Cost-effectiveness of licensed treatment options for restless legs syndrome in the UK and Sweden

References

• National Center on Sleep Disorders Research, National Heart, Lung, and Blood Institute, National Institutes of Health. Restless legs syndrome: Detection and management in primary care. NIH Publication No. 00-3788, 2000
   Google Scholar
• Allen RP, Picchietti D, Hening WA,. et al. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology – a report from the Restless Legs Syndrome Diagnosis and Epidemiology Workshop at the National Institutes of Health. Sleep Med 2003;4:101-19
   PubMed Web of Science ®Google Scholar
• Allen RP, Walters AS, Montplaisir J,. et al. Restless Legs Syndrome Prevalence and Impact, REST General Population Study. Arch Intern Med 2005;165:1286-92
   PubMed Web of Science ®Google Scholar
• Hening W, Walters AS, Allen RP,. et al. Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study. Sleep Med 2004;5:237-46
   PubMed Web of Science ®Google Scholar
• Van de Vijver DAMC, Walley T, Petri H. Epidemiology of restless legs syndrome as diagnosed in UK primary care. Sleep Med 2004;5:435-40
   PubMed Web of Science ®Google Scholar
• Allen RP, Walters AS, Montplaisir J,. et al. Restless legs syndrome prevalence and impact. Arch Intern Med 2005; 165: 1286-92
   PubMed Web of Science ®Google Scholar
• Ulfberg J, Nystrom B, Carter N,. et al. Prevalence of restless legs syndrome among men aged 18 to 64 years: an association with somatic disease and neuropsychiatric symptoms. Mov Disord 2001;16:1159-63
   PubMed Web of Science ®Google Scholar
• Ulfberg J, Nystrom B, Carter N,. et al. Restless legs syndrome among working-aged women. Eur Neurol. 2001;46:17-19
   PubMed Web of Science ®Google Scholar
• Montplaisir J, Boucher S, Poirier G,. et al. Clinical, polysomnographic, and genetic characteristics of restless legs syndrome: a study of 133 patients diagnosed with new standard criteria. Mov Disord 1997;12:61-5
   PubMed Web of Science ®Google Scholar
• Pramipexole Summary of Product Characteristics, EMEA www.emea.europa.eu/humandocs/Humans/EPAR/sifrol/sifrol. htm, [last accessed 20 June 2008]
   Google Scholar
• Pramipexole Product Information, FDA, www.fda.gov/cder/foi/label/2006/020667s011s013lbl.pdf, [last accessed 20 June 2008]
   Google Scholar
• http://www.emea.europa.eu/htms/human/referral/2006.htm, [last accessed 20 June 2008]
   Google Scholar
• Requip prescribing information www.fda.gov/cder/foi/label/2005/020658s013lbl.pdf, [last accessed 20 June 2008]
   Google Scholar
• Silber MH, Ehrenberg BL, Allen RP,. et al. An algorithm for the management of restless legs syndrome. Mayo Clin Proc. 2004; 79:916-22
   PubMed Web of Science ®Google Scholar
• Fulda S, Wetter TC. Emerging drugs for restless legs syndrome. Expert Opin Emerg Drugs 2005;10:537-52
   PubMedGoogle Scholar
• Schapira AH. Restless legs syndrome: an update on treatment options. Drugs 2004;64:149-58
   PubMed Web of Science ®Google Scholar
• National Institute of Clinical Excellence (NICE). Guide to the Methods of Technology Appraisal. London, National Institute of Clinical Excellence (reference NO515). April 2004
   Google Scholar
• Scottish Medicines Consortium. Guidance to Manufacturers for completion of New Product Assessment Form (NPAF) (Clinical and Economic Sections combined) produced by the SMC at www.scottishmedicines.org.uk , [last accessed 20 June 2008]
   Google Scholar
• Pharmaceutical Benefits Board, Sweden. www.lfn.se, [last accessed 20 June 2008]
   Google Scholar
• The International Restless Legs Syndrome Study Group. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med 2003;4:121-32
   Google Scholar
• Hening WA, Allen RP. The reliability, validity and responsiveness of the International Restless Legs Syndrome Study Group rating scale and subscales in a clinical-trial setting. Sleep Med 2006 Jun;7 (4):340-9
   PubMed Web of Science ®Google Scholar
• Briggs AH. Handling uncertainty in cost-effectiveness models. Pharmacoeconomics 2000;17:479-500
   PubMed Web of Science ®Google Scholar
• O’Hagan A, McCabe C, Akeurst R,. et al. Incorporation of uncertainty in health economic modelling studies. PharmacoEconomics 2004;23:529-36
   Web of Science ®Google Scholar
• Thompson SG, Nixon RM, Grieve R. Addressing the issues that arise in analysing multicentre cost data, with application to a multinational study. J Health Econ 2006;25:1015-28
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration (FDA). Federal Register 1991; Volume 64 Number 128. www.cfsan.fda.gov/∼lrd/fr99706b.html [last accessed 20 June 2008]
   Google Scholar
• Morley RS, Chen S, Rheault N. Assessment of the risk factors related to bovine spongiform encephalopathy. Rev Sci Tech 2003;22:157-78
   PubMed Web of Science ®Google Scholar
• George E, Kirsch J, Devlin N. Estimating health state valuations for RLS. Paper presented at the European Health Economics Conference. LSE, London, UK, 10 September 2004
   Google Scholar
• Pramipexole, Drug Advice. www.scottishmedicines.org.uk/smc/files/pramipexole_Mirapexin_(247-06).pdf, [last accessed 20 June 2008]
   Google Scholar
• Loftus J, Connolly M, Allen R, et al. Mapping the International Restless Legs Scale (IRLS) to the EQ-5D by 4 clinicians. Presented at the European Congress of the International Society for Pharmacoeconomic and Outcomes Research, Hamburg, Germany, 24-26 October 2004
   Google Scholar
• Partinen M, Hirvonen K, Jama L,. et al. Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study - The PRELUDE study. Sleep Med 2006;7:407-17
   PubMed Web of Science ®Google Scholar
• Oertel WH, Stiasny-Kolster K,. et al. Efficacy of pramipexole in restless legs syndrome: a six-week, multicenter, randomized, double-blind study (effect-RLS study). Mov Disord. 2007; 22:213-19
   PubMed Web of Science ®Google Scholar
• Winkelman JW, Sethi KD, Kushida CA, et al. Efficacy and safety of pramipexole in restless legs syndrome. Neurology 2006; 67:1034-9
   PubMed Web of Science ®Google Scholar
• Trenkwalder C, Stiasny-Kolster K, Kupsch A,. et al. Controlled withdrawal of pramipexole after 6 months of open-label treatment in patients with restless legs syndrome. Mov Disord. 2006; 21:1404-10
   PubMed Web of Science ®Google Scholar
• Trenkwalder C, Garcia-Borreguero D, Montagna P,. et al. Ropininirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo-controlled study in 10 European countries. J Neurol Neurosurg Psychiatr 2004;75:92-7
   PubMed Web of Science ®Google Scholar
• Walters AS, Ondo WG, Dreykluft T,. et al. Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study. Mov Disord 2004;19:1414-23
   Google Scholar
• Bogan RK, Fry JM, Schmidt MH,. et al. Ropinirole in the treatment of patients with restless legs syndrome: a US-based randomized, double-blind, placebo-controlled clinical trial. Mayo Clin Proc 2006;81:17-27
   PubMed Web of Science ®Google Scholar
• Allen R, Becker PM, Bogan R,. et al. Ropinirole decreases periodic leg movements and improves sleep parameters in patients with restless legs syndrome. Sleep 2004;27:907-14
   PubMed Web of Science ®Google Scholar
• GSK. A study of the maintained efficacy and safety of ropinirole versus placebo in the long term treatment of restless legs syndrome (RLS) (Study No.: SKF-101468/188). ctr.gsk.co.uk/Summary/ropinirole/studylist.asp, [last accessed 20 June 2008]
   Google Scholar
• GSK. A 52 week open-label extension study of the long-term safety of ropinirole in subjects suffering from restless legs syndrome (RLS) (Study No.: SKF-101468/192). ctr.gsk.co.uk/Summary/ropinirole/studylist.asp, [last accessed 20 June 2008]
   Google Scholar
• Quilici S, Abrams KR, Nicolas A, et al. Meta-analysis of the efficacy and tolerability of pramipexole versus ropinirole in the treatment of restless legs syndrome Sleep Med doi:10.1016/j.sleep. 2007.11.020
   Google Scholar
• GSK. A 52 week open-label extension study of the long-term safety of ropinirole in subjects suffering from restless legs syndrome (RLS) (Study No.: SKF-101468/243). ctr.gsk.co.uk/Summary/ropinirole/studylist.asp, [last accessed 20 June 2008]
   Google Scholar
• British National Formulary - British Medical Association and Royal Pharmaceutical Society of Great Britain. 2004. Available from www.bnf.org/, [last accessed 20 June 2008]
   Google Scholar
• Swedish National Formulary. 2005. www.fass.se/LIF/home/index.jsp, [last accessed 20 June 2008]
   Google Scholar
• Garcia-Borreguero D, Ball E. Long-term improvements in sleep and quality of life: data from 52-week studies of ropinirole in RLS. EFNS, Athens, Greece, 17-20 September, 2005
   Google Scholar
• Moore AP, Lloyd A, Scott DA, et al. Ropinirole treatment for RLS: an economic evaluation of costs and outcomes. Poster presented at the 7th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research, Hamburg, Germany, 24-26 October, 2004
   Google Scholar
• Curtis L, Netten A. Unit costs of health and social care. Personal Social Services Research Unit, University of Kent, Canterbury, 2004
   Google Scholar
• Södra Regionvårdsnämnden Regionala Priser och Ersättningar 2005. http://www.skane.se/templates/Page.aspx ?id=192958 [last accessed 20 June 2008]
   Google Scholar
• Abetz L, Vallow S, Kirsch J,. et al. Validation of the Restless Legs Syndrome Quality of Life Questionnaire. Value Health 2005; 8:157-67
   PubMed Web of Science ®Google Scholar
• Statistics Sweden. Wages and salaries in the public and private sector, 2005. www.scb.se, [last accessed 27 September 2007]
   Google Scholar
• Interest and Exchange Rates. www.bankofengland.co.uk/statistics/index.htm , [last accessed 20 June 2008.]; quarterly average April-June 2006, £1 = SEK 13.52
   Google Scholar
• Socialstyrelsen 2006, Nationalla riktlinjer för strokesjukvård 2005, Beslutsstöd för prioriteringar, p 40
   Google Scholar
• Ropinirole, Drug Advice. www.scottishmedicines.org.uk/smc/files/ropinirole_Adartrel_Resubmission_165_05.pdf, [last accessed 20 June 2008]
   Google Scholar