HIRA to develop RWE guidelines for post-listing drug evals

Issues notice on research service...expected to resolve uncertainties in the reimbursement decision-making process

The Health Insurance Review and Assessment Service (HIRA) has begun developing real-world evidence (RWE) guidelines for the evaluation of drugs listed under the post-listing drug control condition, with the goal of resolving uncertainties in the reimbursement decision-making process On the 5th, HIRA announced a request for proposals for research on guidelines for generating real-world evidence (RWE) for drug performance evaluations.” “Recently listed high-priced treatments for serious diseases have high uncertainty in terms of the level of evidence, but they are listed under the condition of post-listing control to improve patient access,” said the agency.

 

”Real-world data (RWD) and real-world evidence (RWE), which are the main sources of drug performance evaluation for post-listing control, are at risk of bias, so it is necessary to improve the reliability of RWE generations.” Drugs listed under the post-listing control condition are those that have only short-term, single-arm, small-patient trial results or have been exempted from submitting pharmacoeconomic evaluation data.

 

HIRA plans to conduct post-listing evaluations to resolve the uncertainty of reimbursement of such drugs.

 

RWE data is used for this purpose, but there is an urgent need for guidelines to improve reliability.

 

Major countries such as the United Kingdom and Canada have developed and utilized their own RWE guidelines to better accommodate their decision-making process.

 

The study aims to ▲ review the current status of RWE utilization for drug performance evaluations make recommendations and ▲ prepare guidelines for generating real-world evidence (RWE) for drug performance evaluations.

 

The study is expected to improve the transparency and quality of domestic RWD collection, secure patient access and safety by generating reliable RWE, and establish an evidence-based expenditure management system.

 

For example, post-listing control using RWE is expected to reduce uncertainties in clinical utility, cost-effectiveness, and financial impact of listed drugs, while strengthening patient access and safety with RWE-based post-listing control.

 

It is also expected that the submission of standardized data prepared according to the guidelines will improve the predictability of pharmaceutical companies and shorten the review period for drug performance evaluation upon listing.

 

The study will be conducted for 9 months from the date of selection and signing of the contract.

 

The total budget for the study is KRW 100 million.