In addition to the importance of compellingly conveying the value of a product in health technology assessments (HTAs), as we’ve highlighted here, it is essential to support this value message with comprehensive, up-to-date literature. Relevant evidence is also required throughout the market access process. SLRs identify, summarise, appraise and present all relevant literature on a specific pre-defined topic, so they are very useful for providing this evidence. However, depending on the availability of relevant studies, they can be time-consuming and costly, so their timing as part of the market access strategy plan should be carefully considered to maximise their use.
While manufacturers must have a clear understanding of unbiased evidence on their new product, SLRs are an essential requirement in HTA submissions for some reimbursement authorities such as the National Institute for Health and Care Excellence (NICE). For HTAs, SLRs identify evidence on the population of patients the new treatment will be used for in order to understand their burden of disease, and for the treatment being submitted plus any relevant treatments already used in order to compare outcomes. For NICE submissions for example, SLRs are required on the clinical efficacy and safety of the intervention and comparators, and the quality of life, economic evaluations and costs and resource use involved with the disease.
HTA submissions require up-to-date data, meaning the SLR searches must not be run too soon before date of submission—in the UK this is no longer than six months prior to submission. Sometimes, therefore, companies arrange to begin literature reviews late in the market access process and check the findings of the SLRs against pre-written submission documents. This is done in order to avoid having to repeat the review closer to the submission date. However, the findings of the SLRs should be used as the evidence source for most of the other sections of the HTA submission, such as the clinical and cost-effectiveness sections, or potentially also other earlier stages of the market access process. The benefits of this include having the best quality available data to base the work on clearly summarised and readily available, for example, information on the clinical value of the new treatment, the burden of the disease on the patients or economic model inputs. This is likely to also save time and therefore costs in writing these sections.
Other parts of the market access strategy could also benefit from having formalised searches long before the HTA submission stage, or even if the drug is not being aimed for a full HTA submission. For example, using SLRs to inform parts of a global value dossier (GVD) ensures that all relevant data on the product and its comparators are identified, reducing bias and therefore making a stronger case. For orphan designation documents, an epidemiology literature review helps to provide a reliable estimate of the incidence or prevalence of the disease. At a very early stage, a gap analysis literature review helps to identify the evidence required from the clinical program, such as the outcomes needed to demonstrate efficacy from trials.
Successful market access often requires supportive evidence that can be clearly presented with confidence that it is free of bias and appropriate for the submitted indication. SLRs can provide this evidence and their integration with other required documents should be carefully considered when creating a market access strategy plan.
At MAP BioPharma, our goal is to accelerate patient access to medicines, devices and diagnostics. We have a wealth of experience in planning market access strategies to deliver the best results to our clients. If you need assistance with market access activities, including the development of SLRs, you’ve come to the right place.
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