COMPARATIVE EFFICACY, HTA ACCEPTABILITY AND ACCESS DIVERGE FOR NEW LUPUS NEPHRITIS THERAPIES IN MOROCCO
Author(s)
Omar Maoujoud, MD, PhD1, Amal Yassine, MD, PhD1, Intissar Haddiya, MD, PhD2.
1ISPOR Morocco, Research Team of pharmacoeconomics & pharmacoepidemiology, Faculty of Medicine Mohammed V University, Rabat, Morocco, 2Department of Nephrology, Faculty of Medicine, Mohammed I University, Oujda, Morocco, Oujda, Morocco.
1ISPOR Morocco, Research Team of pharmacoeconomics & pharmacoepidemiology, Faculty of Medicine Mohammed V University, Rabat, Morocco, 2Department of Nephrology, Faculty of Medicine, Mohammed I University, Oujda, Morocco, Oujda, Morocco.
OBJECTIVES: In Morocco, the only targeted agent available for lupus nephritis is rituximab, used off-label, despite a phase 3 trial that missed its primary endpoint. The agents with positive trials, voclosporine, belimumab and obinutuzumab, are not yet reimbursed. From the public payer (AMO) perspective, we asked which of these three should be funded first, and at what price, relative to the regimen available locally, off-label rituximab plus mycophenolate mofetil.
METHODS: We built a lifetime cohort model driven by renal response rather than by linear eGFR decline, reflecting the relapsing course of the disease. Complete renal response, from a network meta-analysis, lowered the annual hazard of kidney failure. Dialysis costs avoided were estimated from the model itself, as the mortality-adjusted difference between arms, not as a fixed annuity. Each agent was benchmarked against a cost-effectiveness threshold revealed by Moroccan dialysis spending (317,460 MAD per QALY). For each agent we derived the price affordable at this threshold and the discount required from its actual or reconstructed Moroccan price. Analyses included dual-engine and spreadsheet checks and probabilistic sensitivity analysis (10,000 iterations).
RESULTS: The discount required to become cost-effective was 57% for obinutuzumab, 89% for rituximab, 95% for belimumab and 98% for voclosporine. Trial efficacy favoured voclosporine, yet HAS rejected it and Morocco cannot price it. Obinutuzumab required the smallest discount, because it already carries a Moroccan price and is given as a fixed course. Comparative efficacy, HTA acceptability and local access diverged. Results depended entirely on the link between renal response and avoided kidney failure; removing it eliminated all benefit.
CONCLUSIONS: In Morocco, the order in which to fund new lupus nephritis therapies follows price feasibility and access, not trial efficacy. The best-evidenced agent is the least fundable locally. A dialysis-based threshold gives stakeholders a transparent, prospective sequence for access.
METHODS: We built a lifetime cohort model driven by renal response rather than by linear eGFR decline, reflecting the relapsing course of the disease. Complete renal response, from a network meta-analysis, lowered the annual hazard of kidney failure. Dialysis costs avoided were estimated from the model itself, as the mortality-adjusted difference between arms, not as a fixed annuity. Each agent was benchmarked against a cost-effectiveness threshold revealed by Moroccan dialysis spending (317,460 MAD per QALY). For each agent we derived the price affordable at this threshold and the discount required from its actual or reconstructed Moroccan price. Analyses included dual-engine and spreadsheet checks and probabilistic sensitivity analysis (10,000 iterations).
RESULTS: The discount required to become cost-effective was 57% for obinutuzumab, 89% for rituximab, 95% for belimumab and 98% for voclosporine. Trial efficacy favoured voclosporine, yet HAS rejected it and Morocco cannot price it. Obinutuzumab required the smallest discount, because it already carries a Moroccan price and is given as a fixed course. Comparative efficacy, HTA acceptability and local access diverged. Results depended entirely on the link between renal response and avoided kidney failure; removing it eliminated all benefit.
CONCLUSIONS: In Morocco, the order in which to fund new lupus nephritis therapies follows price feasibility and access, not trial efficacy. The best-evidenced agent is the least fundable locally. A dialysis-based threshold gives stakeholders a transparent, prospective sequence for access.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR192
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Reimbursement & Access Policy
Disease
Rare & Orphan Diseases, Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain), Urinary/Kidney Disorders