1. 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

2. 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)

3. 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

4. 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

5. 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

6. 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

7. 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: € 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: €/1.65 = €/g
Pump: €/1.65 = €/g
Δ = %
The material and the technical complexity

11. 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

12. 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.

13. LQI scores indicate a rather good satisfaction in the three scales

14. 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

15. 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

16. 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?

17. 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

18. THANK YOU FOR YOUR ATTENTION