Postherpetic Neuralgia: Current Evidence on the Topical Film-Forming Spray with Bupivacaine Hydrochloride and a Review of Available Treatment Strategies.

PURPOSE OF REVIEW: This is a comprehensive review of the literature about the use of bupivacaine hydrochloride for the treatment of post-herpetic neuralgia (PHN). It briefly reviews the background, biology, diagnosis and conventional treatment for PHN, and then introduces and compares the recent evidence for the use of topical bupivacaine. RECENT FINDINGS: PHN is defined by pain lasting 90 days or more after the initial presentation of herpes zoster ("Shingles", HZ) rash and is the most common complication of this disease. A product of re-activation of the Varicella-Zoster virus (VZV), HZ is diagnosed more than 1 million times annually in the United States. Approximately 20% of patients with HZ will experience PHN and will continue to suffer intermittent neuropathic symptoms, including itching and pain, that is sharp, stabbing, throbbing or burning, with the pain localized to the site of their original rash. This long-lasting pain compares with the severity of long-standing rheumatics and osteo-arthritis and is accompanied by severe allodynia causing significant suffering, and a financial burden that is manifested in both healthcare costs and loss of quality-adjusted life years. Prevention of PHN may be achieved with the Zoster vaccine, although there is still a large segment of unvaccinated population. Moreover, the Zoster vaccine is not always effective for prevention. Current treatment includes medical (systemic tricyclic antidepressants, anticonvulsants and opioids, topical lidocaine and capsaicin) and interventional (subcutaneous Botox injections, nerve blocks and nerve stimulation) therapies. These therapies are not always effective, and each carries their own profile of side effects and risks. Moreover, up to 50% of patients with PHN are refractory to management. Recent evidence is emerging to support the use of topical local anesthetics for the treatment of PHN. Two small studies recently found topical lidocaine spray to be effective in treating paroxysmal pain attacks associated with PHN. Bupivacaine is a longer-lasting local anesthetic, and a film-forming formulation allows easy and durable application to the affected skin. Recent studies show that topical film-forming bupivacaine is safe and as effective as lidocaine for the treatment of PHN. PHN is an important though common complication of HZ and can cause long-lasting pain and disability. Current treatment for PNH is limited by efficacy and safety profiles of individual therapies. Recent evidence points to topical local anesthetics as an effective and safe alternative to conventional therapy. Film-forming bupivacaine may offer a durable and safe option for this otherwise difficult to treat syndrome.

Burden of disease from shingles and post-herpetic neuralgia in the over 80 year olds in the UK.

BACKGROUND: The current UK vaccination programme for herpes zoster (HZ) excludes people aged ≥80 years. This study aimed to quantify the number of individuals ≥80 years who missed HZ vaccination and the consequent epidemiological and economic burden of HZ and post-herpetic neuralgia (PHN). METHODS: Immunocompetent individuals aged ≥80 years between 1st September 2013 and 31st December 2017 in the Clinical Practice Research Datalink were selected and linked to Hospital Episodes Statistics, where available. Rates of HZ and PHN and healthcare resource utilisation were investigated for the overall study population and by age group (80-84, 85-89, ≥90 years old) and the burden of HZ and PHN was projected to the UK population. RESULTS: 4,858 HZ episodes and 464 PHN cases were identified in 255,165 individuals over 576,421 person-years (PY). Rates of HZ and PHN were 8.43 (95% confidence interval [CI] 8.19-8.66) and 0.80 (0.73-0.87) per 1,000 PY respectively and lowest in those aged ≥90 (HZ rate 7.37/1,000 PY; PHN rate 0.56/1,000 PY). Within HZ episodes, 10.27% of GP visits, 5.82% of prescribed medications and 21.65% of hospitalisations were related to HZ/PHN. Median length of hospitalisation increased from 7.0 days for all-cause to 10.5 days for HZ/PHN related hospitalisations. Individuals ≥90 stayed in hospital a median of 3-4 days longer than younger groups. Approximately 2.23 million individuals in the UK missed HZ vaccination since 2013 (1.86 million had never been eligible and 365,000 lost eligibility for HZ vaccination), resulting in an estimated 43,149 HZ episodes. CONCLUSION: This study highlights the impact of the 80-year upper age limit policy on the health system. Our study estimates that 2.23 million individuals in the UK may have lost the opportunity to be vaccinated and that their burden of HZ and PHN remains high, especially among the very elderly.

Cost and utility in immunocompromised subjects who developed herpes zoster during the randomized V212 inactivated varicella-zoster vaccine (ZVIN) trial.

Objectives: Immunocompromised subjects are at increased risk for herpes zoster (HZ) and HZ-related complications, such as post-herpetic neuralgia (PHN). We describe health utilities, health care resource utilization (HCRU), productivity loss and health care costs in recipients of autologous hematopoietic stem-cell transplantation (Auto-HSCT) who developed confirmed HZ in the phase 3 clinical trial. Methods: HCRU, costs, and EQ-5D-3L utility were assessed for 155 confirmed HZ cases observed after receiving inactivated varicella-zoster virus (VZV) vaccine (ZVIN) or placebo. In a prospective, longitudinal 6-month follow up, costs and utilities were analyzed for two health states, HZ without PHN and HZ with PHN. Results: There was a clinically relevant difference in utility between HZ without PHN (mean 0.814) and HZ with PHN (0.729). The disutility for HZ without PHN was estimated to -0.117 and to -0.186 for HZ with PHN. Direct costs (2017 USD) associated with a HZ without PHN episode and HZ with PHN episode was estimated at $3,412 and $3,711, respectively, of which hospitalizations accounted for 90% of the costs. Expert opinion: Both HZ and PHN are associated with considerable disutility in recipients of Auto-HSCT. Costs were comparable to published estimates in other immunocompromised subjects. The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT01229267).

Aggregate health and economic burden of herpes zoster in the United States: illustrative example of a pain condition.

Our objective was to develop comprehensive national estimates of the total burden of herpes zoster (HZ) among U.S. adults, including direct (ie, medical costs) and indirect (ie, productivity losses) costs, as well as its psychosocial impact (ie, quality of life losses). Using a patient-level microsimulation model, we projected health and economic outcomes among U.S. adults aged 18 years and older using a 10-year time horizon. We conducted a comprehensive systematic literature review to generate parameter values and conducted simulation modeling to generate our outcomes, including numbers of cases of uncomplicated HZ, postherpetic neuralgia (PHN), and ocular complications, productivity losses, and losses in quality-adjusted life years (QALYs). We used a societal perspective for outcomes; the costing year was 2015. Projected outcomes for an unvaccinated population included 1.1 million HZ cases, 114,000 PHN cases, and 43,000 ocular complications annually, resulting in approximately 67,000 QALYs lost. HZ and its complications would incur costs of $2.4 billion in direct medical costs and productivity losses annually. Projected QALY losses were most sensitive to HZ and PHN health utility values in the model. Cost estimates were most sensitive to the probability of HZ and to the costs per episode of PHN. The national burden of direct, indirect, and psychosocial HZ costs is substantial. Our results can inform economic analyses for HZ vaccines. Comprehensive, national assessments of the total burden of other painful conditions would be very informative.

Herpes zoster related healthcare burden and costs in immunocompromised (IC) and IC-free populations in England: an observational retrospective database analysis.

OBJECTIVE: Individuals with immunocompromised (IC) conditions are at a higher risk of developing herpes zoster (HZ) than IC-free individuals. This study assessed the healthcare resource utilisation (HCRU) burden and costs, of HZ in IC and IC-free individuals ≥18 years of age (YOA). METHODS: We conducted an observational retrospective study in a cohort of IC (n=621 588) and IC-free (n=621 588) individuals, matched by age, gender and General Practitioner practice region, contributing to the Clinical Practice Research Datalink database from 2000 to 2012 and linked to the Hospital Episode Statistics inpatient data. HCRU (ie, primary and secondary care consultations, hospital inpatient stays and treatment prescriptions) was analysed from 7 days before to: (1) 30, (2) 365 days after the HZ diagnosis date for individuals with (1) HZ only (no postherpetic neuralgia (PHN)) and (2) individuals with HZ and PHN only. Healthcare costs were computed by multiplying the number of units of resources used by the unit costs, summed across all HCRU categories to obtain a total cost per subject. Values were expressed in 2014 UK pound sterling (£) and presented for HZ cases overall, stratified by age (ie, 18-49, 50-59, 60-69, 70-79 and ≥80 YOA) and IC status. RESULTS: The percentage of HZ cases requiring hospitalisation was higher in IC individuals (2.7% vs 0.4% in IC and IC-free individuals aged 18-49 YOA, respectively and 9.5% vs 7.5% in IC and IC-free individuals aged ≥80 YOA, respectively). Similarly, HZ-related mean treatment costs per subject were higher in IC individuals (£189 vs £104 in IC and IC-free individuals aged 18-49 YOA, respectively and £557 vs £401 in IC and IC-free individuals aged ≥80 YOA, respectively). Costs varied considerably by IC condition. CONCLUSIONS: Individuals with IC conditions, have a high burden of HZ, associated with an increased risk of HZ and high HZ-related healthcare costs.

Cost-effectiveness of Recombinant Zoster Vaccine (RZV) and Varicella Vaccine Live (VVL) against herpes zoster and post-herpetic neuralgia among adults aged 65 and over in Japan.

BACKGROUND: The approval of the extended use of 1-dose varicella vaccine (VVL) in adults aged 50 and older against herpes zoster (HZ) in 2016 and the 2-dose recombinant zoster vaccine (RZV) in 2018 raised the need to evaluate the value for money between these two vaccines. METHODS: We conducted a cost-effectiveness analysis with Markov modelling to evaluate the efficiency of the immunisation programmes from payer's perspective. Eight strategies with different ages to receive VVL or RZV were set, namely: 65-84 year old (y.o.), 70-84 y.o., 75-84 y.o., and 80-84 y.o. VVL- or RZV-strategy. Incremental cost-effectiveness ratios (ICERs) compared with curative care scenario were calculated. The health statuses following the target cohort were as follows: acute HZ followed by recovery, post-herpetic neuralgia followed by recovery, post HZ/PHN, recurrence of HZ, and general death. RESULTS: At the vaccination cost ¥8000 (US$73) for 1-dose ZVL and ¥30,000 (US$273) for 2-dose RZV, ICERs ranged from ¥2,633,587/US$23,942 (age 80-84 y.o.) to ¥3,434,267 or US$31,221 (age 65-84 y.o.)/QALY gained for VVL-strategies; from ¥5,262,227 or US$47,838 (age 80-84 y.o.) to ¥6,278,557 or US$57,078/QALY gained (age 65-84 y.o.) for RZV-strategies. Cost-effectiveness acceptability curves derived from probabilistic sensitivity analyses showed that if the cost-effective threshold was at ¥3,000,000 or US$27,273/QALY, the acceptability was 90.7% and 8.8% for 65-84 VVL-strategy and 65-84 RZV-strategy, respectively; if at ¥5,000,000 or US$45,455/QALY, 56.2% and 43.8%, and if at ¥10,000,000 or US$90,909/QALY 11.9% and 88.1%, respectively. CONCLUSION: Vaccinating individuals aged 65-84 y.o., 70-84 y.o., 75-84 y.o., 80-84 y.o. with VVL or RZV to prevent HZ-associated disease in Japan can be cost-effective from payer's perspective, with vaccination costs at ¥8,000 per shot for VVL, ¥30,000 for 2-dose RZV. While the results suggesting that only 65-84 VVL-strategy and 65-84 RZV strategy should be considered when introducing HZ immunisation programme. The optimal strategy varies depending on the willingness-to-pay threshold.

Cross-sectional study on hospitalizations related to herpes zoster in an Italian region, 2008-2016.

INTRODUCTION: To assess the burden of herpes zoster (HZ) by analyzing HZ-related hospital admissions. METHODS: We conducted a population-based descriptive cross-sectional study on all hospitalizations for HZ among the resident population admitted to all public and accredited private hospitals in the Veneto Region (north-east Italy) during the years 2008-2016. HZ hospitalizations were identified from the International Classification of Diseases codes in the hospital discharge records. RESULTS: During the period considered, we identified 3566 HZ-associated admissions, 194 (5.4%) of which were readmissions within 30 days. A complicated HZ diagnosis was mentioned for 44.4% of the patients admitted once and for 65.9% of those admitted twice. In the sample as a whole, 27.0% of patients had at least one comorbidity. Overall, our analysis revealed a gradual increase in hospitalizations with age for both genders, reaching a hospitalization rate for the population over 80 years old of 51.2 × 100,000 for males and 52.8 × 100,000 for females. The average hospitalization rate for HZ-related conditions during the years 2008-2016 was 7.7 per 100,000 population. Postherpetic neuralgia was diagnosed in 8.2% of hospitalizations, with no difference between the genders. The estimated overall cost of HZ-related conditions was approximately €2.7 million a year. CONCLUSIONS: This study suggests that the burden of HZ and its impact on quality of life are of critical relevance to public health decision-making.

Sponsorship Bias in Base-Case Values and Uncertainty Bounds of Health Economic Evaluations? A Systematic Review of Herpes Zoster Vaccination.

BACKGROUND: New health technologies are more likely adopted when they have lower incremental cost-effectiveness ratios (ICERs) and/or when their ICER is presented with more certainty. Industry-funded (IF) health economic evaluations use often more favorable base-case values, leading to more favorable conclusions. PURPOSE: To study whether IF health economic evaluations of varicella-zoster virus vaccination in the elderly use more favorable base-case values and account for less uncertainty than non-industry-funded (NIF) evaluations. DATA SOURCE: PubMed. Data extracted: funding source; incremental cost per quality-adjusted life year (QALY) gained; vaccine price; study quality score; base-case values, uncertainty ranges, and data sources for influential parameters: duration of vaccine protection, utility loss due to herpes zoster (HZ) disease, percentage of HZ patients developing postherpetic neuralgia (PHN), and duration of PHN. DATA SYNTHESIS: qualitative comparisons; Fisher exact test for differences in study quality score and 1-sided Mann-Whitney U tests for differences in base-case values and uncertainty ranges. RESULTS: Despite using the same data sources, IF studies ( n = 10) assume a longer duration of vaccine protection ( U = 56, P = 0.03), have a higher percentage of HZ patients developing PHN ( U = 22/33, P = 0.02/0.03 for ages 60-64/65-69), and tend to use higher HZ utility loss than NIF studies ( n = 11) for their baseline. IF studies show lower ICERs given similar or even higher vaccine prices than NIF studies, consider less uncertainty around the duration of vaccine protection ( U = 8, P < 0.001), and tend to use less uncertainty around the duration of PHN. Yet their quality has been rated equally well, using current standard quality rating tools. CONCLUSION: Researchers and decision makers should be aware of potential sponsorship bias in health economic evaluations, especially in the way source data are used to specify base-case values and uncertainty ranges.

Incidence and costs of herpes zoster and postherpetic neuralgia in German adults aged ≥50 years: A prospective study.

OBJECTIVES: Herpes zoster (HZ) mainly affects elderly people and immunocompromised individuals. HZ is usually characterized by a unilateral painful skin rash. Its most common complication, postherpetic neuralgia (PHN), may cause chronic debilitating pain. This study aimed to estimate the HZ incidence in individuals aged ≥50 years in Germany, the proportion of PHN and the economic burden. METHODS: From 2010 to 2014, HZ patients were recruited when consulting physicians in physician networks covering about 157,000 persons aged ≥50 years. PHN was defined as "worst pain" rated ≥3 on the zoster brief pain inventory persisting or appearing over 90 days after rash onset. Costs were calculated based on medical resource utilization and lost working time. RESULTS: HZ incidence was estimated as 6.7/1000 person-years, increasing with age to 9.4/1000 in ≥80 year-olds. Among 513 HZ patients enrolled, the proportion of PHN was 11.9%, rising with age to 14.3% in HZ patients ≥80 years. Estimated total cost per HZ patient was €156 from the healthcare system perspective and €311 from the societal perspective. CONCLUSIONS: The study confirmed previous findings that HZ causes a substantial clinical and economic burden in older German adults. It also confirmed the age-related increasing risk of HZ and PHN.

Acute herpes zoster and post herpetic neuralgia in primary care: a study of diagnosis, treatment and cost.

Acute herpes zoster and its complication post herpetic neuralgia represent a significant challenge to primary care physicians in their care of an ageing population of patients. This was a cross-sectional observational study by means of a quantitative survey of 1,000 general practitioners registered in Ireland exploring the frequency of diagnosis, methods of treatment and cost of AHZ and PHN in primary care. We recorded an 18% response rate (n = 184) with an 83% completion rate (n = 152/184). 80% of cases of AHZ occurred in patients aged 50 years or more with 81% of study participants encountering cases at a rate of 1-3 patients per month. Famciclovir (37%) and valaciclovir (36%) were the most commonly prescribed antiviral agents. Mild opioids (32%) were the most common analgesic agents used for first line AHZ pain, and pregabalin (37%) the most commonly prescribed analgesic agent for second line AHZ pain. Pregabalin was also the most commonly prescribed analgesic for both first and second line PHN pain (29% and 24%, respectively). The mean per-case direct cost (medication and GP visits) of treating AHZ and PHN in primary care was €195 (range €153-€236) and €201 (range €140-€313), respectively. Based on national sentinel data the estimated annual direct costs of treating AHZ and PHN in primary care is €2,278,196 (range €1,793,399-€2, 763,445). The treatment of AHZ and PHN represents both a significant care and cost burden on primary care resources in Ireland in keeping with other European based studies.

Analysis of real-world health care costs among immunocompetent patients aged 50 years or older with herpes zoster in the United States.

Few peer-reviewed publications present real-world United States (US) data describing resource utilization and costs associated with herpes zoster (HZ) and postherpetic neuralgia (PHN). The primary objective of this analysis (GSK study identifier: HO-14-14270) was to assess direct costs associated with HZ and PHN in the US using a retrospective managed care insurance claims database. Patients ≥ 50 y at HZ diagnosis were selected. Patients were excluded if they were immunocompromised before diagnosis or received an HZ vaccine at any time. A subsample of patients with PHN was identified. Each patient with HZ was matched to ≤ 4 controls without HZ based on age, sex, and health plan enrollment. Incremental differences in mean HZ-related costs ("incremental costs") were assessed overall and stratified by age. Multivariable regression models controlled for the effect of demographic characteristics, prediagnosis costs, and comorbidity burden on costs using a recycled predictions approach. Overall, 142,519 patients with HZ (9,470 patients [6.6%] had PHN) and 357,907 matched controls without HZ were identified. Resource utilization was greater among patients with HZ than controls. After adjusting for demographic and clinical characteristics, annual incremental health care costs for HZ patients vs. controls were $1,210 for patients aged 50-59 years, $1,629 for those 60-64 years, $1,876 for those 65-69 years, $2,643 for those 70-79 years, and $3,804 for those 80+ years; adjusted annual incremental costs among PHN patients vs. controls were $4,670 for patients 50-59 years, $6,133 for those 60-64 years, $6,451 for those 65-69 years, $8,548 for those 70-79 years, and $11,147 for those 80+ years. HZ is associated with a significant cost burden, which increases with advancing patient age. Vaccination may reduce costs associated with HZ through case avoidance.

Herpes zoster vaccine: A health economic evaluation for Switzerland.

Herpes zoster (HZ) or "shingles" results from a reactivation of the varicella zoster virus (VZV) acquired during primary infection (chickenpox) and surviving in the dorsal root ganglia. In about 20% of cases, a complication occurs, known as post-herpetic neuralgia (PHN). A live attenuated vaccine against VZV is available for the prevention of HZ and subsequent PHN. The present study aims to update an earlier evaluation estimating the cost-effectiveness of the HZ vaccine from a Swiss third party payer perspective. It takes into account updated vaccine prices, a different age cohort, latest clinical data and burden of illness data. A Markov model was developed to simulate the lifetime consequences of vaccinating 15% of the Swiss population aged 65-79 y. Information from sentinel data, official statistics and published literature were used. Endpoints assessed were number of HZ and PHN cases, quality-adjusted life years (QALYs), costs of hospitalizations, consultations and prescriptions. Based on a vaccine price of CHF 162, the vaccination strategy accrued additional costs of CHF 17,720,087 and gained 594 QALYs. The incremental cost-effectiveness ratio (ICER) was CHF 29,814 per QALY gained. Sensitivity analyses showed that the results were most sensitive to epidemiological inputs, utility values, discount rates, duration of vaccine efficacy, and vaccine price. Probabilistic sensitivity analyses indicated a more than 99% chance that the ICER was below 40,000 CHF per QALY. Findings were in line with existing cost-effectiveness analyses of HZ vaccination. This updated study supports the value of an HZ vaccination strategy targeting the Swiss population aged 65-79 y.

Cost of shingles: population based burden of disease analysis of herpes zoster and postherpetic neuralgia.

BACKGROUND: Around 30% of the population will experience herpes zoster (HZ), 10% of whom develop postherpetic neuralgia (PHN). Together, these illnesses produce a significant economic burden to the healthcare system. METHODS: Administrative healthcare data collected over the period of April 1st 1997 to March 31st 2014 were analyzed to determine the healthcare system burden of HZ using direct medical costs. Episodes of HZ were identified using international classification of disease (ICD) codes. Trends in age-adjusted (AA) HZ-rates were analyzed by piecewise-regression. Total annual and per-episode costs were determined for drug treatment, medical care, and hospitalizations within each year. RESULTS: The incidence of HZ increased by 49.5% from 1997/98 to 2013/14. Piecewise-regression of AA-rates revealed a steady AA-rate of 4.7 episodes/1000 person-years (PY) from 1997/98 to a breakpoint in 2008/09, after which rates began to increase reaching 5.7 episodes/1000 PY in 2013/14. Drug costs rose significantly (p <0.03) from $89.77/episode (95% CI: $82.96, $96.59) to $127.34/episode (95% CI: $117.24, $137.44). Medical costs increased (p <0.0001) from $57.98/episode (95% CI; $55.26, $60.70) to $78.84/episode (95% CI; $74.08, $83.61). Hospitalization rates declined from 3.10% in 1997/98 to 1.36% in 2011/12, resulting in cost dropping from $397/episode (95% CI; $284, $511) to $195/episode (95% CI; $129, $260). Total annual costs of HZ and PHN were $1,997,183 in 2011/12, 4.7% lower than the 1997/98 costs of $2,095,633. CONCLUSION: A significant increase in annual number of HZ cases was observed, driven largely by demographic factors. A 21% increase in the AA-incidence reveals changes in HZ rates beyond those expected by population shifts. The large increase in incidence of HZ, with rising per episode medical and prescription costs were offset by dramatic drops in hospitalization rates, the net effect of which has been to hold the total costs relatively constant. However, the decrease in hospitalization rates slowed over the last half of the study, settling at 1.3% in the last 4 study years. The likely future of HZ burden is one of rising costs, primarily driven by the demographic shifts of an increasing and aging population.

Burden of herpes zoster and postherpetic neuralgia in Japanese adults 60 years of age or older: Results from an observational, prospective, physician practice-based cohort study.

Approximately one in three persons will develop herpes zoster during their lifetime, and it can lead to serious complications such as postherpetic neuralgia. However, evidence on burden of herpes zoster and postherpetic neuralgia in Japan is limited. This prospective, observational, multicenter, physician practice-based cohort study was conducted in Kushiro, Hokkaido, Japan (Clinicaltrials.gov identifier NCT01873365) to assess the incidence and hospitalization rates of herpes zoster, and the proportion, clinical burden and risk factors for postherpetic neuralgia in adults aged 60 years or more. Within the study area, 800 subjects developed herpes zoster and 412 were eligible for the study. Herpes zoster incidence was 10.2/1000 person-years and higher among women and older subjects. Subjects with herpes zoster required on average 5.7 outpatient consultations. Herpes zoster-associated hospitalization rate was 3.4% (27/800). The proportion of postherpetic neuralgia and other complications was 9.2% (38/412) and 26.5% (109/412), respectively. Statistically significant association with the development of postherpetic neuralgia was male sex (odds ratio [OR], 2.51; 95% confidence interval [CI], 1.17-5.38), age of 70-74 years (OR, 3.51; 95% CI, 1.09-11.3), immunosuppressive therapy (OR, 6.44; 95% CI, 1.26-32.9), severe herpes zoster pain at first consultation (OR, 3.08; 95% CI, 1.10-8.62) and rash on upper arms (vs no rash on upper arms; OR, 3.46; 95% CI, 1.10-10.9). Considerable herpes zoster and postherpetic neuralgia burden exists among elderly in Japan, and there may be predictive factors at the first visit which could be indicative of the risk of developing postherpetic neuralgia.

Pain, Itch, Quality of Life, and Costs after Herpes Zoster.

BACKGROUND: Herpes zoster (HZ) and postherpetic neuralgia are known to have a profound effect on the patient's quality of life, but the incidence and severity of itch and its relation with pain and quality of life in the long term are still relatively unknown. OBJECTIVE: The aim of this study was to measure the presence and severity of pain and itch and impact on quality of life in patients over 50 years old with HZ. METHODS: We enrolled 661 patients with HZ in this 12-month observational study. Patient data were collected via a web-based questionnaire. Outcomes were pain, itch, burden of illness, impact on patient's daily life, impact on quality of life, and healthcare costs. RESULTS: At inclusion, 94% of patients reported any pain, 74.3% significant pain, and 26% severe pain. After 3 months, 18.8% of patients suffered from postherpetic neuralgia. At inclusion, 70.8% of patients had any itch, 39.2% significant itch, and 7.3% severe itch. The occurrence of pain increases costs and has a high impact on the quality of life, lowering EQ-5D scores by an average of 18%. In contrast, itch has little effect on the quality of life. CONCLUSIONS: Pain and itch are highly prevalent months after HZ. Pain caused by HZ has a large impact on quality of life, burden of illness, impact on daily life, and health care costs for these patients. The impact of itch on quality of life is relatively small.

COST-EFFECTIVENESS ANALYSIS OF HERPES ZOSTER VACCINATION IN ITALIAN ELDERLY PERSONS.

OBJECTIVES: Herpes zoster (HZ) is characterized by a painful skin rash. Its main complication is postherpetic neuralgia (PHN), pain persisting or occurring after the rash onset. HZ treatment aims to reduce acute pain, impede the onset complications, and disease progression. The aim of this study was to assess the cost-effectiveness of HZ vaccination compared with no vaccination strategy, within the Italian context. METHODS: The natural history of HZ and PHN was mapped through a Markov model with lifetime horizon. A population of patients aged between 60 and 79 years was hypothesized. Third party payer (Italian National Health Service, I-NHS) and societal perspectives were adopted. Data were derived from literature. RESULTS AND CONCLUSIONS: The incremental cost-effectiveness ratio of the vaccination equaled EUR 11,943 per quality-adjusted life-year (QALY) under the I-NHS perspective and EUR 11,248 per QALY under the societal perspective. Considering a cost-effectiveness threshold of EUR 30,000/QALY, the multi-way sensitivity analysis showed that vaccination is cost-effective regardless of the perspective adopted, in 99 percent of simulations.

Burden of herpes zoster and post-herpetic neuralgia in Sweden.

BACKGROUND: The societal economic burden of herpes zoster in Sweden is not well described today. This study is a top-down analysis of Swedish registers with the objective to describe the burden of herpes zoster and post-herpetic neuralgia in Sweden during 2011. METHODS: Data for inpatient care; outpatient primary and specialized cares; the prescriptions of drugs, sick leave and the number or diagnostic tests were collected from Swedish national databases. The incidence of the disease was estimated based on the number of prescriptions of antiviral drugs. RESULTS: The incidence of herpes zoster was estimated to 315 and 577 cases per 100,000 people for patients at all ages and > = 50 years, respectively. Almost 30,000 patients at all ages were diagnosed with herpes zoster and the societal cost to treat these patients, including the cost to treat those patients who later developed post-herpetic neuralgia, added up to nearly 227 MSEK (31.6 M€) which corresponds to 7,600 SEK (€870) per patient. The main contributors to the total cost for the treatment of HZ patients were primary care (43 %); sick leave (28 %); hospitalization (10 %) and specialist care (7 %). Medication was a relatively small contributor with 8.5 MSEK (4 %; 1.0 M€) to the overall costs for patients at all ages. The corresponding total cost including only patients 50 years and older was 168 MSEK (19.2 M€) or 8,200 SEK (€939) per patient. CONCLUSIONS: The current study demonstrates that the burden of herpes zoster is significant in Sweden. The society, the health care payers and the patients potentially have a lot to gain by introducing a vaccination program to patients 50 years and older and as a consequence reduce the economic and clinical burden of herpes zoster and post-herpetic neuralgia.

The burden of Herpes Zoster and its complications in Poland in according to the age.

BACKGROUND: Incidence of shingles in different regions of the world ranged from 300 to 500/100,000 persons, and in the population older than 80 years of age reaches more than 1000/100,000. In the age group 50+ the incidence is enough high to be a serious medical and economic burden. Lack of details about the incidence and frequency of complications in Polish population let us too made an attempt to assess the scale of the problem, among others to the purpose of the evaluation of the legitimacy of implementing vaccination in the 50+ population. METHODS: First, based on coming data from the Swietokrzyskie Province Division of the National Health Fund we judged the incidence of shingles in this province in 2013 in individual ancient groups and depending on detailed diagnoses and with the division into the basic health, clinic and hospital care. Second, based on gathered data through NIZP-PZH, we judged hospital morbidity connected with shingles in Poland in 2008-2012 years, in individual ancient groups. RESULTS: Extrapolating the data from the Swietokrzyskie province we assess the incidence of shingles on average 338.8/100,000. She is tallest in the age group 50+ (614.3/100,000) and in this group also the most complications are being observed. Hospital morbidity in entire Poland showed in 2008-2012 years the frequency on average 4.93-5.42/100,000, in the group of 0-19 years; 0.10-1.50/100,000, in the group of 20-49 years; 4.9-5.42/100,000 and in the 50+ group--9.99-13.37/100,000. CONCLUSIONS: (1) Shingles, especially in the 50+ age group, constitutes a serious health problem in Poland, being a cause of numerous advices in basic health care and at clinics in Poland, as well of numerous hospitalizations and dangerous complications. (2) It seems, that active immunization against shingles, especially of 50+ persons, would be a favourable solution from the individual, as well as public perspective.

Herpes zoster and postherpetic neuralgia in Catalonia (Spain).

The objective of the study was to analyze the descriptive epidemiology and costs of herpes zoster (HZ) and postherpetic neuralgia (PHN) in people aged ≥50 years in Catalonia (Spain). The incidence of HZ in Catalonia was estimated by extrapolating the incidence data from Navarre (Spain) to the population of Catalonia. The incidence of PHN was estimated according to the proportion of cases of HZ in the case series of the Hospital del Sagrado Corazón de Barcelona that evolved to PHN. Drug costs were obtained directly from the prescriptions included in the medical record (according to official prices published by the General Council of the College of Pharmacists). The cost of care was obtained by applying the tariffs of the Catalan Health Institute to the number of outpatient visits and the number and duration of hospital admissions. The estimated annual incidence of HZ was 31 763, of which 21 532 (67.79%) were in patients aged ≥50 years. The respective figures for PHN were 3194 and 3085 (96.59) per annum, respectively. The mean cost per patient was markedly higher in cases of PHN (916.66 euros per patient) than in cases of HZ alone (301.52 euros per patient). The cost increased with age in both groups of patients. The estimated total annual cost of HZ and its complications in Catalonia was € 9.31 million, of which 6.54 corresponded to HZ and 2.77 to PHN. This is the first Spanish study of the disease burden of HZ in which epidemiological data and costs were collected directly from medical records. The estimated incidence of HZ is probably similar to the real incidence. In contrast, the incidence of PHN may be an underestimate, as around 25% of patients in Catalonia attend private clinics financed by insurance companies. It is also probable that the costs may be an underestimate as the costs derived from the prodromal phase were not included. In Catalonia, HZ and PHN cause an important disease burden (21 532 cases of HZ and 3085 de PHN with an annual cost of € 9.31 million) in people aged ≥50 years, in whom vaccination is indicated.

Cost-effectiveness of vaccination against herpes zoster.

Herpes zoster (HZ) is a common disease among elderly, which may develop into a severe pain syndrome labeled postherpetic neuralgia (PHN). A live-attenuated varicella zoster virus vaccine has been shown to be effective in reducing the incidence and burden of illness of HZ and PHN, providing the opportunity to prevent significant health-related and financial consequences of HZ. In this review, we summarize the available literature on cost-effectiveness of HZ vaccination and discuss critical parameters for cost-effectiveness results. A search in PubMed and EMBASE was performed to identify full cost-effectiveness studies published before April 2013. Fourteen cost-effectiveness studies were included, all performed in western countries. All studies evaluated cost-effectiveness among elderly above 50 years and used costs per quality-adjusted life year (QALY) gained as primary outcome. The vast majority of studies showed vaccination of 60- to 75-year-old individuals to be cost-effective, when duration of vaccine efficacy was longer than 10 years. Duration of vaccine efficacy, vaccine price, HZ incidence, HZ incidence and discount rates were influential to the incremental cost-effectiveness ratio (ICER). HZ vaccination may be a worthwhile intervention from a cost-effectiveness point of view. More extensive reporting on methodology and more detailed results of sensitivity analyses would be desirable to address uncertainty and to guarantee optimal comparability between studies, for example regarding model structure, discounting, vaccine characteristics and loss of quality of life due to HZ and PHN.