Development and psychometric properties of a measurement to ascertain the impact of genitourinary symptoms on health-related quality of life in menopausal women: the Cervantes-GSM questionnaire.

OBJECTIVE: The Cervantes-GSM questionnaire is a novel tool currently being developed to examine the impact of genitourinary symptoms on health-related quality of life in adult women with genitourinary syndrome of menopause (GSM). METHODS: A literature review and cognitive debriefing were conducted in women with GSM, which provided the basis for creating a draft questionnaire. This draft version was pilot-tested to check participant comprehension and ease of completion. The initial draft was then refined to obtain a 15-item version with five domains whose initial psychometric properties were analyzed in 130 adult women with GSM. The psychometric properties tested in this study were factorial structure, feasibility, reliability, and construct validity. RESULTS: The Cervantes-GSM 15-item questionnaire consists of five domains: vulvovaginal symptoms, urinary symptoms, psychological (emotions), interference with daily activities, and sexuality. The instrument was shown to be feasible and easy to complete, regardless of age or educational level. Internal consistency was high (Cronbach α = 0.88). Construct validity was supported by convergent-divergent validity showing higher correlation coefficients between items in their own domain (>0.70) than with the other items and domains in the questionnaire. Cervantes-GSM also showed known group validity with significant differences in total score and most domains (13-20 points, P < 0.01) regardless of whether women chose local treatment of their genitourinary symptoms. CONCLUSION: This study presents a novel questionnaire capable of assessing health-related quality of life in menopausal women with GSM. The tool has shown acceptable preliminary psychometric properties, including feasibility, factor structure, construct validity, and internal consistency.

Disease burden and costs for patients with hip and knee osteoarthritis and chronic moderate-to-severe refractory pain on treatment with strong opioids in Spain.

INTRODUCTION AND OBJECTIVES: To determine the disease burden and costs in patients with hip or knee OA and chronic moderate-to-severe refractory pain, receiving strong opioids in Spain. MATERIALS AND METHODS: This was a 36-month longitudinal secondary analysis of the real-word OPIOIDS study. Patients aged ≥18 years with hip or knee OA and chronic moderate-to-severe refractory pain receiving strong opioids were considered. The disease burden included analgesia assessments (NRS scale), cognitive functioning (MMSE scale), basic activities of daily living (Barthel index), and comorbidities (severity and frequency). Costs due to the use of healthcare resources and productivity loss were estimated. RESULTS: 2832 patients were analyzed; age was 72.0 years (SD=14.3), 76.8% were women. Patients had mainly been treated with fentanyl (n=979; 37.6%), tapentadol (n=625; 24.0%), oxycodone (n=572; 22.0%), and buprenorphine (n=425; 16.3%). Pain intensity decreased by 1 point (13.7%), with a 2.6-point decline in the cognitive scale (14.3%, with a 5.3%-increase in patients with cognitive deficit) over a mean treatment period of 384.6 days (SD: 378.8). Barthel scores decreased significantly yielding to a slightly increase in proportion of patients with severe-to-total dependency; 1.2%-2.9%. In the first year of treatment, average healthcare costs were €2013/patient, whereas the average productivity loss cost was €12,227/working-active patient. DISCUSSION AND CONCLUSIONS: Strong opioids resulted in high healthcare costs with a limited reduction in pain, an increase in cognitive deficit, and a slight increase of patients with severe to total dependency over 36 months of treatment.

Disease burden and costs for patients with hip and knee osteoarthritis and chronic moderate-to-severe refractory pain on treatment with strong opioids in Spain / Carga de la enfermedad y costes en pacientes con osteoartritis de cadera y rodilla con dolor crónico refractario moderado-severo tratados con opioides mayores en España

Introduction and objectives: To determine the disease burden and costs in patients with hip or knee OA and chronic moderate-to-severe refractory pain, receiving strong opioids in Spain. Materials and methods: This was a 36-month longitudinal secondary analysis of the real-word OPIOIDS study. Patients aged ≥18 years with hip or knee OA and chronic moderate-to-severe refractory pain receiving strong opioids were considered. The disease burden included analgesia assessments (NRS scale), cognitive functioning (MMSE scale), basic activities of daily living (Barthel index), and comorbidities (severity and frequency). Costs due to the use of healthcare resources and productivity loss were estimated. Results: 2832 patients were analyzed; age was 72.0 years (SD=14.3), 76.8% were women. Patients had mainly been treated with fentanyl (n=979; 37.6%), tapentadol (n=625; 24.0%), oxycodone (n=572; 22.0%), and buprenorphine (n=425; 16.3%). Pain intensity decreased by 1 point (13.7%), with a 2.6-point decline in the cognitive scale (14.3%, with a 5.3%-increase in patients with cognitive deficit) over a mean treatment period of 384.6 days (SD: 378.8). Barthel scores decreased significantly yielding to a slightly increase in proportion of patients with severe-to-total dependency; 1.2%–2.9%. In the first year of treatment, average healthcare costs were €2013/patient, whereas the average productivity loss cost was €12,227/working-active patient. Discussion and conclusions: Strong opioids resulted in high healthcare costs with a limited reduction in pain, an increase in cognitive deficit, and a slight increase of patients with severe to total dependency over 36 months of treatment.(AU)

Introducción y objetivos: Determinar la carga de la enfermedad y los costes en pacientes con osteoartritis de cadera y rodilla y dolor crónico refractario moderado-severo, en tratamiento con opioides mayores en España. Materiales y métodos: Se trata de un subanálisis de 36 meses de duración, procedente del estudio observacional OPIOIDS. Participaron pacientes con una edad ≥18 años, diagnosticados con osteoartritis de cadera y rodilla y dolor crónico refractario moderado-severo, en tratamiento con opioides mayores. La carga de la enfermedad incluyó la evaluación de la analgesia (escala NRS), del funcionamiento cognitivo (escala MMSE), de la capacidad para realizar las actividades de la vida diaria (índice de Barthel) y de las comorbilidades (gravedad y frecuencia). También se estimaron los costes asociados al uso de recursos sanitarios y a la productividad laboral. Resultados: Se analizaron 2.832 pacientes (edad: 72,0 años [DE: 14,3]; mujeres: 76,8%), que habían sido principalmente tratados con fentanilo (n=979; 37,6%), tapentadol (n=625; 24,0%), oxicodona (n=572; 22,0%) y buprenorfina (n=425; 16,3%). La intensidad del dolor disminuyó una unidad (13,7%), con una reducción de 2,6 unidades en la escala cognitiva (14,3% y aumento del 5,3% en los pacientes con déficit cognitivo) durante una media de 384,6 días (DE: 378,8). Las puntuaciones en la escala de Barthel disminuyeron significativamente, con un ligero aumento en la proporción de pacientes con dependencia grave/total, entre 1,2% y 2,9%. En el primer año, los costes sanitarios medios fueron 2.013€/paciente, mientras que los costes medios de pérdida de productividad fueron 12.227€/trabajador. Discusión y conclusiones: El tratamiento con opioides mayores durante 36 meses implicó elevados costes sanitarios, con una eficacia analgésica limitada, un aumento del déficit cognitivo y un ligero aumento de los pacientes con dependencia grave/total.(AU)

Sensitivity-to-change and predictive validity of the Cervantes Short-Form (C-SF) questionnaire in postmenopausal women.

OBJECTIVES: To explore, for the first time, the ability of the Cervantes Short-Form (C-SF) questionnaire to detect and to predict meaningful changes (sensitivity-to-change and predictive validity) in women with menopausal symptoms receiving any therapeutic management under routine medical care. METHODS: Postmenopausal women included in a registry study were the source of data. Sensitivity-to-change was explored by assessing the responses of C-SF to different type of treatment management: no treatment, natural therapies or systemic hormonal therapy (SHT). Predictive validity assessed the ability of baseline score to predict the reduction in the impact of menopausal symptoms in C-SF scoring equal or higher than one time its minimally important difference (MID) of improvement (response rate). RESULTS: A total of 245 women were enrolled. C-SF score was significantly reduced (better QoL) with SHT by 10.62 points versus no change or 2.32 point by natural therapies or no treatment, respectively (p < 0.001 in both cases). Women declaring better improvement after treatment showed higher significant reduction in C-SF score versus those with no self-perceived improvement or impairment: -12.49 point versus +1.06 and +12.71, respectively (p < 0,01 in both cases). Responder rate showed a significant lineal growing trend with higher C-SF scoring at baseline in women who received SHT: higher scoring showed higher response rates (lineal Chi2 = 15.9, p < 0.001), but not in the case of receiving natural therapies or no treatment. CONCLUSIONS: C-SF was shown to be sensitive-to-change when postmenopausal QOL status changes due to mainly systemic hormonal treatment, therefore, supporting the utilization of this instrument to monitor response to treatment. Likewise, pre-treatment scoring in C-SF was able to predict woman's QOL meaningful response with hormonal treatment.

Development and psychometric properties of the human papillomavirus-quality of life (HPV-QoL) questionnaire to assess the impact of HPV on women health-related-quality-of-life.

PURPOSE: The HPV-Quality-of-Life (HPV-QoL) questionnaire was developed to determine the impact of Human-Papillomavirus (HPV) infection and related interventions on women health-related quality-of-life. This study provides the development and preliminary psychometric properties of a novel HPV-QoL questionnaire for adult women with HPV. METHODS: After reviewing literature and cognitive debriefing interviews in women who had experienced HPV-related conditions, instrument items and domains were developed. A draft questionnaire was pilot tested for comprehension and ease of completion. Psychometric evaluation of the final HPV-QoL scale was conducted in a psychometric study including 252 adult women derived to our centre by a positive HPV test in the cervical cancer screening program and/or presenting genital warts. RESULTS: The present study reveals that the HPV-QoL questionnaire, structured in four domains: general well-being [including psychological well-being and social well-being subdomains], health, contagiousness and sexuality, showed good metric properties of feasibility irrespective of age or educational level, and time to administer was less than 5 min. Internal consistency and temporal stability (reliability) showed values above the acceptable standards. The instrument showed its concurrent validity by means of a significant correlation with mental and sexual existing instruments; GHQ-12 and FSFI questionnaires, respectively, and also known groups validity showing significant differences among the subgroups regarding either sexual dysfunction or mental deterioration. CONCLUSION: This study provides an HPV-QoL questionnaire with an innovative patient-reported outcomes specific measurement tool to assess HRQoL in women with HPV infection. The present study suggests this questionnaire has satisfactory psychometric properties, including validity and reliability. Results support the use of the HPV-QoL questionnaire as a HRQoL measurement instrument for daily medical practice and clinical research.

Sick Leave and Costs in Active Workers with Chronic Osteoarthritis Pain in Spain: Outcomes of the OPIOIDS Real World Study.

Purpose: To estimate the number of sick leave days and productivity costs in active workers with osteoarthritis (OA) who initiated opioid treatment for moderate/severe chronic pain in clinical practice in Spain. Patients and Methods: This is a secondary analysis of the longitudinal, retrospective OPIOIDS study, using electronic medical records (EMR) of patients aged ≥18 years, who started an opioid treatment for moderate/severe chronic OA pain between 2010 and 2015 after treatment failure with ≥1 first-line drugs (acetaminophen, metamizole and/or nonsteroidal anti-inflammatory drugs [NSAIDs]). The number of days of sick leave and productivity costs were analyzed during a follow-up period of 36 months. Results: A total of 5089 patients with moderate/severe chronic OA pain, aged 56.8 years (standard deviation [SD]: 4.6) (56.6% were female), were analyzed: 73.3% of them started a treatment with weak opioids and 26.7% of them were treated with strong opioids. At 36 months, adherence was 21.0% (strong opioids: 15.4%; weak opioids: 23.0%; p<0.001), and 77% of patients had at least one sick leave related with chronic OA pain, with an average of 93 days off work in all working patients (120.5 days in patients with sick leaves). Besides, 16.9% of the study population had sick leave periods that lasted at least 6 months. Pain reduction was modest (-1.2 points; -4.0%, p<0.001). The cost of sick leave was €2594 patient/year, and factors such as older age (ß=0.043), female sex (ß=0.036), comorbidities (ß=0.035) and strong opioid use (ß=0.031) were associated with higher productivity costs (p<0.05 in all associations). Conclusion: Active workers who started opioid treatment for moderate/severe chronic OA pain showed an increased frequency of sick leave and productivity cost, with a modest effect on pain relief. Older age, female sex, comorbidities, and strong opioids were associated with higher costs for society.

Cost-effectiveness analysis of a lung cancer screening programme in Spain.

OBJECTIVE: To evaluate the cost-effectiveness of the implementation of national lung cancer (LC) screening programme (SP) in a high-risk population from the perspective of the Spanish National Health System (NHS). METHODS: A cost-effectiveness analysis for a LC SP was carried out on a lifetime horizon. A Markov model was designed that assumed two scenarios, one with the implementation of the SP and another one without it. Effectiveness and cost of LC management, diagnosis and screening were included in the different health states. Deterministic and probabilistic sensitivity analyses were conducted to evaluate its robustness. A discount rate was set at 3% both for effectiveness and cost. RESULTS: In the base-case, an increase of 4.80 quality-adjusted life years (QALY) per patient was obtained, resulting in an incremental cost-effectiveness ratio of €2345/QALY. Probabilistic sensitivity analysis showed the national LC SP to be cost-effective in 80% of cases (probability=0.8) for a willingness-to-pay threshold equivalent to the gross domestic product per capita in Spain, which was set at €25 854/QALY in 2018 based on the per capita income of Spain. The sensitivity analysis indicates that the obtained results are robust in terms of changes in the presentation rates and costs, and the cost-effectiveness thresholds. CONCLUSIONS: This analysis suggests that the implementation of a LC SP in the high-risk Spanish population would be a cost-effective strategy for the Spanish NHS.

Future projections of opioid use and cost in patients with chronic osteoarthritis pain in Spain.

BACKGROUND: Opioids are widely used in moderate-to-severe chronic pain which is non-responsive to standard analgesics. Prescriptions have increased in Europe in the last decade, although remain lower than in USA. This work projected the future utilization and costs of opioids in chronic osteoarthritis (OA) pain in the Spanish National Health System (NHS). METHODS: An epidemiological model was populated with the opioid dispensing trends from 2010 to 2019 using Spanish Medicinal Agency rates of opioid utilization in subjects over 18 years of age and the real-world OPIOIDS study to estimate chronic-OA-pain patients receiving opioids. A best-fitted trend analysis model was applied estimating the likely number of DHD (defined daily dose/1000 inhabitants per day) to calculate projected opioid utilization and costs for the period 2020-2029. RESULTS: In 2010, an estimated 5.67 DHD were dispensed for the equivalent of 217,076 chronic OA pain patients per day [1.99 DHD, 76,084 refractory to non-steroidal anti-inflammatory drugs (NSAIDs)]. From these trends and OA prevalence, the projected number of DHDs is expected to increase more than threefold to 17.98 DHDs by the year 2029 for the equivalent of 727,356 chronic OA pain patients per day (8.18 DHD, 330,720 refractory to NSAIDs); 41.8% on strong opioids. The estimated cost was €116.9m (€45.0m in NSAID-refractory OA) in 2010 rising by 222% to €376.1m (€199.7m refractory to NSAIDs) by 2029. CONCLUSION: Chronic-OA-pain-related opioid dispensing and costs to the NHS are set to increase more than threefold from 2010 to 2029 in Spain. Using opioids for OA pain is concerning given disease chronicity and other related costs not computed in these projections. PLAIN LANGUAGE SUMMARY: • Opioids are widely used in chronic pain which is non-responsive to standard analgesics. Prescriptions have increased in Europe, although remain lower than in USA. Osteoarthritis (OA) is a degenerative joint disease usually accompanied by pain. Despite not recommended, opioids use in OA have been expanded because this health condition is increasing with ageing and, also, because physicians both primary and specialist boosted their use.• This study aimed to quantify the current burden of opioids used for chronic moderate-to-severe OA pain by estimating the number of defined daily doses per 1000 inhabitants per day (DHD) and associated costs, and to forecast the likely burden on the National Health System (NHS) in Spain for the years 2020-2029.• In 2010, an estimated 5.67 DHDs were dispensed for the equivalent of 217,076 chronic OA pain patients per day. From these trends, the projected number of DHDs is expected to increase more than threefold to 17.98 DHDs by the year 2029 for the equivalent of 727,356 chronic OA pain patients per day; 41.8% on strong opioids. The estimated cost was €116.9m in 2010 rising by 222% to €376.1m by 2029.• Chronic OA-pain-related opioid dispensing and costs to the NHS are set to increase substantially (threefold to more than fourfold) from 2010 to 2029 in Spain. Thus, using opioids for OA pain is concerning given disease chronicity, aging population and other related costs not computed in these projections. Our findings can inform payors and clinicians about ongoing discussions on appropriate analgesic management for longer-term OA pain, including resource requirements at a national level. Clinicians who prescribe opioids for OA pain should consider the potential implications of side effects such as sedation, cognitive deterioration, incremental need of caregivers, particularly in older people, and carefully consider the risk-benefit balance.

Patient self-reported functioning by pain severity and usual analgesic treatment among older adults with osteoarthritis: analysis of the 2017 Spanish National Health Survey.

PURPOSE: Osteoarthritis (OA) pain is among the leading causes of disability worldwide in older people. Since its prevalence is growing in aging, a significant burden for society is expected. This work ascertained whether level of disability in self-reported functioning differs by pain severity and usual analgesic treatment among older OA patients in Spain. METHODS: The Spanish-National-Health-Survey, a large, nationally representative, cross-sectional general health survey including 23,089 persons, was analyzed. Patients aged 65 + years with a self-reported physician OA diagnosis were classified according to severity of pain (no/mild, moderate or severe pain) and treated or untreated with analgesia. Assessment of function included basic and instrumental activities-of-daily-living (BADL, IADL), mental, social, and cognitive functions, scored on a 0% (no limitation) to 100% (complete limitation) standardized metric. Caregiver need for BADL and IADL was also recorded. RESULTS: A total of 3526 patients were analyzed (women 73.3%; age 77.4 [SD: 7.5]). Adjusted functioning scores showed significant association with pain severity, and for BADL, IADL and social function. Patients with severe pain and treated with analgesia had higher limitation scores, ranging on average between 31.5% on BADL, 34.1% on IADL, 45.0% on mental, 42.2% on social, and 23.4% in cognitive domain. The proportions of patients needing a caregiver for BADL (43.4%) and IADL (56.2%) were also the highest in patients with severe pain and treated with analgesia. CONCLUSIONS: Regardless of usual utilization of analgesics, the severity of pain seemed to be the major determinant of functional impairment, and caregiving need, in all domains of functioning in older OA patients in Spain. Existing treatment strategies are analgesics based and do not meet patient needs for adequate pain management.

Disease Burden and Costs in Moderate-to-Severe Chronic Osteoarthritis Pain Refractory to Standard of Care: Ancillary Analysis of the OPIOIDS Real-World Study.

INTRODUCTION: To determine the disease burden and costs in moderate-to-severe chronic osteoarthritis (OA) pain refractory to standard-of-care treatment in the Spanish National Health System (NHS). METHODS: Ancillary analysis of the OPIOIDS real-world, non-interventional, retrospective, 4-year longitudinal study including patients aged at least 18 years with moderate-to-severe chronic OA pain refractory to standard-of-care with sequential NSAIDs plus opioids. Burden assessment included measurement of analgesia, cognitive functioning, basic activities of daily living, severity and frequency of comorbidities, and all-cause mortality. Costs accounted for healthcare resource utilization and related costs (year 2018). RESULTS: Records of 13,317 patients were analyzed; 68.9 (14.7) years old, 71.3% (70.5-72.1%) women, 58.1% refractory to NSAID plus weak opioid and 41.9% to NSAID plus strong opioid, accounting for 10.7% (10.5-10.8%) of patients with chronic OA pain. Mean number of comorbidities was 2.9 (1.8) and its severity was 1.8 (1.7). Pain decreased by 0.9 points (12.2%) and cognitive declined by 2.3 points (9.1%, with 4.3% more patients with cognitive deficit) and dependency worsened by 0.4 points (0.5%, with 2.3% more patients with severe-to-total dependence) over a mean treatment period of 188.6 (185.4-191.8) days on NSAIDs followed by 400.6 (393.7-407.5) days on opioids. The adjusted mortality rate was higher in patients with OA taking NSAID plus strong opioids; hazard ratio 1.44 (1.26-1.65; p < 0.001). The 4-year healthcare cost was €7350/patient (€7193-7507 or €1838/year) and was higher in those taking strong versus weak opioids; €9886 (€9608-10,164, €2472/year) vs. €5519 (€5349-5689, €1380/year), p < 0.001. Analgesia cost (16.0% of total cost, 70.2% opioids) was higher with strong versus weak opioids, 19.6% vs. 11.3%, p < 0.001. CONCLUSIONS: In routine clinical practice in Spain, patients with moderate-to-severe chronic OA pain refractory to standard analgesic treatment with NSAIDs plus opioids reported modest reductions in pain, while presenting a considerable burden of comorbidities, cognitive impairment, and dependency. Healthcare costs significantly increased for the NHS particularly with NSAIDs plus strong opioids.

Disability-adjusted life expectancy lost due to pain severity and usual analgesic treatment among older adults with osteoarthritis in Spain.

BACKGROUND: Osteoarthritis (OA) is a seriously debilitating disease, which prevalence is growing in aging population becoming a substantial burden (BoD) to society. AIM: To assess disability-adjusted life expectancy (DALE) lost by pain severity and usual analgesic treatment among OA adults 65 + year in Spain. METHODS: The National Health Survey, a large, nationally representative, cross-sectional general health survey administered to 23,089 individuals was the data source. Data on subjects of 65 + years with a self-reported physician diagnosis of OA were analysed. Records were cross-classified by pain severity (no pain/mild pain, moderate pain and severe pain) and use of usual analgesics. DALE lost was used as a summary measure of BoD and expressed as both number of years of healthy life-expectancy lost due to disability and percentage of life-expectancy lost. RESULTS: 3389 records were analysed [women 73.3%; age 77.4 (SD 7.5) years]. Older OA patients showed a mean (95% CI) DALE loss of 3.5 (3.3-3.7) years, that represented on average a loss of 35.6% (33.8-37.4) as a percentage of life expectancy. Higher pain severity and analgesic treatment was statistically linked to more years of DALE lost; from 2.8 (2.3-3.2), in no/mild, to 9.0 (8.6-9.4) years in severe pain, and from 32.2% (27.5-36.9) to 90.9% (86.5-95.3) of life expectancy, respectively. DISCUSSION: In Spain, older adults with moderate to severe OA pain receiving usual analgesics showed a substantial BoD in terms of years of DALE lost and percentage of life expectancy lost. CONCLUSIONS: Patients with treated moderate to severe pain showed a more significant burden in term of DALE lost despite analgesic treatment, which apparently fails to meet pain management needs.

Disease burden on health care by pain severity and usual analgesic treatment in patients with symptomatic osteoarthritis: a Spanish nationwide health survey.

BACKGROUND: Osteoarthritis (OA) pain is a health care highly demanding and costing condition. OBJECTIVE: To estimate disease burden on health care in OA in Spain, determining whether burden differs by pain severity and usual analgesic treatment. METHODS: A cross-sectional design using the 2017-Spanish-National-Health-Survey was used to abstract data of 5,234 adult patients (women 70.8%; 69.9 years) with a self-reported physician OA diagnosis. Patients were assembled according to pain severity (no/mild, moderate, severe) and use of usual analgesia (treated [66.5%]/untreated). Healthcare resource utilization (HRU) and corresponding costs were expressed Per-Patient-Per-Year (PPPY) and adjusted for covariates. RESULTS: Average (SD) healthcare cost was €2,274 (5,461) PPPY, with costs linked to outpatient medical visits being the major driver; ~43%. Adjusted PPPY medical visits, days of hospitalization, other healthcare visits, and corresponding costs were significantly higher in severe pain OA patients, compared to moderate or mild/no pain regardless of being currently treated with usual analgesics or not (p < 0.001). Treated OA patients showed higher HRU and costs than untreated patients. CONCLUSIONS: Severity of pain was the main driver of HRU and costs in OA patients from a nationwide representative survey in Spain. These findings seem to be more consistent in treated versus not treated patients with usual analgesics.

Health outcomes and costs in patients with osteoarthritis and chronic pain treated with opioids in Spain: the OPIOIDS real-world study.

OBJECTIVE: The objective of this study was to analyze health outcomes, resource utilization, and costs in osteoarthritis patients with chronic nociceptive pain who began treatment with an opioid in real-world practice in Spain. METHODS: We designed a non-interventional, retrospective, longitudinal study with 36 months of follow-up using electronic medical records (EMRs) from primary care centers, of patients aged 18+ years who began a new treatment with an opioid drug in usual practice for chronic pain due to osteoarthritis. Health/non-health resource utilization and costs, treatment adherence, pain change, cognitive functioning, and dependence for basic activities of daily living (BADL) were assessed. RESULTS: A total of 38,539 EMRs [mean age (SD); 70.8 (14.3) years, 72.3% female; 53.3% hip/knee, 25.0% spine, and 21.7% other sites] were recruited. A total of 19.1% of patients remained on initial opioid at 36 months, without significant differences by osteoarthritis site (p = 0.125). Mean total adjusted cost was €17,915, with 27.7% corresponding to healthcare resources and 72.3% to lost productivity. Hospital admissions for osteoarthritis-related surgical interventions accounted for 15.8% of total healthcare cost. A slight mean pain reduction was observed: -1.3 points, -16.9%, p < 0.001, with increases in cognitive deficit (+3.3%, p < 0.001) and moderate to total dependence for BADL (+15.6%, p < 0.001) in a median duration of opioid use of 203 days (IQR: 89-696). CONCLUSIONS: In real-world practice in Spain, opioid use in osteoarthritis was high, but with low adherence. There were meaningful increases in resource use and costs for the National Health System. Pain reduction was modest, whereas cognitive impairment and dependence for BADL increased significantly.

Economic Evaluation of Combining Pharmaco- and Behavioral Therapies for Smoking Cessation in an Occupational Medicine Setting.

OBJECTIVE: To estimate the budget impact (BI) of funding pharmaco+behavioral therapies for smoking cessation from an employer perspective. METHODS: A hybrid economic model was applied to estimate the BI, which considered up to four cessation attempts over a 3-year horizon. The model estimated the costs of funding a cessation programme, and the mean savings due to avoided loss of productivity and absenteeism because of smoking cessation. RESULTS: 53.8% of smokers quit smoking. The programme, which costs &OV0556;394,468, would generate earnings of &OV0556;1,342,133; with &OV0556;644,974 in incremental net savings. These mean &OV0556;1.64 in return per each euro invested. Results show net benefits from two cigarettes smoked while working every day. CONCLUSIONS: Considering the avoided costs of loss of productivity and absenteeism, funding a smoking cessation programme of pharmaco+behavioral therapies would produce substantial savings for the employer.

Consequences on economic outcomes of generic versus brand-name drugs used in routine clinical practice: the case of treating peripheral neuropathic pain or generalized anxiety disorder with pregabalin.

BACKGROUND: Discrepancies are seen between arguments in favor of and against prescribing generic versus brand-name drugs. OBJECTIVE: To provide real-world evidence on treatment persistence, economic and clinical outcomes of pregabalin, generic versus brand-name (Lyrica®, Pfizer), routinely used to treat neuropathic pain (NP) or generalized anxiety disorder (GAD). METHODS: Electronic medical records from subjects' first starting treatment with pregabalin between January-2015 and June-2016 were analyzed. Persistence, resources utilization, and costs were assessed, along with remitter and responder rates. RESULTS: A total of 4860 records were analyzed. Discontinuation was lower with brand-name than with generic in NP (adjusted hazard ratio [HR]: 0.70 [95% CI: 0.58-0.85], p < 0.001) and GAD patients (HR: 0.63 [0.45-0.84], p < 0.001). Adjusted mean total costs were lower with brand-name: €1500 [1428-1573] vs. €2003 [1864-2143] in NP and €1528 [1322-1734] vs. €2150 [1845-2454] in GAD (both p < 0.001). More patients were remitters/ responders with brand-name in NP (55.0% vs. 46.7% and 59.2% vs. 48.4%, respectively; p < 0.001) and GAD (58.6% vs. 48.7% and 64.6% vs. 47.2%, respectively; p < 0.001). CONCLUSIONS: As a consequence of higher persistence in routine practice, patients who first started therapy with pregabalin brand-name versus generic showed better pain or anxiety outcomes at a lower cost to payers in Spain.

Cost of treating peripheral neuropathic pain with pregabalin or gabapentin at therapeutic doses in routine practice.

AIM: To analyze the cost of peripheral neuropathic pain (PNP) treatment with pregabalin or gabapentin at therapeutic doses in routine clinical practice. METHODS: Analysis of a retrospective, observational study of electronic medical records of patients treated for PNP with therapeutic doses of pregabalin or gabapentin, with 2 years' follow-up, considering PNP type, comorbidities, concomitant analgesia and resource use. RESULTS: The weighted total average cost/patient was lower for pregabalin than gabapentin (€2464 [2197-2730] vs €3142 [2670-3614]; p = 0.014) due to significantly lower both healthcare and non-healthcare costs. This is explained by a significantly lower use of concomitant analgesia, fewer primary care visits and fewer days of sick leave. CONCLUSION: At therapeutic doses, pregabalin was found to have lower healthcare and non-healthcare costs than gabapentin in routine practice.

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.

Budgetary Impact Analysis of Reimbursement Varenicline for the Smoking-Cessation Treatment in Patients with Cardiovascular Diseases, Chronic Obstructive Pulmonary Disease or Type-2 Diabetes Mellitus: A National Health System Perspective.

AIMS: The study aimed to assess the budgetary impact (BI) of reimbursing varenicline in patients with chronic obstructive pulmonary disease (COPD), type-2 diabetes mellitus (t2-DM) or cardiovascular diseases (CVD). METHODS: The BI was estimated comparing the current non-reimbursed scenario versus a projected reimbursed scenario using the Spanish National Health System (SNHS) perspective. A hybrid model was developed using epidemiological data and Markov chains to estimate smoking cessation rates with varenicline during a 5-year horizon. Costs of cessation were considered in the reimbursement scenario only. Efficacy, expressed as a 1-year continuous abstinence rate, was derived from clinical trials. Cost savings due to smoking cessation were extracted from local cost-of-illness studies. Results are shown as incremental cost savings. Univariate sensitivity analysis was also applied. RESULTS: A total of 68,684 patients stopped smoking in the reimbursed scenario compared with 15,208 without reimbursement. In the reimbursed scenario, total savings accounted for €36.3 million, showing 14.6 million accumulated additional savings compared with the scenario without reimbursement. Sensitivity analyses showed results to be robust with monetary savings starting in the third year of modeling. CONCLUSION: Reimbursement of varenicline in smoking cessation is a cost-effective health policy in the SNHS in COPD, t2-DM or CVD, and could produce cost savings starting in the third year of implementation.

Evaluación económica de la desvenlafaxina en el tratamiento de la depresión mayor en España / Economic evaluation of desvenlafaxine in the treatment of major depressive disorder in Spain

INTRODUCCIÓN: El objetivo del análisis fue evaluar el valor clínico y económico del uso de desvenlafaxina-50 mg comparado con la práctica médica (pool de pacientes tratados con duloxetina o venlafaxina) tras el fracaso del tratamiento de primera línea de la depresión mayor en España. MATERIALES Y MÉTODOS: Modelo Markov que sigue una cohorte de pacientes diagnosticados con depresión mayor, tras el fracaso del tratamiento de primera línea con inhibidores selectivos de la recaptación de serotonina y estima la respuesta al tratamiento (porcentaje de remisión y días libres de depresión) y los costes directos incurridos durante el tratamiento. Los datos de eficacia considerados en el análisis fueron obtenidos de ensayos clínicos a partir de una revisión de la literatura. Los principales supuestos del modelo, así como el uso de recursos, fueron validados por expertos clínicos. El análisis de realizó en el año 2014 desde la perspectiva del Sistema Nacional de Salud. RESULTADOS: Debido al menor número de discontinuaciones, iniciar el tratamiento de segunda línea con desvenlafaxina se asoció a un mayor número de días libres de depresión (+1,7) y un mayor porcentaje de pacientes en remisión (+0,5%). Esto se tradujo en un menor coste farmacológico y del manejo de los eventos y en un ahorro total para el Sistema Nacional de Salud de 108 €. CONCLUSIONES: En pacientes no respondedores al tratamiento con inhibidores selectivos de la recaptación de serotonina en primera línea de la depresión mayor, desvenlafaxina-50 mg mostró una efectividad clínicamente similar a los otros tratamientos usados en la práctica médica, pero con un menor coste para el Sistema Nacional de Salud

INTRODUCTION: The objective of this analysis was to evaluate the clinical and economic value of the use of 50 mg-desvenlafaxine compared to the usual care (mix of duloxetine and venlafaxine) in the outpatient treatment of major depressive disorder after first line treatment failure (relapse) in Spain. MATERIALS AND METHODS: A Markov model was used to follow up a cohort of major depressive disorder patients for one year after failure of first-line treatment with a serotonin-specific reuptake inhibitor and estimate outcome measures (percentage remission and depression-free days) and accrued and direct costs incurred during outpatient treatment of major depressive disorder. In order to obtain the efficacy data related to the treatment alternatives, a literature review of clinical trials was performed. A panel of clinical experts validated the use of clinical resources employed in the estimation of economic outcomes together with model assumptions. The analysis was performed in 2014 from the perspective of the National Health System. RESULTS: Due to fewer discontinuations, initiating second line treatment with desvenlafaxine was associated with more depression-free days and a higher percentage of patients in remission versus usual care: 1.7 days and 0.5%, respectively. This was translated into lower drug and events management costs, and an overall cost reduction of € 108 for the National Health System. CONCLUSIONS: In patients who have not responded to a first-line serotonin-specific reuptake inhibitor therapy, desvenlafaxine-50 mg was clinically similar in effectiveness, but a less costly option, compared with a weighted average of duloxetine and venlafaxine for the second-line treatment of major depressive disorder patients from a payer (National Health System) perspective in Spain

[A Dynamic Model to Estimate the Budget Impact of a Pneumococcal Vaccination Program in a 65 Year-old immunocompetent Spanish Cohort with 13-Valent Pneumococcal Conjugate Vaccine]. / La vacunación anti-neumocócica con la vacuna conjugada 13-valente en población inmunocompetente de 65 años: análisis del impacto presupuestario en España aplicando un modelo de transmisión dinámica.

OBJECTIVE: To estimate the 5-year clinical and economic impact of a pneumococcal vaccination program on immunocompetent population aged 65-year-old in Spain. METHODS: A 5 year dynamic model based on differential equations was built for the conceptualization of the burden of pneumococcal disease (PD) on a 65 year-old cohort. A 36.5% of the cohort was vaccinated with an expected efficacy rate of 52.5% as observed in the CAPITA study. The serotype vaccination coverage used was 63.4% (CAPA study), the incidence of pneumococcal disease was 162.2 per 100,000 cases per year (CMBD 2010-2013) and a rate of vaccinated subjects previously from the start of the model of 0.99%. The study used the perspective of The National Health System, and included the costs associated to PD and the conjugate vaccine laboratory selling price. RESULTS: In a 5 years-period, the vaccination with 13-valent pneumococcal conjugate vaccine is expected to avoid 10,360 cases of pneumococcal disease (7,411 in-patient pneumonias) and 699 deaths (14,736 Life Years Gained) in the 65 year old cohort. Vaccination costs of 36.5 million euros would be completely offset by medical cost reduction of 41.5 million euros, yielding to a net saving of 3.8 million constant euros (4.9 million undiscounted). CONCLUSIONS: PCV13 vaccination targeting the cohort of 65 year-old immunocompetent Spanish adults is expected to result in net savings for the National Health System, while decreasing disease burden and averting a substantial number of related deaths.

OBJETIVO: Analizar el impacto económico y sanitario en 5 años de la vacunación de la cohorte española de 65 años inmunocompetente con la vacuna antineumocócica conjugada 13-valente. METODOS: Mediante un modelo de transmisión dinámica basado en ecuaciones diferenciales se analizó la carga de la enfermedad neumocócica (EN) en sujetos de 65 años en 5 años, siendo vacunada anualmente el 36,5% de la cohorte. Se aplicó la eficacia de la vacuna del 52,5% observada en el estudio CAPITA en pacientes de 65 años inmunocompetentes, cobertura de serotipos vacunales del 63,4% (estudio CAPA), incidencia de infección neumocócica de 162,2/100.000 casos año (CMBD 2010-2013) y proporción de vacunados previamente al arranque del modelo del 0,99%. La perspectiva fue la del Sistema Nacional de Salud (SNS). Costes de casos de EN según CMBD y precio de venta de laboratorio de la vacuna conjugada. RESULTADOS: En 5 años la vacunación con vacuna conjugada 13-valente espera evitar 10.360 casos de EN (7.411 hospitalizaciones por neumonías) y 699 muertes (14.736 años de vida ganados -AVG-), en una cohorte de 65 a 69 años de edad. El coste de vacunación esperado de 36,5 millones de euros se compensaría completamente por la reducción de 41,5 millones de costes médicos evitados, con un ahorro neto acumulado de 3,8 millones de euros a precios constantes (4,9 a precios corrientes). CONCLUSIONES: La vacunación con vacuna conjugada 13-valente en adultos de 65 años inmunocompetentes resulta eficiente para el Sistema Nacional de Salud, reduciendo la carga de enfermedad y evitando un número importante de muertes.