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INTERACTION INITIATIVES BETWEEN REGULATORY, HEALTH TECHNOLOGY ASSESSMENT AND COVERAGE BODIES, AND INDUSTRY

Published online by Cambridge University Press:  12 October 2012

Katrine Frønsdal ,
Franz Pichler ,
Logan Mardhani-Bayne ,
Chris Henshall ,
John-Arne Røttingen ,
Berit Mørland  and
Marianne Klemp
Katrine Frønsdal
Affiliation:
Norwegian Knowledge Centre for Health Services (NOKC)
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Abstract

There has been an increased focus on the relationship between health technology assessment (HTA) and regulatory assessments and how regulatory, HTA and coverage bodies, and industry can work better together to improve efficiency and alignment of processes. There is increasingly agreement across sectors that improved communication and coordination could contribute to facilitating timely patient access to effective, affordable treatments that offer value to the health system. Discussions on aspects of this relationship are being held in different forums and various forms of coordination and collaboration are being developed or piloted within several jurisdictions. It is therefore both timely and of value to stakeholders to describe and reflect on current initiatives intended to improve interactions between regulatory, HTA and coverage bodies, and industry. Drawing on 2011 meetings of the HTAi Policy Forum and the Center for Innovation in Regulatory Science (CIRS), this study aims to describe and compare initiatives, and point to success factors and challenges that are likely to inform future work and collaboration.

Keywords

Decision makingHealthHealth policyInsurance coverageRegulatory approvalReimbursementhealth insuranceTechnology assessmentBiomedical
Type
POLICIES
Information
International Journal of Technology Assessment in Health Care , Volume 28 , Issue 4 , October 2012 , pp. 374 - 381
Copyright
Copyright © Cambridge University Press 2012

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References

REFERENCES

1.Australian Government Department of Health and Ageing, Public Benefits Scheme (PBS). Framework for the introduction of parallel TGA and PBAC processes. http://www.pbs.gov.au/infopublication/factsheets/shared/framework-for-introduction-of-parallel-TGA-and-PBAC-processes (accessed August 2011).Google Scholar
2.Breckenridge, A, Woods, K, Walley, T. Medicine's regulation and health technology assessment. Clin Pharmacol Ther. 2010;87:152–154.CrossRefGoogle ScholarPubMed
3.Canadian Agency for Drugs and Technologies in Health (CADTH). Common Drug Review Submission Guidelines for Manufacturers. http://cadth.ca/media/cdr/process/CDR_Submission_Guidelines.pdf (accessed August 2011).Google Scholar
4.Centre for Innovation in Regulatory Science (CIRS). http://www.cirsci.org (accessed August 2011).Google Scholar
5.Centre for Innovation and Regulatory Sciences (CIRS). Evidentiary requirements in clinical development: Synchronising phase III requirements to multiple needs. http://www.cirsci.org/system/files/private/1031%20March%20WS%20synopsis_3May.pdf (accessed August 2011).Google Scholar
6Eichler, H, Bloechl-Daum, B, Abadie, E, et al.Relative efficacy of drugs: An emerging issue between regulatory agencies and third-party payers. Nat Rev Drug Discov. 2010;9:277–291.CrossRefGoogle ScholarPubMed
7.European Medicines Agency (EMA). http://www.ema.europa.eu/ (accessed August 2011).Google Scholar
8.European Medicines Agency (EMA). European Public Assessment Report (EPAR) contribution to relative effectiveness assessments. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/02/WC500073909.pdf (accessed August 2011).Google Scholar
9.European network for HTA (EUnetHTA). EUnetHTA JA WP5: Relative Effectiveness Assessment (REA) of Pharmaceuticals. http://www.eunethta.net/upload/WP5/Link1.pdf (accessed August 2011).Google Scholar
10.European network for HTA (EUnetHTA). EUnetHTA WP5: Relative Effectiveness Assessment (REA) of Pharmaceuticals. Pilot assessment using the draft rapid REA model. http://www.eunethta.eu/upload/WP5/Public%20consultations2012/PC%20June%206%202012/Pazopanib%20report%203rd%20version_120606%20(1).pdf (accessed June 2012).Google Scholar
11.European Union High Level Pharmaceutical Forum. http://ec.europa.eu/pharmaforum/ (accessed October 2011).Google Scholar
12.Executive Agency for Health and Consumers (EAHC). http://ec.europa.eu/eahc/documents/health/tenders/2010/EN/EAHC_2010_05_contract_award_notice.pdf (accessed November 2011).Google Scholar
13.Executive Agency for Health and Consumers (EAHC). Final CAVOD study report. Creation of a process for the exchange of knowledge between Member States and European authorities on the scientific assessment of the clinical added value for orphan medicines. http://ec.europa.eu/eahc/documents/news/CAVOD_Final%20Report_vf_corrected_281011.pdf (accessed June 2012).Google Scholar
14.Food and Drug Administration (FDA). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm274833.htm (accessed June 2012).Google Scholar
15.Food and Drug Administration (FDA). Memorandum of understanding between United States Food and Drug Administration and Centers for Medicare & Medicaid Services. http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm217585.htm (accessed August 2011).Google Scholar
16.Green Park Collaborative (GCP): http://www.htai.org/index.php?id=703 (accessed June 2012).Google Scholar
17.Health Technology Assessment International (HTAi). http://www.htai.org (accessed August 2011).Google Scholar
18.Health technology Assessment International (HTAi) and the international network of agencies for health technology assessment (INAHTA). HTA Glossary. http://www.htaglossery.net (accessed August 2011).Google Scholar
19.Health Technology Assessment International (HTAi). Policy Forum. http://www.htai.org/index.php?id=643 (accessed August 2011).Google Scholar
20.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;27:253–260.CrossRefGoogle ScholarPubMed
21.Liberti, LE, Pichler, F, Walker, S. Preparing for regulatory review and reimbursement decisions: A case for cooperation between regulatory authorities, sponsors and health technology assessment agencies. Pharm Med. 2009;23:263–267.CrossRefGoogle Scholar
22.Medical Products Agency (MPA). Joint scientific advice meetings between the Dental and Pharmaceutical Benefits Agency (TLV) and the Medical Products Agency (MPA). http://www.lakemedelsverket.se/english/product/Medicinal-products/Scientific-advice/Pilot-project-of-joint-scientific-advice-meetings-arranged-by-the-TLV-and-the-MPA/ (accessed August 2011).Google Scholar
23.Medicine Evaluation Committee (MEDEV). http://www.esip.org/files/pb51_0_0.pdf (accessed October 2011).Google Scholar
24.Medicines and Healthcare products Regulatory Agency (MHRA). Voluntary parallel scientific advice with NICE and the MHRA. http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON076350 (accessed August 2011).Google Scholar
25.Tapestry Networks. Pilots of multi-stakeholder consultations in early-stage drug development frequently asked questions. http://www.tapestrynetworks.com/documents/EHILN-multi-stakeholder%20pilots%20FAQs%20-%2010-19-10.pdf (accessed June 2012).Google Scholar
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