9 results
OP43 Translating Cell And Gene Therapy HTA Into Practice – Building The Plane As We Fly It
- Paul Fennessy, Monica Ferrie
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 39 / Issue S1 / December 2023
- Published online by Cambridge University Press:
- 14 December 2023, p. S11
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Introduction
Assessing, funding, and implementing cell and gene therapies are usually based on limited evidence. This requires health technology assessment (HTA) agencies to develop new methodologies; payers to accept risk-based funding; industry to consider the right evidence and price; hospitals to consider if they have the necessary requirements; patients to consider their risk appetite for gene therapies; and health departments to consider all the above. Ensuring timely patient access to these therapies is challenging in Australia’s federated health system. To ensure stakeholders are aligned, all must come to the table and share their respective insights, experiences, and expertise to support planning, decision-making, funding, and commissioning of these therapies. It is time to develop a new consultative and decision-making paradigm to expedite HTAs, funding, commissioning, and timely patient access for cell and gene therapies.
MethodsAustralian federal, state, and territory government representatives agreed to develop a framework that clarifies processes around information sharing, HTA, funding, commissioning, and monitoring of highly specialized therapies and services (including cell and gene therapies). A draft national framework was developed that addresses assessment, funding, and implementation of high cost, highly specialized therapies and services (e.g., bone marrow transplants). However, it is unclear whether non-government stakeholders have been consulted.
ResultsThe framework for assessing, funding, and implementing high cost, highly specialized therapies and services across Australia’s public hospital system is pending endorsement by each of the jurisdictional governments. High-level in nature, the framework’s primary audiences are industry and public hospitals. While not all processes are in place, the framework is forward-looking. A detailed implementation plan is warranted to better inform the roles and requirements of each stakeholder.
ConclusionsThe framework allows stakeholders to better understand government processes regarding assessment, funding, and implementation of high-cost therapies and services, thereby fostering a collaborative environment that supports timely patient access. Articulating process details in a follow-up implementation plan is essential to gain the trust of, and input from, industry, clinicians, and patient representatives.
PP68 When Evidence Takes A Backseat To Politics – The Rise Of Robot Surgery In Australia
- Paul Fennessy
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 39 / Issue S1 / December 2023
- Published online by Cambridge University Press:
- 14 December 2023, p. S70
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Introduction
A 2018 health technology assessment (HTA) on robot-assisted surgery (RAS) led to a national committee recommendation, which some state Health Ministers adopted as policy, which stated: (i) no further public investment in RAS until subsequent HTAs demonstrate improved evidence; and (ii) clinical and patient outcomes from existing platforms should inform future decisions. This work also identified the Royal Australasian College of Surgeons (RACS) does not accredit any RAS training program for Australian surgeons, nor is there any nationally agreed or consistent credentialing mechanism, which creates ambiguity for hospitals (can this surgeon safely deliver?). Some state governments are ignoring its own policy and investing in RAS. At the same time, some public hospitals are ignoring the policy and procuring RAS through affiliated private hospitals. While market competition is expected to reduce price, governments responding to ‘squeaky wheels’ sets a dangerous precedent for high-cost technology procurement, especially if it needs to be replaced, and cost of delivery may not offset revenue generated.
MethodsAustralia’s states and territories can collaborate to commission HTAs. Since 2015, they have, jointly or independently, commissioned HTAs to monitor RAS evidence, which led to the 2018 HTA and policy. However, this policy is being ignored by hospitals and governments.
ResultsRACS is working with local agencies to develop accredited training programs for different RAS platforms, which should offer comfort to provider hospitals regarding surgeon credentialing. Surgeons and patients are increasingly vocal regarding RAS, resulting in some governments investing in RAS. Not consulting with all stakeholders has led to confusion and a questionable role for policy makers. Private hospitals operated by public hospitals are procuring RAS in contravention of the policy and with no consequences, creating further confusion.
ConclusionsWhile accredited surgeon training will improve skills and outcomes, governments ignoring their own policy is resulting in unplanned technology introduction, which led to the need for HTA in the first place. Do we need to rethink the role of HTA, or should we accept that politics trumps evidence?
Demonstrating the influence of HTA: INAHTA member stories of HTA impact
- Sophie Söderholm Werkö, Tracy Merlin, Laurie Jean Lambert, Paul Fennessy, Ana Pérez Galán, Tara Schuller
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 37 / Issue 1 / 2021
- Published online by Cambridge University Press:
- 05 November 2020, e8
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A central function of health technology assessment (HTA) agencies is the production of HTA reports to support evidence-informed policy and decision making. HTA agencies are interested in understanding the mechanisms of HTA impact, which can be understood as the influence or impact of HTA report findings on decision making at various levels of the health system. The members of the International Network of Agencies for HTA (INAHTA) meet at their annual Congress where impact story sharing is one important activity. This paper summarizes four stories of HTA impact that were finalists for the David Hailey Award for Best Impact Story.
The methods to measure impact include: document review; claims analysis and review of reimbursement status; citation analysis; qualitative evaluation of stakeholders’ views; and review of media response. HTA agency staff also observed changes in government activities and priorities based on the HTA. Impact assessment can provide information to improve the HTA process, for example, the value of patient and clinician engagement in the HTA process to better define the assessment question and literature reviews in a more holistic and balanced way.
HTA reports produced by publicly funded HTA agencies are valued by health systems around the globe as they support decision making regarding the appropriate use, pricing, reimbursement, and disinvestment of health technologies. HTAs can also have a positive impact on information sharing between different levels of government and across stakeholder groups. These stories show how HTA can have a significant impact, irrespective of the health system and health technology being assessed.
OP135 CAR T-cell Therapy HTA Informs Australian Policy
- Paul Fennessy, Vanessa Clements
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 35 / Issue S1 / 2019
- Published online by Cambridge University Press:
- 31 December 2019, pp. 30-31
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Introduction
Chimeric antigen receptor (CAR) T-cell therapy is offered as a once-only treatment for patients with certain cancers that are not responsive to standard treatment. While clinicians, patients and their families increasingly seek access to CAR T-cell therapy, there is no revenue stream to support access through public or private health systems.
MethodsThe New South Wales (NSW) Ministry of Health and Victorian Department of Health and Human Services oversighted a health technology assessment (HTA) to explore the status and geography of regulatory frameworks supporting delivery of CAR T-cell therapy, evidence for the safety, efficacy and cost, clinical trials conducted or underway and manufacturing aspects.
ResultsCAR T-cell therapies are approved in the European Union and United States of America, and being considered in Australia, Canada, China and Japan. Efficacy, safety and cost-effectiveness is limited by the size and single-arm design of early stage trials and variation between them. While overall response ranges from 36–93 percent, early results for some cancers are less favorable. Durability of treatment effect is unknown, adverse events are common and can be life-threatening and risk of delayed onset toxicity remains unknown. Treatment requires access to approved manufacturing facilities (none in Australia) and specialist clinical staff.
ConclusionsCAR T-cell therapy is promising and demand is increasing, but the limited safety profile and evidence base should mitigate policy and investment decisions. Broader consideration should be given to developing, or identifying access to, manufacturing and clinical workforce capability and capacity to meet national demand. Australia is likely to encounter similar issues in other jurisdictions, such as limited evidence base and complex safety issues. Factors to be considered on a local and national basis for assessment and implementation include: (i) Regulatory support for industry; (ii) Strategies to manage uncertainties in long-term risks, benefits and costs; (iii) Access to accredited manufacturing facilities; (iv) Developing clinical and manufacturing workforce capability and capacity.
OP64 Implementation Of Whole Exome Sequencing For Rare Diseases
- Paul Fennessy, Marianne Griffin
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 35 / Issue S1 / 2019
- Published online by Cambridge University Press:
- 31 December 2019, p. 16
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Introduction
The Victorian Department of Health and Human Services provided AUD 25 million (i.e. USD 17.3 million) over four years to determine the place of whole exome sequencing (WES) for patients attending public genetics clinics. Comparative analysis of WES and ‘usual care’ determined that WES increased diagnosis rate (from 14 to 58 percent), changed clinical management in one third of patients and identified relatives and couples at high risk of recurrence in future pregnancies. Translating this into routine care requires co-design with clinical and laboratory stakeholders.
MethodsVictoria's clinical and laboratory genetics service system uses a ‘hub and spoke’ model. Representatives from these were invited to join a ‘Clinical Adoption Group’ (CAG) to oversight implementation of new government funding (AUD 2 million (i.e. USD 1.4 million) per year) to ensure statewide access to, and funding of, WES for children with rare undiagnosed genetic conditions. The CAG developed terms of reference, ‘traffic light’ evidence-based eligibility criteria, a pricing model and reporting mechanism, and recommended funding for sequencing, curation, curator training and multidisciplinary team (MDT) meetings to support implementation.
ResultsFunding was distributed across hub and spoke sites reflecting clinical and laboratory demand and workforce requirements. All cases demonstrated clinical utility and were reviewed at MDT meetings. To date, 37 percent of patients have received a diagnosis changing management, with equity of access between metropolitan and regional areas demonstrated. Eligibility criteria are reviewed as new evidence is published to ensure new evidence is incorporated, although curation capacity limits turn-around-times.
ConclusionsCo-designing a statewide and evidence-based clinical model has resulted in sector (i.e. clinician and laboratory) buy-in and supported broad access to funded WES. In addition, the sector has developed a better understanding of how evidence informs policy and funding decisions, which has resulted in delivering equitable WES that provides early diagnosis leading to changed clinical management and cessation of unnecessary interventions.
OP44 Robot-Assisted Surgery: Joint HTA To Inform Australian Policy And Funding
- Paul Fennessy, Vanessa Clements, Olivia Hibbitt
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 35 / Issue S1 / 2019
- Published online by Cambridge University Press:
- 31 December 2019, p. 10
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Introduction
Robot-Assisted Surgery (RAS) has been available in Australia since 2003. There are 50 da Vinci RAS systems in Australia (18 in NSW and 12 in Victoria) with most in the private hospital sector. In Australia the capital cost of a da Vinci RAS system is up to AUD 4 million (USD 2.8 million), which excludes annual maintenance fees of AUD 250,000 (USD 175,000) and consumable costs of AUD 3,500 (USD 2,450) for each procedure.
MethodsThe NSW Ministry of Health and Victorian Department of Health and Human Services commissioned a health technology assessment (HTA) to explore the benefits, risks and economic implications of surgical robotics, which involved a review of the peer reviewed literature, a cost benefit analysis of public sector patients who received RAS and broad stakeholder consultation to document current perspectives on RAS applications.
ResultsRAS is as safe and effective as other surgical modalities when performed by sufficiently skilled surgeons, although evidence generally comes from small studies with limited follow-up time and few studies report long term mortality, morbidity or patient-reported outcomes. Comparative benefits of RAS are uncertain as most studies conclude little or no difference in procedure related or functional outcomes. While RAS reduces length of stay, which offers patient and health system benefits, this is insufficient to fully offset high capital and consumable costs currently charged to Australian providers. Government and clinical stakeholders identified that establishing an RAS service requires consideration of important factors, including: i) Governance is critical; ii) Higher case volumes may improve financial viability; and iii) a need for state-wide/national standards for surgeon training and credentialing.
ConclusionsRAS is as safe and effective as other modalities when performed by skilled surgeons. However, uncertainty remains around long-term outcomes and clinical and cost effectiveness. An accredited training program, monitoring and evaluation will be critical to ensure outcomes data inform ongoing evidence assessment and government policy and investment.
VP40 Robotic Surgery: From Health Technology Assessment To State Health Policy
- Paul Fennessy, Richard King
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, p. 169
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Introduction:
The aging population means more men are diagnosed with prostate cancer, resulting in greater demand for treatment. Robot-assisted radical prostatectomy (RARP) claims to offer additional benefits to patients and providers. The independent Victorian Health Technology Program Advisory Committee assessed safety, clinical effectiveness and cost effectiveness evidence and financial impact to inform policy, access and reimbursement decision-making by state government policy makers and public hospital providers.
Methods:Public and private hospital activity and costs for 2008–09 to 2012–13 from the Victorian Admitted Episodes Database (VAED) and the Victorian Cost Data Collection (VCDC) were identified. Data were extracted and reviewed based on (i) DRGs M01A and B, (ii) primary diagnostic code C61 (ICD-10-AM), and (iii) Australian Classification of Health Interventions procedure codes for open (ORP), laparoscopic (LRP) and RARP, supplemented by Victorian Prostate Cancer Clinical Registry data. English language Health Technology Assessments (HTAs)/systematic reviews published January 2009 to January 2015 were identified and analysed with comparative clinical outcomes data for RARP vs. ORP and RARP vs. LRP analysed. Not all reported the same data and most outcomes data presented were odds ratios and risk ratios.
Results:RARP offers patients a shorter length of stay (LOS) compared with ORP or LRP, but the procedure takes longer to perform. While RARP has similar safety and clinical effectiveness profiles compared with ORP and LRP, published data do not unequivocally demonstrate that RARP is superior to ORP or LRP in terms of clinical outcomes. RARP is more expensive than ORP and LRP. The cost differential increases when capital costs are taken into account. Cost offsets from a reduced LOS are insufficient to justify the higher cost.
Conclusions:Since RARP produces similar clinical outcomes to ORP and LRP but at a higher cost, the Victorian Health Technology Program Advisory Committee considered the case for public sector support of RARP is weak and provided two recommendations: (i) State Government resources are not used to procure RARP capital equipment; (ii) public hospitals can refer patients to a RARP provider, provided costs are negotiated prior to patient transfer and fully covered by the referring hospital.
OP65 Genomics: From Horizon Scanning To National Health Policy
- Paul Fennessy, Brendon Kearney, Linda Mundy, Margaret Howard
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, pp. 23-24
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Introduction:
Technology advances have resulted in cheaper and quicker genomic sequencing (panels, exomes, whole genomes). Uptake into clinical practice has been rapid despite limited consideration of workforce, patient safety, consent, practice standards, guidelines and cost benefit. AUD 150M (USD 113M) has been independently allocated to genomic initiatives by Australian state and federal governments that don't reflect a national approach to genomics.
Methods:Modified horizon scanning (HS) methodology identified issues around genomic sequencing to be considered by governments regarding their support, or otherwise, before appropriate implementation and diffusion into local healthcare systems. A national jurisdictional advisory group was subsequently established that undertook extensive stakeholder consultation across Australia, including written submissions, over a four-month period.
Results:HS identified that genomic sequencing is diffusing rapidly through the health system and flagged issues of pressing concern, including: workforce requirements; education, training and literacy for the medical workforce and community; infrastructure; data; and ethical, legal and social implications (ELSI). HealthPACT recommended a national coordinated approach to policy development across jurisdictional boundaries to ensure appropriate adoption of genomics. Stakeholder consultation confirmed overwhelming support for greater national coordination of the application of genomic knowledge in healthcare. Five strategic priorities were developed to support appropriate integration of genomics into health care for Australians: person-centered approach; workforce; financing; services; and, data. Three principles underpin strategic priorities: i) application of genomic knowledge is ethically, legally and socially responsible and community trust is promoted; ii) access and equity are promoted for vulnerable populations; and, iii) application of genomic knowledge to health care is supported and informed by evidence and research.
Conclusions:HS identified significant policy, workforce, funding and sustainability issues already facing state and territory governments that would, in time, face the federal government. The National Health Genomics Policy Framework outlines an agreed high-level national approach to policy, regulatory and investment decision-making for genomics and was approved by all Australian health Ministers in November 2017.
Assessment of the effectiveness of South Africa's marine protected areas at representing ichthyofaunal communities
- SOFÍA SOLANO-FERNÁNDEZ, COLIN G. ATTWOOD, RUSSELL CHALMERS, BARRY M. CLARK, PAUL D. COWLEY, TRACEY FAIRWEATHER, SEAN T. FENNESSY, ALBRECHT GÖTZ, TREVOR D. HARRISON, SVEN E. KERWATH, STEPHEN J. LAMBERTH, BRUCE Q. MANN, MALCOLM J. SMALE, LIEZE SWART
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- Environmental Conservation / Volume 39 / Issue 3 / September 2012
- Published online by Cambridge University Press:
- 16 April 2012, pp. 259-270
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National and international policies have encouraged the establishment of a representative network of marine protected areas (MPAs) in South Africa, with the aim of protecting marine biodiversity. The extent to which these marine and estuarine protected areas (EPAs) represent marine fish species and communities was assessed by comparing their species compositions with those of exploited areas, as sampled using four fishing techniques. Seven hundred fish species were sampled, representing one-third of South Africa's marine fishes. MPAs in coastal habitats scored c. 40% on the Bray-Curtis measure of similarity for species representativeness, but this score declined markedly for offshore ‘trawlable’ fishing grounds. The combined effects of sampling error, temporal variation and the effects of fishing on relative abundance suggest that 80% similarity would be the maximum achieveable. Forty-nine per cent of all fish species that were recorded were found in the 14 MPAs sampled. Redundancy in the MPA network was low, with fish species most commonly being represented in only one MPA or absent. There was greater redundancy in the 33 EPAs, with 40% of species being found in two or more EPAs, but many of these estuaries were adjacent to each other and embedded in large MPAs. Deep water fish communities (>80 m deep) and communities located on the west and south-east coasts of South Africa were most poorly represented by MPAs. Routine fishery surveys provide a robust and repeatable opportunity to assess species representativeness in MPAs, and the method used could form the basis of an operational definition of ‘representative’. In contrast to an assessment based on presence-absence data, this analysis of quantitative data presents a more pessimistic assessment of protection.