Friday, January 30, 2015

Planning Ahead to Stay Ahead: Integrating PROs and Economic Data in Oncology Trials

The era of moving from regulatory approval to automatic worldwide adoption of a new treatment is long gone. This can be particularly true in oncology, where treatments are often expensive and can potentially be just as harmful as the disease. In the crowded oncology marketplace, collecting patient-reported outcomes (PRO) and economic data during or alongside clinical trials establishes an oncology treatment’s value to regulatory agencies, as well as to governments and private payers, maximizing your return on investment. Moreover, the rise and refinement of ePRO technologies and processes (e.g., smartphone apps, wearable devices and automated data collection/analysis) are making patient-reported data more accessible and cost-effective to collect.

Importance of PROs and Economic Endpoints in Oncology Clinical Trials
The inclusion of PROs in oncology clinical trials enables a better understanding of overall treatment effectiveness, including a more complete risk-benefit profile. In fact, numerous organizations, including the Food and Drug Administration and the American Society for Clinical Oncology, believe that PROs are essential components of clinical research in oncology.

To enable comparison of findings and ensure consistency across trials, the National Cancer Institute’s Symptom Management and Health-Related Quality of Life Steering Committee has recommended that all oncology trials include PRO measures of a core set of 12 symptoms. Using this core set simplifies the comparison of PRO findings across treatments and can facilitate the process of determining treatment value based on PRO findings. Use of additional PRO measures should also be considered to further demonstrate product value. But how do you determine the best measures? Should they be cancer-specific or based on country-specific guidance? Other factors to consider include: the goals of the clinical trial, the type/stage of cancer, existing treatment alternatives and commercial (reimbursement) targets for the product.

As the development of innovative, yet more expensive treatments in oncology continues, reimbursement agencies and other payer groups are increasingly challenged to manage budgets and provide the best possible treatment to patients. In Canada, Australia and many countries in Europe, economic evidence is required for market access and reimbursement of a new product. While such evidence is not explicitly required in the United States, health care decision makers examine treatment-associated medical resource utilization (MRU) in budgetary impact modeling and other reimbursement-related activities. Thus, as with PROs, it’s important to collect these data up front to ensure they are available for health economics analyses before market launch and for discussions with the appropriate market access agencies.

Ensure Success: Work With Health Economics and Outcomes Research Experts
Health Economics and Outcomes Research (HEOR) experts are intimately familiar with PRO-specific regulatory guidelines, as well as specific health economic, costing, modeling and other methodologies needed to satisfy diverse payer and reimbursement agency demands.

Whether HEOR expertise is available in-house or through outside consultants, it’s important to leverage proven intelligence in clinical, regulatory and marketing discussions related to oncology products, no matter the phase of development. This will ensure all PRO-related activities, including PRO selection, training and analyses, are conducted in compliance with the appropriate regulatory guidelines and follow the appropriate methodologies specific to where trials are being conducted globally. Similarly, to maximize reimbursement and product pricing success, clinical development teams should work with HEOR specialists to make sure all health economic activities are initiated early so that all necessary MRU endpoints are included in the clinical trial and the appropriate methodologies and costing techniques have been selected in advance based on the requirements for submission to appropriate agencies.

Including PROs and MRUs in oncology clinical trials should not be an afterthought. In today’s competitive health care marketplace, thoughtful planning of a clinical trial in consultation with HEOR experts can facilitate regulatory approval, lead to a PRO label claim and provide the data needed for market access and reimbursement. Incorporating PRO and MRU endpoints into a clinical trial can save you considerable time and maximize return on investment. Early preparation in consultation with experienced HEOR experts is the best plan for long-term product success.

About Decision Driver Analytics
Founded in 2006, Decision Driver Analytics provides a suite of services that covers the full range of health economics and outcomes research (HEOR) as well as the outreach materials needed to reach investors, health care providers, payers and the public. Utilizing veteran health economists, epidemiologists, biostatisticians, medical writers and reimbursement experts, DDA’s services include complete product life cycle value analysis, strategy and planning, clinical economic study services, predictive modeling analytics, definitive analysis studies, communication and sales training.

Decision Driver Analytics is an Associate Sponsor at this year's Partnerships in Clinical Trials.  Would you like to join them in Boston April 22-25, 2015?  As a reader of this blog, when you register to join us and mention code XP2000BL, you can save $100 off current rates!

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