Conditional Coverage. Access with evidence development. Louise Longworth.
When does NICE recommend the use of health technologies within a programme of evidence development?Presenter: Louise Longworth1Co-authors: J Youn1, L Bojke2, S Palmer2, S Griffin2, E Spackman2 and K Claxton2 1 Health Economics Research Group (HERG), Brunel University, UK 2 Centre for Health Economics, University of York, UKBased on a project funded by the UK MRC-NIHR Methodology Research programme HTAi, Bilbao, Spain. 26 June 2012
Context Interest in linking reimbursement decisions with requirements for evidence development is increasing In the UK, the National Institute for Health and Clinical Excellence (NICE) has previously issued guidance using these types of recommendations A range of terms are used to describe these reimbursement recommendations. Two categories are defined for this study: 1. ‘Only in research’ (OIR): recommends the technology is not used routinely and which recommends that further research is conducted as part of the formal guidance. 2. ‘Approval with research’ (AWR): recommends the technology is used routinely and which recommends further research is conducted as part of the formal guidance
Current NICE Guidance It [The Committee] should consider whether the intervention is reasonably likely to benefit patients and the public, how easily the research can be set up or whether it is already planned or in progress, how likely the research is to provide further evidence, and whether the research is good value for money”. NICE Social value judgements. 2008
AimsTo identify:1. where OIR and AWR recommendations were made or considered in the development of NICE guidance; and2. the considerations that led to those recommendations and to identify any common characteristics in those appraisals.
Methods All draft and final guidance produced by the NICE Technology Appraisals programme up to Jan 2010 were reviewed and those including OIR/AWR recommendations were identified Data were extracted from the guidance documents. These included: – Appraisal process history and characteristics – Information on the technology and condition – Type of recommendation and research requested – Cost-effectiveness data – Key considerations leading to the OIR/AWR recommendation Thematic content analysis of the guidance documents was conducted to extract the stated key considerations.
Results: appraisal characteristics Of 184 appraisals: – 31 included OIR/AWR in draft guidance: 26 OIR; 5 AWR – 29 included OIR/AWR in final guidance: 25 OIR; 4 AWR Single Technology Appraisal 50% (STA) process introduced 40% 30% AWR 20% OIR 10% 0% 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Results: cost-effectiveness estimates* OIR AWR Total Considered cost-effective 2 3 5 Not considered cost-effective 23 1 24 Total 25 4 29* Based on conclusions or preferred estimates for the specific OIR/AWR indication as stated by the Appraisal Committee in the final guidance
Key uncertainties leading to OIR and AWRrecommendationsClinical effectiveness Relative effectiveness (whole…Relative effectiveness (OIR/AWR… Long-term effects Adverse effects AWRCost effectiveness OIR Cost-effectiveness Quality of life Costs 0 5 10 15 20
Conclusions NICE has issued recommendations linking reimbursement to evidence development – usually as ‘Only in research’ but some uses of ‘approval with research’ were evident The use of both OIR and AWR have recently declined – OIR/AWR are rarely used within the STA process; but this does not account for all reduction in use Differences in the stated rationale for OIR and AWR were observed – uncertainty in relative treatment effects for OIR – uncertainty in long-term effects for AWR This review has helped to inform the development of a formal framework for the optimal use of OIR/AWR
Further information Longworth L, Youn J, Bojke L et al. When does NICE recommend the use of health technologies within a programme of evidence development? A systematic review of NICE guidance. Pharmacoeconomics (forthcoming) Claxton K, Palmer S, Longworth L et al. Informing a decision framework for when NICE should recommend the use of health technologies only in the context of an appropriately designed programme of evidence development. Health Technology Assessment Report (forthcoming) email@example.com
AcknowledgementThis research was funded by the MRC-NIHR MethodologyResearch programme in the UK as part of a larger project toestablish an improved framework for formulating approvaland research recommendations under uncertainty at NICE‘Only in Research’ project (G0802659)