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 / 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

OBJETIVO: Analizar el efecto de la edad y el género sobre el dolor y los costes en pacientes con dolor neuropático periférico (DNp) crónico que inician tratamiento con gabapentina (marca) frente a gabapentina genérica (EFG). MÉTODOS: Estudio multicéntrico-retrospectivo, realizado con registros médicos electrónicos (RME) de pacientes de ambos géneros, > 18años, que iniciaron nuevo tratamiento con gabapentina de marca o genérico. Durante un año se midió la adherencia (ratio posesión medicación [RPM]) y la persistencia, la utilización de recursos sanitarios, los costes y la reducción del dolor. RESULTADOS: Se analizaron 1.369 RME (61,1% mujeres; edad 64,6 [15,9] años, 52,4% ≥ 65 años); marca: 400, EFG: 969. La persistencia y la adherencia fueron mayores con marca: 7,3 vs. 6,3 meses (p < 0,001) y 86,5 vs. 81,3% de RPM (p < 0,001). Con marca, se observaron costes sanitarios menores, tanto en < 65 como en ≥ 65años (diferencias medias por paciente de 221 Euros [IC95%: 59-382] y de 217 Euros [51-382], respectivamente [p < 0,01]), como en hombres (diferencias medias de 197 Euros [63-328]) o mujeres (diferencias de 239 Euros [96-397]), p = 0,005 y p = 0,004, respectivamente. Comparado con EFG, el tratamiento con marca mostró una reducción mayor del dolor: 13,5% (10,9-16,2) y 10,8% (8,2-13,5) en < 65 y ≥ 65 años, respectivamente (p < 0,001), así como del 10,7% (8,2-13,2) y del 13,8% (11,0-16,5) en mujeres y hombres, respectivamente (p < 0,001). CONCLUSIONES: Con independencia del género o la edad, los pacientes que iniciaron tratamiento del DNp con gabapentina de marca vs. genérico mostraron un mayor grado de adherencia y persistencia al tratamiento, repercutiendo en unos menores costes sanitarios, a la vez que se observaron mayores reducciones del dolor

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 Euros221 (95%CI: 59-382) and Euros 217 (95%CI: 51-382) in the < 65 and ≥ 65 age groups, respectively (P < .01). Mean difference in cost among men amounted to Euros 197 (63-328), while mean difference in cost among women amounted to Euros 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

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.

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.

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.

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.

Adding pregabalin or gabapentin for the management of community-treated patients with painful diabetic peripheral neuropathy: a comparative cost analysis.

BACKGROUND AND OBJECTIVE: Painful diabetic peripheral neuropathy (pDPN) is a highly prevalent complication of diabetes mellitus, which is associated with substantial costs to society and national health systems. This economic impact varies depending on the therapeutic management provided to patients. The objective of this study was to compare healthcare resource utilization and costs among pDPN patients newly treated with pregabalin or gabapentin in routine medical practice. METHODS: We performed a retrospective medical records study of pDPN patients newly treated with pregabalin or gabapentin as an add-on therapy who are covered by the Badalona Serveis Assistencials (BSA) health plan, a healthcare provider in Spain, from 2006 to 2009. Healthcare resource utilization and days off work were assessed. The societal perspective was used to estimate costs. RESULTS: Three hundred and ninety-five records were eligible for analysis: 227 (57.5%) included pregabalin and 168 (42.5%) gabapentin. Mean (standard deviation) concomitant use of analgesics throughout the study was higher in the gabapentin cohort [3.9 (2.2) vs. 3.1 (2.1); p < 0.05], mainly due to greater use of non-narcotics (78.0 vs. 71.8%; p < 0.05) and opioids (32.7 vs. 28.6%; p < 0.05). Healthcare costs accounted for 59.2% of total costs, of which 71.9% occurred in primary care, with a mean cost per patient of €2,476 (year 2010 values). Adjusted mean (95% CI) total costs were significantly lower in pregabalin-treated patients [€2,003 (1,427-2,579)] than in gabapentin-treated patients [€3,127 (2,463-3,790)] (p = 0.013), mainly due to lower healthcare costs [€1,312 (1,192-1,432) vs. €1,675 (1,537-1,814); p < 0.001]. CONCLUSIONS: Adding pregabalin to existing pDPN therapy resulted in lower total healthcare costs and lower resource utilization than resulted from adding gabapentin.

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.

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.

Real-world treatment of post-herpetic neuralgia with gabapentin or pregabalin.

BACKGROUND AND OBJECTIVES: There are limited data examining the real-world use of gabapentin and pregabalin for the treatment of post-herpetic neuralgia (PHN). This study examines dosing patterns, therapy outcomes, healthcare utilization and costs of patients with PHN who initiate treatment with gabapentin or pregabalin. METHODS: This was a retrospective administrative claims data analysis from July 2005 to February 2010. Patients with PHN initiating gabapentin or pregabalin (index therapy) from January 2006 to February 2009 were identified and were observed for 12 months after index therapy initiation. Outcomes were mean daily dosages of the index therapy, attainment of minimally effective dosages of gabapentin (≥ 1,800 mg/day) or pregabalin (≥ 150 and ≥ 300 mg/day) persistence, discontinuation, index therapy switching, addition of neuropathic pain medications to index therapy, and healthcare resource use and costs. RESULTS: 1,645 patients were identified. The mean daily dosage was 826 mg for gabapentin and 187 mg for pregabalin. Only 52.6 % of patients initiating gabapentin and 56.9 % initiating pregabalin obtained a refill during the post-index period. Approximately 14 % of patients treated with gabapentin reached the target dosage (1,800 mg/day). For pregabalin, 87 % reached ≥ 150 mg/day and 27 % reached ≥ 300 mg/day. On average, patients took 10 weeks to reach 1,800 mg/day gabapentin, and 5.0 and 9.2 weeks to reach ≥ 150 mg/day and ≥ 300 mg/day pregabalin, respectively. Approximately one-third of patients in both index therapy cohorts added a pain medication; more than half added opioids. The percentage of patients switching from either drug (57 %) or adding a therapy (34 %) were similar between index therapy cohorts; opioids were the most common therapy patients switched to or added. CONCLUSION: It appears that gabapentin and pregabalin are not used effectively to treat PHN. Suboptimal dosing and discontinuation may be associated with supplementary use of other analgesics, especially opioids.

Intended and unintended consequences of the gabapentin off-label marketing lawsuit among patients with bipolar disorder.

OBJECTIVE: The number of lawsuits accusing pharmaceutical companies of off-label marketing has risen in recent years. The impact of such lawsuits on drug prescribing and spending has not been examined. We evaluated a nationwide sample to determine whether the $430 million gabapentin off-label marketing lawsuit and accompanying media coverage affected gabapentin market share, substitution of other scientifically substantiated and unsubstantiated anticonvulsants, and anticonvulsant spending of Medicare/Medicaid patients diagnosed with bipolar disorder. METHOD: Using a national 5% sample of Medicare recipients linked to Medicaid claims, we used an interrupted times series design to evaluate the impact of the lawsuit on monthly market share, utilization, and spending from January 1, 2001, to December 31, 2005. RESULTS: The start of the lawsuit was associated with a 28% relative reduction in gabapentin market share (from ∼ 21% to ∼ 15%) and a reduction in the rate of prescribing from 108 prescriptions per 1,000 patients per month before the start of the lawsuit to 90 by the end of follow-up (P < .001). We also observed increases in market share for 3 other anticonvulsants. Total anticonvulsant use and spending per 1,000 patients increased by 13% and 74%, respectively, after the intervention. The increase in anticonvulsant spending was equivalent to $7,554 per 1,000 patients per year higher than expected compared with the baseline trend (P = .01). CONCLUSIONS: We conclude that the lawsuit resulted in a reduction in gabapentin market share, increased market share for other anticonvulsants, and substantially increased total anticonvulsant spending to approximately half of the settlement amount, not counting substitutions of newer drugs for other illnesses affected by the lawsuit. These findings support the need for further study of the effects of current lawsuits regarding off-label drug marketing.

Implementation of a publication strategy in the context of reporting biases. A case study based on new documents from Neurontin litigation.

BACKGROUND: Previous studies have documented strategies to promote off-label use of drugs using journal publications and other means. Few studies have presented internal company communications that discussed financial reasons for manipulating the scholarly record related to off-label indications. The objective of this study was to build on previous studies to illustrate implementation of a publication strategy by the drug manufacturer for four off-label uses of gabapentin (Neurontin, Pfizer, Inc.): migraine prophylaxis, treatment of bipolar disorders, neuropathic pain, and nociceptive pain. METHODS: We included in this study internal company documents, email correspondence, memoranda, study protocols and reports that were made publicly available in 2008 as part of litigation brought by consumers and health insurers against Pfizer for fraudulent sales practices in its marketing of gabapentin (see http://pacer.mad.uscourts.gov/dc/cgi-bin/recentops.pl?filename=saris/pdf/ucl%20opinion.pdf for the Court's findings).We reviewed documents pertaining to 20 clinical trials, 12 of which were published. We categorized our observations related to reporting biases and linked them with topics covered in internal documents, that is, deciding what should and should not be published and how to spin the study findings (re-framing study results to explain away unfavorable findings or to emphasize favorable findings); and where and when findings should be published and by whom. RESULTS: We present extracts from internal company marketing assessments recommending that Pfizer and Parke-Davis (Pfizer acquired Parke-Davis in 2000) adopt a publication strategy to conduct trials and disseminate trial findings for unapproved uses rather than an indication strategy to obtain regulatory approval. We show internal company email correspondence and documents revealing how publication content was influenced and spin was applied; how the company selected where trial findings would be presented or published; how publication of study results was delayed; and the role of ghost authorship. CONCLUSIONS: Taken together, the extracts we present from internal company documents illustrate implementation of a strategy at odds with unbiased study conduct and dissemination. Our findings suggest that Pfizer and Parke-Davis's publication strategy had the potential to distort the scientific literature, and thus misinform healthcare decision-makers.

Costs, work absence, and adherence in patients with partial onset seizures prescribed gabapentin or pregabalin.

BACKGROUND/OBJECTIVE: Few studies have examined cost of illness of epileptic partial onset seizures (POS) from the employer perspective or compared users of gabapentin and pregabalin in treatment of POS. This study compares pharmacotherapy, direct/indirect costs, and work absences of patients with POS newly started on gabapentin or pregabalin. METHODS: Data from employees and dependent spouses with POS starting treatment (index date) with either gabapentin or pregabalin were analyzed. Patients were required to have at least 6 months of health plan enrollment pre- and post-index. Regression modeling compared medical and prescription costs, sick leave (SL), short-term disability (STD), workers' compensation (WC) costs and absence days during the 6-month post-index period. Persistence, adherence (proportion of days covered), impact on adherence of copay, and copay as a percent of salary were modeled. RESULTS: Semiannual medical, drug, SL, STD, and WC costs for gabapentin vs. pregabalin cohorts were $10,306 vs. $9186, $2353 vs. $3387 (P=0.01), $552 vs. $342, $1280 vs. $580, and $170 vs. $30, respectively. SL days (10.8 vs. 1.5, P=0.04) and STD days (9.8 vs. 6.2) were lower in the pregabalin cohort. Persistence (median 94 vs. 70 days) and proportion with ≥ 80% adherence (30% vs. 15%, P=0.049) were greater in the pregabalin cohort. Adherence decreased as copay or copay as a percent of salary increased beyond specific levels in both cohorts. CONCLUSION: Despite higher acquisition costs for branded pregabalin over generic gabapentin, overall direct and indirect costs trended lower for pregabalin users. Additionally, pregabalin users had significantly fewer sick leave days and significantly higher adherence rates than gabapentin users.

Cost-effectiveness analysis of pharmacologic treatment of fibromyalgia in Mexico.

OBJECTIVE: To identify, from the Mexican Public Health System perspective, which would be the most cost-effective treatment for patients with Fibromyalgia (FM). MATERIAL AND METHODS: A Markov model including three health states, divided by pain intensity (absence or presence of mild, moderate or severe pain) and considering three-month cycles; costs and effectiveness were estimated for amitriptyline (50mg/day), fluoxetine (80 mg/day), duloxetine (120 mg/day), gabapentin (900 mg/day), pregabalin (450 mg/day), tramadol/acetaminophen (150 mg/1300 mg/día) and amitriptyline/fluoxetine (50mg/80 mg/día) for the treatment of FM. The clinical outcome considered was the annual rate of pain control. Probabilities assigned to the model were collected from published literature. Direct medical costs for FM treatment were retrieved from the 2006 data of the Mexican Institute of Social Security (IMSS) databases and were expressed in 2010 Mexican Pesos. Probabilistic Sensitivity Analyses were conducted. RESULTS: The best pain control rate was obtained with pregabalin (44.8%), followed by gabapentin (38.1%) and duloxetine (34.2%). The lowest treatment costs was for amitriptyline ($ 9047.01), followed by fluoxetine ($ 10,183.89) and amitriptyline/fluoxetine ($ 10,866.01). By comparing pregabalin vs amitriptyline, additional annual cost per patient for pain control would be around $ 50.000 and $ 75.000 and would result cost-effective in 70% and 80% of all cases. CONCLUSIONS: Among all treatment options for FM, pregabalin achieved the highest pain control and was cost-effective in 80% of patients of the Mexican Public Health System.

Costs of pregabalin or gabapentin for painful diabetic peripheral neuropathy.

OBJECTIVE: To characterize and compare healthcare resource utilization and costs among patients with painful diabetic peripheral neuropathy (pDPN) newly prescribed pregabalin or gabapentin in a real-world clinical setting. STUDY DESIGN: Retrospective cohort analysis using the MarketScan Commercial Claims and Encounters and Medicare Supplemental Databases (2007-2009). METHODS: Patients with new prescriptions for pregabalin or gabapentin (index event) in 2008 and ≥1 healthcare encounter with an ICD-9 code for pDPN (250.6 or 357.2) within 30 days prior to the first prescription were identified and propensity score matched; continuous enrollment 12 months pre- and post-index was required. Pre- to post-index changes in 12-month all-cause and pDPN-attributable resource utilization and costs were compared between pregabalin and gabapentin using a difference-in-difference (DID) approach. RESULTS: A total of 910 pregabalin patients (48.6% female; mean age 63.3 ± 12.1 years) were matched with 910 gabapentin patients (48.8% female; mean age 63.3 ± 12.1 years). The DID showed no significant differences between cohorts for pre- to post-index changes in any of the all-cause resource utilization categories. While prescription costs increased significantly more with pregabalin (DID -$563; p < 0.0001), the DID of $1603 for total healthcare costs per patient indicated that the pre- to post-index increases of $3081 for pregabalin and $4684 for gabapentin patients were comparable (p = 0.8474). Total pDPN-attributable healthcare costs were significantly higher with pregabalin (DID -$385; p < 0.0001), resulting from higher prescription costs (DID -$432; p < 0.0001). Limitations of this study include the inability to specifically link pDPN with medication prescribing; differences between groups despite propensity score matching; use of proxy measures for adherence parameters; and inability to capture efficacy outcomes. CONCLUSIONS: Among patients initiating pregabalin or gabapentin, there were no significant differences between the drugs in the pre- to post-index changes in all-cause total healthcare costs, despite the increase in prescription costs for pregabalin.

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.

Cost analysis of adding pregabalin or gabapentin to the management of community-treated patients with peripheral neuropathic pain.

OBJECTIVE: To compare the cost of adding either pregabalin or gabapentin to the management of community-treated patients with peripheral neuropathic pain (PNP). METHODS: A retrospective observational study was conducted using medical records from a Spanish health care provider claims database. Patients receiving health care for PNP, above 18 years and for which either pregabalin or gabapentin was initiated between 2006 and 2008 were included. Economic evaluation included health care resource utilization costs and costs due to sick leave. RESULTS: A total of 1163 patients with PNP were eligible for analysis: 764 were prescribed pregabalin and 399 gabapentin in addition to current pain therapy. Mean age was 59.2 years and 62.2% were female. Concomitant use of analgesics was higher in the gabapentin cohort (3.2 vs. 2.7; P = 0.003), mainly due to non-steroidal anti-inflammatory drugs (74.9% vs. 69.5%; P = 0.018) and opioids (27.7% vs. 17.9%; P = 0.031). Adjusted total costs per patient was lower in pregabalin-treated patients (€2514 vs. €3241; P = 0.003), due to less sick leave (€1067 vs. €1633; P = 0.018) and lower health care costs (€1447 vs. €1609; P = 0.004). The higher acquisition cost of pregabalin (€351 vs. €191; P < 0.001) was largely compensated with lower costs in medical visits, physiotherapy, hospital stays and concomitant analgesics. CONCLUSIONS: In community-treated patients with PNP, total costs were considerably less for those patients initiated with pregabalin therapy than for those patients starting gabapentin add-on therapy. The relatively higher treatment acquisition cost of pregabalin was largely compensated by the overall lower costs for the other components of health care resources and sick leave, thus reducing the economic impact on the health care provider's budget and society.