The Oncology Department of the Hyderabad-based Nizam's Institute of Medical Sciences (NIMS) has been chosen as the nodal agency for Andhra Pradesh for the Glivec International Patient Assistance Program (GIPAP) to provide treatment to patients with chronic myeloid leukemia and gastrointestinal stromal tumour (GIST). The drug, which costs over Rs 1 lakh for a month's treatment, is being supplied free by the manufacturer, Novartis, according to Kakarla Subba Rao, director of NIMS.
GIPAP is helping patients in 67 countries worldwide. The number of patients who have received free Glivec through GIPAP is about 5620, of which, the GIPAP India programme continues to provide medicine to 1500 existing patients in India. GIPAP was established in 2001 by Novartis to provide the medicine to qualified patients worldwide in countries where the drug is approved for treating Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in various phases according to individual country's approved registration, or Kit (CD117) positive unresectable (inoperable) and / or metastatic malignant gastrointestinal stromal tumours (GIST).
The programme is not available in countries where a generic form of imatinib is available. To be eligible for GIPAP, patients must be properly diagnosed by a qualified physician, not insured or reimbursed and have no other financial recourse. GIPAP is being implemented worldwide, except in the United States and Puerto Rico where Novartis has developed a separate Patient Assistance Program (PAP).
The GIPAP model is designed to provide the drug to individual patients, as opposed to typical donation programmes that deliver drugs through hospitals or other third party distribution organizations. The Max Foundation administers GIPAP on behalf of Novartis, and is responsible for registering qualified patients according to specific medical and financial requirements provided by Novartis. These requirements are in accordance with World Health Organization (WHO) guidelines, which provide global guidance on charitable donation programmes. Novartis is responsible for the actual shipment of the drug to qualified treatment centres that provide the drug to those patients approved by the Foundation.
Treatment centers must qualify for the GIPAP programme and are evaluated primarily on their oncologic / haematologic expertise and diagnostic and monitoring capabilities. Physicians must be registered in order to apply for GIPAP assistance on behalf of their patients to help ensure that appropriate patients for this drug therapy are considered. The physician must be involved in all stages of the treatment (diagnosis, prescription and follow-through).