Hollis KA, Calingaert B, Price M, Andrews E, Moy L, Kooijmans M, Cristiano L, Bozic C. Tysabri TOUCH prescriber program risk management program (RiskMAP) surveys. Poster presented at the ISPE 26th International Conference on Pharmacoepidemiology; August 25, 2010.

BACKGROUND: Tysabri is approved in the US for the treatment of patients with either relapsing forms of multiple sclerosis (MS) or moderate-to-severe Crohn’s disease (CD). Because of the risk of progressive multifocal leukoencephalopathy (PML), Biogen Idec, Inc. and Elan Pharmaceuticals (the Sponsors) implemented a restricted distribution program called the TOUCH Prescribing Program (TPP) as part of a RiskMAP in which all prescribers, infusion sites, and patients who prescribe, administer or receive Tysabri must enroll. Prescribers and infusion sites must attest that they understand the risk of PML and agree to follow the requirements of the TPP, including educating and monitoring patients according to the TPP. Sponsors assess the effectiveness of the RiskMAP through a survey of prescribers and infusion nurses conducted every 6 months.

OBJECTIVES: The primary objective of this survey is to measure how well physicians and infusion site nurses understand the risk of PML with Tysabri treatment and the key risk minimization requirements of the TPP.

METHODS: Surveys for each of the provider groups were developed. Prescribers and infusion nurses were randomly selected from the TPP registry, invited to participate in the survey, and given a direct link to the appropriate Web survey. Between 2006 and 2009, 6 waves of the MS and 3 waves of the CD prescriber and infusion site surveys were conducted.

RESULTS: Percentage of correct responses to the key knowledge questions (KKQ) has been very high across all survey types and waves. Many KKQ were consistently answered correctly by 95% of respondents and the vast majority by 90%. In the most recent wave over 95% of CD and 91% of MS prescribers correctly answered at least 10 of the 11 KKQ.

CONCLUSIONS: Results indicate that health care professionals have a high level of knowledge of the risk of PML with Tysabri treatment and the key risk minimization requirements of the TPP, with little variation across provider group, disease area or time.

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