HARMONIZATION OF HTA-BASED REIMBURSEMENT AND REGULATORY APPROVAL ACTIVITIES: A QUALITATIVE STUDY

Main Article Content

Bernice Tsoi
Daria O'Reilly
Lisa Masucci
Michael Drummond
Ron Goeree

Keywords

Health technology assessment, product approval, healthcare industry, health policy

Abstract

Background


Regulatory approval and reimbursement are necessary to bring health technologies to market. As both are distinct processes, the lack of interaction between regulators and payers has been criticized for resulting in health system inefficiencies.


Objectives


This study describes the experiences of health system stakeholders on the development and implementation of initiatives to better harmonize HTA -reimbursement and regulatory activities, as well as Canadian perceptions on such initiatives.


Methods


Thematic analysis of semi-structured interviews was conducted. Participants represented those whom have published or worked actively in this area or who held positions in HTA and/or reimbursement agencies that gave them insight into the Canadian healthcare system. Interviews were recorded, transcribed and analyzed to identify emerging themes and relationships.


Results


Fourteen individuals from twelve organizations participated, including representatives from Canada, US, UK and Netherlands. Harmonization was identified as either a means to: (i) develop economies of scale in the generation of clinical data; and/or (ii) align the lifecycle of a health technology. For such initiatives to be successfully implemented, the following key issues emerged: (i) fostering healthy relationships; (ii) promoting well -intentions; (iii) defining governance and leadership clearly; and (iv) securing organizational infrastructure.


Conclusions


Attempts to harmonize reimbursement and regulatory activities is in its infancy; although, much can be learned from current Canadian and international experiences. Within Canada there is much interest, although concerns have been raised on the extent to which harmonization is possible. Successful policy implementation would require inter-agency collaborations, with particular attention towards capacity building and strong leadership.

Abstract 103 | PDF Downloads 42

References

1. Altenstetter C, Permanand G. EU regulation of medical devices and pharmaceuticals in comparative perspective. Rev Policy Res 2007;24:385- 405.
2. Health Canada. Canadian Food and Drugs Act and the Food and Drugs Regulation. (June 19 2013). http://laws -lois.justice.gc.ca/eng/acts/F - 27/FullText.html (May 1, 2014).
3. Health Canada. Guidance for industry: management of drugs submission. (December 19, 2013). http://www.hc -sc.gc.ca/dhp - mps/prodpharma/applic -demande/guide -ld/mgmt - gest/mands_gespd -eng.php (May 1, 2014).
4. Health Canada. Management of applications for medical device licences and investigational testing authorizations. (February 4, 2009). http://www.hc -sc.gc.ca/dhp -mps/md -im/applic - demande/pol/mdlapp_demhim_pol -eng.php (May 1, 2014).
5. Eichler HG, Bloechl- Daum B, Abadie E, Barnett D, Konig F, Pearson S. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers. Nat Rev Drug Discov 2010;9:277- 91.
6. Henshall C, Mardhani -Bayne L, Fronsdal KB, Klemp M. Interactions between health technology assessment, coverage, and regulatory processes: Emerging issues, goals, and opportunities. Int J Technol Assess Health Care 2011;27:253- 60.
7. Garrido MV, Kristensen FB, Nielsen CP, Busse R. Health Technology Assessment and Health Policy Making - Current status, challenges and potential. Copenhagen: World Health Organization on behalf the European Observatory on Health Systems and Policies, 2008.
8. Menon D, Stafinski T. Health technology assessment in Canada: 20 years strong? Value Health 2009;12:S14 -9.
9. Barker R. A flexible blueprint for the future of drug development. Lancet 2010;375:357- 9.
10. Liberti LE, Pichler F, Walker SR. Preparing for regulator review and reimbursement decisions - a case for cooperation between regulatory authorities, sponsors and health technology assessment agencies. Pharm Med 2009;23:263- 7.
11. Centre for Innovation in Regulatory Science. Evidentiary requirements in clinical development: synchronising phase III requirements to meet multiple needs (workshop synopsis) Geneva: Centre for Innovation in Regulatory Science Ltd, 2011.
12. Tsoi B, Masucci L, Campbell K, Drummond M, O'Reilly D, Goeree R. Harmonization of reimbursement and regulatory approval processes: a systematic review of international experiences. Expert Rev Pharmacoecon Outcomes Res 2013;13:497- 511.
13. Sorenson C, Drummond M, Kanavos P. Ensuring value for money in health care: the role of health technology assessment in the European Union [Observatory studies series no. 11]. Geneva: World Health Organization, on behalf of the European Observatory on Health Systems and Policies, 2008.
14. Hutton J, Trueman P, Facey K. Harmonization of evidence requirements for health technology assessment in reimbursement decision making. Int J Technol Asse ss Health Care 2008;24:511- 7.
15. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32 -item checklist for interviews and focus groups. Int J Qual Health Care 2007;19:349- 57.
16. Bernard HR, Ryan GW. Analyzing qualitative data: systematic approaches. Thousand Oaks, California: SAGE Publications Ltd, 2011.
17. Thomas J, Harden A. Methods for the thematic synthesis of qualitative research in systematic reviews. BMC Med Res Methodol 2008;8:45.
18. Husereau D, Henshall C, Jivraj J. Adaptive approaches to licensing, health technology assessment, and introduction of drugs and devices. Int J Technol Assess Health Care 2014;30:1- 9.
19. U.S. Food and Drug Administration FDA -CMS parallel review. (June 19, 2014). http://www.fda.gov/MedicalDevices/DeviceRegu lationandGuidance/HowtoMarketYourDevice/Pre marketSubmissions/ucm255678.htm (June 27, 2014)
20. Canadian Agency for Drugs and Technologies in Health. CDR Update [Issue 55]. Ottawa: The Agency, 2008.
21. Natiuonal Institute for Health and Care Excellence. NICE Scientific Advice. (2014). Available: https://www.nice.org.uk/about/What - we -do/Scientific -advice (June 27, 2014).
22. MaRS EXCITE. Application guide. (2014). http://www.marsdd.com/systems -change/mars - excite/apply -excite/ (June 27, 2014).