Assisted Administration Of  Subcutaneous 5-Azacytidine  to The Patient's Home. Significant Reduction Of Indirect Costs Incurred By Care Recipients and Unpaid Caregivers Together With a Total Adhesion To The Treatment Schedule and Same Safety

Administration of azacitidine is planned in-patient daily, there is no experience of its administration to the patient's home. The aim of this work was to evaluate the feasibility of a program of home administration of azacitidine able to reducing the cost-of-illness, to increase adherence to treatment while maintaining the same safety of the therapy given in hospital.

Between Jan 2008 and Dec 2012, 22 consecutive  patients, (MDSs, n = 15; CMML, n = 4; AML, n = 3), were enrolled in the study.

The pharmacoeconomic analysis included assessment of direct costs ( hospital inpatient, physician inpatient, physician outpatient, emergency department nursing home care, specialists’ and other health professionals’ care, diagnostic tests, prescription drugs and drug sundries, and medical supplies),indirect costs incurred by care recipients and unpaid caregivers, including time, productivity and travel cost.

Azacitidine 75 mg/m2/day was administered as a subcutaneous injection for 7 consecutive days  every 4 weeks,  Median age of the patients was 71 years (range, 65–83). Median number of courses delivered to each patient was 9 (range, 3–31) Hematologic responses (CR/PR/mCR) were induced in 6 patients (27.0%)  Median number of treatment courses to achieve any response was 2 (range, 1–6) Adverse events were evaluated for the first 6 courses for all patients, for a total of 124 courses. Major adverse events were cytopenia and cytopenia-related infection. Grade 3 or higher neutropenia was 64.4%) but incidence of febrile episode requiring intravenous antibiotics was  8,4% slightly lower than reported from the pivotal clinical study. Grade 3 or higher non-hematologic toxicities were infrequent. Injection site reaction 0.4 and site pain 0% Median follow-up duration of surviving patients was 46.9 months (range, 11.8–55.5). Of the 14 patients  who were RBC transfusion dependent at baseline, 48.0% of these patients became RBC transfusion independent during the treatment period. Adherence to treatment was 100%.

In our experience, despite the high percentage of elderly patients of whom 36% living in rural area, it was possible to give treatment to all patients with 100% adherence. There has been a reduction in direct medical costs due  to less use of hospitalization, a reduction of indirect costs by 63% due to the lower number of working days lost and a drastic reduction of travel costs, with the same efficacy and safety of administration.

Off Label Use: drug administration at patient home instead of hospital.