PAYER VALUE IN ALTERNATIVE TREATMENT FORMULATIONS- ACCESS TO NEW MEDICINES IN SCHIZOPHRENIA

Author(s)

Morawski J1, Sweeney N2, Nijhuis T11Quintiles Consulting, Hoofddorp, Netherlands, 2Quintiles, Hoofddorp, Netherlands

OBJECTIVES: To gain insights into the perceived value of alternative treatment formulations in the management of schizophrenia. METHODS: A search of 75 health technology assessment (HTA) agencies was performed to identify single technology appraisals published between January 2010 and June 2012 on pharmaceutical treatments for schizophrenia.  Per agency, only the most recent appraisal for each drug identified was selected for analysis. Reasons for recommendation and non-recommendation were evaluated in-depth for each appraisal. RESULTS: In total 32 appraisals (9 rejections; 23 recommendations) were identified across 12 agencies. These appraisals represent the most recent decision made for a specific drug by a particular agency. Overall 5 different formulations were assessed including long-acting depot formulations (14 appraisals), oral immediate release (IR) tablets (13), orodispersible tablets (3), an oral long release (LR) tablet (1), and an oral solution (1). Non-recommendations were only identified for depot, oral IR and oral LR formulations. In most cases high drug costs, lack of head-to-head and long-term clinical data were the main reasons for rejection. Submissions resulting in a recommendation were identified for all but the LR tablet formulation. Reasons for recommendation included proven clinical non-inferiority to direct comparators, cost savings and a better dosing schedule. As most new formulations did not offer a benefit in efficacy, decisions were weighted on cost. In all long-acting formulation submissions, manufacturers stated that use of the drug would lead to improved patient compliance. Only one submission (HAS) provided data to support this claim. SMC and AWMSG were the only agencies to criticise the absence of compliance data. CONCLUSIONS: A higher drug price for a new formulation is only warranted when clear clinical advantages are presented. This is particularly evident for long-acting formulations where a higher price, on grounds of improved compliance, is not favourable. There was very little disparity between agencies in their decision making approach.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PMH55

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Mental Health

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