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Why I’m Bullish on European Market Access (Part 1 of 4)

By Nathan Sigworth, CEO @ CCX

There has been much discussion in market access circles over the last couple of years about the Inflation Reduction Act and its impact on US market access. Less attention has been paid to the JCA — Joint Clinical Assessment — coming to Europe. Next week, as many of us in the access community gather at the EPA conference in Amsterdam, the JCA is top of mind.

Like any regulatory change, the impact of JCA is what we make of it. And I want to share in the next few days why I see JCA and other changes in European Market Access as an opportunity for innovative leaders in pharma and payers to change the way they work in ways that can increase access for patients to the new therapies they need.

What is the JCA?

Joint Clinical Assessment does not facilitate a single access process. Rather there’s a centralized clinical effectiveness readout that is going to be taken into individual jurisdictions where access decisions are made. Pressure will be on manufacturers to quickly negotiate with each payer and launch across Europe following this.

While the intention of the JCA is in part to simplify and reduce the burden for companies while making access more equitable, there’s still a lot of clarification in process. Companies are bracing for a lot of additional work applying for access across multiple health systems simultaneously based on the expectation that joint assessment will require simultaneous access submissions. And as such, companies are already experiencing some chaos and challenges as they prepare. As with any new policy, the clarity will emerge gradually as companies and governments go through this process.

How are market access leaders preparing?

In this complex environment in Europe, there are three ways that I have been hearing from market access leaders that they are are gearing up for JCA:

1. Big, well-resourced pharmaceutical manufacturers will staff up, purchase additional tools, and equip their affiliates to do the same.
2. Smaller manufacturers will outsource more market access efforts to consultants and third parties.
3. Some manufacturers — both big and small — are deprioritizing the timing of launch of Europe, or reconsidering whether to launch at all. These decisions are driven by (a) a perceived increasing simultaneous workload driven by JCA combined with (b) the already perceived lack of European willingness to pay and (c) onerous processes to file for access across many jurisdictions. These deprioritization decisions are most likely to affect treatments for rare diseases, which are already difficult for patients to access.

Welcomed or unwelcomed, JCA could be a catalyst for transformation

All of us in the access community know that there are serious challenges with access in Europe, particularly driven by advances in the science of medicine that simply don’t fit within the frameworks and processes that have worked in the past. I work with many optimistic pragmatists on both the payer and pharma side who got into the business to make a difference for patients. This means that when there is system change — such as JCA — that shakes up the way in which we work, there’s an opportunity to make other beneficial changes to work more efficiently despite — and perhaps because — the change is difficult.

I believe that JCA and other changes provide an opening for innovative leaders to re-make European Market Access in a way that’s better for manufacturers, payers and ultimately patients, provided we step up and take this as an opportunity to re-invent access. In the next few days as many of us gather at EPA in Amsterdam, I’ll be sharing three reasons why I’m bullish on European Market Access: (a) the changing social contract in Europe (b) changes in leverage between companies and payers, and (c) a renaissance of technology to support market access. More soon…

How do you think JCA will change European Market Access? Let me know what you think! nathan@ccx.tech