Contributions
Abstract: P1275
Type: Poster Sessions
Abstract Category: Therapy - Others
Background: The UK Department of Health Multiple Sclerosis Risk Sharing Scheme (RSS) was established in 2002 to enable people with relapsing multiple sclerosis (pwRMS) access to the disease modifying drugs (DMDs) glatiramer acetate (GA) and beta interferon. The RSS included a 10-year observational study of 5,602 pwRMS to assess the long-term clinical and cost effectiveness of the DMDs. The final, 10-year, aggregate results of this study demonstrated that, as a group, the DMDs were both clinically effective and cost effective when modelled over a 50-year time horizon (including a 50% waning effect applied at 10 years).
Objective: To report the final, 10-year clinical and cost effectiveness results from the RSS for GA.
Methods: pwRMS meeting the 2001 Association of British Neurologist (ABN) guidelines were enrolled in the RSS, with choice of DMD treatment subject to patient and physician preference. Expanded Disability Status Scale (EDSS) scores were recorded annually. The projected disease course of untreated pwRMS was modelled using a continuous Markov model utilising natural history data from a subset (data collected from 1980-1996) of the British Columbia MS database who met the same eligibility criteria. Primary outcome measures were disability progression (EDSS) and utility loss for treated versus untreated pwRMS. Cost effectiveness calculations were based on NHS list price (£513.95 per 28 days) and expressed as quality-adjusted life years (QALYs).
Results: 755 pwRMS treated with GA were included in the 10-year RSS analysis (F:M, 582:173; mean age at MS onset: 30.2 years). The untreated cohort included 898 pwRMS with at least one EDSS score after baseline. Mean follow up of pwRMS on GA was 7.12 years. GA led to a 16.5% reduction in EDSS progression (implied hazard ratio [HR] 83.5%) and 25.0% reduction in loss of utility (implied HR 75.0%). Comparison of the 6-year and 10-year data showed no evidence of waning, with only a 1.2% difference in EDSS progression (6-year implied HR 84.7%). The cost per QALY for GA using the 10-year data was £17,841 (≤£30,000 per QALY typically deemed cost-effective).
Conclusions: The 10-year RSS analysis continues to support the long-term efficacy of GA in terms of disability, based on EDSS, and utility with no apparent evidence of a waning in treatment effect. Predicated on the RSS results, GA is highly cost effective at NHS list price.
Disclosure: Gavin Giovannoni has received honoraria for participating in advisory boards from: Abbvie, Atara Bio, Biogen, Sanofi-Genzyme, Genentech, GSK, Merck-Serono, Novartis, Roche, and Teva
Peter Brex has received honoraria from Teva, Genzyme, Biogen, Merck-Serono, MedDay and Roche for attending advisory boards or speaking at meetings. His department has received a grant from Biogen to support service developments
Ewan Walters is an employee of Teva UK Limited, the manufacturer of GA
Sarah Al-Izki is an employee of Teva UK Limited, the manufacturer of GA
Dalbir Dhiraj is an employee of Teva UK Limited, the manufacturer of GA
Klaus Schmierer has received honoraria from Biogen, Merck, Merck Inc., Novartis, Roche, and Teva and is a member of MAGNIFY-MS steering committee. He has received research support from Biogen, EMA, Lipomed, Morris-Saady Charitable Trust, Novartis, Royal College of Radiologists, Barts Charity, MS Society of Great Britain & Northern Ireland, and National MS Society
Abstract: P1275
Type: Poster Sessions
Abstract Category: Therapy - Others
Background: The UK Department of Health Multiple Sclerosis Risk Sharing Scheme (RSS) was established in 2002 to enable people with relapsing multiple sclerosis (pwRMS) access to the disease modifying drugs (DMDs) glatiramer acetate (GA) and beta interferon. The RSS included a 10-year observational study of 5,602 pwRMS to assess the long-term clinical and cost effectiveness of the DMDs. The final, 10-year, aggregate results of this study demonstrated that, as a group, the DMDs were both clinically effective and cost effective when modelled over a 50-year time horizon (including a 50% waning effect applied at 10 years).
Objective: To report the final, 10-year clinical and cost effectiveness results from the RSS for GA.
Methods: pwRMS meeting the 2001 Association of British Neurologist (ABN) guidelines were enrolled in the RSS, with choice of DMD treatment subject to patient and physician preference. Expanded Disability Status Scale (EDSS) scores were recorded annually. The projected disease course of untreated pwRMS was modelled using a continuous Markov model utilising natural history data from a subset (data collected from 1980-1996) of the British Columbia MS database who met the same eligibility criteria. Primary outcome measures were disability progression (EDSS) and utility loss for treated versus untreated pwRMS. Cost effectiveness calculations were based on NHS list price (£513.95 per 28 days) and expressed as quality-adjusted life years (QALYs).
Results: 755 pwRMS treated with GA were included in the 10-year RSS analysis (F:M, 582:173; mean age at MS onset: 30.2 years). The untreated cohort included 898 pwRMS with at least one EDSS score after baseline. Mean follow up of pwRMS on GA was 7.12 years. GA led to a 16.5% reduction in EDSS progression (implied hazard ratio [HR] 83.5%) and 25.0% reduction in loss of utility (implied HR 75.0%). Comparison of the 6-year and 10-year data showed no evidence of waning, with only a 1.2% difference in EDSS progression (6-year implied HR 84.7%). The cost per QALY for GA using the 10-year data was £17,841 (≤£30,000 per QALY typically deemed cost-effective).
Conclusions: The 10-year RSS analysis continues to support the long-term efficacy of GA in terms of disability, based on EDSS, and utility with no apparent evidence of a waning in treatment effect. Predicated on the RSS results, GA is highly cost effective at NHS list price.
Disclosure: Gavin Giovannoni has received honoraria for participating in advisory boards from: Abbvie, Atara Bio, Biogen, Sanofi-Genzyme, Genentech, GSK, Merck-Serono, Novartis, Roche, and Teva
Peter Brex has received honoraria from Teva, Genzyme, Biogen, Merck-Serono, MedDay and Roche for attending advisory boards or speaking at meetings. His department has received a grant from Biogen to support service developments
Ewan Walters is an employee of Teva UK Limited, the manufacturer of GA
Sarah Al-Izki is an employee of Teva UK Limited, the manufacturer of GA
Dalbir Dhiraj is an employee of Teva UK Limited, the manufacturer of GA
Klaus Schmierer has received honoraria from Biogen, Merck, Merck Inc., Novartis, Roche, and Teva and is a member of MAGNIFY-MS steering committee. He has received research support from Biogen, EMA, Lipomed, Morris-Saady Charitable Trust, Novartis, Royal College of Radiologists, Barts Charity, MS Society of Great Britain & Northern Ireland, and National MS Society