The diagnostics industry is facing with increasing policy scrutiny. The In Vitro Diagnostic Device Regulation (IVDR) will newly regulate the European approval system and the new EU Health Technology Assessment (HTA) proposal is already on the table. What is it all about and what could this mean to the diagnostics industry? Here is my short personal take:
Proposal in nutshell (Diagnostics point of view)
- Diagnostics is not Pharma: EU Commission listened to the industry’s voice that current HTA practices are dominantly applied for innovative medicines and not for diagnostics, thus differentiated HTA approach is required.
- Clinical assessment to be done on joint EU level, Member States to take clinical assessment results and focus on economic, non-clinical domains (e.g. economic, organizational, ethical) in their analysis
- Decision on pricing, reimbursement and coverage remain at Members States level
- IVD product scope limited to products in class D with: 1. high medical unmet need, 2. potential impact on patients, public health, or healthcare systems; 3. significant cross-border dimension; 4. resources availability
- EU HTA assessment is not necessarily aligned/linked to the timing of the CE mark (regulatory approval)
- Joint (EU-industry) early scientific assessments are possible and horizon scanning is envisioned
- Staggered approach in introduction: 3+3 years preparation time after EU Parliament approval, expected full scale operation as of 2025
- EU Commission will host HTA Coordination Group, secretariat and IT infrastructure
- The new set up is mainly funded from EU budget, Member State contribution and income from fee per service scientific HTA dialogues.
Potential impact from the diagnostics industry’s point of view:
It’s impossible to predict the future, still some high-level trends could be anticipated:
- Increasing transparency in HTA methods and application for Diagnostics
- More clinical data generation will be required, (most likely demonstrating clinical utility, impact in practice)
- Further industry investments into clinical programs and associated capabilities (e.g. medical, health economics, market access) are envisioned, which could trigger focused, differentiated test development programs and extensive launch preparation
- Since the points above require substantial investments, established organizational setup and affiliate network, probably major players can adjust easier than SME’s
Value Based Reimbursement concepts in Diagnostics are not yet broadly applied. As such one of the main questions remains: How can HTA outcomes trigger clinical adoption, coverage, reimbursement discussions/decisions that truly reflect not only the patient, clinical but also the economic value of those innovative diagnostics technologies? Time will tell.
Results are preliminary and subject to change. Let’ stay on the ball and follow the development.
Norbert
More details: https://ec.europa.eu/health/technology_assessment/eu_cooperation_en