Market access update
Market access in Asia-Pacific: key challenges for manufacturers
Written by Kin Cheng
In this market access update, Kin Cheng summarizes key pharmaceutical and biotechnology market access challenges across countries in Asia-Pacific. The internal and external considerations for manufacturers to accelerate time to market access in the region are also highlighted.
Market access is evolving at a different pace in countries across the Asia-Pacific (APAC) region. Here we share some hard-earned insights from working with manufacturers to overcome market access challenges in the APAC region, taken from our on-demand webinar with Steve Crowley and Jan McKendrick.
Common issues in market access across the Asia-Pacific region
There are several common issues across the APAC region.
- Regulatory processes are in the process of being improved, to narrow the time for regulatory evaluation and approval.
- Health technology assessment (HTA) is an increasing trend in most major countries in the region.
- Price control is a common concern in HTA reviews, and financial risk-share agreements are often implemented.
- Pricing discrepancies between originator brands and generics are being reviewed. This is especially evident in China and Taiwan where the aim is to reduce the discrepancy.
- Global trials are increasing the recruitment of Asian patients to improve local relevance of the trials in the regulatory processes of Asian countries and reduce the time to market.
- There is a greater appetite for and use of evidence in HTA reviews, both from randomized controlled trials (RCTs) and real-world evidence (RWE); this trend is set to continue over the next 5–10 years.
While there are similarities, there are also differences
Differences between countries in the APAC region mainly relate to how mature the HTA process is each country. Australia introduced HTA in 1993 and it is firmly established. Taiwan and Korea both have over a decade of experience in conducting HTAs.
In Japan and China, there is an acceptance that global clinical trials cannot contain all the local data needed for HTA purposes, so RWE is increasingly used to fill the gap between what clinical trials cover and what a payer needs to know. Japan has recently introduced HTA but it is used more in terms of post-market review. China is currently thinking about embracing HTA to evaluate medicines for reimbursement.
In Korea and Taiwan, where comprehensive drug utilization data are available, there is a real opportunity to use these data for commercial purposes to show how products are faring in the real-world versus their comparators, both in terms of clinical effectiveness and cost-effectiveness.
Current issues and challenges for market access in the Asia-Pacific region
There are a range of internal and external issues that manufacturers should consider when approaching market access in the APAC region.
External issues include the following factors:
- evolving healthcare systems and policies
- rapidly evolving market access landscapes, particularly in Japan and China
- the evolving nature of what “HTA” is used for, along with the associated evidence requirements
- the increasing use of different types of data such as RWE to fill evidence gaps.
Internal issues include:
- aligning global, regional, and local thinking across dynamic changing markets
- assessing market access and commercialization risks, opportunities, and evidence needs for products in APAC markets
- developing forward looking integrated evidence plans that cover different payer needs
- improving early planning and cross-functional alignment on local implementation of product development programs.
There is an increasing move for global and regional teams to take a role in understanding the differences and similarities between markets.
Manufacturers should ensure that there is early internal alignment around product development programs. They need to collaborate cross-functionally on key issues and identify commercialization and market access risks within and across markets. They should be forward-looking in terms of evidence generation.
At PRMA Consulting, we have seen that organizations are increasingly looking for systematic processes and agile systems to help them do just that.
You can learn about our APAC strategic consultancy and unique digital solutions in this short on-demand webinar.
To arrange a confidential conversation about your market access needs, please get in touch with our APAC team.
Transforming value and access outcomes in the Asia-Pacific region