Proceed with caution: an economic perspective on the UK's value based pricing proposals

The shift from the Pharmaceutical Pricing Regulation Scheme to Value Based Pricing (VBP) is an important change in the way that medicines will be priced, and consequently, reimbursed in the United Kingdom. Whilst the opportunity to purchase new medicines based on value to society is one that should be welcomed, we should proceed with caution. We highlight ten issues that should be considered relating to innovation, the role and meaning of funding threshold and the adjustments to reflect burden of illness, therapeutic innovation and improvement and wider societal factors. Most importantly, the assessment of value should continue to be based on the characteristics of the displaced activities (e.g. the health produced). To a large extent, all that is changing under VBP are the characteristics being considered; weighted health rather than unweighted health. In addition, we should not totally abandon a cost-utility framework for appraisal just because its current formulation does not match the wider perspective now desired by government

Ledipasvir-Sofosbuvir for treating Chronic Hepatitis C: A NICE Single Technology Appraisal - An Evidence Review Group Perspective

The National Institute for Health and Care Excellence (NICE) invited Gilead, the company manufacturing ledipasvir-sofosbuvir (LDV/SOF), to submit evidence for the clinical effectiveness and cost-effectiveness of LDV/SOF for treating Chronic Hepatitis C. The School of Health and Related Research (ScHARR) Technology Assessment Group was commissioned as the Evidence Review Group (ERG). This paper describes the company’s submission (CS), the ERG review and the subsequent decision of the NICE Appraisal Committee (AC). The ERG produced a critical review of the clinical effectiveness and cost-effectiveness evidence of LDV/SOF based upon the CS. The clinical effectiveness data for LDV/SOF were taken from ten trials, comprised of three Phase III trials and seven Phase II trials. Trials compared different durations of LDV/SOF, with and without ribavirin (RBV). There were no head-to-head trials comparing LDV/SOF with any comparator listed in the NICE scope. Data from the trials were mostly from populations with genotype 1 (GT1) disease, although some limited data were available for populations with genotypes 3 and 4. For GT1 treatment-naïve patients, sustained viral response for 12 weeks (SVR12) rates for LDV/SOF ranged from 93.1% to 99.4% for subgroups of patients with non-cirrhotic disease, whilst SVR rates of 94.1% to 100% were reported for subgroups of patients with compensated cirrhosis. For GT1 treatment-experienced patients, SVR12 rates ranging from 95.4% to 100% were reported for subgroups of non-cirrhotic patients and SVR rates ranging from 81.8% to 100% were reported within subgroups of patients with compensated cirrhosis. Comparator data were not searched systematically as part of the submission, but were based on the company’s previous NICE submission of sofosbuvir, with additional targeted searches. The ERG’s critical appraisal of the company’s economic evaluation highlighted a number of concerns. The ERG’s base case analyses suggested that the incremental cost effectiveness ratios (ICERs) for LDV/SOF (+RBV) are dependent on a) treatment durations, b) whether patients have been previously treated and c) whether patients have liver cirrhosis or not. The AC concluded that it was appropriate to use the approach taken in the ERG’s exploratory analyses, in line with the marketing authorisation, which considered people with and without cirrhosis separately, and estimated the cost-effectiveness for each recommended treatment duration of LDV/SOF

A review of public health economic modelling in the National Institute for Health and Care Excellence (NICE)

Background: The National Institute for Health and Care Excellence (NICE) use economic modelling to inform judgements whenever further insight is required for decision-making. Doing so for public health guidance poses several challenges. The study’s objective was to investigate the level of heterogeneity in NICE’s public health economic models with regards to economic evaluation techniques, perspectives on outcomes and the measurement of non-health benefits. Methods: A review of all economic modelling reports published by NICE’s Centre for Public Health (CPH) as part of their guidance. Results: The review identified 56 eligible pieces of public health over the relevant period. Of these, 43 used economic modelling and 13 used no formal economic model. In total 61 economic models were used. Though the CPH specifies a reference case, in practice there is a large amount of variability from one model to the next. The most common perspective used for evaluations was that of the National Health Service (NHS); the most common economic evaluation approach was cost-utility analysis (CUA). 23 of the 56 topics used other combinations of perspective and technique, which allowed them to incorporate non-health effects, such as productivity, the effect on taxes raised and benefits spending, costs to the criminal justice sector, the effect on educational attainment and general wellbeing. Conclusions: NICE regularly updates its reference case, and non-CUA evaluation techniques have become more prominent in recent years. The results highlight the genuine advantages of having a variety of economic evaluation techniques available, which can be matched with the given topic. While it is always necessary to be wary of the possibility of gamesmanship and cherry picking, there is a surprising alignment between many approaches in certain circumstances

Cost effectiveness of using cognitive screening tests for detecting dementia and mild cognitive impairment in primary care.

INTRODUCTION: We estimated the cost effectiveness of different cognitive screening tests for use by General Practitioners (GPs) to detect cognitive impairment in England. METHODS: A patient-level cost-effectiveness model was developed using a simulated cohort that represents the elderly population in England (65 years and older). Each patient was followed over a lifetime period. Data from published sources were used to populate the model. The costs include government funded health and social care, private social care and informal care. Patient health benefit was measured and valued in Quality Adjusted Life Years (QALYs). RESULTS: Base-case analyses found that adopting any of the three cognitive tests (Mini-Mental State Examination, 6-Item Cognitive Impairment Test or GPCOG (General Practitioner Assessment of Cognition)) delivered more QALYs for patients over their lifetime and made savings across sectors including healthcare, social care and informal care compared with GP unassisted judgement. The benefits were due to early access to medications. Among the three cognitive tests, adopting the GPCOG was considered the most cost-effective option with the highest Incremental Net Benefit (INB) at the threshold of £30 000 per QALY from both the National Health Service and Personal Social Service (NHS PSS) perspective (£195 034 per 1000 patients) and the broader perspective that includes private social care and informal care (£196 251 per 1000 patients). Uncertainty was assessed in both deterministic and probabilistic sensitivity analyses. CONCLUSIONS: Our analyses indicate that the use of any of the three cognitive tests could be considered a cost-effective strategy compared with GP unassisted judgement. The most cost-effective option in the base-case was the GPCOG. Copyright © 2016 John Wiley & Sons, Ltd

A qualitative exploration of patient flow in a developing Caribbean emergency department

Objectives Emergency departments (EDs) are complex adaptive systems and improving patient flow requires understanding how ED processes work. This is important for developing countries where flow concerns are compounded by resource constraints. The Caribbean is one region with developing emergency care systems and limited research in the area. This study aimed to explore the patient flow process in an emergency department in Trinidad and Tobago, identifying organizational factors influencing patient flow. Methods Multiple qualitative methods, including non-participant observations, observational process mapping and informal conversational interviews were used to explore patient flow. The process maps were generated from the observational process mapping. Thematic analysis was used to analyze the data. Setting The study was conducted at a major tertiary level emergency department in Trinidad and Tobago. Participants Patient and staff journeys in the emergency department were observed. Results Six broad categories were identified- 1) ED organizational work processes, 2) ED design and layout, 3) material resources, 4) nursing staff levels, roles, skill mix and use 5) non-clinical ED staff and 6) external clinical and non-clinical departments. The study findings were combined with existing literature to produce a model of factors influencing ED patient flow. Barriers and facilitators to patient flow were highlighted. Conclusion The knowledge gained may be used to strengthen the emergency care system in the local context. The model of ED patient flow may be used to systematically examine factors influencing patient flow, informing policy and practice. However, the study findings should be validated in other settings

Telemonitoring after discharge from hospital with heart failure: cost-effectiveness modelling of alternative service designs.

Objectives To estimate the cost-effectiveness of remote monitoring strategies versus usual care for adults recently discharged after a heart failure (HF) exacerbation. Design Decision analysis modelling of cost-effectiveness using secondary data sources. Setting Acute hospitals in the UK. Patients Patients recently discharged (within 28 days) after a HF exacerbation. Interventions Structured telephone support (STS) via human to machine (STS HM) interface, (2) STS via human to human (STS HH) contact and (3) home telemonitoring (TM), compared with (4) usual care. Main outcome measures The incremental cost per quality-adjusted life year (QALY) gained by each strategy compared to the next most effective alternative and the probability of each strategy being cost-effective at varying willingness to pay per QALY gained. Results TM was the most cost-effective strategy in the scenario using these base case costs. Compared with usual care, TM had an estimated incremental cost effectiveness ratio (ICER) of £11 873/QALY, whereas STS HH had an ICER of £228 035/QALY against TM. STS HM was dominated by usual care. Threshold analysis suggested that the monthly cost of TM has to be higher than £390 to have an ICER greater than £20 000/QALY against STS HH. Scenario analyses performed using higher costs of usual care, higher costs of STS HH and lower costs of TM do not substantially change the conclusions. Conclusions Cost-effectiveness analyses suggest that TM was an optimal strategy in most scenarios, but there is considerable uncertainty in relation to clear descriptions of the interventions and robust estimation of costs