Sun Pharmaceutical Industries Ltd announced the extension of its Imatinib Mesylate Savings Card programme beyond July 31, 2016. Sun Pharma launched this programme as part of the imatinib mesylate launch in February 2016. The programme is aimed at delivering greater access to the drug by patients who have commercial insurance, but whose out-of-pocket cost may exceed an affordable amount.  

As part of the Imatinib Mesylate Savings Card programme extension, Sun Pharma will continue to offer up to US$ 700 reduction on each eligible patient’s initial out-of-pocket cost from their commercial insurer thereby reducing the patient’s out-of-pocket co-payment to as low as $10. This benefit will cover a patient’s monthly fills for a 30-day supply of Sun Pharma’s imatinib mesylate prescribed for Ph+CML, a form of chronic myeloid leukaemia through the extension period.

During the first six months following its launch on February 1st, more than 5,000 prescriptions for Sun Pharma’s imatinib mesylate have been filled by patients utilizing this savings card program. The benefit to patients was in the range of a 50% to 60% reduction in out-of-pocket costs. Patients in USA who wish to utilize this programme can download the savings card by visiting Sun Pharma’s imatinib mesylate website at www.imatinibrx.com. The company will also continue its hub service wherein patients can call and speak with a trained healthcare professional and discuss FDA approved uses for imatinib mesylate (under Sun Pharma’s ANDA.)  Patients in USA can access Sun Pharma’s hub service through the toll-free helpline number +1 844-502-5950.

Imatinib mesylate is a kinase inhibitor indicated for the treatment of: Newly diagnosed adult and paediatric patients with Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) in chronic phase;  Patients with Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy; Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL);   Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements;   Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown;  Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRá fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L- PDGFRá fusion kinase negative or unknown; Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

As stated in the FDA approval letter, Sun Pharma’s imatinib mesylate ANDA contains a statement under section 505(j)(2)(A)(viii) of the FD&C Act representing that its application did not seek approval for the method of treatment covered under US Patent No. 6958335 (‘335 patent). According to the FDA’s Orange Book, the ’335 patent covers the “indication for the treatment of patients with KIT (CD117) positive unrespectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).”  As a result, the FDA has not approved Sun Pharma’s imatinib mesylate tablet products for this indication.