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.
"In the face of these developments, there has yet to be research exploring how Ps&Ps could be involved in reimbursement decision-making for " orphan drugs " or drugs for rare diseases (DRDs), and what role they might play in that process – some exceptions notwithstanding  . As we detail below, reimbursement decision-making for DRDs poses supplementary challenges to the ones already facing decision-making for common drugs or other areas of research and care. "
[Show abstract][Hide abstract] 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 · 1.91 Impact Factor
"While clinicians, who subscribe to the 'medicalindividualistic' decision system, were concerned with individual patient outcomes, administrators/managers, who subscribe to the 'fiscal-managerial' decision system, were concerned with the implications of decisions on the budget (Danjoux et al. 2007; Gordon et al. 2009). This conflict was more evident in scenarios where decisions affected identifiable patients such as medicines selection processes (Gallego et al. 2007). "
[Show abstract][Hide abstract] ABSTRACT: Priority setting research has focused on the macro (national) and micro (bedside) level, leaving the meso (institutional, hospital) level relatively neglected. This is surprising given the key role that hospitals play in the delivery of healthcare services and the large proportion of health systems resources that they absorb. To explore the factors that impact upon priority setting at the hospital level, we conducted a thematic review of empirical studies. A systematic search of PubMed, EBSCOHOST, Econlit databases and Google scholar was supplemented by a search of key websites and a manual search of relevant papers' reference lists. A total of 24 papers were identified from developed and developing countries. We applied a policy analysis framework to examine and synthesize the findings of the selected papers. Findings suggest that priority setting practice in hospitals was influenced by (1) contextual factors such as decision space, resource availability, financing arrangements, availability and use of information, organizational culture and leadership, (2) priority setting processes that depend on the type of priority setting activity, (3) content factors such as priority setting criteria and (4) actors, their interests and power relations. We observe that there is need for studies to examine these issues and the interplay between them in greater depth and propose a conceptual framework that might be useful in examining priority setting practices in hospitals.
Health Policy and Planning 03/2014; 30(3). DOI:10.1093/heapol/czu010 · 3.47 Impact Factor
"First, different data sources were used, including literature, documents and interviews, which allowed for a triangulation of sources in developing emerging concepts . For example, study participants discussed the challenge of making decisions based on insufficient data, a challenge that was also found in a study by Gallego et al. . Second , codes and themes were developed with other team members in a group session as a check on bias. "
[Show abstract][Hide abstract] 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 · 1.91 Impact Factor
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