Clinical Outcomes, Laboratory Safety, and Drug-Acquisition Cost Analysis of Generic versus Brand-Name Palbociclib in HR+/HER2− Metastatic Breast Cancer: A Real-World Ambispective Cohort Study from Iraq

Abstract

Background: The usage of Palbociclib for the treatment of HR+/HER2− breast cancer metastases is expensive, compromising its accessibility for patients in LMICs. Iraq needs evidence about generics: effectiveness, safety and price.
Objective: The aim was to compare 12-month disease control rate, overall response rate, laboratory safety, progress-free survival, and drug-acquisition cost of Ibrance® vs. IPI-Palbo® in Iraqi patients with HR+/HER2− metastatic breast cancer.
Methods: This Ambispective cohort included 57 women receiving Palbociclib plus endocrine at Anbar Cancer Center, Iraq. The patients received either brand-name (n=20) or generic (n=37) Palbociclib. CT evaluated the response of the tumor based on RECIST 1.1 at 4, 8 and 12 months. We were assessing the blood and chemical parameters in subjects. Analysis was performed of drug-acquisition costs, cost-effectiveness ratios, Kaplan-Meier progression-free survival and multivariable logistic regression for 12-month disease control.
Results: The rates of disease control were similar between the two groups at a twelve-month follow-up (60.0% vs.59.5%; p=1.000), as were the overall response rates at twelve months (15.0% versus 10.8%; p=0.687). There were no discontinuations due to (clinically) acceptable laboratory differences. Brand acquisition cost was almost four times greater (4,447,016 vs. 1,106,503 IQD; p<0.001) with IPI-Palbo® being the cost-effective option.
Conclusion: The generic version of Palbociclib showed similar efficacy in 12-month disease control with acceptable laboratory safety at lower cost. Overall, our study supports the value of generic Palbociclib to practice in Iraq oncology, which warrants a prospective confirmation.