ASSESSING THE AVAILABILITY OF DRUGS MARKETED IN THE US AND SWITZERLAND

Author(s)

Zeukeng M1, Seoane-Vazquez E2, Szeinbach S3
1University of Geneva, Geneva, Switzerland, 2MCPHS University, Boston, MA, USA, 3Ohio State University, Columbus, OH, USA

OBJECTIVES: The availability of drugs in a market may affect patient care, health outcomes and costs. The objective of this study was to assess differences in the availability of human drugs marketed in the US and in Switzerland as of January 1, 2015. METHODS: Information about all drugs approved in the US and Switzerland was derived from the Food and Drug Administration (FDA) and the Swiss Agency for Therapeutic Products (Swissmedic) respectively. The list of drugs reimbursed by the Swiss mandatory insurance was extracted from the Federal Office of Public Health. Drugs were classified according to the WHO anatomical therapeutic chemical classification (ATC). Descriptive statistics and the chi-square test were performed. RESULTS: The FDA listed 2,491 different active ingredients and combinations (AICs) approved and marketed in the US, while the Swissmedic list contained 1,345 AICs. The US listed 138 orphan drug AICs of which 68.8% were listed by Swissmedic and 63.0% were included in the Swiss reimbursement list. Overall, 73% of the US AICs were listed by Swissmedic and 67% were reimbursed, while 29.8% AICs approved in Switzerland were not approved in the US. A statistically significant (p < 0.05) higher percentage of non-orphan AICs marketed in the US than orphan AICs were listed by Swissmedic. ATC codes were available for 94.8% of drugs approved by the FDA and 99.1% by Swissmedic. The nervous system was the ATC class with the highest proportion of US approved drugs marketed in Switzerland. CONCLUSIONS: Two-thirds of the AICs marketed in the US were marketed in the Swiss market. Orphan drugs have less presence in the Swiss than in the US market. Future research should compare the approval processes in both countries and evaluate the impact of the availability of drugs on patients’ outcomes and cost.

Conference/Value in Health Info

2015-05, ISPOR 2015, Philadelphia, PA, USA

Value in Health, Vol. 18, No. 3 (May 2015)

Code

PHP50

Topic

Health Policy & Regulatory, Real World Data & Information Systems

Topic Subcategory

Approval & Labeling, Health & Insurance Records Systems, Health Disparities & Equity

Disease

Multiple Diseases

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