subcutaneous administration of gammanorm® in immune- deficient patients by rapid push: report of...

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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

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Page 1: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,

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 PROGRAMMESATURDAY, NOVEMBER 01, 2014

Page 2: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,

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)

Page 3: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,

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

Page 4: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,

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

Page 5: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,

Company-sponsored Patient Support Program (PSP)

• 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

Company

Doctor

3rd Party

Nurse

Patient

contract contractinform

scontacts Directs

Page 6: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,

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

Page 7: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,

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

Page 8: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,
Page 9: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,
Page 10: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,
Page 11: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,

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

Page 12: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,

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.

Page 13: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,

LQI scores indicate a rather good satisfaction in the three scales

Page 14: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,

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 

Page 15: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,

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 

Page 16: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,

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?

Page 17: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,

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

Page 18: SUBCUTANEOUS ADMINISTRATION OF GAMMANORM® IN IMMUNE- DEFICIENT PATIENTS BY RAPID PUSH: REPORT OF THE BELGIAN EXPERIENCE. A. RENIERS, C. HEIJMANS, N. NOLS,

THANK YOU FOR YOUR ATTENTION

[email protected]