Following the successful session on budget impact analyses (Five simple and effective ways to improve budget impact analyses and obtain drug reimbursement), JSS Medical Research will be presenting Indirect treatment comparisons and network meta-analyses for managers and directors: concept and application using a non-technical, user-friendly tool. This introductory course is meant to:
1) Conceptualize indirect treatment comparisons (ITCs)
2) Recognize the different types
3) Understand their advantages and disadvantages
The session includes a hands-on workshop using a simple ITC tool requiring no technical experience.
The indirect treatment comparison (also referred to as network meta-analysis and multiple treatment comparison) is a new methodology on everyone’s radar as it is in high demand and frequently used by health technology assessment (HTA) agencies, particularly the Canadian Agency for Drugs and Technologies in Health (CADTH).
After the session, the attendee will be able to answer the following questions:
- Do you understand how this new technology might impact clinical development and market access?
- Can you consider the feasibility of an indirect treatment comparison (ITC) when strategically planning a product’s clinical development or market access approach?
- Can you predict the results of an ITC under the simplest scenario (product A vs. B using their comparison against product C)?
- Can you integrate the results of an ITC in an economic evaluation and estimate the resulting incremental cost-effectiveness ratio?
- Can you suggest the optimal inclusion and exclusion criteria of a phase III study design to fit with an existing ITC?
- Would you be able to interpret and defend the performance of a product in an ITC, or justify why an ITC cannot be performed?
- Can you recognize a naïve ITC?
- Can you tell the difference between a network meta-analysis (NMA) and mixed treatment analysis (MTC)?
- Can you identify which type(s) of ITC can be performed given the available evidence?
This session is geared towards the pharmaceutical industry, specifically managers, directors, and senior executives who are elaborating clinical development or market access strategies. As the session requires no biostatistical or technical expertise, it will provide great value for individuals with no prior knowledge or those who attended a training aimed at performing the complex analytics that left them more puzzled than inspired. No methodology for performing the ITC will be discussed and as such, the session might be unsuited for analysts, biostatisticians or economic modellers. However, during the second half of the session, a hands-on workshop will teach participants how to use a simple ITC tool to estimate outcomes. The tool, compatible with all Windows systems, will be accessible for download at no charge from the corporate website of JSS Medical Research. For the practical portion, prior understanding of effect estimates (hazard ratio, odds ratio, rate difference, etc.) is preferable but not necessary. In brief, the session is ideal for anyone wishing to stay up-to-date on the newest methodologies.
In a nutshell, the indirect treatment comparison can be described as a way of pooling clinical evidence to establish the relative efficacy of treatments never compared against each other but compared against a common comparator, without breaking randomisation. For example, if treatment A and treatment B have never been compared in a randomized clinical trial, but they have both been compared to the standard of care, treatment C, in a similar patient population, an indirect treatment comparison anchored on “C” can provide a relative effect estimate of “A” versus “B”. Indirect treatment comparisons are particularly useful as more often than not, the phase III clinical trial did not include the relevant active comparator(s). Moreover, in order to obtain more precise estimates, the indirect treatment comparison can be applied using both direct and indirect clinical evidence.
For the health technology assessment, the relative treatment effect against the appropriate comparator is needed to demonstrate the added clinical benefit. The relative treatment effect is integrated in the economic model to demonstrate cost-effectiveness to payers for optimal market access.
Why is facilitating market access so important? Obtaining drug reimbursement has never been as difficult as it presently is. In North America, Europe and Australia, manufacturers requesting reimbursement by drug plans are required to produce a voluminous submission including, in addition to the clinical evidence: the burden of illness, the costs associated with the disease, a systematic review of literature, a thorough analysis of the cost-effectiveness of the product (preferably over the patient’s lifetime) and the budget impact analysis. It is now recognized that the drug coverage on public drug plans directly affects the prescribing patterns of physicians, regardless of coverage on more generous private drug plans. Moreover, it is of the utmost importance to file the reimbursement request as soon as the marketing authorization is granted, and to do so, it is necessary to have the submission ready beforehand. A delay in reimbursement is synonymous to a delay in reaching full market access potential, which would not deprive a company of their initial sales, but rather deprive of the peak sales achieved just before the end of patent exclusivity.
Marie Maxime Hubert, M.Sc., Health Economics and Outcomes Research Manager, JSS Medical Research
Ms. Hubert is a project leader with a unique combination of scientific and economic expertise. Prior to reviewing reimbursement submissions as part of her duties on the common drug review at the Canadian agency for drugs and technologies in health, she worked on reimbursement dossiers in multinational Pharmaceutical companies (Sanofi-Aventis and AbbVie, formerly Abbott). She gained a practical understanding of economics, data analysis and drug policies as economic consultant at IMS Health and Brogan Inc. Ms. Hubert is currently affiliated with JSS Medical Research, the largest Canadian-owned contractual research organization. JSS Medical Research has over 25 years of experience in health economics and outcomes research, with a strong expertise in biostatistics and epidemiology. Ms. Hubert holds a bachelor in biomedical sciences, a graduate diploma in drug development and a master’s degree in Pharmaceutical sciences with a double specialization in pharmacoepidemiology and pharmacoeconomics.
Who Should Attend?
Type of organization: Pharmaceutical and Biotechnology companies
Department: Market Access, Patient Access, Reimbursement, Health Economics and Outcomes Research (HEOR), Medical Affairs, Clinical Research
Type of position: Associate, Manager, Director, President, Principal and Senior Executives
JSS Medical Research
Founded in 1985, JSS Medical Research Inc. is a contract research organization (CRO) that offers patient access services in addition to clinical research, such as: economic analyses for reimbursement, the collection of patient-reported outcomes alongside clinical trials, the complete management of post-marketing observational studies, registries and administrative databases, meta-analyses, drug utilization reviews and medical writing. Being a science-based CRO, JSS Medical Research understands the science behind Pharmaceutical market dynamics and has the expertise required to guide companies in the drug reimbursement process. JSS Medical Research earned its credibility from delivering high quality, scientifically rigorous and sound clinical research services.