Following the agreement on a new licensing model between the Medicines Patent Pool (MPP) & Novartis in collaboration with the ATOM Coalition, generic, quality-assured nilotinib is now available on NCDconnect! This initiative is crucial in making lifesaving treatments available to patients in low- and middle-income countries (LMICs), significantly lowering the barriers to care.
Nilotinib, an essential medicine for treating chronic myeloid leukaemia (CML), offers hope for patients suffering from this life-threatening condition. CML is a type of blood cancer characterised by the rapid growth of abnormal white blood cells. Globally, leukaemia accounts for approximately 474,500 new cases each year, with chronic myeloid leukaemia representing about 15-20% of adult cases. The availability of medications like nilotinib, particularly in low- and middle-income countries (LMICs), is crucial as they provide an effective treatment option for patients who might otherwise have limited access to lifesaving medicines.
To make nilotinib more globally accessible, the MPP and Novartis signed a voluntary licence agreement for the cancer medicine in 2022. This agreement opened the door for four generic manufacturers to supply affordable versions of nilotinib at higher volumes, lowering the barriers to treatment for CML patients in LMICs. Hetero is leading the effort as the first to receive US FDA approval for its generic nilotinib, guaranteeing high-quality standards hand-in-hand with affordability.
What is NCDconnect’s role?
IDA Foundation plays a strategic role in this effort, coordinating the sourcing of nilotinib from Hetero and making it globally accessible through our digital procurement platform, NCDconnect. With an initial focus on key markets like El Salvador, Ethiopia, Honduras, Indonesia, and the Philippines, IDA and its partners in the ATOM Coalition work closely with local governments, healthcare providers, and regulatory authorities to fast-track product registration and importation waivers. By ensuring timely registration, clearance, and distribution in these countries, the ATOM Coalition and IDA aim to create a streamlined supply chain that delivers affordable nilotinib to patients in need.
Moreover, IDA collaborates with The Max Foundation, MPP, and in-country partners of the UICC-led ATOM Coalition to augment quality-assured manufacturing capacity, understand market size, strengthen capacity along the complete patient continuum, and address the financial and social barriers to care on the ground.
How does this agreement improve affordable access?
The outcomes of this access programme are poised to be transformative. First, the availability of generic nilotinib at price estimates ranging from $150-200 per month—compared to $1,200 – 2,500 for the branded version—will significantly reduce the financial burden on patients and healthcare systems. This reduction will allow more CML patients to receive consistent and effective treatment, improving survival rates and quality of life. The programme also highlights the importance of collaboration between pharmaceutical companies, international organisations, and local governments to address healthcare gaps in LMICs.
As the programme advances, visibility into patient demand and local market conditions will be key challenges, but we are convinced that the goal of expanding access to nilotinib in low-income countries is well within reach.
Stay tuned for more program updates!