Effectiveness and Safety of Palbociclib: Brand vs. Generic in Iraqi Stage IV Breast Cancer Patients

The main problem, though, is that there is no local study performed that evaluates the effectiveness, safety, and tolerability of palbociclib in Iraqi patients. Although conducted worldwide, the clinical benefit established with palbociclib may not apply to the outcomes in Iraq, due to the difference in patients, the health care system, and continuity of treatment, which do not resemble those present in countries of high income. Another equally urgent problem is the absence of comparative studies performed on the branded palbociclib (Ibrance®) and the versions that are now entering the Iraqi market. The high cost of branded forms of palbociclib and the out-of-pocket payment in the bulk of them make it necessary for patients to resort to the generic forms, in view of the absence of comparative data showing clinical equivalence. The oncologists, at the same time, lack data that show whether substitution leads to any loss of efficacy or safety, and the information is lacking to determine the consequences of procurement and reimbursement policies. Thus, the problem addressed in this thesis is two-fold in nature: (1) the absence of real-world data on the outcome of palbociclib therapy in Iraqi breast cancer patients and the absence of comparative studies on branded versus generic evaluations in Iraq. In the absence of local data, treatment will have to be based on result extrapolation from foreign studies instead of local data, which may lead to undesirable results in the way of results and efficiency of administration of limited health care resources.