THE COST OF TREATING MUCORMYCOSIS WITH ISAVUCONAZOLE COMPARED WITH LIPOSOMAL AMPHOTERICIN B FOLLOWED BY POSACONAZOLE IN THE UNITED KINGDOM: ECONOMIC EVALUATION OF THE PHASE III VITAL STUDY AND FUNGISCOPE™ MATCHED CASE-CONTROL ANALYSIS
Kuessner D1, Bagshaw E2, Blackney M2, Cornely O A3,4, Heimann S3, Posthumus J1 1Basilea Pharmaceutica International Ltd., Basel, Switzerland, 2Covance Market Access, London, UK, 3University Hospital of Cologne, Department I of Internal Medicine, Cologne, Germany, 4Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Clinical Trials Centre Cologne (ZKS Köln), University of Cologne, Cologne, Germany
BACKGROUND AND OBJECTIVES RESULTS • Mucormycosis is a rapidly progressive invasive fungal disease, with a high risk of mortality, which mainly affects immunocompromised or critically ill people1–3. Base case • The cost of treating patients with mucormycosis is substantial, due to prolonged use of high-cost antifungals4,5, lengthy hospital stays4–6, and the management of adverse events (AEs)7. • Total per-patient mucormycosis treatment costs were estimated to be £26,810 with ISAV versus £41,855 with L-AMB + POSA; Figure 2 and Table 3. • Until recently, the only licensed antifungals for mucormycosis were formulations of amphotericin B (AMB): • This represents a saving of 36% with ISAV relative to L-AMB + POSA. −− Liposomal AMB (L-AMB) – the standard treatment for mucormycosis in the United Kingdom (UK) – carries a risk of renal toxicity, particularly at the high doses (over 5 mg/kg)8,9 commonly used in mucormycosis10, which increases the likelihood of dose reductions and • The greatest driver of savings was drug acquisition costs, due to a lower daily drug cost for ISAV than for L-AMB + POSA, combined with a discontinuations9. shorter duration of IV therapy. −− L-AMB is not available as an oral formulation8, which means that, if outpatient maintenance therapy is required, a step-down to off-label • Hospitalisation costs were considerably lower for ISAV than for L-AMB + POSA, as the IV-to-oral switch occurred earlier for ISAV patients than oral posaconazole (POSA) may be made10. for those given L-AMB + POSA. • Isavuconazole (ISAV) is an intravenous (IV) and oral, broad-spectrum, triazole antifungal indicated in the European Union (EU) for the treatment • Monitoring and administration costs were also lower with ISAV than with L-AMB + POSA. of mucormycosis in adults for whom AMB is inappropriate, and for invasive aspergillosis11. • ISAV has comparable efficacy to AMB ± POSA in the primary treatment of mucormycosis, and an acceptable safety profile12. Figure 2. Base case per-patient cost of mucormycosis treatment • A health-economic model was developed to explore the per-patient cost to the UK healthcare system of treating mucormycosis with ISAV alone compared with L-AMB followed by off-label, maintenance POSA.d with managing these events, over a five-year period 50,000 £ 40,000 £ ,
METHODS Per-patient cost 30,000 £ Cost factors: • The model took a cost-minimisation approach. The rationale for this was that a matched case-control analysis comparing the ISAV VITAL of mucormycosis £ , £ , Monitoring and study with the FungiScope™ registry of emerging fungal infections showed no significant difference in Day 42 all-cause mortality between treatment (£) 20,000 administration mucormycosis patients treated with ISAV or AMB (mainly L-AMB) ± POSA12. £ , Hospitalisation • ISAV is licensed in the EU for use only in patients for whom AMB is deemed inappropriate. However, L-AMB, the standard of care, is the most 10,000 appropriate comparator for ISAV as, in clinical practice, in cases of intolerance, L-AMB treatment may be continued but at a reduced dose10. rug acquisition 0 Figure 1. Model structure L-AMB + POSA ISAV Total cost 41,855 26,810 Total cost L-AMB + POSA Total cost ISAV Values have been rounded. Length of treatment daily Length of treatment daily drug costs (IV oral) drug costs (IV oral) Table 3. Base case per-patient cost of mucormycosis treatment
Length of hospital stay Length of hospital stay L-AMB + POSA ISAV Saving ISAV versus daily hospitalisation cost daily hospitalisation cost L-AMB + POSA, Cost source Resource use Cost, £ Resource use Cost, £ £ (% change) Monitoring costs (tests applied Monitoring costs (tests applied test costs) + administration test costs) + administration IV drug 27.2 days 18,189 15.5 days 4,978 13,210 (73) costs (IV treatment days IV costs (IV treatment days IV administration cost) administration cost) Oral drug 121.8 days 9,163 133.5 days 11,668 -2,504 (-27) Results of cost-minimisation analysis Total drug Formula: 149.0 days 27,352 149.0 days 16,646 10,706 (39) (total cost of L-AMB + POSA) – (total costs of ISAV) acquisition