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‘I believe in MSD Korea and the Korean government'
by Eo, Yun-Ho Jan 24, 2024 05:46am
Patrick Tung Executive Director, Regional Market Access Head, Asia Pacific at MSD Applying for reimbursement extensions to 13 indications at the same time is an unprecedented move. This move was made by MSD Korea for its immuno-oncology drug Keytruda (pembrolizumab), and the case has been marked as a ‘historical first’ ever since the introduction of the positive-listing system in Korea. Applying for the reimbursement of 13 indications is not an easy task. Since Keytruda is a risk-sharing agreement (RSA) drug, each indication must undergo an evaluation process similar to that of a new drug to be eligible for reimbursement. Indications approved through Phase III trials must go through a pharmacoeconomic evaluation review to prove cost-effectiveness, while those approved based on Phase II trials must negotiate with the government and waive the pharmacoeconomic evaluation process. As expected, the process was not easy. Since applying for reimbursement extensions last year, Keytruda has had 7 indications submitted to the National Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee, but none have crossed the threshold. The remaining 6 indications are scheduled to be presented in the first CDDC meeting of the new year in 2024. Dailypharm met up with Patrick Tung, Head of Market Access at MSD Asia Pacific, to find out more about the company’s plans to expand Keytruda's reimbursement coverage in Korea. -It's 13 indications. You've gained quite a lot of attention with the simultaneous application. Why did you use this strategy to extend reimbursement for Keytruda in Korea? The 13 indications we applied for this time are all aggressive cancers that threaten patients' survival, but for which no or only a few alternative options exist. Therefore, there remained a dire need for improved access to treatments that have verified efficacy. Keytruda has demonstrated its value in all 13 of the indications. We believe it is our responsibility to improve access so that as many patients as possible can enjoy the therapeutic benefits of Keytruda. To help address the unmet need in the treatment field, we decided to apply for a reimbursement extension for all 13 indications at once. - There must have been some heated discussions within the company before applying, What were your biggest concerns? What advice did you give to the Korean team? When you put the patients first, applying for the reimbursement extension by itself was not a difficult decision. Our only concern was that since we were applying for so many indications at once, it would take quite some time for the government officials to review and process the application. Rather than advice, I have expressed my support for the Korean team. The market access team at MSD Korea is made up of skilled and experienced professionals, so I'm sure they'll eventually get it done. -Do you expect the reimbursement standard to be extended to cover all 13 indications? Honestly, it is difficult to predict the outcome at this point. However, I believe we will be able to find a solution as long as we share the common goal of improving access to treatment for cancer patients in Korea. Our Korean team and MSD are ready to work together to find that solution. However, this is the first time MSD has ever applied for the reimbursement of 13 indications at once as well. As this is unprecedented in Korea, HIRA will also need to conduct a thorough review taking many factors into consideration. – How is Keytruda being reimbursed in countries in the Asia-Pacific region? It is reimbursed in some countries and the cost is fully by the patient in others. However, in general, reimbursement for Keytruda is increasing worldwide across multiple indications. The number of reimbursed indications has been increasing in particular in the Asia Pacific region. For example, many countries, including Australia, Taiwan, and Singapore, have been continuously making efforts to extend reimbursement for Keytruda. For example, in Australia, the Pharmaceutical Benefits Advisory Committee gave a positive recommendation and confirmed Keytruda’s reimbursed use for early triple-negative breast cancer and metastatic or recurrent triple-negative breast cancer this year, following last year's approvals for cervical cancer and urothelial cancer. - Is there a reimbursement system that you would like Korea to refer to? Over the past year, we have seen reimbursement progress made for several indications in Australia. Taiwan is also making significant progress in expanding Keytruda’s reimbursement, and encouraging discussions are being made in some emerging countries as well. While it's difficult to replicate what is being done in these other countries, many countries, such as Australia and the United Kingdom, are taking a flexible approach to reimbursement for products with multiple indications. Also, Canada and other European countries have introduced concepts such as Multi-Year Multi-Indication, which allows drugs to be priced and contracted based on prescription volume, which allows the countries to reduce the time to reimbursement compared to the current system. A proposal to adopt a similar concept has recently been submitted in Australia and is currently being reviewed by the PBAC. Of course, the situation in these countries is very different from Korea, including their ICER threshold, but can still be good cases to consider when devising ways to move more flexibly within the current system. - What factors in the Korean reimbursement environment do you believe are contributing to the relative delay in Korea’s reimbursement of innovative cancer drugs compared to other countries? Korea seems to have a great and very rigorous insurance system. In any country, you need a system that is flexible enough to accommodate new products that provide real value to patients when they come to market. We do not need to ‘reinvent the wheel.’ It's about learning from the past and finding ways to make new products work within the existing regulatory environment. Also, it's not just the system that needs to be flexible. Flexibility is also needed in the funding of innovative medicines. The UK has a Cancer Drug Fund to ensure rapid access to cancer drugs, so creating a fund like this can be a good idea. We understand that the Cancer Drug Fund has been so successful that the UK has created an additional Innovative Medicines Fund to expand the range of eligible drugs.