Rising Costs of Otic Drops: Review of a National Database.

OBJECTIVES: US prescription drug prices have increased substantially during the past decade and now account for approximately 17% of total US health expenditures. Otic drop prices are of particular interest given their common use in otolaryngologic clinical practice. We hypothesized that otic drop prices increased at a rate significantly higher than the overall inflation rate. We considered potential causes for otic drop price fluctuations during this period and whether they could be correlated with corporate restructuring events. METHODS: Publicly available data on otic antibiotic drop pricing was assessed from 2012 to 2020 and were correlated with contemporaneous publicly available information about corporate and political events. RESULTS: CiproHC (Alcon Laboratories, Inc., Fort Worth, TX, US), Ciprodex (Alcon Laboratories, Inc., Fort Worth, TX, US), Cortisporin-TC (Endo Pharmaceuticals, Dublin, Ireland), Coly-Mycin S (JHP Pharmaceuticals, LLC, Rochester, MI, US), generic neomycin-polymixin-HC otic drop, ciprofloxacin otic drop, and ofloxacin otic had overall change in cost between January 2014 and January 2020 of 69.9%, 63%, 268.9%, 219.5%, 232.5%, 13%, and 62.4%, respectively. Generic ofloxacin otic drop showed the most price fluctuation, temporarily rising 945% from July 2015 to its peak price of $26/mL in October 2016. CONCLUSION: Otic drop prices have been volatile, with overall price increases higher than overall inflation. Drug pricing is not transparent, making it difficult for prescribers and patients alike to be cost conscious when choosing the best therapy. We outline six factors that contribute to high US medication prices and also highlight two examples of otic drops that underwent significant price fluctuation during the studied period. LEVEL OF EVIDENCE: V Laryngoscope, 131:E1069-E1075, 2021.

Acceptability, adherence and economic analyses of a new clinical pathway for the identification of non-responders to glaucoma eye drops: a prospective observational study.

BACKGROUND/AIMS: Assess whether a new clinical pathway for glaucoma was acceptable to patients and healthcare professionals and whether it provided useful clinical information on non-responsiveness and non-adherence to the treatment of elevated intraocular pressure with latanoprost eye drops. METHODS: A single arm non-randomised prospective observational study incorporating new glaucoma/ocular hypertension patients. To assess issues of acceptability, qualitative observation and interviews were conducted with patients and healthcare professionals. To determine clinical responsiveness, intraocular pressures were measured before and 4 hours after a clinician-instilled eye drop over two distinct appointments. Adherence data were collected using a Medicine Event Monitoring System. Economic analyses compared the costs between novel and standard care pathways. RESULTS: Of 72 patients approached, 53 entered the study (74.3%) and 50 completed all procedures (94.3%). Intraocular pressure was reduced more than 15% in 83 out of 92 study eyes by final visit (90.2%). The non-response rate was 5.1% once the effect of low adherence was minimised. For the 1376 drop instillation days under observation, eye drops were instilled as prescribed on 1004 days (73.0%), over-instilled on 137 days (9.9%) and not instilled on 235 days (17.1%). The Cardiff Model of Glaucoma Care involved negligible cost, although acceptance for healthcare professionals showed variation. CONCLUSIONS: The Cardiff Model of Glaucoma Care offers novel clinical and adherence insights at marginal costs while acceptable to patients. Healthcare professionals felt that 4 hour and 4 week follow-up appointments could cause administrative problems. A streamlined version of the pathway has therefore been developed to facilitate clinical adoption. TRIAL REGISTRATION NUMBER: ISRCTNID:ISRCTN75888393.

A cost minimisation analysis comparing iStent accompanying cataract surgery and selective laser trabeculoplasty versus topical glaucoma medications in a public healthcare setting in New Zealand.

PURPOSE: To produce an economic comparison of the iStent ab interno trabecular microbypass implant accompanying cataract surgery and selective laser trabeculoplasty (SLT) as first-line treatment versus topical medications for open-angle glaucoma in New Zealand in 2016. METHODS: The current annual costs of 19 available fully subsidised topical glaucoma medications by Pharmaceutical Management Agency (Pharmac) in 2016 were identified. Adjustments for pharmacist prescribing charges and previously described wastage levels were applied. The costs to perform iStent implantation and the cost to perform SLT were obtained from the local distributors, with the latter taking into account staff and consumable cost. Procedure costs divided by eye drops' cost produced a break-even level in equivalent years of eye drops use. RESULTS: The range of annual eye drop cost was NZD$42.25 to NZD$485.11, with an average of NZD$144.81. Comparison of annual eye drop cost with iStent cost revealed 3 of 19 (15.8%) drops breaking even within 5 years, 9 of 19 (47.3%) within 10 years, and 12 of 19 (63.2%) within 15 years. The cost of bilateral SLT performed by a consultant was NZD$102.30 (breaking even in 0.71 years). The equivalent cost for a registrar was NZD$97.59 (breaking even in 0.67 years). CONCLUSION: Economically, the iStent would appear to be a reasonably cost-effective treatment for glaucoma patients undergoing cataract surgery in a public healthcare setting in New Zealand, particularly for those using more expensive topical glaucoma medications, whilst SLT appears to be a worthwhile consideration as a first-line treatment for glaucoma in New Zealand.

Regulatory and Economic Considerations of Retinal Drugs.

The advent of anti-VEGF therapy for neovascular age-related macular degeneration and macular edema secondary to retinal vein occlusion and diabetes mellitus has prevented blindness in tens of thousands of people. However, the costs of these drugs are without precedent in ophthalmic drug therapeutics. An analysis of the financial implications of retinal drugs and the impact of the Food and Drug Administration on treatment of retinal disease must include not only an evaluation of the direct costs of the drugs and the costs associated with their administration, but also the cost savings which accrue from their clinical benefit. This chapter will discuss the financial and regulatory issues associated with retinal drugs.

Using multidose eyedrops in a health care setting: a policy and procedural approach to safe and effective treatment of patients.

IMPORTANCE: Quality and safety of eyedrop use for patients treated in a health care setting play a vital role in the delivery of health care. OBJECTIVE: To describe the development of a policy and procedural approach to the use of multidose eyedrops in multiple patients, approved and accepted by The Joint Commission in compliance with preferred practice standards in ophthalmology, the safe handling and administration of multidose eyedrops, and cost benefits of a multidose eyedrop approach. DESIGN, SETTING, AND PATIENTS: Using a policy and procedural approach, we petitioned The Joint Commission for approval and evaluated the cost benefits of implementation of a multidose process for eyedrop administration in patients undergoing surgery and treatment at the Utah Valley Regional Medical Center, Provo. RESULTS: The Joint Commission approved our policy and procedural approach, implemented in April 2012. Cost savings to both patients and the facility were significant. Costs to patients undergoing a single cataract operation were decreased as much as $283.85. Costs to the facility were decreased by $330.91 per cataract case. CONCLUSIONS AND RELEVANCE: Approval of our policy and processes indicates that The Joint Commission validates our policy and its adherence to accepted preferred practice guidelines of safe handling and administration of multidose eyedrops and establishes precedence that may be followed by other eye care facilities and health care organizations in the future. Our policy provides a safe and effective process for administering eyedrop medications to patients as well as controlling excessive health care costs to both patients and health care facilities.

Topical glaucoma therapy cost in Mexico.

Glaucoma is an important cause of irreversible blindness that represents a significant economic burden; most direct costs of glaucoma are drug-related. We calculated the annual cost of some of the most commonly prescribed glaucoma medications in Mexico, according to their average wholesale price (AWP) and dose regimen. Annual costs ranged from USD4.97 for Imot 15 ml (timolol 0.5 %; Laboratorios Sophia) to USD675.39 for Alphagan 5 ml (brimonidine 0.2 %; Allergan, Inc.). ß-Blockers were the least expensive glaucoma medications (range USD20.44-55.44). Alphagan 5 ml was 250 % more expensive than other selective α(2)-agonists. Of the carbonic anhydrase inhibitors, dorzolamide 2 % was less expensive than brinzolamide 1 % (USD326.91 vs. USD418.96). The annual cost for prostaglandin analogs ranged from USD235.58 for bimatoprost 0.03 % to USD337.78 for latanoprost 0.005 %. Some fixed combinations were less expensive than separate combinations. The average annual cost for all treatments increased by 27.87 ± 10.09 % between 2009 and 2012. Annual glaucoma therapy cost seems to be lower in Mexico than in other countries, due to a lower AWP, especially for some medications made by Mexican laboratories.

Avaliação do custo de colírios lubrificantes a base exclusivamente de carboximetilcelulose no mercado brasileiro / Evaluation of the cost of lubricating eye drops based exclusively on carboxymethylcellulose in the brazilian market

OBJETIVO: Avaliar o custo do uso dos colírios lubrificantes mais utilizados no mercado nacional que apresentam na formulação o mesmo princípio ativo - carboximetilcelulose, considerando o número total de gotas presente em cada frasco dos colírios. MÉTODOS: Foi realizado um estudo experimental utilizando três frascos de cada um dos colírios Lacrifilm® (colírio 1) e Fresh Tears® (colírio 2). Para análise do custo dos colírios contou-se o número de gotas de cada frasco correlacionando os preços dos mesmos. O preço considerado para cada medicação foi o mínimo ao consumidor com alíquota de 17% publicado para o mês de janeiro de 2012. A análise estatística foi efetuada em SPSS® 18. A comparação das variáveis quantitativas analisadas foi procedida através do teste não paramétrico Mann-Whitney e correlação linear de Spearman, sendo considerada uma diferença estatisticamente significante um valor de probabilidade inferior a 0,05. RESULTADOS: Verificou-se que há diferença estatisticamente significativa entre as marcas de colírios avaliados com relação ao número total de gotas. O colírio 1 apresentou o maior número de gotas. CONCLUSÃO: O colírio 1, que tem o maior número de gotas por frasco, também é o que tem o preço mais acessível. Portanto, verifica-se que é o produto mais econômico, ou seja, o paciente pagará menos por cada gota.

OBJECTIVE: The objective of this study is to evaluate the cost of the use of lubricant eye drops, which are more used in the national market and contain in its formulation the same active ingredient - carboximeticelulose -, by considering their total number of drops in each flask. METHODS: An experimental study was accomplished by using three flasks of each one of the following eye drops: Lacrifilm®(eye drop 1) and Fresh Tears®(eye drop 2). To the analysis of their cost, the number of drops of each flask was counted, correlating them with their price. The price considered for each medication was the minimum to consumer with an aliquot of 17% published for the month of January 2012. The statistical analysis was accomplished in SPSS®18. The comparison of the quantitative variables evaluated was followed through the non-parametric test Mann-Whitney and Spearman linear correlation, in which a significant statistical difference was considered, a value of probability inferior to 0,05. RESULTS: It was verified statistically significant difference between brands of eye drops evaluated in relation to their total number of drops per flask as well as to their prices. Eye drop 1 presented greater number of drops. CONCLUSION: Eye drop 1, which has the greater number of drops per flask, also has the lowest price. Therefore, it is verified that the product is the most economical, what means that the patient will pay less for each drop.

An adherence based cost-consequence model comparing bimatoprost 0.01% to bimatoprost 0.03%.

OBJECTIVES: Estimate the long-term direct medical costs and clinical consequences of improved adherence with bimatoprost 0.01% compared to bimatoprost 0.03% in the treatment of glaucoma. METHODS: A cost-consequence model was constructed from the perspective of a US healthcare payer. The model structure included three adherence levels (high, moderate, low) and four mean deviation (MD) defined health states (mild, moderate, severe glaucoma, blindness) for each adherence level. Clinical efficacy in terms of IOP reduction was obtained from the randomized controlled trial comparing bimatoprost 0.01% with bimatoprost 0.03%. Medication adherence was based on observed 12 month rates from an analysis of a nationally representative pharmacy claims database. Patients with high, moderate and low adherence were assumed to receive 100%, 50% and 0% of the IOP reduction observed in the clinical trial, respectively. Each 1 mmHg reduction in IOP was assumed to result in a 10% reduction in the risk of glaucoma progression. Worse glaucoma severity health states were associated with higher medical resource costs. Outcome measures were total costs, proportion of patients who progress and who become blind, and years of blindness. Deterministic sensitivity analyses were performed on uncertain model parameters. RESULTS: The percentage of patients progressing, becoming blind, and the time spent blind slightly favored bimatoprost 0.01%. Improved adherence with bimatoprost 0.01% led to higher costs in the first 2 years; however, starting in year 3 bimatoprost 0.01% became less costly compared to bimatoprost 0.03% with a total reduction in costs reaching US$3433 over a lifetime time horizon. Deterministic sensitivity analyses demonstrated that results were robust, with the majority of analyses favoring bimatoprost 0.01%. Application of 1 year adherence and efficacy over the long term are limitations. CONCLUSIONS: Modeling the effect of greater medication adherence with bimatoprost 0.01% compared with bimatoprost 0.03% suggests that differences may result in improved economic and patient outcomes.

Drug use in primary open angle glaucoma: a prospective study at a tertiary care teaching hospital.

OBJECTIVE: To study drug use pattern in patients of primary open angle glaucoma (POAG) and to analyze the cost of different anti-glaucoma medications. MATERIALS AND METHODS: This prospective study was carried in the glaucoma clinic of a tertiary care teaching hospital over a period of 9 months. The data collected for patients with POAG included the patient's demographic details and the drugs prescribed. Data were analyzed for drug use pattern and cost drugs used. RESULTS: In a total 180 prescriptions (297 drugs) analyzed, most drugs (83.83%) were prescribed by topical route as eye drops. ß blockers (93.88%) were found to be the most frequently prescribed for POAG. Timolol (82.22%) was the most frequently prescribed drug and timolol with acetazolamide (17.22%) was the most commonly prescribed drug combination. Fixed dose combinations constituted 26.66% of prescriptions. ß blockers were found to be cheaper than other anti-glaucoma drugs while prostaglandins analogs were the costliest. Instructions about the route, frequency and duration of treatment were present in all prescriptions. However, instructions regarding instillation of eye drops were missing in all prescriptions.

[Increased treatment costs through use of nonpreserved antiglaucoma agents?]. / Steigerung der Behandlungskosten durch die Verwendung unkonservierter Antiglaukomatosa?

The cost alterations for the transfer from antiglaucoma agents with preservatives to those without preservatives will be discussed. The resulting cost increases are only moderate.

Cost of dry eye treatment in an Asian clinic setting.

OBJECTIVES: To estimate the cost and patterns of expenditure of dry eye treatment. METHODOLOGY: We retrieved data on the type and cost of dry eye treatment in Singapore National Eye Centre from pharmacy and clinic inventory databases over a 2 year period (2008-2009) retrospectively. According to the type of treatment, data were sorted into 7 groups; meibomien gland disease (MGD) treatment, preservative free lubricant eye drops, preserved lubricant eye drops, lubricant ointments and gels, cyclosporine eye drops, oral supplements and non-pharmacological treatments/procedures. Each recorded entry was considered as one patient episode (PE). Comparisons in each group between two years were carried out using Pearson Chi-Square test. Significance level was set at alpha  =  0.05. RESULTS: Cost data from 54,052 patients were available for analysis. Total number of recorded PEs was 132,758. Total annual expenditure on dry eye treatment for year 2008 and 2009 were US$1,509,372.20 and US$1,520,797.80 respectively. Total expenditure per PE in year 2008 and 2009 were US$22.11 and US$23.59 respectively. From 2008 to 2009, there was a 0.8% increase in total annual expenditure and 6.69% increase in expenditure per PE. Pharmacological treatment attributes to 99.2% of the total expenditure with lubricants accounting for 79.3% of the total pharmacological treatment expenditure. Total number of units purchased in preservative free lubricants, cyclosporine eye drops and MGD therapy have increased significantly (p<0.001) whereas number of units purchased in preserved lubricants and ointments/gels have reduced significantly (p<0.001) from 2008 to 2009. CONCLUSION: Dry eye imposes a significant direct burden to health care expenditure even without considering indirect costs. Health care planners should be aware that these direct costs appear to increase over the time and more so for particular types of medications. Given the limitations of socio-economic data, true societal costs of Dry eye syndrome are likely to be much higher than estimated.

Estudo sobre os fatores relacionados a interrupção do tratamento do glaucoma / Study of the factors related to stop the treatment of glaucoma

OBJETIVO: Identificar causas relacionadas com a não aderência ao tratamento do glaucoma primário de ângulo aberto e sugerir meios para posteriormente minimizá-las. MÉTODOS: Foi aplicado um questionário a pacientes portadores de glaucoma primário de ângulo aberto no Hospital Universitário Gaffrée e Guinle, escolhidos aleatoriamente, para avaliação dos fatores relacionados com a interrupção do tratamento. Para isso, utilizou-se uma análise univariada, pelo teste exato de Fisher, e considerou estatisticamente significativo p<0,05. RESULTADOS: A partir do questionário, identificou-se dois subgrupos, um que já havia interrompido o tratamento e outro que nunca o havia interrompido, compostos por 25 e 11 pacientes respectivamente. Estes grupos foram comparados entre si e todos os parâmetros analisados. O custo dos medicamentos (p=0,001) e o fator esquecimento (p=0,007) foram estatisticamente relevantes para a interrupção do tratamento da doença. As demais variáveis testadas não obtiveram significância estatística. CONCLUSÃO: O custo dos medicamentos e o fator esquecimento foram os fatores mais importantes para interrupção do tratamento.

The objective was to identify causes related to noncompliance of primary open-angle glaucoma and suggest ways to minimize them later. A questionnaire was given to patients with primary open angle glaucoma in Hospital Gaffrée Guinle, chosen randomly, to assess factors related to discontinuation of treatment. For this we used a univariate analysis by Fisher's exact test and considered statistically significant p <0.05. From the questionnaire, we identified two sub-groups, who had stopped treatment and another who had never stopped for 25 compounds and 11 patients respectively. These groups were compared, and all parameters examined. The cost of drugs (p = 0.001) and forgetting factor (p = 0.007) were statistically significant for discontinuation of treatment of disease. The other variables tested did not achieve statistical significance. CONCLUSION: The cost of drugs and forgetting to take medication were the factors most important to withholding treatment.

Low-cost protocol for the production of autologous serum eye drops by blood collection and processing centres for the treatment of ocular surface diseases.

OBJECTIVES: To create a low-cost protocol for the production of autologous serum eye drops (ASEs) by blood collection and processing centres using standard equipment and staff already available. The protocol must observe local and federal regulatory authorities' requirements for good manufacturing practice. AIM: The final aim is to improve accessibility to ASEs for patients who need them and to implement similar production parameters at all institutions producing ASEs. BACKGROUND: Despite evidence of the beneficial effects of ASEs in the treatment of severe ocular surface diseases, ASEs are not approved by most federal regulatory bodies in the United States or Europe. In some countries, such as the United States, access to ASEs is extremely limited and cost-prohibitive. Blood processing centres are in optimal position to help in increasing accessibility and lowering the cost of these products. MATERIALS/METHODS: Standard blood processing equipment, staff and materials were chosen for the protocol. The protocol was designed to minimise the risk of contamination as much as possible. RESULTS: A low-cost, open system protocol for production of ASEs was generated that can be implemented by most blood collection and processing centres in the United States and Europe. CONCLUSION: Efforts should be made to propagate a similar protocol for the production of ASEs in blood centres capable of collecting and processing blood products, making this service affordable and uniformly accessible to patients.

[Impact of the consumption of ophthalmic topical antibiotics]. / Impacto del consumo de antibióticos de uso tópico oftalmológico.

INTRODUCTION: The aim of the study was to value the impact of the consumption of the topical antibiotics used in ophthalmology and to lay the foundations for their prudent use. MATERIAL AND METHODS: A descriptive study about antibiotic use in Spain between 1st January 2004 and 31th December 2008 was carried out. Drugs used in the study had to follow the next criteria: topical administration and ophthalmic antibiotics only or in association. Data of the number of vials and nosocomial consumption were provided by Intercontinental Marketing Services (IMS) and Health National System, respectively. RESULTS: Nosocomial and community ophthalmologic antiinfectives in 2008 mean a cost of 4.9 and 24.4 millions of euros, respectively increasing a 5.5% respect to the previous year. Six millions of vials were used, 65% were antibiotics alone and 35% antibiotics in association. The most used ophthalmic antibiotics in monoterapy were the aminoglycosides (tobramycin and gentamicin), followed by the quinolones while the most used ophthalmic antibiotic in association were gramicidine plus neomycine plus polimixin B. CONCLUSIONS: The ophthalmic antiinfectives market, alone and in association, used in the nosocomial and community context means 30 millions of euros and shows an increase about 6%. Strict measures in the antibiotic use are not taken incount in the context of the ophthalmic topical antibiotics.