Presentation (CTI)

OBJECTIVES: Tacrolimus is licensed for immunosuppressive therapy in adult patients who have received a kidney transplant (KTx). Envarsus® is an extended-release form of tacrolimus, that may offer clinical and economic benefits in fast metaboliser patients who require high doses of immunosuppression to maintain efficacy. A targeted literature review was conducted to identify economic, HCRU, and HRQoL evidence to inform cost-effectiveness modelling and the relative value of Envarsus®.
METHODS: A targeted search of the PubMed database (January 2015-January 2026) was conducted. Eligible records included economic evaluations, and HCRU and HRQoL studies in adult KTx recipients. Study selection followed predefined inclusion criteria, prioritising UK-based evidence.
RESULTS: Of 2,076 records identified, 90 met the eligibility criteria, and 17 were synthesised. Tacrolimus-based regimens were consistently identified as the most cost-effective immunosuppressive strategy versus comparators; however, substantial heterogeneity within prolonged-release tacrolimus (PR-TAC) formulations was observed. Evidence indicated that Envarsus® achieves similar health outcomes (QALYs) to immediate-release tacrolimus (IR-TAC) at broadly comparable costs, suggesting economic parity. In contrast, evidence for Envarsus suggested a trend towards improved effectiveness (higher QALYs) alongside lower or comparable costs compared to Advagraf® (PR-TAC), indicating a favourable cost-effectiveness profile. Subgroup analyses highlighted pharmacokinetic variability as an important driver of outcomes, with Envarsus® associated with greater QALY gains in fast metabolisers. HRQoL improved post-transplant (EQ‑5D: ~0.64-0.77 pre-transplant versus 0.78-0.90 post-transplant). HCRU data confirmed high upfront transplant costs and substantial long-term costs associated with graft failure and transplant complications, correlated with pharmacokinetic variability.
CONCLUSIONS: Identified literature suggests that Envarsus® should be considered distinct from other TAC‑PR formulations with clinical and economic advantages, particularly in fast metabolisers. These findings support consideration of Envarsus® as a distinct intervention in future modelling. Key UK data gaps remain but do not preclude further economic evaluation, including subgroup analyses in fast metabolisers.