MALAYSIA – Asian countries, like India, have been struggling to find a middle ground to the effective pricing of drugs and medical devices over the past year and several are looking at health technology assessment (HTA) programs as a solution for this issue in the coming year.

Boston-headquartered consulting firm Analysis Group Inc. recently worked with researchers from the Japan’s University of Tokyo, Seoul, South Korea’s Ewha Woman’s University and Peking University in China to look at how HTA programs in those three East Asian countries varied and what could be gleaned from their experiences.

“The benefits of adopting HTA programs have long been known across Europe. It’s encouraging to see the evolution of HTA programs in Asia, even at such varied stages of adoption. Each of the three HTA programs we studied – Japan, South Korea and China – showed a few prominent successes that should buoy efforts in the future,” Hongbo Yang, vice president with Analysis Group, told BioWorld Asia.

“HTAs have been adopted over the past three decades by many countries, including England, France, Spain, Sweden, Germany, Italy, the Netherlands, Canada and Australia. For these, HTAs are an integral part of the health care system. It’s been slower in Asia, although that’s starting to change as the various countries improve their health care systems, as well as the growing necessity to provide the best value for money, while safeguarding accessibility of care. ”

Yang said that South Korea represented “an ideal case study” to illustrate how HTA capabilities can be quickly and successfully implemented within a universal health care system. Out of the three countries, it has the longest running HTA, which was established in 2006.

“Two years after incorporating HTA into reimbursement decision making, manufacturers submitted 91 new drug applications, and 70% of them resulted in a positive recommendation. The most impactful criteria in determining a final recommendation were clinical benefits and cost-effectiveness,” she said.

Japan also recently completed a three-year pilot program that led to a national program in 2019. It incorporated HTA processes for pricing certain rare disease, pediatric and anticancer therapies. Premiums for those were reduced to 30%, 60%, and 90% based on meeting certain thresholds for a key metric referred to as quality of life years (QALY).

In China, the Ministry of Human Resources and Social Security used HTAs during price negotiations with the manufacturers of 44 drugs. Thirty-six of them were approved for inclusion in the National Reimbursement Drug List, with a 10% to 20% copay and an average price reduction of 44%, with the highest price reduction amounting to 70%.

It’s clearly a mixed basket in East Asia alone.

“Each country is unique in how they’ve embraced HTAs, which is just a function of the different health care systems, politics and maturity of the pharmacoeconomics market per country. The big difference is really in how long each country has been using HTAs, which leads to different levels of program maturity,” said Yang.

And that has also presented different challenges for each country.

“South Korea initially hadn’t set clear guidelines, which led to dissatisfaction among manufacturers and health care providers, and challenges for the submission and review of materials. They’ve since resolved this and are seeing a much smoother process now,” said Yang.

Yang notes that a lack of real-world evidence is what’s slowing down HTA maturity in Japan. But she expects that the forthcoming nationwide electronic medical record system will go a long way toward solving this issue.

“In addition, the pharmaceutical industry’s concerns regarding the use of pricing measures such as incremental cost-effectiveness ratio (ICER) and QALY will need to be assuaged, and the rationale that cost effectiveness will have in determining final pricing and reimbursement decisions will need to be clarified,” she said.

The use of HTAs in China is fragmented, and not fully incorporated into the health policy-making process, according to Analysis Group. And this creates a host of challenges.

“Although the government appears to place increasing importance on HTA to rein in health care costs while expanding access to care, decision making still relies heavily on expert opinion and experience rather than evidence-based data,” said Yang.

Challenges shared by all three nations include: developing more pharmacoeconomic expertise, and generally raising awareness of the benefits of the HTA appraisal process among the general public, clinical settings, and pharmaceutical and medical device industries.

As to how other Asian regulators should build and incorporate HTA in their drug/med-tech pricing decisions, Analysis Group’s findings concluded there is no one-size-fits-all approach to it, and efforts should be customized to fit existing and often complex coverage, reimbursement, and pricing schemes.

“Once the overall objective of the HTA has been clearly established, guidance should be provided on the type of evidence that should be considered by HTA, what the evaluation progress should be, and how the HTA evaluation results impact coverage, reimbursement and pricing,” said Yang.

Since HTAs rely on country-specific, real-world data, the processes for generating this need to be created first.

“The data needs to be specific to the various populations within the health care system, otherwise their impact will be minimal. This is one area that international collaborations and networks can provide crucial guidance and support,” said Yang.

Analysis Group’s study also shows that transparency of the HTA appraisal process is essential.

“All stakeholders should be involved to avoid misperceptions that the effort may limit patient access to expensive but clinically beneficial health technologies,” said Yang.

“Transparency will also be essential to dispel notions that the system is being abused by either the government or industry during pricing negotiations.”

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