Evidence requirements and assessment methods access differ between health technology assessment (HTA) agencies. The HTA Core Model® provides a standardized approach to HTA, targeting evidence sharing and collaboration between participating HTA bodies. It is fit for purpose from an industry perspective and was used by pharmaceutical company Roche to develop a framework for internal assessment of evidence required for market access and coverage/reimbursement (“access evidence”).

Tools were developed to systematically scope, assess, plan, and summarize access evidence generation. The tools were based mainly on the first four HTA Core Model® domains and rolled-out in selected development teams in 2017. Five months after full implementation, the impact of tools was assessed in an internal survey.

Systematic access evidence generation started with the Access Evidence Questionnaire, to scope evidence requirements and identify evidence gaps. Findings were summarized in the Access Evidence Metric, which assessed the alignment of available/planned evidence against HTA bodies’ requirements and developed scope mitigation strategies. The Access Evidence Plan was then used to plan and document (additional) evidence generation. Once generated, evidence was summarized in the Access Evidence Dossier. A survey of twenty-seven Roche employees involved in evidence generation showed that the tools made discussions around access strategies and evidence more efficient and transparent.

The HTA Core Model® provided a useful framework around which to optimize internal evidence generation and assessment. The benefits of using a standardized HTA approach in industry mirror those expected from implementing the HTA Core Model® in HTA agencies.

The HTA Core Model® was developed to improve the transferability of health technology assessment (HTA) between settings. The model has been used by HTA agencies but is also of interest to manufacturers, for improving internal evidence generation and communicating with other HTA stakeholders. To establish if the model is fit for purpose from an industry perspective, the pharmaceutical company Roche, collaborating with the European Network for HTA (EUnetHTA), conducted an assessment of the model.

A questionnaire was developed to evaluate all assessment elements in the HTA Core Model v2.0 for their usefulness in meeting payers’ evidence needs and demonstrating value. The questionnaire was completed by country affiliate teams working in evidence generation and reimbursement submissions for pharmaceuticals. Survey results were discussed in workshops to ensure consistency and alignment between teams.

The questionnaire was completed by six teams. An additional team from global pricing and market access participated in workshops. Model domains pertaining to the health problem and current technology use, technology description, clinical effectiveness, and economic value were considered most important because they meet payers’ evidence needs. Overall, the model was considered useful to improve the efficiency of HTA evidence generation, share evidence internally, and communicate value to payers and HTA agencies.

From an industry perspective, the HTA Core Model provides a useful framework and common terminology for efficient generation of transferable HTA evidence. The timeliness, efficiency, and transparency of HTA processes could be improved by a more standardized approach to HTA across settings.

Medical records are a tenet of good medical practice and provide one method of communicating individual follow-up arrangements, informing research data, and documenting medical intervention.

The objective of this review was to look at one source (the published literature) of medical records used by foreign medical teams (FMTs) in sudden onset disasters (SODs). The published literature was searched systematically for evidence of what medical records have been used by FMTs in SODs.

The style and content of medical records kept by FMTs in SODs varied widely according to the published literature. Similarly, there was great variability in practice as to what happens to the record and/or the data from the record following its use during a patient encounter. However, there was a paucity of published work comprehensively detailing the exact content of records used.

Without standardization of the content of medical records kept by FMTs in SODs, it is difficult to ensure robust follow-up arrangements are documented. This may hinder communication between different FMTs and local medical teams (LMTs)/other FMTs who may then need to provide follow-up care for an individual. Furthermore, without a standard method of reporting data, there is an inaccurate picture of the work carried out. Therefore, there is not a solid evidence base for improving the quality of future response to SODs. Further research targeting FMTs and LMTs directly is essential to inform any development of an internationally agreed minimum data set (MDS), for both recording and reporting, in order that FMTs can reach the World Health Organization (WHO) standards for FMT practice.

JafarAJN, NortonI, LeckyF, RedmondAD. A Literature Review of Medical Record Keeping by Foreign Medical Teams in Sudden Onset Disasters. Prehosp Disaster Med. 2015;30(2):1-7.

Nutrient Reference Values (NRV) are evidence-based benchmarks for assessing the dietary adequacy of individuals and population groups as well as informing public health nutrition policies and programmes. The present paper presents the findings of an analysis of the views of submitters to a draft document associated with the development of the 2006 NRV for Australia and New Zealand. The aim of the study was to explore how these views were reflected in the policy-making process and final policy document.

The information necessary to fulfil this aim required access to stakeholder submissions to the NRV development process and this necessitated exploiting the provisions of the Commonwealth of Australia’s Freedom of Information (FOI) Act 1982. We understand that the present research represents the first time that an FOI request seeking information about a National Health and Medical Research Council food and nutrition policy process has been made and therefore is novel in its approach to public health nutrition policy analysis.

The analysis of stakeholder submissions identified that stakeholders had particular concerns about the conduct of the review process and the future application of the nutrient values to policy and programmes. There is a lack of evidence that the majority of stakeholder comments were addressed in the final NRV document.

Although these findings cannot be interpreted to assess the validity or otherwise of the set nutrient values, they do raise questions about the process for their development and the adequacy of the final document to reflect the views of key stakeholders.