Less welcome are the associated challenges of a less stable evidence base at launch and potential high costs of these new technologies and therapies. Payers fear that so many therapies are being developed at such a fast pace that they cannot afford to introduce them into the system, despite their promised clinical benefit. Companies face uncertainty around reimbursement and the expectations for post-authorisation real world data generation. Patients also face the real possibility that treatments will be developed that could help them but that they are unable to access.
Affordability and the acceptance of real-world evidence are hot topics without clear solutions. Increasingly, innovative, value-based contracts (VBCs) are being agreed, with payers and companies looking at ways to bring therapies to patients. VBCs can focus on ensuring access, driving uptake, or both. They can address concerns about the evidence base, particularly when it comes to longer term outcomes in chronic or progressive conditions. They can also address barriers in infrastructure, capacity, diagnosis and affordability. The more complex the VBC, the more difficult it can be to agree, requiring significant resource from both companies and payers to develop. As they become more frequent, particularly for innovative therapies, we anticipate a shift from payers towards standardising VBCs. However, this does not mean one approach for all.
Recently we have seen successful launches of innovative therapies, but they can often take a long time and uptake may be slower than anticipated, something we have seen even with the highly effective Zolgensma for Spinal Muscular Atrophy. As VBCs become more common, companies are generally taking one of three approaches: a single global VBC strategy regardless of market, a region-by-region strategy or a country-by-country approach.
TO DEVELOP GLOBAL STRATEGIES AND THE TOOLS THAT WILL BEST SUPPORT LOCAL TEAMS ACHIEVE SUCCESS, GLOBAL MARKET ACCESS TEAMS NEED TO UNDERSTAND THE EXTERNAL ENVIRONMENT ACROSS COUNTRIES, AS WELL AS THE BROADER LANDSCAPE, HOW THIS IS LIKELY TO CHANGE AND HOW THE COMPANY CAN INFLUENCE ANY SUCH CHANGE.
None of these approaches fully consider the external environment across countries, or the broader landscape. Instead, we recognise that there are commonalities between countries across the world that may not readily map onto geographical regions – Europe alone will require more than one type of VBC to address different payer preferences.
To develop global strategies and the tools that will best support local teams achieve success, global market access teams need to understand the external environment across countries, as well as the broader landscape, how this is likely to change and how the company can influence any such change. By mapping out the similarities and differences between markets, companies can move to more tailored access approaches that recognise the commonalities and differences between markets, regardless of geography.
Global teams will succeed where they are able to identify a small number of market archetypes in terms of their readiness to agree VBCs and the types of agreement that will fit well within their healthcare systems, their policy priorities, the current provision in the specific therapeutic area and capacity to deliver the new therapy.
This will enable global teams to identify a limited number of approaches to VBCs for an asset and the markets where they are most likely to succeed. Global teams can provide parameters for local teams to work within, to select the right VBC strategy first time, increasing the chance of securing a VBC that works for all stakeholders and brings products to the patients who need them.