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ERSAP Diagnosis & Testing Program

Improving access to CML diagnostic testing and monitoring globally

Improving access to diagnostics is one of the most challenging issues to address on a large scale. Through small grants and partnerships with CML centres of excellence the ERSAP Diagnosis and Testing Program plans to enable centres in emerging regions to increase their local capacity to conduct diagnostic and long term monitoring of their CML patients. We hope that, for the first time in many cases, physicians will be able to locally confirm the diagnosis of CML patients, leading to better treatment and long term care. This has the potential to dramatically alter the lives of the patients and their families, in some cases whole communities.

When the iCMLf was first conceived one of the major motivations for forming a global foundation was our concern that the remarkable progress seen over the past decade in CML management with the development and clinical application of imatinib was largely confined to the more developed countries. Our mission to improve CML outcomes GLOBALLY made the care of CML patients in the less developed nations our number one priority. One of the most cost-effective ways we could make an impact initially was through physician education and training. We have made good progress in our first program to facilitate preceptorships for physicians from emerging regions (see article page 1) and our e-education program (article on page 3) has also made a solid start. We now need to embark on a more complex and ambitious program that will require more resources and a thoughtful management. We would like to improve access to diagnostic tests and monitoring for CML patients in Emerging Economic Regions.

Pat Garcia-Gonzalez from The Max Foundation has been working towards the same goal. She has recognised the importance of these services from her perspective running the Glivec International Patient Assistance Program (GIPAP) program to provide imatinib to CML patients with limited means who are from the emerging regions. She saw that a drug access program without adequate support from a diagnosis and monitoring program was not optimal.

What is the need for diagnosis testing?

It could be argued that the diagnosis of CML can be made with a moderate level of confidence by clinical and morphological studies alone without the need to BCR-ABL mRNA testing or detection of the Philadelphia (Ph) chromosome in marrow metaphases. However this assumes a level of experience and training that will not always be available. Detection of BCR-ABL or the Ph chromosome provides a definite diagnosis in the right clinical context.  

Many hospitals and clinics in developing countries do not have the capability to confirm the diagnosis of CML either by cytogenetics or by molecular tests, which results in patients not being able to access the medication available to enhance and extend their quality of life.  To increase access to these tests for patients in emerging regions the iCMLf, in partnership with the Max Foundation aims to set up facilities at a local level to either bring high quality testing to the patient, or to develop a low cost strategy for sending patient samples to a central laboratory for testing.

There are hundreds of CML patients globally who can't access imatinib through the GIPAP program because they can't afford a diagnostic test. The GIPAP program specifies that to be eligible for free or subsidised imatinib you need either a positive PCR test, or a positive FISH test for BCR-ABL. In some cases eligibility to GIPAP gives patients in emerging regions the only realistic chance they have to receive imatinib, the gold standard therapy for CML.

What is the need for monitoring?

Many patients who are able to access imatinib through GIPAP or other national programs do not have access to regular molecular or cytogenetic monitoring. This means that the first sign of poor drug adherence, drug resistance or disease progression is often frank haematological relapse or blast crisis. Salvage therapy in these settings is often ineffective so that the opportunity to intervene at an early stage when a switch in therapy or an allogeneic transplant may have been effective is lost.

Reliable, sensitive monitoring is important to evaluate the effect of treatment, provided that the tests are performed on a regular basis. It is also critical that the treating physician is able to interpret the result appropriately. It may not be realistic to aim for ongoing 3-6 monthly testing in all patients so our initial focus will be on achieving early molecular screening 6 and 12 months after therapy begins. We know that patients who are not below 10% BCR-ABL (IS) by these time points have a high risk of progression. Identifying these patients within the first year may provide the opportunity for an effective intervention such as an increased dose of imatinib, a switch to another TKI or consideration for allogeneic transplant.

Self sufficient sites

The long-term goal for this program is to provide equipment and training for clinical and laboratory staff at the local level. This will allow specific centres in emerging regions to become self-sufficient for diagnosis and monitoring of their CML patients.

How can we achieve our goals?

To quote Lao Tzu, the journey of a thousand miles begins with one step. As part of the Emerging Regions Support and Partnership (ERSAP) Diagnosis and Testing Program the iCMLf would like to form partnerships with CML doctors and centres in emerging regions to develop diagnostic and monitoring services. No single model of how this will work optimally is assumed. It is likely that solutions will be different in different countries. The strategic placement of an automated machine in a centre plus the provision of appropriate training and support may be an effective solution in one centre. In another situation training of local technicians to establish and maintain an in-house assay may be the most cost-effective way to establish a local service. We will be the facilitators of this process but the emphasis will be on finding partners in emerging regions who want to work out a local solution and can leverage local support on top of the limited support we are able to offer at present from the iCMLf. The iCMLf will provide seed funding to assist in funding tests, reagents, sample transport and the logistics to conduct the program. To ensure high quality of care there is a need to establish strong links between local centres and CML centres of excellence, to provide the technical and clinical support necessary for result interpretation and clinical follow up.

To facilitate this, in 2011 the iCMLf will offer a limited number of grants to hematology centres in Emerging Regions. These grants will be awarded on evaluation of submitted proposals that clearly demonstrate how the funded activity will improve access to CML diagnosis and testing. The grants will provide funding of up to a maximum of US $10,000 per grant along with additional support from a partnering CML centre of excellence.

This model, with the iCMLf as facilitator of locally driven enterprises, rather than as a controller of the program will allow the local sites the flexibility to run the program according to their local situation with the support of a CML centre of excellence. After the first year the success of the different projects will be evaluated to refine and enhance the program to achieve maximum cost-effectiveness.

For further information about the iCMLf funding and support to increase access to CML diagnosis and monitoring contact nicola.evans@cml-foundation.org.

Prof Tim Hughes
Co-founder of the iCMLf