Contributions
Abstract: EP1683
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Alemtuzumab (ALEM) and ocrelizumab (OCR) each demonstrated improved clinical efficacy outcomes vs SC IFNB-1a in patients with active relapsing MS (RMS) in randomised phase 3 clinical trials over 2 years (y) (ALEM: CARE-MS I [NCT00530348]/CARE-MS II [NCT00548405]; OCR: OPERA I [NCT01247324]/OPERA II [NCT01412333]). ALEM demonstrated durable efficacy over 6 y in an extension (NCT00930553) in the absence of continuous treatment. OCR launched in the US at lower annual cost than other therapies.
Goal: To evaluate the relative clinical and economic benefit of ALEM vs OCR in patients with RMS in the US.
Methods: A Markov model (using British Columbia MS data to project disease progression) of patients transitioning in annual cycles through EDSS health states, was run from a US payer perspective. The modelled population represented demographic and clinical characteristics of pooled treatment-naive and -experienced patients from CARE-MS I and II. ALEM and OCR efficacy inputs were derived from network meta-analysis. Compared to no treatment, the relative risk (95% CI) for reducing relapses was 0.31 (0.26-0.36) for ALEM and 0.35 (0.26-0.47) for OCR. The hazard ratio for slowing 6-month (mo) confirmed disability worsening was 0.41 (0.27-0.63) for ALEM and 0.46 (0.29-0.72) for OCR. For ALEM (12 mg/d IV; baseline: 5 d; 12 mo later: 3 d; as-needed retreatment: ≥12 mo after previous course for relapse/MRI activity), acquisition cost was $103,749 in Y1 (Course 1) and $62,250 in Y2 (Course 2) and all subsequent courses. For OCR, acquisition cost was $65,000 annually. Administration and monitoring costs per year were lower for OCR than ALEM. Safety information was extracted from FDA-approved prescribing information.
Results: Over a 20-y horizon, 8.89 quality-adjusted life y (QALYs) and $426,169 total costs were accumulated with ALEM vs 8.46 QALYs and $908,742 total costs with OCR. Patients on ALEM had fewer relapses (mean: 7.1) compared with those on OCR (mean: 8.5). QALY loss due to adverse events was -0.126 for ALEM vs -0.006 for OCR. The OCR withdrawal rate and the assumption of ALEM durable efficacy over 6 y were identified as the most influential model parameters.
Conclusion: In this analysis, ALEM is projected to be cost-saving and more effective vs OCR. Results should be interpreted with caution as a head-to-head comparison is unavailable, but they offer evidence of economic and clinical benefits of ALEM vs OCR from a US payer perspective.
Study support: Sanofi.
Disclosure:
VC, NJ, DP, NC: Employees of Pharmerit International.
AS, CG, LH: Employees of Sanofi.
IM: Previously employed by Sanofi.
Abstract: EP1683
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Alemtuzumab (ALEM) and ocrelizumab (OCR) each demonstrated improved clinical efficacy outcomes vs SC IFNB-1a in patients with active relapsing MS (RMS) in randomised phase 3 clinical trials over 2 years (y) (ALEM: CARE-MS I [NCT00530348]/CARE-MS II [NCT00548405]; OCR: OPERA I [NCT01247324]/OPERA II [NCT01412333]). ALEM demonstrated durable efficacy over 6 y in an extension (NCT00930553) in the absence of continuous treatment. OCR launched in the US at lower annual cost than other therapies.
Goal: To evaluate the relative clinical and economic benefit of ALEM vs OCR in patients with RMS in the US.
Methods: A Markov model (using British Columbia MS data to project disease progression) of patients transitioning in annual cycles through EDSS health states, was run from a US payer perspective. The modelled population represented demographic and clinical characteristics of pooled treatment-naive and -experienced patients from CARE-MS I and II. ALEM and OCR efficacy inputs were derived from network meta-analysis. Compared to no treatment, the relative risk (95% CI) for reducing relapses was 0.31 (0.26-0.36) for ALEM and 0.35 (0.26-0.47) for OCR. The hazard ratio for slowing 6-month (mo) confirmed disability worsening was 0.41 (0.27-0.63) for ALEM and 0.46 (0.29-0.72) for OCR. For ALEM (12 mg/d IV; baseline: 5 d; 12 mo later: 3 d; as-needed retreatment: ≥12 mo after previous course for relapse/MRI activity), acquisition cost was $103,749 in Y1 (Course 1) and $62,250 in Y2 (Course 2) and all subsequent courses. For OCR, acquisition cost was $65,000 annually. Administration and monitoring costs per year were lower for OCR than ALEM. Safety information was extracted from FDA-approved prescribing information.
Results: Over a 20-y horizon, 8.89 quality-adjusted life y (QALYs) and $426,169 total costs were accumulated with ALEM vs 8.46 QALYs and $908,742 total costs with OCR. Patients on ALEM had fewer relapses (mean: 7.1) compared with those on OCR (mean: 8.5). QALY loss due to adverse events was -0.126 for ALEM vs -0.006 for OCR. The OCR withdrawal rate and the assumption of ALEM durable efficacy over 6 y were identified as the most influential model parameters.
Conclusion: In this analysis, ALEM is projected to be cost-saving and more effective vs OCR. Results should be interpreted with caution as a head-to-head comparison is unavailable, but they offer evidence of economic and clinical benefits of ALEM vs OCR from a US payer perspective.
Study support: Sanofi.
Disclosure:
VC, NJ, DP, NC: Employees of Pharmerit International.
AS, CG, LH: Employees of Sanofi.
IM: Previously employed by Sanofi.