Ching-Yun Wei1, Ruben G W Quek2, Guillermo Villa3, Shravanthi R Gandra2, Carol A Forbes4, Steve Ryder4, Nigel Armstrong4, Sohan Deshpande4, Steven Duffy4, Jos Kleijnen5, Peter Lindgren6. 1. Kleijnen Systematic Reviews Ltd., Unit 6, Escrick Business Park, Riccall Road, Escrick, York, YO19 6FD, UK. ching-yun@systematic-reviews.com. 2. Amgen Inc., Thousand Oaks, CA, USA. 3. AMGEN (Europe) GmbH, Zug, Switzerland. 4. Kleijnen Systematic Reviews Ltd., Unit 6, Escrick Business Park, Riccall Road, Escrick, York, YO19 6FD, UK. 5. School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands. 6. IHE-Institutet för Hälso-och Sjukvårdsekonomi, Lund, Sweden.
Abstract
BACKGROUND: Previous reviews have evaluated economic analyses of lipid-lowering therapies using lipid levels as surrogate markers for cardiovascular disease. However, drug approval and health technology assessment agencies have stressed that surrogates should only be used in the absence of clinical endpoints. OBJECTIVE: The aim of this systematic review was to identify and summarise the methodologies, weaknesses and strengths of economic models based on atherosclerotic cardiovascular disease event rates. METHODS: Cost-effectiveness evaluations of lipid-lowering therapies using cardiovascular event rates in adults with hyperlipidaemia were sought in Medline, Embase, Medline In-Process, PubMed and NHS EED and conference proceedings. Search results were independently screened, extracted and quality checked by two reviewers. RESULTS: Searches until February 2016 retrieved 3443 records, from which 26 studies (29 publications) were selected. Twenty-two studies evaluated secondary prevention (four also assessed primary prevention), two considered only primary prevention and two included mixed primary and secondary prevention populations. Most studies (18) based treatment-effect estimates on single trials, although more recent evaluations deployed meta-analyses (5/10 over the last 10 years). Markov models (14 studies) were most commonly used and only one study employed discrete event simulation. Models varied particularly in terms of health states and treatment-effect duration. No studies used a systematic review to obtain utilities. Most studies took a healthcare perspective (21/26) and sourced resource use from key trials instead of local data. Overall, reporting quality was suboptimal. CONCLUSIONS: This review reveals methodological changes over time, but reporting weaknesses remain, particularly with respect to transparency of model reporting.
BACKGROUND: Previous reviews have evaluated economic analyses of lipid-lowering therapies using lipid levels as surrogate markers for cardiovascular disease. However, drug approval and health technology assessment agencies have stressed that surrogates should only be used in the absence of clinical endpoints. OBJECTIVE: The aim of this systematic review was to identify and summarise the methodologies, weaknesses and strengths of economic models based on atherosclerotic cardiovascular disease event rates. METHODS: Cost-effectiveness evaluations of lipid-lowering therapies using cardiovascular event rates in adults with hyperlipidaemia were sought in Medline, Embase, Medline In-Process, PubMed and NHS EED and conference proceedings. Search results were independently screened, extracted and quality checked by two reviewers. RESULTS: Searches until February 2016 retrieved 3443 records, from which 26 studies (29 publications) were selected. Twenty-two studies evaluated secondary prevention (four also assessed primary prevention), two considered only primary prevention and two included mixed primary and secondary prevention populations. Most studies (18) based treatment-effect estimates on single trials, although more recent evaluations deployed meta-analyses (5/10 over the last 10 years). Markov models (14 studies) were most commonly used and only one study employed discrete event simulation. Models varied particularly in terms of health states and treatment-effect duration. No studies used a systematic review to obtain utilities. Most studies took a healthcare perspective (21/26) and sourced resource use from key trials instead of local data. Overall, reporting quality was suboptimal. CONCLUSIONS: This review reveals methodological changes over time, but reporting weaknesses remain, particularly with respect to transparency of model reporting.
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