BackgroundInternational guidelines recommend nintedanib (OFEV®) as an option for the treatment of idiopathic pulmonary fibrosis (IPF).ObjectiveThe objective of this study was to assess the cost effectiveness of nintedanib versus pirfenidone, N-acetylcysteine and best supportive care (BSC) for the treatment of IPF from a UK payer’s perspective.MethodsA Markov model was designed to capture the changes in the condition of adults with IPF. Efficacy outcomes included mortality, lung function decline and acute exacerbations. Treatment safety (serious adverse events) and tolerability (overall discontinuation) were also considered. The baseline risk of these events was derived from patient-level data from the placebo arms of nintedanib clinical trials (TOMORROW, INPULSIS-1, INPULSIS-2). A network meta-analysis (NMA) was conducted to estimate the relative effectiveness of the comparator treatments. Quality of life and healthcare resource use data from the clinical trials were also incorporated in the economic model.ResultsNintedanib showed statistically significant differences against placebo on acute exacerbation events avoided and lung function decline. In the cost-effectiveness analysis, the results were split between two treatments with relative low costs and modest effectiveness (BSC and N-acetylcysteine) and two that showed improved effectiveness (lung function) and higher costs (nintedanib and pirfenidone). All comparators were assumed to have similar projected survival and the difference in quality-adjusted life-years (QALYs) was driven by the acute exacerbations and lung function estimates. In the base-case deterministic pairwise comparison with pirfenidone, nintedanib was found to have fewer acute exacerbations and resulted in less costs and more QALYs gained.ConclusionsCompared with BSC (placebo), nintedanib and pirfenidone were the only treatments to show statistical significance in the efficacy parameters. We found substantial uncertainty in the overall cost-effectiveness results between nintedanib and pirfenidone. N-Acetylcysteine was largely similar to BSC but with a worse survival profile.INPULSIS-1 and INPULSIS-2 ClinicalTrials.gov numbers, NCT01335464 and NCT01335477Electronic supplementary materialThe online version of this article (doi:10.1007/s40273-016-0480-2) contains supplementary material, which is available to authorized users.
A553CVD group compared to COPD patients without CVD (399€ vs. 361€ , p= 0.007). COPD related annual utilization of pharmaceuticals was higher in the CVD group (72.3% vs. 70.1%, p= 0.003), whereas AC for medications did not differ between groups (360€ vs. 346€ , p= 0.109). Neither COPD related hospital utilization (4.0% vs. 3.9%, p= 0.796), nor AC (156€ vs. 161€ , p= 0.779) differed between groups. ConClusions: Although this study is limited by a relatively short exposure time to CVD and observation period (360 days), comorbid CVD has an effect on COPD related sector specific annual utilization and direct medical costs. This indicates an intensified treatment need of COPD in the presence of CVD and the need for effective co-treatment strategies.
NICE introduced the end-of-life (EOL) criteria, giving more weight to QALYs for life-extending, and EOL interventions. In May 2014, the Scottish Medicines Consortium (SMC) introduced the Patient and Clinician Engagement (PACE) process for evaluating EOL medicines and medicines used to treat very rare conditions, to allow a more flexible approach to considering such medicines. These two initiatives allow a greater cost per QALY gained willingnessto-pay threshold than usual in the United Kingdom (UK), however there are differences in their requirements and outcomes. The aim of this study was to compare the process and conclusions drawn by NICE and the SMC for health technology appraisal submissions either meeting NICE EOL criteria after May 2014, or being accepted into the PACE process based on EOL. MethOds: All technologies reviewed under the PACE process, NICE EOL criteria or both were identified. Information collected included whether EOL criteria were met, incremental cost effectiveness ratio (ICER) and SMC and NICE decisions. Results: In total, 15 technologies were reviewed. Of the 15, 14 were reviewed under PACE; 8 were given positive SMC Advice, 3 were given restricted positive SMC Advice and 3 were given negative SMC Advice. Of the 14 technologies reviewed under the PACE process, 7 were reviewed by NICE, 4 met EOL criteria, 2 of which were given positive NICE Guidance. cOnclusiOns: Of those technologies considered by both NICE and SMC since May 2014, fewer met the NICE EOL criteria than the PACE EOL criteria, and fewer still received positive NICE Guidance. There are differences in access to interventions for diseases with short life expectancies within the UK, although further research into the changing Cancer Drugs Fund is needed. PHP70 Causes and Cost ImPaCt of VarIabIlItIes on tHe a&e Ward utIlIzatIon aCross HosPItals In sPaInfernandez-Santos J Nextium6, Maidenhead, UK PHP69 all qalys are equal, but some qalys are more equal tHan otHers; a
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A657the relevant clinical criteria. Individual Cancer Drug Fund requests (ICDFRs) can also be made for patients outside of routine cohort CDF criteria for rare diseases or, in cases where a decision has been made not to fund a cohort, for patients for whom clinical exceptionality from this cohort can be demonstrated. ICDFRs are screened to ensure that the request is appropriate and are then appraised by one of four regional CDF panels. This research aimed to evaluate whether access to oncologics through ICDFRs varies by region. Methods: ICDFR outcomes data (April 2013-March 2014 was extracted from the NHS website and stratified by NHS estimates of the resident population by region. All statistical analyses were performed using a Chi-squared test. Results: 1029 ICDFR applications were received for consideration (London, 301; East and Midlands, 231; North England, 181; South England, 316), 46% of which were deemed ineligible by screening, significantly varying by region (p< 0.0001, range 22% (North England) to 67% (East and Midlands)). 50% of screened ICDFRs were approved, which varied substantially by region (p< 0.0001, range 37% (East and Midlands) to 72% (South England)). Overall, around 5.5 ICDFRs were accepted per million patients across England, however, between regions this ratio varied over six-fold (range 1.9 (East and Midlands) to 12.0 (South England)). ConClusions: The notable variations in ICDFR screening, acceptance, and population level approval rates, which are larger than what we may expect based on regional variations in case mix, suggest that regional areas must further collaborate to ensure that patients have equitable access to the Cancer Drugs Fund.
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