Trend analysis of proton pump inhibitor consumption and expenditure: The real-world evidence.

INTRODUCTION: Proton pump inhibitors (PPIs) constitute a widely utilized pharmaceutical class, frequently associated with notable instances of therapeutic inappropriateness. Such patterns of misuse not only contribute to elevated healthcare expenditure, but may also exacerbate clinical conditions in certain patients. METHODS: A comprehensive analysis was conducted between 2019 and 2023 to assess all prescriptions dispensed using the Anatomical, Therapeutic and Chemical (ATC) classification system, which allowed trends among primary PPIs to be visualized. This was achieved by calculating the defined daily dose (DDD) and then defining the total expenditure incurred on these drugs. RESULTS: With regard to the prescription of PPIs, an upward trend in consumption was observed with a decreasing expenditure, due to the phenomena of drug generics and increased competition between pharmaceutical companies, ranging from €9,512,481.22 in the first six months of 2019 to €8,509,820.80 in the first six months of 2023. From 2019 to 2023, consumption increased by approximately 3 million DDDs for a total ranging from 18,483,167.59 DDDs to 21,480,871.00 DDDs. Pantoprazole and esomeprazole, the most expensive drugs compared to omeprazole, rabeprazole and lansoprazole, accounted for 61.4% of therapies in the first six months of 2023, up from 2019, where these two drugs were prescribed 54.9%. CONCLUSION: Within this analysis, we provide an illustrative representation of the prescribing trends for PPIs within a European context. Omeprazole, rabeprazole and lansoprazole appear to be the cheapest drugs compared to pantoprazole and esomeprazole. However, the results show that the most widely used PPIs, despite their therapeutic equivalence, are precisely the high-cost ones, thus generating higher expenditure for central governments.

The Impact of Prescribing Monitoring Policy on Drug Use and Expenditures in China: A Multi-center Interrupted Time Series Study.

BACKGROUND: A prescribing monitoring policy (PMP) was implemented in November 2015 in Anhui province, China, the first province to pilot this policy to manage the use and costs of select drugs based on their large prescription volumes and/ or costs in hospitals. This study evaluated the impact of PMP on the use and expenditures of different drugs in three tertiary hospitals in Anhui. METHODS: We obtained monthly drug use and expenditures data from three tertiary hospitals in Anhui (November 2014 through September 2017). An interrupted time series (ITS) design was used to estimate changes in defined daily doses (DDDs per month) and drug expenditures (dollars per month) of policy-targeted and non-targeted drugs after PMP implementation. Drugs were grouped based on whether they were recommended (recommended drugs) by any clinical guidelines or not (non-recommended drugs), or if they were potentially over-used (proton pump inhibitors, PPIs). RESULTS: After PMP, DDDs and costs of the targeted PPIs (omeprazole) declined while use of non-targeted PPIs increased correspondingly with overall sustained declines in total PPIs. The policy impact on recommended drugs varied based on whether the targeted drugs have appropriate alternatives. The DDDs and costs of recommended drugs that have readily accessible appropriate alternatives (atorvastatin) declined, which offset increases in its alternative non-target drugs (rosuvastatin), while there was no significant change in those recommended drugs that did not have appropriate alternative drugs (clopidogrel and ticagrelor). Finally, the DDDs and costs of non-recommended drugs decreased significantly. CONCLUSION: PMP policy impact was not the same across different drug groups. PMP did help contain the use and costs of potentially over-used drugs and non-recommended drugs. PMP did not seem to reduce the use of first-line therapeutic drugs recommended by clinical treatment guidelines, especially those lacking alternatives; such drugs are unlikely appropriate candidates for PMP.

Assessment of gastrointestinal health in racing Alaskan sled dogs using capsule endoscopy and inflammatory cytokines.

OBJECTIVES: Exercise-induced gastrointestinal syndrome occurs in dogs and people and might compromise athlete performance by increasing intestinal permeability and causing gastrointestinal erosions. Racing sled dogs often receive acid suppressant prophylaxis which decreases the incidence of gastric erosions induced by exercise. The objectives were to quantify intestinal injury by measuring serum pro-inflammatory cytokine concentrations before and after exercise and to evaluate gastrointestinal mucosa using video capsule endoscopy after exercise. MATERIALS AND METHODS: Prospective study of 12 racing Alaskan sled dogs receiving approximately 1 mg/kg omeprazole once daily from the day before the race until race completion. Blood was drawn before and 8 to 10 hours after an endurance race for the quantification of cytokines. Gastrointestinal tract mucosa was assessed with video capsule endoscopy immediately post-race. RESULTS: Eight of nine dogs (89%; 95% confidence interval 52 to 100%) had gastric erosions; all dogs (100%, 95% confidence interval 63 to 100%) had small intestinal erosions. Most of the dogs (seven of nine) had straw or foreign material present. Cytokine levels were not different from before to after the race. CLINICAL SIGNIFICANCE: Video capsule endoscopy identified gastrointestinal tract mucosal erosions after exercise in all dogs receiving once-daily omeprazole treatment, though other causes for the lesions besides exercise are possible.

Trends in prescribing volumes and costs of proton pump inhibitors in three outpatient specialties: a three-year retrospective study in a tertiary hospital in Thailand.

OBJECTIVES: The study determined a comparative three-year trend in prescribing volumes and costs of proton pump inhibitors in three outpatient specialties of a tertiary hospital. METHODS: Prescription data for three consecutive fiscal years (2016-2018) were extracted from a tertiary hospital electronic database, for the gastrointestinal, cardiovascular and orthopaedic outpatient specialties. The data collected were individual proton pump inhibitors, overall and individual prescribing volumes (capsule/tablet) and costs, stratified by specialty and fiscal year. KEY FINDINGS: Of the three specialties, the largest volume of proton pump inhibitor prescriptions, mostly for omeprazole, comes from the orthopaedic specialty (46%). In terms of prescribing costs, at the top is the cardiovascular specialty (45.75%). Lansoprazole, which is one of the proton pump inhibitors on in the national list of essential medicines, contributed most to the cost. Prescribing proton pump inhibitors that are not included in the national list of essential medicines were responsible for over 90% of the costs in the cardiovascular and gastrointestinal specialties. An escalating trend in prescribing varied proton pump inhibitors, that is, esomeprazole, lansoprazole, pantoprazole, dexlansoprazole and rabeprazole, all of which were not on the list of essential medicines, was evident in the latter. CONCLUSIONS: The highest volume of proton pump inhibitor prescribing-mostly of omeprazole, was issued by the orthopaedic specialty. The cardiovascular specialty was responsible for the largest amount of cost. The increases in the uses and costs of varying proton pump inhibitors which were outside the national list of essential medicines were notable in the gastrointestinal specialty.

Prospective observational study of the use of omeprazole and maropitant citrate in veterinary specialist care.

The proton pump inhibitor omeprazole is administered to dogs with gastroduodenal ulceration or oesophagitis, whereas the neurokinin-1 receptor antagonist maropitant citrate is licensed as an antiemetic drug. In people, omeprazole is overprescribed in hospitals, increasing the risk of adverse effects and imposing unnecessary costs in healthcare. To investigate the use of omeprazole and maropitant in our veterinary specialist hospital, we conducted a prospective observational study in its Medicine and Surgery wards, recording patient data and obtaining contemporaneous information from clinicians about their reasons for administering either drug. In doing so, we find omeprazole and maropitant are administered to a large proportion of dogs, including to many of those with no presenting signs suggestive of gastrointestinal disease. We find prescribing clinicians consider both drugs safe but often underestimate their financial cost. We find the stated reasons and objective predictors of administration of both drugs vary according to clinical setting but that these modalities yield concordant results. Reviewing the manner of administration and stated indications for use of both drugs, we find omeprazole is often administered outside dosing recommendations, and both drugs are frequently administered for aims that are unlikely to be achieved when considering their known biological effects in dogs. In conclusion, our work reveals probable overprescribing of omeprazole and maropitant citrate in hospitalised dogs, highlighting a need for initiatives to decrease inappropriate prescribing.

Informe diário de evidências COVID-19: busca realizada em 15 de julho de 2020 / COVID-19 daily evidence report: search conducted on July 15, 2020

O Informe Diário de Evidências é uma produção do Ministério da Saúde que tem como objetivo acompanhar diariamente as publicações científicas sobre tratamento farmacológico e vacinas para a COVID-19. Dessa forma, são realizadas buscas estruturadas em bases de dados biomédicas, referentes ao dia anterior desse informe. Não são incluídos estudos pré-clínicos (in vitro, in vivo, in silico). A frequência dos estudos é demonstrada de acordo com a sua classificação metodológica (revisões sistemáticas, ensaios clínicos randomizados, coortes, entre outros). Para cada estudo é apresentado um resumo com avaliação da qualidade metodológica. Essa avaliação tem por finalidade identificar o grau de certeza/confiança ou o risco de viés de cada estudo. Para tal, são utilizadas ferramentas já validadas e consagradas na literatura científica, na área de saúde baseada em evidências. Cabe ressaltar que o documento tem caráter informativo e não representa uma recomendação oficial do Ministério da Saúde sobre a temática. Foram encontrados 14 artigos e 6 protocolos.

Efficacy of Omeprazole, Tetracycline, and 4 Times Daily Dosing of Amoxicillin in Helicobacter pylori Eradication in Limited Resource Area in Bhutan: A Prospective Randomized Trial (BHUTAN Study).

Backgrourd: H. pylori-associated gastric cancer is the first cancer-related death in Bhutan. Effective regimen for H. pylori eradication is essential to reduce risk of developing gastric cancer. Clarithromycin is not widely used in this limited resource country. Aim of this study was to evaluate proper regimen and prevalence of antibiotic resistance pattern for H. pylori eradication in Bhutan. METHODS: Five hundred and forty-six patients underwent gastroscopy during GASTROCAMP between October 2014 and April 2015 in Bhutan and 77 patients were enrolled. Four gastric biopsies were obtained for rapid urease test, histopathology, H. pylori culture with Epsilometer test. All H. pylori-positive patients were randomized to receive either 7-day or 14-day of 500 mg amoxicillin four times daily, 500 mg tetracycline four times daily, and 20 mg omeprazole twice daily. RESULTS: Seventy-seven subjects were enrolled (54 females, 23 males, mean age = 45.4 years). Of 77 patients, 52 (67.5%) received 7-day regimen while 25 (32.5%) had 14-day regimen. Prevalence of H. pylori was 38.2%. Antibiotic resistance was 80.0% for metronidazole, 11.1% for levofloxacin and no resistance seen in amoxicillin, tetracycline and clarithromycin. Overall eradication rates of 7-day and 14-day regimens were 51.9% and 80.0%, p = 0.02. Female and age ≥40 years had significantly higher eradication rate when receiving 14-day compared to 7-day regimen (94.1% vs. 45.9%, OR = 18.82; 95% CI 2.26-157.02, p = 0.0007 and 86.7% vs. 50.0%, OR = 6.50; 95% CI 1.25-33.91, p = 0.02, respectively). CONCLUSIONS: Fourteen-day regimen might be an acceptable regimen for H. pylori eradication in limited resource area such as Bhutan. Female and age ≥40 years should receive longer duration of treatment. This 14-day regimen could at least reduce the risk of developing H. pylori-associated diseases especially peptic ulcer with complications and gastric cancer which lead to many deaths in Bhutan.
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Assessment of the potential therapeutic effects of omeprazole in Schistosoma mansoni infected mice.

Schistosomiasis is a neglected chronic parasitic disease with a significant lasting morbidity. Currently, praziquantel (PZQ) is the most efficient drug for schistosomiasis worldwide. However, the possibility of the occurrence of resistance to PZQ is increasing. Therefore, there is a vital need to find new antischistosomal drugs or to increase the efficacy of the existing ones. Omeprazole is a proton pump inhibitor which is reported to have antiparasitic properties. Thus, the aim of this study was to assess the potential therapeutic effects of omeprazole in experimental Schistosoma mansoni infection either alone or in combination with PZQ. For this aim, 80 laboratory bred mice were divided into 3 groups; uninfected control, infected untreated control, and infected and treated at tenth week P.I. The last group was divided into three subgroups that received either PZQ alone, omeprazole alone, or both drugs. The effectiveness of treatment was assessed by adult worm counts, liver egg count, scanning electron microscopy of adult worms, histopathological, and immunohistochemical (GFAP) examination. There was significant reduction of adult worm counts, liver egg counts, size, diameter of hepatic granulomas, hepatic fibrosis, and GFAP expression in the group that received combined treatment as compared to PZQ group. Moreover, the tegumental changes were more evident in the group that received combined treatment. In conclusion, the administration of omeprazole with PZQ improved the efficacy of PZQ in the treatment of Schistosomiasis mansoni.

Evaluation of the efficacy and safety of the hybrid scheme for eradication therapy of Helicobacter pylori infection.

AIM: The aim is to conduct a comprehensive comparative study of the efficacy and safety of the hybrid scheme of eradication therapy (ET) in patients with peptic ulcer of the stomach or duodenum associated with Helicobacter pylori. MATERIALS AND METHODS: Materials and methods. In a prospective, randomized comparative study, 180 patients were divided into three equal groups of 60 people, depending on the prescribed 10-day ET regimen. Group 1 - the standard triple scheme (omeprazole, amoxicillin and clarithromycin); group 2 - four-component therapy with preparations of bismuth (omeprazole, tetracycline, metronidazole, bismuth tricalium dicitrate); group 3 - hybrid scheme (first 5 days: omeprazole and amoxicillin, the next 5 days: omeprazole, amoxicillin, clarithromycin, metronidazole). The effectiveness of ET was determined with the help of a breath test a month after the end of therapy. Adverse events were recorded by patients in specially developed diaries. Pharmacoeconomic analysis was carried out using the "cost-effectiveness" method with calculation of the CER coefficient. RESULTS: Results and discussion. The effectiveness of standard triple therapy was 73.3% (ITT), 75.9% (PP); four-component therapy with bismuth preparations - 78.3% (ITT), 82.4% (PP); hybrid scheme - 85% (ITT), 91% (PP). Hybrid therapy proved to be significantly more effective than standard triple therapy with a odds ratio (OR) of 3.25; 95% confidence interval (CI) 1.08-9.73 (p=0.043, χ2=4.75, p-level=0.029298). The incidence of adverse events with the use of triple, four-component and hybrid ET regimens was 15; 18.3 and 28.3% respectively. The OR of at least one adverse event in patients receiving a hybrid ET regimen compared with triple therapy was 2.24 (95% CI 0.91-5.53, p=0.0823, χ2=3.14, p-level=0.076394), and compared with the four-component therapy - 1.76 (95% CI 0.74-4.17, p=0.2804, χ2=1.68, p-level=0.194924). According to the results of the pharmacoeconomic analysis, the most profitable from an economic point of view was a hybrid ET scheme with a CER of 20.1. CONCLUSION: The conclusion. Hybrid therapy showed the greatest effectiveness in comparison with the triple and four-component ET regimens, however, the incidence of side effects in patients receiving the hybrid ET scheme was higher, although it remained within the acceptable level for use in clinical practice. Pharmacoeconomic analysis also showed the advisability of designating a hybrid ET scheme. The obtained data allow to draw a conclusion about the necessity of further study of the efficiency and safety of the hybrid ET scheme.

Informe de evaluación científica en la evidencia disponible: colitis ulcerosa / Scientific evaluation report for available evidence: ulcerative colitis

INTRODUCCIÓN: La colitis ulcerosa es una enfermedad inflamatoria crónica que afecta la mucosa del colon en forma continua, comprometiendo el recto y una porción variable de la extensión del resto del colon, sin la presencia de granulomas en la biopsia. En esta enfermedad, el sistema inmune reconoce esta porción del colon como ajena al cuerpo y lo ataca generando úlceras que caracterizan a esta enfermedad. Se considerarán para su evaluación aquellas solicitudes realizadas conforme al Reglamento que establece el proceso destinado a determinar los diagnósticos y tratamientos de alto costo con sistema de protección financiera, según lo establecido en los artículos 7° y 8° de la Ley N° 20.850. Estas solicitudes no son vinculantes para el Ministerio de Salud debiendo, sin embargo, tomar especialmente en cuenta aquellas solicitudes y opiniones que hayan sido realizadas por sus comisiones técnicas asesoras y por las asociaciones de pacientes incluidas en el Registro de Asociaciones de Pacientes que crea la Ley 20.850. De igual forma, para ser incorporadas en el proceso de evaluación científica de la evidencia, cada intervención debe cumplir con los criterios establecidos en el Artículo 6o del Reglamento mencionado, según lo indicado en el Numeral 9 del presente informe. TECNOLOGÍAS SANITARIA DE INTERÉS: Los tratamientos que son evaluados en este informe se pueden clasificar en inmunosupresores (azatioprina), antinflamatorios (mesalazina y sulfasalazina), inhibidores de secreciones de ácido gástrico (lansoprazol y omeprazol), agentes antioxidantes (colestiramina), y Anti-TNFs (adalimumab, golimumab e infliximab). Cada uno de estos tratamientos se utiliza en pacientes con distintos avances de la enfermedad ya para reducir el avance de ésta (azatioprina, mesalazina y Anti-TNFs), o para el alivio de algunos síntomas (lansoprazol, omeprazol y colestiramina). EFICACIA DE LOS TRATAMIENTOS: Se extrajeron 31 revisiones sistemáticas que incluyen 11 ensayos controlados aleatorizados que evaluaban la eficacia de adalimumab, golimumab e infliximab en pacientes con colitis ulcerosa moderada a grave. El tratamiento con adalimumab aumenta ligeramente el número de pacientes que cicatrizan su mucosa e incrementan su score IBDQ (calidad de vida) en más de 12 puntos, a las 8 semanas. El tratamiento con golimumab probablemente aumenta el número de pacientes que responden clínicamente a las 6 semanas, mientras que probablemente aumenta ligeramente el número de pacientes que remite y cicatrizan su mucosa a las 6 semanas. Además, golimumab probablemente no genera diferencias en cuanto a la calidad de vida (cuestionario IBDQ) de pacientes con colitis ulcerosa. El tratamiento con infliximab aumenta el número de pacientes que presentan respuesta clínica a las 8 semanas, mientras que reduce ligeramente el número de pacientes que reciben colectomía a las 54 semanas. No se encontró evidencia de eficacia de los tratamientos sobre una menor hospitalización o una menor estadía hospitalaria, ni estudios que evaluaran la eficacia en niños con colitis ulcerosa. ALTERNATIVAS DISPONIBLES: Para pacientes con colitis ulcerosa moderada o grave que sean refractarios a una primera línea de tratamiento (generalmente con anti-inflamatorios o inmunosupresores), se recomienda la proctocolectomía restauradora con reservorio íleo anal. Este procedimiento remueve completamente el colon y el recto, preservando el esfínter anal, generalmente produciendo una excelente función intestinal y continencia fecal. El reservorio ubicado en la zona pélvica interna sirve para los contenidos intestinales. Esta cirugía se puede realizar en etapas, en la primera etapa se puede realizar una colectomía subtotal más una ileostomía, o extirpación total de colon y el recto, con ejecución de un reservorio ileal que se protege con una ileostomía, luego en la siguiente etapa se cierra la ileostomía. CONCLUSIÓN: Para dar cumplimiento al artículo 28° del Reglamento que establece el proceso destinado a determinar los diagnósticos y tratamientos de alto costo con Sistema de Protección Financiera, según lo establecido en los artículos 7°y 8° de la ley N°20.850, aprobado por el decreto N°13 del Ministerio de Salud, se concluye que el presente informe de evaluación se considera favorable, de acuerdo a lo establecido en el Título III. de las Evaluaciones Favorables de la Norma Técnica N° 0192 de este mismo ministerio.

Using Drug Prescribing Patterns to Identify Stewards of Cost-Conscious Care.

PURPOSE: To characterize family physicians (FPs) who are stewards of care by consistently prescribing omeprazole over esomeprazole. METHODS: Cross-sectional analysis of physicians prescribing omeprazole or esomeprazole under Medicare Part D in 2014. RESULTS: There was a regional trend with 49% of Western FPs but only 6% of Southern FPs rarely prescribing esomeprazole. Physicians had increased odds of being a steward if they worked with a care coordinator (P < .001), at a patient-centered medical home (P < .001), or in a large practice (P < .001). CONCLUSIONS: If these findings are replicated across multiple drugs, future outreach could be conducted based on provider prescribing patterns.

The budget impact of using enteric-coated aspirin 325 mg + immediate-release omeprazole 40 mg to prevent recurrent cardiovascular events.

OBJECTIVE: Aspirin (acetylsalicylic acid; ASA) is commonly used for secondary prevention of cardiovascular (CV) events, but may be associated with gastrointestinal (GI) adverse events, which can reduce adherence. Use of ASA co-therapy with proton pump inhibitors in patients at risk may be suboptimal. PA32540 (Yosprala™) is a coordinated-delivery tablet combining EC-ASA 325 mg and immediate-release omeprazole 40 mg. The objective of this flexible budget impact model was to project the financial consequences of introducing PA32540 325 mg/40 mg to prevent recurrent CV events, while reducing ASA-associated GI events in US adults. METHODS: A Markov Model was employed to estimate health state transitions associated with ASA 75-325 mg, ASA 75-325 mg + generic delayed-release omeprazole 40 mg, PA32540, or clopidogrel 75 mg to prevent recurrent CV events. Health states included ulcers, GI bleeding, CV events, and death. Model inputs included demographics, treatment dosages, treatment costs, adverse GI and CV events, and premature death. Data from peer-reviewed literature and censuses enabled appropriate allocation of CV and GI disease prevalence and mortality. The PA32540 non-adherence rate was conservatively set at 20%. PA32540 market share was set to 50%. RESULTS: The model projected annual savings of $81.0 million to $190.9 million within 1-5 years after PA32540 introduction to the plan, which included 134,558 members at risk for recurrent CV events. These values translate into savings of $602 (year 5) to $1,419 (year 1) per patient per year, and $81 (year 5) to $191 (year 1) per member per year. These values were robust to variations in parameters under a deterministic sensitivity analysis. CONCLUSION: PA32540 use to prevent recurrent CV events was associated with cost reductions in each year examined with the model. From a health plan perspective, PA32540 is likely to have a net overall effect, resulting in significant cost savings.

Informe de evaluación científica basada en la evidencia disponible: colitis ulcerosa / Scientific evaluation report based on available evidence: ulcerative colitis

INTRODUCCIÓN: La colitis ulcerosa es una enfermedad inflamatoria crónica que afecta la mucosa del colon en forma continua, comprometiendo el recto y una porción variable de la extensión del resto del colon, sin la presencia de granulomas en la biopsia. En esta enfermedad, el sistema inmune reconoce esta porción del colon como ajena al cuerpo y lo ataca generando úlceras que caracterizan a esta enfermedad. TECNOLOGÍAS SANITARIAS ANALIZADAS: Adalimumab, azatioprina, golimumab, infliximab, mesalazina, lansoprazol, omeprazol, sulfasalazina y colestiramina. EFICACIA DE LOS TRATAMIENTOS: Se extrajeron 31 revisiones sistemáticas que incluyen 11 ensayos controlados aleatorizados que evaluaban la eficacia de adalimumab, golimumab e infliximab en pacientes con colitis ulcerosa moderada a grave. El tratamiento con adalimumab aumenta ligeramente el número de pacientes que cicatrizan su mucosa e incrementan su score IBDQ (calidad de vida) en más de 12 puntos, a las 8 semanas. El tratamiento con golimumab probablemente aumenta el número de pacientes que responden clínicamente a las 6 semanas, mientras que probablemente aumenta ligeramente el número de pacientes que remite y cicatrizan su mucosa a las 6 semanas. Además, golimumab probablemente no genera diferencias en cuanto a la calidad de vida (cuestionario IBDQ) de pacientes con colitis ulcerosa. El tratamiento con infliximab aumenta el número de pacientes que presentan respuesta clínica a las 8 semanas, mientras que reduce ligeramente el número de pacientes que reciben colectomía a las 54 semanas. No se encontró evidencia de eficacia de los tratamientos sobre una menor hospitalización o una menor estadía hospitalaria, ni estudios que evaluaran la eficacia en niños con colitis ulcerosa. ANÁLISIS ECONÓMICO: Infliximab resultó ser la alternativa que presentó mayor efectividad. Sin embargo, la efectividad incremental en relación a adalimumab es sólo de 0,66 QALYs, superándolo en costes en aproximadamente un 45%. Infliximab y golimumab fueron los tratamientos que presentaron mayor costo en relación a adalimumab. En esto se incluyen los costos de efectos adversos serios, porcentaje de pacientes que se sometían a colectomía mientras estaban en terapia con algún biológico y los costos de administración de infliximab. Para este último se consideró un costo mayor, ya que como su administración es intravenosa se deben considerar las horas en que el paciente debe estar en una sala de observaciones para que se le administre el biológico. En cuanto a las agencias internacionales, Inglaterra recomienda el uso de adalimumab, infliximab o golimumab en pacientes con colitis ulcerosa moderada a grave, siempre y cuando la terapia convencional no funcione o no sea la adecuada. El impacto presupuestario calculado para el primer año de tratamiento fue de MM$1.810 para adalimumab, $MM2.424 para infliximab, y MM$353.378 para golimumab. CONCLUSIÓN: Para dar cumplimiento al artículo 28° del Reglamento que establece el proceso destinado a determinar los diagnósticos y tratamientos de alto costo con Sistema de Protección Financiera, según lo establecido en los artículos 7°y 8° de la ley N°20.850, aprobado por el decreto N°13 del Ministerio de Salud, se concluye que el presente informe de evaluación se considera favorable, de acuerdo a lo establecido en el Título III. de las Evaluaciones Favorables de la Norma Técnica N° 0192 de este mismo ministerio.

Modeling the cost-effectiveness of ilaprazole versus omeprazole for the treatment of newly diagnosed duodenal ulcer patients in China.

OBJECTIVES: To evaluate the cost-effectiveness of 10 mg ilaprazole once-daily vs 20 mg omeprazole once-daily to treat newly-diagnosed duodenal ulcer patients in China. METHODS: A decision tree model was constructed and the treatment impact was projected up to 1 year. The CYP2C19 polymorphism distribution in the Chinese population, the respective cure rates in the CYP2C19 genotype sub-groups, the impact of Duodenal Ulcer (DU) on utility value and drug-related side-effect data were obtained from the literature. The total costs of medications were calculated to estimate the treatment costs based on current drug retail prices in China. Expert surveys were conducted when published data were not available. Probabilistic sensitivity analysis was performed to gauge the robustness of the results. RESULTS: Ilaprazole, when compared with omeprazole, achieved a better overall clinical efficacy. For the overall population, ilaprazole achieved an incremental cost effectiveness ratio (ICER) of ¥132 056 per QALY gained. This is less than the WHO recommended threshold of 3-times the average GDP per capita in China (2014). Furthermore, sub-group analysis showed that ilaprazole is cost-effective in every province in CYP2C19 hetEM patients and in the most developed provinces in CYP2C19 homEM patients. Probabilistic sensitivity analysis suggests that the results are robust with 97% probability that ilaprozole is considered cost-effective when a threshold of 3-times China's average GDP per capita is considered. LIMITATION: This study didn't have the data of ilaprazole combined with Hp eradication therapy. Caution should be taken when extrapolating these findings to DU patients with an Hp eradication therapy. CONCLUSIONS: The cost-effectiveness analysis results demonstrated that ilaprazole would be considered a cost-effective therapy, compared with omeprazole, in Chinese DU patients based on the efficacy projections in various CYP2C19 polymorphism types.

Prescribing efficiency of proton pump inhibitors in China: influence and future directions.

BACKGROUND: Pharmaceutical expenditure is currently rising by 16% per annum in China, greater in recent years. Initiatives to moderate growth include drug pricing regulations, essential medicine lists and encouraging generic prescribing. These are principally concentrated in hospitals, which currently account for over 80% of total pharmaceutical expenditure. However, no monitoring of prescribing and perverse incentives encouraging physicians and hospitals to profit from drug procurement encourages irrational prescribing. This includes greater utilisation of originators versus generics as well as injectables when cheaper oral equivalents are available. The objective of the paper is to assess changes in proton pump inhibitor (PPI) utilisation and expenditure in China as more generics become available including injectables. METHODS: Observational retrospective study of PPI utilisation and procured expenditure between 2004 and 2013 in the largest teaching hospital in Chongqing District as representative of China. RESULTS: Appreciable increase in PPI utilisation during the study period rising 10.4 fold, with utilisation of generics rising faster than originators. Oral generics reached 84% of total oral preparations in 2013 (defined daily dose basis), with generic injectables 93% of total injectables by 2013. Injectables accounted for 42% of total PPI utilisations in 2008 and 2009 before falling to below 30%. Procured prices for oral preparations reduced over time (-34%). Generic oral omeprazole in 2010 was 87% below 2004 originator prices, mirroring reductions seen in Western Europe. Injectable prices also decreased over time (-19%). However, injectables typically 4.3 to 6.8 fold more expensive than equivalent orals - highest for injectable lansoprazole at 13.4 to 18.0 fold. High utilisation of more expensive oral PPIs as well as injectables meant that PPI expenditure increased 10.1 fold during the study period. Lower use of injectables, and only oral generic omeprazole, would result in accumulated savings of CNY249.65 million, reducing total accumulated expenditure by 84%. CONCLUSIONS: Encouraging to see high utilisation of generic PPIs and low prices for oral generics. However, considerable opportunities to enhance prescribing efficiency through greater use of oral generic omeprazole.

BUDGET IMPACT ANALYSIS OF USING OMEPRAZOLE IMMEDIATE-RELEASE ORAL SUSPENSION IN REPLACE OF INTRAVENOUS PANTOPRAZOLE IN CRITICALLY ILL PATIENTS.

OBJECTIVES: The aim of the present study was to estimate the financial consequence of using omeprazole immediate-release (IR) oral suspension versus pantoprazole intravenous infusion for preventing stress-related upper gastrointestinal bleeding in critically ill patients from the perspective of the health care system. METHODS: An Excel-based model was developed to compare the cost of prevention of upper gastrointestinal bleeding early after intensive care admission using the current intravenous (IV) pantoprazole formulation versus omeprazole IR oral suspension. Total costs included the cost of acid suppressive drugs and related clinical outcomes. Inputs were obtained from a local clinical trial, the Ministry of Health database, insurance organizations, hospital and pharmacy registries, the relevant literature, and expert opinion. The robustness of the input data was investigated by one-way sensitivity analysis. The model was developed based on the results of a randomized control trial (RCT), in which experimental and control groups received omeprazole and pantoprazole, respectively. RESULTS: According to the proposed model, the cost of gastrointestinal (GI) bleeding prevention using pantoprazole IV was US$ 950,000 while US$ 750,000 was spent on receiving omeprazole oral suspension. These costs led to the annual cost-saving of almost US$ 200,000 (US$4 per member, per month) for the health care system. CONCLUSIONS: In the present study, a budget impact analysis was performed to assess the financial consequences of using omeprazole IR oral suspension in place of pantoprazole IV for prevention of upper gastrointestinal bleeding. The better preventive effect of omeprazole IR oral suspension when compared with conventional therapy using pantoprazole IV was the major reason for the final comparative budgetary savings.

Diretrizes para diagnóstico e erradicação do utilizando medicamentos da Atenção Primária (SUS) / Guidelines for diagnosis and eradication of using Primary Care Medicines (Unified Health System)

INTRODUÇÃO: O H. pylori é uma bactéria gram-negativa que coloniza a mucosa, e como não possui nenhum competidor importante, uma vez estabelecida forma uma monocultura no estômago. A infecção por H. pylori é a mais comum entre os seres humanos e está relacionada com alguns processos patogênicos do sistema gastrintestinal superior, neoplásicos e inflamatórios . A prevalência de H. pylori é maior em países subdesenvolvidos e em desenvolvimento podendo atingir até 50% das crianças já aos cinco anos de idade e acima de 70% aos 10 anos de idade. Esse valor elevado na infância, expressa a condição de vida dos indivíduos nessa fase da vida, uma vez que a aquisição da infecção pelo H. pylori ocorre principalmente neste período, e, de forma geral, o indivíduo passa a albergar a bactéria por toda sua vida . A transmissão do H.pylori ocorre normalmente de pessoa para pessoa, pela rota oral-oral, por meio de vômito e possivelmente saliva, e talvez pela rota oro-fecal. Transmissão pela água, provavelmente por contaminação fecal, pode ser uma importante fonte de infecção, especialmente em populações expostas à água não tratada. OBJETIVO: Disponibilizar aos prescritores e aos demais profissionais de saúde informações importantes quanto ao tratamento da infecção por Helicobacter pylori com os medicamentos amoxicilina 500 mg, claritromicina 500 mg, metronidazol 250 mg e omeprazol 20 mg, disponibilizados aos usuários do Sistema Único de Saúde (SUS) em Minas Gerais pelo Componente Básico da Assistência Farmacêutica. SITUAÇÃO - PROBLEMA: O medicamento claritromicina 500 mg foi incluído no rol de medicamentos disponibilizados para o tratamento da infecção por Helicobacter pylori por meio da publicação da Deliberação CIB-SUS/MG n° 1.392, de fevereiro de 2013 que estabeleceu a Relação Estadual de Medicamentos para o Programa Farmácia de Minas: Atenção Primária à Saúde. Dessa forma, são disponibilizados quatro medicamentos, quais sejam: -Amoxicilina 500 mg (cápsulas); -Claritromicina 500 mg (comprimidos); -Metronidazol 250 mg (comprimidos); e -Omeprazol 20 mg (cápsulas). Com essa nova inclusão, faz-se necessário esclarecimento sobre os regimes de tratamento para a infecção por H. Pylori. METODOLOGIA DE BUSCA DA LITERATURA: Para a condução dessa Nota Técnica buscou-se recomendações e diretrizes oficiais brasileiras na Biblioteca Virtual em Saúde (BIREME), no banco de estudos da Rede Brasileira de Avaliação de Tecnologias em Saúde (REBRATS), e nos websites do Ministério da Saúde, Agência Nacional de Vigilância Sanitária, Agência de Saúde Suplementar dentre outros. Buscaram-se também por revisões sistemáticas recentes e/ou ensaios clínicos. Buscaram-se, também, por Consensos da Federação Brasileira de Gastrenterologia e complementarmente por Consensos estrangeiros. TRATAMENTO: O Consenso brasileiro recomenda como primeira linha de tratamento da infecção por H. pylori a associação de um inibidor de bomba de prótons (em dose padrão) à claritromicina 0,5 g e à amoxicilina 1,0 g (Terapia Tripla) administrados duas vezes ao dia por 07 dias. No Brasil, esse regime terapêutico rende taxa de erradicação de 80%. CONCLUSÕES: A relação direta entre infecção por H. pylori e o desenvolvimento de adenocarcinoma gástrico ressalta a importância do tratamento. A taxa de erradicação com a Terapia Tripla é elevada, de 80%, entretanto é fundamental que todo o paciente seja orientado sobre a importância de cumprir o esquema terapêutico como prescrito e do início ao fim para de evitar a ocorrência de resistência bacteriana. Dessa forma, o envolvimento de profissionais de saúde capacitados a orientar sobre as doenças e sobre as possíveis reações adversas ao tratamento é fundamental.

Evolutions in both co-payment and generic market share for common medication in the Belgian reference pricing system.

BACKGROUND: In Belgium, a co-insurance system is applied in which patients pay a portion of the cost for medicines, called co-payment. Co-payment is intended to make pharmaceutical consumers more responsible, increase solidarity, and avoid or reduce moral hazards. OBJECTIVE: Our objective was to study the possible influence of co-payment on sales volume and generic market share in two commonly used medicine groups: cholesterol-lowering medication [statins (HMG-CoA reductase inhibitors) and fibrates] and acid-blocking agents (proton pump inhibitors and histamine H2 receptor antagonists). METHODS AND DATA: The data were extracted from the Pharmanet database, which covers pharmaceutical consumption in all Belgian ambulatory pharmacies. First, the proportion of sales volume and costs of generic products were modelled over time for the two medicine groups. Second, we investigated the relation between co-payment and contribution by the national insurance agency using change-point linear mixed models. RESULTS: The change-point analysis suggested several influential events. First, the generic market share in total sales volume was negatively influenced by the abolishment of the distinction in the maximum co-payment level for name brands and generics in 2001. Second, relaxation of the reimbursement conditions for generic omeprazole stimulated generic sales volume in 2004. Finally, an increase in co-payment for generic omeprazole was associated with a significant decrease in omeprazole sales volume in 2005. The observational analysis demonstrated several changes over time. First, the co-payment amounts for name-brand and generic drugs converged in the observed time period for both medicine groups under study. Second, the proportion of co-payment for the total cost of simvastatin and omeprazole increased over time for small packages, and more so for generic than for name-brand products. For omeprazole, both the proportion and the amount of co-payment increased over time. Third, over time the prescription of small packages shifted to an emphasis on larger packages. CONCLUSIONS: As maximum co-payment levels decreased over time, they overruled the reference pricing system in Belgium. The changes in co-payment share over time also significantly affected sales volume, but whether physicians or patients are the decisive actors on the demand side of pharmaceutical consumption remains unclear.

Patterns of proton pump inhibitor utilization in gastroesophageal reflux disease and the effect of restrictions on reimbursement: a nationwide prescription database study.

OBJECTIVE: To assess the drug utilization patterns for proton pump inhibitors (PPIs) prescriptions dispensed in periods with and without restrictions on reimbursement in a public healthcare system. MATERIAL AND METHODS: Data on all PPI prescriptions dispensed for gastroesophageal reflux disease (GERD) was retrieved from the Norwegian Prescription Database (NorPD) from 1 January 2004 to 31 January 2008. PPI utilization patterns were studied in new and current users of PPI in periods affected and not affected by a change in prescription policy. RESULTS: The policy change resulted in 39% of esomeprazole patients discontinuing PPI therapy during a 12-month period while 23% discontinued PPI therapy during a period not affected by the policy change. The shift frequency to a different PPI was low, 5% and 7% respectively, during periods not affected by policy change. Despite a required shift in most esomeprazole patients, 64% still continued on esomeprazole. Among the 36% who shifted from esomeprazole to a different PPI, 25% subsequently shifted back to esomeprazole. In new PPI users, the proportion of esomeprazole users declined from 57% before to 20% after the introduction of the policy change. CONCLUSIONS: Despite GERD being a chronic disease in most patients, there was a high degree of alteration seen in the utilization patterns of PPIs. A high proportion discontinued PPI therapy indicating mild symptoms or remission. The switching between different PPIs was low indicating good efficacy and tolerability in most patients. The policy change was more effective in new PPI users compared with the mandated shift in ongoing esomeprazole users.

Generic substitution, financial interests, and imperfect agency.

Policy makers around the world seek to encourage generic substitution. In this paper, the importance of prescribing physicians' imperfect agency is tested using the fact that some Swiss jurisdictions allow physicians to dispense drugs on their own account (physician dispensing, PD) while others disallow it. We estimate a model of physician drug choice with the help of drug claim data, finding a significant positive association between PD and the use of generics. While this points to imperfect agency, generics are prescribed more often to patients with high copayments or low incomes.