A systematic review of pharmacoeconomic studies for pregabalin.

BACKGROUND: With anticonvulsant, anxiolytic, and analgesic properties, pregabalin has been evaluated for neuropathic pain and fibromyalgia (FM). These chronic conditions diminish patients' quality of life and increase healthcare utilization and costs. OBJECTIVE: To assess the current understanding of economic outcomes associated with pregabalin in neuropathic pain and FM. METHODS: Using keywords related to economic outcomes and pregabalin, we systematically searched MEDLINE- and EMBASE-indexed literature and nonindexed "grey" literature on neuropathic pain and FM published from March 2001 to October 2012. Included studies reported economic findings associated with pregabalin. RESULTS: In the past 11 years, 55 publications assessed the direct costs, resource use, or cost-effectiveness of pregabalin for neuropathic pain and FM. Studies generally lacked comparability due to heterogeneous patient populations, assumptions, time periods, and geographies. In the US, following treatment initiation, pregabalin resulted in similar or higher levels of healthcare use for FM compared with duloxetine. In contrast, medical costs for neuropathic pain did not significantly differ after initiation of pregabalin vs. duloxetine or other standard therapies in the US, but in Spain and Sweden, retrospective database studies suggested that pregabalin was cost-saving vs. gabapentin. Few economic analyses estimated indirect costs. CONCLUSIONS: Neuropathic pain and FM are associated with high healthcare resource use and costs. Economic studies of pregabalin in neuropathic pain and FM indicate some results favorable to other forms of care, but heterogeneity among study designs and populations hinder comparisons. Future economic analyses should aim to address data gaps regarding effects of pregabalin on productivity and resource use.

Patient demographics and health plan paid costs in chronic inflammatory demyelinating polyneuropathy.

INTRODUCTION: We determined health plan paid costs and healthcare resource usage of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). METHODS: CIDP patients from 9 U.S. commercial health plans with claims in 2011 were identified from the Accordant Health Services claims database. We examined demographics, prevalence of comorbidities, prescribed drugs, place of service, and mean annual health plan paid costs per patient. RESULTS: From 6.5 million covered lives, 73 (56% men; mean age 47) met study entry criteria. The most prescribed therapies were intravenous immunoglobulin (IVIg) (26% of patients), gabapentin (26%), and prednisone (16%). The annual health plan paid cost was $56,953. Pharmacy cost was the major cost driver (57% of the total), and IVIg totaled 90% of the pharmacy costs. CONCLUSIONS: Healthcare costs for CIDP patients are substantial, with a large burden in pharmacy usage. Studies are needed to determine optimal long-term treatment strategies for CIDP, particularly related to IVIg.

Cost comparison of adding pregabalin or gabapentin for the first time to the therapy of patients with painful axial radiculopathy treated in Spain.

OBJECTIVES: This paper aims to compare the costs of initiating pregabalin or gabapentin in the therapeutic management of patients with painful axial radiculopathy in routine medical practice. METHODS: A retrospective claim database analysis was carried-out using medical records of patients of both gender aged >18 years with axial painful radiculopathy (ICD-9-CM codes: 353.0 [cervical], 353.3 [thoracic] or 353.1 [lumbar]) who initiated pregabalin or gabapentin therapy between 2006 and 2008. The economic evaluation included healthcare resource utilisation and corresponding costs from a third-payer perspective during 12 months post index date. Estimates of indirect costs due to sick leave were also computed. RESULTS: A total of 571 records were eligible for analysis: 375 (66%) treated with pregabalin and 193 (34%) gabapentin. Time since diagnosis, duration of treatment, prevalence of most co-morbidities and previous use of analgesics were comparable. However, concomitant use of analgesics was higher in the gabapentin cohort; 3.1 (1.7) vs. 2.8 (1.8); p<0.05, mainly due to greater use of opioids (31.1% vs. 21.2%; p<0.05) and non-narcotic drugs (63.7% vs. 52.1%; p<0.01). Adjusted total costs per patient were significantly lower in the pregabalin group; €2.472 (2.101-2.836) vs. €3.346 (2.866-3.825); p=0.005, due to lower absenteeism costs; €1.012 (658-1.365) vs. €1.595 (1.129-2.062); p=0.042, and lower adjusted healthcare costs; €1.460 (1.360-1.560) vs. €1.750 (1.618-1.882); p=0.001. CONCLUSIONS: In a population setting, pregabalin-treated patients with painful radiculopathies were considerably less costly for the healthcare payer than those treated with gabapentin in routine clinical practice. Patients treated with pregabalin had significantly fewer days of sick leave than gabapentin-treated patients.

Pregabalin versus gabapentin in the management of peripheral neuropathic pain associated with post-herpetic neuralgia and diabetic neuropathy: a cost effectiveness analysis for the Greek healthcare setting.

BACKGROUND: The anticonvulsants pregabalin and gabapentin are both indicated for the treatment of peripheral neuropathic pain. The decision on which treatment provides the best alternative, should take into account all aspects of costs and outcomes associated with the two therapeutic options. The objective of this study was to examine the cost - effectiveness of the two agents in the management of patients with painful diabetic neuropathy or post - herpetic neuralgia, under the third party payer perspective in Greece. METHODS: The analysis was based on a dynamic simulation model which estimated and compared the costs and outcomes of pregabalin and gabapentin in a hypothetical cohort of 1,000 patients suffering from painful Diabetic Peripheral Neuropathy (DPN) or Post-Herpetic Neuralgia (PHN). In the model, each patient was randomly allocated an average pretreatment pain score, measured using an eleven-point visual analogue scale (0 - 10) and was "run through" the model, simulating their daily pain intensity and allowing for stochastic calculation of outcomes, taking into account medical interventions and the effectiveness of each treatment. RESULTS: Pregabalin demonstrated a reduction in days with moderate to severe pain when compared to gabapentin. During the 12 weeks the pregabalin arm demonstrated a 0.1178 (SE 0.0002) QALY gain, which proved to be 0.0063 (SE 0.0003) higher than that in the gabapentin arm. The mean medication cost per patient was higher for the pregabalin arm when compared to the gabapentin arm (i.e. €134.40) over the 12 week treatment period. However, this higher cost was partially offset by the reduced direct medical costs (i.e. the cost of specialist visits, the cost of diagnostic tests and the other applied interventions). Comparing costs with respective outcomes, the ICERs for pregabalin versus gabapentin were €13 (95%CI: 8 - 18) per additional day with no or mild pain and €19,320 (95%CI: 11,743 - 26,755) per QALY gained. CONCLUSIONS: Neuropathic pain carries a great disease burden for patients and society and, is also, associated with a significant economic burden. The treatment of pain associated with DPN and PHN with pregabalin is a cost-effective intervention for the social security in Greece compared to gabapentin. Thus, these findings need to be taken into consideration in the decision - making process when considering which therapy to use for the treatment of neuropathic pain.

Costs and health resources utilization following switching to pregabalin in individuals with gabapentin-refractory neuropathic pain: a post hoc analysis.

PURPOSE: To analyze the changes in pain severity and associated costs resulting from resource utilization and reduced productivity in patients with gabapentin-refractory peripheral neuropathic pain who switched to pregabalin therapy in primary care settings in Spain. PATIENTS AND METHODS: This is a post hoc analysis of a 12-week, multicentre, noninterventional cost-of-illness study. Patients were included in the study if they were over 18 years of age and had a diagnosis of chronic, treatment-refractory peripheral neuropathic pain. The analysis included all pregabalin-naïve patients who had previously shown an inadequate response to gabapentin and switched to pregabalin. Severity of pain before and after treatment with pregabalin, alone or as an add-on therapy, was assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ) and its related visual analogue scale (VA). Healthcare resource utilization, productivity (including lost-workday equivalents [LWDE]), and related costs were assessed at baseline and after pregabalin treatment. RESULTS: A total of 174 patients switched to pregabalin had significant and clinically relevant reductions in pain severity (mean [SD] change on SF-MPQ VA scale, -31.9 [22.1]; P < 0.05 vs. baseline; effect size, 1.87). Reduction in pain was similar with both pregabalin monotherapy and add-on therapy. Significant reductions in healthcare resource utilization (concomitant drug use [in pregabalin add-on group], ancillary tests, and unscheduled medical visits) were observed at the end of trial. Additionally, there were substantial improvements in productivity, including a reduction in the number of LWDE following pregabalin treatment (-18.9 [26.0]; P < 0.0001). These changes correlated with substantial reductions in both direct (-652.9 ± 1622.4 €; P < 0.0001) and indirect healthcare costs (-851.6 [1259.6] €; P < 0.0001). CONCLUSIONS: The cost of care in patients with gabapentin-refractory peripheral neuropathic pain appeared to be significantly reduced after switching to pregabalin treatment, alone or in combination with other analgesic drugs, in a real-life setting.

Treatment choice, duration, and cost in patients with interstitial cystitis and painful bladder syndrome.

INTRODUCTION AND HYPOTHESIS: In order to better understand provider treatment patterns for interstitial cystitis (IC)/painful bladder syndrome, we sought to document the therapies utilized and their associated expenditures using a national dataset. METHODS: A cohort was created by applying the ICD-9 diagnosis of IC (595.1) to INGENIX claims for the year 1999. Subjects were followed for 5 years, and patterns of care and related expenditures were evaluated. RESULTS: Of 553,910 adults insured in 1999, 89 subjects had a diagnosis of IC with 5-year follow-up data. All subjects were treated with oral medication(s), 26% received intravesical treatments, and 22% underwent hydrodistension. Total expenditures per subject were $2,808. CONCLUSIONS: The majority of IC expenditures were attributable to oral medical therapy. Hydrodistension and intravesical instillations were utilized in less than 25% of patients. Hydrodistension was used more frequently among subjects with a new diagnosis; this may reflect its utilization as part of a diagnostic algorithm.

Clinical characteristics, pharmacotherapy and healthcare resource use among patients with fibromyalgia newly prescribed gabapentin or pregabalin.

OBJECTIVE: To characterize comorbidities, pain-related pharmacotherapy, and healthcare resource use among patients with fibromyalgia (FM) newly prescribed pregabalin or gabapentin in clinical practice. METHODS AND DESIGN: Using the PharMetrics Database, FM patients (International Classification of Diseases, Ninth Revision, Clinical Modification code 729.1X) newly prescribed pregabalin (n = 1,606; mean age 49.9 +/- 9.6 years; 87.9% female) and gabapentin (n = 930; mean age 49.5 +/- 9.6 years; 86.6% female) on/after July 1, 2007 were identified. Prevalence of comorbidities, pharmacotherapy, and healthcare resource use/costs (pharmacy, outpatient, inpatient, total) were examined during the 6 months preceding (preindex) and following (postindex) the date of their first pregabalin or gabapentin (index) prescription. RESULTS: Patients in both cohorts had a variety of comorbidities and used multiple medications. There were significant decreases (P values < 0.05) in the use of nonsteroidal anti-inflammatory drugs (32.1% vs. 29.5%), anticonvulsants (27.0% vs. 22.0%), and combination therapies in the pregabalin cohort in the postindex period. There were significant increases (all P values < 0.05) in use of short-acting opioids (58.8% vs. 63.7%), any opioids (61.5% vs. 65.6%), serotonin-norepinephrine reuptake inhibitors (22.5% vs. 24.5%), anticonvulsants (16.3% vs. 26.2%), benzodiazepines (33.2% vs. 36.6%), topical agents (6.6% vs. 9.0%), and combination therapies in the gabapentin cohort. Although there were no changes in units of healthcare resources used, there were increases in the postindex period in hospitalization, medications, and total costs for pregabalin, and office visits and medication costs for gabapentin (all P values < 0.05). CONCLUSIONS: Results suggest a high comorbidity and medication use burden in FM patients in this study. Further evaluation is warranted to clarify differences in resource utilization/costs observed with these two anticonvulsants.

Are N-of-1 trials an economically viable option to improve access to selected high cost medications? The Australian experience.

OBJECTIVE: To explore the economic viability of N-of-1 trials for improving access to selected high cost medications in Australia. METHODS: Cost and effectiveness estimates were derived from two N-of-1 trials conducted by The University of Queensland from 2003 to 2005-celecoxib versus sustained-release paracetamol for osteoarthritis in a general practice setting and gabapentin versus placebo for chronic neuropathic pain in a hospital setting. Effectiveness was determined by the proportion of responders to each medication. The costs of trials were offset against the savings generated by subsequent changes in prescribing. Decision analysis models with semi-Markov processes were used to compare different scenarios of N-of-1 trials versus usual care. RESULTS: The fixed cost of performing N-of-1 trials was approximately AUS$23,000 for each trial and the variable cost was approximately AUS$1300 per participant. Clinical outcomes favored celecoxib over paracetamol in 17% of participants and gabapentin over placebo in 24% of participants. Modeling these results showed that the cost-offsets from efficient use of medications were less than the cost of running a trial; however, the incremental costs per quality-adjusted life-year gained were AUS$6,896 and AUS$29,550 for the gabapentin/placebo and celecoxib/paracetamol trials, respectively, over a 5-year horizon. Key factors affecting the viability were the time horizon modeled, the variable cost per participant, the probability of response to the intervention medication, and rates of use in nonresponders and the usual care alternative. CONCLUSIONS: The N-of-1 strategy offers a realistic and viable option for increasing access to selected high cost medications where the medications are used for the symptomatic treatment of chronic disease, have rapid onset of action, and clinical response is unpredictable without a trial.

A cost-utility comparison of four first-line medications in painful diabetic neuropathy.

BACKGROUND: Painful diabetic neuropathy is common and adversely affects patients' quality of life and function. Several treatment options exist, but their relative efficacy and value are unknown. OBJECTIVE: To determine the relative efficacy, costs and cost effectiveness of the first-line treatment options for painful diabetic neuropathy. METHODS: Published and unpublished clinical trial and cross-sectional data were incorporated into a decision analytic model to estimate the net health and cost consequences of treatment for painful diabetic peripheral neuropathy over 3-month (base case), 1-month and 6-month timeframes. Efficacy was measured in QALYs, and costs were measured in $US, year 2006 values, using a US third-party payer perspective. The patients included in the model were outpatients with moderate to severe pain associated with diabetic peripheral neuropathy and no contraindications to treatment with tricyclic antidepressants. Four medications were compared: desipramine 100 mg/day, gabapentin 2400 mg/day, pregabalin 300 mg/day and duloxetine 60 mg/day. RESULTS: Desipramine and duloxetine were both more effective and less expensive than gabapentin and pregabalin in the base-case analysis and through a wide range of sensitivity analyses. Duloxetine offered borderline value compared with desipramine in the base case ($US47,700 per QALY), but not when incorporating baseline-observation-carried-forward analyses of the clinical trial data ($US867,000 per QALY). The results were also sensitive to the probability of obtaining pain relief with duloxetine. CONCLUSIONS: Desipramine (100 mg/day) and duloxetine (60 mg/day) appear to be more cost effective than gabapentin or pregabalin for treating painful diabetic neuropathy. The estimated value of duloxetine relative to desipramine depends on the assumptions made in the statistical analyses of clinical trial data.

Cost-effectiveness analysis of a lidocaine 5% medicated plaster compared with gabapentin and pregabalin for treating postherpetic neuralgia: a german perspective.

OBJECTIVE: This study set out to assess the cost effectiveness of using a 5% lidocaine (lignocaine) medicated plaster for the treatment of postherpetic neuralgia (PHN) compared with gabapentin, pregabalin 300 mg/day or 600 mg/day in German primary care. The analysis took the perspective of the Statutory Health Insurance scheme (GKV). METHODS: A Markov model was used to calculate the costs (2007) and benefits of the lidocaine plaster, gabapentin 1800 mg/day and pregabalin 300 or 600 mg/day over a 6-month time horizon in elderly patients with PHN who experienced insufficient pain relief with standard analgesics and could not tolerate or had contraindications to tricyclic antidepressants. The model calculated the cost per quality-adjusted life-year (QALY) gained and the cost per additional month without symptoms or intolerable adverse effects. The majority of transition probabilities were obtained from randomized controlled trials identified from a systematic literature review. Further model inputs, including resource use, concomitant medication and long-term efficacy/adherence data, were obtained from a Delphi panel. Utility values were taken from a previous study and age adjusted. Cost data were obtained from official price tariffs. Mortality, indirect costs and costs associated with inpatient treatment were not considered in the present analysis due to the perspective and time horizon employed. RESULTS: Over the 6-month period modelled, the mean total therapy cost per patient treated with the lidocaine plaster was euro911, compared with euro728 for gabapentin, euro875 for pregabalin 300 mg/day and euro977 for pregabalin 600 mg/day. Treatment with the lidocaine plaster was related to greater numbers of QALYs and more months without symptoms or intolerable adverse effects (mean 0.300 QALYs and 4.06 months per patient) than with gabapentin (mean 0.247 QALYs and 2.72 months), pregabalin 300 mg/day (mean 0.253 QALYs and 3.02 months) or pregabalin 600 mg/day (mean 0.256 QALYs and 3.22 months). The lidocaine plaster cost euro3453/QALY gained and euro137 per additional month without adverse effects or symptoms relative to gabapentin and euro766/QALY and euro35 per month without adverse effects or symptoms relative to pregabalin 300 mg/day. The lidocaine plaster dominated pregabalin 600 mg/day, being less costly and more effective. Probabilistic sensitivity analysis indicated that there is a 99.36% chance that the lidocaine plaster is the most clinically effective treatment considered in the analysis and a 99.09% chance that the lidocaine plaster is the most cost-effective treatment of the four therapies considered in the analysis if the GKV is willing to pay at least euro20 000/QALY gained. Extensive deterministic sensitivity analyses demonstrated that the findings are robust. CONCLUSIONS: The 5% lidocaine-medicated plaster is a cost-effective treatment option for the management of PHN in Germany compared with gabapentin and both 300 and 600 mg/day of pregabalin.

Clinical and economic consequences of treating patients with peripheral neuropathic pain with brand name or generic drugs in routine clinical practice: The effects of age and sex. / Efecto de la edad y el género sobre las consecuencias clínicas y económicas del tratamiento con especialidad farmacéutica de marca o genérica en pacientes con dolor neuropático periférico en práctica clínica habitual.

OBJECTIVE: We aimed to analyse the effects of age and sex on pain and cost for patients with chronic peripheral neuropathic pain (PNP) who have started treatment with brand name gabapentin versus generic gabapentin (EFG). METHODS: We conducted a retrospective multicentre study using electronic medical records (EMR) for patients of both sexes, older than 18, who began treatment with brand name or generic gabapentin. Adherence (medication possession ratio [MPR]), persistence, use of healthcare resources, cost, and pain reduction were measured for one year. RESULTS: We analysed 1369 EMRs [61.1% women; mean age 64.6 (15.9), 52.4%≥65 years]; 400 used brand name drugs while 969 used generic gabapentin. Persistence and adherence were higher in patients using brand name gabapentin (7.3 vs 6.3 months, P<.001; 86.5% vs 81.3% MPR, P<.001). Lower healthcare costs were observed in patients using brand-name gabapentin in both age groups (<65 and ≥65). Mean difference in cost per patient amounted to €221 (95%CI: 59-382) and €217 (95%CI: 51-382) in the <65 and ≥65 age groups, respectively (P<.01). Mean difference in cost among men amounted to €197 (63-328), while mean difference in cost among women amounted to €239 (96-397) (P=.005 and P=.004, respectively). Compared with EFG, brand treatment showed greater pain relief: 13.5% (10.9-16.2) and 10.8% (8.2-13.5) in <65 and ≥65year patients, respectively (P<.001), and 10.7% (8.2-13.2) and 13.8% (11.0-16.5) in women and men respectively (P<.001). CONCLUSIONS: Regardless of sex and age, patients who started PNP treatment with brand name medication showed greater persistence and adherence to treatment than those taking generic drugs. Brand name treatment also involved lower healthcare costs, and greater pain relief.

Characteristics and impact of drug detailing for gabapentin.

BACKGROUND: Sales visits by pharmaceutical representatives ("drug detailing") are common, but little is known about the content of these visits or about the impact of visit characteristics on prescribing behavior. In this study, we evaluated the content and impact of detail visits for gabapentin by analyzing market research forms completed by physicians after receiving a detail visit for this drug. METHODS AND FINDINGS: Market research forms that describe detail visits for gabapentin became available through litigation that alleged that gabapentin was promoted for "off-label" uses. Forms were available for 97 physicians reporting on 116 detail visits between 1995 and 1999. Three-quarters of recorded visits (91/116) occurred in 1996. Two-thirds of visits (72/107) were 5 minutes or less in duration, 65% (73/113) were rated of high informational value, and 39% (42/107) were accompanied by the delivery or promise of samples. During the period of this study, gabapentin was approved by the US Food and Drug Administration only for the adjunctive treatment of partial seizures, but in 38% of visits (44/115) the "main message" of the visit involved at least one off-label use. After receiving the detail visit, 46% (50/108) of physicians reported the intention to increase their prescribing or recommending of gabapentin in the future. In multivariable analysis, intent to increase future use or recommendation of gabapentin was associated with receiving the detail in a small group (versus one-on-one) setting and with low or absent baseline use of the drug, but not with other factors such as visit duration, discussion of "on-label" versus "off-label" content, and the perceived informational value of the presentation. CONCLUSIONS: Detail visits for gabapentin were of high perceived informational value and often involved messages about unapproved uses. Despite their short duration, detail visits were frequently followed by physician intentions to increase their future recommending or prescribing of the drug.

A cost-effectiveness comparison of desipramine, gabapentin, and pregabalin for treating postherpetic neuralgia.

OBJECTIVES: To compare the net health effects and costs resulting from treatment with different first-line postherpetic neuralgia (PHN) medications. DESIGN: Cost-utility analysis using published literature. PARTICIPANTS: Hypothetical cohort of patients aged 60 to 80 with PHN. INTERVENTIONS: Desipramine 100 mg/d, gabapentin 1,800 mg/d, and pregabalin 450 mg/d. MEASUREMENTS: A decision model was designed to describe possible treatment outcomes, including different combinations of analgesia and side effects, during the first 3 months of therapy for moderate to severe PHN. The main outcome was cost per quality-adjusted life-year (QALY) gained. Costs were estimated using the perspective of a third-party payer. Multivariate, univariate, and probabilistic sensitivity analyses were performed, and the time frame of the model was varied to 1-month and 6-month horizons. RESULTS: Desipramine was more effective and less expensive than gabapentin or pregabalin (dominant) under all conditions tested. Gabapentin was more effective than pregabalin but at an incremental cost of $216,000/QALY. Below $140/month, gabapentin became more cost-effective than pregabalin at a threshold of $50,000/QALY, and below $115/month gabapentin dominated pregabalin. CONCLUSION: Desipramine appears to be more effective and less expensive than gabapentin or pregabalin for the treatment of older patients with PHN in whom it is not contraindicated. After its price falls, generic gabapentin will likely be more cost-effective than pregabalin.

Cost-effectiveness of a lidocaine 5% medicated plaster relative to gabapentin for postherpetic neuralgia in the United Kingdom.

BACKGROUND: Approximately 50% of elderly patients develop postherpetic neuralgia (PHN) after herpes zoster infection (shingles). A lidocaine 5% medicated plaster marketed in the United Kingdom in January 2007 has been shown to be an effective topical treatment for PHN with minimal risk of systemic adverse effects. OBJECTIVE: This paper assessed the cost-effectiveness of using a lidocaine plaster in place of gabapentin in English primary care practice to treat those PHN patients who had insufficient pain relief with standard analgesics and could not tolerate or had contraindications to tricyclic antidepressants (TCAs). The analysis took the perspective of the National Health Service (NHS). METHODS: The costs and benefits of gabapentin and the lidocaine plaster were calculated over a 6-month time horizon using a Markov model. The model structure allowed for differences in costs, utilities, and transition probabilities between the initial 30-day run-in period and maintenance therapy and also accounted for add-in medications and drugs received by patients who discontinued therapy. Most transition probabilities were based on non-head-to-head clinical trials identified through a systematic review. Data on resource utilization, discontinuation rates, and add-in or switch medications were obtained from a Delphi panel; cost data were from official price tariffs. Published utilities were adjusted for age and were supplemented and validated by the Delphi panel. RESULTS: Six months of therapy with the lidocaine plaster cost pound 549 per patient, compared with pound 718 for gabapentin, and generated 0.05 more quality-adjusted life-years (QALYs). The lidocaine plaster therefore dominated gabapentin (95% CI, dominant- pound 2163/QALY gained). Probabilistic sensitivity analysis showed that there was a 90.15% chance that the lidocaine plaster was both less costly and more effective than gabapentin and a 99.99% chance that it cost < pound 20,000/QALY relative to gabapentin. Extensive deterministic sensitivity analyses confirmed the robustness of the conclusions. CONCLUSION: This study found that the lidocaine 5% medicated plaster was a cost-effective alternative to gabapentin for PHN patients who were intolerant to TCAs and in whom analgesics were ineffective, from the perspective of the NHS.

Cost of treatment of peripheral neuropathic pain with pregabalin or gabapentin in routine clinical practice: impact of their loss of exclusivity.

To analyze the effect of loss of exclusivity of data on the cost of treatment of peripheral neuropathic pain (PNP) with pregabalin or gabapentin in routine clinical practice. A retrospective observational study, with electronic medical records for patients enrolled at primary care centers managed by the health care provider Badalona Serveis Assistencials, who initiated treatment of PNP with pregabalin or gabapentin. The analysis used drugs and resources prices for year 2015. The 1163 electronic medical records (pregabalin; N = 764, gabapentin; N = 399) for patients (62.2% women) with a mean (standard deviation) age of 59.2 (14.7) years were analyzed. Treatment duration was slightly shorter with pregabalin than with gabapentin (5.2 vs 5.5 months; P = 0.124), with mean doses of 227.4 (178.6) mg and 900.0 (443.4) mg, respectively. The average study drug cost per patient was higher for pregabalin than for gabapentin; €214.6 (206.3) vs €157.4 (181.9), P < 0.001, although the cost of concomitant analgesic medication was lower; €176.5 (271.8) vs €306.7 (529.2), P < 0.001. The adjusted average total cost per patient was lower in those treated with pregabalin than in those treated with gabapentin; €2,413 (2119-2708) vs €3201 (2806-3.597); P = 0.002, owing to significantly lower health care costs; €1307 (1247-1367) vs €1538 (1458-1618), P < 0.001, and also non-health care costs; €1106 (819-1393) vs €1663 (1279-2048), P = 0.023, that was caused by a significantly lower use of concomitant medication, fewer medical visits to primary care, and fewer days of sick leave. After loss of exclusivity of both drugs, pregabalin continued to show lower health care and non-health care costs than gabapentin in the treatment of PNP in routine clinical practice.

Cost-effectiveness of pregabalin for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia: a Canadian perspective.

BACKGROUND: Neuropathic pain (NeP) is a chronic condition that occurs frequently with diabetes and herpes zoster infection. In addition to potentially lasting many years, the relationship between chronic pain, anxiety/depression, and sleep, also referred to as the triad of pain, causes functional impairment in many areas of life. OBJECTIVE: The aim of this study was to examine the 12-week cost-effectiveness of 2 treatments of NeP, pregabalin versus gabapentin, in managing diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN) in a Canadian setting. METHODS: A stochastic simulation model evaluating NeP treatment was adapted to the Canadian setting. Using data from clinical trials of pregabalin (150-600 mg/d) and gabapentin (900-3600 mg/d), the model simulated 12-week treatment outcomes for patients with DPN or PHN. Resource utilization was identified through an Internet-based survey among 80 Canadian physicians. Utility values (as measured using the EuroQol EQ-5D) were obtained from 126 NeP patients participating in a cross-sectional study conducted at Canadian primary care sites. The economic analysis was expressed as incremental cost per quality-adjusted life year (QALY) gained and as incremental cost per day with no or mild pain. Model sensitivity to changes in key parameters was assessed. RESULTS: Following 12-week treatment, compared with gabapentin, pregabalin was projected to result in 6 and 9 additional days with no or mild pain for patients with DPN and PHN, respectively. Pregabalin therapy was estimated to provide an additional 0.0047 QALY and 0.0086 QALY over gabapentin administration, for DPN and PHN, respectively. Mean (SE) direct costs per DPN patient were estimated as 837.53 Can dollars (37.31 dollars) (2004 dollars) with gabapentin and 818.49 dollars (36.50 dollars) with pregabalin, and per PHN patient as 720.61 dollars (33.70 dollars) with gabapentin and 667.07 dollars (25.33 dollars) with pregabalin. Model findings were sensitive to variation in the dose and corresponding cost of the comparator, but not in other parameters. CONCLUSION: Based on the results of this analysis, in the treatment of NeP associated with DPN or PHN, pregabalin was a dominant or cost-effective treatment strategy compared with gabapentin.

Economic evaluation of oral treatments for neuropathic pain.

UNLABELLED: The effectiveness of amitriptyline, carbamazepine, gabapentin, and tramadol for the treatment of neuropathic pain has been demonstrated, but it is unknown which one is the most cost-effective. We designed a cost-utility analysis of a hypothetical cohort with neuropathic pain of postherpetic or diabetic origin. The perspective of the economic evaluation was that of a third-party payor. For effectiveness and safety estimates, we performed a systematic review of the literature. For direct cost estimates, we used average wholesale prices, and the American Medicare and Clinical Laboratory Fee Schedules. For utilities of health states, we used the Health Utilities Index. We modeled 1 month of therapy. For comparisons among treatments, we estimated incremental cost per utility gained. To allow for uncertainty from variations in drug effectiveness, safety, and amount of medication needed, we conducted a probabilistic Monte Carlo simulation. Amitriptyline was the cheapest strategy, followed by carbamazepine, and both were equally beneficial. Gabapentin was the most expensive as well as the least beneficial. A multivariable probabilistic simulation produced similar results to the base-case scenario. In summary, amitriptyline and carbamazepine are more cost-effective than tramadol and gabapentin and should be considered as first-line treatment for neuropathic pain in patients free of renal or cardiovascular disease. PERSPECTIVE: Prescription practices should be based on the best available evidence, which includes the evaluation of the medication's cost-effectiveness. This does not mean that the cheapest or the most expensive, but rather the most cost-effective medication should be chosen-the one whose benefits are worth the harms and costs. We report a cost-effectiveness evaluation of treatments for neuropathic pain.

Cost-effectiveness of duloxetine versus routine treatment for U.S. patients with diabetic peripheral neuropathic pain.

UNLABELLED: The purpose of this study was to compare the cost-effectiveness of duloxetine versus routine treatment in management of diabetic peripheral neuropathic pain (DPNP). Two hundred thirty-three patients with DPNP who completed a 12-week, double-blind, placebo-controlled, randomized, multicenter duloxetine trial were re-randomized into a 52-week, open-label trial of duloxetine 60 mg twice daily versus routine treatment. Routine treatment included pain management therapies. Effectiveness was measured by using the bodily pain domain (BP) of the Medical Outcomes Study Short Form 36 (SF-36). Costs were analyzed from 3 perspectives: third party payer (direct medical costs), employer (direct and indirect medical costs), and societal (patient's out-of-pocket costs and total medical costs). Costs of study medications were not included because of limited data. Bootstrap method was applied to calculate statistical inference of the incremental cost-effectiveness ratio (ICER). Routine treatment most frequently used included gabapentin (56%), venlafaxine (36%), and amitripytline (15%). From employer and societal perspectives, duloxetine was cost-effective (ICER= -342 dollars and -429 dollars, respectively, per unit of SF-36 BP; both P

Gabapentin for the Management of Chronic Pelvic Pain in Women (GaPP1): A Pilot Randomised Controlled Trial.

Chronic pelvic pain (CPP) affects 2.1-24% of women. Frequently, no underlying pathology is identified, and the pain is difficult to manage. Gabapentin is prescribed for CPP despite no robust evidence of efficacy. We performed a pilot trial in two UK centres to inform the planning of a future multicentre RCT to evaluate gabapentin in CPP management. Our primary objective was to determine levels of participant recruitment and retention. Secondary objectives included estimating potential effectiveness, acceptability to participants of trial methodology, and cost-effectiveness of gabapentin. Women with CPP and no obvious pelvic pathology were assigned to an increasing regimen of gabapentin (300-2700 mg daily) or placebo. We calculated the proportion of eligible women randomised, and of randomised participants who were followed up to six months. The analyses by treatment group were by intention-to-treat. Interviews were conducted to evaluate women's experiences of the trial. A probabilistic decision analytical model was used to estimate cost-effectiveness. Between September 2012-2013, 47 women (34% of those eligible) were randomised (22 to gabapentin, 25 to placebo), and 25 (53%) completed six-month follow-up. Participants on gabapentin had less pain (BPI difference 1.72 points, 95% CI:0.07-3.36), and an improvement in mood (HADS difference 4.35 points, 95% CI:1.97-6.73) at six months than those allocated placebo. The majority of participants described their trial experience favorably. At the UK threshold for willingness-to-pay, the probabilities of gabapentin or no treatment being cost-effective are similar. A pilot trial assessing gabapentin for CPP was feasible, but uncertainty remains, highlighting the need for a large definitive trial.

Long-term cost-effectiveness of initiating treatment for painful diabetic neuropathy with pregabalin, duloxetine, gabapentin, or desipramine.

Painful diabetic neuropathy (PDN) affects nearly half of patients with diabetes. The objective of this study was to compare the cost-effectiveness of starting patients with PDN on pregabalin (PRE), duloxetine (DUL), gabapentin (GABA), or desipramine (DES) over a 10-year time horizon from the perspective of third-party payers in the United States. A Markov model was used to compare the costs (2013 $US) and effectiveness (quality-adjusted life-years [QALYs]) of first-line PDN treatments in 10,000 patients using microsimulation. Costs and QALYs were discounted at 3% annually. Probabilities and utilities were derived from the published literature. Costs were average wholesale price for drugs and national estimates for office visits and hospitalizations. One-way and probabilistic (PSA) sensitivity analyses were used to examine parameter uncertainty. Starting with PRE was dominated by DUL as DUL cost less and was more effective. Starting with GABA was extendedly dominated by a combination of DES and DUL. DES and DUL cost $23,468 and $25,979, while yielding 3.05 and 3.16 QALYs, respectively. The incremental cost-effectiveness ratio for DUL compared with DES was $22,867/QALY gained. One-way sensitivity analysis showed that the model was most sensitive to the adherence threshold and utility for mild pain. PSA showed that, at a willingness-to-pay (WTP) of $50,000/QALY, DUL was the most cost-effective option in 56.3% of the simulations, DES in 29.2%, GABA in 14.4%, and PRE in 0.1%. Starting with DUL is the most cost-effective option for PDN when WTP is greater than $22,867/QALY. Decision makers may consider starting with DUL for PDN patients.