Advertisement

PharmacoEconomics

, Volume 35, Issue 8, pp 777–791 | Cite as

Defining and Measuring the Affordability of New Medicines: A Systematic Review

  • Fernando Antoñanzas
  • Robert Terkola
  • Paul M. Overton
  • Natalie Shalet
  • Maarten Postma
Systematic Review

Abstract

Background

In many healthcare systems, affordability concerns can lead to restrictions on the use of expensive efficacious therapies. However, there does not appear to be any consensus as to the terminology used to describe affordability, or the thresholds used to determine whether new drugs are affordable.

Objectives

The aim of this systematic review was to investigate how affordability is defined and measured in healthcare.

Methods

MEDLINE, EMBASE and EconLit databases (2005–July 2016) were searched using terms covering affordability and budget impact, combined with definitions, thresholds and restrictions, to identify articles describing a definition of affordability with respect to new medicines. Additional definitions were identified through citation searching, and through manual searches of European health technology assessment body websites.

Results

In total, 27 definitions were included in the review. Of these, five definitions described affordability in terms of the value of a product; seven considered affordability within the context of healthcare system budgets; and 15 addressed whether products are affordable in a given country based on economic factors. However, there was little in the literature to indicate that the price of medicines is considered alongside both their value to individual patients and their budget impact at a population level.

Conclusions

Current methods of assessing affordability in healthcare may be limited by their focus on budget impact. A more effective approach may involve a broader perspective than is currently described in the literature, to consider the long-term benefits of a therapy and cost savings elsewhere in the healthcare system, as well as cooperation between healthcare payers and the pharmaceutical industry to develop financing models that support sustainability as well as innovation.

Keywords

Healthcare System Gross Domestic Product Oseltamivir Budget Impact Sofosbuvir 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Author contributions

All authors designed the study, analysed the results, reviewed all draft versions of the manuscript and approved the final version for submission. Paul Overton conducted the systematic review and wrote the manuscript.

Compliance with Ethical Standards

Funding

This work was supported by Novartis Pharma AG (Basel, Switzerland) under the AGORA initiative (Advisory Group On Reimbursement and Access, a European Think Tank aiming to optimise access for patients to innovative treatments).

Conflict of interest

Fernando Antoñanzas, Robert Terkola and Maarten Postma have received honoraria and travel support related to this study from Novartis Pharma AG under the AGORA initiative. At the request of the AGORA Think Tank, support for the systematic review was provided by Paul Overton (Beacon Medical Communications Ltd) and Natalie Shalet (NAS Healthcare Solutions Ltd), whose organisations received project funding from Novartis Pharma AG. Maarten Postma has received research grants and honoraria from various pharmaceutical companies, unrelated to this study.

Data availability

All data generated during this study are included in this published article and its supplementary information files.

Supplementary material

40273_2017_514_MOESM1_ESM.docx (36 kb)
Supplementary material 1 (DOCX 35 kb)

References

  1. 1.
    Siddiqui M, Rajkumar SV. The high cost of cancer drugs and what we can do about it. Mayo Clin Proc. 2012;87(10):935–43.CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Rosenthal ES, Graham CS. Price and affordability of direct-acting antiviral regimens for hepatitis C virus in the United States. Infect Agents Cancer. 2016;11:24.CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Abboud C, Berman E, Cohen A, et al. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood. 2013;121(22):4439–42.CrossRefPubMedCentralGoogle Scholar
  4. 4.
    Antonanzas F, Terkola R, Postma M. The value of medicines: a crucial but vague concept. Pharmacoeconomics. 2016;34(12):1227–39.CrossRefPubMedGoogle Scholar
  5. 5.
    Kanavos P, Vandoros S, Irwin R, et al. Differences in costs of and access to pharmaceutical products in the EU, 2011. http://www.lse.ac.uk/businessAndConsultancy/LSEConsulting/pdf/pharmaceuticals.pdf. Accessed 4 Mar 2016.
  6. 6.
    Garrison L, Towse A. The drug budget silo mentality in Europe: an overview. Value Health. 2003;6(Suppl. 1):S1–9.CrossRefPubMedGoogle Scholar
  7. 7.
    Brockis E, Marsden G, Cole A, Devlin N. A review of NICE methods across health technology assessment programmes: differences, justifications and implications. Office of Health Economics Research Paper 16/03 2016. https://www.ohe.org/publications/review-nice-methods-across-health-technology-assessment-programmes-differences. Accessed 14 Nov 2016.
  8. 8.
    Carone GSC, Xavier A. Cost-containment policies in public pharmaceutical spending in the EU. 2012. http://ec.europa.eu/economy_finance/publications/economic_paper/2012/pdf/ecp_461_en.pdf. Accessed 14 Nov 2016.
  9. 9.
    Hollis A. Sustainable financing of innovative therapies: a review of approaches. Pharmacoeconomics. 2016;34(10):971–80.CrossRefPubMedGoogle Scholar
  10. 10.
    Claxton K, Martin S, Soares M, et al. Methods for the estimation of the National Institute for Health and Care Excellence cost-effectiveness threshold. Health Technol Assess. 2015;19(14):1–504.CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    Haycox A. Why cancer? Pharmacoeconomics. 2016;34(7):625–7.CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    NHS England. Appraisal and funding of cancer drugs from July 2016 (including the new Cancer Drugs Fund). 2016. https://www.england.nhs.uk/wp-content/uploads/2013/04/cdf-sop.pdf. Accessed 23 Aug 2016.
  13. 13.
    Oxford English dictionary. Oxford: Oxford University Press; 2009.Google Scholar
  14. 14.
    Dranitsaris G, Truter I, Lubbe MS, et al. Improving patient access to cancer drugs in India: using economic modeling to estimate a more affordable drug cost based on measures of societal value. Int J Technol Assess Health Care. 2011;27(1):23–30.CrossRefPubMedGoogle Scholar
  15. 15.
    Mauskopf JA. Prevalence-based versus incidence-based economic evaluations for the assessment of new health care interventions. Value Health. 2012;15(4):A170.CrossRefGoogle Scholar
  16. 16.
    Nagase H, Moriwaki K, Kamae M, et al. Cost-effectiveness analysis of oseltamivir for influenza treatment considering the virus emerging resistant to the drug in Japan. Value Health. 2009;12(Suppl. 3):S62–5.CrossRefPubMedGoogle Scholar
  17. 17.
    Vos T, Corry J, Haby MM, et al. Cost-effectiveness of cognitive-behavioural therapy and drug interventions for major depression. Aust N Z J Psychiatry. 2005;39(8):683–92.PubMedGoogle Scholar
  18. 18.
    National Institute of Health and Care Excellence. Guide to the methods of technology appraisal 2013. https://www.nice.org.uk/process/pmg9/resources/guide-to-the-methods-of-technology-appraisal-2013-pdf-2007975843781. Accessed 4 Oct 2016.
  19. 19.
    Orlewska E, Ancuta I, Anic B, et al. Access to biologic treatment for rheumatoid arthritis in Central and Eastern European (CEE) countries. Med Science Monit. 2011;17(4):SR1–13.Google Scholar
  20. 20.
    Zueger P, Becker R. The affordability of oncology and HIV/AIDs technologies in Brazil compared to the United States and other OECD countries. Value Health. 2013;16(7):A684.CrossRefGoogle Scholar
  21. 21.
    Jørgensen J, Kefalas P. Reimbursement of licensed cell and gene therapies across the major European healthcare markets. J Mark Access Health Policy. 2015;3:1–12.Google Scholar
  22. 22.
    Haute Autorité de Santé. Methods for health economic evaluation. http://www.has-sante.fr/portail/jcms/c_2035665/en/methods-for-health-economic-evaluation. Accessed 4 Oct 2016.
  23. 23.
    Mauskopf J, Chirila C, Birt J, et al. Drug reimbursement recommendations by the National Institute for Health and Clinical Excellence: have they impacted the National Health Service budget? Health Policy. 2013;110(1):49–59.CrossRefPubMedGoogle Scholar
  24. 24.
    Agenzia Italiana del Farmaco. Glossary. http://www.aifa.gov.it/en/glossary/20/lettera. Accessed 22 Aug 2016.
  25. 25.
    Souliotis K, Hasardzhiev S, Agapidaki E. A conceptual framework of mapping access to health care across EU countries: the patient access initiative. Public Health Genom. 2016;19(3):153–9.CrossRefGoogle Scholar
  26. 26.
    Institute for Clinical and Economic Review. Evaluating the value of new drugs and devices. 2016. http://icer-review.org/wp-content/uploads/2016/02/Slides-on-value-framework-for-website-v4-13-16.pdf. Accessed 4 Oct 2016.
  27. 27.
    Bozkaya D, Migliaccio-Walle K, O’Day K. Assessing prescription drug value in the united states: a hypothetical example comparing ASCO and ICER framework outcomes. Value Health. 2016;19(3):A1.CrossRefGoogle Scholar
  28. 28.
    Schlander M, Schwarz O. Affordability of increasing health care expenditures in Germany: a macroeconomic analysis. Gesundheitsokonomie Qualitatsmanagement. 2005;10(3):178–87.CrossRefGoogle Scholar
  29. 29.
    Cameron A, Ewen M, Ross-Degnan D, et al. Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis. Lancet. 2009;373(9659):240–9.CrossRefPubMedGoogle Scholar
  30. 30.
    Cameron A, Bansal A, Dua T, et al. Mapping the availability, price, and affordability of antiepileptic drugs in 46 countries. Epilepsia. 2012;53(6):962–9.CrossRefPubMedGoogle Scholar
  31. 31.
    Jingi AM, Noubiap JJN, Onana AE, et al. Access to diagnostic tests and essential medicines for cardiovascular diseases and diabetes care: cost, availability and affordability in the west region of Cameroon. PLoS One. 2014;9(11):1–10.Google Scholar
  32. 32.
    Ngorsuraches S, Chaiyakan K. Equitable prices of single-source drugs in Thailand. Appl Health Econ Health Policy. 2015;13(4):389–97.CrossRefPubMedGoogle Scholar
  33. 33.
    Helfer AP, Camargo AL, Tavares NU, et al. Affordability and availability of drugs for treatment of chronic diseases in the public health care system. Rev Panam Salud Publica. 2012;31(3):225–32.CrossRefPubMedGoogle Scholar
  34. 34.
    Lemus F, Rivas R. Afforda bility of antihypertensive treatment in Mexico. Value Health. 2013;16(7):A705.CrossRefGoogle Scholar
  35. 35.
    Iyengar S, Tay-Teo K, Vogler S, et al. Prices, costs, and affordability of new medicines for hepatitis C in 30 countries: an economic analysis. PLoS Med. 2016;13(5):e1002032.CrossRefPubMedPubMedCentralGoogle Scholar
  36. 36.
    Niëns LM, Van de Poel E, Cameron A, et al. Practical measurement of affordability: an application to medicines. 2012. http://www.who.int/bulletin/volumes/90/3/10-084087/en/. Accessed 4 Oct 2016.
  37. 37.
    Niëns LM, Brouwer WBF. Measuring the affordability of medicines: importance and challenges. Health Policy. 2013;112(1–2):45–52.CrossRefPubMedGoogle Scholar
  38. 38.
    O’Donnell O, van Doorslaer E, Wagstaff A, Lindelow M. Analyzing health equity using household survey data. 2007. http://siteresources.worldbank.org/INTPAH/Resources/Publications/459843-1195594469249/HealthEquityFINAL.pdf. Accessed 4 Oct 2016.
  39. 39.
    Mokaya J, Gray WK, Walker RW. Mapping the availability, price and affordability of drugs used to treat Parkinson’s disease in Kenya. Move Disord. 2015;30:S427.CrossRefGoogle Scholar
  40. 40.
    Homedes N, Ugalde A. Availability and affordability of new medicines in Latin American countries where pivotal clinical trials were conducted. Bull World Health Org. 2015;93(10):674–83.CrossRefPubMedPubMedCentralGoogle Scholar
  41. 41.
    World Health Organization. A model quality assurance system for procurement agencies. 2007. http://apps.who.int/medicinedocs/documents/s14866e/s14866e.pdf. Accessed 25 Jan 2017.
  42. 42.
    Jönsson B, Persson U, Wilking N. Innovative treatments for cancer in Europe: value, cost and access. IHE report. Lund: IHE; 2016:2. http://www.ihe.se/innovative-treatments-1.aspx. Accessed 12 Jan 2017.
  43. 43.
    Prasad V, Cifu A. Medical reversal: why we must raise the bar before adopting new technologies. Yale J Biol Med. 2011;84(4):471–8.PubMedPubMedCentralGoogle Scholar
  44. 44.
    National Institute for Health and Care Excellence and National Health Service England. Proposals for changes to the arrangements for evaluating and funding drugs and other health technologies appraised through NICE’s technology appraisal and highly specialised technologies programmes. https://www.nice.org.uk/Media/Default/About/what-we-do/our-programmes/technology-appraisals/NICE_NHSE_TA_and_HST_consultation_document.pdf. Accessed 15 Nov 2016.
  45. 45.
    Bloomberg. Bayer warns planned German price curbs may restrict drug access. https://www.bloomberg.com/news/articles/2016-11-14/bayer-warns-planned-german-price-curbs-may-restrict-drug-access. Accessed 5 Dec 2016.
  46. 46.
    Morel T, Arickx F, Befrits G, et al. Reconciling uncertainty of costs and outcomes with the need for access to orphan medicinal products: a comparative study of managed entry agreements across seven European countries. Orphanet J Rare Dis. 2013;8(1):198.CrossRefPubMedPubMedCentralGoogle Scholar
  47. 47.
    Toumi M, Remuzat C, El Hammi E, et al. Current process and future path for health economic assessment of pharmaceuticals in France. J Market Access Health Policy, [S.l.], v. 3, June 2015. http://www.jmahp.net/index.php/jmahp/article/view/27902. Accessed 25 Jan 2017.
  48. 48.
    PHARMAC. Fact sheet #4: making funding decisions. 2016. https://www.pharmac.govt.nz/assets/factsheet-04-making-funding-decisions.pdf. Accessed 19 Apr 2017.
  49. 49.
    London School of Economics. Tender loving care? Purchasing medicines for continuing therapeutic improvement and better health outcomes. 2016. http://eprints.lse.ac.uk/67824/. Accessed 10 Nov 2016.
  50. 50.
    Sullivan SD, Mauskopf JA, Augustovski F, et al. Budget impact analysis-principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health. 2014;17(1):5–14.CrossRefPubMedGoogle Scholar
  51. 51.
    Jena AB, Stevens W, Gonzalez YS, et al. The wider public health value of HCV treatment accrued by liver transplant recipients. Am J Manag Care. 2016;22(6 Spec No.):Sp212–9.PubMedGoogle Scholar
  52. 52.
    Tufts Center for the Study of Drug Development. Briefing: cost of developing a new drug. 2014. http://csdd.tufts.edu/files/uploads/Tufts_CSDD_briefing_on_RD_cost_study_-_Nov_18,_2014..pdf. Accessed 20 Apr 2017.
  53. 53.
    Grabowski DC, Lakdawalla DN, Goldman DP, et al. The large social value resulting from use of statins warrants steps to improve adherence and broaden treatment. Health Aff (Millwood). 2012;31(10):2276–85.CrossRefGoogle Scholar
  54. 54.
    Kleinke JD, McGee N. Breaking the bank: three financing models for addressing the drug innovation cost crisis. Am Health Drug Benefits. 2015;8(3):118–26.PubMedPubMedCentralGoogle Scholar
  55. 55.
    Schleidgen S, Klingler C, Bertram T, et al. What is personalized medicine: sharpening a vague term based on a systematic literature review. BMC Med Ethics. 2013;14(1):55.CrossRefPubMedPubMedCentralGoogle Scholar
  56. 56.
    Draghia-Akli R. Enabling personalized medicine in Europe: a look at the European Commission’s funding activities in the field of personalized medicine research. Per Med. 2012;9(2):151–5.CrossRefGoogle Scholar
  57. 57.
    Lee JK, Kim DW, Keam B, et al. The impact of molecularly targeted treatment on direct medical costs in patients with advanced non-small cell lung cancer. Cancer Res Treat. 2015;47(2):182–8.CrossRefPubMedGoogle Scholar
  58. 58.
    Ansari D, Tingstedt B, Andersson R. Pancreatic cancer: cost for overtreatment with gemcitabine. Acta Oncol. 2013;52(6):1146–51.CrossRefPubMedGoogle Scholar
  59. 59.
    Antonanzas F, Juarez-Castello C, Rodriguez-Ibeas R. Pharmaceutical patents, R&D incentives and access to new drugs: new ways of progress at the crossroad. Eur J Health Econ. 2011;12(5):393–5.CrossRefPubMedGoogle Scholar
  60. 60.
    Antonanzas F, Rodriguez-Ibeas R, Juarez-Castello CA. Should the patent system for pharmaceuticals be replaced? A theoretical approach. Expert Rev Pharmacoecon Outcomes Res. 2014;14(5):617–26.CrossRefPubMedGoogle Scholar
  61. 61.
    Zallman L, Nardin R, Malowney M, et al. Affordability of health care under publicly subsidized insurance after Massachusetts health care reform: a qualitative study of safety net patients. Int J Equity Health. 2015;14:112.CrossRefPubMedPubMedCentralGoogle Scholar
  62. 62.
    Organisation for Economic Co-operation and Development/Europena Union. Health at a glance: Europe 2014. doi: 10.1787/health_glance_eur-2014-en. Accessed 15 Nov 2016.

Copyright information

© Springer International Publishing Switzerland 2017

Authors and Affiliations

  1. 1.Department of EconomicsUniversity of La RiojaLogronoSpain
  2. 2.College of PharmacyUniversity of FloridaGainesvilleUSA
  3. 3.Unit of PharmacoTherapy, Epidemiology and Economics (PTE2), Department of PharmacyUniversity of GroningenGroningenThe Netherlands
  4. 4.Beacon Medical CommunicationsBrightonUK
  5. 5.NAS Healthcare SolutionsSurbitonUK
  6. 6.University Medical Center Groningen, Institute of Science in Healthy Aging & healthcaRE (SHARE)University of GroningenGroningenThe Netherlands
  7. 7.Department of Epidemiology, University Medical Center GroningenUniversity of GroningenGroningenThe Netherlands

Personalised recommendations