MARKET ACCESS FOR PHARMACEUTICALS IN EUROPE- FUTURE PERSPECTIVES

Author(s)

Rémuzat C1, Kornfeld A1, Kornfeld M1, Thivolet M1, Gilabert-Perramon A2, Toumi M3
1Creativ-Ceutical, Paris, France, 2Government of Catalonia, Barcelona, Spain, 3Aix-Marseille University, Marseille, France

Background: Market access for pharmaceuticals is evolving in a fast-changing environment : (1)Pressure of  European Union (EU) Member States (MS) on health insurance budgets; (2) Dramatic technological advances; targeting new biological pathways, advanced therapy medicinal products, personalized medicines, expansion of digital medicine; (3) Initiatives from regulators and payers to develop synergies,  e.g., collaborations between HTA agencies and multi-HTA/parallel early advice; (4) Increased payer risk-aversion and increasing products with limited information at launch; (5) Healthcare organisations moving towards integrated healthcare services (6) Ageing population and growing prevalence of chronic conditions, co-morbidities, and life threatening diseases;  (7) Increased access inequity between EU MS . Discussion: Cost-containment measures will increase under close supervision of parliaments. Fast development of electronic communication will allow online monitoring of drug utilisation. Adaptive licensing and limited evidence at time of launch will lead to generalization of coverage with evidence development. A more pragmatic approach in clinical trial designs should be considered to cope with concomitant development of companion diagnostics, segmentation of treated patients with targeted therapies; adaptive pathways should evolve from pilot to standard approach. Post-launch observational studies will become unavoidable to meet regulators and payers’ expectations. Pan-European HTA coordination could lead to one single European HTA body assessing drugs prior to national HTA and pricing and reimbursement process. Managed entry agreements, ambulatory DRG, and bundled payments might become standard models. Integrated health services will expand, shifting payers role to health care providers. Differential pricing will address access inequity. Conclusion: Sustainability of healthcare systems will remain at the heart of drug funding decisions. Drug market access will evolve through extended collaborations and interactions between key stakeholders. Drug licensing, pricing and reimbursement decisions will be increasingly coordinated to enable fast patient access to innovative therapies. Real-world data will be central to switch from initial restricted access to progressive wider coverage.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PHP346

Topic

Health Policy & Regulatory

Disease

Multiple Diseases

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×