and it is also in line with the direction of the current government policy, which stresses the proper use of limited resources and the abolition of regulations.

 

If we dismiss the benefits of the system and discuss its abolition or bring in more post-marketing control regulations than now, the door of opportunity for patients will only get narrower and narrower.” Dr.

 

Young Chul Moon, Professor of Hemato-Oncolgoy at Ewha Womans University Mokdong Hospital, who actively treats patients in the field, also supported the improvement and maintenance of the PE exemption system.

 

In particular, Moon’s diagnosis was that Korea’s new drug reimbursement speed was too slow despite the existence of the PE exemption track.

 

His concern was that the speed of new drug reimbursement could be further delayed with the removal of the PE exemption system.

 

Therefore, Moon proposed an improvement plan that raises the standards for submitting the PE exemption plan while further activating the system for its better management.

 

Moon said, “New drugs that are in need of rapid reimbursement are not being introduced fast enough, even with the PE exemption system in place.

 

It took over 6 months for Kymriah’s reimbursement, and patients and doctors are all concerned that reimbursement will further be delayed with the removal of the PE exemption system.” "Also, tighter pharmacoeconomic evaluations are made for drugs like anticancer drugs that are reimbursed through the PE exemption track.

 

The Cancer Disease Deliberation Committee requests the companies to submit PE data to determine the price and request price cuts.

 

Many drugs give up reimbursement even after applying for PE exemptions.” “We should encourage faster introduction of innovative drugs that improve patients’ lives, even if we bear the cost to some extent, and instead, we should establish a system to conduct reevaluations every 2-3 years.

 

There is also a need for a policy to secure health insurance finances and stabilize drug prices by lowering the price of generics and biosimilars while encouraging their use.” Dong-Geun Lee, Director of the Korean Pharmacists’ Association for Healthy Society, objected to the system, claiming that it had changed into a system that maximized the benefits of pharmaceutical companies.

 

Just as concerns were raised when the system was introduced in 2015, the price of new drugs has been set at a higher price due to the PE exemption system, and the system is becoming a chronic go-to regulation for companies rather than an exception.

 

Lee said, "When the system was introduced during the Park Geun-Hye administration, civic groups opposed it because the system will accept the drug prices of advanced countries as is.

 

We were concerned that it would have the effect of increasing the price of new drugs that should have been reimbursed through the positive listing system.

 

We need to find out how much of these concerns have been resolved today.” “The purpose of the PE exemption system is to enhance patient access but it is used as a beneficial system for pharmaceutical companies that exempts the submission of safety and efficacy review data that pharmaceutical companies are required to submit.

 

It was an exception at the time of introduction, but as it improved, the number of such exemptions continued to increase, and 17 drugs that have comparator drugs took the PE exemption track." Eun-Young Bae, Professor of Pharmacy at Gyeongsang National University also claimed the need to minimize the use of the system.

 

Bae said the government should reduce the use of the PE exemption track to only when necessary to resolve its side effects such as how it adversely affects the reimbursement of of latecomer drugs.” In particular, Professor Bae dismissed concerns that access to new drugs for patients will decrease if the PE exemption system is abolished, saying, "We need to regard the two separately.” Professor Bae said “I do not mean that the PE exemption drugs should be non-reimbursed.

 

"However, there is no decision-making measure available to use when clinical evidence is accumulated for PE exemption drugs that were approved through a simplified pathway.

 

In order to make the best decision, we have to decide based on sufficient grounds, but the problem is that the PE exemption system does not allow this to happen.” “I don't think abolishing the PE exemption system will act as the main obstacle that hinders prompt reimbursement of new drugs.

 

There are other ways to speed up patients' access to new drugs by conducting rolling evaluations even before the data is complete." Chang-Hyun Oh, Director of Pharmaceutical Benefits at MOHW, said that he agrees that there is a need to evaluate the pros and cons of the PE exemption system, and will collect various opinions and make efforts to make the best decision.

 

Oh said, “The PE exemption system was established through social consensus, and the side effects of the system are just being discussed now, 6-7 years after its implementation.

 

We conducted a preceding study last year, and we would need to simulate various scenarios after a system improvement plan is proposed based on the study, such as by adding a risk-sharing condition to the Pe exemption system, etc.”