NHS Digital Data Release Register - reformatted

Kingston University London

Project 1 — DARS-NIC-200139-H2X2Y

Opt outs honoured: No - data flow is not identifiable (Does not include the flow of confidential data)

Sensitive: Non Sensitive

When: 2019/09 — 2019/09.

Repeats: One-Off

Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii)

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Outpatients

Objectives:

Kingston University requires NHS Digital data for scientific research purposes only. These purposes are fulfilled through accessing pseudonymised data which significantly reduces the ability to identify the data subjects. Kingston University is the sole data controller and also processes the data for this study. Kingston University has determined that the data required are adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed (scientific research) and that appropriate safeguards in the form of technical and organisational measures are in place according to Regulation. No other organisations process the data for the purpose of this research. The scientific study is conducted in the public interest of making available, through scientific publication and dissemination of final results, a measure of the economic burden sustained by public health authorities in the United Kingdom with reference to the management of major diseases caused by HPV virus. This can provide the basis for the formulation and implementation of knowledge-based policies. Human Papillomavirus (HPV) is the most common sexually transmitted virus and causes a substantial burden of disease in men and women. The prevalence of HPV remains unacceptably high. Among adults aged 18-59 in 2013-14, about 45 per cent of men and 40 per cent of women had genital HPV infection. The availability of vaccines led to the beginning of population wide immunisation programmes in most Western Countries. Recently, following new scientific evidence and advice from an independent panel of experts (Joint Committee on Vaccination and Immunisation - JCVI), UK Government announced the existing vaccination programme for girls will be extended to adolescent boys to protect them against HPV-related diseases. In this light, researchers in the Institute for Leadership and Management in Health (ILMH) at Kingston University deem it relevant to estimate the economic burden associated with HPV at the present time. In the face of the expected changes in the allocation that will follow the introduction of the universal vaccination plan, it is considered important to assess the current use of resources due to HPV-induced malignancies. The objective of this research study is to estimate the economic burden of HPV in the UK, accounting for total direct medical costs associated with nine major HPV-related diseases. The use of Hospital Episode Statistics Admitted Patient Care (APC) and Outpatient (OP) data would enhance the quality of the study accounting for patterns in hospital activity. This would allow for a more accurate estimation of the economic burden from the perspective of the NHS. To achieve that, Kingston University requires HES APC and OP records for use in the “Economic burden of HPV9-related diseases in UK” research project and established the Institute for Leadership and Management in Health (ILMH) to undertake the research. The objective is to assess the resource utilisation, hence the number of services and treatments provided (ICD10CM and OPCS-4) to each hospitalised patient with a specific diagnosis (HRG). Access to HES APC and OP data will enable the researchers to estimate the number of hospitalised patients with specific diagnoses as identified by the ICD10CMs and HRGs. Pseudonymised record level data will be used to calculate hospitalisation rates associated with HRGs. Namely the malignancies considered in the present application are cervical, vulvar, vaginal, penile, head and neck cancer. The study would estimate outpatient costs based on the information (e.g.: number of average visits) suggested by the extant literature and clinical experts. These costs would be associated to the appropriate tariff to calculate a measure of the average cost per patient. Researchers in the ILMH at Kingston University require access to pseudonymised data from 2015-2018 for a cohort of patients defined through a set of inclusion criteria. These will allow researchers to identify naïve patients, defined as those who, in the two years previous to their hospital admission: 1) did not fall in any of the requested ICD10CM; 2) did not show any other malignant tumours. Kingston University require HES data on naïve patients for a period of three years after their first hospitalisation as suggested by clinical experts involved in previous publications. Researchers require access to HES APC and OP data for NHS hospitals in England only. All hospital episodes for eligible patients are required in order to account for the total number of services provided by NHS to patients with HPV-related diagnose(s). This will allow to measure the overall use of resources associated with hospitalized patients identified by ICD10CM code related to HPV. The extracted data will be linked to the national tariffs related to each HRG diagnosis. In this way, lifetime costs will be obtained. These will be then linked to epidemiological data (prevalence of HPV and genotype fractions) to calculate the overall economic burden at national level. Sensitivity analysis (probabilistic and deterministic) will be conducted to take into account the uncertainty around inputs and to provide a correct range of estimation. Kingston University has determined that there are no moral or ethical issues and no risk of potential harm at any stage of the processing activities. Results will be disseminated in aggregate form only, being the objective that of estimating the overall burden of HPV-related diseases from the perspective of the National Payer (NHS) in UK. The dissemination will take form of scientific publication in peer-reviewed journals.

Expected Benefits:

Human Papillomavirus (HPV) is the most common sexually transmitted virus and causes a substantial burden of disease in men and women. As reported by Cancer Research UK, there are around 3,200 new cervical cancer cases in the UK every year (2013-2015) which is the 14th most common cancer. Cervical cancer accounts for 2% of all new cancer cases in females in the UK (2015). Incidence rates for cervical cancer are projected to rise by 43% in the UK between 2014 and 2035, to 17 cases per 100,000 females by 2035. The objective of the present study is to estimate direct costs associated with the incident cases of nine major HPV related diseases: cervical cancer, cervical dysplasia, vulvar, vaginal, anus, penis and head and neck cancers, anogenital warts, and RRP in UK. In 2018 in Italy, where a similar study was conducted by researchers of ILMH, Kingston University, a prevalence of 1.1 million cases of which 975 thousand associated to cervical conditions (86%), and 158 thousand to non-cervical (14%) was found. In 2018, the total direct costs associated with the annual incident cases of the nine major HPV malignancies in Italy were estimated to be €542.7 million, with a credible range of €346.7 - €782.0 million. The purpose of the present study is to replicate the analysis, by applying the same methodology based on the UK data. This is considered relevant for policy considerations as the UK and Italy were the first two countries in Europe which allowed previous girl vaccination programmes to be extended to adolescent boys. In this light, Kingston University expect to estimate the economic consequences and potential savings which will be further discussed in the present scientific research. Benefits will be measured by the impact of the scientific publication to the scientific community. This can be achieved through citations and dissemination of the results and by the adoption of knowledge-based decisions from policy makers. Reference: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/cervical-cancer The present analysis will constitute a tool for keeping records of the expected economic effects over time. Specifically, the results of this study will provide an estimation of annual direct costs associated with major HPV related diseases in UK. The study will present evidence of direct costs for cervical and non-cervical malignancies including those affecting man such as penile, anal, head and neck cancers as well as anogenital warts. The fraction of HPV costs by gender will be calculated and discussed in the light of the expected changes induced by the new vaccination plan that includes boys. The NHS and the general population will benefit from the analysis in several ways. Firstly, a snapshot of the resource utilisation will be useful to improve resource allocation and understanding dynamics in public health spending. Secondly, the evidence will positively affect the application of the universal vaccination plan. Thirdly, future analyses will be able to compare results achieved by the new immunisation plan and compare these with the preceding patterns of resource utilisation as represented by the present work. Finally, the estimation of the total economic burden due to HPV will inform decision makers on the potential savings, which may follow the newly approved vaccination plan.

Outputs:

The final output of the present research project is the production of a scientific article to be submitted to peer-reviewed journals publishing studies in health economics and health technology assessment (HTA). The estimated submission date is October 2019. Aggregated findings of the study such as average hospitalisation rates and average lifetime cost per case will be included. The final output will contain only data in aggregated form and at national level. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide and compliant with the MHSDS disclosure control rules including suppression and rounding. Also, in order to target an audience of researchers and policy makers, a short version of the article abstract will be submitted through scientific papers and presented to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2019 annual conference and the Health Technology Assessment International (HTAI) 2019 annual meeting. The final version of the research will be shared among organisations such as “HPV Action” to enable the engagement with the scientific and policy-making communities.

Processing:

Kingston University requires access to HES Admitted Patient Care (APC) and Outpatient (OP) data. To achieve that, Kingston University will securely transfer a file of ICD10 CM codes (eligibility criteria) to NHS Digital. NHS Digital will identify all patients who had an episode with one of these ICD10 codes in the 2015/16 financial year. Any patients who also had an episode with one of these codes during the previous 2 years will be excluded from the cohort. For the remainder of the cohort, NHS Digital will extract all hospital episodes for all eligible patients for the period from 2015-18. NHS Digital will return a pseudonymised extract of data from HES APC and OP with no personal identifying information. Data will not be used for commercial purposes, or direct marketing or provided in any form to any third party. The extracted data will be linked to economic data derived from two main sources: a) systematic literature review; b) publicly available national tariffs and prices associated to HRGs. Specifically, tariffs and, when not available, data from literature, will be multiplied by the number of patients as reported by HES extraction to calculate lifetime costs per diagnosis. To achieve that, Kingston University has included a number of inclusion criteria to allow eligible patients to be identified and to enable costs related to ICD10CM diagnoses only to be calculated. Eligible patients are those who, in the two years previous to their hospital admission: 1) did not fall in any of the requested ICD10CM; 2) did not show any other malignant tumours. Kingston University require HES data on naïve patients for a period of three years after their first hospitalisation. Such inclusion criteria and the period of time were defined through an ongoing discussion with academics and clinic experts as well as applied by previously published literature. Based on real world data from HES, a probabilistic, incidence-based estimation model will be developed to estimate aggregate measure of economic burden in UK. Specifically, the average lifetime costs per patient, per diagnosis, will result from linking HES data to tariffs. The total economic burden at UK level will be obtained by associating lifetime costs with prevalence rates of HPV included malignancies as derived from the systematic literature review. Furthermore, data from published literature will be applied to calculate the fraction of lifetime costs attributable to HPV infection and to each HPV genotype group. Also, the fraction of costs attributable to men and women will be calculated as some malignancies are gender specific. Given the potential impact of findings on NHS policy, it is essential to minimise uncertainty. Therefore, to consider the variability of the data used to inform the estimation model (by linking real evidence from HES from England with literature evidence), a Probabilistic (PSA) and Deterministic Sensitivity Analysis (DSA) will be performed and included in the study analysis. Data requested will only be accessed by individuals within the ILMH at Kingston University who have authorisation from the Director of ILMH to access the data for the purpose(s) described. Researchers involved in the project are employees of Kingston University. As substantive employees at Kingston University they will only carry out data processing for which they have been appropriately trained in data protection and confidentiality. There will be neither requirement nor attempt to re-identify individuals from the data. Kingston University has determined that there is minimal risk to re-identification as the data is pseudonymised. An estimation of the average, lifetime cost of patients with major HPV-related disease in the United Kingdom will be the final output. Also, a measure of the overall direct costs on the NHS will be obtained by reporting lifetime costs to the prevalence of HPV-related diseases in the UK. No personal data are required nor employed for the purposes of the scientific research. Lifetime costs are calculated as the mean value of tariffs associated with average number of hospital episodes per patient. The data will not be made available to any third parties, other than in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide. Data will be accessed by members at ILMH at Kingston University only. No remote access will be performed. Kingston University stores the data on a server at Kingston Business School, which can be only accessed at this location. All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data). The Data will only be used for the purposes described in this agreement.