Market access update
Completing the puzzle: market access in Asia-Pacific
Written by Jan McKendrick
The Asia-Pacific (APAC) region may be the world’s second-largest pharmaceutical market – but it’s also one of the most complex when it comes to market access. In the major Asian markets – such as China, Japan, Singapore, and South Korea – policy isn’t just diverse, it changes rapidly.
Moreover, with very little information in the public domain, keeping track of the environment can be incredibly difficult. Global teams need to make sure that their evidence packages are in line with what’s happening locally on the ground. But how do you do that when your situation analysis is restricted by poor visibility? Success requires a different approach.
In many parts of the world, particularly Europe, market access processes are typically framed around health technology assessments (HTAs). In the UK, for example, teams can almost “isolate” NICE and configure their market access programs around a clearly defined HTA roadmap. In Asian markets, however, this isn’t an option. The links between price, HTA, reimbursement, and regulatory are so pronounced that you have to look at the whole system. This, in turn, requires cross-functional alignment across all market access disciplines. Old-fashioned silo working is a major barrier to agile and efficient market access strategies. Integration and collaboration are crucial.
Fundamentally, market access in APAC is a broad and complex jigsaw. Completing it requires joined-up thinking to see the bigger picture and understand how all the pieces fit together.
Understanding evidence risk
The main challenge for global teams approaching APAC markets centers around understanding “evidence risk”. Does the evidence you’re generating respond to local unmet need? And if it does, will it actually have an impact on the commercial prospects for your drug? Critical success factors include:
- understanding diverse, complex, and rapidly evolving regulatory, therapeutic, and market access landscapes
- early planning and cross-functional alignment on local implementation of development plans
- designing holistic plans for assets, rather than focusing on single indications and submissions
- integrated evidence generation plans that reflect variable payer needs across the region
- global/affiliate engagement to identify issues, priorities, and evidence gaps
- agility and capability to address evidence gaps
- institutional memory to support business continuity through employee turnover.
The potential domains of evidence risk are wide-ranging, encompassing aspects such as unmet need, trial design, comparative clinical benefit, budget impact, pricing, and cost-effectiveness. The drivers differ from market to market. For example, in China, treatments on the National Reimbursement Drugs List (NRDL) are essentially nominated by clinicians (with the exception of medicines with accelerated regulatory approval, which automatically make the list). The strategic considerations for pharma are broad. Are you going to get a different regulatory pathway? What does that mean? Will it accelerate you making the NRDL, or will your drug spend a prolonged period in the self-pay market where patients have to pay for their treatments? If so, how are you going to convince clinicians to recommend your drug to patients? There are HTA elements in the processes, and clinicians are increasingly interested in cost-effectiveness data. However, do those data drive decision-making? Not always. If you don’t price your product appropriately, cost-effectiveness may not help you.
In Japan, you will always get a price for your drug – the challenge is making sure it’s the best price possible. What evidence will you need to achieve it? The answers don’t live in isolation. For example, you may want to wait for a competitor to launch to give you a better reference price. Similarly, with Japan revising its drugs prices every other year, you’ll almost certainly need to consider where your medicine fits into that process – and, critically, what data you will require – further down the line. Once again, a holistic view of all the influences around your product is essential.
The current trend is seeing a shift away from clinician-led decision-making in favor of an evidence-based approach. Markets such as South Korea and Taiwan have well established HTA models that have long embraced the need for evidence. Now their larger neighbours are following suit; China’s recent changes to the NRDL are geared towards embracing different types of evidence, while Japan’s introduction of HTA is motivated by similar ambitions with a view to managing costs. It’s a direction of travel that’s only going to continue across the region. The question is: how can pharma’s global teams be sure that their evidence focuses on the aspects that matter most?
A systematic approach
With APAC markets each having distinct characteristics and priorities, developing the right evidence generation strategy requires insight, agility, and collaboration. A good approach is for global or regional teams to identify the resonant issues across all markets, then work closely with affiliates to filter out which of these make sense in the local context. It isn’t easy. To get there, companies need:
- a consistent framework for assessing evidence risk across markets
- informed, collaborative, and integrated decision-making
- an integrated evidence generation plan
- enhanced prioritization at the regional and/or market level.
So how can you achieve it? Technology is a great enabler. At PRMA Consulting, we’ve supercharged our expert knowledge of the payer landscape with digital innovation that gives market access teams rapid access to insight that informs their evidence generation strategy. Our suite of digital applications includes the PRMA Healthcheck®, which provides a systematic and consistent approach to analyzing the various factors that influence APAC pricing, reimbursement, and market access.
This free eBook describes how the application gives companies a customizable framework for value assessment that highlights the most resonant local priorities, and helps them identify and address evidence risk.
Market access success in APAC depends on understanding how all the pieces of the jigsaw fit together. If you want to solve the puzzle, it might be time to bring your market access capabilities into the digital age – and feel the power of joined-up thinking.
Transforming value and access outcomes in the Asia-Pacific region