GAVIN OUTTERIDGE

The EU HTA Regulation: BioPharma’s Construction Challenge

The EU HTA Regulation: BioPharma’s Construction Challenge

The EU HTA Regulation: BioPharma’s Construction Challenge

The EU HTA Regulation: BioPharma’s Construction Challenge

The European Union’s new Health Technology Assessment (HTA) Regulation demands that innovative biotech and pharma companies submit a new type of value dossier to access EU markets. Is your Company ready?

The EU HTA Regulation: BioPharma’s Construction Challenge

GAVIN OUTTERIDGE & CATHERINE CHAMOUX

The EU HTA Regulation: BioPharma’s Construction Challenge

The EU HTA Regulation: BioPharma’s Construction Challenge

To date, each of the 27 EU markets required its own national dossier submission for drug pricing & reimbursement – sometimes multiple dossiers and supporting economic models. Most innovator biotech and pharma companies, with multiple launched products, have standardised processes for country-level submission strategy, dossier compilation and governance approval.

Adding in a new, mandatory dossier, which addresses the clinical value component at the EU-wide level, is a significant change to such standard business practice.

If your Company is a clinical stage biotech launching its first product with a European staff in single figures, this pan-European process is almost a gift from the gods – but you will still likely need a capable value & access partner, routinely operating at the European level, to develop a truly European (rather than single country) submission strategy and ensure the ultimate dossier aligns.

If your Company is a more established biotech, with >1 product on the market and a few in the pipeline, staffed by country clusters like DACH, BeNeLux and the Nordics, a pan-European process is perhaps readily manageable with a team of a dozen or so across key internal stakeholder groups – but still likely needs to appoint a value & access expert team to align across the clusters and, again, develop a truly European submission strategy and dossier.

If your Company is a major global biopharma with 20+ European GMs used to decision-making power, each of whom has Medical, Marketing and Market Access staff involved, the complexity multiplies. This huge community then also needs to co-ordinate with HQ equivalents, all within the mere 20-week window from “exhaustive” dossier submission to assessment publication that has been set by the regulation. Here, the business process re-design and governance adjustments needed to deliver on time but maintain strategic and operational alignment across countries requires not just expert value & access co-ordination but also effective management consultancy from advisors who also understand the content.

If you are launching oncology treatments or ATMPs in Europe from 2025 you must design now the matrix teams, tech-enabled business processes and governance structures necessary to deliver on the requirements of this new HTA regulation. Otherwise delays to market, restricted access and reduced price and revenues will inevitably result.

Contact us to partner with AESARA’s specialist market access management consultants to get your Company ready for this major change to bringing innovative medicines to market in Europe.

(1) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282

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