The Multiple Sclerosis Risk Sharing Scheme Monitoring Study--early results and lessons for the future.
BACKGROUND
Risk sharing schemes represent an innovative and important approach to the problems of rationing and achieving cost-effectiveness in high cost or controversial health interventions. This study aimed to assess the feasibility of risk sharing schemes, looking at long term clinical outcomes, to determine the price at which high cost treatments would be acceptable to the NHS.


METHODS
This case study of the first NHS risk sharing scheme, a long term prospective cohort study of beta interferon and glatiramer acetate in multiple sclerosis (MS) patients in 71 specialist MS centres in UK NHS hospitals, recruited adults with relapsing forms of MS, meeting Association of British Neurologists (ABN) criteria for disease modifying therapy. Outcome measures were: success of recruitment and follow up over the first three years, analysis of baseline and initial follow up data and the prospect of estimating the long term cost-effectiveness of these treatments.


RESULTS
Centres consented 5560 patients. Of the 4240 patients who had been in the study for a least one year, annual review data were available for 3730 (88.0%). Of the patients who had been in the study for at least two years and three years, subsequent annual review data were available for 2055 (78.5%) and 265 (71.8%) patients respectively. Baseline characteristics and a small but statistically significant progression of disease were similar to those reported in previous pivotal studies.


CONCLUSIONS
Successful recruitment, follow up and early data analysis suggest that risk sharing schemes should be able to deliver their objectives. However, important issues of analysis, and political and commercial conflicts of interest still need to be addressed.
Pickin
Mark
M
Medical Care Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. d.m.pickin@sheffield.ac.uk
Cooper
Cindy L
CL
Chater
Timothy
T
O'Hagan
Anthony
A
Abrams
Keith R
KR
Cooper
Nicola J
NJ
Boggild
Mike
M
Palace
Jackie
J
Ebers
George
G
Chilcott
James B
JB
Tappenden
Paul
P
Nicholl
Jon
J
D000328:Adult; D003362:Cost-Benefit Analysis; D005260:Female; D005500:Follow-Up Studies; D000068717:Glatiramer Acetate; D017048:Health Care Costs; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016899:Interferon-beta / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000191:economics*; D019982:Organizational Case Studies; D017063:Outcome Assessment, Health Care / Q000191:economics*; D010455:Peptides / Q000627:therapeutic use*; D011446:Prospective Studies; D020414:Risk Sharing, Financial; D006113:United Kingdom
D007155:Immunologic Factors; D007166:Immunosuppressive Agents; D010455:Peptides; D000068717:Glatiramer Acetate; D016899:Interferon-beta