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1.
J Opioid Manag ; 20(4): 281-288, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39321048

RESUMEN

OBJECTIVE: The United States (US) opioid epidemic is a continued burden on the healthcare system and on the lives of individuals affected by the consequences of opioid abuse/misuse. The objective of this study was to use real-world data from intentional abuse/misuse exposures managed by US poison centers to compare clinical outcomes and quantify healthcare costs among three study cohorts: -exposures that involved Xtampza ER®, other oxycodone extended-release (ER), and oxycodone immediate-release (IR). STUDY DESIGN: A real-world, observational study. MAIN OUTCOME MEASURES: Descriptive statistics were used to describe patient and exposure characteristics. Drug utilization-adjusted rates of intentional abuse/misuse and clinical outcomes were used to determine relative risk. Healthcare cost estimates were calculated by extrapolating average charge per opioid-related disorder emergency department (ED) visit and per inpatient stay based upon case disposition rates, adjusted for population and drug utilization. RESULTS: Compared to Xtampza ER, exposures that involved other oxycodone ER were 7.4 times more likely to be intentional abuse/misuse, 25.9 times more likely to result in major effect or death, 9.7 times more likely to require a visit to the ED, and 14.3 times more likely to result in hospital admission. Similar results were found for oxycodone IR when compared to Xtampza ER. CONCLUSIONS: This study is the first of its kind to synthesize clinical outcomes with opioid-related healthcare costs, suggesting that even when Xtampza ER is abused/misused, the rates of major effect/death, ED visits, and hospital admissions were significantly lower than those for other oxycodone-containing medications, resulting in relatively low downstream opioid-related healthcare costs.


Asunto(s)
Analgésicos Opioides , Trastornos Relacionados con Opioides , Oxicodona , Humanos , Oxicodona/efectos adversos , Oxicodona/economía , Oxicodona/administración & dosificación , Trastornos Relacionados con Opioides/epidemiología , Trastornos Relacionados con Opioides/economía , Masculino , Analgésicos Opioides/efectos adversos , Analgésicos Opioides/economía , Femenino , Adulto , Persona de Mediana Edad , Costos de la Atención en Salud , Centros de Control de Intoxicaciones/economía , Centros de Control de Intoxicaciones/estadística & datos numéricos , Estados Unidos/epidemiología , Adulto Joven , Preparaciones de Acción Retardada , Adolescente , Resultado del Tratamiento , Servicio de Urgencia en Hospital/economía , Servicio de Urgencia en Hospital/estadística & datos numéricos
2.
PLoS One ; 15(4): e0231763, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32302346

RESUMEN

OBJECTIVE: To evaluate the efficacy, safety and cost-effectiveness of Oxycodone Hydrochloride Controlled-release Tablets (CR oxycodone) and Morphine Sulfate Sustained-release Tablets (SR morphine) for moderate to severe cancer pain titration. METHODS: Randomized controlled trials meeting the inclusion criteria were searched through Medline, Cochrane Library, Pubmed, EMbase, CNKI,VIP and WanFang database from the data of their establishment to June 2019. The efficacy and safety data were extracted from the included literature. The pain control rate was calculated to eatimate efficacy. Meta-analysis was conducted by Revman5.1.4. A decision tree model was built to simulate cancer pain titration process. The initial dose of CR oxycodone and SR morphine group were 20mg and 30mg respectively. Oral immediate-release morphine was administered to treat break-out pain. The incremental cost-effectiveness ratio was performed with TreeAge Pro 2019. RESULTS: 19 studies (1680 patients)were included in this study. Meta-analysis showed that the pain control rate of CR oxycodone and SR morphine were 86% and 82.98% respectively. The costs of CR oxycodone and SR morphine were $23.27 and $13.31. The incremental cost-effectiveness ratio per unit was approximate $329.76. At the willingness-to-pay threshold of $8836, CR oxycodone was cost-effective, while the corresponding probability of being cost-effective at the willingness-to-pay threshold of $300 was 31.6%. One-way sensitivity analysis confirmed robustness of results. CONCLUSIONS: CR oxycodone could be a cost-effective option compared with SR morphine for moderate to severe cancer pain titration in China, according to the threshold defined by the WHO.


Asunto(s)
Dolor en Cáncer/tratamiento farmacológico , Dolor en Cáncer/economía , Economía Farmacéutica , Morfina/economía , Morfina/uso terapéutico , Oxicodona/economía , Oxicodona/uso terapéutico , Análisis Costo-Beneficio , Árboles de Decisión , Preparaciones de Acción Retardada/uso terapéutico , Humanos , Sesgo de Publicación , Riesgo , Resultado del Tratamiento
3.
Indian J Med Ethics ; 4(3): 183-193, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31727614

RESUMEN

This paper provides a review of Purdue Pharma, LP's development and marketing of the long-acting oral narcotic OxyContin®. Within five years of the drug's launch, OxyContin® became the number-one prescribed Schedule II narcotic in the United States. This commercial success was in part the result of a marketing campaign that promoted questionably "distinctive" benefits and minimised the very real dangers of OxyContin®, which include abuse, addiction, overdose, and death. The marketing was based on scientifically invalid or unproven claims of safety and efficacy, inappropriate, off-label marketing, and inadequate warnings. When the FDA belatedly asked for changes to some of the marketing language, Purdue exploited these changes to further marketing objectives and misled healthcare practitioners. This case highlights questions of industry and governmental/regulatory accountability and responsibility for the production, marketing and sale of pharmaceutical products that increase risk while driving enhanced profits.


Asunto(s)
Analgésicos Opioides/efectos adversos , Analgésicos Opioides/economía , Etiquetado de Medicamentos/ética , Mercadotecnía/ética , Oxicodona/efectos adversos , Oxicodona/economía , Decepción , Etiquetado de Medicamentos/legislación & jurisprudencia , Humanos , Mercadotecnía/legislación & jurisprudencia , Trastornos Relacionados con Opioides/complicaciones , Responsabilidad Social , Trastornos Relacionados con Sustancias/complicaciones , Estados Unidos , United States Food and Drug Administration
5.
Pharmacoepidemiol Drug Saf ; 28(1): 25-30, 2019 01.
Artículo en Inglés | MEDLINE | ID: mdl-29766592

RESUMEN

PURPOSE: Diverted prescription opioids are significant contributors to drug overdose mortality. Street price has been suggested as an economic metric of the diverted prescription opioid black market. This study examined variables that may influence the street price of diverted oxycodone and oxymorphone. METHODS: A cross-sectional study was conducted utilizing data from the previously validated, crowdsourcing website StreetRx. Street price reports of selected oxycodone and oxymorphone products, between August 22, 2014 and June 30, 2016, were considered for analysis. Geometric means and 95% confidence intervals were calculated comparing prices per milligram of drug in US dollars. Univariate and multivariable regressions were used to examine the influence of dosage strength, drug formulation, and bulk purchasing on street price. RESULTS: A total of 5611 oxycodone and 1420 oxymorphone reports were analyzed. Across various dosages and formulations, geometric mean prices per milligram ranged between $0.12 and $1.07 for oxycodone and $0.73 and $2.90 for oxymorphone. For a 2-fold increase in dosage strength, there is a 24.0% (95% CI: -28.1%, -19.6%, P < 0.001) and a 22.5% (95% CI: -24.2%, -20.8%, P < 0.001) decrease on average in price per milligram for oxycodone and oxymorphone, respectively. Lower potency, high dosage strength, crush-resistant opioids, and those purchased in bulk were significantly cheaper. CONCLUSION: Street prices for diverted oxycodone and oxymorphone are influenced by multiple factors including potency, dosage, formulation, and bulk purchasing. Buyers who purchase large quantities of low potency, large dosage, crush-resistant formulation prescription opioids can expect to achieve the lowest price.


Asunto(s)
Drogas Ilícitas/economía , Narcóticos/economía , Oxicodona/economía , Oximorfona/economía , Desvío de Medicamentos bajo Prescripción/economía , Comercio/economía , Comercio/estadística & datos numéricos , Estudios Transversales , Sobredosis de Droga/etiología , Sobredosis de Droga/prevención & control , Humanos , Drogas Ilícitas/efectos adversos , Narcóticos/efectos adversos , Trastornos Relacionados con Opioides/etiología , Trastornos Relacionados con Opioides/prevención & control , Oxicodona/efectos adversos , Oximorfona/efectos adversos , Desvío de Medicamentos bajo Prescripción/estadística & datos numéricos , Estudios Prospectivos , Estados Unidos
6.
J Manag Care Spec Pharm ; 23(8): 902-912, 2017 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-28737985

RESUMEN

BACKGROUND: Health plans use formulary restrictions (e.g., prior authorization, step therapy, tier change, nonformulary status) in an effort to control cost and promote quality, safety, and appropriate prescription utilization. Some Medicare payers perceive that the inclusion of certain agents, such as branded oxycodone HCl extended-release tablets (OERs), on their formularies is associated with attracting high-cost members to the plan. OBJECTIVE: To evaluate disenrollment rates, patient migration, and subsequent health care costs among OER users who disenrolled from a national Medicare Advantage Prescription Drug plan (study-MAPD) in the plan year following OER nonformulary restriction. METHODS: A retrospective, longitudinal cohort study using IMS pharmacy and medical claims data between July 1, 2011, and December 31, 2014, was conducted. In the study-MAPD, adults aged ≥ 18 years who were chronic OER users with ≥ 2 OER claims 6 months before the nonformulary restriction date on January 1, 2013 (index date) and with continuous activity in pharmacy and medical claims for 6 months pre- and post-index were included in the study. Comparison years of 2012 and 2014 prerestriction/postrestriction were selected. All groups were followed for 6 months postindex. Year-to-year disenrollment rates of OER patients and the overall plan, as well as patient characteristics and costs of those who disenrolled from and those who remained with the plan, were measured. Costs were compared using a difference-in-differences approach. RESULTS: This study identified 2,935 eligible OER users from the study-MAPD population after imposing nonformulary restrictions on OERs on January 1, 2013. Mean age was 62.1 years, and 59.8% were female. The mean Charlson Comorbidity Index score was 1.83 for those 1,001 patients with medical claims data. For comparison years 2012 (prerestriction) and 2014 (postrestriction), 2,248 and 2,222 OER patients were identified, respectively. Patient characteristics were similar across patient cohorts in all 3 study years. Disenrollment rates for OER users (12.9%, 5.5%, and 14.3% for years 2012, 2013, and 2014, respectively) were lower or similar to those of the overall plan (18.3%, 7.6%, and 14.1%, respectively, for the same 3 years). Approximately 40% of OER users who disenrolled from the study-MAPD migrated to plans also imposing a nonformulary restriction on OERs, while about 25% moved to plans with less restrictive OER coverage. The majority (59.9%) of patients continued OER use irrespective of their disenrollment from the study-MAPD in 2013. Although a nonsignificant decrease ($117; P = 0.340) in per patient per month (PPPM) cost was observed among OER patients postrestriction (from 2012 to 2013), the difference-in-difference analysis indicated a net postrestriction increase of $124 (P = 0.461) in PPPM for OER patients. CONCLUSIONS: This study found little evidence to support any consistent directional effect on patient enrollment behavior as a result of an OER non-formulary restriction. Implementation of an OER nonformulary restriction did not lead to higher OER patient disenrollment or lower patient costs in the study-MAPD. DISCLOSURES: Funding for this study was provided by Purdue Pharma. De, Chen, and Wade are employees of QuintilesIMS, a for-profit company that was contracted by Purdue Pharma to undertake this research. Sweet was a paid consultant for Purdue Pharma at the time of this study. Study concept and design were contributed by Chen, Wade, and De. Chen, De, and Wade collected the data, which were interpreted by all the authors. The manuscript was written by Chen and De, along with Sweet and Wade, and revised by all the authors.


Asunto(s)
Medicare Part C/economía , Oxicodona/economía , Medicamentos bajo Prescripción/economía , Femenino , Costos de la Atención en Salud , Humanos , Revisión de Utilización de Seguros/economía , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Estados Unidos
8.
Arthritis Care Res (Hoboken) ; 69(2): 234-242, 2017 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-27111538

RESUMEN

OBJECTIVE: To evaluate the cost-effectiveness of incorporating tramadol or oxycodone into knee osteoarthritis (OA) treatment. METHODS: We used the Osteoarthritis Policy Model to evaluate long-term clinical and economic outcomes of knee OA patients with a mean age of 60 years with persistent pain despite conservative treatment. We evaluated 3 strategies: opioid-sparing (OS), tramadol (T), and tramadol followed by oxycodone (T+O). We obtained estimates of pain reduction and toxicity from published literature and annual costs for tramadol ($600) and oxycodone ($2,300) from Red Book Online. Based on published data, in the base case, we assumed a 10% reduction in total knee arthroplasty (TKA) effectiveness in opioid-based strategies. Outcomes included quality-adjusted life years (QALYs), lifetime cost, and incremental cost-effectiveness ratios (ICERs) and were discounted at 3% per year. RESULTS: In the base case, T and T+O strategies delayed TKA by 7 and 9 years, respectively, and led to reduction in TKA utilization by 4% and 10%, respectively. Both opioid-based strategies increased cost and decreased QALYs compared to the OS strategy. Tramadol's ICER was highly sensitive to its effect on TKA outcomes. Reduction in TKA effectiveness by 5% (compared to base case 10%) resulted in an ICER for the T strategy of $110,600 per QALY; with no reduction in TKA effectiveness, the ICER was $26,900 per QALY. When TKA was not considered a treatment option, the ICER for T was $39,600 per QALY. CONCLUSION: Opioids do not appear to be cost-effective in OA patients without comorbidities, principally because of their negative impact on pain relief after TKA. The influence of opioids on TKA outcomes should be a research priority.


Asunto(s)
Analgésicos Opioides/economía , Analgésicos Opioides/uso terapéutico , Osteoartritis de la Rodilla/tratamiento farmacológico , Osteoartritis de la Rodilla/economía , Oxicodona/uso terapéutico , Tramadol/uso terapéutico , Anciano , Anciano de 80 o más Años , Simulación por Computador , Análisis Costo-Beneficio , Femenino , Humanos , Masculino , Persona de Mediana Edad , Oxicodona/economía , Tramadol/economía
9.
J Med Econ ; 19(3): 277-91, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-26535790

RESUMEN

BACKGROUND: Approximately 20-30% of Canadians suffer from chronic pain. Guidelines for the management of chronic pain support the use of controlled-release (CR) opioids to treat chronic pain. Although effective in managing chronic pain, oxycodone is associated with high rates of opioid-induced constipation (OIC). The cost-effectiveness of a combination of oxycodone for the management of pain and naloxone for the relief of OIC has not previously been evaluated for Canada. METHODS: A decision analytic model was developed to estimate the cost-utility of combination oxycodone/naloxone compared to oxycodone alone in four populations. Drug costs for managing pain and healthcare costs related to managing OIC were included in the analysis and the primary measure of effectiveness was quality adjusted life years (QALYs) derived from OIC rates observed in clinical trials. The analysis was conducted from a healthcare system perspective, used a 1-year time horizon, and results were expressed in 2015 Canadian dollars. RESULTS: In all four patient populations, there was a trade-off between slightly higher total expected costs for Targin treated patients compared to oxycodone treated patients, but also improved clinical benefits in terms of reduced OIC, which resulted in higher QALYs for patients. Although analgesic costs were found to be slightly higher for Targin treated patients, Targin also resulted in cost offsets to the healthcare system in terms of less rescue laxative drug use and other resources required for the management of OIC. The resulting 1-year cost-utility of Targin compared to oxycodone ranged from $2178-$7732 per QALY gained in the base case analysis, and it was found that these cost-utility results remained robust and at low values throughout a series of one-way deterministic analyses of uncertainty. CONCLUSION: The clinical effectiveness of oxycodone/naloxone in managing pain and OIC compared to CR oxycodone alone resulted in low cost-utility estimates.


Asunto(s)
Analgésicos Opioides/economía , Analgésicos Opioides/uso terapéutico , Dolor Crónico/tratamiento farmacológico , Estreñimiento/inducido químicamente , Naloxona/economía , Naloxona/uso terapéutico , Antagonistas de Narcóticos/economía , Antagonistas de Narcóticos/uso terapéutico , Oxicodona/economía , Oxicodona/uso terapéutico , Manejo del Dolor/economía , Adulto , Canadá , Estreñimiento/prevención & control , Análisis Costo-Beneficio , Combinación de Medicamentos , Femenino , Humanos , Masculino , Método de Montecarlo , Años de Vida Ajustados por Calidad de Vida , Resultado del Tratamiento
10.
Anesthesiology ; 123(6): 1256-66, 2015 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-26378397

RESUMEN

BACKGROUND: Common standard practice after complex arthroscopic elbow surgery includes hospital admission for 72 h. The authors hypothesized that an expedited care pathway, with 24 h of hospital admission and ambulatory brachial plexus analgesia and continuous passive motion at home, results in equivalent elbow range of motion (ROM) 2 weeks after surgery compared with standard 72-h hospital admission. METHODS: A randomized, single-blinded study was conducted after obtaining approval from the research ethics board. Forty patients were randomized in a 1:1 ratio using a computer-generated list of random numbers into an expedited care pathway group (24-h admission) and a control group (72-h admission). They were treated equally aside from the predetermined hospital length of stay. RESULTS: Patients in the control (n = 19) and expedited care pathway (n = 19) groups achieved similar elbow ROM 2 weeks (119 ± 18 degrees and 121 ± 15 degrees, P = 0.627) and 3 months (130 ± 18 vs. 130 ± 11 degrees, P = 0.897) postoperatively. The mean difference in elbow ROM at 2 weeks was 2.6 degrees (95% CI, -8.3 to 13.5). There were no differences in analgesic outcomes, physical function scores, and patient satisfaction up to 3 months postoperatively. Total hospital cost of care was 15% lower in the expedited care pathway group. CONCLUSION: The results suggest that an expedited care pathway with early hospital discharge followed by ambulatory brachial plexus analgesia and continuous passive motion at home is a cost-effective alternative to 72 h of hospital admission after complex arthroscopic elbow surgery.


Asunto(s)
Analgésicos/administración & dosificación , Artroscopía , Plexo Braquial/efectos de los fármacos , Codo/cirugía , Bombas de Infusión , Dolor Postoperatorio/tratamiento farmacológico , Acetaminofén/administración & dosificación , Acetaminofén/economía , Acetaminofén/uso terapéutico , Adulto , Analgesia/economía , Analgesia/métodos , Analgésicos/economía , Analgésicos/uso terapéutico , Analgésicos no Narcóticos/administración & dosificación , Analgésicos no Narcóticos/economía , Analgésicos no Narcóticos/uso terapéutico , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/economía , Analgésicos Opioides/uso terapéutico , Análisis de Varianza , Antiinflamatorios no Esteroideos/administración & dosificación , Antiinflamatorios no Esteroideos/economía , Antiinflamatorios no Esteroideos/uso terapéutico , Análisis Costo-Beneficio , Equipos Desechables , Femenino , Estudios de Seguimiento , Humanos , Indometacina/administración & dosificación , Indometacina/economía , Indometacina/uso terapéutico , Pacientes Internos , Tiempo de Internación/estadística & datos numéricos , Masculino , Oxicodona/administración & dosificación , Oxicodona/economía , Oxicodona/uso terapéutico , Satisfacción del Paciente/estadística & datos numéricos , Rango del Movimiento Articular , Método Simple Ciego
11.
J Opioid Manag ; 11(3): 199-210, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-25985805

RESUMEN

OBJECTIVE: To quantify the potential impact of reductions in positive subjective measures from human abuse liability studies on real-world rates of nonmedical use of prescription drugs and associated healthcare resource utilization and costs. DESIGN: Positive subjective endpoints "overall drug liking," in-the-moment "drug liking," and "drug high" Emaxs (peak effects) were recorded from published studies. Nonmedical use data were obtained from the 2010 National Survey on Drug Use and Health (NSDUH) and Drug Abuse Warning Network surveys. Multivariate regressions evaluated the association between the positive subjective endpoints and nonmedical use rates, controlling for prescription volume, whether the drug is an opioid, and controlled substance schedule. A published budget-impact model was used to assess healthcare resource utilization and cost impacts of abuse-deterrent opioid formulations. RESULTS: A five-point reduction in overall drug liking/drug liking/drug high Emax was associated with a 0.25/0.10/0.05 (standard errors: 0.11/0.12/0.07) percentage point decrease in the NSDUH lifetime nonmedical use rates. Those decreases yielded a 11.3/4.2/2.1 percent reduction compared to the samples' lifetime nonmedical use rates of 2.21/2.38/2.36 percent. On the basis of a number of assumptions, these reductions were associated with private payer cost reductions for a morphine and oxycodone abuse-deterrent formulation in the ranges of $147.9-324.1 million and $230.7-958.7 million, respectively. CONCLUSIONS: Reductions in overall drug liking were significantly associated with reduced real-world nonmedical use, healthcare utilization, and costs. Associations using drug high and drug liking were directionally consistent with this finding though not statistically significant. A reduction in positive subjective measures associated with an abuse-deterrent formulation has potential to reduce abuse and associated healthcare utilization and costs.


Asunto(s)
Analgésicos Opioides/economía , Analgésicos Opioides/uso terapéutico , Costos de los Medicamentos , Recursos en Salud/economía , Trastornos Relacionados con Opioides/economía , Trastornos Relacionados con Opioides/prevención & control , Medicamentos bajo Prescripción/economía , Medicamentos bajo Prescripción/uso terapéutico , Analgésicos Opioides/efectos adversos , Analgésicos Opioides/química , Presupuestos , Química Farmacéutica , Ahorro de Costo , Recursos en Salud/estadística & datos numéricos , Humanos , Modelos Econométricos , Morfina/economía , Morfina/uso terapéutico , Análisis Multivariante , Trastornos Relacionados con Opioides/psicología , Oxicodona/economía , Oxicodona/uso terapéutico , Aceptación de la Atención de Salud , Medicamentos bajo Prescripción/efectos adversos , Medicamentos bajo Prescripción/química
14.
Asian Pac J Cancer Prev ; 15(20): 8797-800, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-25374210

RESUMEN

OBJECTIVE: To analyze cost-effectiveness of morphine, MS contin and oxycodone in the treatment of cancer pain, providing guidance for rational drug use in the clinic. METHODS: Confirmed by histology, a total of 171 patients with various cancers who required analgesic treatment were selected and divided into 3 groups, 57 cases for each group, given morphine, MS contin and oxycodone, respectively. If there appeared a poor short-term effect or aggravated sudden pain during the treatment, a short-acting morphine injection was given and adverse reactions were processed by symptomatic treatment. The pain relief rate and adverse reactions of groups were observed and pharmacoeconomics evaluation was undertaken. RESULTS: The pain relief rates with morphine, MS contin and oxycodone were 89.5%(51/57), 91.2%(52/57) and 93.0%(53/57), respectively, with no difference samong groups (χ2=4.4489, P=0.6162). The occurrence rates of adverse reactions were 59.7%(34/57), 54.4%(31/57) and 43.9%(25/57), again with no significant variation (P>0.05). The ratios of cost-effectiveness (C/E) for the 3 groups were 14.6±7.21, 15.0±7.44 and 16.1±8.10. When the price of 3 kinds of analgesics was reduced by 10%, the ratios of cost-effectiveness were 12.2±6.53, (13.4±6.08 and 14.5±6.74 but there was no differences when compared with before the price adjustment (t=1.86, P=0.0651; t=1.30, P=0.1948; t=1.17, P=0.2453). CONCLUSION: Morphine, MS contin and oxycodone give similar pain relief and adverse reaction rates but of all, morphine is the preferred drug for the treatment of cancer pain from the perspective of pharmacoeconomics.


Asunto(s)
Analgésicos Opioides/administración & dosificación , Economía Farmacéutica , Morfina/administración & dosificación , Neoplasias/complicaciones , Oxicodona/administración & dosificación , Dolor/tratamiento farmacológico , Dolor/economía , Adulto , Anciano , Analgésicos Opioides/economía , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Morfina/economía , Oxicodona/economía , Dolor/etiología , Dimensión del Dolor , Pronóstico
15.
Recenti Prog Med ; 105(11): 415-9, 2014 Nov.
Artículo en Italiano | MEDLINE | ID: mdl-25424235

RESUMEN

The management of chronic pain still represent a challenge for physicians. Opioids are the main stem in the treatment of chronic severe pain, not only for their potency, but as they act as central drugs. The main limit to their utilization in clinical practice is the prevalence of side effects, in particular in the gastrointestinal tract, whose constipation represents the most common. Two new formulations are nowadays available on the market: tapentadol PR (TAP PR) and oxycodone/naloxone (OXN). A recent meta-analysis showed that both drugs have a better tolerability profile than a tradizional opioid, such as oxycodone CR (OXY CR), but TAP PR reduces by 47% (RR=0.53) the percentage of patients discontinuing treatment because of side effects, compared to 24% (RR=0.76) of OXN. A similar advantage has been reported in the reduction of the risk of developing nausea and/or vomiting: TAP PR reduces the risk by 47% (RR=0.53), while OXN reduces the risk by only by 10% (RR=0.90). Both drugs reduced by about 40% the risk of constipation (RR=0.61 for TAP PR and for OXN). These results have been recently confirmed by a direct comparison of the two formulations (TAP PR vs OXN) in patients with chronic low back pain with neuropathic component. Both drugs were reported to be effective in reducing pain intensity and neuropathic symptoms, however TAP PR resulted superior to OXN in terms of analgesic efficacy, quality of life, and tolerability, in particular regarding constipation and adherence to treatment. A pharmacoeconomic analysis can be useful to understand the costs of these clinical advantages, and can be done by using a probabilistic analisys and by populating a Markov model that simulates the transition in time of 100 patients through 4 different possible health states: 1) still on treatment; 2) presence of adverse events; 3) discontinuation; 4) death. Both treatments (TAP PR and OXN) have been shown to have an excellent cost-effectiveness profile. In the case of OXN, in one year, 0.29 QALYs were gained compared to the use of OXY CR at an additional cost of € 138 resulting in a cost per QALY gained of € 475 (€ 138/0.29). In the case of TAP PR, instead, 0.31 QALYs were gained with additional savings due to the reduction of drug side effects, hospitalizations and emergency department access. Therefore, the use of TAP PR implies an average saving of € 31.6 per patient. These data are the results of a pharmacoeconomic model and require a further validation in clinical practice.


Asunto(s)
Dolor Crónico/tratamiento farmacológico , Naloxona/uso terapéutico , Oxicodona/uso terapéutico , Fenoles/uso terapéutico , Analgésicos Opioides/efectos adversos , Analgésicos Opioides/economía , Analgésicos Opioides/uso terapéutico , Dolor Crónico/economía , Análisis Costo-Beneficio , Combinación de Medicamentos , Costos de los Medicamentos , Economía Farmacéutica , Humanos , Modelos Económicos , Naloxona/efectos adversos , Naloxona/economía , Oxicodona/efectos adversos , Oxicodona/economía , Fenoles/efectos adversos , Fenoles/economía , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Tapentadol
18.
J Med Econ ; 17(4): 279-87, 2014 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-24559196

RESUMEN

OBJECTIVES: In the US, prescription opioids with technology designed to deter abuse have been introduced to deter drug abuse without hindering appropriate access for pain patients. The objective of this study was to estimate changes in medical costs following the introduction of a new formulation of extended-release (ER) oxycodone HCl (oxycodone) with abuse-deterrent technology in the US. METHODS: Health insurance claims data were used to estimate changes in rates of diagnosed opioid abuse among continuous users of extended-release opioids (EROs) following the introduction of reformulated ER oxycodone in August 2010. This study also calculated the excess medical costs of diagnosed opioid abuse using a propensity score matching approach. These findings were integrated with published government reports and literature to extrapolate the findings to the national level. All costs were inflated to 2011 US dollars. RESULTS: The introduction of reformulated ER oxycodone was associated with relative reductions in rates of diagnosed opioid abuse of 22.7% (p < 0.001) and 18.0% (p = 0.034) among commercially-insured and Medicaid patients, respectively. There was no significant change among Medicare-eligible patients. The excess annual per-patient medical costs associated with diagnosed opioid abuse were $9456 (p < 0.001), $10,046 (p < 0.001), and $11,501 (p < 0.001) for commercially-insured, Medicare-eligible, and Medicaid patients, respectively. Overall, reformulated ER oxycodone was associated with annual medical cost savings of ∼$430 million in the US. LIMITATIONS: Because of the observational research design of this study, caution is warranted in any causal interpretation of the findings. Portions of the study relied on prior literature, government reports, and assumptions to extrapolate the national medical cost savings. CONCLUSIONS: This study provides evidence that reformulated ER oxycodone has been associated with reductions in abuse rates and substantial medical cost savings. Payers and policy-makers should consider these benefits as they devise and implement new guidelines and policies in this therapeutic area.


Asunto(s)
Analgésicos Opioides/economía , Analgésicos Opioides/uso terapéutico , Oxicodona/economía , Oxicodona/uso terapéutico , Dolor/tratamiento farmacológico , Adulto , Analgésicos Opioides/administración & dosificación , Ahorro de Costo , Preparaciones de Acción Retardada , Femenino , Servicios de Salud/economía , Servicios de Salud/estadística & datos numéricos , Humanos , Revisión de Utilización de Seguros/estadística & datos numéricos , Masculino , Medicaid/estadística & datos numéricos , Medicare/estadística & datos numéricos , Persona de Mediana Edad , Trastornos Relacionados con Opioides/prevención & control , Oxicodona/administración & dosificación , Estados Unidos
19.
Curr Med Res Opin ; 30(6): 1139-51, 2014 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-24528146

RESUMEN

OBJECTIVE: Chronic pain is a leading cause of disability and represents a relevant societal burden. Opioids are widely used for managing chronic non-cancer pain; however, the high incidence of side effects is often the main reason for discontinuation. Two formulations have recently been studied to improve the tolerability of opioids (tapentadol extended release [ER] and oxycodone/naloxone ER), but a direct comparison between these drugs is not available in the literature. The comparative cost effectiveness of these two drugs has not previously been assessed. The objective of this meta-analysis is a clinical and economic evaluation of tapentadol ER and oxycodone/naloxone ER for the treatment of musculoskeletal pain, by indirect comparison with controlled release (CR) oxycodone. METHODS: A structured literature review was conducted to identify published data for the health-economic model. The authors performed a meta-analysis on three selected randomized controlled trials (RCTs) for each treatment (tapentadol ER and oxycodone/naloxone ER). As measure of treatment effect, risk ratio was calculated, compared to the control active treatment (CR oxycodone), for the following outcomes: discontinuation rate due to adverse events, due to gastrointestinal (GE) side effects and central nervous system (CNS) side effects. A Markov model was developed to compare the cost effectiveness of tapentadol ER and oxycodone/naloxone ER. Four health states were defined: (1) patients still on treatment; (2) occurrence of adverse events (gastroenterology, central nervous system); (3) treatment discontinuation as consequence of ineffectiveness of treatment; and (4) treatment discontinuation as consequence of adverse events. RESULTS: Both drugs showed a significant clinical advantage over the active control, CR oxycodone; however, tapentadol ER resulted in a better risk ratio reduction for the primary outcome of discontinuation rate due to adverse events and for the secondary outcome nausea and vomiting. The two drugs gave equivalent results in the capacity of reduction of constipation risk. In the economic evaluation both interventions were cost effective compared with CR oxycodone. However, tapentadol ER showed the most favorable results as in 65% of cases it was less costly and produced a considerable quality adjusted life years (QALY) gain. The higher impact of tapentadol ER on the cost effectiveness results was probably due to the price and the lower incidence of adverse events and related discontinuation rate, resulting in a further economic advantage. CONCLUSION: Both tapentadol ER and oxycodone/naloxone ER are cost effective interventions compared with CR oxycodone; however, tapentadol ER was shown to provide better clinical outcomes at lower costs.


Asunto(s)
Dolor Crónico/tratamiento farmacológico , Dolor Musculoesquelético/tratamiento farmacológico , Naloxona/administración & dosificación , Naloxona/economía , Oxicodona/administración & dosificación , Oxicodona/economía , Fenoles/administración & dosificación , Fenoles/economía , Análisis Costo-Beneficio , Preparaciones de Acción Retardada , Humanos , Italia , Naloxona/efectos adversos , Oxicodona/efectos adversos , Fenoles/efectos adversos , Tapentadol , Resultado del Tratamiento
20.
J Pain ; 14(10): 1122-30, 2013 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-23816949

RESUMEN

UNLABELLED: This study evaluated changes in abuse exposures, therapeutic error exposures, and diversion into illegal markets associated with brand extended-release oxycodone (ERO) following introduction of reformulated ERO. Original ERO and reformulated ERO street prices also were compared. Data from the Poison Center and Drug Diversion programs of the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System were used. Quarterly rates 2 years prior to introduction of reformulated ERO (October 2008 through September 2010) were compared to quarterly rates after introduction (October 2010 through March 2012) using negative binomial regression. Street prices were compared using a mixed effects linear regression model. Following reformulated ERO introduction, poison center ERO abuse exposures declined 38% (95% confidence interval [CI]: 31-45) per population and 32% (95% CI: 24-39) per unique recipients of dispensed drug. Therapeutic error exposures declined 24% (95% CI: 15-31) per population and 15% (95% CI: 6-24) per unique recipients of dispensed drug. Diversion reports declined 53% (95% CI: 41-63) per population and 50% (95% CI: 39-59) per unique recipients of dispensed drug. Declines exceeded those observed for other prescription opioids in aggregate. After its introduction, the street price of reformulated ERO was significantly lower than original ERO. PERSPECTIVE: This article indicates that the abuse, therapeutic errors, and diversion of ERO declined following the introduction of a tamper-resistant reformulation of the product. Reformulating abused prescription opioids to include tamper-resistant properties may be an effective approach to reduce abuse of such products.


Asunto(s)
Analgésicos Opioides , Control de Medicamentos y Narcóticos , Errores de Medicación/estadística & datos numéricos , Oxicodona , Mal Uso de Medicamentos de Venta con Receta/estadística & datos numéricos , Trastornos Relacionados con Sustancias/epidemiología , Trastornos Relacionados con Sustancias/prevención & control , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/economía , Química Farmacéutica , Costos y Análisis de Costo , Preparaciones de Acción Retardada , Costos de los Medicamentos , Humanos , Drogas Ilícitas , Estudios Longitudinales , Oxicodona/administración & dosificación , Oxicodona/economía , Centros de Control de Intoxicaciones , Estados Unidos/epidemiología
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