Biosimilar Trastuzumab's Public Reimbursement inOncologyusing Cost-Effectiveness Evidence
Author(s)
Ruchita Rajesh Ranazunjare, PharmD.
Student, Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, Pune, India.
Student, Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, Pune, India.
Problem Statement: One of the primary causes of cancer-related mortality and morbidity among Indian women is HER2-positive breast cancer. Guidelines prescribe trastuzumab as a treatment for this population, but historically, public oncology clinics in India have not been able to provide extensive access to it due to its high purchasing cost. Whether biosimilar trastuzumab might be practically incorporated into government-funded chemotherapy pathways without jeopardizing financial sustainability was the main concern for state health authorities.
Description: To determine the cost-effectiveness and economic impacts of adding biosimilar trastuzumab to a major Indian state's essential medicines list (EML), a health economic review was conducted. The study compared biosimilar trastuzumab with chemotherapy against chemotherapy alone to patients with early-stage HER2-positive breast cancer using a decision-analytic method and a government payer perspective. Real-world data retrieved from Indian cancer registries was used to explain the clinical efficacy inputs, which were taken from published randomized trials. Estimates of utilized resources from tertiary cancer institutions and public procurement costs were evidence of cost inputs. The incremental cost-effectiveness ratio (ICER) produced by the model was ₹92,000 every quality-adjusted life year (QALY) gained, which is significantly smaller than the common willingness to pay threshold for India. A five-year budget impact analysis projected that expected reduction in hospitalization and disease recurrence rates would compensate for the additional expenses of ₹125 crore. The outcomes were examined in cooperation with national health technology assessment body (HTAIn) and given to the State Health Authority as a verification report.
Lessons Learned: Incorporating localized HEOR data positively influenced governmental purchasing practices and made it easier to include biosimilar trastuzumab in the state's EML based on research. Academic-government cooperation, early and ongoing interaction with individuals making decisions, and the utilization of data were key elements of success. A significant downstream influence on population-level cancer care equity was indicated by following the implementation evaluation, which showed a 60% rise in trastuzumab availability across public tertiary care facilities in just one year.
Stakeholder Perspective: This example is given from the perspective of the HTAIn body and the government payer, who worked together to overcome major accessibility and reimbursement challenges in oncology care by utilizing health economic research. The study demonstrates the direct application of HEOR to influence government health care allocation of resources in low- and middle-income countries.
Description: To determine the cost-effectiveness and economic impacts of adding biosimilar trastuzumab to a major Indian state's essential medicines list (EML), a health economic review was conducted. The study compared biosimilar trastuzumab with chemotherapy against chemotherapy alone to patients with early-stage HER2-positive breast cancer using a decision-analytic method and a government payer perspective. Real-world data retrieved from Indian cancer registries was used to explain the clinical efficacy inputs, which were taken from published randomized trials. Estimates of utilized resources from tertiary cancer institutions and public procurement costs were evidence of cost inputs. The incremental cost-effectiveness ratio (ICER) produced by the model was ₹92,000 every quality-adjusted life year (QALY) gained, which is significantly smaller than the common willingness to pay threshold for India. A five-year budget impact analysis projected that expected reduction in hospitalization and disease recurrence rates would compensate for the additional expenses of ₹125 crore. The outcomes were examined in cooperation with national health technology assessment body (HTAIn) and given to the State Health Authority as a verification report.
Lessons Learned: Incorporating localized HEOR data positively influenced governmental purchasing practices and made it easier to include biosimilar trastuzumab in the state's EML based on research. Academic-government cooperation, early and ongoing interaction with individuals making decisions, and the utilization of data were key elements of success. A significant downstream influence on population-level cancer care equity was indicated by following the implementation evaluation, which showed a 60% rise in trastuzumab availability across public tertiary care facilities in just one year.
Stakeholder Perspective: This example is given from the perspective of the HTAIn body and the government payer, who worked together to overcome major accessibility and reimbursement challenges in oncology care by utilizing health economic research. The study demonstrates the direct application of HEOR to influence government health care allocation of resources in low- and middle-income countries.
Code
IC11
Topic
Economic Evaluation, Epidemiology & Public Health, Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
Oncology