Advertisement

Using Post-market Utilisation Analysis to Support Medicines Pricing Policy: An Australian Case Study of Aflibercept and Ranibizumab Use

  • Anna Kemp-Casey
  • Nicole Pratt
  • Emmae Ramsay
  • Elizabeth E. Roughead
Original Research Article

Abstract

Objectives

To describe how post-market utilisation analysis in Australia informs cost-effectiveness assessment and pricing decisions, using aflibercept and ranibizumab as case studies.

Methods

Pharmaceutical claims were used to identify initiators of aflibercept and ranibizumab in the year after aflibercept-listing (December 2012), and ranibizumab initiators in the year before aflibercept listing. The dispensing rates for each cohort were calculated, and their demographic and clinical characteristics compared using Kruskal–Wallis tests.

Results

Aflibercept and ranibizumab each accounted for half the age-related macular degeneration market following ranibizumab listing. Aflibercept initiators had similar dispensing rates to ranibizumab initiators in the pre- and post-aflibercept era (~ three scripts during the first 90 days, and eight to nine scripts during the following 12 months). All cohorts were similar in terms of their age, sex, residential aged-care status and geographic remoteness, and no differences were observed in their overall co-morbidity scores and history of thromboembolic events.

Conclusions

Contrary to clinical trial protocols, post-market utilisation research for ranibizumab and aflibercept demonstrates equivalent use in practice in terms of dose frequency, and the demographic and clinical characteristics of initiators. This supports Australia’s decision to pay the same price for each rather than giving a premium to aflibercept. Many other countries are likely overpaying for aflibercept if their utilization patterns are similar to Australia’s, and could benefit from incorporating routine utilisation assessment.

Notes

Acknowledgements

We are grateful to Dr Alicia Segrave, DUSC Secretary, for comments on an earlier draft of this paper. This work was supported by an Australian Government National Health and Medical Research Council Centre of Research Excellence in Post-Marketing Surveillance of Medicines and Medical Devices grant (GNT1040938).The funding organization had no role in the design or conduct of this research.

Data Availability Statement

This study involved the analysis of existing health service data collected by the Australian Department of Veterans’ Affairs. These data are only available to researchers who have received ethical and scientific approval. Further information about data access is available at https://www.dva.gov.au/health-and-wellbeing/research-and-development/dva-data-research.

Author Contributions

EER and AKC conceived the study. EER, NP and ER assisted with the acquisition of data. AKC drafted the manuscript. ER performed the statistical analyses. NP aided with data interpretation and critically reviewed the statistical content of the manuscript. All authors read, critically reviewed and approved the final manuscript.

Compliance with ethical standards

Ethics approval was obtained from the University of South Australia Human Research Ethics Committee (reference, P099/10) and the Department of Veterans’ Affairs Human Research Ethics Committee (reference, E010/010). This work was supported by an Australian Government National Health and Medical Research Council Centre of Research Excellence in Post-Marketing Surveillance of Medicines and Medical Devices grant (GNT1040938).The funding organization had no role in the design or conduct of this research. NP and EER are current members, and AK is a former member, of the Drug Utilisation Sub Committee of the Pharmaceutical Benefits Advisory Committee. The views expressed in this paper do not necessarily reflect the views of the Drug Utilisation Sub Committee or the Australian Department of Health. ER has no conflicts to declare.

References

  1. 1.
    Booth CM, Tannock IF. Randomised controlled trials and population-based observational research: partners in the evolution of medical evidence. Br J Cancer. 2014;110:551.CrossRefGoogle Scholar
  2. 2.
    Department of Health and Ageing. About the PBS. 2017; http://www.pbs.gov.au/info/about-the-pbs. Accessed 13 Dec 2017.
  3. 3.
    Drug Utilisation Sub-Committee. Age related macular degeneration: utilisation analysis. 2015. http://www.pbs.gov.au/info/industry/listing/participants/public-release-docs/aflibercept-ranibizumab-prd-2015-06. Accessed 10 Aug 2017.
  4. 4.
    Brown DM, Kaiser PK, Michels M. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1432–44.CrossRefGoogle Scholar
  5. 5.
    Brown DM, Michels M, Kaiser PK, et al. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: two-year results of the ANCHOR study. Ophthalmology. 2009;116:57–65.CrossRefGoogle Scholar
  6. 6.
    Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1419–31.CrossRefGoogle Scholar
  7. 7.
    Department of Health. Public summary document for Ranibizumab, solution for intravitreal injection, 3.0 mg/0.3 mL, Lucentis®, March 2007. 2007; http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2007-03/pbac-psd-ranibizumab-mar07/. Accessed 24 Oct 2018.
  8. 8.
    Heier JS, Brown DM, Chong V, et al. Intravitreal aflibercept (VEGF Trap-Eye) in wet age-related macular degeneration. Ophthalmology. 2012;119:2537–48.CrossRefGoogle Scholar
  9. 9.
    Department of Health. Public summary document for Aflibercept, solution for intravitreal injection, 40 mg per mL, Eylea®—March 2012. 2012. http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2012-03/aflibercept.pdf. Accessed 24 Oct 2018.
  10. 10.
    Australian Government Department of Health. PBS and RPBS section 85 date of processing and date of supply data. 2018; http://www.pbs.gov.au/info/statistics/dos-and-dop/dos-and-dop. Accessed 15 Mar 2018.
  11. 11.
    Methodology. WHOCCfDS. International language for drug utilisation research. www.whocc.no/. Accessed 3 Mar 2017.
  12. 12.
    Affairs AGDoV. Veterans’ health cards. 2014; https://www.dva.gov.au/health-and-wellbeing/veterans-health-cards. Accessed 11 May 2017.
  13. 13.
    Hugo Centre for Migration and Population Research. ARIA and Accessibility. 2017; http://www.adelaide.edu.au/apmrc/research/projects/category/aria.html. Accessed 29 June 2017.
  14. 14.
    Sales AE, Liu CF, Sloan KL, et al. Predicting costs of care using a pharmacy-based measure risk adjustment in a veteran population. Med Care. 2003;41:753–60.PubMedGoogle Scholar
  15. 15.
    Lu CY, Barratt J, Vitry A, Roughead E. Charlson and Rx-Risk comorbidity indices were predictive of mortality in the Australian health care setting. J Clin Epidemiol. 2011;64:223–8.CrossRefGoogle Scholar
  16. 16.
    National Centre for Classification in Health. The international statistical classification of diseases and related health problems, 10th revision, Australian modification (ICD-10-AM). Sydney: National Centre for Classification in Health; 2006.Google Scholar
  17. 17.
    Gillies MC, Nguyen V, Daien V, et al. Twelve-month outcomes of ranibizumab vs. aflibercept for neovascular age-related macular degeneration: data from an observational study. Ophthalmology. 2016;123:2545–2553.CrossRefGoogle Scholar
  18. 18.
    Skelly A, Carius H, Bezlyak V, Chen FK. Dispensing patterns of ranibizumab and aflibercept for the treatment of neovascular age-related macular degeneration: a retrospective cohort study in Australia. Adv Ther. 2017;34:2585–600.CrossRefGoogle Scholar
  19. 19.
    Ferreira A, Sagkriotis A, Olson M, et al. Treatment frequency and dosing interval of ranibizumab and aflibercept for neovascular age-related macular degeneration in routine clinical practice in the USA. PLoS One. 2015;10:e0133968.CrossRefGoogle Scholar
  20. 20.
    Johnston S, Wilson K, Huang A, et al. Retrospective analysis of first-line anti-vascular endothelial growth factor treatment patterns in wet age-related macular degeneration. Adv Ther. 2013;30:1111–27.CrossRefGoogle Scholar
  21. 21.
    Lotery A, Griner R, Ferreira A, Milnes F, Dugel P. Real-world visual acuity outcomes between ranibizumab and aflibercept in treatment of neovascular AMD in a large US data set. Eye. 2017;31:1697–706.CrossRefGoogle Scholar
  22. 22.
    Vorum H, Olesen TK, Zinck J, Størling Hedegaard M. Real world evidence of use of anti-VEGF therapy in Denmark. Curr Med Res Opin. 2016;32:1943–50.CrossRefGoogle Scholar
  23. 23.
    Holz FG, Bandello F, Gillies M, et al. Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme. Br J Ophthalmol. 2013;97:1161–7.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  1. 1.Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical SciencesUniversity of South AustraliaAdelaideAustralia

Personalised recommendations