South Australian Medicines Evaluation Panel in review: providing evidence-based guidance on the use of high-cost medicines in the South Australian public health system.

Objective The South Australian Medicines Evaluation Panel (SAMEP) was established in 2011 to make evidence-based recommendations on the funding of high-cost medicines in South Australian public hospitals via a high-cost medicines formulary. SAMEP represents one component of South Australia's process for state-based health technology assessment (HTA). The aim of this study was to describe the experience of SAMEP in the context of Australia's complex governance model for hospital-based care. Methods A retrospective review was conducted of the SAMEP process and outcomes of medicine evaluations. Decision summaries and meeting minutes were reviewed and reflected upon by the authors to explore the views of the SAMEP membership regarding the function of the committee and state-based HTA more broadly. Results SAMEP has reviewed 29 applications, with 14 (48%) listed on the high-cost medicines formulary. Three applications have been the subject of outcome review and confirm expectations of patient benefit. Conclusion Retrospective review of the committee experience suggests that state-based HTA as operationalised by SAMEP is feasible, provides greater equity of access to high-cost medicines in the South Australian public hospital system and allows for access with evidence development. What is known about the topic? State-based hospital funders often need to make decisions on the provision of high-cost medicines for which there is no national guidance or subsidy. Little published information exists about state-based approaches to medicines evaluation and reimbursement within public hospitals in Australia. What does this paper add? The South Australian experience demonstrates a method for states and territories to tackle the challenges of providing evidence-based access to high-cost medicines in Australian public hospitals. What are the implications for practitioners? This paper provides information for other jurisdictions considering state-based approaches to medicines evaluation and contributes to the broader literature about state-based HTA in Australia.

The development of funding recommendations for health technologies at the state level: A South Australian case study.

OBJECTIVES: State governments often face capped budgets that can restrict expenditure on health technologies and their evaluation, yet many technologies are introduced to practice through state-funded institutions such as hospitals, rather than through national evaluation mechanisms. This research aimed to identify the criteria, evidence, and standards used by South Australian committee members to recommend funding for high-cost health technologies. METHODS: We undertook 8 semi-structured interviews and 2 meeting observations with members of state-wide committees that have a mandate to consider the safety, effectiveness, and cost-effectiveness of high-cost health technologies. RESULTS: Safety and effectiveness were fundamental criteria for decision makers, who were also concerned with increasing consistency in care and equitable access to technologies. Committee members often consider evidence that is limited in quantity and quality; however, they perceive evaluations to be rigorous and sufficient for decision making. Precise standards for safety, effective, and cost-effectiveness could not be identified. CONCLUSIONS: Consideration of new technologies at the state level is grounded in the desire to improve health outcomes and equity of access for patients. High quality evidence is often limited. The impact funding decisions have on population health is unclear due to limited use of cost-effectiveness analysis and unclear cost-effectiveness standards.

INAHTA IMPACT STORY: LEGISLATIVE AND ACCREDITATION REQUIREMENTS FOR OFFICE-BASED SURGERY IN AUSTRALIA.

BACKGROUND: There is growing trend for some surgical procedures previously performed in hospitals to be done in alternative settings, including office-based facilities. There has been some safety concerns reported in the media, which document serious adverse events following procedures performed in an office-based setting. To understand the current regulatory oversight of surgery in this setting ASERNIP-S conducted a review of the legislative and accreditation process governing these facilities in Australia. METHODS: Using rapid review methodology, internet searches targeted government Web sites for relevant publicly-available documents. Use of consolidated versions of legislative instruments ensured currency of information. Standards were sourced directly from the issuing authorities or those that oversee the accreditation process. RESULTS: Within Australia, healthcare facilities for surgery and their licensing are defined by each state and territory, which results in significant jurisdictional variation. These variations relate to the need for anesthesia beyond conscious sedation and listing of procedures in legislative instruments. In 2013, Australia adopted National Safety and Quality Health Service standards (NSQHS standards) for the accreditation of hospitals and day surgery centers; however, there is no NSQHS standard for office-based facilities. The main legislative driver for compliance is access to reimbursement schemes for service delivery. CONCLUSIONS: The legislative and accreditation framework creates a situation whereby healthcare facilities that provide services outside the various legal definitions of surgery and those not covered by a reimbursement scheme, can operate without licensing and accreditation oversight. This situation exposes patients to potential increased risk of harm when receiving treatment in such unregulated facilities.

Practical applications of rapid review methods in the development of Australian health policy.

Rapid reviews (RRs) are a method of evidence synthesis that can provide robust evidence to support policy decisions in a timely manner. Herein we describe the methods used to conduct RRs and present an illustrative case study to describe how RRs can be used to inform contemporary Australian health policy. The aim of the present study was to explore several important aspects of how RRs can inform decision makers. RRs are conducted within limited time frames of as little as 4 weeks. Policy questions may focus on issues of efficacy, service delivery and service organisation rather than reimbursement of new services, which is better answered by a more comprehensive assessment. RRs use flexible and pragmatic methods, which aim to balance the objectivity and rigour required of the reviews within limited time frames. This flexibility allows for great variation across products with regard to length, depth of analysis and methods used. As a result, RRs can be specifically tailored to address targeted policy questions and are a useful tool in the development of Australian health policy.

Self-Expanding Metallic Stents for the Management of Emergency Malignant Large Bowel Obstruction: a Systematic Review.

OBJECTIVES: This paper evaluates the safety and effectiveness of self-expanding metallic stents (SEMS) for the management of emergency malignant colorectal obstruction in patients otherwise requiring multi-stage surgery. No systematic review has been conducted comparing SEMS to only multi-stage surgery. METHODS: Bibliographic databases, including Cochrane, PubMed, EMBASE, and CINAHL, were searched in September 2011 and repeated in November 2013. A pre-determined protocol outlined the study inclusion and appraisal. RESULTS: Forty articles were included, seven compared SEMS to multi-stage surgery. Included studies were of low to moderate quality. Bowel perforation was the most severe stent-related complication, while tumor- and stent-related events occurred most frequently. No significant differences in rates of obstruction relief were reported between treatments, and results regarding relative quality of life were inconclusive. SEMS recipients progressed to elective surgery sooner and required shorter post-procedural hospital stays, but commonly required re-intervention. SEMS provided enduring palliative relief of obstruction, with comparable survival longevity between treatments. Conclusion: SEMS placement is a viable alternative to multi-stage surgery, providing patients with benefits as a bridge-to-surgery and relief of obstruction in a palliative context, with minimal differences in clinical success and safety compared to multi-stage surgery.

Stereotactic anatomical localization in complex sinus surgery: A systematic review and meta-analysis.

OBJECTIVE: It is recognized that stereotactic anatomical localization (SAL) is a useful tool in endoscopic sinus surgery (ESS), but it may be most beneficial for complex rather than routine sinus procedures. This review sought to determine the safety and efficacy of SAL in complex indications for ESS. DATA SOURCES: PubMed, EMBASE, Centre for Reviews and Dissemination, and the Cochrane Library were searched from inception up to April 4, 2014. REVIEW METHODS: English studies comparing ESS with and without SAL in complex cases were included. Complex surgery included revision surgery, inverted papilloma, extensive sinus disease, or biopsy of tumors that are not exophytic. Safety outcomes included total, major, minor, orbital, dural, and major hemorrhage complications. Efficacy outcomes included operation completion, revision surgery, and patient-reported outcomes. Meta-analysis generated fixed-effects Mantel-Haenszel odds ratios (OR) and confidence intervals (CI). RESULTS: A total of 2,381 studies were identified, of which nine met the inclusion criteria. Meta-analyses indicated a reduction in the likelihood of total (OR = 0.58; 95% CI, 0.37-0.92), major (OR = 0.36; 95% CI, 0.18-0.75), and orbital complications (OR = 0.38; 95% CI, 0.17-0.83). There was no demonstrated benefit of SAL at reducing revision surgery (OR = 0.64; 95% CI, 0.38-1.08), major hemorrhage (OR = 0.77; 95% CI, 0.29-2.06), or minor complications (OR = 0.85; 95% CI, 0.48-1.50). CONCLUSION: Due to the rare outcomes under investigation, the included primary studies largely lacked the power to identify a statistically meaningful effect of SAL in ESS. However, meta-analyses of primary studies demonstrated a decreased likelihood of total, major, and orbital complications in complex ESS with the use of SAL.