Retigabine for the adjunctive treatment of adults with partial-onset seizures in epilepsy with and without secondary generalization: A NICE single technology appraisal

PharmacoEconomics

Volumn 31, Issue 2, 2013, Pages 101-110

  Craig, Dawn ^a   Rice, Stephen ^a   Paton, Fiona ^a   Fox, David ^a   Woolacott, Nerys ^a  

^a UNIVERSITY OF YORK   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CARBAMAZEPINE; CLOBAZAM; ESLICARBAZEPINE ACETATE; ETIRACETAM; GABAPENTIN; HARKOSERIDE; LAMOTRIGINE; OXCARBAZEPINE; PLACEBO; PREGABALIN; RETIGABINE; TIAGABINE; TOPIRAMATE; VALPROIC ACID; ZONISAMIDE;

ADJUVANT THERAPY; ANTICONVULSANT THERAPY; APHASIA; BALANCE DISORDER; BLURRED VISION; CONFUSION; CONSTIPATION; COORDINATION DISORDER; COST EFFECTIVENESS ANALYSIS; DIZZINESS; DOSE RESPONSE; DRUG COST; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG INDUSTRY; DRUG RESEARCH; DRUG RESPONSE; EPILEPSY; FOCAL EPILEPSY; GAIT DISORDER; GENERALIZED EPILEPSY; HUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SOMNOLENCE; TREMOR;

ADOLESCENT; ADULT; ANTICONVULSANTS; CARBAMATES; COST-BENEFIT ANALYSIS; DECISION SUPPORT TECHNIQUES; DRUG INDUSTRY; EPILEPSIES, PARTIAL; HUMANS; MODELS, THEORETICAL; PHENYLENEDIAMINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEIZURES; YOUNG ADULT;

EID: 84876270587     PISSN: 11707690     EISSN: 11792027     Source Type: Journal    
DOI: 10.1007/s40273-012-0018-1     Document Type: Review

References (55)

1. National Institute for Health and Clinical Excellence. Guide to the single technology appraisal (STA) process. London: NICE; 2006. http://www.nice.org.uk/nicemedia/pdf/STA-Process-Guide.pdf. Accessed 1 Feb 2011.
2. Sculpher M. Single technology appraisal at the UK National Institute for Health and Clinical Excellence: a source of evidence and analysis for decision making internationally. Pharmacoeconomics. 2010;28(5):347-9.
3. Rodgers M, Griffin S, Paulden M, et al. Alitretinoin for severe chronic hand eczema: a NICE single technology appraisal. Pharmacoeconomics. 2010;28(5):351-62.
4. Bagust A, Greenhalgh J, Boland A, et al. Cetuximab for recurrent and/or metastatic squamous cell carcinoma of the head and neck: a NICE single technology appraisal. Pharmacoeconomics. 2010;28(6):439-48.
5. Stevenson M, Pandor A. Febuxostat for the management of hyperuricaemia in patients with gout: a NICE single technology appraisal. Pharmacoeconomics. 2011;29(2):133-40.
6. Scotland G, Waugh N, Royle P, et al. Denosumab for the prevention of osteoporotic fractures in post-menopausal women: a NICE single technology appraisal. Pharmacoeconomics. 2011;29(11):951-61.
7. Dickson R, Bagust A, Boland A, et al. Erlotinib monotherapy for the maintenance treatment of non-small cell lung cancer after previous platinum-containing chemotherapy: a NICE single technology appraisal. Pharmacoeconomics. 2011;29(12):1051-62.
8. McKenna C, Maund E, Sarowar M, et al. Dronedarone for the treatment of atrial fibrillation: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(1):35-46.
9. Holmes M, Carroll C, Papaioannou D. Dabigatran etexilate for the prevention of venous thromboembolism in patients undergoing elective hip and knee surgery: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(2):137-46.
10. Yang H, Craig D, Epstein D, et al. Golimumab for the treatment of psoriatic arthritis: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(4):257-70.
11. Boyers D, Jia X, Jenkinson D, et al. Eltrombopag for the treatment of chronic immune or idiopathic thrombocytopenic purpura: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(6):483-95.
12. Burch J, Griffin S, McKenna C, et al. Omalizumab for severe persistent asthma in children aged 6-11 years: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(11):991-1004.
13. Whyte S, Pandor A, Stevenson M. Bevacizumab for metastatic colorectal cancer: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(12):1119-32.
14. Kilonzo M, Hislop J, Elders A. Pazopanib for the first-line treatment of patients with advanced and/or metastatic renal cell carcinoma: a NICE single technology appraisal. Pharmacoeconomics. 2013;31(1):15-24.
15. Spackman E, Rice S, Norman G, et al. Trastuzumab for the treatment of HER2 positive metastatic gastric cancer: a NICE single technology appraisal. Pharmacoeconomics (in press).
16. Rafia R, Simpson E, Stevenson M, et al. Trabectedin for the treatment of advanced metastatic soft tissue sarcoma: a NICE single technology appraisal. Pharmacoeconomics (in press).
17. Simpson EL, Fitzgerald P, Evans P, Tappenden P, Kalita N, Reckless JPD, Bakhai A. Bivalirudin for the treatment of ST-segment elevation myocardial infarction: a NICE single technology appraisal. Pharmacoeconomics (in press).
18. Greenhalgh J, Bagust A, Boland A, et al. Rituximab for the first-line maintenance treatment of follicular non-Hodgkin's lymphoma: a NICE single technology appraisal. Pharmacoeconomics (in press).
19. Armstrong N, Manuela J, van Asselt T, et al. Golimumab for the treatment of ankylosing spondylitis: a NICE single technology appraisal. Pharmacoeconomics (in press).
20. Tosh J, Archer R, Davis S, et al. Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying anti-rheumatic drugs: a NICE single technology appraisal. Pharmacoeconomics (in press).
21. Kearns B, Lloyd-Jones M, Stevenson M, et al. Cabazitaxel for the second-line treatment of metastatic hormone refractory prostate cancer: a NICE single technology appraisal. Pharmacoeconomics (in press).
22. National Institute for Health and Clinical Excellence. Epilepsy (partial): retigabine (adjuvant). London: NICE; 2011. http://guidance.nice.org. uk/TA/Wave23/33. Accessed 1 Feb 2011.
23. Sander JW, Hart YM, Johnson AL, et al. National general practice study of epilepsy: newly diagnosed epileptic seizures in a general population. Lancet. 1990;336:1267-71.
24. Schmidt D, Jacob R, Loiseau P, et al. Zonisamide for add-on treatment of refractory partial epilepsy: a European double-blind trial. Epilepsy Res. 1993;15:67-73.
25. Granata T, Marchi N, Carlton E, et al. Management of the patient with medically refractory epilepsy. Expert Review of Neurotherapeutics; 2009. 9:1791-1802.
26. Luciano A, Shorvon SD. Results of treatment changes in patients with apparently drug-resistant chronic epilepsy. Ann Neurol. 2007;62:375-81.
27. Callaghan B, Anand K, Hesdorffer D, et al. Likelihood of seizure remission in an adult population with refractory epilepsy. Ann Neurol. 2007;62:382-9.
28. Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000;342:314-9.
29. GlaxoSmithKline Group. A randomized, double-blind, placebo-controlled, parallel group, multicenter, dose-ranging, efficacy and safety study of retigabine (D-23129; GKE-841) administered as add-on therapy in patients with partial epilepsy [Study 205; ID no.: 3065A1-205-AU/EU/US]. London: GSK, 2009.
30. GlaxoSmithKline Group. A randomized, double-blind, placebo-controlled, multicenter, parallel-group phase 3 study to determine the efficacy and safety of retigabine (1200 mg/day) used as adjunctive therapy in refractory epilepsy patients with partial-onset seizures [RESTORE 1; ID no.: VRX-RET-E22-301]. London: GSK, 2009.
31. GlaxoSmithKline Group. A randomized, double-blind, placebo-controlled, multicenter, parallel-group phase 3 study to determine the efficacy and safety of two doses of retigabine (900 mg/day and 600 mg/day) used as adjunctive therapy in refractory epilepsy patients with partial-onset seizures [RESTORE 2; ID no. VRX-RET-E22-302]. London: GSK, 2009.
32. GlaxoSmithKline group. A multicenter, open-label, long-term, safety, tolerability, and efficacy study of retigabine in adult patients with epilepsy (extension of study 205) (D-23129/3225) [Study 205; ID no.: 3065A1-212]. London: GSK.
33. GlaxoSmithKline Group. Interim report: a multicenter, open-label, long-term, safety, tolerability and efficacy study of retigabine in adult epilepsy patients with partial-onset seizures (extension of study VRX-RET-E22-301) [Study 303; RESTORE 1; ID no.: VRX-RET-E22-303]. London: GSK.
34. GlaxoSmithKline Group. Interim report: a multicenter, open-label, long-term, safety, tolerability and efficacy study of retigabine in adult epilepsy patients with partial-onset seizures (extension of study VRX-RET-E22-302) [Study 304; RESTORE 2; ID no. VRX-RET-E22-304]. London: GSK.
35. Marson A, Kadir Z, Hutton J, et al. The new antiepileptic drugs: a systematic review of their efficacy and tolerability. Epilepsia. 1997;38:859-80.
36. National Institute for Health and Clinical Excellence. Clinical guideline (in development) - the epilepsies: pharmacological management of the epilepsies in adults and children in primary and secondary care (partial update of NICE CG20). London: NICE, 2011. http://www.nice.org.uk/guidance/index.jsp?action= folder&o=52446. Accessed 28 Jan 2011.
37. Ben-Menachem E, Gabbai A, Hufnagel A, et al. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Res. 2010;89:278-85.
38. Elger C, Halász P, Maia J, BIA Investigators Study Group, et al. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: a randomized, double-blind, placebo-controlled, parallel-group phase III study. Epilepsia. 2009;50(3):454-63.
39. Gil-Nagel A, Lopes-Lima J, Almeida L, BIA Investigators Study Group, et al. Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures. Acta Neurol Scand. 2009;120(5):281-7.
40. Ben-Menachem E, Biton V, Jatuzis D, et al. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. Epilepsia. 2007;48:1308-17.
41. Chung S, Sperling M, Biton V, et al. Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial. Epilepsia. 2010;51:958-67.
42. Halász P, Kälviäinen R, Mazurkiewicz Beldziska M, et al. Adjunctive lacosamide for partial-onset seizures: efficacy and safety results from a randomized controlled trial. Epilepsia. 2009;50:443-53.
43. Arroyo S, Anhut H, Kugler A, et al. Pregabalin add-on treatment: a randomized, double-blind, placebo-controlled, dose-response study in adults with partial seizures. Epilepsia. 2004;45:20-7.
44. Beydoun A, Uthman B, Kugler A, et al. Safety and efficacy of two pregabalin regimens for add-on treatment of partial epilepsy. Neurology. 2005;64:475-80.
45. Elger C, Brodie M, Anhut H, et al. Pregabalin add-on treatment in patients with partial seizures: a novel evaluation of flexible-dose and fixed-dose treatment in a double-blind, placebo-controlled study. Epilepsia. 2005;46:1926-36.
46. French J, Kugler A, Robbins J, et al. Dose-response trial of pregabalin adjunctive therapy in patients with partial seizures. Neurology. 2003;60:1631-7.
47. Lee B, Yi S, Hong S, et al. Pregabalin add-on therapy using a flexible, optimized dose schedule in refractory partial epilepsies: a double-blind, randomized, placebo-controlled, multicenter trial. Epilepsia 2009;50:464-74. http://dx.doi.org/10.1111/j.1528-1167.2008.01954.x. Accessed 26 Sept 2010.
48. Kalviainen R, Brodie M, Duncan J, et al. A double-blind, placebo-controlled trial of tiagabine given three-times daily as add-on therapy for refractory partial seizures. Northern European Tiagabine Study Group. Epilepsy Res. 1998;30:31-40.
49. Sachdeo R, Leroy R, Krauss G, et al. Tiagabine therapy for complex partial seizures. A dose-frequency study. The Tiagabine Study Group. Arch Neurol. 1997;54:595-601.
50. Uthman B, Rowan A, Ahmann P, et al. Tiagabine for complex partial seizures: a randomized, add-on, dose-response trial. Arch Neurol. 1998;55:56-62.
51. Brodie M, Duncan R, Vespignani H, et al. Dose-dependent safety and efficacy of zonisamide: a randomized, double-blind, placebo-controlled study in patients with refractory partial seizures. Epilepsia. 2005;46:31-41.
52. Sackellares J, Ramsay R, Wilder B, et al. Randomized, controlled clinical trial of zonisamide as adjunctive treatment for refractory partial seizures. Epilepsia. 2004;45:610-7.
53. Selai C, Trimble M, Price M, et al. Evaluation of health status in epilepsy using an EQ-5D questionnaire: a prospective, observational, 6-month study of adjunctive therapy with anti-epileptic drugs. Curr Med Res Opin. 2005;21(5):733-9.
54. National Institute for Health and Clinical Excellence. The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care [CG20]. London: NICE; 2004. http://guidance.nice.org.uk/ CG20. Accessed 1 Feb 2011.
55. Craig D, Rice S, Paton F, Fox D, Wollacott N. Retigabine for the adjunctive treatment of adults with partial onset seizures in epilepsy with and without secondary generalisation: a Single Technology Appraisal. Southampton: Health Technology Assessment Programme, 2011.