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AbstractObjective:To evaluate cost-effectiveness of brentuximab vedotin in patients with relapsed/refractory Hodgkin lymphoma who have received autologous stem cell transplantation, from a Scottish healthcare payer perspective.Methods:A Microsoft Excel-based partitioned survival model comprising three health states (progression-free survival [PFS], post-progression survival, and death) was developed. Relevant comparators were chemotherapy with or without radiotherapy (C/R) and C/R with intent to allogeneic hematopoietic stem cell transplantation (alloSCT). Data were obtained from the pivotal phase II single-arm trial in 102 patients (SG035-0003; NCT00848926), a systematic literature review and clinical expert opinions (where empirical evidence was unavailable). PFS and overall survival for brentuximab vedotin were estimated using 5-year follow-up data from SG035-0003, and extrapolated using event rates observed for comparator treatments from published survival data. Resource use included drug acquisition and administration; alloSCT; treatment of adverse events; and long-term follow-up. Deterministic and probabilistic sensitivity analyses were conducted to evaluate the impact of uncertainty.Results:In the base case, the incremental cost-effectiveness ratio (ICER) for brentuximab vedotin was £38,769 per quality-adjusted life year (QALY) vs C/R, whereas C/R with intent to alloSCT was dominated by brentuximab vedotin. ICERs for brentuximab vedotin generated by the deterministic sensitivity analysis ranged between £32,000–£54,000 per QALY. Including productivity benefits reduced the ICER to £28,881 per QALY.Limitations:Limitations include lack of comparative data from this single arm study and the heterogeneous population. Inconsistent baseline characteristic reporting across studies prevented complete assessment of heterogeneity and the extent of potential bias in clinical and cost-effectiveness estimates.Conclusions:Although the base case ICER is above the threshold usually applied in Scotland, it is relatively low compared with other orphan drugs, and lower than the ICER generated using a previous data cut of SG035-0003 that informed a positive recommendation from the Scottish Medicines Consortium, under its decision-making framework for assessment of ultra-orphan medicines.

AbstractBackground:Patients treated with epidermal growth factor receptor inhibitors (EGFRIs) may develop dermatologic adverse drug reactions (ADRs) that may affect patients’ quality-of-life, require medical care, and may lead to substantial costs. This study assessed the economic burden of dermatologic ADRs in colorectal cancer (CRC), head and neck cancer (HNC), and non-small cell lung cancer (NSCLC) patients.Methods:Adult patients with 1 diagnosis for the study cancer initiated on EGFRIs indicated for CRC, HNC, and NSCLC were selected from a large commercial database (MarketScan Commercial Database [2000–2010]; Thomas Reuters, New York, NY). For each cancer type, patients were classified into two mutually exclusive cohorts: ‘ADR’ (patients with 1 ADR following EGFRI initiation) and ‘ADR-free’ (patients without any ADR). Patients were observed from the index date up to the end of continuous healthcare plan enrollment or 90 days after EGFRI discontinuation, whichever occurred first. For each cancer group, the proportion of patients and the incidence rate (IR) of experiencing 1 dermatologic ADR were reported. Incidence rate ratios for healthcare resource utilization and monthly incremental costs (2010 USD) were estimated using Poisson regression and generalized linear or two-part models, respectively.Results:Overall, the proportion of patients with 1 ADR ranged between 20.5–36.4 across cancer groups (IR ranged between 44.2–57.4 per 100 patient-years). After adjusting for confounders, in each cancer group, ADR patients had higher incidence of healthcare resource utilization, generally driven by higher incidence of emergency room visits and incurred incremental total monthly healthcare costs that ranged between 2284–3210 across cancer groups.Limitations:There was no clinical measure of cancer staging and ADR severity in the database.Conclusions:Results suggest that patients with CRC, NSCLC, and HNC, who may benefit from EGFRI therapies, may also incur a substantial economic burden that is associated with dermatologic ADRs.