Building an Effective Evidence Strategy: Don’t Just Set It and Forget It

Richard Hallquist, MBA, MA
Principal
IQVIA Medical Affairs

Diana Morgenstern, MD, FACP
Executive Strategist
IQVIA Medical Affairs

Jennifer LiMarzi
Senior Medical Writer
IQVIA Medical Communications

The development and ongoing success of a clinical therapy relies on a foundation of evidence to help healthcare providers (HCP), patients, payers, and other stakeholders make informed decisions. An evidence strategy identifies the most important gaps in a therapy’s current evidence and outlines a plan to close those prioritized gaps.

The rationale for evidence strategies

The aim of formulating and regularly evaluating an evidence strategy is to provide the necessary information to support a product’s appropriate adoption into clinical care, drive cost and time efficiencies, and improve patient outcomes at launch and beyond.

Excellent launches are consistently backed by robust evidence, specifically real world evidence (RWE), that addresses existing gaps. In three competitive therapeutic areas, IQVIA found that excellent launches had 47% more published RWE than non-excellent launches. Payers, HCPs, health technology assessment (HTA) bodies, regulators, and other stakeholders look to evidence beyond clinical trials to contextualize the findings, understand the burden of disease, and provide insights on patient and societal perspectives, as well as other needs not captured by study results.

Best practices for developing evidence strategies

There are generally three phases in the development of an effective evidence strategy:

1. Identify the evidence needs by working with a cross-functional organizational team. It’s important to get input from all key functions and geographies on those needs.
2. Discuss and prioritize the identified needs.
3. Assemble a roadmap outlining initial, high-level study concepts. The evidence strategy output and roadmap should then be socialized among stakeholders for awareness and next steps.

After these phases, external validation of the roadmap and the identified needs is also recommended. Priority evidence needs or high-level study concepts may be validated, for example, at an advisory board meeting or through stakeholder interviews.

Why regularly evaluate evidence strategies

Developing a compelling evidence strategy is no easy task, as the competitive landscape and stakeholder needs are constantly evolving. What may have been an outstanding evidence strategy two years prior to product launch is likely to miss the mark two years after if it is not adapted to address new questions and challenges.

The rationale for continuous evaluation of an evidence strategy is rooted in the fact that you can’t predict developments that will impact a product. For example:

• Standard of care can change, which is especially common in oncology and diseases driven by inflammatory pathways, like rheumatoid arthritis and severe asthma.
• Major competitors may release data, potentially leading to new regulatory approvals. In immuno-oncology, strategies typically need to be refreshed annually due to many competitors, a changing standard of care, and evolving patient-testing methods.
• New challenges may emerge for an existing product, such as a significant safety signal or an unexpectedly negative view from an HTA body.

Key considerations when executing an effective re-evaluation

Re-evaluation of an evidence strategy is not a one-size-fits-all process and should be tailored to each specific product and situation. Changes in the external environment and treatment landscape can serve as a starting point to determine the intensity of the re-evaluation.

To ensure a comprehensive assessment, a combination of several activities is often recommended. An evidence landscape assessment, including an examination of evidence from both clinical trials and congress abstracts, can help identify data gaps that need to be addressed. Available real-world data, such as electronic health records or claims data, can be used to understand care gaps. The synthesis of internal insights, including input from field medical teams, can aid in identifying critical evidence needs in local markets that support appropriate product use and reimbursement. Additionally, cross-functional workshops can be used to identify and prioritize unaddressed evidence needs.

Insights from conducting such activities are instrumental in revising an evidence strategy and supporting the subsequent work to develop study options and concepts to address identified evidence gaps.

Re-evaluation in action: Case Example

In a recent oncology engagement, an IQVIA customer faced a challenge as several competitor trials were set to release results within the next 12 months. The customer's internal teams held differing opinions on the potential impact of the competitor data and what role new evidence generation for their own product could play in reinforcing the appropriate use of their therapy. The customer’s existing evidence strategy had not undergone a substantial revision for 18 months.

To address these issues, IQVIA Medical Affairs conducted two workshops with the customer. The first focused on gathering external stakeholder questions, while the second centered on the key competitor read-outs and how this information could change the evidence strategy. These workshops fostered robust discussions about where there was a true need for additional evidence generation, versus where there was a need to communicate existing evidence.

The outcome of these efforts was a revised evidence strategy with four strategic imperatives, specific to the customer's product, that articulated the top unaddressed evidence needs. This resulted in updates to the evidence generation plans, budgeting, scientific communications plans, field medical strategy, and other relevant areas.

Conclusions

Evaluation of an evidence strategy requires an ongoing assessment of the evidence landscape, synthesis of external stakeholder insights, and identification and alignment of internal needs across various functions. Although challenging, re-evaluation should be considered on an ongoing basis and during annual budgeting cycles, with more frequent assessments in therapeutic areas with rapidly evolving treatment landscapes.

Working with a partner like IQVIA Medical Affairs can provide you with valuable external perspectives on the evidence and care landscapes, RWE, clinical trials, and specific indications. A well-executed evidence strategy evaluation drives both internal alignment and access to appropriate treatments for the patients who need them most.