ACCESSIBILITY OF ORPHAN DRUGS IN FRANCE, UK AND GERMANY- DIFFERENT APPROACHES WITH REGARD TO HTA AND PRICES

Author(s)

Grandfils N*;Hounkanlin H, Troubat A IMS Health, PARIS LA DEFENSE, France

OBJECTIVES: To describe availability of orphan drugs in France, UK and Germany and to compare agencies’ assessments and prices. METHODS: All the products designated as orphan drugs by the European Commission and commercialized at least in one of the three countries were included in the study. Comparison of prices is made per dosage and is based on prices per standard unit, using IMS MIDAS database. Comparison of assessments is based on Transparency Committee opinions, NICE guidances and IQWIG benefit assessments. RESULTS: 62 products (103 dosages/forms) were included in this study. 47 (76%; 84 dosages/forms) are commercialized in the 3 countries, 8 (13%) products in only 2 countries (6 both in Germany and UK and 2 both in Germany and France) and 7 (11%) only in 1 country (6 in Germany only and 1 in France only). Among the 84 products/dosage/forms available in the three countries, most of them are available at hospital (respectively 68, 70 and 77 in Germany, France and UK) but those available through retail pharmacists are much numerous in Germany (72 of them) than in France (29) or UK (30). German and UK manufacturer March 2013 retail prices more often higher than French one, despite the fact that among the 49 orphan drugs commercialized in France, 31 are innovative products (ASMR rate I to III) For instance, French assessment  of pirfenidone was less favorable than the Germans’one,  and German price is thus +65.2% higher than French price. French and UK HTA assessments for azacitidine were both positive and led to similar prices. CONCLUSIONS: Most orphan drugs are available in the three studied countries but accessibility to them seems to be  different and depends on HTA results.

Conference/Value in Health Info

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

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

Code

PHP23

Topic

Health Policy & Regulatory

Topic Subcategory

Pricing Policy & Schemes

Disease

Multiple Diseases

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