Monthly Index Of Medical Specialities Research Articles

Pharmacoeconomic analysis of Oral & Injectable Proton Pump Inhibitors available in India

Introduction: Proton pump inhibitors (PPIs) effectively suppress acid secretion and play an essential role in peptic ulcer disease and gastroesophageal reflux disease. There is a genuine concern about overutilizing PPIs, leading to significantly high costs and undesirable outcomes. An increase in the patient medication cost was associated with decreased adherence to prescription medication. Hence, this study assessed the cost variation of proton pump inhibitors (PPI) drugs.
 Methods: The cost of different brands of commonly used PPIs was sorted out by referring latest “Monthly Index of Medical Specialties” October – December 2021, and 1mg online pharmacy. The cost of 10 dosage forms (Tablets/capsules) in INR of each brand, Cost Ratio, and Percentage Cost Variation for individual drug brands was calculated in the case of an oral drug, and the cost of one vial or ampoule was noted in the case of injectable drug. At last, the cost ratio and percentage cost variation of various brands was compared.
 Results: The data analysis showed a significant variation in the costs of different brands of proton pump inhibitors available In the Indian market. Percentage variation in cost for oral preparations of proton pump inhibitors marketed in India was found to be tablet/capsule Rabeprazole 20mg (1540%), Omeprazole 20 mg(718.18%), Pantoprazole 40mg (504.16%), Esomeprazole 20mg (173.68%), Lansoprazole 15 mg (84.90 %), Omeprazole 40 mg (60.34%) and with injectable preparations IVR abeprazole 20mg (1090.90%), Omeprazole 40 mg (347.36%), Esomeprazole 40mg (216.66%), Pantoprazole 20mg (164.44 %), Pantoprazole 40mg (51.16%).
 Conclusion: There is a wide variation in the prices of proton pump inhibitors available in the market. Regulatory authorities, pharma companies, and physicians should maximize their efforts to reduce the cost of drugsThe need to search for reliable process indicators for the effectiveness of anti-diabetic therapy has been expressed in the literature. Process indicators have been described as essential processes that contribute to achieving outcomes

Pharmacoeconomic analysis of oral and injectable proton pump inhibitors available in India

Introduction: Proton pump inhibitors (PPIs) effectively suppress acid secretion and play an important role a lot of gastrointestinal disorders. PPIs are generally used long term by the patients. This can cause an increase in patient cost and subsequent decrease in adherence to the prescription. Hence, this study was done to assess the cost variation of PPIs. Methods: The cost of different brands of commonly used PPIs (10 capsules/tablets for oral drugs and one ampoule/vial for injectable drugs) was tabulated by referring to the “Monthly Index of Medical Specialties” October – December 2021, and 1mg online pharmacy. The cost ratio and percentage cost variation for various brands of a particular strength and dosage form was calculated and compared. Cost ratio >2 and cost variation >100% was considered significant. Results: The results showed a huge variation in costs of different brands with the highest being Rabeprazole 20mg (Cost ratio-16.4, Percentage cost variation-1540%) in oral formulation and Rabeprazole 20mg (11.9, 1090%) in the injectable formulation. Among oral drugs, Omeprazole 40mg has the lowest cost ratio and percentage cost variation (1.60, 60.34%) and Pantoprazole 40mg (1.51, 51.16%) in case of injectable formulations. Conclusion: There is a wide variation in the prices of PPIs available in the market. Huge demand for the commonly orally prescribed drugs like Omeprazole 20mg and Pantoprazole 40mg could be the reason for the high cost. Among injectable preparations, Pantoprazole 40mg is the most commonly prescribed but it has an acceptable cost ratio which is a positive sign.

Pharmacoeconomic Analysis of Fixed-Dose Combinations of Proton Pump Inhibitors Available in India.

Introduction The global proton pump inhibitors (PPIs) market wasvalued at US$ 2.9 billion in 2020 and is expected to exhibit a compound aggregated growth rate of 4.30% during the forecast period (2020-2027), as they are regularly prescribed for many gastrointestinal disorders, and the treatment usually lasts for a longer period. PPIs are usually combined with antiemetics and prokinetic drugs. The price of PPIs for the same combination varies a lot, which can lead to a lot of financial burden on the patients. Objective To evaluate the cost ratio and percentage cost variation of commonly used PPIs in various combinations. Methodology The cost of different brands of commonly used PPIs in combination with other drugswas analyzedin our study. A total of21 different combinations (10 capsules/tablets for oral use) were tabulated by referring to the "Monthly Index of Medical Specialities" October-December 2021, and 1mg online pharmacy. The cost ratio and percentage cost variation for various brands of a particular strength and dosage form were calculated and compared. Cost ratio > 2 and cost variation > 100% were considered significant. Results The results showa huge variation (1788.88%)in costs of different brands with the highest being rabeprazole 20 mg and domperidone 10 mg (cost ratio: 18.88, percentage cost variation: 1788.88%) in oral formulation, followed by pantoprazole 40 mg and itopride 150 mg. The minimum cost ratio (1.35) and percentage cost variation (1.35%) is for pantoprazole 40 mg and levosulpiride 75 mg. Logistic regression analysis between the number of brands and percentage cost variation gives an R2 value of 0.0923. Conclusion There is a wide variation in the prices of PPIs available in the market, which can inadvertently increase the financial burden of therapy on patients. Physicians need to be made aware of these price differences so that they can choose the best available alternative for patients, which can help in increasing compliance with the prescribed drugs.

A study of various existing interventions for the treatment of hypertension in the Indian market under the Jan Aushadhi Scheme: A price control aspect for consideration by Journal of Health Policy & Outcomes Research

Aim: Analysis of the percentage price differences among the widely prescribed antihypertensive drugs available on the Indian retail market and under the Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana (PMBJP) or the Jan Aushadhi scheme. Materials and Methods: The prices of frequently prescribed various antihypertensive brands were collected and organized by using latest Monthly Index of Medical Specialties. The price of 1 dosage form in INR of each brand was extracted. Based on the price of various brands, average price of each drug was calculated and compared with the price of PMBJP drugs. Additionally, literature review was performed to place the results in perspective. Results: The prices of prescribed antihypertensive medicines were analyzed and compared with PMBJP drugs. In monotherapy, Metoprolol 25 mg showed a maximum price difference of 89.08%; in combination therapy, Ramipril 5 mg plus Hydrochlorothiazide 12.5 mg indicates maximum price difference of 90.76%. In addition, Telmisartan 40 mg demonstrate 88.59%, Ramipril 5 mg plus Hydrochlorothiazide 12.5 mg demonstrate 90.76%, Ramipril 5 mg plus Hydrochlorothiazide 12.5 mg and Amlodipine 5 mg indicates 90.38% price variation in one treatment course based on the grading of hypertension. Further, on literature review 11 relevant articles were found which were consistent with the results of this study. Conclusion: The results of our study show huge differences between the prices of PMBJP drugs and branded drugs available in India. It suggests that moving towards PMBJP drugs may lessen the financial strain on the patients and their caregivers. The prescriber should make an informed decision and choose the cheaper antihypertensive drugs to lessen the financial burden on the patient leading to maximum patient adherence.

Information on migraine drugs in commonly available Indian drug information sources - Whether we satisfied the community needs?

Drug information can be obtained from various drug information sources that were available as government (National Formulary of India [NFI]; Central Drugs Standard Control Organization [CDSCO]), as well as commercial documents (Current Index of Medical Specialties [CIMS] and Monthly Index of Medical Specialties [MIMS]). Irrational drug usage may happen due to wide variation in the information available in these sources. In this study, we tried to assess these variations in a sample of drugs for the acute-specific management of migraine with ergot and Triptans antimigraine drugs in drug information sources such as NFI, CIMS, MIMS, and CDSCO. Scoring was done for various drug information based on the completeness of information about drugs used in acute-specific management of migraine. The scores for the completeness of drug information about the selected antimigraine drugs are 18.37% for CIMS (Ergotamine, Sumatriptan, Rizatriptan, and Zolmitriptan), 21.1% for NFI (Dihydroergotamine, Sumatriptan), 72.79% for MIMS (Ergotamine tartrate, Sumatriptan, Rizatriptan, Naratriptan, zolmitriptan, Almotriptan) and 21.77% for CDSCO (Ergotamine tartrate, Sumatriptan, Rizatriptan, Naratriptan, Zolmitriptan, eletriptan and almotriptan). The information for the antimigraine drugs available from various sources found to so much deficient. Necessary steps need to be taken in case of government public or hard documents to streamline drug information available with them as well the commercial documents as to provide reliable drug information uniformly for promoting rational use of the drug.

Cost variation analysis of various brands of selective serotonin reuptake inhibitors currently available in the Indian market: An observational study

Background: India being the world’s largest supplier of generic drugs provides 50% of the drugs globally. Selective Serotonin Reuptake Inhibitors (SSRI) (hereafter referred to as SSRI) is the most commonly prescribed drugs for depression (prevalence of 5.25%) and Anxiety (prevalence of 5.8%). The cost of these drugs influences the patient compliance with treatment and thereby the clinical outcome significantly. Aim and Objectives: The aim of the study was to analyze the cost-variation of SSRIs available in the Indian market. Materials and Methods: Maximum and minimum costs of various SSRIs used in the treatment of depression and anxiety were obtained from the monthly index of medical specialties (November 2020) online, Jan Aushadhi Sugam App (Generic drugs), and National Pharmaceutical Pricing Authority online. The cost of various SSRI being manufactured by different companies in the same strength and dosage form were compared. Cost ratio (Maximum cost/Minimum cost) and percentage cost variation ([{Max cost–Min cost}/Min cost] × 100) in INR (₹) were calculated. Data were analyzed and represented using descriptive statistics. Results: Percentage cost variation was maximum with Fluoxetine 20 mg (3477.85%), followed by Sertraline 50 mg (1631.61%) and Escitalopram 10 mg (1288.89%). Percentage cost variation was minimum with Vilazodone 40 mg (16.31%). Conclusion: This study provides awareness about cost variation among different brands of SSRI used in the treatment of depression and anxiety. Wide variation can cause dissatisfaction, poor compliance, and economic burden among patients. It strengthens the usage of generic drugs among general population and healthcare providers.

PDB25 The Cost-Effectiveness of ORAL Semaglutide in Patients Treated with Currently Available GLP-1 Receptor Agonists - a UK Perspective

Oral semaglutide is now available in the United States and Canada, and received marketing authorisation in April 2020 from the EMA for use in Europe. There are already a number of glucagon-like peptide 1 receptor agonists (GLP-1RA) available in either once-daily or once-weekly injectable formulations; semaglutide is the first orally administered GLP-1RA. Unlike the majority of economic evaluations which focus on a specific comparator, the objective of this assessment takes a holistic, real-world approach and compares the cost-effectiveness of oral semaglutide with the currently prescribed GLP-1RA class. To inform the calculations, long-term economic evaluations were conducted in the IQVIA CORE Diabetes Model using the results of a published network meta-analysis and UK-specific costs of treatment and diabetes-related complications. The results of these model simulations were then weighted according to current country-specific GLP-1RA market shares (Feb–Apr 2020). Costs of diabetes treatments were taken from the Monthly Index of Medical Specialities, June 2020, with costs and impact on quality of life of diabetes-related complications taken from published sources. The UK standard discount rate of 3.5% was used. The use of oral semaglutide resulted in reduced lifetime costs and quality-adjusted life-years (QALY; £24,309 and 8.61, respectively) versus injectable GLP-1RAs (£24,561 and 8.59, respectively). These results show that oral semaglutide is dominant (less costly and more effective), with predicted savings of £251 and an increase of 0.03 QALYs per patient when compared with the current market-mix of GLP-1 RA treatments. The results of this analysis show that oral semaglutide is a cost-effective treatment option for patients for whom a GLP-1RA is appropriate. The comparison provided here is relevant to payers, as it demonstrates what they are currently paying versus the new oral formulation. Physician and patient preference is important when selecting which GLP-1RA to prescribe for a patient.

Coexisting Conditions among Children and Adolescents with Cancer in a Section of the South African Private Health Sector: Perspectives from Drug Utilization Data

Coexisting conditions are relatively common in children with cancer, however, there is a paucity of information on the prevalence of coexisting conditions in children with cancer in South Africa. This cross-sectional study aimed at investigating the common coexisting conditions occurring in children and adolescents younger than 19 years undergoing cancer chemotherapy in a section of the South African private health sector. Medicine claims data from 1 January 2008 to 31 December 2017 were queried to identify coexisting conditions using the International Classification of Diseases, Tenth Revision (ICD-10) codes indicated on reimbursed claims. Where ICD-10 codes per claim were non-specific, the pharmacological drug classes of non-cytotoxic medications claimed alongside these codes were categorized using the Monthly Index of Medical Specialties (MIMS) classification system and analyzed using the drug utilization 90% (DU90%) principle. Analysis of sub-pharmacologic drug classes was stratified according to gender and age groups. The reimbursement category of these medicines was noted. Data were analyzed descriptively. A total of 173 participants were included in the study. ICD-10 codes were available for 13.65% (N = 2631) of medicine claims. Diseases of the respiratory system (J00–J99, 7.15%), gastrointestinal tract (K00–K95, 1.60%), and skin disorders (L00–L99, 0.95%) were the most prevalent specific diagnoses identified. Non-specific ICD-10 codes were recorded on 86.35% (n = 2272) of non-cytotoxic medicine claims. The most frequently utilized pharmacological classes of medications included antimicrobial agents (17.40%), respiratory system agents (13.91%), and analgesics (10.64%). As determined from ICD-10 codes and medication claimed on reimbursed claims, children and adolescents being treated for cancers mostly suffered from acute conditions, in particular, microbial infections and diseases of the respiratory system. This indicates the need for the integration of antimicrobial surveillance programs into childhood and adolescent cancer care to curb antimicrobial infections.

A Cost Variation Analysis of Drugs Available in the Indian Market for the Management of Thromboembolic Disorders.

IntroductionCardiovascular diseases (CVDs) have become one of the major causes of mortality among the Indian population. The costs of anticoagulant, antiplatelet, and fibrinolytic drugs that are used to treat various thromboembolic disorders and used as prophylactics for individuals at high risk of CVDs vary widely in the Indian pharmaceutical market. The aim of this study was to evaluate the cost variation of different brands of drug formulations and to compare the branded prices of the formulations with their corresponding generic and ceiling prices.Materials and methodsThis study followed an analytical method. Costs of various drugs were obtained from the October - December 2019 edition of the Current Index of Medical Specialities (CIMS) and December 2019 edition of the Monthly Index of Medical Specialities (MIMS) India. Cost ratio and percentage variation in cost per tablet/capsule/injection of different drugs available in the Indian market and manufactured by different pharmaceutical companies were calculated. Comparison of the branded prices with generic and ceiling prices was also performed for different drugs by using information available from official websites.ResultsPercentage variation in cost among the commonly prescribed drugs for the management of thromboembolic disorders was found to be highest for prasugrel 10 mg tablet (1,408.44%) while it was lowest for fondaparinux 2.5 mg / 0.5 ml injection (20%). Among the commonly prescribed drugs that are under Drugs Prices Control Order (DPCO) price control, streptokinase 1.5 MIU injection had the highest cost variation (132.02%) while enoxaparin 60 mg / 0.6 ml injection had the lowest (4.99%). Among some of the important formulations under the Jan Aushadhi scheme (JAS), acenocoumarol 2 mg tablet had the highest cost variation (680.09%) and cilostazol 50 mg tablet had the lowest (55.46%).ConclusionsWide differences exist in the costs of various anticoagulants, antiplatelets, and fibrinolytics available in the Indian market. The prescribing physician should be aware of theses variations and prescribe medicines accordingly, keeping in mind the financial status of the patients.

The Association Between Drug Burden Index (DBI) and Health-Related Outcomes: A Longitudinal Study of the 'Oldest Old' (LiLACS NZ).

The prescribing of medications with anticholinergic and/or sedative properties is considered potentially inappropriate in older people (due to their side-effect profile), and the Drug Burden Index (DBI) is an evidence-based tool which measures exposure to these medications. Life and Living in Advanced Age: a Cohort Study in New Zealand (LiLACS NZ) is an ongoing longitudinal study investigating the determinants of healthy ageing. Using data from LiLACS NZ, this study aimed to determine whether a higher DBI was associated with poorer outcomes (hospitalisation, falls, mortality and cognitive function and functional status) over 36months follow-up. LiLACS NZ consists of two cohorts: Māori (the indigenous population of New Zealand) aged ≥ 80years and non-Māori aged 85years at the time of enrolment. Data relating to regularly prescribed medications at baseline, 12months and 24months were used in this study. Medications with anticholinergic and/or sedative properties (i.e. medications with a DBI > 0) were identified using the Monthly Index of Medical Specialities (MIMS) medication formulary, New Zealand. DBI was calculated for everyone enrolled at each time point. The association between DBI at baseline and outcomes was evaluated throughout a series of 12-month follow-ups using negative binomial (hospitalisations and falls), Cox (mortality) and linear (cognitive function and functional status) regression analyses (significance p < 0.05). Regression models were adjusted for age, gender, general practitioner (GP) visits, socioeconomic deprivation, number of medicines prescribed and one of the following: prior hospitalisation, history of falls, baseline cognitive function [Modified Mini-Mental State Examination (3MS)] or baseline functional status [Nottingham Extended Activities of Daily Living (NEADL)]. Full demographic data were obtained for 671, 510 and 403 individuals at baseline, 12months and 24months, respectively. Overall, 31%, 30% and 34% of individuals were prescribed a medication with a DBI > 0 at baseline, 12months and 24months, respectively. At baseline and 12months, non-Māori had a greater mean DBI (0.28 ± 0.5 and 0.27 ± 0.5, respectively) compared to Māori (0.16 ± 0.3 and 0.18 ± 0.5, respectively). At baseline, the most commonly prescribed medicines with a DBI > 0 were zopiclone, doxazosin, amitriptyline and codeine. In Māori, a higher DBI was significantly associated with a greater risk of mortality: at 36months follow-up, adjusted hazard ratio [95% confidence interval (CI)] 1.89 (1.11-3.20), p = 0.02. In non-Māori, a higher DBI was significantly associated with a greater risk of mortality [at 12months follow-up, adjusted hazard ratio (95% CIs) 2.26 (1.09-4.70), p = 0.03] and impaired cognitive function [at 24months follow-up, adjusted mean difference in 3MS score (95% CIs) 0.89 (- 3.89 to - 0.41), p = 0.02). Using data from LiLACS NZ, a higher DBI was significantly associated with a greater risk of mortality (in Māori and non-Māori) and impaired cognitive function (in non-Māori). This highlights the importance of employing strategies to manage the prescribing of medications with a DBI > 0 in older adults.

Time-to-onset of treatment for hypertension and hyperlipidaemia in South African diabetes mellitus patients: A survival analysis using medicine claims data.

Hypertension and hyperlipidaemia have high prevalence among diabetics and increase patients' risk of cardiovascular diseases, ultimately affecting prognosis negatively. Medicine claims data have gained prominence in the study of drug-related events and outcomes. There is paucity of publications on the time-to-onset of treatment for these conditions among South African diabetics using secondary data. This study aims to determine the time-to-onset of treatment for hypertension and hyperlipidaemia among diabetics using a South African medicine claims data. Survival analysis was conducted using retrospective data of patients enrolled continuously with a Pharmaceutical Benefit Management (PBM) company in South Africa from 1 January 2008 to 31 December 2016. We identified patients based on International Classification of Diseases, Tenth Revision (ICD-10) diagnoses codes for type 2 diabetes mellitus (E11) who were receiving antidiabetic medication according to the National Pharmaceutical Product Index (NAPPI) codes provided by the Monthly Index of Medical Specialities (MIMS) classification code 19.1 (N=2996). Among these patients, we then selected those who had ICD-10 codes for hypertension (I10, I11, I12, I13, I15, O10 and O11) who were receiving antihypertensive medications, and those who had hyperlipidaemia (E78.5), who received antihyperlipidaemics during the study period. Data were extracted using SAS® system version 9.4 classification codes. The Kaplan-Meier approach, used to compare the survival experience of patients who commenced treatment for hypertension and hyperlipidaemia, was conducted using IBM® SPSS® version 25. The time to the commencement of treatment of hypertension and hyperlipidaemia among the diabetics were measured in days. With 2008 serving as the index year, we followed up on patients until 31 December 2016. A total of 494 patients with an average age of 53.5 (SD 11.1)years were included in the study, 34.8% of whom were females. Prevalence of hyperlipidaemia and hypertension among patients were 35.0% and 45.6%, respectively. Average time-to-onset of treatment for hyperlipidaemia was 2684.4 (SD 42.2)days compared to 2434.2 (SD 47.6)days for hypertension. There was no statistically significant difference in age and sex among patients who started treatment for either of these conditions during the study (P=0.404; Cohen's d=0.132 for hyperlipidaemia and P=0.644, Cohen's d=0.059 for hypertension). Within an average of 6years after an index period of 1year free of disease, diabetics may commence treatment for hyperlipidaemia, hypertension or both. With all significant data appropriately captured, medicine claims data can be effectively used in survival analysis to determine time-to-onset of treatment for hyperlipidaemia and hypertension among diabetics.

Critical caveats in using product information/pregnancy categories for pregnant or breastfeeding patients

Many healthcare professionals (HCPs) base their advice to pregnant or breastfeeding women on Monthly Index of Medical Specialties, Medical Director or the Consumer Medicines Information, which draw from manufacturers’ product information. This information does not reflect evidence-based studies, but rather is based on animal studies conducted prior to the product’s approval for use in humans and is rarely updated. The aim of this paper is to inform HCPs of the evidence-based resources available to assist decision making when treating pregnant or breastfeeding women. Women often have conditions that require treatment during their pregnancies. Experience at MotherSafe indicates that women who are pregnant or breastfeeding are frequently treated with excessive caution or even refused needed treatment by doctors and pharmacists. Product information and evidence-based sources often vary greatly in their recommendations for pregnant and lactating women. By not assessing the risks and benefits for their patients, an adverse outcome for mothers and babies may well be the result – the very outcome the cautious approach of HCPs seeks to avoid.

AN EVALUATION OF FIXED DOSE COMBINATIONS (FDCs) USED FOR TREATMENT OF DIABETES IN INDIAN MARKET

Objective: To analyse the rationality of various FDCs used in the treatment Diabetes Mellitus and to find out the irrational FDCs existing in Indian market. Material and Methods: Study Design: Analytical study. Data on FDC's available in the Indian market was collected from Current Index of Medical Specialities (CIMS) and Monthly Index of Medical Specialities (MIMS) and their rationality was analysed using a pretested tool based on FDCs listed in WHO essential list of medicines and National List of Essential Medicines (NLEM), others based on their pharmacodynamic activity, Pharmacokinetic parameters and significant drug interactions occurring due to API (Active pharmaceutical ingredients) contained within the product Result: A total of 18 combinations were analysed, among those 11 combinations were irrational. Conclusion: Predominantly irrational FDCs are being circulated in the Indian market hence through analyses by prescribers is needed before prescribing to patients in order to avoid ADR. This calls for a close scrutiny of marketed FDC's and educating prescribers to use them with great care and caution also indicates a serious review of regulatory framework for drug manufacturing and marketing.&#x0D; KEYWORDS: Fixed Dose Combinations; Antidiabetics; Irrational.

PDB76 - COST-EFFECTIVENESS ANALYSIS OF EMPAGLIFLOZIN IN COMPARISON TO LIRAGLUTIDE BASED ON CARDIOVASCULAR OUTCOME TRIALS

In the cardiovascular outcome trials (CVOTs) EMPA-REG OUTCOME, and LEADER, empagliflozin (SGLT-2 inhibitor), and liraglutide (GLP-1) + standard of care (SoC) were compared to SoC (placebo arm in the trial) in patients with type 2 diabetes (T2D) and established cardiovascular disease (CVD). This study assessed the cost-effectiveness of empagliflozin+SoC in comparison to liraglutide+SoC in patients with T2D and established CVD based on the respective CVOTs using the UK National Health Service (NHS) perspective. The IQVIA Core Diabetes Model (CDM) was calibrated to reproduce the clinical event rates observed in the EMPA-REG OUTCOME trial. Baseline characteristics and observed effects on physiological parameters (HbA1c, BMI, blood pressure, lipids) were used as inputs. Network meta-analysis provided the relative risks for cardiovascular outcomes with empagliflozin versus liraglutide. Microvascular outcomes were predicted by standard CDM risk equations. The relative treatment effect on the CVOTs was assumed for five years, the modelling horizon of the analysis. The CDM was populated with UK event costs and quality of life data taken from literature. Drug costs were from the British National Formulary and Monthly Index of Medical Specialities. Discounting of 3.5% was applied. Over a 5-year time horizon, CDM projected 2.608 and 2.506 QALY and 14,473GBP and 18,820GBP total costs for empagliflozin+SoC and liraglutide+SoC, respectively, making empagliflozin+SoC the dominant strategy. Projected mortality rate was 10.52% for empagliflozin+SoC and 13.26% for liraglutide+SoC. Myocardial infarction rate was comparable (6.10% vs. 6.14%), non-fatal stroke rate was higher (3.42% vs. 2.43%) and heart failure rate was lower in the empagliflozin arm (5.79% vs. 7.66%) compared to the liraglutide arm. One-way and probabilistic sensitivity analyses showed robustness of the results. Based on the results of the CVOTs, cost effectiveness analysis suggested that empagliflozin+SoC was dominant compared to liraglutide+SoC from the UK NHS perspective over a 5-year time horizon.

PDB63 - COST-EFFECTIVENESS ANALYSIS OF EMPAGLIFLOZIN TREATMENT IN PATIENTS WITH TYPE 2 DIABETES AND CHRONIC HEART FAILURE BASED ON SUBGROUP OF EMPA-REG OUTCOME IN THE UNITED KINGDOM

In type 2 diabetes (T2D) patients with established CV disease, empagliflozin reduced heart failure hospitalizations (HHF) and CV death compared to SoC, regardless of HF at baseline. Given the poor outcomes and economic burden of these comorbidities, we investigated the cost-effectiveness of empagliflozin on top of SoC in T2D patients with HF at baseline over a lifelong time horizon from a UK perspective. Discrete event simulation economic model was developed to project CV events including HHF, CV death, and kidney outcomes for EMPA-REG OUTCOME T2D patients with HF at baseline. Respective risk equations were derived using event-free survival curves with time-dependent covariates. Model validity was assessed by comparing predicted and observed outcomes at three years. UK unit costs of complications and QoL data were obtained from literature. The drug costs were from the British National Formulary and Monthly Index of Medical Specialties. Outcomes included event rates per 100 patient-years (PYs), life years (LYs), costs, and quality-adjusted life years (QALYs). Patients on empagliflozin were projected to experience fewer events of 1st HHF (3.64 vs 4.61 per 100 PY) and recurrent HHF (2.78 vs 4.92 per 100 PY), CV deaths (6.07 vs 7.37 per 100 PY), and non-fatal MI (2.67 vs 3.31 per 100 PY), but higher event rate for non-fatal stroke (2.57 vs 1.54 per 100 PY), compared to SoC. Treatment with empagliflozin projected 1.22 LYs and 0.65 QALYs gained. Incremental Cost-Effectiveness Ratio (ICER) for empagliflozin compared with SoC was £434/QALY. Probabilistic sensitivity analyses suggested that the probability of empagliflozin being cost-effective in patients with T2D and HF at a threshold of £20,000/QALY was 89%. Based on results of EMPA-REG OUTCOME, this cost effectiveness analysis suggests that empagliflozin on top of SoC is a cost-effective treatment option for patients with T2D and chronic HF from the UK NHS perspective.

Oral health impacts of medications used to treat mental illness

BackgroundMany psychotropic medications affect oral health. This review identified oral side effects for antidepressant, antipsychotic, anticonvulsant, antianxiety and sedative drugs that are recommended in Australia for the management of common mental illnesses and provides recommendations to manage these side-effects. MethodsThe Australian Therapeutic Guidelines and the Australian Medicines Handbook were searched for medications used to treat common mental health conditions. For each medication, the generic name, class, and drug company reported side-effects were extracted from the online Monthly Index of Medical Specialties (eMIMs) and UpToDate databases. Meyler's Side Effect of Drugs Encyclopaedia was used to identify additional oral adverse reactions to these medications. ResultsFifty-seven drugs were identified: 23 antidepressants, 22 antipsychotics or mood stabilisers, and 12 anxiolytic or sedative medications. Xerostomia (91%) the most commonly reported side effect among all classes of medications of the 28 identified symptoms. Other commonly reported adverse effects included dysguesia (65%) for antidepressants, and tardive dyskinesia (94%) or increased salivation (78%) for antipsychotic medications. ConclusionsWhile xerostomia has often been reported as a common adverse effect of psychotropic drugs, this review has identified additional side effects including dysguesia from antidepressants and tardive dyskinesia and increased salivation from antipsychotics. Clinicians should consider oral consequences of psychotropic medication in addition to other side-effects when prescribing. For antidepressants, this would mean choosing duloxetine, agomelatine and any of the serotonin re-uptake inhibitors except sertraline. In the case of antipsychotics and mood stabilisers, atypical agents have less oral side effects than older alternatives.

Managing the oral side-effects of medications used to treat multiple sclerosis.

Many medications used to manage multiple sclerosis (MS) affect oral health. This review aimed to identify the oral side-effects of the current drugs recommended in Australia to treat MS and make dental practitioners aware of the range of symptoms. The Australian Therapeutic Guidelines and the Australian Medicines Handbook were searched for medications used to treat MS. For each medication, the generic name, class, route of administration, dosage and drug company reported side-effects were extracted from the online Monthly Index of Medical Specialties (MIMs) database. Meyler's Side-effect of Drugs Encyclopaedia was used to identify any additional oral adverse reactions to medications used to treat MS. Fourteen drugs were identified for the treatment of MS progression and 13 drugs for the treatment of MS symptoms. For these medications, 18 oral side-effects were documented: xerostomia was the most common, followed by dysgeusia, dysphagia, mouth ulceration and sinusitis. Anticholinergic drugs caused xerostomia while immunosuppressants resulted in more infection-related side-effects. Dental practitioners should be aware of the range of symptoms likely to be reported by this population. Clinicians are encouraged to continue providing dental care for their patients who develop MS and refer complex cases to specialists.

PSS15 - Budget Impact of Apremilast for Moderate to Severe Plaque Psoriasis in the UK

Apremilast is an orally administered, small-molecule phosphodiesterase-4 inhibitor. It has a novel mechanism of action, targeting multiple steps implicated in the pathogenesis of psoriasis. Apremilast was approved by the European Medicines Agency in 2015 for the treatment of moderate-to-severe chronic plaque psoriasis (PsO) in adult patients who failed to respond to or have a contraindication to, or are intolerant to other systemic therapies. We assessed the budget impact of introducing apremilast in the current treatment portfolio for psoriasis from the UK payer perspective. A 5-year budget impact model was developed using a prevalence-based approach. The target population was estimated based on the total UK population, annual population growth rate, prevalence of PsO, and proportion of patients with moderate-to-severe disease. The total psoriasis population was divided into 3 categories: untreated patients, patients receiving ≥1 conventional systemic non-biologic therapy (SNBT), and patients on biologics. Biologic treatments included adalimumab, etanercept, infliximab, secukinumab, and ustekinumab. Biosimilars for etanercept and infliximab were also considered. Drug costs were quoted from the British National Formulary (BNF) and the Monthly Index of Medical Specialties (MIMS). Administration costs were obtained from the National Clinical Guideline Centre (NCGC); physician visit and laboratory test costs were informed by National Health Service (NHS) reference costs, the NCGC, and literature values. Over a 5-year period, the number of patients treated with apremilast was estimated to increase from 69 to 1,980. Inclusion of apremilast decreased the total budget by 2.19% (£735,221,377 vs. £751,645,055) relative to the world without. In the final year, drug acquisition costs decreased by 4.43% (£124,099,644 vs. £129,856,022), administration costs by 18.67% (£671,543 vs. £825,667), and monitoring costs by 2.81% (£21,291,886 vs. £21,907,514), yielding a net cost saving of 4.28%. Inclusion of apremilast in the PsO treatment regimen in the UK was cost saving in all respects

The impact of pharmacists' input to reduce serotonin syndrome drug interactions in an Australian hospital.

Drug interactions contribute significantly to adverse-related events and hospital admissions. Example of common drug interactions includes combinations of medications that induces serotonin syndrome. Pharmacists are well placed in the multidisciplinary team to alert prescribers of these drug interactions and offer an alternative management. The objective is to evaluate the effectiveness of pharmacists' input in preventing patients being discharged on clinically relevant drug interactions that have the potential to cause serotonin syndrome in an Australian hospital. A retrospective cross-sectional audit of patients' case notes who were prescribed a combination of drugs likely to induce serotonin syndrome on admission were examined over a 3-month period. A predefined list of serotonin syndrome-inducing drugs of severity 1 and 2 was used to search for patients on these drug combinations on admission. The severities of the drug combinations were classified as per the Monthly Index of Medical Specialties drug interactions guide. Subsequent pharmacists' interventions were recorded on discharge to observe any change in prescribing practice. Descriptive statistics were used to analyze the data. P values were obtained using the Student's t-test and Fisher's exact tests. A total of 144 patients over 3 months were identified to have been prescribed a combination of drugs with a potential to cause serotonin syndrome during admission. Of these patients, 79 and 21% were prescribed combination of serotonergic drugs that were classified as severity 1 and 2, respectively, according to Monthly Index of Medical Specialties. A total of 56% (n = 81) of the audited patients were discharged with no serotonin syndrome-inducing drug combinations and 44% (n = 63) were discharged on serotonin syndrome-inducing drug combinations of severity 1 or 2. Pharmacist input has led to a significant reduction (relative risk reduction 44%; P < 0.0001) in the total number of patients who were discharged on severity 1 and 2 serotonin syndrome-inducing drug combinations. There were 87 patients (60%) who had a pharmacist input during admission. In this subset of the cohort, 36% (n = 31) of patients were discharged on serotonin syndrome-inducing drug combinations (combined both severity 1 and 2) compared with 56% (n = 32) in those who did not get a pharmacist input, P = 0.017. In addition, 64% (n = 56) of patients in this group were discharged on no serotonin syndrome-inducing drug combinations compared with 44% (n = 25) in the nonpharmacist group, P = 0.017. The audit highlights the pharmacists' role in significantly reducing clinically relevant drug interaction in patients prescribed serotonin syndrome-inducing drug combination in a single-center Australian hospital on discharge.

Difference in described indications of medicines among drug information sources in India: An issue urgently to be addressed.

Background:Drug information can be obtained from various sources such as National Formularies, drug package inserts (PI), other sources such as Monthly Index of Medical Specialities (MIMS), Current Index of Medical Specialities, and the information available with the regulators. Any variation in the information available in different sources can promote irrational drug use. In this study, we assessed this variation in a sample of commonly used drugs.Materials and Methods:Fifty commonly used drugs were analyzed for any variation (both quantitative and qualitative) in information on indications as mentioned in commonly used drug information sources such as Central Drugs and Standards Control Organization (CDSCO) website, National Formulary of India (NFI), MIMS, and PI of medicines.Results:We observed a variation in average number of indications per drugs given in CDSCO (2.2 ± 0.25), NFI (3.51 ± 0.42), MIMS (2.98 ± 0.29), and PI (3.18 ± 3.52). The CDSCO and NFI did not contain information about indication for 10 and 17 drugs, respectively, while MIMS and PI contained information about all the selected drugs. A subset analysis was done for 24 such drugs which were mentioned in all the four sources and it was found that NFI had listed the maximum number of indications per drug (3.79 ± 0.53), followed by PI (3.08 ± 0.44), MIMS (3.04 ± 0.51), and CDSCO website (2.66 ± 0.37) and this difference was found to be statistically significant (P = 0.02). We also observed some gross qualitative variation regarding drug information given in different sources.Conclusion:Variation exists in the quantity and quality of information available on indications about drugs available in various sources. Necessary steps need to be taken to harmonize drug information available across various sources so as to provide reliable and uniform drug information thereby promoting rational drug use.