Indirect treatment comparisons (ITCs) refer to a comparison of different healthcare interventions using data from separate studies, in contrast to a direct comparison within randomized controlled trials (RCTs). Indirect treatment comparisons are often used because of a lack of, or insufficient, evidence from head-to-head comparative trials.
Indirect treatment comparisons have become valuable in evidence-based healthcare decision-making in disease prevention, diagnosis and treatment, and in other aspects of health. For example, clinicians, policymakers, and healthcare technology assessment (HTA) agencies worldwide often make decisions related to treatment in a given therapeutic area – they need to evaluate how a product’s clinical effects compare with already available treatment options for the indication in question.
Although guidelines for conduct and transparent reporting of ITCs have been published, they fail to discuss strategic considerations regarding selection of the most appropriate indirect comparison method to align with analytic objectives and in considering types of data available to the research team. Furthermore, manufacturers may need to develop different strategies to reach payers, patients, and providers. Therefore, manufacturers must be proactive in their approach to global ITC programs when launching new products.
EVERSANA’s roadmap to a successful launch strategy starts early, while maintaining agility to pivot along the path to commercialization. The steps involved in a typical global ITC program are described in the following diagram.
Finding a right-fit partner for global ITC program development has become increasingly important, especially as hundreds of new biotherapeutics – cell therapies, gene therapies, bispecific antibodies, antibody drug conjugates, vaccines, etc. – move through a burgeoning biologics pipeline. But what criteria, skills, and experience make for a good research partner?
At EVERSANA, we see these eight strategic considerations for launching a successful global ITC program.
- Begin Early
- Identify the Right Partner
- Engage Medical Team
- Country Representation
- Multi-faceted Analytics Strategy while Adhering to Accepted, Rigorous Methods
- Develop Technical Reports and Careful Articulation of Defensible Conclusions
- Proactive Publication Planning
- Updates in Timely Manner
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The author thanks Chris Cameron, Ph.D., P. Stat, Chief Scientific Officer of EVERSANA’s Global Value & Evidence research team for his excellent support in the quality review of this article.
ISPOR 2020. Virtual ISPOR 2020 Workshop: Developing and implementing an indirect treatment comparison (ITC) program to support global health technology assessment (HTA) and reimbursement submissions. May 20, 2020. Chris Cameron.
As Senior Director of the Value & Evidence team at EVERSANA, Imtiaz leads evidence synthesis projects that support global HEOR initiatives involving systematic literature reviews, indirect treatment comparisons, and health economic modeling, to support reimbursement…