Cost-effectiveness of prasugrel in a US managed care population

Abstract

Objective:

Decision-makers in the US may be interested in the applicability to their populations of cost-effectiveness results generated from clinical trial populations.

Methods:

An economic model estimating the cost-effectiveness of prasugrel plus aspirin relative to clopidogrel plus aspirin for patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) was developed from a managed care organization (MCO) perspective. The model estimated 15-month cardiovascular events or bleeding-related outcomes, life expectancy, and costs for patients who received thienopyridine treatment during and after a PCI following a diagnosis of ACS. Post-ACS event rates for patients treated with clopidogrel were from an MCO. The relative risks of these events with prasugrel compared with clopidogrel were from a head-to-head clinical trial.

Results:

The results of the base-case analysis indicated that, in an MCO population, use of prasugrel-based therapy rather than clopidogrel-based therapy at current prices resulted in cost-savings and fewer clinical events over the 15 months after an ACS diagnosis followed by PCI. At possible lower prices for generic clopidogrel-based therapy, the cost-effectiveness ratio for prasugrel-based therapy compared with clopidogrel-based therapy was between $6643 and $13,906 per life-year gained. The results were most sensitive to the relative costs of the two treatments and the cost for hospital stays.

Limitations:

Limitations of the study included lack of follow-up of patients disenrolling from the MCO before the end of the 15-month observation period, the assumption of equal relative risks of events in an MCO as in the clinical trial, and the lack of information on the ratio of cost to charges in the MCO database.

Conclusions:

Use of prasugrel-based therapy compared with clopidogrel-based therapy in ACS patients having a PCI resulted in cost-savings at current prices and favorable cost-effective ratios at likely generic prices for clopidogrel-based therapy because of offsetting savings in the costs of rehospitalization.     

Economic outcomes with prasugrel versus clopidogrel in acute coronary syndrome patients: observations from prasugrel users and matched clopidogrel users

Abstract

Objective:

To compare healthcare costs between clopidogrel and prasugrel over 30-day and 365-day periods after discharge from the hospital or emergency room (ER) in patients treated with prasugrel who were hospitalized or had an ER visit for an acute coronary syndrome (ACS) event.     

Cost of care for new versus recurrent acute coronary syndrome patients

Abstract

Introduction: The economic burden of acute coronary syndrome (ACS) continues long after the acute event has resolved. This study compared ACS-related costs between new and recurrent ACS patients using retrospective claims data from a large US health plan.

Methods: Patients with ACS were identified using ICD-9 codes between the 1st January 2001 and the 30th June 2003. The first diagnosis was defined as the index event. Patient claims were examined 1 year before, and up to 1 year after, the index event. Hospitalisations, revascularisations and costs for new and recurrent cohorts were compared. Multivariate regression was used to examine cost predictors.

Results: In total, 15,508 patients were identified, 82% had new ACS. The new ACS cohort was more likely to have myocardial infarction and be hospitalised for the index event, leading to higher index event costs. However, the recurrent ACS cohort had more re-hospitalisations, longer lengths of inpatient stay and a higher probability of revascularisation during follow-up. The index event cost per patient and per patient-month was higher for new ACS patients. After adjusting for confounding factors, multivariate cost models revealed annualised follow-up medical costs were 9.9% higher (p=0.017) and annualised follow-up pharmacy costs were 8.3% higher (p≤0.0001) for the new ACS cohort.

Conclusion: Newly diagnosed ACS patients had significantly higher adjusted costs in the year following the index event, but recurrent ACS patients still experienced high medical costs. More emphasis by providers and patients on adherence to treatment guidelines may be one step to improving patient outcomes.

*This paper was presented in part at the Academy of Managed Care Pharmacy Annual Meeting, 7th April 2006.     

Prasugrel vs clopidogrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention: a model-based cost-effectiveness analysis for Germany,Sweden, the Netherlands,and Turkey

Abstract

Objective:

To evaluate the long-term cost-effectiveness of 12-months treatment with prasugrel vs clopidogrel from four European healthcare systems’ perspectives (Germany, Sweden, the Netherlands, and Turkey).

Methods:

In the TRITON-TIMI 38 trial, patients with an acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) were treated with prasugrel or clopidogrel. Prasugrel reduced the composite end-point (cardiovascular death, MI, or stroke), but increased TIMI major bleeding. A Markov model was constructed to facilitate a lifetime horizon for the analysis. A series of risk equations constructed using individual patient data from TRITON-TIMI 38 was used to estimate risks of clinical events. Quality-adjusted life-years (QALYs) were derived by weighting survival time by estimates of health-related quality-of-life. Incremental cost-effectiveness is presented based on differences in treatments’ mean costs and QALYs for the licensed population in TRITON-TIMI 38, and the sub-groups of UA-NSTEMI, STEMI, diabetes, and the ‘core clinical cohort’ (<75 years, ≥60?kg, no history of stroke or TIA).

Results:

Mean cost of study drug was €364 (Turkey) to €818 (Germany) higher for prasugrel vs clopidogrel. Rehospitalization costs at 12 months were lower for prasugrel due to reduced rates of revascularization, although hospitalization costs beyond 12 months were higher due to longer life expectancy associated with lower rates of non-fatal MI in the prasugrel group. The incremental cost per QALY saved with prasugrel in the licensed population ranged from €6520 (for Sweden) to €14,350 for (Germany). Prasugrel’s cost per QALY was more favourable still in the STEMI and diabetes sub-groups of the licensed population.

Limitations:

Probabilistic analyses of the whole trial population is impractical due to the number of individual patient profiles over which population level results are calculated.

Conclusion:

Among patients undergoing PCI for ACS, treatment with prasugrel compared with clopidogrel resulted in favourable cost-effectiveness profiles from these healthcare systems’ perspectives.     

Cost-effectiveness analysis of solifenacin versus oxybutynin immediate-release in the treatment of patients with overactive bladder in the United Kingdom

Abstract

Objective:

To carry out a cost-utility analysis comparing initial treatment with solifenacin 5?mg/day vs oxybutynin immediate-release (IR) 15?mg/day for the treatment of patients with overactive bladder (OAB) from the perspective of the UK National Health Service (NHS).

Methods:

A Markov model with six health states was developed to follow a cohort of OAB patients treated with either solifenacin or oxybutynin during a 1-year period. Costs and utilities were accumulated as patients transited through the health states in the model and a drop-out state. Some of the solifenacin patients were titrated from 5?mg to 10?mg/day at 8 weeks. A proportion of drop-out patients were assumed to continue treatment with tolterodine ER. Utility values were obtained from a Swedish study and pad use was based on a multinational clinical trial. Adherence rates for individual treatments were derived from a UK database study. For pad use and utility values, the drop-out state was split between those patients who were no longer receiving treatment and those on second-line therapy. Patients on second-line therapy who drop-out were referred for a specialist visit. Results were expressed in terms of incremental cost-utility ratios.

Results:

Total annual costs for solifenacin and oxybutynin were £504.30 and £364.19, respectively. First-line drug use represents 49% and 4% of costs and pad use represent 23% and 40% of costs for solifenacin and oxybutynin, respectively. Differences between cumulative utilities were small but were greater for solifenacin (0.7020 vs 0.6907). The baseline incremental cost-effectiveness ratio was £12,309/QALY.

Conclusion:

Under the baseline assumptions, solifenacin would appear to be cost-effective with an incremental cost-utility of less than £20,000/QALY. However, small differences in utility between the alternatives and the large number of drop-outs means that the results are sensitive to small adjustments in the values of utilities assigned to the drop-out state.     

Assessment of Resource Use and Costs Associated with Parathyroidectomy for Secondary Hyperparathyroidism in End Stage Renal Disease in the UK

Introduction:

Secondary hyperparathyroidism (SHPT) is a major complication of end stage renal disease (ESRD). For the National Health Service (NHS) to make appropriate choices between medical and surgical management, it needs to understand the cost implications of each. A recent pilot study suggested that the current NHS healthcare resource group tariff for parathyroidectomy (PTX) (£2071 and £1859 in patients with and without complications, respectively) is not representative of the true costs of surgery in patients with SHPT.

Objective:

This study aims to provide an estimate of healthcare resources used to manage patients and estimate the cost of PTX in a UK tertiary care centre.

Methods:

Resource use was identified by combining data from the Proton renal database and routine hospital data for adults undergoing PTX for SHPT at the University Hospital of Wales, Cardiff, from 2000–2008. Data were supplemented by a questionnaire, completed by clinicians in six centres across the UK. Costs were obtained from NHS reference costs, British National Formulary and published literature. Costs were applied for the pre-surgical, surgical, peri-surgical, and post-surgical periods so as to calculate the total cost associated with PTX.

Results:

One hundred and twenty-four patients (mean age?=?51.0 years) were identified in the database and 79 from the questionnaires. The main costs identified in the database were the surgical stay (mean?=?£4066, SD?=?£,130), the first month post-discharge (£465, SD?=?£176), and 3 months prior to surgery (£399, SD?=?£188); the average total cost was £4932 (SD?=?£4129). From the questionnaires the total cost was £5459 (SD?=?£943). It is possible that the study was limited due to missing data within the database, as well as the possibility of recall bias associated with the clinicians completing the questionnaires.

Conclusion:

This analysis suggests that the costs associated with PTX in SHPT exceed the current NHS tariffs for PTX. The cost implications associated with PTX need to be considered in the context of clinical assessment and decision-making, but healthcare policy and planning may warrant review in the light of these results.     

Estimating the quality-of-life impact and cost-effectiveness of alpha-blocker and anti-muscarinic combination treatment in men with lower urinary tract symptoms related to benign prostatic hyperplasia and overactive bladder

Abstract

Objective:

A 12-week clinical trial (TIMES) demonstrated that therapy with tolterodine extended release (TOL)?+?tamsulosin (TAM) provides clinical benefits vs TOL or TAM monotherapy or placebo (PBO) in men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB). The present analysis estimated the costs and quality-adjusted life-years (QALYs) associated with these therapies from the perspective of the UK healthcare system.

Methods:

TIMES cohorts receiving TOL, TAM, TOL?+?TAM, or PBO were followed from therapy initiation to 12 weeks. A decision-tree model was used to extrapolate the 12-week results to 1 year (including need for surgery owing to treatment failure at 12 weeks) and to track patients’ outcomes (symptoms, utility, and costs). Because TIMES did not include costs and QALYs, data from the EpiLUTS epidemiologic survey (12,796 males) were used to model a mathematical relationship between LUTS (daytime and nocturnal frequency, urgency episodes, urgency urinary incontinence episodes, and International Prostate Symptom Score [IPSS]), quality-of-life, and utility. This was used to convert improvements in TIMES patients’ LUTS into utility scores and QALYs. The model included drug and surgery procedure costs and hospital length of stay.

Results:

Incremental QALYs of TOL?+?TAM vs PBO, TAM, and TOL were 0.042, 0.021, and 0.013, and corresponding incremental costs were £189, £223, and ?£70, respectively, resulting in cost-utility ratios for TOL?+?TAM of £4508/QALY gained compared with PBO and £10,381/QALY gained compared with TAM. TOL?+?TAM combination therapy was both more effective and cost-saving compared with TOL. Univariate sensitivity analyses showed that patient utility was most responsive to changes in drug efficacy on IPSS and urgency episodes. Changing the percentage of patients undergoing surgery did not substantially affect model outcomes. The main limitation of the study was that the relation between LUTS and patient utility was based on an indirect association.

Conclusions:

TOL?+?TAM combination therapy appears to be cost-effective compared with TOL or TAM monotherapy or PBO in male patients with LUTS.     

Healthcare costs for Crohn’s disease patients treated with infliximab: a propensity weighted comparison of the effects of treatment adherence

Objective:

The objective for the research was to evaluate the direct healthcare costs for Crohn’s disease (CD) patients categorized by adherence status.

Methods:

Adult patients with ≥1 claim for infliximab and ≥2 claims for CD who were continuously insured for 12 months before and after their first infliximab infusion (index date) were identified in a 2006–2009 US managed care database. Patients were excluded if they had rheumatoid arthritis claims, received infliximab billed as a pharmacy benefit, or received another biologic drug. Patients were categorized as being either adherent or intermittently adherent to infliximab using a pre-defined algorithm. Total and component direct costs, CD-related costs, rates of surgery, and days of hospitalization were estimated for the 360-day post-index period. Propensity weighted generalized linear models were used to adjust the cost estimates for potential confounding variables.

Results:

The total propensity weighted cost for infliximab adherent patients was $40,425 (95% CI?=?[$38,686, $42,242]), compared to $41,082 (95% CI?=?[$38,163, $44,223]) for the intermittently adherent (p?=?0.71). However, adherent patients had lower total direct medical costs, exclusive of infliximab, that were $13,097 (95% CI?=?[$12,141, $14,127]) compared with $20,068 (95% CI?=?[$17,676, $22,784]) for intermittently adherent patients as a result of substantially lower hospital and outpatient costs (p?Conclusions:

Greater drug-related costs for infliximab adherent patients were offset by lower costs from hospitalization and outpatient visits. These findings indicate that adherent patients have improved clinical outcomes, at a similar aggregate cost, than patients who are only intermittently adherent to therapy.     

A cost-effectiveness analysis of MMX mesalazine compared with mesalazine in the treatment of mild-to-moderate ulcerative colitis from a UK perspective

Abstract

Objectives: To perform a cost-utility analysis of a new formulation of mesalazine (Mezavant XL, MMX mesalazine) versus an existing oral mesalazine (Asacol; mesalazine) from the UK National Health Service perspective.

Methods: A 5-year Markov cohort model was developed. Costs were obtained from the literature and utilities from an independent study. Uncertainty was evaluated using one-way and probabilistic sensitivity analyses (PSA). The potential effect of dosing frequency on adherence and possible long-term effects of remission maintenance on colorectal cancer (CRC) rates were also investigated.

Results: The model suggested that 5-year therapy with MMX mesalazine was likely to generate gains when compared with mesalazine, including a gain of 0.011 QALYs per patient, 19 more remission days, and 12% fewer hospitalizations and surgical episodes. These gains came at an increase in total NHS direct cost of £8, resulting in an incremental cost-effectiveness ratio (ICER) of £749. The PSA suggested that MMX mesalazine had a 62% chance of resulting in cost savings, and a 74% chance of being cost effective (£20,000 threshold). Extended analysis including adherence and CRC effects suggested further incremental benefit of MMX mesalazine over mesalazine could be expected. Limitations include uncertainty in extrapolation to a 5-year time horizon and impact of adherence and drug acquisition costs on outcomes.

Conclusion: The pharmacoeconomic analysis suggested that MMX mesalazine is likely to produce small, but worthwhile, increases in total NHS direct cost while increasing time in remission and associated quality of life, when compared with mesalazine. Advantages in adherence to treatment with MMX mesalazine relative to mesalazine suggested that further health gains and cost savings can be obtained. Overall, these results suggest that MMX mesalazine is a cost-effective treatment for UC.     

Costs of bleeds relating to acute coronary syndrome therapies

Objective: To estimate the costs to manage selected types of bleeding complications in patients with acute coronary syndrome (ACS) treated with antithrombotics, including antiplatelet, and fibrinolytic therapies: decrease in haemoglobin >3 g/dL, puncture site, and bleeding requiring transfusion of blood products.

Methods: Retrospective chart reviews of ACS patients experiencing decrease in Hb, puncture site, or bleeding requiring transfusion were conducted in hospitals in France, Germany, Italy, Spain and Sweden to determine the total length of stay (LOS), stay post-bleeding, procedures to identify the extent of bleeding, number and types of transfusion products, patient demographics, reason for hospital admission and disposition upon discharge. Country-specific costs were applied to estimate the average cost per patient by type of bleeding event.

Results: Records of 158 ACS patients with the bleeding complications were examined (26.9% decrease in Hb, 35.5% puncture site, and 37.8% transfusion). The average LOS was 10.6 days for decreasing Hb, 7.7 days for puncture site bleeding, and 11.3 days for patients receiving transfusions due to these bleeding events. The average costs per patient ranged between €3,986 and €10,252. The LOS ranged widely both within and across countries.

Limitations: The study has a small sample size and costs are confounded by co-morbidities.

Conclusions: The estimated costs for decreasing Hb, puncture site bleeding and bleeding resulting in transfusions provide a tool for researchers to conduct economic analyses of bleeding events associated with therapies for ACS.     

Resource utilization and healthcare costs for acute coronary syndrome patients with and without diabetes mellitus

Abstract

Objective:

This study compared differences in healthcare costs and resource utilization for acute coronary syndrome (ACS) patients with and without diabetes mellitus (DM).

Methods:

A retrospective cohort study of a large, US employer-based claims database identified adults hospitalized for ACS between 01/01/2005 and 12/31/2006 and categorized them based on DM status. Resource utilization and costs during the index hospitalization and in the 12-month follow-up period were compared for ACS patients with and without DM using the propensity score stratification bootstrapping method, adjusting for differences in demographic and clinical characteristics.

Results:

Of 12,502 patients who met selection criteria, 3,040 (24%) had a history of DM and 9,462 (76%) did not. Patients with DM were older, female, and had higher rates of previous cardiovascular and renal diseases. After the propensity score stratification, patients with DM incurred higher index hospitalization costs ($32,577 vs. $29,150, p?<?0.01) as well as higher total follow-up healthcare costs ($35,400 vs. $24,080, p?<?0.01), including higher inpatient ($17,278 vs. $11,247, p?<?0.01), outpatient ($12,357 vs. $8,853, p?<?0.01), and pharmacy costs ($5,765 vs. $3,980, p?<?0.01).

Limitations:

General limitations exist with any retrospective claims database analysis including potential diagnostic or procedural coding inaccuracies. Additionally, the patient population was representative of a working-age population with employer-sponsored health insurance and results may not be generalizable to other patient populations.

Conclusions:

DM is significantly associated with increased healthcare resource utilization and costs for ACS patients.     

Inflammatory bowel disease: healthcare costs for patients who are adherent or non-adherent with infliximab therapy

Objective:

Healthcare costs of inflammatory bowel disease are substantial. This study examined the effect of adherence versus non-adherence on healthcare costs in patients with inflammatory bowel disease.

Methods:

Adults who started infliximab treatment between 2006 and 2009 and had a diagnosis of inflammatory bowel disease were identified from MarketScan Databases. Medication adherence was defined as an infliximab medication possession ratio of 80% or greater in the first year. Mean treatment effects (adherence versus non-adherence) on costs in adherent patients were estimated with propensity-weighted generalized linear models.

Results:

A total of 1646 patients were identified. Significant variables in the model used to develop propensity weights were age, year of infliximab initiation, having Medicare coverage, presence of supplementary diagnoses, office as the place of service for infliximab initiation, prior aminosalicylate use, prior outpatient costs, number of prior outpatient visits, and number of prior colonoscopies. Mean total costs in adherent (n?=?674) and propensity-weighted non-adherent (n?=?972) patients were $41,713 versus $47,411 overall (p?p?p?p?p?p?=?0.460).

Limitations:

Costs associated with infliximab administration (infusions, adverse events) were captured in healthcare costs (inpatient, outpatient, and emergency room), not in infliximab costs. The influence of adherence on indirect costs (e.g., time lost from work) could not be determined. Reasons for non-adherence were not available in the database.

Conclusions:

In patients who were adherent to infliximab treatment (a medication possession ratio of 80% or greater in the first year), adherence versus non-adherence was associated with lower total healthcare costs, supporting the overall value of infliximab adherence in patients with inflammatory bowel disease.     

A cost-effectiveness analysis of levodopa/carbidopa intestinal gel compared to standard care in late stage Parkinson’s disease in the UK

Abstract

Objective:

Evaluation of cost-effectiveness of levodopa/carbidopa intestinal gel (LCIG), compared to standard care (SC) in patients with advanced Parkinson’s disease (aPD) in the UK.

Design:

Markov model to quantify costs and outcomes associated with LCIG versus SC in aPD patients at Hoehn and Yahr (H&Y) stages 3, 4 or 5 experiencing >50% OFF time per day. Time horizon was lifetime, LCIG treatment was assumed to last maximal 5 years after which patients revert to SC. Model comprised 12 aPD health states according to H&Y status and daily time spent in OFF state. Cost analyses are reported from a UK NHS and Personal Social Services perspective. Uncertainties were assessed through one-way sensitivity analyses.

Comparators:

LCIG, providing patients with continuous dopaminergic stimulation to maximise functional ON time during the day and SC, defined as medically determined best available oral medication.

Main outcome measures:

Cost-effectiveness, based on quality adjusted life years gained, presented as an incremental cost-effectiveness ratio.

Results:

Lifetime analysis yields an incremental cost per QALY of £36,024 for LCIG compared to SC (incremental cost £39,644, QALY gain 1.1). Results were sensitive to time on treatment, health state on treatment initiation, and estimates of long term benefit (OWSA results from £32,127 to £66,421 per QALY). Findings must be considered in the context of the study limitations which were mainly due to data availability constraints.

Conclusions:

LCIG is an effective treatment, reducing OFF time and improving quality of life in advanced PD. It provides value for money in levodopa-responsive aPD patients with severe motor fluctuations when no other treatment options are effective or suitable. Given LCIG is an orphan drug, it is reasonable to suggest that it may be considered cost-effective in the UK setting. However, further research is needed to complete current data gaps and increase robustness of the model.     

Retrospective database study to assess the economic impact of hip fracture in the United Kingdom

Objective:

Publications containing recent, real-world data on the economic impact of hip fractures in the UK are lacking. This retrospective electronic medical records database analysis assessed medication and healthcare resource use, direct healthcare costs, and factors predicting increased resource use and costs in adult UK hip fracture patients.

Methods:

Data were obtained from the Clinical Practice Research Datalink linked to the Hospital Episode Statistics for adult patients hospitalized for their first hip fracture between January 1, 2006 and March 31, 2011 (index event); healthcare costs were calculated from the National Health Service perspective using 2011–2012 cost data.

Results:

Data from 8028 patients were analyzed. Resource use and costs were statistically significantly higher in the year following fracture (mean total [standard deviation (SD)] cost £7359 [£14,937]) compared with the year before fracture (mean total [SD] cost £3122 [£9435]; p?Conclusions:

Although we did not capture all pre- and post-index costs and healthcare utilization, this study provides important insights regarding the characteristics of patients with hip fracture, and information that will be useful in burden-of-illness and economic analyses.     

The economic burden of advanced Parkinson’s disease: an analysis of a UK patient dataset

Abstract

Background:

To evaluate the cost burden of patients with advanced Parkinson’s disease (PD) according to the waking hours per day spent in OFF state. An analysis of resource use comprising medical services, professional care and informal care data from an observational, cross-sectional study was conducted.

Methods:

A total of 60 physicians comprising 40 neurologists and 20 geriatricians across the UK participating in the Adelphi PD Disease Specific Programme took part. There were 302 PD patients at H&Y stages 3–5. Patients were characterised according to the percentage of time per day spent in OFF state (<25%, 26–50%, 51–75%, >75%).

Results:

Average 12-monthly total costs increased according to the time spent in OFF state from £25,630 in patients spending less than 25% of their waking hours in OFF to £62,147 for patients spending more than 75% of their time in OFF. Overall, 7% of costs were attributed to direct medical care, while 93% were split between direct non-medical professional care (50%) and indirect informal care (43%).

Limitations:

Low patient numbers in the more advanced disease stages of PD led to very little or no data to directly inform some of the severe health states of the analysis. Data gaps were filled in with data derived from a regression analysis which may affect the robustness of the analysis.

Conclusion:

This study illustrates the increasing costs of advancing PD, in particular related to the time spent in OFF state, and identifies that the foremost cost burden is associated with the care needs of the patient rather than medical services.     

Economic evaluation of sevelamer for the treatment of hyperphosphatemia in chronic kidney disease patients not on dialysis in the United Kingdom

Abstract

Objectives:

To determine the cost effectiveness of sevelamer vs calcium carbonate in patients with chronic kidney disease and not on dialysis (CKD-ND) from the perspective of the National Health Service (NHS) in the UK.

Methods:

A Markov decision analytic model was developed to estimate (1) total life years (LYs), quality-adjusted life years (QALYs), and costs for patients treated with sevelamer or calcium carbonate; and (2) incremental costs per LY gained (LYG) and per QALY gained for sevelamer vs calcium carbonate. Data informing probability transitions to all-cause death and dialysis inception in CKD-ND patients were taken directly from the INDEPENDENT-CKD study and were extrapolated beyond the 3-year clinical trial using Weibull regression analysis. Estimates of health utility and costs (in £2011) were derived from the published literature.

Results:

Over a lifetime horizon, sevelamer treatment resulted in a gain of 2.05 LYs and 1.56 QALYs per patient, an increase of £37,282 in total costs per patient vs calcium carbonate (3.5% discount), and a per-patient cost of £18,193/LYG and £23,878/QALY gained. Results were robust to alternative assumptions in key parameters; results were most sensitive to alternative assumptions regarding the mean daily dose of sevelamer, impact of sevelamer on dialysis initiation, cost of dialysis, and health utility estimates. The probabilistic sensitivity analysis showed that sevelamer was cost-effective vs calcium carbonate in 93% of simulations at a willingness-to-pay threshold of £30,000/QALY gained.

Limitations:

While the model simulated a real-world clinical setting, this analysis was subject to limitations common to all decision analytic models, in that it used a mix of data sources and relied on several assumptions. Not all variables that impact real-world outcomes and costs were included in this model.

Conclusions:

Sevelamer is a cost-effective option compared to calcium carbonate for the first-line treatment of hyperphosphatemia in CKD-ND patients in the UK.     

The cost-effectiveness of onabotulinumtoxinA for the prophylaxis of headache in adults with chronic migraine in the UK

Abstract

Background:

Although chronic migraine is associated with substantial disability and costs, few treatments have been shown to be effective. OnabotulinumtoxinA (Botox, Allergan Inc., Irvine, CA) is the first treatment to be licensed in the UK for the prophylaxis of headaches in adults with chronic migraine. This study aims to evaluate the cost-effectiveness of onabotulinumtoxinA in this indication in the UK.

Methods:

A state-transition (Markov) model was developed comparing onabotulinumtoxinA to placebo. Efficacy data and utility values were taken from the pooled Phase III REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical trials program (n?=?1384). Estimates of resource utilisation were taken from the International Burden of Migraine Study (IBMS), and stopping rules were informed by published medical guidelines and clinical data. This study estimated 2-year discounted costs and quality-adjusted life years (QALYs) from the UK National Health Service perspective.

Results:

At 2 years, treatment with onabotulinumtoxinA was associated with an increase in costs of £1367 and an increase in QALYs of 0.1 compared to placebo, resulting in an incremental cost-effectiveness ratio (ICER) of £15,028. Treatment with onabotulinumtoxinA reduced headache days by an estimated 38 days per year at a cost of £18 per headache day avoided. Sensitivity analysis showed that utility values had the greatest influence on model results. The ICER remained cost-effective at a willingness to pay threshold of £20,000–£30,000/QALY in the majority of scenario analyses as well as in probabilistic sensitivity analysis, where onabotulinumtoxinA was cost-effective on 96% of occasions at a threshold of £20,000/QALY and 98% of occasions at £30,000/QALY.

Conclusion:

OnabotulinumtoxinA has been shown to reduce the frequency of headaches in patients with chronic migraine and can be considered a cost-effective use of resources in the UK National Health Service. The uncertainties in the model relate to the extrapolation of clinical data beyond the 56-week trial.