How specialist advisers can help navigate a new era of JCA and pricing reforms

As Joint Clinical Assessments in Europe and pricing reforms in the US reshape healthcare market access, specialist firms with deep expertise, proprietary data and AI-enabled capabilities are well placed to help clients navigate the next phase of growth. To discuss this, Inflexion recently hosted a dinner chaired by Dr Mel Formica, Senior Adviser and healthcare industry expert with over 20 years of experience in scaling businesses globally in the space. 

The introduction of Joint Clinical Assessments (JCAs) alongside increasingly complex pricing mechanisms such as Most Favoured Nation (MFN) provisions and international reference pricing is reshaping market access across the US and Europe. What are the early implications for life sciences companies?

Mel Formica: It's still early days for JCAs, so we're only beginning to understand how they'll work in practice. They don't simplify market access or replace national pricing and reimbursement decisions; they add another layer to an already broad process.

The biggest impact is on evidence generation. I'm now advising companies to think much earlier about whether their clinical programme will satisfy not one or two Health Technology Assessment (HTA) bodies, but potentially the needs of 27 Member States, before they even begin country-level pricing negotiations. Pricing remains national, but the evidence now has to withstand scrutiny across multiple systems, each with different expectations around comparators, endpoints and data.

For developers, particularly smaller and mid-size biotechs, that's a difficult trade-off: more comprehensive evidence packages mean greater trial complexity, more resource and higher cost, yet a favourable JCA doesn't guarantee better pricing when reimbursement stays country-specific.

That's where specialist market access advisers come in, because companies increasingly need support early in development to design evidence strategies that anticipate how different markets will read the same clinical data, and where the gaps could emerge before launch.

Is this making Europe a less attractive market for mid-size pharmaceutical and biotech companies?

Mel: I believe JCAs, combined with increasingly complex pricing mechanisms such as MFN provisions and international reference pricing, do make Europe a more challenging commercial destination.

For a US biotech, a natural question now is whether launching in Europe could have negative consequences for pricing elsewhere. We're already seeing businesses delay or even reconsider their European launch because the US often represents the bulk of future revenues.

Some European governments are already exploring ways to remain competitive. Spain has introduced confidential net-price arrangements to mitigate this. Other countries facing similar exposure risk may follow suit.

There are also geopolitical considerations that we should bear in mind. If fewer US biopharma companies prioritise Europe, it creates opportunities for others. China now accounts for around one-third of global clinical trials and continues to invest heavily in life sciences. Chinese companies operate under different, usually lower price commercial models, meaning Europe could become an increasingly attractive market to expand into despite lower reimbursement levels.

What role will AI play, and where does human expertise still matter?

Mel: AI already plays a key role. We're seeing it accelerate analytical work, support predictive modelling and compress activities that previously took weeks or months into days. In my view it will be transformational over the next three to five years, especially for evidence generation and commercialisation. Human judgement though will always remain key. I believe the real advantage comes from combining AI with proprietary data and deep sector expertise. AI can process information incredibly quickly, but it can't make the strategic judgements that experienced market access professionals make every day around evidence generation, pricing strategy or reimbursement.

What capabilities will distinguish professional services firms that consistently deliver successful reimbursement and market access outcomes?

Mel: The firms that invest in specialist capabilities, unique data assets and AI-enabled workflows will be best positioned to help clients in this increasingly challenging environment.

Clients want advisers who intimately understand individual healthcare systems, have access to unique datasets and can translate increasingly complex evidence requirements into successful reimbursement strategies.

Generalist consulting firms may find that increasingly difficult because AI is making generic analysis easier to produce. 

How can private equity help companies respond to these changes?

Mel: Beyond capital, I think PE’s real value is in providing operational firepower, and helping management teams expand their strategy, while acting as a sounding board. Just as importantly, firms such as Inflexion bring hands-on expertise through their Value Acceleration Team, supporting their businesses with digital transformation, commercial strategy, talent and technology while sharing learnings from across the portfolio.

For founder-led businesses, that's very valuable. The strongest private equity partnerships are about helping founders realise the full potential of their vision. In specialist technical businesses, founders often have unique scientific or commercial expertise that remains crucial to the company's success. Therefore, it’s important to build around that expertise. Combining investment, operational expertise and specialist capabilities enables businesses to grow significantly faster than they could on their own in a market becoming more complex every year.

Ambitious businesses can grow faster with the right capital and expertise, with Inflexion’s flexible funding offering minority or majority capital and access to a sizeable team to accelerate growth. The Inflexion team has significant experience in supporting the growth of a number of healthcare companies of different sizes, including CNX Therapeutics, Ensera, Rosemont and Upperton Pharma. All have access to Inflexion’s value acceleration strategies of M&A, digital enhancement, international expansion, commercial effectiveness, sustainability and talent management.

For entrepreneurs and founders within the healthcare ecosystem, we offer a partnership built on sector knowledge and track record. We have backed businesses at similar stages before, we understand the regulatory and commercial dynamics of the sector, and we have a track record of building businesses internationally from a strong domestic base. Please get in touch if you’d like to learn more.