CHRONIC MYELOGENEOUS LEUKAEMIA

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Glivec® International Patient Assistance Program (GIPAP)

The Glivec® International Patient Assistance Program (GIPAP) is one of the most comprehensive and far-reaching cancer access programs ever developed on a global scale.

Novartis designed GIPAP to provide Glivec (imatinib) free of cost to eligible patients in developing countries who meet specific medical and socio-economic guidelines. Through The Max Foundation, GIPAP also provides information and referral assistance to patients, their family members and caregivers.

Specifically:

  • GIPAP helps patients who are properly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) patients and to patients with c-Kit (CD117) positive unresectable (inoperable) and/or metastatic malignant gastrointestinal stromal tumors (GISTs).
  • GIPAP helps patients who are not insured, not reimbursed, cannot pay for treatment privately, and are in developing countries that have minimal reimbursement capabilities.

GIPAP is more than a drug donation program; its goal is to optimize successful Glivec treatment by providing patients with emotional support and increasing awareness within their communities.

The Max Foundation, as Novartis’ main partner in the administration of GIPAP, provides socio-economic evaluation of patients, guides physicians through the patient evaluation process, and provides emotional support, information and referral assistance to patients, their family members and care givers. In addition, we monitor patients to support the highest standard of patient care, collaborate with Novartis to identify and qualify eligible medical centers and physicians worldwide, and protect confidential patient information and data received in the course of program administration.

Through The Max Foundation’s partnership with Novartis, experienced physicians and local organizations, GIPAP has been able to reach patients who would otherwise not have access to Glivec for their life-threatening diseases.

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 physicians.

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 criteria
  • 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 conditions:

  • 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 reasons

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.

Qualification Requirements for GIPAP

In order to qualify for GIPAP, the patient must meet specific eligibility criteria in medical and socio-economic areas as required by Novartis. GIPAP requirements were developed in line with WHO guidelines on access to medicines.

Medical Qualifications:

  • Patient has been properly diagnosed by a physician qualified to diagnose, treat and regularly monitor patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) and/or c-kit (CD117) positive unresectable (inoperable) and/or metastatic malignant gastrointestinal stromal tumours (GIST).
  • CML patients must fall within one of the following classifications: 1)The country in which the chronic phase Ph+ CML patient lives has approved the registration of Glivec® treatment for newly diagnosed Ph+ CML patients. 2)The patient is suffering from accelerated phase or blast crisis Ph+ CML. 3)Treatment for chronic phase Ph+ CML has been attempted first with interferon and the patient has not responded to the drug or the physician confirms that the patient cannot tolerate it.
  • The patient’s physician must follow treatment guidelines outlined in the Glivec® package leaflet and then supply progress information.

Socio-economic Qualifications:

  • Patient cannot benefit from any reimbursement or insurance scheme
  • Patient cannot afford to pay for treatment privately

Other Qualifications:

  • Patients must be in developing countries that have minimal reimbursement capabilities where regulatory approval or at least an import license for Glivec for CML/GIST has been obtained; and where no generic versions of imatinib are available and reimbursement negotiations have been completed.
  • The patient’s physician and clinic must be qualified.
  • The patient must be a country resident.
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