Economic evaluation of linaclotide for the treatment of adult patients with irritable bowel syndrome with constipation in the United States

Abstract

Objectives:

To use techniques of decision-analytic modeling to evaluate the effectiveness and costs of linaclotide vs lubiprostone in the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C).

Methods:

Using model inputs derived from published literature, linaclotide Phase III trial data and a physician survey, a decision-tree model was constructed. Response to therapy was defined as (1) a ≥14-point increase from baseline in IBS-Quality-of-Life (IBS-QoL) questionnaire overall score at week 12 or (2) one of the top two responses (moderately/significantly relieved) on a 7-point IBS symptom relief question in ≥2 of 3 months. Patients who do not respond to therapy are assumed to fail therapy and accrue costs associated with a treatment failure. Model time horizon is aligned with clinical trial duration of 12 weeks. Model outputs include number of responders, quality-adjusted life-years (QALYs), and total costs (including direct and indirect). Both one-way and probabilistic sensitivity analyses were conducted.

Results:

Treatment for IBS-C with linaclotide produced more responders than lubiprostone for both response definitions (19.3% vs 13.0% and 61.8% vs 57.2% for IBS-QoL and symptom relief, respectively), lower per-patient costs ($803 vs $911 and $977 vs $1056), and higher QALYs (0.1921 vs 0.1917 and 0.1909 vs 0.1894) over the 12-week time horizon. Results were similar for most one-way sensitivity analyses. In probabilistic sensitivity analyses, the majority of simulations resulted in linaclotide having higher treatment response rates and lower per-patient costs.

Limitations:

There are no available head-to-head trials that compare linaclotide with lubiprostone; therefore, placebo-adjusted estimates of relative efficacy were derived for model inputs. The time horizon for this model is relatively short, as it was limited to the duration of available clinical trial data.

Conclusions:

Linaclotide was found to be a less costly option vs lubiprostone for the treatment of adult patients with IBS-C.     

A case-control comparison of direct healthcare-provider medical costs of chronic idiopathic constipation and irritable bowel syndrome with constipation in a community-based cohort

Objective: Patients with constipation account for 3.1 million US physician visits a year, but care costs for patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) compared to the general public have received little study. The study aim was to describe healthcare utilization and compare medical costs for patients with IBS-C or CIC vs matched controls from a community-based sample.

Methods: A nested case-control sample (IBS-C and CIC cases) and matched controls (1:2) for each case group were selected from Olmsted County, MN, individuals responding to a community-based survey of gastrointestinal symptoms (2008) who received healthcare from a participating Rochester Epidemiology Project (REP) provider. Using REP healthcare utilization data, unadjusted and adjusted standardized costs were compared for the 2- and 10-year periods prior to the survey for 115 IBS-C patients and 230 controls and 365 CIC patients and 730 controls. Two time periods were chosen as these conditions are episodic, but long-term.

Results: Outpatient costs for IBS-C ($6,800) and CIC ($6,284) patients over a 2-year period prior to the survey were significantly higher than controls ($4,242 and $5,254, respectively) after adjusting for co-morbidities, age, and sex. IBS-C outpatient costs ($25,448) and emergency room costs ($6,892) were significantly higher than controls ($21,024 and $3,962, respectively) for the 10-year period prior. Unadjusted data analyses of cases compared to controls demonstrated significantly higher imaging costs for IBS-C cases and procedure costs for CIC cases over the 10-year period.

Limitations: Data were collected from a random community sample primarily receiving care from a limited number of providers in that area.

Conclusions: Patients with IBS-C and CIC had significantly higher outpatient costs for the 2-year period compared with controls. IBS-C patients also had higher ER costs than the general population.     

The burden of immune thrombocytopenia in adults: Evaluation of the thrombopoietin receptor agonist romiplostim

Abstract

Background:

Immune thrombocytopenia (ITP) is a chronic, immune-mediated disease characterized by a transient or long-lasting decrease in platelet counts. ITP is associated with numerous serious clinical consequences. Discussed here are clinical aspects of ITP, the humanistic and economic burden of ITP, and current treatment options with a focus on romiplostim, a thrombopoietin (TPO) receptor agonist. The aim of this review is to provide decision-makers with the background information necessary to evaluate the value of romiplostim.

Scope:

PubMed was searched for relevant, English-language papers published from January 2006 through November 2011 relating to the epidemiology and treatment options of chronic ITP, and, focusing on the TPO mimetic romiplostim, patient-reported outcomes (PRO) and economic burden. Recent select conference abstracts were also reviewed.

Findings:

The initial clinical management of ITP (e.g., corticosteroids, immunoglobulins) is often associated with adverse events and recommended for short-term use only. Splenectomy, a potentially curative second-line treatment, is associated with increased risks of bleeding and infection, and patients often require additional long-term drug intervention. ITP and its sequelae are associated with a substantial burden on patients’ health-related quality-of-life (HRQoL) and increased medical costs. Use of TPO receptor agonists in ITP patients may represent a more efficient use of healthcare resources than existing therapies.

Conclusion:

While this literature review is not a systematic review, e.g., it considers only approved therapies and published literature written in English, it provides a comprehensive overview of the clinical, humanistic, and economic factors that should be considered in treating ITP, particularly with new agents such as romiplostim. Among the limited number of safe and effective therapies currently available for chronic ITP, highly effective and well-tolerated medications such as romiplostim may reduce the healthcare resource utilization associated with ITP while improving patients’ HRQoL.     

Economic burden of venous thromboembolism: a systematic review

Abstract

Objective:

Deep vein thrombosis and pulmonary embolism – together referred to as venous thromboembolism (VTE) – result in a major burden on healthcare systems. However, to the authors’ knowledge no comprehensive review of the economic burden of VTE has so far been published.

Methods:

A literature search was carried out to identify references published in English since 1997 using Medline, the Cochrane Library and the Health Economic Evaluations Database. The primary outcomes of interest were ‘all-cause’ VTE and VTE after major orthopedic surgery.

Results:

A total of 1,037 full research articles and abstracts were screened for inclusion in the review. Of these, ten cost-of-illness studies were identified that met the inclusion criteria and are included in the current review. The results of large US database analyses vary, indicating costs of the initial VTE of approximately US$3,000–9,500. The total costs related to VTE over 3 months (US$5,000), 6 months (US$10,000) and 1 year (US$33,000) were considerable. Studies conducted in the European Union indicate lower additional inpatient costs after VTE of €1,800 after 3 months and €3,200 after 1 year, which still represent a considerable impact on healthcare systems. Complications after VTE can be very expensive, with estimates of the additional cost of treating the post-thrombotic syndrome ranging from $426 to $11,700 and heparin-induced thrombocytopenia from $3,118 to $41,133. A limitation of studies using older data is that recent changes in the treatment of VTE may affect the generalizability of these findings.

Conclusions:

Complications associated with VTE are frequent and costly. In particular, the cost of complications resulting from prophylaxis and treatment of VTE, such as post-thrombotic syndrome and heparin-induced thrombocytopenia, had a considerable economic impact.     

Economic and quality of life burden of anemia on patients with CKD on dialysis: a systematic review

Abstract

Aims: The overall cost and health-related quality of life (HRQoL) associated with current treatments for chronic kidney disease (CKD)-related anemia are not well characterized. A systematic literature review (SLR) was conducted on the costs and HRQoL associated with current treatments for CKD-related anemia among dialysis-dependent (DD) patients.

Materials and methods: The authors searched the Cochrane Library, MEDLINE, EMBASE, NHS EED, and NHS HTA for English-language publications. Original studies published between January 1, 2000 and March 17, 2017 meeting the following criteria were included: adult population; study focus was CKD-related anemia; included results on patients receiving iron supplementation, red blood cell transfusion, or erythropoiesis stimulating agents (ESAs); reported results on HRQoL and/or costs. Studies which included patients with DD-CKD, did not directly compare different treatments, and had designs relevant to the objective were retained. HRQoL and cost outcomes, including healthcare resource utilization (HRU), were extracted and summarized in a narrative synthesis.

Results: A total of 1,625 publications were retrieved, 15 of which met all inclusion criteria. All identified studies included ESAs as a treatment of interest. Two randomized controlled trials reported that ESA treatment improves HRQoL relative to placebo. Across eight studies comparing HRQoL of patients achieving high vs low hemoglobin (Hb) targets, aiming for higher Hb targets with ESAs generally led to modest HRQoL improvements. Two studies reported that ESA-treated patients had lower costs and HRU compared to untreated patients. One study found that aiming for higher vs lower Hb targets led to reduced HRU, while two other reported that this led to a reduction in cost-effectiveness.

Limitations: Heterogeneity of study designs and outcomes; a meta-analysis could not be performed.

Conclusions: ESA-treated patients undergoing dialysis incurred lower costs, lower HRU, and had better HRQoL relative to ESA-untreated patients. However, treatment to higher Hb targets led to modest HRQoL improvements compared to lower Hb targets.     

Comprehensive assessment of patients with irritable bowel syndrome with constipation and chronic idiopathic constipation using deterministically linked administrative claims and patient-reported data: the Chronic Constipation and IBS-C Treatment and Outcomes Real-World Research Platform (CONTOR)

Abstract

Aims

To characterize a US population of patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) using CONTOR, a real-world longitudinal research platform that deterministically linked administrative claims data with patient-reported outcomes data among patients with these conditions.     

Economic burden of healthcare-associated infection in US acute care hospitals: societal perspective

Abstract

Background:

Assessing the costs of healthcare-associated infection (HAI) is challenging. Methodological issues abound. Previous estimates have been derived in diverse ways from varied perspectives in different settings with dissimilar data. Results can be confusing. Full societal costs, which are more inclusive than commonly reported direct hospital costs, have never been fully measured or reported.

Objective:

To update, combine, and expand previous cost estimates to determine the annual societal burden of illness (direct medical, non-medical, and indirect costs) arising from HAIs in US acute-care hospitals.

Methods:

The research approach encompassed literature and internet searches; reference identification, selection, and review; then data abstraction, compilation, and analyses to estimate full societal costs. Previously published systemic reviews, surveillance reports, and individual clinical studies, along with newly computed component costs, all contributed to final estimates.

Results:

HAIs in US acute-care hospitals lead to direct and indirect costs totaling $96–$147 billion annually. These results are subject to the same limitations as previous studies from which contributing data were derived.

Conclusion:

The enormous clinical and economic burden of infection places HAIs high on the list of devastating and costly illnesses, such as cancer, heart attack, stroke, and diabetes, thereby mandating further research and greater efforts to contain a pressing healthcare problem.     

Humanistic and economic impacts of hepatitis C infection in the United States

Abstract

Objective:

Prior research examining the effect of hepatitis C virus (HCV) on health-related quality of life (HRQoL) and healthcare costs is flawed because non-patient controls were not adequately comparable to HCV patients. The current study uses a propensity score matching methodology to address the following research question: is the presence of diagnosed hepatitis C (HCV) associated with poorer health-related quality of life (HRQoL) and greater healthcare resource use?

Methods:

Using data from the 2009 US National Health and Wellness Survey, patients who reported a HCV diagnosis (n?=?695) were compared to propensity-matched controls (n?=?695) on measures of HRQoL and healthcare resource use. All analyses applied sampling weights to project to the US population.

Results:

HCV patients reported significantly lower levels of HRQoL relative to the matched-control group, including the physical component score (39.6 vs. 42.7, p?<?0.0001) and health utilities (0.63 vs. 0.66, p?<?0.0001). The number of emergency room visits (0.59 vs. 0.44, p?<?0.05) and physician visits (7.7 vs. 5.9, p?<?0.05) in the past 6 months were significantly higher for the HCV group relative to matched controls.

Conclusion:

The results of this study suggest that HCV represents a substantial burden on patients by having a significant and clinically-relevant impact on key dimensions of HRQoL as well as on utilization of healthcare resources, the latter of which would result in increased direct medical costs.

Limitations:

Due to limitations of the internet survey approach (e.g., inability to confirm HCV diagnosis), future research is needed to confirm these findings.     

The societal impact of pain in the European Union: health-related quality of life and healthcare resource utilization

Abstract

Objectives:

This paper reports on the results of a series of quantitative assessments of the association of severe and frequent pain with health-related quality of life and healthcare resource utilization in five European countries.

Methods:

The analysis contrasts the contribution of the increasing severity and frequency of pain reported against respondents reporting no pain in the previous month. The data are taken from the 2008 National Health and Wellness Survey. Single-equation generalized linear regression models are used to evaluate the association of pain with the physical and mental component scores of the SF-12 questionnaire as well as health utilities generated from the SF-6D. In addition, the role of pain is assessed in its association with healthcare provider visits, emergency room visits and hospitalizations.

Results:

The results indicate that the experience of pain, notably severe and frequent pain, is substantial and is significantly associated with the SF-12 physical component scores, health utilities and all aspects of healthcare resource utilization, which far outweighs the role of demographic and socioeconomic variables, health risk factors (in particular body mass index) and the presence of comorbidities. In the case of severe daily pain, the marginal contribution of the SF-12 physical component score is a deficit of ?17.86 compared to those reporting no pain (population average score 46.49), while persons who are morbidly obese report a deficit of only ?6.63 compared to those who are normal weight. The corresponding association with health utilities is equally dramatic with a severe daily pain deficit of ?0.19 compared to those reporting no pain (average population utility 0.71).

Conclusions:

For the five largest EU countries, the societal burden of pain is considerable. The experience of pain far outweighs the contribution of more traditional explanations of HRQoL deficits as well as being the primary factor associated with increased provider visits, emergency room visits and hospitalizations.     

Cost effectiveness of teriparatide and PTH(1-84) in the treatment of postmenopausal osteoporosis

Abstract

Objectives:

The purpose was to assess the cost effectiveness from a societal perspective of the recombinant human parathyroid hormones: PTH(1-34) (teriparatide) and PTH(1-84) for patients with osteoporosis with similar characteristics to patients treated in normal clinical practice in Sweden.

Methods:

A Markov model of osteoporosis in postmenopausal women was developed using 6-month cycles and a lifetime horizon. The model was populated with patients similar to the Swedish cohort of the European Forsteo Observational Study (postmenopausal women; mean age: 70 years, total hip T-score: ?2.7 and 3.3 previous fractures). The cost effectiveness of both teriparatide and PTH(1-84) was estimated compared to no treatment and each other. Relative effectiveness assumptions were based on efficacy estimates from two phase III clinical trials.

Results:

The cost per QALY gained of teriparatide vs. no treatment was estimated at €43,473 and PTH(1-84) was estimated at €104,396. Teriparatide was indicated to be less costly and associated with more life-years and QALYs than PTH(1-84). When assuming no treatment effect on hip fractures the cost per QALY gained was €88,379. In the sensitivity analysis the cost effectiveness did not alter substantially with changes in the majority of the model parameters except for the residual effect of the treatment after stopping therapy.

Conclusions:

Based on the efficacy estimates from pivotal clinical trials and characteristics of patients treated in clinical practice in Sweden, teriparatide seems to be a more cost-effective option than PTH(1-84) when compared to no treatment. The relative efficacy between the two PTH compounds was based on an indirect comparison from two separate clinical trials which has to be considered when interpreting the results.     

Flexible insulin dosing improves health-related quality-of-life (HRQoL): a time trade-off survey

Abstract

Purpose:

People with insulin-treated diabetes often face strict regimens with inflexible dose timing, frequent injections, and frequent self-measured blood glucose (SMBG) testing. The objective of this study was to estimate the health-related quality-of-life (HRQoL) impact of these aspects using time trade-off (TTO) methods.

Methods:

HRQoL was examined via a TTO survey in the UK, Canada, and Sweden with separate analyses of 2465 respondents from the general population, 274 people with type 1 diabetes, and 417 people with type 2 diabetes. Respondents evaluated health states with diabetes, SMBG testing, and basal injections that were once-daily time flexible, once-daily at a fixed time, and twice-daily at a fixed time in a basal or basal–bolus regimen.

Results:

Time-flexible basal injections were associated with 0.016 and 0.013 higher utility vs a fixed time of injection for basal-only and basal–bolus regimens, respectively, as evaluated by the general population. The diabetes respondents confirmed the basal-only results with 0.015 higher utility, but the difference in utility was non-significant for basal–bolus. Once-daily injections had higher utility compared with twice-daily injections for basal (0.039 and 0.042) and basal–bolus (0.022 and 0.021) regimens, as evaluated by the general population and people with diabetes, respectively. Increased frequency of SMBG negatively affected health utility.

Limitations:

This study has the limitation that it measures hypothetical health states rather than the HRQoL of people with these health states; furthermore, it could be suggested that the web-based nature of this survey is biased towards literate respondents with internet access and IT competence.

Conclusions:

Flexible dosing and fewer injections have a positive HRQoL impact, which potentially may enhance therapy adherence and could contribute to improved long-term outcomes. The impact of flexibility is greater in people treated with basal-only insulin regimens, and diminishes if bolus injections are part of the treatment regimen.     

Converting EORTC QLQ-C30 scores to utility scores in the brigatinib ALTA study

Abstract

Aims: Health utilities summarize a patient’s overall health status. This study estimated utilities based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30), a widely used measure of health-related quality-of-life (HRQoL) in oncology, using published mapping algorithms.

Materials and methods: Data were from the Anaplastic Lymphoma Kinase (ALK) in Lung Cancer Trial of brigatinib (ALTA; NCT02094573), an open-label, international, phase 2 study. ALTA evaluated the efficacy and safety of two randomized dosing regimens of brigatinib in patients with locally advanced or metastatic ALK?+?non-small cell lung cancer (NSCLC) that had progressed on prior therapy with crizotinib. QLQ-C30 scores were mapped to European Quality-of-Life-5 Dimensions (EQ-5D) utility scores using two published algorithms (Khan et al. for EQ-5D-5L; Longworth et al. for EQ-5D-3L). The impact of brigatinib treatment on health utilities over time was assessed.

Results: The analysis included 208 subjects. Mean baseline utility scores for both algorithms ranged between 0.60???0.71 and increased to 0.78 by cycle 5. Utility improvements were sustained during most of the treatment, before disease progression. Minor variations were observed between utility scores; Khan et al. estimates were approximately 0.01 or 0.02 points lower than Longworth et al. estimates.

Limitations: Algorithms considered were limited to those available in the published literature at the time of the study. This utility analysis was exploratory, and the ALTA trial did not include an internal control group (i.e. standard of care) and was not powered to detect differences in QoL/utility outcomes between treatment arms.

Conclusions: Converting QLQ-C30 scores into utilities in trials using established mapping algorithms can improve evaluation of medicines from the patient perspective. Both algorithms suggested that brigatinib improved health utility in crizotinib-refractory ALK?+?NSCLC patients, and improvements were maintained during most of the treatment.

Clinicaltrials.gov identifier: NCT02094573     

Elicitation of health state utilities associated with differing durations of morning stiffness in rheumatoid arthritis

Abstract

Objective:

Specific symptoms of rheumatoid arthritis (RA), including joint stiffness and functional disability, are most severe in the morning. ‘Morning stiffness’ has a negative impact on health-related quality-of-life (HRQoL); however, how HRQoL is correlated to morning stiffness duration is unknown. The objective of this study was to obtain population-based utility values associated with different durations of morning stiffness in RA.

Design and methods:

The time-trade-off (TTO) approach was used to elicit utility values for four different health states (HS), which differed in morning stiffness duration. One hundred and nine members of the UK general public rated each HS in individual face-to-face interviews with trained investigators. TTO scores were converted into utility values. Visual Analog Scale (VAS) scores were obtained to validate TTO scores.

Results:

On a scale of 0 (death) to 1 (full health), a mean utility value of 0.45?±?0.29 was elicited for ～3?h of morning stiffness (anchor HS), 0.50?±?0.28 for 2–3?h of morning stiffness (HS1), 0.61?±?0.25 for 1–2?h of morning stiffness (HS2) and 0.78?±?0.20 for <1?h of morning stiffness (HS3). The difference between each HS was statistically significant (p?<?0.01). Mean VAS utility scores followed the same trend. Utility incrementally increased with each HS associated with a shorter duration of morning stiffness. Limitations of this research include potential bias from the TTO method due to the discounting effect of time, scale compatibility, and loss aversion.

Conclusions:

The UK population-based utility values show a reduction in morning stiffness duration in RA is associated with improved HRQoL. Despite the impact of morning stiffness on HRQoL, it is rarely evaluated and little is known as to how it is affected by current treatments. The results of this study can be applied in future cost-utility analyses of healthcare interventions which target an improvement in morning stiffness duration for RA patients.     

Cost-effectiveness of add-on treatments to metformin in a Swedish setting: liraglutide vs sulphonylurea or sitagplitin

Objective:

To evaluate long-run cost-effectiveness in a Swedish setting for liraglutide compared with sulphonylureas (glimepiride) or sitagliptin, all as add-on to metformin for patients with type 2 diabetes insufficiently controlled with metformin in monotherapy.

Methods:

The IHE Cohort Model of Type 2 Diabetes was used to evaluate clinical and economic outcomes from a societal perspective. Model input data were obtained from two clinical trials, the Swedish National Diabetes Register and the literature. Cost data reflected year 2013 price level. The robustness of results was checked with one-way-sensitivity analysis and probability sensitivity analysis.

Results:

The cost per QALY gained for liraglutide (1.2?mg) compared to SU (glimepiride 4?mg), both as add-on to metformin, ranged from SEK 226,000 to SEK 255,000 in analyzed patient cohorts. The cost per QALY for liraglutide (1.2?mg) vs sitagliptin (100?mg) as second-line treatment was lower, ranging from SEK 149,000 to SEK 161,000. Costs of preventive treatment were driving costs, but there was also a cost offset from reduced costs of complications of ～20%. Notable cost differences were found for nephropathy, stroke, and heart failure. The predicted life expectancy with liraglutide increased the cost of net consumption for liraglutide.

Limitations:

The analysis was an ex-ante analysis using model input data from clinical trials which may not reflect effectiveness in real-world clinical practice in broader patient populations. This limitation was explored in the sensitivity analysis. The lack of specific data on loss of production due to diabetes complications implied that these costs may be under-estimated.

Conclusions:

Treatment strategies with liraglutide 1.2?mg improved the expected quality-of-life and increased costs when compared to SU and to sitagliptin for second-line add-on treatments. The cost per QALY for liraglutide was in the range considered medium by Swedish authorities.     

The societal burden of pain in Germany: Health-related quality-of-life,health status and direct medical costs

Abstract

Objectives:

The purpose of this paper is to estimate the impact of the severity and frequency of pain on health-related quality-of-life (HRQoL), self-reported health status, and direct medical costs in Germany.

Methods:

Data are from the internet-based 2010 National Health and Wellness Survey (NHWS). Estimates of the impact of pain experience are generated by a series of regression models. In the case of HRQoL the physical and mental summary scores from the SF-12, together with SF-6D utilities, are evaluated within an ordinary least squares framework. Health status is assessed through an ordered logit model. Direct medical costs are estimated through a semi-logarithmic healthcare cost function. Socioeconomic characteristics, health risk behaviors, and the Charlson Comorbidity Index (CCI) are introduced as control variables in all regressions.

Results:

An estimated 23.96% of the adult German population (16.39 million) reported experiencing pain in the last 30 days. Of these 13.16% reported severe pain. The experience of frequent severe and moderate pain has a significant deficit impact on HRQoL. For those experiencing severe daily pain, the deficit in the SF-12 physical component score (PCS) is ?17.930 (95% CI: ?18.720 to ?17.140), the SF-12 mental component score (MCS) is ?8.787 (05% CI: ?9.857 to ?7.716), and SF-6D absolute utilities ?0.201 (95% CI: ?0.214 to ?0.188); with self-reported health status the deficit impact of severe daily pain is also substantial (OR?=?29.000; 95% CI: 23.000–36.580). In the case of direct medical costs severe daily pain increases healthcare provider costs by 101.6% and total direct costs by 123.9%.

Limitations:

The NHWS is an internet survey. The principal limitation is that as a self-report there is no separate validation of pain severity or chronicity.

Conclusions:

The experience of pain has a substantial negative impact on HRQoL, health status, and resource utilization in Germany. If pain is considered as a disease in its own right, the experience of chronic pain presents policy-makers with a major challenge.     

Prevalence and impact of constipation and bowel dysfunction induced by strong opioids: a cross-sectional survey of 520 patients with cancer pain: DYONISOS study

Abstract

Objective:

To describe the prevalence of opioid-induced constipation (OIC) in patients with cancer pain according to the Knowles-Eccersley-Scott symptom score (KESS), the different symptoms of opioid-induced bowel dysfunction (OIBD), and to assess the impact of OIBD on patient’s quality-of-life.

Methods:

A cross-sectional observational study, using the KESS questionnaire and the physician’s subjective assessment of constipation, and other questionnaires and questions on constipation, OIBD, and quality-of-life, carried out on 1 day at oncology day centres and hospitals.

Results:

Five hundred and twenty patients were enrolled at 77 centres in France; 61.7% of patients (n?=?321) showed a degree of constipation that is problematic for the patient according to KESS (between 9–39). Even more patients, 85.7% (n?=?438), were considered constipated according to the physician’s subjective assessment—despite laxative use (84.7% of patients). Quality-of-life was significantly reduced in constipated vs non-constipated patients for both PAC-QoL (p?<?0.0001 for total score and each dimension) and the SF-12 questionnaires (statistically significant for all dimensions except physical state and role physical). OIC and OIBD led to hospitalization (16% of patients), pain (75% of patients), and frequent changes in opioid and laxative treatment.

Key limitations:

This cross-sectional study, in a selected population of cancer patients, has measured prevalence and impact of OIBD. Further confirmation could be sought through the use of longitudinal studies, and larger populations, such as non-cancer pain patients treated with opioids

Conclusions:

Cancer patients taking opioids for pain are very frequently constipated, even if they are prescribed laxatives. This leads to relevant impairments of quality-of-life.     

Pain,health related quality of life and healthcare resource utilization in Spain

Objectives:

The aim of this paper is to consider the relationship between the experience of pain, health related quality of life (HRQoL) and healthcare resource utilization in Spain.

Methods:

The analysis contrasts the contribution of pain severity and frequency of pain reported against respondents reporting no pain in the previous month. Data are from the 2010 National Health and Wellness Survey (NHWS) for Spain. Single equation generalized linear regression models are used to evaluate the association of pain with the physical and mental component scores of the SF-12 questionnaire as well as health utilities generated from the SF-6D. In addition, the role of pain is assessed in its association with self-reported healthcare provider visits, emergency room visits and hospitalizations in the previous 6 months.

Results:

The results indicate that the experience of pain, notably severe and frequent pain, is substantial and is significantly associated with the SF-12 physical component scores, health utilities and all aspects of healthcare resource utilization, which far outweighs the role of demographic and socioeconomic variables, health risk factors (in particular body mass index) and the presence of comorbidities. In the case of severe daily pain, the marginal contribution of the SF-12 physical component score is a deficit of ?17.86 compared to those reporting no pain (population average score 46.49), while persons who are morbidly obese report a deficit of only ?6.63 compared to those who are normal weight. The corresponding association with health utilities is equally dramatic with a severe daily pain deficit of ?0.186 compared to those reporting no pain (average population utility 0.71). The impact of pain on healthcare resource utilization is marked. Severe daily pain increases traditional provider visits by 208.8%, emergency room visits by 373.0% and hospitalizations by 348.5%.

Limitations:

As an internet-based survey there is the possibility of bias towards those with internet access, although telephone sampling is used to supplement responses. Respondents are asked to describe their experience of pain; there is no independent check on the accuracy of responses. Finally, while certain acute pain categories are omitted, the study focuses on pain in the last month and not on pain chronicity.

Conclusions:

The societal burden of severe and frequent pain in Spain is substantial. Although not reported on before, at a national level, the deficit impact of the experience of pain far outweighs the contribution of more traditional explanations of HRQoL deficits as well as being the primary factor associated with increased provider visits, emergency room visits and hospitalizations.     

Health economic evaluation of a vaccine for the prevention of herpes zoster (shingles) and post-herpetic neuralgia in adults in Belgium

Abstract

Objective:

To determine the cost-effectiveness of vaccination against herpes zoster (HZ) and post-herpetic neuralgia (PHN) in individuals aged 60 years and older in Belgium.

Methods:

A Markov model was developed to compare the cost-effectiveness of vaccination with that of a policy of no vaccination. The model estimated the lifetime incidence and consequences of HZ and PHN using inputs derived from Belgian data, literature sources, and expert opinion. Cost-effectiveness was measured by the incremental cost-effectiveness ratio (ICER), expressed as cost per quality-adjusted life-year (QALY) gained.

Results:

Vaccination in individuals aged 60 years and older resulted in ICERs of €6,799 (third party payer perspective), €7,168 (healthcare perspective), and €7,137 (societal perspective). The number needed to vaccinate to prevent one case was 12 for HZ, and 35 or 36 for PHN depending on the definition used. Univariate sensitivity analyses produced ICERs of €4,959–19,052/QALY; duration of vaccine efficacy had the greatest impact on cost-effectiveness. Probabilistic sensitivity analysis showed at least a 94% probability of ICERs remaining below the unofficial €30,000 threshold.

Discussion:

Key strengths of the model are the combination of efficacy data from a pivotal clinical trial with country-specific epidemiological data and complete sensitivity analysis performed. Main limitations are the use of non country-specific PHN proportion and non Belgian disease-specific utilities. Results are comparable with those recently published.

Conclusions:

HZ vaccination in individuals aged 60 years and older would represent a cost-effective strategy in Belgium.