Pharmacoeconomic Appraisal of Treating Head and Neck Cancer with Various Chemotherapy and Chemoirradiation Regimens Using Branded and Jan-aushadhi Drugs in India.

According to recent studies, head and neck cancers (HNC) make up a substantial proportion of all cancers in India and are proportionately high in the lower socioeconomic people practising tobacco and alcohol. Chemotherapy is a crucial component of treating HNC, and this study was carried out to determine the Cost Minimization Analysis (CMA) by comparing the price of the high and least expensive branded drugs marketed in India. This study was performed to understand the cost difference (CD), Cost ratio (CR) and percentage of cost variation (PCV) of both individual drugs and the standard anticancer regimens. The Current Index of Medical Stores was used to determine the costs of the most and least expensive branded medications and analysed. The results indicated that Paclitaxel-Cisplatin-5 Fluoruracil chemotherapy regimen exhibited the greatest variance in cost, with the Jan Aushadhi brand of medicine costing 8.1 times and 4.3 times less than the most expensive and cheapest branded drugs, respectively. The cost of the concurrent cisplatin regimen with Jan Aushadi Medicine was Rs 1764, Rs 3489.64 with the lowest branded drug, and Rs 8477 with the most expensive branded drug. Also when compared to Jan Aushadhi medication, the cost of Ciplatin was 4.8 times higher with the most expensive branded drug and 2 times higher with the least expensive branded drug. As far as the authors are aware of this is the first study that addresses the pharmacoeconomic appraisal of treating HNC with various chemotherapy and chemoirradiation regimens. This study will help oncologists, pharmacists, and healthcare workers comprehend the financial advantages of treating breast cancer with less expensive chemotherapeutic agents instead of brand-name medications.

Pharmaceutical marketing: the example of drug samples.

Branded drug samples are one of the most important promotional tools that pharmaceutical manufactures employ. Pharmaceutical sales representatives ("drug reps") use samples to gain access to physicians and other prescribers. Sample provision is closely intertwined with visits by drug reps; detailing visits convince physicians to try new products, while sampling maintains the flow of prescriptions. Only drugs with the highest profit margins are sampled. Although physicians believe that samples save patients money, patients who receive samples have higher overall out-of-pocket costs. Most studies have found that patients in financial need are least likely to receive samples. Pharmaceutical marketers pitch samples as a low-risk way to deal with diagnostic uncertainty. In fact, there is no evidence that samples aid diagnosis. Sample availability may compromise patient safety by reducing compliance with guidelines and steering patients towards newer drugs, for which adverse effects have not been well-delineated. Although physicians believe that samples improve adherence for low-income patients, branded samples do not improve access or adherence Samples are not a charitable activity, but are instead a highly effective form of drug marketing. Sampling of branded drugs increase drug costs for everyone. Only a cohesive effort by clinicians, legislators and policymakers can end this practice. Evidence supports a ban on sample distribution of branded products.

Cost-Effectiveness Analysis of Branded Drugs With Market Demand and Insurance.

OBJECTIVES: Cost-effectiveness analysis of branded pharmaceuticals presumes that both cost (or price) and marginal effectiveness levels are exogenous. This assumption underlies most judgments of the cost-effectiveness of specific drugs. In this study, we show the theoretical implications of letting both factors be endogenous by modeling pharmaceutical price setting with and without health insurance, along with patient response to the prices that depend on marginal effectiveness. We then explore the implications of these models for cost-effectiveness ratios. METHODS: We used simple textbook models of patient demand and pricing behavior of drug firms to predict market equilibria in the drug and insurance markets and to generate calculations of the cost-effectiveness ratios in those settings. RESULTS: We found that ratios in market settings can be much different from those calculated in cost-effectiveness studies based on exogenous prices and treatment of all patients at risk rather than those who would demand treatment in a market setting. We also found that there may be considerable similarity in these market cost-effectiveness ratios across different products because drug firms with market power set profit-maximizing prices. CONCLUSIONS: We found that market cost-effectiveness ratios will always indicate an excess of benefits over cost. Insurance will lead to less favorable ratios than without insurance, but when insurers bargain with drug firms, rather than taking their prices as given, cost-effectiveness ratios will be more favorable.

Use of antiseizure medications and safety of branded versus generic formulations: A comparative study on Tuscan administrative databases.

PURPOSE: To assess patterns of use of antiseizure medications (ASMs) and to compare the safety of generic versus branded formulations in terms of admission to hospital or to emergency department (ED). METHODS: We conducted a drug utilization study with a propensity score-matched design using the administrative databases of the Italian Tuscany region. New users of ASMs during 2015 with no history of neoplasia were considered and their first prescription was classified as: available only as branded (only-B-ASM); branded with generic available (B-ASM); and generic (G-ASM). Patients with G-ASM first prescription were matched with four patients with B-ASM prescription. Participants were followed up for one year or until the date of death or diagnosis of neoplasia. Cox regression models were fitted to estimate the risk of admission to hospital or ED. RESULTS: We identified 36,601 ASM new-users, including 2094 (6.4%) with only-B-ASM as first prescription, 24,588 (74.9%) with B-ASM, and 5788 (17.6%) with G-ASM. We found no differences in the risk of admission to hospital or ED (Hazard Ratio (HR), 0.92; 95% Confidence Interval (CI), 0.85-1.02) among users of generic ASMs compared to those using branded ASMs. CONCLUSIONS: In our study population, generic ASMs were used less than branded ones. The similarity in the safety of branded and generic formulations suggests that generic ASMs could be the preferred formulation in current clinical practice resulting in a substantial decrease in the cost of treatment.

The economic impact of the transition from branded to generic oncology drugs.

Background: Economic evaluations are an integral component of many clinical trials. Costs used in those analyses are based on the prices of branded drugs when they first enter the market. The effect of genericization on the cost-effectiveness (ce) or cost-utility (cu) of an intervention is unknown because economic analyses are rarely updated using the costs of generic drugs. Methods: We re-examined the ce or cu of regimens previously evaluated in Canadian Cancer Trials Group (cctg) studies that included prospective economic evaluations and where genericization has occurred or is anticipated in Canada. We incorporated the new costs of generic drugs to characterize changes in ce or cu. We also determined acceptable cost levels of generic drugs that would make regimens reimbursable in a publicly funded health care system. Results: The four randomized controlled trials included (representing 1979 patients) were cctg br.10 (early lung cancer, adjuvant vinorelbine-cisplatin vs. observation, n = 172), cctg br.21 (metastatic lung cancer, erlotinib vs. placebo, n = 731), cctg co.17 (metastatic colon cancer, cetuximab vs. best supportive care, n = 557), and cctg ly.12 (relapsed or refractory lymphoma, gemcitabine-dexamethasone-cisplatin vs. cytarabine-dexamethasone-cisplatin, n = 619). Since the initial publication of those trials, the genericization of vinorelbine, erlotinib, cetuximab, and cisplatin has taken place or is expected in Canada. Costs of generics improved the ces and cus of treatment significantly. For example, genericization of erlotinib ($1460.25 per 30 days) resulted in an incremental cost-effectiveness ratio (icer) of $45,746 per life-year gained compared with $94,638 for branded erlotinib. Likewise, genericization of cetuximab ($275.80 per 100 mg) produced an icer of $261,126 per quality-adjusted life-year (qaly) gained compared with $299,613 for branded cetuximab. Decreases in the cost of generic cetuximab to $129.39 and $63.51 would further improve the icer to $150,000 and $100,000 per QALY respectively. Conclusions: Genericization of a costly oncology drug can modify the ce and cu of a regimen significantly. Failure to revisit economic analyses with the costs of generics could be a missed opportunity for funding bodies to optimize value-based allocation of health care resources. At current levels, the costs of generics might not be sufficiently low to sustain publicly funded health care systems.

North American cost analysis of brand name versus generic drugs for the treatment of glaucoma.

BACKGROUND: According to the World Health Organization, glaucoma is a leading cause of irreversible blindness worldwide. By 2020, 80 million people will be affected by glaucoma in the world, which represents a significant financial burden to society. Glaucoma medications alone make up 38-52% of the total direct cost. The purpose of this research is to conduct a cost-minimization analysis to evaluate brand-name medications versus generic medications for treating glaucoma patients. METHODS: The per-bottle cost (in Canadian dollars) of brand-name drugs for glaucoma was obtained from the wholesaler, McKesson Canada, and, for generic drugs, from the Ontario Drug Benefit (ODB) Formulary. Further, a wastage adjustment fee, a pharmacy mark-up, and an ODB dispensing fee ($CAD) was added to the cost of both brand and generic. Previously published frequencies of medication prescription were utilized to calculate the average annual cost for each class of brand and generic. For each medication class and for mono-, bi-, and tri-drug therapy, the cost differential between brands and generics over a six-year period was computed and analyzed from third-party payer perspective. RESULTS: In descending order, the average annual government-funded health care system costs were: combination drugs such as Cosopt® ($748.23) were the most expensive, followed by prostaglandin analogs ($246.36), carbonic anhydrase inhibitors (CAIs) ($45.04), α-agonist ($30.34), ß-blockers ($29.29), and cholinergic agonists ($16.51). Brand-name mono-drugs are 34% more expensive compared to generics. Brand-generic percentage cost differential for various medication classes over a six-year period was the highest for prostaglandin analogous (44%), followed by ß-blockers (35%), α-agonist (31%), cholinergic agonists (22%), combination drugs (10%), and CAIs (1%). CONCLUSION: Brand-name drugs are relatively more expensive than their generic counterparts, with variable cost differentials depending on drug class.

Evaluation of physical properties and dose equivalency of generic versus branded latanoprost formulations.

The purpose of this study was to comparatively evaluate the pharmaceutical characteristics of various marketed generic formulations of prostaglandin analogue latanoprost in the Indian market. Three generics of latanoprost and one branded (Xalatan) formulation (five vials each) were obtained from authorized agents from the respective commercial sourcing having the same batch number. These formulations were coded, and the labels were removed. At a standardized room temperature of 25 °C, the concentration, osmolarity, drop size, pH, and total drops per vial were determined for Xalatan and all the generics of latanoprost. The concentration of various brands varied between 50.49 ± 0.36 and 58.90 ± 0.52 µg/ml as compared to the standard labeled concentration of 50 µg/ml on the latanoprost vials. The concentration of drugs in individual drop varied from 1.30 ± 0.05 to 1.78 ± 0.04 µg/drop. The volume of drug formulation per bottle varied from 2.4 ± 0.12 to 2.6 ± 0.09 ml/bottle. The number of drops per bottle varied from minimum of 88.60 ± 0.10 drops to maximum of 102.0 ± 4.3 drops across all the formulations, while the drop size varied from 25.72 ± 2.70 to 29.97 ± 1.38 µl. The osmolarity of 2/4 drugs was within 300 mOs M (±10 %). The specific gravity varied between 0.98 ± 0.01 and 1.007 ± 0.01, while pH was between 7.05 ± 0.004 and 7.13 ± 0.005. Two of the generic brands were outside the United States pharmacopoeia limits (±10%) for ophthalmic formulation, with concentration exceeding the limits by 3 % (p = 0.151) and 8 % (p = 0.008), respectively. This pilot study highlights that there are significant variations in the drug concentrations and physical properties of generic latanoprost formulations. Although none of the brands had concentrations below the recommended level, two of the brands had concentrations exceeding the limits by 3 and 8 %, respectively.

Evaluation of Physical Properties of Generic and Branded Travoprost Formulations.

PURPOSE: Comparative evaluation of pharmaceutical characteristics of three marketed generic vs branded travoprost formulations. MATERIALS AND METHODS: Three generic travoprost formulations and one branded (Travatan without benzalkonium chloride) formulation (10 vials each), obtained from authorized agents from the respective companies and having the same batch number, were used. These formulations were coded and labels were removed. At a standardized room temperature of 25°C, the drop size, pH, relative viscosity, and total drops per vial were determined for Travatan (Alcon, Fort Worth, TX, USA) and all the generic formulations. Travoprost concentration in all four brands was estimated by using liquid chromatography-coupled tandem mass spectrometry LCMS. RESULTS: Out of the four formulations, two drugs (TP 1 and TP 4) were found to follow the United States Pharmacopoeia (USP) limits for ophthalmic formulation regarding drug concentration, while the remaining two drugs failed due to the limits being either above 110% (TP 2) or below 90% (TP 3). Two of them (TP 1 and TP 2) had osmolality of 313 and 262 mOsm respectively, which did not comply with the osmolality limits within 300 mOsm (+ 10%). The pH of all the formulations ranged between 4.7 and 5.9, and the mean drop size was 30.23 ± 6.03 uL. The total amount of drug volume in the bottles varied from 2.58 ± 0.15 to 3.38 ± 0.06 mL/bottle. CONCLUSION: There are wide variations in the physical properties of generic formulations available in India. Although some generic drugs are compliant with the pharmacopeia standards, this study underscores the need for a better quality control in the production of generic travoprost formulations. How to cite this article: Wadhwani M, Mishra SK, Angmo D, Velpandian T, Sihota R, Kotnala A, Bhartiya S, Dada T. Evaluation of Physical Properties of Generic and Branded Travoprost Formulations. J Curr Glaucoma Pract. 2016;10(2):49-55.