Medical Services Advisory Committee Research Articles

Making recommendations to subsidize new health technologies in Australia: A qualitative study of decision-makers’ perspectives on committee processes

ObjectivesTo explore experiences of, and perspectives on, health technology assessment (HTA) processes used to produce recommendations about subsidizing new medicines, and medical technologies in Australia, from the perspectives of those experienced in these processes. MethodsSemi-structured interviews with a diverse group of 18 informants currently or previously members of the Pharmaceutical Benefits Advisory Committee (PBAC) or the Medical Services Advisory Committee (MSAC). Participants were interviewed September 2021-February 2022. Transcripts were analyzed using reflexive thematic analysis. Results3 major themes were identified: contrasting technical and decision-making stages, resisting reductionist approaches, and navigating decision-making trade-offs. Participants discussed the complexities of the evaluative HTA process, especially when considering uncertainty in the evidence. As part of the current process, a deliberative decision-making stage was considered essential, allowing a flexible approach to decision making to consider factors beyond strength and quality of quantifiable data in the technical evaluation. Participants acknowledged these less-quantifiable factors were sometimes considered implicitly or were difficult to describe and this, paired with commercial in confidence requirements, presented challenges with respect to the desire to increase transparency. Conclusion (s)As HTA processes for new medicines and medical technologies in Australia continue to be reviewed, the balance between retaining flexibility during deliberation, confidentiality for sponsors and the public's desire for greater transparency may be a fruitful area for continuing research.

OP71 Road To Public Funding Of Cancer Codependent Technologies In Australia In The Last Ten Years

IntroductionIn Australia, cancer codependent technologies (cCDTs) mostly comprise a biomarker targeting medicine and a companion diagnostic test (CDx). Health technology assessment (HTA) of cCDTs is carried out to inform funding deliberations on CDxs by the Medical Services Advisory Committee (MSAC) and on personalized medicine by the Pharmaceutical Benefits Advisory Committee (PBAC). To understand the strengths and weaknesses of this dual assessment mechanism, we studied the journey of cCDTs in getting funding support from the two committees since the introduction of the codependent technology evaluation framework.MethodsPublic summary documents summarizing deliberations by each committee were reviewed from 2012 to 2022. Information was retrieved on the patient indication, date, biomarkers related to the tests, and PBAC or MSAC funding outcomes. The alignment of HTA decisions, time taken until dual funding approval (if approved), and the reasons for discrepant and negative decision-making were determined.ResultsFrom 2012 to 2022, a total of 26 cCDT applications were submitted to PBAC and MSAC, corresponding with 43 paired PBAC/MSAC considerations and 11 single committee considerations. Non-small cell lung cancer and programmed cell death ligand 1 were the most frequently nominated cancer and biomarker test, respectively. When a cCDT was submitted in the same decision round to both committees, 60 percent of funding decisions were aligned, reaching 73 percent when the considerations were made separately (resubmissions). Only 9 percent of considerations received polarized, where one committee supported and the other committee rejected funding. After multiple resubmissions, 73 percent of cCDTs obtained dual funding support after an average of 34.8 weeks, with considerations by PBAC and MSAC occurring an average of 2.3 and 1.9 times, respectively.ConclusionsMost cCDTs obtain funding support, but only after multiple resubmissions to PBAC and MSAC. Polarized decisions are rare. Reasons for rejection primarily relate to uncertain clinical benefit and an unacceptably high incremental cost-effectiveness ratio.

PP41 Using Medicare Claims Data To Support Reimbursement Of A Novel Leadless Pacing System For The Management Of Bradycardia

IntroductionThe Micra Transcatheter Pacing System (Micra TPS) is a single-chamber transcatheter leadless pacemaker (LPM). LPMs do not require leads or a subcutaneous pocket, which represent the primary sources of device-related complications with conventional transvenous pacemakers (TVPMs). Complications such as infections and lead dislodgements cause significant patient burden, which have significant economic consequences. Running a randomized controlled trial (RCT) to estimate risk differences of infrequent events requires large sample sizes and long follow-up periods. Real-world observational data, while informative, requires an appropriate study design and statistical adjustments to control for potential biases.MethodsThe Micra Coverage with Evidence Development (CED) study was a cohort study of LPM versus TVPM based on US Medicare claims data of 16,431 patients with 2-year follow up (LPM: n=6,219; TVPM: n=10,212). Propensity score matching (PSM) was applied to account for differences in baseline characteristics. As no RCT was identified in the literature, this study was presented to the Australian payer as the primary source of clinical evidence, upon which a cost-utility analysis was conducted.ResultsAfter PSM, the CED study demonstrated significantly more complications with TVPM versus LPM with adjusted rates of 6.5 percent and 4.6 percent (p<0.001). Significant differences favoring LPM (p<0.01) were observed in device breakdown (1.4% vs 2.0%), dislodgment (0.4% vs 1.2%) and infection (<0.1% vs 0.6%). Based on these findings, a claim of superior safety was accepted by Medical Services Advisory Committee (MSAC) to support reimbursement. In making this decision, MSAC considered that the large sample size and propensity weighting overcame some of the potential biases and the magnitude of the benefit supported cost-effectiveness relative to TVPM.ConclusionsThe lack of a sufficiently powered RCT with an extended follow-up period can mean the impact and benefits of new technologies that reduce clinically important adverse events of relative infrequency are not formally incorporated into payer decision making, particularly where RCTs are a requirement. A well-designed observational study can provide valuable, real-world evidence to support a HTA for reimbursement decisions.

PP75 Using Real World Evidence To Support The Reimbursement Of Proton Therapy Across A Broad Range Of Rare Cancers

IntroductionThe Australian Bragg Centre for Proton Therapy and Research in Adelaide will be Australia’s first center with the capacity to deliver proton beam therapy (PBT). PBT uses energy from protons to target cancer cells while minimizing damage to surrounding healthy tissue, including vital organs. Compared to X-ray (photon) radiation therapy (PRT), PBT reduces the risk of serious and long-term complications.To improve access to PBT, the South Australian Health and Medical Research Institute (SAHMRI) submitted an application to the Medical Services Advisory Committee (MSAC) including a cost utility analysis (CUA) comparing PBT with PRT to treat specific pediatric/adolescent and young adult (AYA) and rare adult tumors.MethodsA systematic review identified 28 comparative, mostly real-world studies to support the conclusion that PBT has superior safety and non-inferior efficacy to PRT in the requested indications. The key challenge for the CUA was to quantify the cost and quality of life implications of the superior safety profile across a wide range of indications with a limited comparative evidence base. A simple lifetime decision analytic model was developed which modeled the rates, costs and utilities associated with relevant toxicities. The complications of radiotherapy are often chronic and included secondary malignancies, visual impairments, endocrine dysfunction, dysphagia, hearing loss and intellectual disability. Some of these toxicities are only applicable to patients with cranial cancers. Therefore, the event rates applied in the evaluation were adjusted to account for the proportion of patients within each population estimated to have extracranial cancers.ResultsWhen results in the adult and pediatric/AYA populations were weighted across the expected utilization of PBT (34% adults, 66% pediatric/AYA) in each population, PBT was dominant relative to PRT.ConclusionsIn November 2020, MSAC recommended funding PBT in specific populations at high risk of long-term side effects from PRT. To address uncertainties around the evidence base, MSAC further requested the following:•All patients receive comparative photon/proton plans to determine eligibility•A national registry is established for patients treated with PBT.

PP147 What Does Real World Evidence (RWE) Offer Health Technology Assessment (HTA) Procedures In Australia?

IntroductionMedical device health technology assessment (HTA) in Australia is largely coordinated by the Medical Services Advisory Committee (MSAC). Its remit to improve the public’s health by deciding where to allocate public healthcare funding, can be enhanced by considering real world evidence (RWE). Existing data sources have limitations that can be addressed through RWE, including coverage of Australian patient populations who may not meet trial eligibility criteria, and long-term follow-up through data linkage and datasets. We partnered with a university to explore what information could be gained from an analysis of linked administrative patient data, with a view to addressing current evidence gaps and/or limitations. The findings can be used as a source of local data to define patient populations, estimate actual costs of care, and enable more comprehensive economic modeling to inform medical device HTA.MethodsThe University-developed New South Wales Cardiovascular Cohort dataset, comprising person-level longitudinal NSW administrative data for all patients admitted to hospital with a cardiovascular diagnosis from 2001 onwards, linked to national Medicare Benefits Schedule and Pharmaceutical Benefits Scheme claims data, was interrogated.ResultsWorking with RWE is resource intensive in terms of time and costs. The potential of these data was revealed as the research progressed. It was possible to continually refine the data analyzed and reported,as well as expand the data requested. Varied expertise is required to accurately analyze the administrative datasets, particularly clinical classification skills and expertise in methods for causal inference using observational data. Findings from this study will enable the refinement of information for MSAC submissions, including identifying the most relevant patient population and reporting comprehensive costs, beyond an admitted hospital setting. The data will enhance engagement with clinicians and refine messaging, for example regarding patient risk factors.ConclusionsRWE enhances Australian HTA applications. Local data, extended periods of time and insights not apparent from a focus on admitted hospital episodes can be revealed. Data can be refined during the process for specificity and applicability.

Use of Health Technology Assessment for the Continued Funding of Health Technologies: The Case of Immunoglobulins for the Management of Multifocal Motor Neuropathy.

Funding decisions for many health technologies occur without undergoing health technology assessment (HTA), in particular, without assessment of cost effectiveness (CE). Immunoglobulins in Australia are an interesting case study because they have been used for a long time for various rare disorders and their price is publicly available. Undertaking an HTA enables us to assess CE for an intervention for which there is limited clinical and economic evidence. This study presents a post-market review to assess the CE of immunoglobulins for the treatment of multifocal motor neuropathy (MMN) compared with best supportive care. A Markov model was used to estimate costs and quality-adjusted life-years (QALYs). Input sources included randomised controlled trials, single-arm studies, the Australian clinical criteria for MMN, clinical guidelines, previous Medical Services Advisory Committee (MSAC) reports and inputs from clinical experts. Sensitivity analyses were conducted to assess the uncertainty and robustness of the CE results. The cost per patient of treating MMN with immunoglobulin was AU$275,853 versus AU$26,191when no treatment was provided, with accrued QALYs of 6.83 versus 6.04, respectively. The latter translated into a high incremental cost-effectiveness ratio (ICER) of AU$317,552/QALY. The ICER was most sensitive to the utility weights and the price of immunoglobulins. MSAC advised to continue funding of immunoglobulins on the grounds of efficacy, despite the high and uncertain ICER. Beyond the ICER framework, other factors were acknowledged, including the high clinical need in a patient population for which there are no other active treatments available. This case study highlights the challenges of conducting HTA for already funded interventions, and the efficiency trade-offs required to fund effective high-cost therapies in rare conditions.

Real-World Outcomes with CD19 CAR T-Cell Therapy for B-Cell Malignancies in Regional/Rural Australia: Results from the Queensland CAR T-Cell Program

Aim: Chimeric antigen receptor T cell (CAR-T) therapies targeting CD19 have transformed treatment of relapsed/refractory large B cell lymphoma and B cell leukaemia (B-ALL). Our institution is the sole provider of CAR T-cell therapy in Queensland and northern Australia; servicing a population of approximately 6 million people over 3.8 million km2. In Australia, the commercial CAR T-cell program is only available and funded for patients who meet the nationwide guidelines that are stipulated by the Medical Services Advisory Committee (MSAC). Here we present clinical outcomes of all patients treated with commercial CAR T-cell products since the program commenced. Method: All patients referred to the Royal Brisbane and Women's Hospital commercial CAR T-cell program between July 2020 to July 2022 were identified. Clinical and laboratory data were obtained by retrospective chart review. The primary outcome was overall response rate (ORR; defined as combined incidence of complete [CR] and partial [PR] responses) at day 30 and day 180 post infusion. Secondary outcomes included mortality and incidence of cytokine release syndrome (CRS) and immune effector cell acute neurotoxicity syndrome (ICANS). Results: Of the 84 patients referred during the study period, 39 have received CAR-T infusion, resulting in 36 evaluable at D30 and 27 evaluable at D180 (see Figure 1). Indication for CAR T-cell therapy included B-ALL (7%) and large B cell lymphoma (93%). ORR for the entire cohort was 72% (26/36) at D30 and 41% (11/27) at D180. At D30, CR was 12 (33%) and PR 14 (39%). By D180, 6 remained in CR but another 4 PR converted to CR. CRS and ICANS occurred in 82% and 28% respectively. There were 0 episodes of grade ≥ 3 CRS, and 4 episodes of grade ≥3 ICANS. At census date, 12 (31%) patients had died due to either progressive disease (11; 28%) or severe infection (1; 3%). Conclusion: Northern Australia's geographically dispersed regional/rural population, spanning multiple state health jurisdictions, presents unique logistical challenges to the successful implementation of a highly complex and novel cellular therapy program, particularly when commencing during the COVID-19 pandemic. Despite these potential barriers, our program's data demonstrates that CD19 CAR T-cell therapy is deliverable and produces similar outcomes to those reported in other real-world studies. These results reflect state-wide co-operation between regional haematologists and the tertiary referral centre throughout apheresis, bridging, and post-CAR-T care. Our commercial CAR T-cell program is now complemented by investigator-initiated clinical trials using locally manufactured CAR products. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Assessing the value of precision medicine health technologies to detect and manage melanoma.

Assessing the value of precision medicine health technologies to detect and manage melanoma.

Roadmap to incorporating group A Streptococcus molecular point-of-care testing for remote Australia: a key activity to eliminate rheumatic heart disease.

Roadmap to incorporating group A Streptococcus molecular point-of-care testing for remote Australia: a key activity to eliminate rheumatic heart disease.

A Cost-Effectiveness Analysis of AcrySof IQ Vivity Intraocular Lens (IOL) from Private Health Fund Perspective in Australia

PurposeAcrySof IQ Vivity is a unique non-diffractive extended depth of focus intraocular lens with wavefront-shaping X-WAVE technology. This study evaluated the cost-effectiveness of AcrySof IQ Vivity intraocular lens (DFT015) compared with standard aspheric monofocal intraocular lens (SN60WF), from a private health fund perspective in Australia.MethodsA Markov model was developed using the following health states: well, need for spectacles (near/distance/bifocal/varifocal), very bothersome visual disturbances (glare/haloes/starbursts) – with/without spectacles, and death. Model inputs were sourced from a randomized clinical study (NCT03010254), published literature, prostheses list and clinical opinion. A lifetime horizon (up to 30 years) was considered, and cost and health outcomes were discounted at 5% per annum. Model outcomes included incremental cost–effectiveness ratio defined as incremental cost per quality adjusted life year gain. Sensitivity and scenario analyses were also conducted.ResultsBilateral implantation of DFT015 intraocular lens provided quality adjusted life year gain of 0.16 at an incremental cost of AU$307 compared to bilateral SN60WF, leading to an incremental cost-effectiveness ratio of AU$1908/quality adjusted life year, well below the cost-effectiveness threshold (Range: AU$45,000-AU$75,000) typically used by Medical Services Advisory Committee in Australia. Results were most sensitive to intraocular lens costs, post-operative spectacle dependence, and disutility due to wearing glasses. Robustness of the results was further confirmed by probabilistic sensitivity analysis and scenario analyses.ConclusionAcrySof IQ Vivity intraocular lens is a highly cost-effective treatment strategy with improved vision-related quality of life outcomes for presbyopic cataract surgery patients.

Evidence-based funding of new imaging applications and technologies by Medicare in Australia: How it happens and how it can be improved.

BackgroundThe Medical Services Advisory Committee (MSAC) is responsible for the assessment of medical imaging tests proposed for public funding. A number of factors related to the clinical or cost effectiveness of an imaging service may impact on the funding decision.ObjectiveTo determine what evidentiary and economic factors impact most on MSAC recommendations for the funding of imaging tests.MethodsInformation was extracted on health technology assessments (HTAs) of medical imaging tests published on the MSAC website, with a funding decision between 2006 to July 2021. Imaging tests with diagnostic, staging or screening indications were eligible. Data were extracted in test‐indication pairs and included data on evidence quality, quantity, consistency of findings, cost‐effectiveness and financial impact. Multivariate logistic regression analysis was performed with adjustments for clustered data.ResultsOverall, 42 imaging test applications to MSAC were included, representing 91 clinical indications. Most were diagnostic tests. The most common evidentiary concerns reported by MSAC were limited evidence (36%), low quality evidence (26%), and applicability of the data (22%). The reference standard for diagnostic accuracy was imperfect or not appropriate in 25% of the indications. In regression analyses, uncertainty about cost‐effectiveness of an imaging service predicted most negative funding decisions.ConclusionsThe single biggest contributor to a negative funding decision by MSAC was uncertainty about the cost‐effectiveness of the imaging service. This was likely driven by uncertainty regarding the impact on patient health. HTAs that are able to demonstrate the clinical utility of a new imaging service are more likely to publicly funded.

Evaluating genetic and genomic tests for heritable conditions in Australia: lessons learnt from health technology assessments

The Medical Services Advisory Committee (MSAC) is an independent non-statutory committee established by the Australian government to provide recommendations on public reimbursement of technologies and services, other than pharmaceuticals. MSAC has established approaches for undertaking health technology assessment (HTA) of investigative services and codependent technologies. In 2016, MSAC published its clinical utility card (CUC) Proforma, an additional tool to guide assessments of genetic testing for heritable conditions. We undertook a review and narrative synthesis of information extracted from all MSAC assessments of genetic testing for heritable conditions completed since 2016, regardless of the HTA approach taken. Ten assessments met our inclusion criteria, covering a range of testing methods (from gene panels to whole-exome sequencing) and purposes (including molecular diagnosis, genetic risk assessment, identification of congenital anomaly syndromes, and carrier screening). This analysis identified a range of methodological and policy challenges such as how to incorporate patient and societal preferences for the health and non-health outcomes of genomic testing, how best to capture the concept of co-production of utility, and how to engage clinicians as referrers for genomics tests whilst at the same time ensuring equity of access to a geographically dispersed population. A further challenge related to how qualitative assessments of patient and community needs influenced the evidence thresholds against which decisions were made. These concepts should be considered for incorporation within the value assessment frameworks used by HTA agencies around the world.

2021 CSANZ and ANZSCTS Position Statement on the Operator and Institutional Requirements for a Transcatheter Aortic Valve Implantation (TAVI) Program in Australia

This document establishes the minimum standard for accreditation of institutions and operators as endorsed by the Cardiac Society of Australia and New Zealand (CSANZ) and the Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS). The original Joint Society Position Statement was ratified in August 2014. This 2021 update replaces the original and serves as a consensus within which the Conjoint Committee for Trancatheter Aortic Valve Implantation (TAVI) Accreditation will function, as recommended by Medical Services Advisory Committee (MSAC) Determination for TAVI. This is not a Guideline Statement but takes into consideration regional, legislative, and health system factors important to establishing requirements for TAVI accreditation in Australia.

Ranzcp efforts to improve access to funded treatments

IntroductionAustralia has a universal health insurance scheme covering part costs for private mental health care and which supports the public system. The Medical Benefits Schedule (MBS) schedule provides a recommended fee for each service, the amount the Australian Government thinks the service should cost. Many patients still pay a gap fee for the service. Similarly a system for medications, the Pharmaceutical Benefits Scheme (PBS) subsidises the cost of medicines for most medical conditions. As new evidence emerges in the treatment of psychiatric conditions, it is important that the MBS and PBS are updated so patients receive subsidised best practice treatment.ObjectivesTo provide an overview of RANZCP efforts to expand treatment availability through evidence and advocacy to government.MethodsThe RANZCP made submissions to the independent Medical Services Advisory Committee (MSAC) requesting an MBS listing for repetitive transcranial magnetic stimulation (rTMS) for treatment of antidepressant medication-resistant major depressive disorder. Submissions were made to the independent Pharmaceutical Benefits Advisory Committee (PBAC) to request ability to prescribe quetiapine in 25mg ranges for maintenance therapy.ResultsFollowing RANZCP submissions, the MSAC supported public funding for initial treatment with rTMS for adults with major depression who have tried antidepressant medicine or psychological therapy and remain unwell. The PBAC has recommended changes allowing prescription of 25mg quetiapine tablets for maintenance therapy for acute mania, bipolar 1 disorder and in the treatment of schizophrenia following RANZCP submission.ConclusionsThe RANZCP has achieved access to treatments to provide optimal symptom relief for people living with mental illness.

Health Technology Assessment in Australia: The Pharmaceutical Benefits Advisory Committee and Medical Services Advisory Committee

Health technology assessment (HTA) was introduced in Australia for the reimbursement of pharmaceuticals in 1992 and in the following years for procedures, diagnostic tests, and devices. The Australian health system is largely funded by the government. The Pharmaceutical Benefits Scheme is a national list of prescription pharmaceuticals for which the patient pays a small copayment. HTA submissions to the Pharmaceutical Benefits Scheme are assessed by the Pharmaceutical Benefits Advisory Committee. The Medical Benefits Scheme provides ambulatory medical services and HTA submissions are assessed by the Medical Services Advisory Committee. This article describes the processes of reimbursement in Australia as well as the special case of codependent technologies (eg, diagnostic test and a therapeutic drug) where a combined Medical Services Advisory Committee and Pharmaceutical Benefits Advisory Committee application is required. There are many future challenges for HTA in Australia, with growing pressure to provide early access to promising treatments and high cost personalized medicines looming on the horizon. However, Australia is well placed to deal with these issues as the early adoption of HTA and coexistence between industry, academia and the payer has proven to be a fertile environment for developing capacity to undertake and evaluate HTA.

Funding of prostate magnetic resonance imaging leads to fewer biopsies and potential savings to health systems in the management of prostate cancer.

To assess the impact of the introduction of multiparametric magnetic resonance imaging of the prostate (mpMRIp) on the number of prostate biopsies performed in Australia. Australian Medicare published statistics from 1 July 2007 to 30 June 2019 were obtained from publically available databases for prostate-specific antigen (PSA) testing, prostate biopsy, and mpMRIp. Analysis was divided into three time periods broadly based on availability of mpMRI to the Australian public: 2007-2012 (no mpMRIp), 2012-2018 (mpMRIp available, privately funded), and 2018-2019 (mpMRIp available with Medicare funding). Introduction of mpMRIp was hypothesised to reduce the number of prostate biopsies performed. PSA testing numbers were used as a control. The economics model, proposed by the Medical Services Advisory Committee (MSAC), was analysed for cost savings. Accounting for variations in PSA testing, the introduction of mpMRIp from 2012 coincided with a reduction in the number of prostate biopsies by an average of 354.7/month (95% CI 175, 534.4; P<0.001). Whilst the number of mpMRIp performed for the initial 12months was underestimated by the MSAC at 38470 vs 20149 (+$8.3million Australian dollars), we estimate the annual savings from reduced number biopsies and biopsy-associated complications to be $13.2 ± 9.6million. Availability of mpMRIp in Australia has correlated with a significant reduction in prostate biopsy rates, with an estimated annual saving of $13.2 ± 9.6million. Government funding of this diagnostic service has the potential to improve health equity and save on health expenditure.

ASERNIP-S: unusual acronym, outstanding results.

In the late 1990s, concerns regarding the introduction of new surgical procedures arose following the rapid uptake of some minimally invasive procedures. At that time, the evidence was not clear on the safety and effectiveness of these new procedures, and it was recommended that data be collected to look at both short- and long-term outcomes. Based on a UK group, 'the Safety and Efficacy Register of New Interventional Procedures (SERNIP)', the Australian SERNIP was born under the auspices of the Royal Australasian College of Surgeons, with '-S' added to the acronym to highlight the focus on surgery. ASERNIP-S was established to review the evidence on new interventional procedures before their introduction into the Australian healthcare system. The programme operated with initial national government funding for 7 years. Following establishment of the Medical Services Advisory Committee, ASERNIP-S became a contractor and remains so today. ASERNIP-S was an also an early adopter of Horizon Scanning, a key activity informing of new procedures/technologies on the verge of introduction into our healthcare system. A strong international reputation of ASERNIP-S is recognised, both by lead roles of international networks and in working relationships with overseas agencies. In recent years the remit of ASERNIP-S has expanded to include research and evaluation services across the Royal Australasian College of Surgeons (including committees) and for Specialty Surgical Societies. Externally funded work is growing, including for the Federal Office of Public Health in Switzerland and the Ludwig Boltzmann Institute in Austria. It is unknown what the future will be for this unusually titled programme, but its long history in promoting and supporting surgical evidence and innovation is clear.

PCN356 ARE CANCER DRUGS ASSOCIATED WITH A COMPANION DIAGNOSTIC TEST TAKING LONGER TO BE REIMBURSED IN AUSTRALIA?

In Australia, co-dependent technologies that require reimbursement are assessed by two committees: the Pharmaceutical Benefits Advisory Committee (PBAC) and the MSAC (Medical Services Advisory Committee). Most of co-dependent technologies evaluated by the PBAC since March 2011 have been for cancer medicines. We tested the hypothesis that cancer medicines with an associated submission to the MSAC take longer to be reimbursed than those with no co-dependency. We examined the PBAC outcomes for cancer medicines considered by the PBAC between March 2011 and December 2018 to identify those with an associated MSAC submission. Medicine registration details were obtained from the Therapeutic Goods Administration website. Serial issues of the Schedule of Pharmaceutical Benefits from March 2011 to June 2019 were examined to determine PBS listing dates. Our study metrics were the average number of PBAC submissions required to obtain a PBAC recommendation and the average time from date of registration to date of PBS listing. It took, on average, 2.27 PBAC submissions for a cancer medicine with an associated MSAC submission to obtain a PBAC recommendation; the mean for a cancer medicine with no MSAC submission is 2.03. Cancer medicines with an associated MSAC submission also took longer, on average, to be listed on the PBS after their registration (1,493 days versus 717 days). These results should be interpreted with caution given the inclusion of some medicines with a complex history. A recent report[1] estimated that co-dependent medicines take on average twice as long to be reimbursed in Australia, compared to non-co-dependent medicines. This is supported by the findings from our study. Further consideration is needed to reduce the delay in funding for co-dependent medicines, including alignment of the reimbursement processes. [1] Sansom Institute for Health Research. Cancer Biomarkers in Australia. University of South Australia, 2017.

PP26 Shift From Regional To Federal Funding: Methodological Considerations

IntroductionAustralia has a two-tier public funding system, and many genetic tests are funded by different states and territories prior to being considered for public funding by the Federal government. In this context, health technology assessments (HTAs) of genetic tests for heritable conditions are problematic. We aimed to discuss the possible impacts on HTA methodology of a shift from regional to federal funding for genetic testing for heritable conditions.MethodsSeveral HTA reports and economic models on genetic tests considered by the Medical Services Advisory Committee (MSAC) were reviewed and compared to ‘real world’ clinical practice.ResultsEvery HTA of germline testing performed for the MSAC have so far compared genetic testing versus no genetic testing. However, testing for BRCA1/2 for patients with breast cancer currently occurs in Familial Cancer Centres, and testing for germline mutations for familial hypercholesterolaemia currently occurs through specialist lipid clinics. In both settings, the index patient and family members are given multidisciplinary support, including genetic counselling. The HTA comparison therefore did not reflect what the true clinical and cost-effectiveness impact of federal funding would be. Federal funding means that tests may be ordered by a broader range of specialists or general practitioners. The evidence identified was predominantly sourced from specialised centres, where knowledge regarding how to interpret the tests is high. The clinical utility of these tests largely depended on how clinicians understood and conveyed the results.ConclusionsThe benefit of testing may have been overestimated due to the comparator and setting used (i.e. specialised and centralized care, associated with high clinical utility). Any HTA of genetic testing for heritable conditions, which could result in a shift in the delivery of testing or care for the patient, should consider the applicability of the evidence identified. Further, it should assess the subsequent impact this may have on the effectiveness and cost-effectiveness of the test and the quality of care provided for patients and their family.

The impact of orthopaedic research evidence on health financing in Australia

BackgroundIn Australia, approval by the Medical Services Advisory Committee (MSAC) is an important step in the implementation of new health technologies. The MSAC considers health technology assessments (HTA) when submitting a recommendation to the Minister of Health on a new technology’s suitability for public funding. Despite being such a critical tool in formulating policy, there has been little scrutiny on the impact of limited evidence on the performance of a national HTA agency’s mandate. We aim to determine the proportion of HTAs of orthopaedic technologies prepared for the MSAC that were supported by higher levels of evidence for effectiveness, and whether this affected the MSAC’s ability to conclude on efficacy. We also investigated whether the availability of higher level evidence affected the performance of cost-effectiveness analyses.MethodsWe performed a cohort study of all HTAs prepared for the MSAC from 1998 to 2017 with regards to new technologies in orthopaedic surgery.ResultsWe identified seven HTAs encompassing nine orthopaedic technologies for inclusion. Higher levels of evidence were available for assessing the technology’s effectiveness in six out of the nine technologies. The results did not show a statistically significant relationship between the availability of higher level evidence and MSAC’s ability to make a clear conclusion on the assessment of effectiveness (P = 0.5). The proportion of HTAs where a cost-effectiveness analysis was performed was significantly higher (P < 0.05) when higher levels of evidence were available for the assessment of effectiveness.ConclusionsThe results indicate that there is a paucity of high quality evidence in the formulation of health policy with regards to the implementation of new orthopaedic technologies in the public healthcare system. This represents an opportunity for strong leadership from surgeons to help develop the tools needed for effective clinical decision-making.