Why is There Discordance between the Reimbursement of High-Cost ‘Life-Extending’ Pharmaceuticals and Medical Devices? The Funding of Ventricular Assist Devices in Australia
New health technologies often yield health benefits, but often at a high cost. In Australia, the processes for public reimbursement of high-cost pharmaceuticals and medical devices are different, potentially resulting in inequity in support for new therapies. We explore how reimbursement is different for medical devices compared with pharmaceuticals, including whether higher cost-effectiveness thresholds are accepted for pharmaceuticals. A literature review identified the challenges of economic evaluations for medical devices compared with pharmaceuticals. We used the ventricular assist device as a case study to highlight specific features of medical device funding in Australia. We used existing guidelines to evaluate whether ventricular assist devices would fulfil the requirements for the “Life-Saving Drugs Program”, which is usually reserved for expensive life–extending pharmaceutical treatments of serious and rare medical conditions. The challenges in conducting economic evaluations of medical devices include limited data to support effectiveness, device-operator interaction (surgical experience) and incremental innovations (miniaturisation). However, whilst high-cost pharmaceuticals may be funded by a single source (federal government), the funding of high-cost devices is complex and may be funded via a combination of federal, state and private health insurance. Based on the Life-Saving Drugs Program criteria, we found that ventricular assist devices could be funded by a similar mechanism to that which funds high-cost life-extending pharmaceuticals. This article highlights the complexities of medical device reimbursement. Whilst differences in available evidence affect the evaluation process, differences in funding methods contribute to inequitable reimbursement decisions between medical devices and pharmaceuticals.
SS, NvDL and SG designed and wrote the manuscript; CH reviewed the manuscript and provided clinical input. All authors read and approved the final manuscript.
Compliance with Ethical Standards
This research is supported by an Australian Government Research Training Program Scholarship.
Conflict of interest
Sopany Saing and Stephen Goodall have no conflicts of interest that are directly relevant to the content of this article. Naomi van der Linden is employed by AstraZeneca Netherlands. Christopher Hayward has received honoraria and grants from Medtronic LLC unrelated to the current article. Christopher Hayward has received travel support to attend meetings and speak at meetings sponsored by Novartis AG and Medtronic LLC, unrelated to the current article. St Vincent’s Hospital owns patents licensed to Medtronic LLC unrelated to the current article.
Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.
- 1.Australian Government Department of Health. Pharmaceutical Benefits Scheme—hepatitis C medicines 2016. Canberra (ACT); 2016.Google Scholar
- 2.Australian Minister for Health. PBS listing for Kalydeco and Soliris. Canberra (ACT): The Hon Peter Dutton MP Minister for Health; 2014.Google Scholar
- 3.Australian Government Department of Health. Application 1519: tisagenlecleucel (CTL019) for treatment of refractory/relapsed CD19-positive leukaemia and lymphoma. PICO confirmation: Medical Services Advisory Committee; 2018 (last updated: 25 Jun 2018). http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1519-public. Accessed 10 Jan 2019.
- 5.Australian Government Department of Health. Prostheses list: part A. Canberra (ACT): Australian Government Department of Health; 2018.Google Scholar
- 7.Baumgardner JR, Neumann PR. Balancing the use of cost-effectiveness analysis across all types of health care innovations. 2017. http://healthaffairs.org/blog/2017/04/14/balancing-the-use-of-cost-effectiveness-analysis-across-all-types-of-health-care-innovations/. Accessed 14 Apr 2017.
- 12.Heart Foundation. Heart transplants and organ donation. Canberra (ACT): The Heart Foundation; 2010. https://www.heartfoundation.org.au/images/uploads/publications/Heart-Transplants-Donations.pdf. Accessed 21 Mar 2019.
- 16.Jarl J, Gerdtham U-G. Economic evaluations of organ transplantations—a systematic literature review. Nordic J Health Econ. 2012;1(1):61–82.Google Scholar
- 18.Clarke A, Pulikottil-Jacob R, Connock M, Suri G, Kandala N-B, Maheswaran H, et al. Cost-effectiveness of left ventricular assist devices (LVADs) for patients with advanced heart failure: analysis of the British NHS bridge to transplant (BTT) program. Int J Cardiol. 2014;171(3):338–45.CrossRefPubMedGoogle Scholar
- 21.Pulikottil-Jacob R, Suri G, Connock M, Kandala N-B, Sutcliffe P, Maheswaran H, et al. Comparative cost-effectiveness of the HeartWare versus HeartMate II left ventricular assist devices used in the United Kingdom National Health Service bridge-to-transplant program for patients with heart failure. J Heart Lung Transplant. 2014;33(4):350–8.CrossRefPubMedGoogle Scholar
- 22.Sharples LD, Dyer M, Cafferty F, Demiris N, Freeman C, Banner NR, et al. Cost-effectiveness of ventricular assist device use in the United Kingdom: results from the evaluation of Ventricular Assist Device Programme in the UK (EVAD-UK). J Heart Lung Transpl. 2006;25(11):1336–43.CrossRefGoogle Scholar
- 30.Australian Government Department of Health. Medicare benefits schedule book. 1 May 2017 ed. Canberra (ACT): Commonwealth of Australia; 2017.Google Scholar
- 32.Australian Institute of Health and Welfare. Hospital resources 2015–16: Australian hospital statistics. Canberra (ACT): Australian Institute of Health and Welfare; 2017.Google Scholar
- 33.Association Australian Private Hospitals. Private hospitals service provision: APHA facts on private hospitals. Canberra (ACT): Australian Private Hospitals Association; 2016.Google Scholar
- 35.National Health Service. National institute for Health and Clinical Excellence. Appraising life-extending, end of life treatments. 2009. https://www.nice.org.uk/guidance/gid-tag387/resources/appraising-life-extending-end-of-life-treatments-paper2. Accessed 27 Feb 2017.
- 36.National Institute for Health and Clinical Excellence. Abiraterone for castration resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen 2012. https://www.nice.org.uk/guidance/TA259. Accessed 18 Mar 2019.
- 40.Australian Government Department of Health. Life Saving Drugs Program—Information for patients, prescribers and pharmacists. Canberra (ACT); 2019. http://www.health.gov.au/internet/main/publishing.nsf/Content/lsdp-criteria. Accessed 10 Jan 2019.
- 41.University of Adelaide. Life Saving Drugs Programme review: technical assessment. Canberra (ACT): Pharmaceutical Benefits Schedule. 2015. http://www.pbs.gov.au/reviews/lsdp-technical-assessment-report/lsdp-review-technical-assessment-april-2015.pdf. Accessed 21 Mar 2019.
- 42.Australian Government Department of Health. Procedure guidance for medicines funded through the Life Saving Drugs Program (LSDP). Canberra (ACT); 2018. http://www.health.gov.au/internet/main/publishing.nsf/content/FD13E541FA14735CCA257BF0001B0AC0/$File/Procedure-guidance-for-medicines-funded-through-the-LSDP.pdf. Accessed 21 Mar 2019.
- 43.Australian Institute of Health and Welfare. Cardiovascular disease, diabetes and chronic kidney disease: Australian facts. Prevalence and incidence. Canberra (ACT): Australian Institute of Health and Welfare; 2014.Google Scholar
- 46.Australian Government Department of Health. Medicare benefits schedule book: operating from 01 May 2017. Canberra (ACT): Australian Government Department of Health; 2017.Google Scholar
- 47.Canadian Agency for Drugs and Technologies in Health. Drugs for rare diseases: evolving trends in regulatory and health technology assessment perspectives. Ottawa: CADTH; 2013 [updated 2016 Feb]. (Environmental scan; issue 42).Google Scholar
- 50.Shemesh E, Deroma L, Bembi B, Deegan P, Hollak C, Weinreb NJ, et al. Enzyme replacement and substrate reduction therapy for Gaucher disease. Cochrane Database Syst Rev. 2015;3:CD010324.Google Scholar
- 51.El Dib R, Gomaa H, Carvalho RP, Camargo SE, Bazan R, Barretti P, et al. Enzyme replacement therapy for Anderson–Fabry disease. Cochrane Database Syst Rev. 2016;7:CD0066632016.Google Scholar
- 52.Estep JD, Starling RC, Horstmanshof DA, Milano CA, Selzman CH, Shah KB, et al. Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: results from the ROADMAP study. J Am Coll Cardiol. 2015;66(16):1747–61.CrossRefPubMedGoogle Scholar
- 55.Pharmaceutical Benefits Scheme. Life Savings Drugs Program. Canberra (ACT): Australian Government Department of Health; 2016. http://www.health.gov.au/internet/main/publishing.nsf/Content/lsdp-criteria. Accessed 21 Mar 2019.