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Development and application of classification methodologies for comparing reimbursement decision-making processes for new medicines

Allen, Nicola 2015. Development and application of classification methodologies for comparing reimbursement decision-making processes for new medicines. PhD Thesis, Cardiff University.
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Abstract

Health Technology Assessment (HTA) considers the therapeutic effectiveness of a health technology and may also evaluate cost-effectiveness. The aim of this study was to evaluate HTA agencies, their relationship to regulatory authorities and other decision-makers and to identify common appraisal practices with respect to the economic and therapeutic evaluation of new medicines. The national reimbursement pathways for 33 European jurisdictions were evaluated to identify two taxonomic sets that categorise HTA agencies by evaluating the relationship between the HTA, regulatory and decision-making functions within the reimbursement system (System taxonomy) and the processes for appraisal and conducting the clinical and economic evaluation (Process taxonomy).Ten distinct archetype groups were subsequently identified by comparing the two taxonomic sets. National HTA recommendations were identified for nine European jurisdictions with varied health care systems and approaches for HTA, to enable comparisons using the classification tool to assess correlation. HTA decisions were also identified from four countries that have generally similar approaches for HTA (Australia, Canada, England and Scotland) to understand the rationale for discordant HTA recommendations. The Canadian HTA environment was evaluated in greater detail to understand the impact of the national non-mandatory HTA recommendations for coverage decisions from four provinces (Alberta, British Columbia, Ontario and Quebec). Senior representatives and final decision-makers from these four provinces completed the study questionnaire and participated in semi-structured interviews to provide further insights regarding the impact of the national Canadian HTA agency. Comparisons of HTA recommendations from national HTA agencies with general similarities (Australia, Canada, England and Scotland) identified significant differences and a range of causes for discordant recommendations, such as: submission timing, comparator choice and willingness to accept risk. Results for comparing Canadian national HTA recommendations with coverage decisions from four provinces demonstrated much greater overall concordance (κ (kappa coefficient) =0.432 to κ=0.663) than comparing Canadian national HTA recommendations with Australia, England and Scotland (κ=0.129 to κ=0.336). Feedback from the semi-structured v interviews also indicated that participating provincial payers increasingly rely on the national HTA agency. The development of a novel classification tool, comparisons of HTA recommendations from very different and also generally similar HTA agencies and the evaluation of the Canadian HTA environment have ultimately led to the proposal of a progressive alignment approach which supports on-going efforts to create a more efficient European HTA environment.

Item Type: Thesis (PhD)
Status: Unpublished
Schools: Pharmacy
Subjects: Q Science > Q Science (General)
Uncontrolled Keywords: HTA, classification, reimbursement, market access and decision-making
Date of First Compliant Deposit: 30 March 2016
Last Modified: 13 Aug 2018 01:30
URI: http://orca.cf.ac.uk/id/eprint/75508

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