OVERVIEW OF COVERAGE WITH EVIDENCE DEVELOPMENT IN SWEDEN

Author(s)

Schroeder M*1;Kornfeld A2;Ben Abdallah I2;Rémuzat C2, Toumi M3 1Creativ-Ceutical, Copenhagen, Denmark, 2Creativ-Ceutical, Paris, France, 3University Claude Bernard Lyon 1, Lyon, France

OBJECTIVES: Coverage with evidence development (CED) in Sweden has become common over the last decade. It is considered as a tool to address uncertainty. The objective of this research is to assess from 2005 to 2012  CED in Sweden. METHODS: We downloaded available CED from pricing authority (TLV) database, and extracted detailed information in an ad hoc grid developed for that purpose. The following information was extracted: date of product approval, name, indication,  date of CED installation, end of CED, type of evidence to be generated, limitation of initial file supporting the need of additional evidences. RESULTS: 28 cases were retrieved covering 9 main disease areas. 11 were for orphan drugs and 10 for Central nervous system (CNS) disorders including depression anxiety, epilepsy, pain, ADHD, schizophrenia, restless syndrome and Parkinson disease. Other were classified as follow, 5 for cardiovascular disorders, 3 oncology, 2 diabetes, 2 respiratory disorders and 5 others. The main drivers to request CED were  weak cost-effectiveness model (14 cases) driven by uncertainty about utility, patients benefit, transition probabilities, model structure etc.. The second reason was low  relevance of clinical evidence for clinical practice (8 cases), followed by long term efficacy extrapolation (5 cases) and others mainly related to comparative effectiveness, daily dosage, safety, target population, etc..  (11 cases). For each CED more than one driver could be identified. Requirements were mostly real world evidence generation. CONCLUSIONS: CED in Sweden is likely to be driven more by uncertainty than drug prices due to low involvement of oncology, inflammation and other disease area where biologics are prescribed. Orphan drugs represent a leading target for CED as often little information is available at time of launch. Most CED are not finalised to assess the actual CED  impact on long term coverage.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PR4

Topic

Health Policy & Regulatory

Topic Subcategory

Coverage with Evidence Development & Adaptive Pathways

Disease

Multiple Diseases

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