White Paper

When too early isn’t early enough: Scalable early-phase literature reviews to optimize reimbursement and maximize resources

Kunal Srivastava
Chief Practice Officer, Evidence Evaluation Consulting

Evidence from literature reviews is a prerequisite throughout the clinical development of an intervention. Appropriately designed targeted literature reviews (TLRs) can provide accurate evidence on areas such as treatment landscape, burden of disease, comparators and outcomes. As an intervention moves through a pipeline towards regulatory approval and possible reimbursement, structured TLRs that can be later expanded and built into gold-standard systematic literature reviews (SLRs) provide substantial efficiencies.

The expansion of a well-designed TLR into an SLR will result in better-designed SLRs, ensuring that the correct and relevant inputs will be available for modelling, global value dossiers (GVDs) and payer submissions. This can prevent timeline delays due to clarifications and rework. It also minimizes the risk that health technology assessment (HTA) bodies and payers believe the evidence has been inappropriately collated, analysed and evaluated – a concern that could prevent optimal reimbursement.

Selecting the right type of literature reviews and approaching them as a continuum of associated studies not only conserves time and resources, but also improves the probability of successful reimbursement. We recommend a long-term strategy that builds over time to add complexity and detail only as it is required.

Approaches to conducting an evidence review

Evidence generation can be accomplished using various approaches based upon the objective and application of the work. The figure below depicts the different approaches for evidence review, presented according to their relative level of quality and robustness.

Strength of evidence flow from TLR to gold-standard SLR

A gold-standard SLR is required for HTA submissions to agencies such as NICE (England), the SMC (Scotland), IQWiG (Germany) and HAS (France), to name a few. SLRs are also used as part of the development of a GVD and are submitted to various markets based upon the market access plan.

A structured TLR can be designed with clearly defined inclusion/exclusion criteria and a pragmatic search strategy that is reproducible and scalable to a gold-standard SLR, as and when required. A structured TLR can also function as an early-stage systematic review with limited information in terms of study design or comparators but with clear options for scalability with minimum rework.

Difference between a gold-standard SLR and a TLR

The key difference between SLRs and TLRs is highlighted in the table below.

Differences between gold-standard SLRs and structured TLRs

Approaches to conducting a TLR

TLRs can be conducted using a variety of approaches depending upon the objective of the work. The different approaches for TLRs and the key differences between them are depicted in the table below.

Variations in TLR approaches according to review objectives

Expanding a structured TLR to a gold-standard SLR

A well-designed structured TLR informs early pipeline appropriately and can be easily expanded to a gold-standard SLR at an appropriate time without a lot of rework, hence offering efficiency in timelines, efforts and costs. The table below explains the process of expanding a well-designed structured TLR to an SLR while considering the efficiencies of preserving the screening and extraction work done at the TLR stage and expanding it with additional information and quality control.

Considerations to expand a well-designed structured TLR to an SLR

Choosing the right type of literature review and the right approach early on can make a huge difference in both the success and the overall cost and time associated with demonstrating value to payers. Commissioning various standalone TLRs and SLRs will likely result in reviews that become unusable after serving their immediate objectives, whereas commissioning a series of associated and joint TLRs that can then be expanded to broader, gold-standard SLRs can provide time and cost efficiencies as they are used multiple times across a single asset and overall pipeline. While the right long-term planning at the initial stages does not necessarily require additional resources, careful thinking is vital to ensure every review commissioned is fit for future expansion and is scalable.

Therefore, rather than considering reviews that identify the relevant evidence to be a discrete set of standalone materials, we recommend seeing such reviews as a continuum, from early development through to HTA submission and even post-launch. Doing so will avoid the inefficiencies that result from needing to re-run statistical analyses or adjust modelling inputs; ensure confidence by review groups and payers and thus aiding smooth decision making; and allow you to make well-informed decisions about the value of your product and how best to demonstrate this throughout its life cycle.

For more information, or to discuss how we can help you maximize the value and impact of your literature reviews, please contact us.

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