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