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Australian Health Review Australian Health Review Society
Journal of the Australian Healthcare & Hospitals Association
RESEARCH ARTICLE

Factors associated with Pharmaceutical Benefits Advisory Committee decisions for listing medicines for diabetes and its associated complications

Mohammad M. Haque A , Mutsa Gumbie B , Megan Gu B and Gnanadarsha Dissanayake C D *
+ Author Affiliations
- Author Affiliations

A Translational Health Research Institute, School of Medicine, Western Sydney University, Parkside Cresent, Campbelltown, NSW 2560, Australia.

B Macquarie University Centre for the Health Economy, Macquarie University, Macquarie Park, NSW, Australia.

C New South Wales Ministry of Health, NSW, Australia.

D School of Mathematics and Statistics, University of Sydney, NSW, Australia.

Australian Health Review 47(2) 139-147 https://doi.org/10.1071/AH22198
Submitted: 8 January 2022  Accepted: 24 November 2022   Published: 22 December 2022

© 2023 The Author(s) (or their employer(s)). Published by CSIRO Publishing on behalf of AHHA.

Abstract

Objective To retrospectively analyse the key factors associated with listing decisions by the Pharmaceutical Benefits Advisory Committee (PBAC) for medicines for diabetes and its complications on the Pharmaceutical Benefits Scheme.

Methods The clinical and economic evidence were retrieved from public summary documents (PSD) of all major submissions between July 2005 and March 2020. A multivariate binary logit regression analysis was conducted to assess the relationship between the categorical explanatory variables and PBAC recommendations.

Results We identified a total of 211 PSD of which 118 (56%) were recommended for listing. Clinical and economic uncertainty were significantly and inversely associated with the PBAC recommendation. Submissions with high clinical and economic uncertainty were less likely to be recommended.

Conclusion Our findings will enhance the understanding of medical professionals, pharmaceutical companies, and other stakeholders about the rationale of PBAC reimbursement decisions for these medicines and assist prospective applicant sponsor companies in preparing their submissions.

Keywords: comorbid, complications, diabetes, factor, PBAC, PBS, PSD, recommendation.


References

[1]  Australian Bureau of Statistics. Causes of death, Australia. Canberra: ABS; 2021. Available at https://www.abs.gov.au/statistics/health/causes-death/causes-death-australia/2020 [verified 16 July 2022].

[2]  Australian Institute of Health and Welfare. Diabetes. Canberra: Commonwealth of Australia; 2020. Available at https://www.aihw.gov.au/reports/diabetes/diabetes/contents/deaths-from-diabetes [verified 6 March 2021].

[3]  Australian Bureau of Statistics. Diabetes. Canberra: ABS; 2022. Available at https://www.abs.gov.au/statistics/health/health-conditions-and-risks/diabetes/latest-release [verified 16 July 2022].

[4]  Iglay K, Hannachi H, Joseph Howie P, et al. Prevalence and co-prevalence of comorbidities among patients with type 2 diabetes mellitus. Curr Med Res Opin 2016; 32 1243–52.
Prevalence and co-prevalence of comorbidities among patients with type 2 diabetes mellitus.Crossref | GoogleScholarGoogle Scholar |

[5]  Pimentel LGM, Gracitelli CPB, Sant’Ana Cardoso da Silva L, et al. Association between Glucose Levels and Intraocular Pressure: Pre- and Postprandial Analysis in Diabetic and Nondiabetic Patients. J Ophthalmol 2015; 2015 832058
Association between Glucose Levels and Intraocular Pressure: Pre- and Postprandial Analysis in Diabetic and Nondiabetic Patients.Crossref | GoogleScholarGoogle Scholar |

[6]  Varma R, Bressler NM, Doan QV, et al. Prevalence of and risk factors for diabetic macular edema in the United States. JAMA Ophthalmol 2014; 132 1334–40.
Prevalence of and risk factors for diabetic macular edema in the United States.Crossref | GoogleScholarGoogle Scholar |

[7]  Dunstan DW, Zimmet PZ, Welborn TA, et al. The rising prevalence of diabetes and impaired glucose tolerance: the Australian Diabetes, Obesity and Lifestyle Study. Diabetes Care 2002; 25 829–34.
The rising prevalence of diabetes and impaired glucose tolerance: the Australian Diabetes, Obesity and Lifestyle Study.Crossref | GoogleScholarGoogle Scholar |

[8]  Magliano DJ, Shaw JE, Shortreed SM, et al. Lifetime risk and projected population prevalence of diabetes. Diabetologia 2008; 51 2179–86.
Lifetime risk and projected population prevalence of diabetes.Crossref | GoogleScholarGoogle Scholar |

[9]  Davis WA, Peters KE, Makepeace A, et al. Prevalence of diabetes in Australia: insights from the Fremantle Diabetes Study Phase II. Intern Med J 2018; 48 803–9.
Prevalence of diabetes in Australia: insights from the Fremantle Diabetes Study Phase II.Crossref | GoogleScholarGoogle Scholar |

[10]  Tapp RJ, Shaw JE, Harper CA, et al. The prevalence of and factors associated with diabetic retinopathy in the Australian population. Diabetes Care 2003; 26 1731–7.
The prevalence of and factors associated with diabetic retinopathy in the Australian population.Crossref | GoogleScholarGoogle Scholar |

[11]  Mathew TH, Corso O, Ludlow M, et al. Screening for chronic kidney disease in Australia: a pilot study in the community and workplace. Kidney Int 2010; 77 S9–16.
Screening for chronic kidney disease in Australia: a pilot study in the community and workplace.Crossref | GoogleScholarGoogle Scholar |

[12]  Davis JW, Chung R, Juarez DT. Prevalence of comorbid conditions with aging among patients with diabetes and cardiovascular disease. Hawaii Med J 2011; 70 209–13.

[13]  Walls HL, Magliano DJ, Stevenson CE, et al. Projected progression of the prevalence of obesity in Australia. Obesity 2012; 20 872–8.
Projected progression of the prevalence of obesity in Australia.Crossref | GoogleScholarGoogle Scholar |

[14]  Roever L, Tse G, Biondi-Zoccai G. Trends in cardiovascular disease in Australia and in the world. Eur J Prev Cardiol 2018; 25 1278–9.
Trends in cardiovascular disease in Australia and in the world.Crossref | GoogleScholarGoogle Scholar |

[15]  Keel S, Xie J, Foreman J, et al. Prevalence of glaucoma in the Australian National Eye Health Survey. Br J Ophthalmol 2019; 103 191–5.
Prevalence of glaucoma in the Australian National Eye Health Survey.Crossref | GoogleScholarGoogle Scholar |

[16]  Lee CMY, Colagiuri R, Magliano DJ, et al. The cost of diabetes in adults in Australia. Diabetes Res Clin Pract 2013; 99 385–90.
The cost of diabetes in adults in Australia.Crossref | GoogleScholarGoogle Scholar |

[17]  Jan S, Essue BM, Leeder SR. Falling through the cracks: the hidden economic burden of chronic illness and disability on Australian households. Med J Aust 2012; 196 29–31.
Falling through the cracks: the hidden economic burden of chronic illness and disability on Australian households.Crossref | GoogleScholarGoogle Scholar |

[18]  Ademi Z, Liew D, Chew D, et al. Drug treatment and cost of cardiovascular disease in Australia. Cardiovasc Ther 2009; 27 164–72.
Drug treatment and cost of cardiovascular disease in Australia.Crossref | GoogleScholarGoogle Scholar |

[19]  Colagiuri S, Lee CMY, Colagiuri R, et al. The cost of overweight and obesity in Australia. Med J Aust 2010; 192 260–4.
The cost of overweight and obesity in Australia.Crossref | GoogleScholarGoogle Scholar |

[20]  Wyld MLR, Lee CMY, Zhuo X, et al. Cost to government and society of chronic kidney disease stage 1–5: a national cohort study. Intern Med J 2015; 45 741–7.
Cost to government and society of chronic kidney disease stage 1–5: a national cohort study.Crossref | GoogleScholarGoogle Scholar |

[21]  Dirani M, Crowston JG, Taylor PS, et al. Economic impact of primary open-angle glaucoma in Australia. Clin Exp Ophthalmol 2011; 39 623–32.
Economic impact of primary open-angle glaucoma in Australia.Crossref | GoogleScholarGoogle Scholar |

[22]  Cieslik LK, Cresswell NR, Fineberg D, Mariani JA, Patel HC. Prescription trends and costs of diabetes medications in Australia between 2003 and 2019: an analysis and review of the literature. Intern Med J 2022; 52 841–7.
Prescription trends and costs of diabetes medications in Australia between 2003 and 2019: an analysis and review of the literature.Crossref | GoogleScholarGoogle Scholar |

[23]  Diabetes Australia. Managing your diabetes. Canberra: Diabetes Australia; 2021. Available at https://www.diabetesaustralia.com.au/managing‐diabetes/ [verified 15 March 2021].

[24]  Piette JD, Kerr EA. The impact of comorbid chronic conditions on diabetes care. Diabetes Care 2006; 29 725–31.
The impact of comorbid chronic conditions on diabetes care.Crossref | GoogleScholarGoogle Scholar |

[25]  Standards of medical care for patients with diabetes mellitus. Diabetes Care 2003; 25 S33–49.
Standards of medical care for patients with diabetes mellitus.Crossref | GoogleScholarGoogle Scholar |

[26]  Struijs JN, Baan CA, Schellevis FG, et al. Comorbidity in patients with diabetes mellitus: impact on medical health care utilization. BMC Health Serv Res 2006; 6 84
Comorbidity in patients with diabetes mellitus: impact on medical health care utilization.Crossref | GoogleScholarGoogle Scholar |

[27]  McEwen LN, Casagrande SS, Kuo S, Herman WH. Why Are Diabetes Medications So Expensive and What Can Be Done to Control Their Cost? Curr Diab Rep 2017; 17 71
Why Are Diabetes Medications So Expensive and What Can Be Done to Control Their Cost?Crossref | GoogleScholarGoogle Scholar |

[28]  Conner F, Pfiester E, Elliott J, Slama-Chaudhry A. Unaffordable insulin: patients pay the price. Lancet Diabetes Endocrinol 2019; 7 748
Unaffordable insulin: patients pay the price.Crossref | GoogleScholarGoogle Scholar |

[29]  Babar Z-U-D, Ramzan S, El-Dahiyat F, Tachmazidis I, Adebisi A, Hasan SS. The Availability, Pricing, and Affordability of Essential Diabetes Medicines in 17 Low-, Middle-, and High-Income Countries. Front Pharmacol 2019; 10 1375
The Availability, Pricing, and Affordability of Essential Diabetes Medicines in 17 Low-, Middle-, and High-Income Countries.Crossref | GoogleScholarGoogle Scholar |

[30]  Chin KL, Hidayat FM, Ofori-Asenso R, et al. Trends in the Dispensing and Costs of Glucose-Lowering Medications Among Older Australians: Findings from National Claims Data. Drugs Aging 2020; 37 393–8.
Trends in the Dispensing and Costs of Glucose-Lowering Medications Among Older Australians: Findings from National Claims Data.Crossref | GoogleScholarGoogle Scholar |

[31]  Australian Government Department of Health. About the PBS. Canberra: Commonwealth of Australia; 2021. Available at http://www.pbs.gov.au/info/about-the-pbs [verified 17 January 2021].

[32]  Australian Government Department of Health. Pharmaceutical Benefits Advisory Committee (PBAC) Membership. Canberra: Commonwealth of Australia; 2021. Available at https://www.pbs.gov.au/info/industry/listing/participants/pbac [verified 21 March 2021].

[33]  Australian Government Department of Health. Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (PBAC). Canberra: Commonwealth of Australia; 2016. Available at https://pbac.pbs.gov.au [verified 28 January 2021].

[34]  Australian Government Department of Health. Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme (including consideration of vaccines for the National Immunisation Program). Canberra: Commonwealth of Australia; 2021. Available at http://www.pbs.gov.au/info/industry/listing/listing-steps [verified 17 April 2021].

[35]  Australian Government Department of Health. Public Summary Documents by Product. Canberra: Commonwealth of Australia; 2021. Available at https://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/public-summary-documents-by-product [verified 17 April 2021].

[36]  Clement FM, Harris A, Li JJ, et al. Using effectiveness and cost-effectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada. JAMA 2009; 302 1437–43.
Using effectiveness and cost-effectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada.Crossref | GoogleScholarGoogle Scholar |

[37]  Mauskopf J, Chirila C, Masaquel C, et al. Relationship between financial impact and coverage of drugs in Australia. Int J Technol Assess Health Care 2013; 29 92–100.
Relationship between financial impact and coverage of drugs in Australia.Crossref | GoogleScholarGoogle Scholar |

[38]  Turkstra E, Bettington E, Donohue ML, et al. Pharmaceutical Benefits Advisory Committee Recommendations in Australia. Int J Technol Assess Health Care 2017; 33 521–8.
Pharmaceutical Benefits Advisory Committee Recommendations in Australia.Crossref | GoogleScholarGoogle Scholar |

[39]  Chim L, Kelly PJ, Salkeld G, et al. Are cancer drugs less likely to be recommended for listing by the Pharmaceutical Benefits Advisory Committee in Australia? Pharmacoeconomics 2010; 28 463–75.
Are cancer drugs less likely to be recommended for listing by the Pharmaceutical Benefits Advisory Committee in Australia?Crossref | GoogleScholarGoogle Scholar |

[40]  Karikios DJ, Chim L, Martin A, et al. Is it all about price? Why requests for government subsidy of anticancer drugs were rejected in Australia. Intern Med J 2017; 47 400–7.
Is it all about price? Why requests for government subsidy of anticancer drugs were rejected in Australia.Crossref | GoogleScholarGoogle Scholar |

[41]  Australian Government Department of Health. Confidentiality and transparency. Canberra: Commonwealth of Australia; 2021. Available at https://www.pbs.gov.au/info/industry/listing/procedure-guidance/3-confidentiality-transparency/confidentiality-and-transparency [verified 11 March 2021].

[42]  Rocchi A, Miller E, Hopkins RB, et al. Common Drug Review recommendations: an evidence base for expectations? Pharmacoeconomics 2012; 30 229–46.
Common Drug Review recommendations: an evidence base for expectations?Crossref | GoogleScholarGoogle Scholar |

[43]  Abraham J. The pharmaceutical industry as a political player. Lancet 2002; 360 1498–502.
The pharmaceutical industry as a political player.Crossref | GoogleScholarGoogle Scholar |

[44]  Australian Government Department of Health. Section 2 Clinical evaluation. Canberra: Commonwealth of Australia; 2016. Available at https://pbac.pbs.gov.au/section 2-clinical-evaluation.html [verified 5 April 2021].

[45]  Wonder M, Dunlop S. Assessment of the Quality of the Clinical Evidence in Submissions to the Australian Pharmaceutical Benefits Advisory Committee: Fit for Purpose? Value Health 2015; 18 467–76.
Assessment of the Quality of the Clinical Evidence in Submissions to the Australian Pharmaceutical Benefits Advisory Committee: Fit for Purpose?Crossref | GoogleScholarGoogle Scholar |

[46]  Niyomnaitham S, Page A, La Caze A, et al. Utilisation trends of rosiglitazone and pioglitazone in Australia before and after safety warnings. BMC Health Serv Res 2014; 14 151
Utilisation trends of rosiglitazone and pioglitazone in Australia before and after safety warnings.Crossref | GoogleScholarGoogle Scholar |

[47]  Hill SR, Mitchell AS, Henry DA. Problems with the interpretation of pharmacoeconomic analyses: a review of submissions to the Australian Pharmaceutical Benefits Scheme. JAMA 2000; 283 2116–21.
Problems with the interpretation of pharmacoeconomic analyses: a review of submissions to the Australian Pharmaceutical Benefits Scheme.Crossref | GoogleScholarGoogle Scholar |

[48]  George B, Harris A, Mitchell A. Cost-effectiveness analysis and the consistency of decision making: evidence from pharmaceutical reimbursement in Australia (1991 to 1996). Pharmacoeconomics 2001; 19 1103–9.
Cost-effectiveness analysis and the consistency of decision making: evidence from pharmaceutical reimbursement in Australia (1991 to 1996).Crossref | GoogleScholarGoogle Scholar |

[49]  Harris AH, Hill SR, Chin G, et al. The role of value for money in public insurance coverage decisions for drugs in Australia: a retrospective analysis 1994-2004. Med Decis Making 2008; 28 713–22.
The role of value for money in public insurance coverage decisions for drugs in Australia: a retrospective analysis 1994-2004.Crossref | GoogleScholarGoogle Scholar |

[50]  Ngo P. The Influence of Cost-Effectiveness Evaluations on Reimbursement in Australia: A Retrospective Study of Decisions made by the Pharmaceutical Benefits Advisory Committee. Pharmaceut Med 2014; 28 187–93.
The Influence of Cost-Effectiveness Evaluations on Reimbursement in Australia: A Retrospective Study of Decisions made by the Pharmaceutical Benefits Advisory Committee.Crossref | GoogleScholarGoogle Scholar |

[51]  Harris A, Li JJ, Yong K. What Can We Expect from Value-Based Funding of Medicines? A Retrospective Study. Pharmacoeconomics 2016; 34 393–402.
What Can We Expect from Value-Based Funding of Medicines? A Retrospective Study.Crossref | GoogleScholarGoogle Scholar |

[52]  Schey C, Meier G, Pan J. Metastatic Renal Cell Cancer: An Analysis of Reimbursement Decisions. Adv Ther 2019; 36 1266–78.
Metastatic Renal Cell Cancer: An Analysis of Reimbursement Decisions.Crossref | GoogleScholarGoogle Scholar |

[53]  Wonder M, Chin G. What impact does ‘conventional’ economic evaluation have on patient access to new orphan medicines? A comparative study of their reimbursement in Australia (2005–2012). Expert Rev Pharmacoecon Outcomes Res 2015; 15 843–50.
What impact does ‘conventional’ economic evaluation have on patient access to new orphan medicines? A comparative study of their reimbursement in Australia (2005–2012).Crossref | GoogleScholarGoogle Scholar |

[54]  Phan YHL, De Abreu Lourenco R, Haas M, et al. Key considerations in reimbursement decision-making for multiple sclerosis drugs in Australia. Mult Scler Relat Disord 2018; 25 144–9.
Key considerations in reimbursement decision-making for multiple sclerosis drugs in Australia.Crossref | GoogleScholarGoogle Scholar |

[55]  Australian Government Department of Health. PBAC Statement of Endorsement for transparency measures and standardised redactions to Public Summary Documents. 23 July 2020. Available at https://www.pbs.gov.au/pbs/news/2020/07/pbac-statement-of-endorsement-for-transparency-measures [verified 16 February 2021].