Author
Listed:
- Claire McKenna
- Emma Maund
- Muhammad Sarowar
- David Fox
- Matt Stevenson
- Chris Pepper
- Nerys Woolacott
- Stephen Palmer
Abstract
The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of dronedarone (Multaq®, Sanofi-Aventis Limited, UK) to submit evidence on the clinical and cost effectiveness of the anti-arrhythmic drug (AAD) for the treatment of atrial fibrillation (AF) and atrial flutter, as part of the Institute’s single technology appraisal (STA) process. The Centre for Reviews and Dissemination and the Centre for Health Economics, both at the University of York, were commissioned to act as the independent Evidence Review Group (ERG). This article provides a description of the company submission, the ERG review and NICE’s subsequent decisions regarding the use of dronedarone within the UK NHS. The ERG review comprised a critique of the submitted evidence on the clinical effectiveness and cost effectiveness of dronedarone. The ERG examined the search strategy used to obtain relevant evidence, the selection of studies included in the assessment, outcome measures chosen and statistical methods employed. The ERG also validated the manufacturer’s decision analytic model and used it to explore the robustness of the cost-effectiveness results to key assumptions. The main clinical effectiveness evidence supporting the use of dronedarone as a treatment for AF came from four randomized controlled trials. These trials were compared with a broader set of trials examining the effectiveness of other AADs for AF: amiodarone, sotalol and class 1c agents (flecainide and propafenone). The evidence suggested that all AADs decreased the recurrence of AF but dronedarone had the smallest effect. A mixed treatment comparison analysis of the trials showed that dronedarone was associated with a lower risk of all-cause mortality than other AADs, but this was highly uncertain. There was limited evidence to assess the effect of dronedarone on stroke, and no statistically significant differences between dronedarone and other AADs were found for treatment discontinuation. From the evidence presented by the manufacturer, dronedarone appeared highly cost effective in each of the population groups examined compared with using standard baseline therapy alone as first-line treatment, or compared with sotalol or amiodarone as first-line AAD, with incremental cost-effectiveness ratios (ICERs) well below £20 000 per QALY gained. The ICER for dronedarone relative to class 1c agents was around £19000 per QALY. Although the evidence presented by the manufacturer indicated that dronedarone was cost effective, the estimates of treatment effect relative to other AADs and safety in the longer term were highly uncertain. The NICE Appraisal Committee in its preliminary guidance did not recommend the use of dronedarone for AF. However, following the response from a large number of consultees and commentators, NICE revised its preliminary guidance to allow the use of the drug in a specific subgroup of AF patients with additional cardiovascular risk factors. Copyright Adis Data Information BV 2012
Suggested Citation
Claire McKenna & Emma Maund & Muhammad Sarowar & David Fox & Matt Stevenson & Chris Pepper & Nerys Woolacott & Stephen Palmer, 2012.
"Dronedarone for the Treatment of Atrial Fibrillation,"
PharmacoEconomics, Springer, vol. 30(1), pages 35-46, January.
Handle:
RePEc:spr:pharme:v:30:y:2012:i:1:p:35-46
DOI: 10.2165/11594280-000000000-00000
Download full text from publisher
As the access to this document is restricted, you may want to search for a different version of it.
Citations
Citations are extracted by the
CitEc Project, subscribe to its
RSS feed for this item.
Cited by:
- Jane Burch & Susan Griffin & Claire McKenna & Simon Walker & James Paton & Kath Wright & Nerys Woolacott, 2012.
"Omalizumab for the Treatment of Severe Persistent Allergic Asthma in Children Aged 6–11 Years,"
PharmacoEconomics, Springer, vol. 30(11), pages 991-1004, November.
- Sophie Whyte & Abdullah Pandor & Matt Stevenson, 2012.
"Bevacizumab for Metastatic Colorectal Cancer,"
PharmacoEconomics, Springer, vol. 30(12), pages 1119-1132, December.
- Dwayne Boyers & Xueli Jia & David Jenkinson & Graham Mowatt, 2012.
"Eltrombopag for the Treatment of Chronic Immune or Idiopathic Thrombocytopenic Purpura,"
PharmacoEconomics, Springer, vol. 30(6), pages 483-495, June.
- Sophie Whyte & Abdullah Pandor & Matt Stevenson, 2012.
"Bevacizumab for Metastatic Colorectal Cancer,"
PharmacoEconomics, Springer, vol. 30(12), pages 1119-1132, December.
Corrections
All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:pharme:v:30:y:2012:i:1:p:35-46. See general information about how to correct material in RePEc.
If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.
We have no bibliographic references for this item. You can help adding them by using this form .
If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.
For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com .
Please note that corrections may take a couple of weeks to filter through
the various RePEc services.