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Mapping Access to Orphan MedicinalProducts (OMPs) in Sweden
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.
2018 (English)Independent thesis Advanced level (degree of Master (One Year)), 20 credits / 30 HE creditsStudent thesis
Abstract [en]

Mapping Access to Orphan Medicinal Products (OMPs) in SwedenSalam GumaDegree Project 30c, Master of Science Programme in PharmacyDepartment of Pharmaceutical Biosciences, Supervisor: Karolina Antonov, Examiner: Agneta Freijs

Background: One of the primary aims of Regulation No 141/2000 is to stimulate research on orphan medicinal products (OMPs) for the treatment of rare diseases. An Office of Health Economics (OHE) study has shown that there are variations in the access to OMPs between United Kingdom, France, Germany, Italy and Spain. In Sweden, the Dental and Pharmaceutical Benefits Agency (TLV) decides on prices and reimbursement and the New Therapies (NT) Council provide County Councils with recommendations for use based on the same ethical platform as TLV.

Aim: The aim of this study was to use the same methodology - as in the OHE paper - to make an analysis of access to OMPs, approved for sale between 2001 and 31 May 2016, in Sweden compared with countries in the OHE paper.

Methods: The availability of OMPs in Sweden was measured based on information from FASS. Access to OMPs depends on reimbursement by TLV and/or recommendation by the NT council. Access - that OMPs have prescribed to patients and sold at pharmacies - was measured based on sales statistics.

Result: An increase in availability to OMPs within EU has been observed - 123 OMPs has been authorised by EC. The availability of OMPs in Sweden is quite good; 104 of 123 OMPs are available as compared to Germany (134 of 143 OMPs) and Spain (79 of 143 OMPs). About 49.6% of the 123 OMPs available in Sweden were also reimbursed in Sweden until 31 December 2017 but only seven OMPs were recommended for use by the NT council. In Sweden, the average time delay from EC authorisation to reimbursement was 15.5 months and the median delay was 9.75 months.

Conclusions: This shows that high orphan medicine prices need not limit the access to OMPs since decisions on access to OMPs are influenced by healthcare priorities as expressed in reimbursement decisions and health care recommendations such as those made by the NT council.

Place, publisher, year, edition, pages
2018. , p. 41
National Category
Pharmaceutical Sciences
Identifiers
URN: urn:nbn:se:uu:diva-353459OAI: oai:DiVA.org:uu-353459DiVA, id: diva2:1217429
Subject / course
Pharmacotherapy
Educational program
Master of Science Programme in Pharmacy
Supervisors
Examiners
Available from: 2018-06-13 Created: 2018-06-13 Last updated: 2018-06-13Bibliographically approved

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