Will RWD-based reimb agreements be more beneficial?

Will reimbursement contracts that use RWD catch 3 birds with 1 stone?

HIRA holds an International symposium on performance assessment of high-priced drugs using RWD

So-young Lee, Director of HIRA’s Pharmaceutical Performance Assessment Division, “Industry may be negative to applying performance assessments but the system has many advantages”

On the 28th, HIRA held an international symposium on

Drug reimbursement contracts satisfy all parties involved when they achieve three goals: The first is patient access, the second is sustained revenue for the pharmaceutical company, and the third is budget management for the payer.

 

“A fair price is one that can satisfy both the seller and the buyer,” said So-young Lee, Director of Health Insurance and Assessment Service’s Pharmaceutical Performance Assessment Division.

 

”A fair price should guarantee transparency, R&D, production costs, and innovation.” So, what kind of reimbursement agreement can satisfy all three conditions?

 

Experts say that a reimbursement agreement based on RWD (real-world data) can be a good alternative.

 

On the 28th, HIRA held an international symposium on 'RWD-based performance assessment of high-priced drugs' at the Ambassador Seoul Pullman Hotel in Jangchung-dong, Seoul.

 

At the symposium, Lee delivered a keynote address on the topic of 'Sustainable access to high-cost drugs through RWD-based cooperation'.

 

The use of the performance-based assessment system using RWD is in its infancy in Korea and other countries.

 

In Korea, the system was first introduced in 2022 for the rare disease drug Kymriah.

 

In order to reduce the uncertainty of drugs that received an exemption from pharmacoeconomic evaluations, the system applies post-reimbursement patient evaluation to determine whether or not to reimburse the drug.

 

Until now, the cost-effectiveness evaluations of new drugs were determined based on clinical trial data rather than real-world patient data, but there is a global movement to use RWD data of high-priced drugs as clinical trial results do not resolve uncertainties.

 

The UK established a real-world evidence (RWE using RWD) framework in February 2022 and has been continuing to update its guidance on valuation using RWE.

 

“Ultra-high-priced drugs present uncertainties due to disease characteristics and ethical issues,” said Lee, adding, “ It is difficult to standardize clinical trials, and there may not be a comparator drug or enough follow-up data.” In such cases, it is difficult to analyze the cost-effectiveness, and even then, it is difficult to ensure reliability.

 

Among the high-priced drugs listed for reimbursement in Korea, there are already 11 drugs that cost more than KRW 100 million per year.

 

For these drugs, performance-based managed reimbursement contracts are being implemented as their pharmacoeconomic evaluation are difficult and clinical uncertainty high.

 

To date, 5 drugs are receiving patient-level performance-based evaluations and 1 drug-level evaluation.

 

“The industry is negative about the outcome-based drug evaluation,” Director Lee said, ”The industry believes that the system is not objectively valid or reliable.” However, Lee emphasized that RWD, if utilized well, can be used to ensure reliability and fair pricing that satisfies patients, pharmaceutical companies, and the payer.

 

“The advantage of RWD is that evidence can be gathered from the R&D stage to benefit patients, and the incompleteness of the system can be reduced if pharmaceutical companies and the insurer can work together to link a lot of data.

 

If we can ensure full-cycle collaboration based on transparency, the system will not shrink the pharmaceutical industry while ensuring access to good drugs for patients.” Of course, there are limitations.

 

Data analysis needs to be done while protecting patient privacy, and transparency and uniformity of data still remain a challenge.

 

However, standardization efforts are underway in each country.

 

“There is still a lack of confidence in the system using RWD to evaluate cost-effectiveness, as well as limited transparency, data quality issues, and bias,” said Dr.

 

Vandana Ayyar Gupta, Scientific Advisor of NICE in the UK, another keynote speaker at the event, ”This is why NICE is working to update its guidance and create an RWE framework for its support.”    “Real-world data and real-world evidence are being used by NICE in a variety of ways, and the number of use cases is expanding,” said Dr.

 

Gupta.

 

”The RWE framework will continue to be updated through communication between developers and NICE based on rapidly evolving methodologies and technological advances.”