About RAREready™
The EU RAREready™ is an AI-enhanced framework created by swii.ch health to help biopharma companies succeed in the new era of EU Joint Clinical Assessments (JCA). We work at the intersection of regulation, evidence, and patient voice, ensuring rare disease sponsors are fully prepared for the challenges of the EU Health Technology Assessment Regulation (HTAR).
Our approach blends regulatory alignment, patient engagement, and affiliate readiness. The result: sponsors close evidence gaps, strengthen submissions, and deliver strategies that meet the needs of regulators, payers, and most importantly patients.
Why RAREready™ Exists
The EU HTA Regulation (EU 2021/2282) introduces Joint Clinical Assessments to harmonise evaluations across Member States.
- From 2025, oncology medicines and advanced therapies entered scope.
- From 2028, orphan medicines follow.
- By 2030, all centrally authorised medicines will require a JCA.
For rare disease developers, this creates new challenges:
- Tight timelines – just 130 days from CHMP opinion to final JCA report.
- Complex PICO scoping – clinical practices vary widely across Member States.
- Patient involvement requirements – despite barriers with capacity, training, and representativeness.
RAREready™ bridges these gaps – helping sponsors prepare early, engage effectively, and navigate EU JCA with confidence.
Our 4D Framework
Our proven 4D Framework provides a structured pathway:
- Discover – Map regulatory, patient, and evidence landscapes.
- Diagnose – Identify PICO-related evidence gaps and affiliate risks.
- Define – Co-create strategies with affiliates, advocacy groups, and HTA experts.
- Deliver – Execute using AI-enabled tools, affiliate playbooks, and sprint programmes.
This framework ensures sponsors are JCA-ready, affiliate-aligned, and patient-centred.
How We Help
Through our 100-Day Sprint and tailored advisory programmes, we deliver:
- Patient Evidence Gap Identifier – AI-supported PICO scoping analysis.
- Affiliate Readiness Playbooks – step-by-step checklists and templates for local teams.
- Lay Summary & Access Narrative Builders – clear communication for patients and assessors.
- Traceability Logs & Risk Registers – audit-ready compliance tools.
- Training & Clinics – practical sessions on PICO scoping, JCA timelines, and patient engagement.
Every tool is designed to simplify complexity while aligning with EU HTA guidance.
Who We Work With
RAREready™ is built for:
- Mid-sized pharma and biotech sponsors preparing for EU submissions.
- Market access and HEOR leads building JCA capabilities.
- Patient engagement leaders and affiliates seeking structured, transparent processes.
We partner with patient advocacy groups, affiliates, and HTA experts to ensure strategies are representative, credible, and effective.
Our Commitment
- Patients first – embedding lived experience in every decision.
- Regulatory alignment – in step with HTA Coordination Group and EU procedural guidance.
- Practical tools – resources that affiliates and sponsors can actually use.
- Responsible innovation – AI to enhance, not replace, the patient voice.
F.A.Q.
Frequently Asked Questions
The regulation harmonises Health Technology Assessments across EU Member States. From 2025 to 2030, all new centrally authorised medicines will be assessed via Joint Clinical Assessments (JCAs).
A JCA compares the clinical effectiveness of new medicines using the PICO framework (Population, Intervention, Comparator, Outcomes). It must be completed within 130 days of CHMP opinion.
Patient perspectives improve the relevance of assessments, ensure quality-of-life outcomes are included, and increase transparency. Yet most organisations face barriers such as technical language, unclear impact, and lack of capacity.
We provide structured playbooks, evidence mapping, patient engagement strategies, and AI-enabled tools that align with EU procedural guidance. We help sponsors avoid evidence gaps and strengthen their affiliate and patient strategies.
Mid-sized EU/US pharma and biotech companies developing rare disease medicines, along with their market access teams, affiliates, and advocacy partners.
We specialise in rare disease and combine regulatory expertise, patient insight, and practical AI tools—making us uniquely positioned to help sponsors succeed under the EU HTAR.