Priority of corporate responsibility – Novartis has a demonstrated commitment and strong history of promoting and ensuring patient access to its innovative drug therapies.
Novartis is deeply committed to making its innovative therapies broadly available to patients. Through creative and sustainable public-private collaborations, Novartis works with local partners to implement access initiatives that meet local needs, coordinating with government funding mechanism and local healthcare structures and capabilities already in place in each country. In countries, where Nilotinib is commercially available, Novartis works to provide access to Nilotinib through programs modeled on Imatinib access initiatives.
Introduction of International Patient Assistance Program (TIPAP)
Although Imatinib has an unusually high rate of success, there are some chronic myeloid leukemia patients with Philadelphia Chromosome positive (Ph+ CML) who do not achieve an adequate response , stop responding, or are intolerant of the medicine. For these patients, Nilotinib is now available, a next generation tyrosine kinase inhibitor, to meet the needs of the adult patients with chronic or accelerated phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) who have not responded or are no longer responsive to or are unable to tolerate prior therapy, including Imatinib? (imatinib mesylate). Nilotinib was introduced in 46 countries by mid-year 2008, extending the innovative therapies available from Novartis Oncology to even more cancer patients in need of life-extending solutions.
Throughout the second half of 2008 and 2009, Nilotinib Global Patient Access Programs are being introduced in countries where Nilotinib is approved, Imatinib International Patient Assistance programs (GIPAP) are active, and where local infrastructure can support sustainable drug access programs. Novartis will continue its strong partnerships with The Max Foundation to implement and administer both GIPAP and TIPAP.
Novartis will also provide Nilotinib through both Shared Contribution and Co-pay Models in countries where these access models are available for Imatinib. Financial eligibility for Nilotinib Global Patient Access Programs will be consistent with criteria employed for Imatinib.
Shared Accountability
Novartis Oncology will also provide Nilotinib through Shared Contribution and Co-pay Models in countries where these access models are available for Imatinib. This approach increases the sustainability of the program by sharing accountability with other partners, thus allowing more patients to be reached.
- Shared Contribution Model (SCM)
Government healthcare systems, charities, or other payors, and Novartis Oncology share the cost of the medication. Novartis Oncology partners with national, provincial, and municipal governments to cover the cost of treatment for patients in need, with no payment by the patient. SCM benefits patients eligible to receive partial government healthcare reimbursement for Nilotinib. This partnership-based model is customized to address local jurisdiction needs throughout a country if necessary, so Shared Contribution reimbursement schemes and third party partners may vary.
- Co-pay
Novartis Oncology and the patient share the cost of Nilotinib on a sliding scale depending upon the patient’s ability to pay. The Co-pay Model assists patients who do not meet the TIPAP financial eligibility criteria and have no government, private or other means of reimbursement is available.. Patients contribute part of the cost of their treatment annually based on established criteria, with Novartis Oncology covering the balance.
Nilotinib Accredited Physicians and Certified Centers
The criteria for Nilotinib Global Patient Access Programs physicians and treatment centers (institutions) have been carefully defined. They apply to full donation (TIPAP) and shared accountability models (both SCM and Co-pay).
Certified Institutions as TIPAP Institutions must meet the criteria below
-
Pass the site evaluation according to the medical criteria
-
Availability of Cytogenetic testing by bone marrow and/or FISH (specific examination)
-
Availability of ECG monitoring capabilities
-
Availability of Cardiology expertise
-
Availability of Internet access
-
Designated staff responsible for drug storage and accountability
-
Follow Standard of Practice (SOP) of Stock management
Accredited Physicians as TIPAP physicians must meet the criteria below
Individual countries will determine if the selection conditions have been met. Physician selection is finalized only when online training results are analyzed and deemed successful.
Ultimately, each country will have a network of Nilotinib physicians and treatment centers/institutions to successfully implement the multiple Nilotinib patient access models.
Eligibility for Nilotinib Patient Access Programs
Patients eligibility who wish to participate in Nilotinib patient access programs must meet both economic and clinical criteria modeled on the World Health Organization (WHO) guidelines on charitable donation programs. This is consistent with criteria employed for GIPAP.
Economic Criteria
1
Patients are not insured
2
Patients are not reimbursed
3
cannot pay for treatment privately
4
Patients are in countries that have minimal reimbursement capabilities.
Clinical Criteria
Novartis Oncology, working with leading experts in CML around the world, has developed criteria to help hematologists and oncologists determine when it is appropriate to prescribe Nilotinib for particular patients.
1. Patients must have been properly diagnosed with imatinib-resistant Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and must be ? 18 years of age
Partners in Sustainable Patient Access
The success of GIPAP, and now the Nilotinib patient access programs, is due in large part to the seamless and complementary collaboration between Novartis Oncology and its main partners:
It takes resourceful and committed partnerships such as these to make the comprehensive patient access program effective on the local level in many diverse countries—and to provide a necessary depth of service.
While Novartis Oncology is responsible for identifying qualified medical centers and physicians, and for donating and supplying Imatinib and Nilotinib to qualified treatment centers, we rely on our partnerships such as The Max Foundation and future affiliations with other local organizations—to customize and maximize the success of the evolving Imatinib and Nilotinib Global Patient Access Programs.
The Max Foundation (TMF), as the main partner for Novartis Oncology in the administration of GIPAP, TIPAP, and Nilotinib Shared Contribution Model in select countries, is an invaluable collaborator and asset to our access programs’ achievements. TMF will continue to:
-
Verify and screen patients for medical and socio-economic qualifications
-
Guide physicians through patient evaluation process
-
Provide emotional support, information and referral assistance to patients, their family members and caregivers, regardless of their country of origin or economic status
-
Monitor patients to support the highest standard of patient care
-
Help identify and qualify eligible medical centers and physicians worldwide
