Will PE exemption drugs be reevaluated based on RWD?

HIRA holds a public hearing on measures for performance-based reimbursement management of drugs

Will produce post-marketing effect and PE evaluation data on drugs using real-world data

May be used for reevaluation of ultra-high-priced drugs and PE exemption drugs

A public hearing on measures for performance-based reimbursement management of drugs that was held on the afternoon of the 20th at the main auditorium of the Catholic University of Korea’s Institute of Biomedical Industry

Will ultra-high-priced drugs or drugs exempted from receiving pharmacoeconomic evaluations be reevaluated based on actual patient administration data after being listed for reimbursement?

 

Starting with Kymriah first last year, as drugs were applied a performance-based refund type RSA for reimbursement, an interpretation that it would now be possible to reevaluate the price of high-priced drugs or drugs that are waived PE evaluations based on real-world data has been proposed.

 

The ‘Public hearing on measures for performance-based reimbursement management of drugs’ that was held on the 20th at the main auditorium of the Catholic University of Korea’s Institute of Biomedical Industry is likely to serve as the starting point for re-evaluation using RWD on high-priced drugs or PE exemption drugs.

 

RWD refers to actual patient clinical data collected post-reimbursement, such as health insurance claims data, hospital medical records, surveys, and post-marketing drug survey data.

 

Real-world evidence (RWE) is actual clinical grounds derived from RWD.

 

The public hearing was prepared to share the results of RWD/RWE research conducted by the Korea Cancer Study Group and HIRA for the past 5 years and to collect various opinions on the use of RWD/RWE-based drug reimbursement management guidelines.

 

On the day, Chi-Hoon Maeng, Professor of Kyung Hee University’s School of Medicine, announced the results of his study that evaluated the efficacy and safety of paclitaxel-ramucirumab combination therapy through RWD data in patients with advanced gastric cancer.

 

In addition, Jung-hoon Ahn, Professor of Health Convergence at Ewha Womans University Graduate School, prepared a pharmacoeconomic evaluation result based on the RWE data of the paclitaxel-ramucirumab combination therapy based on Professor Maeng's interpretation of the results.

 

The two results have significance in that the post-marketing evaluation was conducted based on RWE.

 

Ji-Hye Byun, associate researcher at HIRA followed the two presentations with an announcement of the RWE guidelines for reimbursement management through drug performance evaluation, which contained a whole RWE utilization plan from Step 1:reimbursement plan to Step 4: reevaluations.

 

Steps 1 and 2 contain measures identical to what has been applied to Kymriah and Zolgensma – the current performance-based refund type RSA.

 

The plan is to reimburse drugs based on the pharmaceutical company’s RWE evaluation, and then when the medical institutions submit RWD data, the authorities evaluate the drug’s performance and receive a refund from the company for patients who fail treatment.

 

Steps 3 and 4 evolve further from current plans.

 

HIRA plans to work with external experts to analyze RWD data for reimbursement reevaluations.

 

If implemented, high-cost drugs that have submitted PE data but have a highly uncertain Incremental Cost-Effective Ratio (ICER) or drugs for which PE evaluation data were not or could be submitted can be reevaluated after reimbursement with RWD.

 

The ‘PE evaluation data waiver system,’ or ‘PE exemption system’ had been applied in 2015 to benefit rare disease drugs or anticancer drugs with no alternatives.

 

This year, subjects were expanded to benefit drugs for pediatric patients that demonstrate an improvement in quality of life.

 

Managing reimbursement through RWD allows for post-marketing evaluation of drugs that have unclear cost-effectiveness rather than prior evaluations, thereby offering an advantage in being able to shorten the reimbursement listing process, and strengthening access to high-priced drugs for severe and rare diseases.

 

Also, post-marketing evaluations can help improve the financial soundness of health insurance and offer transparent management of reimbursement as decisions are made based on real-world data.

 

On the other hand, RWD collection adds a burden to the various other parties involved, such as the burden of data collection posed on the doctors and the risk of refunding the drug cost of patients who fail treatment on the companies’ part.

 

However, the measures presented at the public hearing are not specific guidelines and will require serious opinion-gathering processes to be implemented as an actual policy.

 

Dong-Churl Suh, Director of the Pharmaceutical Policy Research Institute, who participated at the hearing as a panelist, pointed out, "RWD data analysis presents rise to transparency issues.

 

The results can vary depending on the data source, so many considerations would need to be made for its implementation, including on how to secure data transparency.” However, the government was more for the use of RWD as a way to reduce uncertainties in financial management regarding high-priced drugs and PE exemption drugs.

 

Mi-Young Yoo, Director-General of the Pharmaceutical Benefits at HIRA, said, “Since the introduction of the positive listing system in 2006, many drugs have been listed for reimbursement through various systems including the PE exemption system to enable better patient access.

 

So this is now the time a post-marketing measure needs to be implemented.

 

Although social consensus should be made on its need, such a management system can be a way to ensure an appropriate level of financial soundness within limited insurance.” Chang-Hyun Oh, Director of Pharmaceutical Benefits at MOHW, added, “Addressing the uncertainty that follows the listing of high-priced drugs reimbursed with PE exemption is a pending task for all.

 

As a tool, I expect RWD to become a good way to cover the uncertainties that remain in the area.”