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GIPAP, historical perspective and current objectives

Since early 2002, the Glivec International Patient Assistance Program (GIPAP) has provided a bridge to Glivec access for CML patients from 80 countries in Latin America, Africa, Asia Pacific and Eastern Europe. Developed and sponsored by Novartis and launched just a few months after the drug received FDA approval, the program has provided unprecedented access to state of the art treatment in so-called developing countries almost simultaneously with the Western World. As a result, for the past eight years more than 1,000 hematologists and 30,000 CML patients in developing countries have been able to benefit from access to Glivec treatment.

GIPAP operates in designated countries with program guidelines developed by Novartis in line with WHO recommendations for international drug donations. As such is serves patients who have confirmed Ph+ CML disease, following the locally approved indication. The program is administered in most countries by The Max Foundation and eligible patients must verify that they do not have reimbursement, insurance or other means to access treatment. As administrator, The Max Foundation liaises with each GIPAP physician, confirms the need and qualifications of each patient and informs Novartis of the approval. Novartis, in turn, supplies the drug on a patient-by-patient basis to each physician for a period of three months at a time.

A program of this magnitude for an oncology product in countries with stressed healthcare systems had never been implemented before and has presented unique challenges which include: issues with drug importation and control of drug distribution in-country; lack of needed resources available for treating physicians; and lack of diagnostic capabilities at the medical centers. On the patient side, poverty and distance from the qualified hematologists can affect treatment adherence.

Support systems established early on in the development of the program have served to offset some of the challenges inherent to the environment.

Some of the main medical centers in countries with large populations, such as India, are provided with clinical coordinators that support physicians in the administrative process. The Max Foundation established a network of local advocates who facilitate internet related administrative work for physicians; as well as follow patients one-on-one providing support with transportation issues and access to diagnostics among other services. Further, The Max Foundation developed a web based application that allows the team to communicate with physicians in real time to coordinate the care of each patient.

Today GIPAP continues to serve more than 20,000 CML patients some of whom have been on Glivec treatment for eight years. In many of the countries where GIPAP used to be the only means for access to treatment, new, more sustainable access models, are currently being launched in collaboration with local MOH and other local stakeholders. In several countries, newly diagnosed patients can now access services and support from formal patient organizations established by CML patient leaders; and disease management programs are being rolled out to support compliance.

GIPAP has shown that access to oncology products in developing countries can be a key factor in the development of stronger healthcare systems by showing the many benefits of early diagnosis and good treatment. Still one must pose the question, “Now what?” My response would be that it is up to all stakeholders to join in partnership and ensure sustainable access to the newest treatments, and this is where the global community will benefit from the leadership of the International CML Foundation, a meeting of the minds to further research to help patients all around the world.

Pat Garcia-Gonzalez
Executive Director
The Max Foundation