In recent years, a variety of ‘accelerated access’ schemes have been introduced by pharmaceutical regulators and funders globally. These schemes aim to overcome perceived regulatory and reimbursement barriers to accessing medicines – particularly for patients with limited time or therapeutic options. However, patient access to approved medicines is mediated by a number of third parties including regulators and payers, and physicians who act both as gatekeepers and guides to prescribed medications. It is therefore essential to know how physicians think about accelerated access as they are responsible for advising patients on and prescribing medicines made available via these pathways. We conducted semi-structured interviews with 18 Australian physicians focusing on their attitudes towards accelerated access. We identified three ‘archetypes’ of physicians: ‘confident accelerators’, ‘cautious accelerators’, and ‘decelerators’. Although all acknowledged the potential risks and benefits of accelerated access, they disagreed on their magnitude and extent and how they should be balanced in both policy formation and clinical practice. Overall, our results illustrate the diversity of clinical opinions in this area and the importance of monitoring both the prescribing and clinical outcomes that result from accelerated access programmes to ensure that these are both clinically and morally acceptable.

Objectives: In recent years, numerous frameworks have been developed to enhance the legitimacy of health technology assessment processes. Despite efforts to implement these “legitimacy frameworks,” medicines funding decisions can still be perceived as lacking in legitimacy. We, therefore, sought to examine stakeholder views on factors that they think should be considered when making decisions about the funding of high-cost breast cancer therapies, focusing on those that are not included in current frameworks and processes.

Methods: We analyzed published discourse on the funding of high-cost breast-cancer therapies. Relevant materials were identified by searching the databases Google, Google Scholar, and Factiva in August 2014 and July 2016 and these were analyzed thematically.

Results: We analyzed fifty published materials and found that stakeholders, for the most part, want to be able to access medicines more quickly and at the same time as other patients and for decision makers to be more flexible with regards to evidence requirements and to use a wider range of criteria when evaluating therapies. Many also advocated for existing process to be accelerated or bypassed to improve access to therapies.

Conclusions: Our results illustrate that a stakeholder-derived conceptualization of legitimacy emphasizes principles of accelerated access and is not fully accounted for by existing frameworks and processes aimed at promoting legitimacy. However, further research examining the ethical, political, and clinical implications of the stakeholder claims raised here is needed before firm policy recommendations can be made.