From 1 April 2026, AIFA’s updated HTA guidelines will come into effect, making the process more tightly aligned with the EU Regulation 2021/2282, and more structured in terms of clinical and economic evidence requirements for new pricing and reimbursement submissions.
This revised HTA guidance was also developed in the context of AIFA’s own governance reform, following the replacement of CTS and CPR by the Commissione Scientifica ed Economica del farmaco (CSE).
To succeed under the updated framework, manufacturers will need to ensure a fully integrated and localised value story built on the HTA-grade evidence that AIFA expects.
This includes structured PICO considerations, robust uncertainty analysis, a stronger emphasis on comparative effectiveness and explicit added clinical benefit, and a sharper focus on economic value.
Negotiation strategy will increasingly depend on demonstrating credible value for money and budget-impact certainty under enhanced HTA standards.
What is changing?
AIFA’s HTA framework update is not simply a template refresh; it marks a structural shift towards a more rigorous, EU-aligned HTA paradigm. In practice, AIFA is integrating Joint Clinical Assessment (JCA) outputs into its national process while preserving Italian decision-making on economic value, innovativeness, pricing and reimbursement. For manufacturers, this means less duplication in the submission of EU-level clinical evidence, but greater pressure to localise the Italian value story.
Payers will continue to favour Italian data on epidemiology, treatment pathways, comparators, and resource-use assumptions to support credible market sizing and a payer value proposition that is relevant to the Italian healthcare system. The absence of a localised value proposition creates payer uncertainty, which directly translates into a weaker negotiating position for manufacturers.
In this context, appropriate economic dossier preparation requires earlier and more systematic planning of models, including sensitivity and scenario analyses to ensure that claims are grounded in the national clinical context.
Within the guidelines, there is also a renewed emphasis on methodological robustness of comparative analysis, including indirect comparisons and network meta-analyses, where head-to-head evidence is not feasible. This reflects AIFA’s broader push for greater transparency and reproducibility in economic assessment.
Therefore, evidence plans need two layers: a pan-European clinical package suitable for JCA, and a country-specific layer for place in therapy, budget impact and localised economic narrative to support pricing negotiations.
Implications for HTA strategy and cross-functional planning
The traditional model, in which national reimbursement is treated as a downstream concern following the EMA regulatory dossier, is becoming increasingly risky. P&R submission planning now needs to start earlier and progress in parallel across EU HTA and national level strategy.
The strategic conclusion for manufacturers is straightforward: from 1 April 2026, success in Italy will depend less on repeating JCA clinical evidence and more on demonstrating how that EU-level evidence translates into a compelling Italian payer value narrative.
Successful companies will …
- Treat JCA and national P&R submissions as a single integrated workplan, with shared critical path and clear ownership by therapy area value leads.
- Run cross-functional launch readiness initiatives that explicitly test alignment with the evolving EU HTA landscape.
- Incorporate national-level EU4 payer requirements into phase IIb/III design, ensuring at least one arm, subgroup or endpoint aligns with local standard of care.
- Preplan indirect treatment comparisons and RWE (registries, chart reviews, local utilisation studies) so that analyses mature in time for the first national level P&R submission wave, not years after launch.
What next?
Remap Consulting has built a strong track record in supporting pharmaceutical and biotech companies with advisory boards and HTA submission strategy across a wide range of therapeutic areas and market access challenges.
Our expert team helps clients design and deliver high-value advisory boards that generate actionable payer, clinician, and policy insights, ensuring discussions are closely aligned with strategic decisions on evidence generation, value communication, and access planning.
We also support clients in developing robust HTA submissions by strengthening value narratives, refining evidence packages, stress-testing assumptions, and aligning clinical, economic, and policy arguments with local decision-maker expectations. Contact us to start an informal conversation.
References
- AIFA, Linee Guida per la compilazione del dossier… and related notice on operational start from 1 April 2026. (Aifa)
- AIFA, Aggiornamento portale e-Dossier in vista dell’entrata in vigore delle nuove Linee guida. (Aifa)
- European Commission, Questions and Answers on the new Health Technology Assessment; Joint Clinical Assessments.
- EMA, New EU rules for health technology assessments become effective. (European Medicines Agency (EMA))
- AIFA, Ufficio Procedure Europee di HTA. (Aifa)