What is GIPAP?
For its breakthrough cancer therapy Glivec, Novartis designed The Glivec® International
Patient Assistance Program, or GIPAP, one of the most comprehensive and far-reaching
cancer access programs ever developed on a global scale. The “direct-to-patient”
model is designed to provide the drug directly to individual patients by their treating
Since its implementation in early 2002, GIPAP has provided Glivec to more than 19,000
patients in 80 developing countries with minimal reimbursement capabilities who
would not otherwise have access to the drug to treat their life-threatening diseases.
Currently, there is no other global cancer program like it in existence. Its success
is due in large part to its ability to adapt program goals to local rules/ regulations.
GIPAP is accessible to eligible patients who:
- are properly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid
leukaemia (CML) patients and to patients with c-Kit (CD117) positive unresectable
(inoperable) and/or metastatic malignant gastrointestinal stromal tumours (GISTs)
- cannot benefit from any reimbursement or insurance scheme
- are unable to pay for treatment privately as determined by pre-established socio-economic
- are in developing countries that have minimal reimbursement capabilities
- are in developing countries where regulatory approval for Glivec has been obtained
- are in developing countries where no generic versions of imatinib are available
Unlike traditional donation programs that deliver drugs through hospitals or other
third party distribution organizations, Glivec is delivered/dispensed directly to
patients by their treating physician/pharmacist.
As Novartis’ main partner in the administration of GIPAP, The Max Foundation is
responsible for reviewing and verifying patients’ eligibility according to specific
medical requirements provided by Novartis and performing socio-economic evaluations.
These requirements are in line with World Health Organization (WHO) guidelines,
which provide global guidance on charitable donation programs. Novartis is responsible
for identifying qualified medical centers and physicians, and for donating and supplying
Glivec to qualified treatment centers that provide the drug to those patients approved
by The Max Foundation.
To qualify to administer GIPAP, a qualified center must be able to fulfill the following
- Understand and accept the general and local conditions of the GIPAP program
- Have qualified hematology or cancer specialists that are able to provide expert
opinion on the indication and the response to therapy
- Have the capacity to perform a bone marrow aspiration / biopsy and detect the Philadelphia
chromosome to establish diagnosis for CML patients
- Have the capacity to stain for CD117 with antibody in GIST patients
- If a medical center doesn't have diagnostic capacities for either CML/GIST, this
center can submit an application form for GIPAP to the Max Foundation provided the
patient has been properly diagnosed in another qualified center
- Provide basic diagnostic and laboratory services to ensure patient follow-up such
as hematology, biochemistry, pathology and X-rays
- Provide supportive care, at a minimum blood transfusions and antibiotics
- Receive, store and keep track of the Glivec packs received and distributed according
to the instructions given by Novartis
- Report Serious Adverse Events to Novartis
- Keep records of patients' data and of detailed drug accountability's data
Novartis may not qualify a Center or a physician meeting the above-mentioned criteria
if the country has already enough Qualified Centers/physicians or for non-compliance
In countries where Novartis Oncology does not have a local presence, Novartis partners
with The Max Foundation and with Axios International to administer GIPAP. Axios
assists private and public organizations in creating and implementing practical
healthcare programs in the developing world.