Chronic Myeloid Leukemia patients call for quality and consistency when generics are introduced to treat their cancer
On 2-4 May 2014, patient organisations from 58 countries supporting patients and families affected by Chronic Myeloid Leukemia (CML) met in Serbia to learn from medical experts, share best practice in patient advocacy and grow their organisation's capacity. An important topic of increasing attention discussed between patients and health professionals was the introduction of generics in CML treatment. Patients welcome that generics may improve patient access to more affordable therapies in many countries. However, patients also raise concerns about impact on their cancer when switched between different products for non-medical reasons, if these products’ equivalence in terms of quality and efficacy is uncertain.
With the imatinib patent expiring between 2013 and 2019, the introduction of generic versions is inevitable in many countries. Generics to treat CML have been introduced recently e.g. in Argentina, Bosnia-Herzegovina, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Dominican Republic, Guatemala, Ecuador, Egypt, Estonia, India, Kazakhstan, Lebanon, Latvia, Lithuania, Macedonia, Malta, Nepal, Philippines, Peru, Russia, Romania, Serbia, Slovenia, Slovakia, South Africa, Turkey and Uruguay.
Following intensive discussions at the global CML Advocates Network's global meeting of representatives of CML patient advocates on 2-4 May, CML patient groups call to governments, health authorities and healthcare professionals to minimize potential uncertainties and risks for patients with the following five measures:
- No generic drug to treat CML should be provided to patients without reliable proof of quality as well as equivalence of pharmacokinetics and bioavailability. Generic drugs should be approved by the appropriate authorities of the respective country or region, also reflecting a narrow therapeutic range of these cancer drugs.
- When treating severe cancer diseases like leukemias with generics, further comparative clinical data should be collected, demanded by regulatory bodies, and published, to ensure comparable clinical efficacy of products with the same compound.
- A CML patient should not be switched between products with the same compound for non-medical reasons, provided this patient already responds optimally to the current product and tolerates it well.
- If a switch for non-medical reasons between products with the same compound is enforced, this should not happen more frequently than once in a year, to allow a consistent follow-up of responses and side effects on the same CML treatment. If a patient loses its response or experiences a significant increase of toxicities after switching to the other product, the patient must have the option to return to the previous treatment, or switch to another treatment if available.
- After switching between products with the same compound, more frequent monitoring should be conducted to detect potential differences in effectiveness or side effects early.
This declaration complements the “Baveno Declaration”, signed by more than 50 CML patient organisations in 2008 to call for best practice in CML care, improved access to cancer treatment, and better adherence to international treatment guidelines.
Chronic Myeloid Leukemia (CML) is a rare cancer affecting blood stem cells. It is a form of leukaemia characterized by the increased and unregulated growth of cells in the bone marrow and the accumulation of these cells in the blood. It is caused by a genetic rearrangement in chromosomes 9 and 22.
Current oral treatments have turned CML from a lethal into a chronic disease. Still in the early 1990s, only every fourth patient survived 10 years following the diagnosis with CML. The introduction of targeted therapies in 2001 have improved the 10-year survival to 84% today, if treated effectively. However, as demonstrated in clinical trials, maintaining a stable response requires continuous effective treatment. Suboptimal dosing, low adherence or cessation of treatment has shown to lead to recurrence and acceleration of the disease in most patients. Performing a bone marrow transplantation is still the only cure of CML, and the only feasible treatment of the disease in advanced phases.
About the CML Advocates Network
The CML Advocates Network is the global network for leaders of Chronic Myeloid Leukemia (CML) patient groups. It connects more than 80 patient organizations in more than 60 countries on all continents. Its aim is to grow capacity in patient advocacy organizations, to stimulate collaboration and best practice sharing, to provide educational resources, and to work with key stakeholders in the area of leukemia care and patient advocacy.
To help patient advocates to understand the background on CML generics, it has launched a Resource & Knowledge Center, pulling together all information that is known to the patient community to date. See http://www.cmladvocates.net/generics
The CML Advocates Network was set up in 2005 and is run by CML patients and carers. It is hosted by the Leukemia Patient Advocates Foundation, a patient-led global non-profit organization registered in Switzerland.
In case of questions, please contact the CML Advocates Network at
Press Release, 21 May 2014