Presentation (CTI)

OBJECTIVES: Lupus nephritis (LN) is a common and severe organ manifestation of systemic lupus erythematosus that can progress to end-stage kidney disease (ESKD), requiring a substantial use of healthcare resources including dialysis and renal transplantation. A cost-effectiveness model was developed for appraisal by UK health technology assessment agencies to evaluate obinutuzumab (OBI) in combination with standard therapy (ST). The analysis attempted to translate short-term clinical trial outcomes into long-term benefits associated with delaying ESKD.
METHODS: We developed a 9-state Markov model (6-month cycle) and simulated patient pathways over a lifetime horizon (72 years) from the perspective of the NHS and Personal Social Services. Patients entered the model in chronic kidney disease (CKD) stages 1-3b with active disease and transitioned between complete response, partial response or active disease states, progressing to CKD stage 4, CKD stage 5 (dialysis or transplant) and death. Clinical efficacy for OBI+ST versus ST alone was derived from the REGENCY study (NCT04221477). A network meta-analysis compared OBI+ST with rituximab (RTX) + ST. Time-to-renal-flare data were used to predict differences in transitions to CKD stage 4.
RESULTS: OBI+ST generated greater health benefits by delaying progression through CKD stages towards ESKD versus ST alone and versus RTX+ST. OBI+ST resulted in an incremental cost-effectiveness ratio of £5,131 versus ST alone and dominated RTX+ST at list prices when considering renal flares as a full surrogate for transition to CKD stage 4. When softening this surrogacy assumption in a threshold analysis, OBI+ST remained cost effective versus ST alone at a willingness-to-pay threshold of £25,000-35,000/quality-adjusted life-year and dominated RTX+ST at list prices.
CONCLUSIONS: OBI+ST provides significant health-economic benefit by improving short-term response, slowing progression to ESKD and reducing long-term healthcare spending on advanced CKD. Under the rigorous NICE appraisal framework, OBI+ST proved to be a highly cost-effective treatment option for adults with active LN in the UK.