SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE-DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS, R. ROMBAUT, R. PECHE (BELGIUM) INGID PROGRAMME SATURDAY, NOVEMBER 01, 2014

Disclosure of potential conflicts of interest Home Nursing Reniers An bvba acts as a third party in a Patient Support Program financed by Octapharma Benelux SA Travel and accommodation costs for ESID 16th Biennial Meeting have been covered by Octapharma Benelux SA (in the framework of the contractual obligations of training between Octapharma and HNRA)

Subjects addressed   Moving from IVIG at hospital to SCIG at home Patient Support Program (PSP) Rapid push versus pump(s) Belgian patients’ cohort Measuring patients’ satisfaction in the framework of a PSP Case reports Key messages

Moving from IVIG at hospital to SCIG at home   Reason for the treating physician: for the best interest of patients, lack of place at the one-day clinic Reasons for the patient: avoiding the hospital setting, tolerance, venous access, less days out of school/work, distance to hospital… Interest for health payers: lower costs Objective: to increase patients’ quality of life and satisfaction Moving patients from hospital- to home-therapy with self-infusion is a challenge for the patient and the health care staff Is a specific therapeutic circumstance where Patient Support Programs can be useful

Company-sponsored Patient Support Program (PSP) Doctor 3rd Party Nurse Patient contract informs contacts Directs 3 Octapharma-sponsored PSPs for gammanorm® in Belgium Some hospitals have their own PSP Objectives of PSP : the quality of care Proper use of drug Adherence to treatment Patients’ satisfaction Delegation of responsibility by treating physician without loss of control Logistics

Role of nurse in PSP for home infusion of IG   Patients’ information on treatment modalities allowing an informed decision by the patient in dialogue with the treating physician = Information session at home before decision on administration modality Initial training = First administration made by nurse at the hospital Initiation of home treatment = Presence of the nurse for the first one to three home administration(s) Follow-up of treatment and report to treating physician = Visit at home preferably at the occasion of an administration around every 3 months or at patient’s request Reporting adverse events, compliance, satisfaction and problems to the treating physician Logistics of products, material and disposables

Rapid push versus pump(s)   Individual choice at a given time in a given situation Duration and frequency of administrations Rapid push: normally 1ml/min 20 ml twice a week = 40 min Same dose (40 ml/week) with pump takes around 100 min if two sites of injection are used Patient’s involvement Slightly more involved when rapid push Costs Material Infusion with pump: 12.39 € per infusion (considering 1 pump and a life span of 4 years of the pump) Rapid push: 1.22 € Total cost per gram in case of 10 ml (1.65 g) / injection and 40 €/g IG: Rapid push: 66.27 €/1.65 = 40.74 €/g Pump: 73.44 €/1.65 = 47.51 €/g Δ = + 16.62 % The material and the technical complexity

Patients’ cohort   32 patients in the HNRA PSP at the time of abstract submission Not all patients were offered the choice between pump and rapid push by their treating physician 22 patients currently on gammanorm® had this choice All patients were previously treated at the hospital by IVIG 15 (12 adults and 3 children) are on rapid push, 7 (4 adults and 3 children) on pump Age: from 2 to 71 Duration of treatment: from several months to more than 3 years 10 to 60 ml per week 1 to 3 injections per week for rapid push; 1 injection per week by pump Injections made by patients, mother, nurse or friend Sites of injection: belly (90%), thigh, arm

Measuring patients’ satisfaction with treatment in the framework of a PSP   Adherence to treatment is dependant of patients’ satisfaction with treatment Measuring patients’ satisfaction with treatment was so an objective of the PSP Life Quality Index (LQI) and SF-36 (CHQ-PF50 in patients < 14 years) have been tried in a test series of 8 patients The SF36 is a well-known generic HRQoL instrument for adults (≥14 years) consisting of 36 items forming nine sub-scales that has been regularly used for evaluating HRQoL in PID patients under immunoglobulin treatment. In our test series, SF36 scores appear however to be greatly influenced by concomitant morbidities and not correlated to LQI scores. LQI is a patients’ satisfaction questionnaire initially developed for PID patients under IVIG. It was here limited to three scales, namely “treatment interference”, “treatment-related problems and “therapy setting”. From our limited experience, LQI seems to be an interesting easy-to-use tool for an objective evaluation of the satisfaction of PID patients receiving SCIG at home.

LQI scores indicate a rather good satisfaction in the three scales

Case report: patient 011   19 year old Male On rapid push for more than 2 years Self infusion in the belly 3 times a week (20 ml twice and 10 ml once) 50 minutes per week Compliance not good LQI: OK Decision to move to pump in September 2014 Reason: 3x/week is too much, administrations at school (stays at the boarding school) with its social impact Now only home injections once a week ?: would this choice improved patient’s satisfaction LQI will be measured after 6 months of pump administration Conclusion: Besides LQI OK, understanding specific problems is important Home and school are different settings

Case report: patient 015   60 year old Male On rapid push for 16 months now after IV therapy at hospital 50 ml/week; 3 injections per week Self administration in the belly Concomitant disease and treatment: chemotherapy for gastric tumor Initially lack of compliance due to the burden of chemotherapy Strict follow-up by nurse and support and encouragement (phone calls, visits, …) Currently good compliance and LQI OK while SF36 reflecting concomitant disease Improvement of health status (no more infection episode) Conclusion: Nurse’s intervention has greatly improved compliance leading to better health status

Case report: patient 021   2 year old Male On rapid push for 11 months now after a first IV administration at hospital 10 ml once a week in 15 min Injection made by mother in the tight with child in his chair playing with a tablet Concomitant disease: epilepsy Previously, frequency of epilepsy crises increased because of repeated fever episodes According to mother: less infection episodes under rapid push and less epilepsy crises and better (social) life for the whole family Conclusion: Rapid push is a relatively easy procedure for young children A better control of infectious episodes has a positive impact on concomitant disease and on the family environment Remark: A 1.5 year old child has been recently put on rapid push 6 ml once a week in 12 minutes Decision by the mother because of gain of time: how to maintain a 1.5 year old child quiet during 45 minutes with pump?

Key messages   Rapid push is a method of SCIG administration that is, to our opinion, to be considered for home administration of IG in both adults and children Moving patients from hospital to home is an opportunity and a challenge PSP is an efficient tool for an optimal quality of care at home PSP specialized nurse plays a pivotal role in treatment adherence and completion and proper use of drug Filling-in patient satisfaction questionnaire such as LQI once or twice a year could be a way to evaluate objectively patients’ satisfaction with treatment. This will be proposed to treating physicians in the framework of this PSP LQI is however, to our opinion, complementary to the more personal (subjective) evaluation of satisfaction and problems by the PSP nurse

THANK YOU FOR YOUR ATTENTION an.reniers@telenet.be