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INTRODUCTION: Quick and equitable market access to vaccines is a global priority. However, market access routes for vaccines are complex and differ to those for pharmaceuticals. Furthermore, there is variation in decision making between countries due to local requirements. This work aims to increase awareness of the key elements of these pathways and the stakeholders involved in EU and non-EU countries.
METHODS: Pragmatic desk-based research was undertaken in November 2023 to explore key elements of the market access pathways for vaccines and how these differ between countries. Specifically, the countries of interest were England, France, Germany, Italy, Spain, United States (US), and Canada. Where available, information was extracted about the key stages and stakeholders involved in the decision-making pathway as well as details about any post-licensing monitoring, the value assessment framework used, vaccine pricing and the procurement process. In addition, examples of barriers to vaccine access were extracted. A narrative summary of the key findings and between-country differences will be presented.
RESULTS: National Immunization Technical Advisory Groups (NITAGs) are key stakeholders in all countries explored, with varying roles. The evidence requirements differ among countries, such as Germany's requirement for economic and epidemiological modelling. The Vaccine Monitoring Platform coordinates studies for post-authorization monitoring of vaccines across EU countries. However, England is not part of this network and uses a national agency instead. Vaccine procurement and pricing also differ (e.g. France uses individual reimbursement, England uses national tendering, and Canada uses regional tendering). There is variation within the US on vaccine pricing, depending on the healthcare provider. Barriers to vaccine access are well reported.
CONCLUSIONS: These results can influence the market access strategy of vaccine developers to ensure rapid and equitable vaccine access across countries. Several between-country differences in vaccine market access routes are identified; for example, the role of NITAGs, evidence requirements, and post-licensing monitoring processes. Barriers to vaccine access have been reported in the literature, with some organizations providing recommendations to overcome these.
INTRODUCTION: While systematic reviews (SRs) are regarded as the gold standard in healthcare evidence reviewing (and a requirement of many health technology assessments [(HTAs)]), other types of review also play an important role throughout a product's lifecycle. Drawing on more than thirty years' experience in conducting reviews, we present key points to consider when deciding which review type might be required.
METHODS: SRs are recommended when a comprehensive search and synthesis approach is required, for example HTAs. They have highly structured methods, emphasizing bias minimization, transparency, and replicability. "Rapid," "pragmatic," or "targeted" reviews are increasingly popular due to their accelerated timelines and reduced costs, with methodological shortcuts possible at various stages. Scoping reviews explore what is known about a topic and typically have a broad research question. "Reviews of reviews" or "overviews" identify existing SRs on an established topic. Finally, "living reviews" follow the same process as an SR or rapid review but incorporate new evidence on a continual or regular basis.
RESULTS: Rapid reviews may be appropriate when flexibility exists regarding the scope and review methods. Any limitations due to methodological shortcuts must be acknowledged in a transparent manner. Scoping reviews are useful for pioneering research ahead of an SR, or early in a product's development phase, when an overall understanding of the evidence base is required. Reviews of reviews are particularly useful when the size of the primary study literature means that a review of primary studies would be unfeasible. Living reviews are best suited to topics where the evidence base is changing rapidly, or the best information is needed quickly.
CONCLUSIONS:
When considering conducting or commissioning a review, organizations should consider the intended audience for the review, the resources, time, and budget available, and the size of the existing literature. Although SRs remain the gold standard, a rapid review, scoping review, or review of reviews may offer a more suitable way to approach a given research question.
BACKGROUND: "Kooth" is a web-based mental health platform commissioned by the National Health Service (NHS), local authorities, charities, and businesses in the UK. The platform gives children and young people (CYP) access to an online community of peers and a team of counsellors. This study reports an early economic evaluation of the potential benefits of Kooth in the UK.
METHODS: An early evidence cost calculator was built to estimate the potential costs and savings of implementing Kooth from a UK NHS and crime sector perspective. A decision tree structure was used to track the progress of CYP with emerging mental health needs (EMHN), comparing CYP with access to Kooth to CYP without access to Kooth. The model implemented a 12-month time horizon and followed a typical Kooth contract in relation to costing, engagement, and CYP demographics.
RESULTS: The base case results followed a cohort of 2160 CYP. The results of the cost calculator estimated that engagement with Kooth is associated with a cost saving of £469,237 to the NHS across a 12-month time horizon, or £236.15 per CYP with an EMHN. From a combined NHS and UK crime sector perspective, the cost savings increased to £489,897, or £246.54 per CYP with an EMHN. The largest cost savings were provided by an estimated reduction of 5346 GP appointments and 298 antidepressant prescriptions. For this cohort, the model predicted that engagement with Kooth averted 6 hospitalisations due to suicidal ideation and 13 hospitalisations due to self-harm. Furthermore, the number of smokers and binge drinkers was reduced by 20 and 24, respectively. When a crime sector perspective was taken, 3 crimes were averted.
DISCUSSION: This early model demonstrates that Kooth has the potential to be a cost-saving intervention from both an NHS and a combined NHS and UK crime sector perspective. Cost savings were provided through aversion in clinical and social outcomes. The model used a conservative approach to balance the uncertainty around assumptions of the intermediate outcomes (GP and medication use). However, it is limited by a paucity of costing data and published evidence relating to the impact of digital mental health platforms.
Severe aortic stenosis is a disease affecting the heart valves with a growing prevalence in Europe and globally. Transcatheter aortic valve implantation (TAVI) is a treatment for this condition, which is an alternative to open heart surgery, using a less invasive ('keyhole') approach. Around 70% of the specialist
TAVI centres in the UK, which offer this procedure, employ a specialist TAVI nurse. However, many of these roles are not on substantive contracts and some of these nurses may be working under heavy burdens given the number of procedures performed by the centre. York Health Economics Consortium (YHEC) has undertaken a project to assess the potential value that specialist TAVI nurses bring to the patient pathway within the NHS, based on information obtained from TAVI nurses at seven hospitals in the UK.
BACKGROUND: Differentiating between bacterial and viral lower respiratory tract infections (LRTIs) presents a challenge for clinicians. This impacts patient management and treatment decisions, meaning patients with suspected viral infections often receive unnecessary antibiotics. The objective of this care pathway analysis (CPA) was to establish the potential positioning of a new test (MeMed BV) in the LRTI pathway in UK Emergency Departments (EDs).
MATERIALS: Semi-structured interviews of clinicians with experience in the diagnosis and management of LRTIs and budget holders were undertaken via Zoom. Thematic analysis and qualitative synthesis were conducted.
RESULTS: Ten clinicians, three budget holders, and one diagnostic adoption specialist were interviewed between July and August 2023. Based on the clinicians' feedback, we developed a flow-diagram of the main decision points in the current diagnostic pathway for LRTIs and a separate diagram including the new test. From the interviews, the main variations between hospitals were the timing of blood draw and availability of diagnostic point-of-care tests (POCTs). Clinicians made recommendations about the unmet clinical needs (e.g. reducing people going to EDs for LRTI unnecessarily and identifying bacterial infections likely to deteriorate); new test positioning (at the beginning of the pathway to identify patients for further testing and antibiotic prescriptions); and potential barriers to adoption (e.g. cost of the test and pipetting constraints). They also discussed evidence requirements (e.g. need for UK outcome data and cost effectiveness compared with the current standard of care); further technical development with associated benefits (e.g. finger prick version of the test for children); and potential value propositions (e.g. reduction of ED waiting times and admissions while waiting for test results in the most severe population with uncertain diagnoses). Budget holders advised on the process for test adoption: clinical and laboratory staff are key decision makers, with POCTs processed through clinicians and laboratory tests through the laboratory team. A business case is needed on a hospital-by-hospital basis.
CONCLUSIONS: The analysis provides useful information to inform evidence generation and test implementation. Since CPA is an iterative process, value propositions and test positioning need further refinement and validation through clinical studies, economic assessments, and clinical opinion elicitation.
