Hostname: page-component-cd9895bd7-gvvz8 Total loading time: 0 Render date: 2024-12-25T17:13:11.160Z Has data issue: false hasContentIssue false

PATIENT PERSPECTIVE IN HEALTH TECHNOLOGY ASSESSMENT OF PHARMACEUTICALS IN FINLAND

Published online by Cambridge University Press:  19 August 2014

Jenni Kleme
Affiliation:
University of Helsinki, Faculty of Pharmacy, Division of Pharmacology and Pharmacotherapy
Marika Pohjanoksa-Mäntylä
Affiliation:
University of Helsinki, Faculty of Pharmacy, Division of Pharmacology and Pharmacotherapy
Marja Airaksinen
Affiliation:
University of Helsinki, Faculty of Pharmacy, Division of Pharmacology and Pharmacotherapy
Hannes Enlund
Affiliation:
Finnish Medicines Agency
Helena Kastarinen
Affiliation:
Finnish Medicines Agency
Piia Peura
Affiliation:
Finnish Medicines Agency
Katri Hämeen-Anttila
Affiliation:
Finnish Medicines Agency

Abstract

Objectives: The need to consider the patient perspective in health technology assessments (HTA) has been widely recognized. In July 2012, the Finnish Medicines Agency (Fimea) published a national recommendation for integrating the patient perspective into the HTAs of pharmaceuticals. The aim of this study is to describe the development of the recommendation for integrating the patient perspective into the HTA process of pharmaceuticals in Finland.

Methods: The development of the recommendation was based on a review of international recommendations and experiences of patient and public involvement in HTA. The draft recommendation was tested in two focus group discussions (n = 7 patients) and three individual interviews among diabetes patients (type 1 or 2) using long-acting insulin treatment. The recommendation was open for public consultation in April 2012 and revised according to the comments received.

Results: Patients will be involved in multiple stages of Fimea's HTA process. The recommendation includes step-by-step instructions on how to assess the patient perspective. The main focus is on qualitative interviews, which will be conducted at the beginning of the assessments to gain information, particularly on patient preferences and values, including positive and negative outcomes important to patients and ethical and social aspects of the medicine's use.

Conclusions: The recommendation will act as a tool to integrate patients’ experiences, needs and preferences into Fimea's HTAs of pharmaceuticals.

Type
Methods
Copyright
Copyright © Cambridge University Press 2014 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. Hailey D, Nordwall M. Survey on the involvement of consumers in health technology assessment programs. Int J Technol Assess Health Care. 2006;22:497499.Google Scholar
2. Facey K, Boivin A, Gracia, J, et al. Patients’ perspectives in health technology assessment: A route to robust evidence and fair deliberation. Int J Technol Assess Health Care. 2010;26:334340.Google Scholar
3. Gagnon, MP, Desmartis, M, Lepage-Savary, D, et al. Introducing patients’ and the public's perspectives to health technology assessment: A systematic review of international experiences. Int J Technol Assess Health Care. 2011;27:3142.Google Scholar
4. Entwistle, VA, Renfrew, MJ, Yearley, S, Forrester, J, Lamont, T. Lay perspectives: Advantages for health research. BMJ. 1998;316:463466.Google Scholar
5. Hansen, HP, Lee, A, van Randwijk, CB. Patient aspects: A review of fifty-eight Danish HTA reports. Int J Technol Assess Health Care. 2011;27:330336.Google Scholar
6. Moran, R, Davidson, P. An uneven spread: A review of public involvement in the National Institute of Health Research's Health Technology Assessment program. Int J Technol Assess Health Care. 2011;27:343347.Google Scholar
7. Gagnon, MP, Gagnon, J, St-Pierre, M, et al. Involving patients in HTA activities at local level: a study protocol based on the collaboration between researchers and knowledge users. BMC Health Serv Res. 2012;12:14.CrossRefGoogle Scholar
8. EUnetHTA. HTA core model for medical and surgical interventions. Version 1.3. Copenhagen: EUnetHTA; 2011.Google Scholar
9. Finlex Data Bank. Health Care Act 1326/2010. http://www.finlex.fi/en/laki/kaannokset/2010/en20101326 (accessed December 7, 2012).Google Scholar
10. Ministry of Social Affairs and Health. Medicines Policy 2020. Towards efficient, safe, rational and cost-effective use of medicines. Helsinki: Ministry of Social Affairs and Health; 2011:10.Google Scholar
11. Finlex Data Bank. Act on the Finnish Medicines Agency, 593/2009. http://www.finlex.fi/fi/laki/ajantasa/2009/20090593 (accessed December 7, 2012).Google Scholar
12. Finnish Medicines Agency. Fimea recommendation for the assessment of the therapeutic and economic value of pharmaceuticals. Serial Publication Fimea Develops, Assesses and Informs 2/2012. http://www.fimea.fi/instancedata/prime_product_julkaisu/fimea/embeds/fimeawwwstructure/21537_Fimea_KAI_JULKAISUSARJA_2_2012_netti.pdf (accessed August 17, 2012).Google Scholar
13. Oliver, S, Milne, R, Bradburn, J, et al. Involving consumers in a needs-led research programme: A pilot project. Health Expect. 2001;4:1828.Google Scholar
14. National Board of Health, Danish Centre for Health Technology Assessment (DACEHTA). A review of organizational and patient related assessments in HTAs published by INAHTA members. Copenhagen: National Board of Health. Danish Centre for Health Technology Assessment; 2007.Google Scholar
15. Hansen, HP, Lee, A. Patient aspects and involvement in HTA: An academic perspective. Pharm Policy Law. 2011;13:123128.Google Scholar
16. Lee, A, Skött, LS, Hansen, HP. Organizational and patient-related assessments in HTAs: State of the art. Int J Technol Assess Health Care. 2009;25:530536.Google Scholar
17. Staniszewska, S, Brett, J, Mockford, C, Barber, R. The GRIPP checklist: Strengthening the quality of patient and public involvement reporting in research. Int J Technol Assess Health Care. 2011;27:391399.Google Scholar
18. Bowman-Busato, J. Patient engagement in health technology assessment (HTA). Pharm Policy Law. 2011;13:193201.Google Scholar
19. National Institute for Health and Clinical Excellence. Guide to the methods of technology appraisal (reference N1618). London; NICE; 2008.Google Scholar
20. Kristensen, FB, Sigmund, H, eds. Health technology assessment handbook. Copenhagen: Danish Centre for Health Technology Assessment, National Board of Health; 2007.Google Scholar
21. Britten, N, Jones, R, Murphy, E, Stacy, R. Qualitative research methods in general practice and primary care. Fam Pract. 1995;12:104114.Google Scholar
22. Silverman, D. Doing qualitative research. London: Sage; 2005.Google Scholar
23. Elo, S, Kyngäs, H. The qualitative content analysis process. J Adv Nurs. 2008;62:107115.Google Scholar
24. Oravilahti, T, Kastarinen, H, Enlund, H, et al. The therapeutic and economic value of insulin glargine and insulin detemir compared with NPH insulin in the treatment of Type 1 and Type 2 diabetes mellitus. Finnish Medicines Agency Fimea. Serial Publication Fimea Develops, Assesses and Informs 2/2013. http://www.fimea.fi/download/22826_KAI_2_2013.PDF (accessed January, 16, 2013).Google Scholar
25. Peyrot, MP, Rubin, RRP, Lauritzen, T, et al. Resistance to insulin therapy among patients and providers: Results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diabetes Care. 2005;28:26732679.Google Scholar
26. Nair, KM, Levine, MA, Lohfeld, LH, Gerstein, HC. “I take what I think works for me”: a qualitative study to explore patient perception of diabetes treatment benefits and risks. Can J Clin Pharmacol. 2007;14:251259.Google Scholar
27. Brod, M, Kongso, JH, Lessard, S, Christensen, TL. Psychological insulin resistance: Patient beliefs and implications for diabetes management. Qual Life Res. 2009;18:2332.Google Scholar
28. Gauvin, F, Abelson, J, Giacomini, M. “It all depends”: Conceptualizing public involvement in the context of health technology assessment agencies. Soc Sci Med. 2010;70:15181526.CrossRefGoogle ScholarPubMed
29. Finnish Medicines Agency. Fimea's recommendation for integrating the patient perspective through interview study with the assessment of the therapeutic and economic value of pharmaceuticals and corresponding medicines information. Serial Publication Fimea Develops, Assesses and Informs 3/2012. http://www.fimea.fi/instancedata/prime_product_julkaisu/fimea/embeds/fimeawwwstructure/21538_Fimea_KAI_JULKAISUSARJA_HTA_3_2012_nettiversio.pdf (accessed August 17, 2012).Google Scholar