Challenges plague Asia's health tech assessment programmes

Solutions focus on improving HTAs’ integration to current drug pricing schemes.

Asian countries have been slow to adopt Health Technology Assessments (HTA) in informing medicine pricing and reimbursement decisions, but countries such as Japan, Korea, and China have made relenting efforts to put HTA programmes in place, according to research published in the Value in Health journal.

Amidst the current HTAs of such countries, an analysis of the countries’ HTA performance shows that there is still room to enhance programmes and address pain points in each of their healthcare systems, said in the research.

Japan had piloted a three-year HTA programme that started in April 2016, supervised by the country’s Central Social Insurance Medical Council (Chuikyo).

As part of the pilot program, seven drugs, including sofosbuvir, daclatasvir, and nivolumab, and six medical devices were selected for cost-effectiveness assessment, and were reported using an Incremental cost-effectiveness ratio (ICER). Subsequently, Chuikyo employed the ICER to adjust medicine pricing to be based on a quality-adjusted life year (QALY) threshold of 5 million yen for a 10% reduction in health insurance premium, after which the premium will be reduced by up to 90% until the threshold of 10 million yen is reached, said in the report.

Following the end of the pilot program in April 2019, Japan instituted new HTA processes for ICER-based pricing, targeting new and existing drugs and medical devices of significant budget impact. From the previous ICER pricing standard, the assessment route was changed into 3-step reductions of premium, by 30%, 60%, and 90% according to 5, 7.5, and 10 million yen per QALY, respectively.

As Japan looks to fully embrace HTA, several challenges lie ahead. In particular, some unique features of the Japanese pricing and reimbursement system, such as fixed-fee schedule, will undoubtedly make the incorporation of HTA into existing practices challenging for both the government and manufacturers, noted in the report.

China’s HTA practices are entirely another picture. Its Health Policy and Technology Assessment Network, which comprises 29 agencies, universities, hospitals, and professional associations, was established in 2016 by the China National Health Development Research Center (CNHDRC) to develop HTA capacity and expertise. Further into the Government’s HTA efforts, a nationwide task force was initiated in the country in 2018 to formally update the HTA guidelines implemented in 2015, which are expected to be released in 2019.

Whilst HTA continues to make progress in China, the country still holds room to fully incorporate HTA into the health policy-making process.

The use of HTA is fragmented, and there is currently no single HTA agency operating at the national level that supervises and coordinates all HTA activities, said in the report. HTA would need to be fully and formally integrated into the existing pricing and reimbursement processes, and such integration would require an official and well-recognized authority to regulate and implement the use of HTA, suggested in the report.

South Korea’s pioneering stance
South Korea became the first Asian country to officially implement an HTA and the country had even introduced the positive list system (PLS) in 2006, which includes a formal HTA process for new drugs.

Two years after the launch of HTA, manufacturers submitted 91 new drug applications, and 70% of them resulted in a positive recommendation. The two criteria that have had the most impact in determining a final recommendation were clinical benefits and cost-effectiveness.

In 2008, the National Evidence-based Healthcare Collaborating Agency (NECA) was established to conduct HTA research in the country, and after two years, HTA processes pertaining to procedures and diagnostics were transferred from HIRA to NECA

Since then, NECA had introduced a topic solicitation program in which topics suggested by the general public or experts were selected for HTA review.

One of the biggest remaining challenges of South Korea’s HTA is the development of professional staff with the necessary pharmacoeconomic expertise, said in the report. One key future challenge to further develop HTA capabilities in South Korea will be training and recruiting human resources, stated in the recommendations in the research.