Priority setting for high cost medications (HCMs) in public hospitals in Australia: a case study.
ABSTRACT Health care providers (HCPs) are increasingly aware of pressures on funding for health care services, including high cost medicines (HCMs). Allocating resources to innovative and expensive medications is particularly challenging and the decision-making processes and criteria used to allocate resources to HCMs have not been widely described in the literature. This case study aimed to describe the operations of the first reported High Cost Drug Sub-Committee (HCD-SC) in a public hospital in Australia. In addition the study also evaluated the decision-making process using Daniel and Sabin's ethical framework of "accountability for reasonableness". Some lessons emerged from the description of the operations of the HCD-SC. Decisions were not solely based on effectiveness and cost. Additional factors such as "clinical need" and the lack of an alternative treatment were involved in decisions about access to HCMs. Members of the HCD-SC also considered it was important to have consistency in the way decisions were being made. The findings from this study provide an evidence base for developing strategies to improve this hospital's decision-making process regarding access to HCMs.
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ABSTRACT: Recently there has been an increase in the active involvement of publics and patients in healthcare and research, which is extending their roles beyond the passive recipients of medicines. However, there has been noticeably less work engaging them into decision-making for healthcare rationing exercises, priority setting, health technology assessment, and coverage decision-making. This is particularly evident in reimbursement decision-making for ‘orphan drugs’ or drugs for rare diseases. Medicinal products for rare disease offer particular challenges in coverage decision-making because they often lack the ‘evidence of efficacy’ profiles of common drugs that have been trialed on larger populations. Furthermore, many of these drugs are priced in the high range, and with limited health care budgets the prospective opportunity costs of funding them means that those resources cannot be allocated elsewhere. Here we outline why decision-making for drugs for rare diseases could benefit from increased levels of publics and patients involvement, suggest some possible forms that involvement could take, and advocate for empirical experimentation in this area to evaluate the effects of such involvement. Focus is given to the Canadian context in which we are based; however, potentialities and challenges relating to involvement in this area are likely to be similar elsewhere.Health Policy 01/2015; 119(5). DOI:10.1016/j.healthpol.2015.01.009
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ABSTRACT: To describe stakeholder involvement in the priority setting and appeals processes across five drug reimbursement recommendation committees. We conducted qualitative case studies of how five independent drug advisory committees from Canada, Israel, England and Wales, Australia, and the USA made funding decisions for six expensive drugs. Interviews with 48 informants were conducted with committee members, patient groups, and industry representatives. Different stakeholders were allowed, in varying degrees, to participate in the formal mechanisms for revisions and appeals of decisions. Participants identified a number of stakeholder groups who were already involved in the process, as well as stakeholders whom they believed should be included in the decision-making process. A central component of a legitimate and fair priority setting process is to make priority setting explicit and to involve both pertinent values and stakeholders in decision-making. Study participants believed that the involvement of multiple stakeholder groups within the deliberative and appeals/revisions processes would contribute to a fair and legitimate drug reimbursement process.Health Policy 01/2012; 105(2-3):226-35. DOI:10.1016/j.healthpol.2011.12.002
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ABSTRACT: To describe the process of priority setting for two orphan drugs - Cerezyme and Fabrazyme - in Canada, Australia and Israel, in order to understand and improve the process based on stakeholder perspectives. We conducted qualitative case studies of how three independent drug advisory committees made decisions relating to the funding of Cerezyme and Fabrazyme. Interviews were conducted with 22 informants, including committee members, patient groups and industry representatives. (1) Description: Orphan drugs reimbursement recommendations by expert panels were based on clinical evidence, cost and cost-effectiveness analysis. (2) Evaluation: Committee members expressed an overall preference for the current drug review process used by their own committee, but were concerned with the fairness of the process particularly for orphan drugs. Other informants suggested the inclusion of other relevant values (e.g. lack of alternative treatments) in order to improve the priority setting process. Some patient groups suggested the use of an alternative funding mechanism for orphan drugs. Priority setting for drugs is not solely a technical process (involving cost-effective analysis, evidence-based medicine, etc.). Understanding the process by which reimbursement decisions are made for orphan drugs may help improve the system for future orphan drugs.Health Policy 10/2010; 100(1):25-34. DOI:10.1016/j.healthpol.2010.09.008