Insight Series: The Value of Real-World Evidence in Canadian Drug Commercialization – Part 1

What is RWE?

Although the definition of real-world evidence may vary amongst various experts, it is most simply defined as evidence obtained from analyzing data that is collected outside of a RCT in a real world setting. While data obtained from RCTs provides insights on drug efficacy in patients who are recruited based on specific inclusion and exclusion criteria in a specific population with a study drug that is delivered in a controlled environment, RWE is based on data collected in a real-world setting using health system data from a larger, more heterogeneous population. RWE helps to provide insights into drug effectiveness in routine clinical practice amongst varying populations, and can help answer important questions in health care, from a regulatory, payer, clinical practice, and product development perspective.

Real-world data can come from a variety of sources, including retrospective or prospective observational studies, observational registries, and the following:

Figure 1: Sources of Real World Data

Industry
Patient support programs, patient or disease registries and surveys, pharmacovigilance, financial assistance information

Logistics
Wholesale and distribution sales information, pharmacy data, product sales information

Institutions
Hospital administrative data, clinical data from electronic health/medical records (EHR/EMR), hospital billing data, molecular and laboratory results data

Public
Payer claims data, public registries, Canadian Institute for Health Information (CIHI), provincial data (e.g. Institute for Clinical Evaluative Sciences (ICES), Alberta Health Services, etc.), population health surveys (e.g. socioeconomic data), hospital data

Private
Pharmacy Benefits Manager and claims data (TELUS Health, ESI Healthcare, etc.), insurance adjudication data, employer benefits plans

Patients
Patient reported outcomes, patient requested data, disease risk assessments, personal digital health applications (includes consumer wearables, sensor data from personal medical devices, and smartphone health apps), social media, patient-powered research networks

Commercial Application of RWE

There are many opportunities to use RWE to optimize, generate, and discover value along the product lifecycle. To meet post-authorization evidence requirements and derive relevant commercial insights, however, requires development of an evidence generation strategy and proactive plan at the outset, and integration with a cross-functional group of internal stakeholders.

From a commercialization lens, RWE can help manufacturers gain credible insights that can inform commercial decision-making, sales forecasting, resource planning, and reimbursement throughout the lifecycle of the drug (Figure 2).

Figure 2: Uses of RWE over the Product Lifecycle

Pre-launch

Commercial Assessment and Planning

•  Disease epidemiology
• Shape target product profile, identify unmet need/ disease burden
• Risk planning and label negotiation (describing suitable patients’ characteristics, identifying possible criteria)
• Forecast potential market and launch uptake
• Patient support program design

Market Access

• Cost effectiveness and budget impact data for HTA submissions
• Indirect costs (time lost from work, lost earnings)

Launch

Market Access and Payer Trends

• Market access and payer negotiation
• Payer trends and time to reimbursement
• Tracking post-authorization real-world outcomes
• Adherence tracking

Commercial Planning

• Financial assistance planning
• Conversion
• Drug utilization/ prescribing
• Sales operations, targeting, resource allocation
• Sales forecasting
• Label expansion
• Patient data and adherence
• Key Performance Indicator (KPI) tracking

Growth

Market Access

• Expansion and reassessment of reimbursement listing criteria, conversion planning
• Tracking post-authorization real-world outcomes
• Supporting translational research to improve patient outcomes
• Informing treatment guidelines
• Generation of scientifically relevant publications with steering committee

Commercial Planning

• Drug utilization/ prescribing, persistence and adherence monitoring
• Sales operations, targeting, resource allocation
• Sales forecasting
• Patient data and adherence
• KPI tracking

Maturity

Commercial Planning

• Sales operations, targeting, resource allocation
• Loss of exclusivity (LOE) planning
• Benchmarking performance for new entrants (defense of market position)
• Sales forecasting
• Patient data
• KPI tracking

Innomar Value of RWE Series

When launching a specialty drug there are many considerations in the development of an evidence generation strategy that will help guide post-authorization evidence requirements, market access, and commercial strategic planning.  In this every-changing, challenging market access environment, leveraging RWE is critical to ensure payers and HTA decision-makers understand the value of your product in a real world setting.   Over the next several months, Innomar will provide a deeper dive into the use of RWE, including how to design your patient support program to be a credible source of data, and how to use RWE to meet the evidence needs of payers and HTAs. We will also use real-world case studies to illustrate how manufacturers can leverage RWE along all phases of drug commercialization.

This article is one in a series provided by Innomar Strategies to update manufacturers on relevant changes and new information in the specialty pharmaceutical marketplace.