Novartis is launching a new global clinical support program that aims to improve the outcomes of patients with Ph+ chronic myeloid leukemia treated with its CML drug Gleevec.
According to Novartis, the program, called CML Alliance, will offer patients and physicians healthcare services to personalize Gleevec treatment, including patient education, access to Gleevec blood level monitoring, standardized molecular testing, access to reimbursement support services, and information on clinical trials with investigational agents and existing therapies in CML.
“The purpose of CML Alliance is to help healthcare providers who treat Ph+ CML and their patients fully optimize CML therapy,” Novartis said.
CML Alliance is a global program that will be “customized to best meet the needs and the regulatory and legal requirements of each country,” Novartis Oncology said in an e-mail.
Novartis markets Gleevec in more than 30 countries. It was not immediately clear whether CML Alliance would be available to all of them. However, the company said that Gleevec blood level testing is “currently being developed as part of the US program” and details will be available “soon.”
Novartis considers blood level monitoring to be critical to improving Gleevec efficacy and safety. “There are a number of factors that affect Gleevec blood levels, such as drug-drug interactions and adherence,” Novartis said. “So, physicians may get benefit from this testing to identify Gleevec patients who are non-adherent, [have] high drug clearance, [may be experiencing] drug-drug interactions or … serious side effects.”
The Canadian Example
Novartis Canada’s recent partnership with Warnex to perform bioanalytical and pharmacogenomic services for its Gleevec blood level-monitoring program is one example of how the CML Alliance may play out in a particular country [see PGx Reporter 04-11-07].
Warnex said in a statement that its Bioanalytical Services division will use liquid chromatography and mass spec technologies to test blood levels of Gleevec to “help identify non-adherence or suboptimal dosing.”
Warnex also will perform PCR-based diagnostic tests to determine if patients have chromosomal abnormalities such as a CYP3A4 mutation, which is responsible for metabolism of the drug, according to Gleevec’s label.
“Physicians may get benefit from this testing to identify Gleevec patients who are non-adherent, [have] high drug clearance, [may be experiencing] drug-drug interactions or … serious side effects.”
According to Novartis, in Canada, physicians will decide when patients get tested for mutations. Patients who have limited or no response to Gleevec will be the most likely candidates for genetic testing.
“Depending on mutation testing results, physicians may decide to change the therapy for their patient, [by for example] increasing Gleevec’s dose,” Novartis said.
Novartis noted that Warnex will not compile patient data to help ensure that genetic information remains anonymous.
The cost to patients for the blood monitoring and molecular testing services provided by CML Alliance will differ from country to country, and will depend on patients’ health insurance or their economic circumstances.
However, Novartis noted that “most of the services of CML Alliance are at no cost to healthcare professionals or patients.”
In the Canadian program, for instance, all patients on Gleevec and enrolled in the program will receive blood level testing and sample shipping for free. However, the program will not cover the cost of the doctor’s services or for the blood drawing.