Access to High-Cost Technologies in Asia Pacific

he HTAi Asia Policy Forum is a unique leadership meeting bringing together senior representatives from public and private sector organizations using and producing Health Technology Assessment (HTA) in the Asia Pacific region. In 2018, the Forum convened over 60 thought leaders from 12 countries, including 13 pharmaceutical and device manufacturers and representatives from the World Health Organization, to discuss how access to high-cost technologies could be improved in the region. There was a particular focus on the use of Managed Entry Schemes (MES) as a mechanism to improve access.

The group discussed and debated the issues for two days and developed the following consensus statement on the issues relevant to Asia:

1. Defining “high-cost” is difficult and must be context- and country-specific.
2. Definitions must consider health system diversity, culture, stage of UHC (UnitedHealthcare) development, as well as differences in regulatory approval pathways and legislation.
3. Important factors for all countries in the region to consider when investing in high-cost technologies include:
   1. Severity and burden of disease
   2. Affordability and overall budget impact
   3. Value and impact of technologies with regard to patient and healthcare outcomes
   4. Transparency among all stakeholders
   5. The time horizon of value accrual of a technology and the entire care pathway.
4. There is limited use of Managed Entry Schemes (MES) in the region; overall, experience is limited to financial schemes (discounts or rebates) mainly for pharmaceuticals rather than other health technologies, including medical devices.
5. MES and Coverage with Evidence Development (CED) are mechanisms that may be implemented to facilitate patient access to healthcare that may otherwise be challenging for health systems. They should not be viewed as alternatives to appropriate funding of a health system.
6. Road maps and rules of engagement: An MES ‘road map’ that articulates the ‘rules of engagement’ would be a useful tool to be implemented at a local level for all stakeholders – patients, providers, payers, and industry. A road map may
   1. ensure that the issues and potential solutions are clearly identified before the MES commences;
   2. provide different guidance for the introduction of new and innovative drugs, devices, and treatments for rare disease, with each of these technology types possibly requiring an alternative approach; and
   3. acknowledge that full evaluation of an MES should be undertaken, taking into account outcomes from all stakeholders, and should include the possible restriction of use or, in some cases, even removal of the technology if expected outcomes are not met, or the broadening of access when outcomes are met.

This consensus statement is important for several reasons. First and foremost, the agreement between governments, HTA agencies, and industry on these critical issues is indicative of increased trust and ability to collaborate. Secondly, the agreement reflects an acknowledgement of the importance of issues such as budget impact, value, and overall and lifetime costs associated with a technology when considerations on reimbursement are being made. What is clear from the statement is that the country contexts and local values and policies are paramount to understand and incorporate when appropriate market access is considered.

Regarding mechanisms such as MES, these do present opportunities to facilitate access for patients in the Asia Pacific region. However, as stated, these mechanisms should be considered the “exception rather than the rule.” The administrative and clinical burden of implementing MES should not be underestimated, and the MES should not be used as an alternative to a negative recommendation on reimbursement. MES should only be used where there are genuine expectations on both sides (i.e., HTA and industry) that the technology in question will eventually demonstrate the requisite value to ensure that the risk to the payer has been offset by an increased certainty in the benefits.

A roadmap to provide guidance on when to use an MES, under what conditions, and with what considerations should be defined a priori, and it was deemed to be a useful next step in the region. While a roadmap would not be a mandatory requirement that all health systems in Asia should adhere to, it would provide a useful reference, or even starting point, for many countries in this region. The ability to collaborate and transfer knowledge across countries and systems is a strength that many countries in the region are recognizing with greater frequency and are using to optimal effect.

As a rapidly increasing health technology market, Asia Pacific is striving to ensure that patients in the region have equitable access to innovative technologies that improve quality of life and extend life expectancy. However, the importance of making sure this is done in a sustainable manner is paramount to all policy makers, providers, and payers in the region. This thorny issue will be a key theme of the 2020 HTAi Annual Meeting held in Beijing June 20-24, 2020. The meeting will provide an opportunity for the HTA community and wider stakeholder groups to further these important discussions on delivering access to the “best” high-cost technologies for the patient, health system, payers, industry, and beyond.