Health Technology Assessment (HTA) typically involves the development of systematic literature reviews (SLR) to form the evidence base from which reimbursement decisions are made. Data identified by SLRs are in the public domain and in more common disease areas (such as oncology), sponsors tend to include the same trials and data in their SLRs as their competitors.

Here, we explore 1) how the need for comprehensive global SLRs results in considerable overlap between sponsors’ SLR packages; 2) the increasing challenge of managing large SLRs due to the volume of literature and rate at which new data are published; and 3) a solution to these challenges via curated ready-to-use global SLRs delivered via a subscription model.

How the need for comprehensive SLRs leads to overlap in evidence packages

SLRs for HTA purposes must comprehensively include all treatments for a disease. Narrower approaches specific to a sponsor’s treatment risk introducing selection bias and may be deemed as “cherry-picking” by HTA bodies. As the evidence base evolves, narrow approaches may omit pipeline treatments that go on to become the standard of care, thus limiting the long-term validity of the SLR. In addition, the standard of care differs by country and treatment pathway. Consequently, sponsors must include all treatments relevant to the context of each of their local affiliates, known as a “global SLR.” Sponsors must undergo the same methodological steps to conduct HTA-standard SLRs (search strategies, screening, data extraction), therefore, for a given specific disease, the base-case global SLR will greatly overlap between sponsors in terms of the included trials and data.

The increasing challenge of managing large SLRs

Conducting comprehensive global SLRs that include all available treatments is becoming a greater challenge due to rapidly emerging new treatments and, consequently, the exponentially increasing volume of newly published evidence. Ahead of going to market, sponsors must invest extensively in SLR activities and often require the expertise of external consultants. As the rate at which the evidence base continues to grow, SLR packages can rapidly become obsolete unless newly published evidence is identified via regular updates. Solutions are urgently needed to find more efficient ways for our industry to identify and synthesize data via SLRs. We, as an industry, have a responsibility to patients to reduce duplication and the time it takes for new treatments to be assessed.

A solution: Curated ready-to-use global SLRs

While sponsors traditionally commission a consultancy vendor with the expertise required to conduct their global SLRs de novo, Cytel is leading a shift towards consultancy-curated global SLRs that sponsors can subscribe to. Cytel conducts and updates SLRs in multiple indications delivered through the interactive web-based platform, LiveSLR®, which clients can subscribe to and access regularly updated SLRs. LiveSLR® subscribers can also commission bespoke adaptations and updates to meet their exact requirements. Common requests for bespoke adaptations include extraction of specific subgroup data, inclusion of newly published data ahead of a local submission, and expansion of an indication. Subscribers can also choose Artificial Intelligence (AI) monitoring of new literature so that SLR updates can be optimally timed.

Setting a new precedent for HTA

As Cytel goes to market with curated ready-to-use SLR libraries, we are engaging with members of HTA external assessment groups (EAG). HTA bodies rely on EAGs to critique company submissions in terms of the quality of evidence and methods. Their opinion regarding the acceptability of consultancy-curated SLRs and evidence identification through subscribed SLRs is paramount. To date, this engagement has been very positive, with recognition that SLRs conducted via a third party could reduce both the risk of bias within SLRs and research wastage across the industry.

For EAGs, it is the quality of the submitted SLR itself that is of importance. So long as methods are fully transparent and robust, consultancy-curated SLRs delivered via a subscription do not violate the evidence requirements of HTA bodies. All Cytel SLRs come with full methodology. The LiveSLR® platform is a comprehensive repository that includes full search strategy, Preferred Reporting Items for Systematic reviews, and Meta-Analyses (PRISMA) diagrams, excluded study listing, validated data extractions, and downloadable full reports​.

Most health economics and outcomes research/market access professionals rely on precedent to inform their strategy for reimbursement. As the HTA landscape evolves with the incoming European Union Joint Clinical Assessment and other collaborations to reduce duplication, Cytel anticipates that alternative solutions to traditional SLRs will emerge and become a new precedent within the HTA setting.

Cytel has seven regularly updated HTA-compliant SLRs:

Interested in learning more? Watch Vicki’s on-demand webinar “Accelerated HTA Timelines: Unlock the Power of Ready-to-Use SLRs”:

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