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Background: Branded drugs contribute disproportionately to high prescription drug spending. Pharmaceutical companies utilize patent extension "evergreening" techniques that contribute to high drug costs. Aims: This article describes various patent extension techniques and analyzes the tactic of combining generic drugs with branded drugs, using metformin combinations for diabetes treatment as a case study. It examines the argument that FDCs enhance adherence and compares the cost of several branded fixed‐dose combinations with the cost of their individual constituents. Materials & Methods: We reviewed literature on patent extension techniques in both medical and marketing literature, supplemented by our own extensive files. We performed a price analysis of several branded pharmaceuticals and generically available equivalents. Prescription drug prices were determined using GoodRx.com, and prices of over‐the‐counter products were established based on the prices of two chain wholesalers. Patent and formulation information was taken from the FDA Orange Book: Approved Drugs with Therapeutic Equivalence Evaluations database. Results: "Evergreening" patent extension tactics include the sequential release of different formulations, minor dosing changes, and fixed‐dose combinations (FDCs). A "new use" provides an opportunity for a company to re‐patent, rebrand, and remarket one drug for multiple indications. It is unclear whether or not FDCs enhance adherence. Branded fixed‐dose combinations generally cost far more than their individual constituents. FDCs that combine metformin with other drugs are an exception, often costing the same as the non‐metformin component. Discussion: Patent extension tactics increase drug costs while providing little additional benefit to patients. Minor alterations in formulations or dosing may provide no clinical benefits. Many FDCs are expensive and fail to provide cost‐justified improvements in clinical outcomes, compared to equivalent generic drugs that would save money while delivering an equal standard of care. Combining newer hypoglycemic drugs with metformin, a gold‐standard, generic, inexpensive drug, does not appear to cost more than individual constituents but offers no clinical advantage over metformin alone. Conclusion: Evergreening tactics should be reined in, as they represent significant cost to the healthcare system and to patients. Physicians and other prescribers should avoid prescribing FDCs, or slightly tweaked "new" drugs. Patented drug combinations generate profit without innovation. [ABSTRACT FROM AUTHOR]

PURPOSE: The financial toxicity of anticancer drugs is well-documented, but little is known about the costs of drugs used to manage cancer-associated symptoms. METHODS: We reviewed relevant guidelines and compiled drugs used to manage seven cancer-associated symptoms (anorexia and cachexia, chemotherapy-induced peripheral neuropathy, constipation, diarrhea, exocrine pancreatic insufficiency, cancer-associated fatigue, and chemotherapy-induced nausea and vomiting). Using GoodRx website, we identified the retail price (cash price at retail pharmacies) and lowest price (discounted, best-case scenario of out-of-pocket costs) for patients without insurance for each drug or formulation for a typical fill. We describe lowest prices here. RESULTS: For anorexia and cachexia, costs ranged from $5 US dollars (USD; generic olanzapine or mirtazapine tablets) to $1,156 USD (brand-name dronabinol solution) and varied widely by formulation of the same drug or dosage: for olanzapine 5 mg, $5 USD (generic tablet) to $239 USD (brand-name orally disintegrating tablet). For chemotherapy-induced peripheral neuropathy, costs of duloxetine varied from $12 USD (generic) to $529 USD (brand-name). For constipation, the cost of sennosides or polyethylene glycol was <$15 USD, whereas newer agents such as methylnaltrexone were expensive ($1,001 USD). For diarrhea, the cost of generic loperamide or diphenoxylate-atropine tablets was <$15 USD. For exocrine pancreatic insufficiency, only brand-name formulations were available, range of cost, $1,072 USD-$1,514 USD. For cancer-associated fatigue, the cost of generic dexamethasone or dexmethylphenidate was <$15 USD, whereas brand-name modafinil was more costly ($1,284 USD). For a 4-drug nausea and vomiting prophylaxis regimen, costs ranged from $181 USD to $1,430 USD. CONCLUSION: We highlight the high costs of many symptom control drugs and the wide variation in the costs of these drugs. These findings can guide patient-clinician discussions about cost-effectively managing symptoms, while promoting the use of less expensive formulations when possible. [ABSTRACT FROM AUTHOR]

Drug utilization studies in developing countries is evolving. Rising medication cost for hypertensive patients is a major cause of noncompliance to therapy. The study was a cross-sectional drug utilization review involving outpatients in two purposively selected hospitals (secondary and tertiary) in Abeokuta, Southwestern Nigeria. Data and relevant information were obtained from the patients' medical records domiciled in the outpatients' hospital records department. Descriptive and inferential statistics were used at p < 0.05. Total medication cost to patients was USD$48,575; out of which antihypertensive medications accounted for 46% (USD$21,588) in two referral hospitals. Ramipril was the most prescribed in both hospitals. Generic drugs were cheaper than their branded alternatives. Study outcomes are beneficial for managing costs for hypertensive patients. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: A core evaluation framework that captures the health care and societal benefits of value added medicines (VAMs, also often called repurposed medicines) was proposed in Report 1, aiming to reduce the heterogeneity in value assessment processes across countries and to create incentives for manufacturers to invest into incremental innovation. However, this can be impactful only if the framework can be adapted to heterogeneous health care financing systems in different jurisdictions, and the cost of evidence generation necessitated by the framework takes into account the anticipated benefits for the health care system and rewards for the developers. Areas covered: The framework could potentially improve the pricing and reimbursement decisions of VAMs by adapting it to different country specific decision-contexts such as deliberative processes, augmented cost-effectiveness frameworks or formal multi-criteria decision analysis (MCDA); alternatively, some of its domains may be added to current general evaluation frameworks of medicines. The proposed evaluation framework may provide a starting point for practices based on which VAMs can be exempted from generic pricing mechanisms or can be integrated into the reimbursement and procurement system, allowing for price differentiation according to their added value. Besides evidence from RCTs, pricing and reimbursement decision processes of VAMs should allow for ex-ante non-RCT evidence for certain domains. Alternatively, relying on ex-post evidence agreements—such as outcome guarantee or coverage with evidence development—can also reduce decision uncertainty. Conclusions: The core evaluation framework for VAMs could trigger changes in the existing pricing, reimbursement and procurement practices by improving the appraisal of the added value created by incremental innovation. [ABSTRACT FROM AUTHOR]

This pharmacoepidemiology study uses insurance claims data to compare generic substitutions for drugs with vs without manufacturer copayment coupons in California vs surrounding states in the year before and after a January 2018 California ban on coupons intended to incentivize use of more expensive brand-name medication. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To determine whether elimination of co-pays for prescription drugs affects medication adherence and total health care spending. STUDY DESIGN: Retrospective comparative study. METHODS: We conducted a difference-in-differences comparison in the year before and after expansion of a Zero Dollar Co-pay (ZDC) prescription drug benefit in commercially insured Louisiana residents. Blue Cross and Blue Shield of Louisiana members with continuous disease management program enrollment were analyzed, of whom 6463 were enrolled in the ZDC program and 1821 were controls who were ineligible because their employers did not opt in. RESULTS: After ZDC expansion, medication adherence fell in the control group and rose in the ZDC group, with a relative increase of 2.1 percentage points (P = .002). Medical spending fell by $71 per member per month (PMPM) (P = .027) in the ZDC group relative to controls. Overall, there was no significant increase in the cost of drugs between treatment and controls. However, when drugs were further categorized, there was a significant increase of $8 PMPM for generic drugs and no significant difference for brand name drugs. Comparisons of medication adherence rates by household income showed the largest relative increase post ZDC expansion among low-income members. CONCLUSIONS: Elimination of co-pays for drugs indicated to treat chronic illnesses was associated with increases in medication adherence and reductions in overall spending of $63. Benefit designs that eliminate co-pays for patients with chronic illnesses may improve adherence and reduce the total cost of care. [ABSTRACT FROM AUTHOR]

To control costs and improve access, nations can adopt strategies employed in the United Kingdom to control pharmaceutical prices and spending. Current policy evolved from a system created in 1957 that allowed manufacturers to set launch prices, capped manufacturers' rates of return, and later cut list prices. These policies did not effectively control spending and had limited effects on purchase prices. The United Kingdom currently controls pharmaceutical spending in 4 ways. (a) Since 1999, it has typically paid no more than is cost-effective. (b) Since 2017, for medicines that will have a significant budget impact, National Health Service England seeks discounts from cost-effective prices or seeks to limit access for 2 years to patients with the greatest need. (c) Since 2014, statutes and a voluntary scheme have required branded manufacturers to pay the government rebates to recoup the difference between the global pharmaceutical budget and actual spending. (d) For hospitals, generics and some patented drugs are procured through competitive bidding; community pharmacies are reimbursed through a system that provides an incentive to beat average generic market prices. These policies controlled the growth of spending, with the largest effects following budget controls in 2014. Changes since 2008 have reduced savings, first by paying more than is cost-effective for cancer drugs and then by applying higher cost-effectiveness thresholds for some drugs used to treat cancer and certain other drugs. [ABSTRACT FROM AUTHOR]

At present, pay for prescription models are insufficient at containing costs and improving access to medicines. Subscription financing through tenders, licensing fees and unrestricted or fixed volumes can benefit stakeholders across the supply chain. Pharmaceutical manufacturers can reduce the need for marketing expenses and gain certainty in revenue. This will decrease costs, improve predictability in budget expenditure for payers and remove price as a barrier of access from patients. Inherently, low- and middle-income countries lack the purchasing power to leverage price discounts through typical price arrangements. These markets can realise substantial savings for branded and generic medicines through subscription financing. Procuring of on-patent and off-patent drugs requires separate analysis for competition effects, the length of contract and encouraging innovation in the medicine pipeline. Prices of competitive on-patent medicines and orphan drugs can be reduced through increased competition and volume. Furthermore, pooling expertise and resources through joint procurement has the potential for greater savings. Incentivising research and development within the pharmaceutical industry is essential for sustaining a competitive market, preventing monopolies and improving access to expensive treatments. However, technical capacity, forecasting demand and the quality of generic medicines present limitations which necessitate government support and international partnerships. Ultimately, improving access requires progressive financing mechanisms with patients and cost containment in mind. [ABSTRACT FROM AUTHOR]

Generic medicines have been available to consumers for ∼40 years, with varying degrees of uptake in different countries. Despite offering equivalent therapeutic qualities, generic medicines still struggle to be accepted by consumers. This study examines the role of a consumer's affective state and framing effects on the purchase of a branded versus a generic pharmaceutical product. These issues are examined in an experiment, with independent manipulations of consumer anxiety levels and the framing of generic alternatives by the pharmacist. The sample comprised 426 men and women within Australia who completed an online survey with a scenario of purchasing a pharmaceutical after visiting a General Practitioner. Results indicate that those consumers experiencing higher levels of anxiety and where the doctor prescribed the branded medicine are more likely to choose branded medicines over cheaper, generic alternatives. The effect of framing the generic alternative as either 'generic' or 'cheaper' was not significant. [ABSTRACT FROM AUTHOR]

Background To address the growing threat of multidrug-resistant organisms, policymakers are seeking ideas to promote development of novel antibiotics. In 2018, the REVAMP Act was proposed in Congress to reward manufacturers of certain novel antibiotics with transferrable market exclusivity vouchers. Methods We estimated the economic impact of this proposal by identifying antimicrobial drugs approved by the FDA from 2007–2016 that would likely have qualified for an exclusivity voucher and matching each drug to the highest-revenue fast-track drug facing generic entry within 4 years after the antibiotic was approved. Assuming a spending decrease of 75% after generic entry, we calculated the per-drug and total societal costs of these transferrable market exclusivity extensions over a decade. Results We identified 10 antimicrobials that would have qualified for an exclusivity voucher, each of which was matched with 1 of 17 fast-track drugs facing generic entry through July 2019. These 10 drugs had a median annual revenue before generic entry of $249 million (range, $26 million–$2.7 billion). Accounting for a 75% spending reduction after generic entry, the median excess spending associated with 12 months of extended exclusivity was $187 million, for a total of $4.5 billion over 10 years. Conclusions While market exclusivity extensions are a politically appealing mechanism to encourage novel antibiotic development, this approach would cost public and private payers billions of dollars over the next decade. [ABSTRACT FROM AUTHOR]

In the article, the author discusses the challenges in ensuring the quality and effectiveness of generic medicines. He cites issues on generic drug quality by presenting the side effects experienced by his kid with attention deficit hyperactivity disorder (ADHD) who was prescribed generic methylphenidate. Also cited are the challenges faced by the U.S. Food and Drug Administration (FDA) in regulating generic drugs.

Introduction: Pharmaceutical research and development (R&D) is costly and only a minority of patients can access innovative medicines due to affordability constraints. Value-added medicines (VAMs) can offer potential benefits at significantly lower R&D costs.Areas Covered: VAMs may address different health care needs and problems, including off-label use of medicines, poor patient adherence, problems related to polypharmacy, need for home and/or personalized health care services. However, several barriers prevent societies from maximizing the benefits of incremental innovation related to VAMs. Generic manufacturers have limited budget and experience to demonstrate the value of new VAMs. Current market exclusivity options do not efficiently exclude freeridership and do not guarantee a return on investment for VAM innovators. Value propositions of VAMs are limitedly consistent with current HTA frameworks, consequently, incremental innovation is not acknowledged, nor rewarded with differential pricing by payers. Moreover, VAMs are often perceived solely as generic medicines by prescribers.Expert Opinion: Current practices may need to be reconsidered to exploit the full societal benefit of VAMs, including more efficient policies to guarantee market exclusivity for incremental innovation, acknowledgment of a fair price premium based on a specific value framework and the acceptance of low-cost evidence generation methods. [ABSTRACT FROM AUTHOR]

The Affordable Care Act contained a range of provisions that altered prescription drug access and affordability for patients, payers, and providers. Yet the act stopped short of instituting systemic changes in the pricing of drugs, in part to address concerns that more fundamental changes might disrupt the development of new medicines. Looking back a decade after the Affordable Care Act became law, we found that new drug approvals have accelerated and the therapeutic advances embodied in some novel medicines are substantial--as are the prices that companies are charging for them. The lack of affordability of prescription drugs has become an increasing challenge for American patients and payers, particularly those with limited budgets. In this article we consider how things have changed in the past decade and how missed opportunities in the Affordable Care Act's passage figure prominently in the current drug pricing debate. [ABSTRACT FROM AUTHOR]

Background: Generic substitution (GS) was introduced in Finland in 2003 and supplemented with a reference price system (RPS) in 2009. Patients play a vital role in the acceptance of GS and the use of less expensive generic medicines. The objective of this study was to explore Finnish pharmacy customers' experience with allowing and refusing GS. Specific aims were to investigate the reasons for (1) allowing and (2) refusing GS and (3) to determine the prescription medicine-related factors influencing the customer's choice of an interchangeable prescription medicine.Methods: A questionnaire survey was conducted in February 2018. Questionnaires were handed out from 18 community pharmacies across Finland to customers ≥18 years who purchased for themselves a prescription medicine included in the RPS. A descriptive approach was used in the analysis using frequencies, the Chi-square test and Fisher's exact test.Results: The final study material consisted of 1043 questionnaires (response rate 40.0%). Of the customers, 47.9% had both allowed and refused GS, 41.2% had only allowed GS and 6.0% had only refused GS. Customers had allowed GS because they wanted to lower their medicine expenses (75.5%), or because the prescribed medicine (30.8%) or medicine they had used before (27.4%) was unavailable at the pharmacy. The main reasons for refusing GS were an insignificant price difference between interchangeable medicines (63.3%) and satisfaction with the medicine used before (60.2%). The main factors influencing customers' choice of an interchangeable prescription medicine were price (81.1%), familiarity (38.4%) and availability (32.8%). Customers who had allowed GS chose the medicine based on price. Customers who had only refused GS appreciated familiarity more than the price of the medicine.Conclusions: GS is a common practice in Finnish community pharmacies. The price of the medicine was the most important factor affecting customers' decision to allow or refuse GS and the choice of an interchangeable prescription medicine. Thus, customers should receive information about medicine prices at the pharmacy in order to help them make their decision. However, individual needs should also be taken into account in counselling because customers regard several factors as important in their choice of an interchangeable medicine. [ABSTRACT FROM AUTHOR]

The article suggests ways for clinicians to help reduce medicines wastage and improve patient health. It discusses the importance of targeting intervention needs of patients to support adherence via communication, decision-making and provision of information resources. Emphasis is also given on the significance of detecting hidden changes in patients to improve care. The option to provide non-medicinal treatment based on patient choice and clinical appropriateness is considered.

In response to brand-name drug manufacturers developing co-pay assistance programs to help patients pay high out- of-pocket costs for expensive brand-name drugs, insurers have developed co-pay accumulator adjustment programs (CAAPs) that exclude payments made by drug manufacturer assistance programs when calculating whether beneficiaries have met their yearly out-of-pocket maximums. By doing so, these programs are intended to drive beneficiaries to lower-priced generic alternatives. A rule finalized in July 2020 makes such programs permissible even when a brand- name drug does not have a generic or medically appropriate alternative, while not requiring transparency from payers about the existence of such programs. This commentary explains how CAAPs work and how this finalized rule may affect spending on prescription drugs. [ABSTRACT FROM AUTHOR]

The legal tactics that drug manufacturers use to extend drug patents may be the biggest impediment to lowering drug prices and to Congress acting on pricing. Until now, that is. [ABSTRACT FROM AUTHOR]

Objective: To analyze factors associated with changes in prescription drug use and expenditures in the United States from 1999 to 2016, a period of rapid growth, deceleration, and resumed above-average growth.Data Sources/study Setting: The Medical Expenditure Panel Survey (MEPS), containing household and pharmacy information on over five million prescription drug fills.Study Design: We use nonparametric decomposition to analyze drug use, average payment per fill, and per capita expenditure, tracking the contributions over time of socioeconomic characteristics, health status and treated conditions, insurance coverage, and market factors surrounding the patent cycle.Data Collection/extraction Methods: Medical Expenditure Panel Survey data were combined with information on drug approval dates and patent status.Principal Findings: Per capita utilization increased by nearly half during 1999-2016, with changes in health status and treated conditions accounting for four-fifths of the increase. In contrast, per capita expenditures more than doubled, with individual characteristics only explaining one-third of the change. Other drivers of spending during this period include the changing pipeline of new drugs, drugs losing exclusivity, and changes in generic competition.Conclusions: Long-term trends in treated conditions were the fundamental drivers of medication use, whereas factors involving the patent cycle accelerated and decelerated spending growth relative to trends in use. [ABSTRACT FROM AUTHOR]

Aim: The study was undertaken to reveal the differences in statin users' characteristics, the views on generic drugs between brand-name statin users and generic statin users, and the factors associated with being generic statin users.Subjects and methods: A questionnaire survey was conducted on patients visiting community pharmacies in order to have their prescriptions including statins dispensed. Respondents answered their views on the questionnaire items using a 5-point Likert-type scale, then answers were dichotomized. Odds ratios were calculated to analyze respondent's views and respondents' characteristics associated with being generic users.Results: In total, 122 patients agreed to participate in the survey; with regard to respondent's views associated with being generic statin users, those agreeing "I have a concern in switching any currently taken drugs to generic drugs" were less likely to be generic statin users [OR (95% CI): 0.13, (0.05-0.35)]. Respondents agreeing "generic drugs are less expensive than brand-name drugs" were more likely to be generic users [4.55, (1.77-11.67)]. No respondent's characteristics were associated with being generic statin users. The majority of respondents agreed "I don't mind taking the generic drugs that my physician prescribe". With regard to how much cost savings would encourage them to substitute, 1000-1999 Japanese Yen per pharmacy visit was most often indicated by the respondents.Conclusion: A certain level of cost saving is necessary for patients to substitute. Physician-initiated substitution reduce patients' concerns in switching. The introduction of a kind of policy to widen the price difference between brand-name drugs and generic drugs should be considered as one of the policy options. [ABSTRACT FROM AUTHOR]

Abstract Objective We investigated the South African tendering system for medicines to (a) evaluate its impact on prices and market concentration over a 14-year period and (b) analyze the accuracy of government forecasts of drug demand. Methods We calculated Herfindahl-Hirschman indexes to measure market concentration levels based on all pharmaceutical tender contracts issued by the South African government between 2003 and 2016 (n = 8701). We estimated price indexes to track changes in medicine costs over this period. We compared prices set through tenders in the public health care system to the corresponding prices in the private system. We also analyzed government data on procurement in selected drug classes to assess the accuracy of demand forecasts. Findings Between 2003 and 2016, the prices of medicines in most tender categories in the public health care system dropped by an average of around 40% or more. The prices of medicines procured for the public system through tenders were almost always lower than those sold in the private system. Tenders generally remained moderately to highly competitive over time (i.e., Herfindahl-Hirschman indexes < 2500), although the number of different firms winning contracts decreased in many categories. There were large discrepancies between the drug need estimates by the government and the quantities it went on to procure, with estimates off by more than 50% in most drug classes (9/16 observations). Conclusion Tendering may be an effective measure to lower drug costs. Because most tenders remained competitive over time, price decreases may be durable. South African government officials should monitor the availability and prices of medicines to ensure continued access to affordable medicines for patients, as it may be undermined by the decreasing number of firms winning contracts over time. Given the large discrepancy between forecasts and procurements, the government would benefit from improving the accuracy of its demand forecasts. Highlights • Tendering was linked to large price cuts for many medicines in South Africa. • It did not appear to have an adverse effect on market concentration. • Yet there has been a drop in the number of firms winning contracts over time. • The South African government should improve its forecasts of drug demand. [ABSTRACT FROM AUTHOR]

Objectives: To develop and test a method for approximating generic entry of top-selling drugs.Methods: The procedure involved 1) identifying products' key patents as those with a patent term restoration extension (whenever relevant) or otherwise as the first expiring patent listed in the US Food and Drug Administration's patent register, 2) determining whether the key patent had been extended through an associated pediatric extension, 3) identifying other regulatory exclusivities associated with the drug, and 4) categorizing key patents as active ingredient (or extended) patents versus secondary patents. The accuracy and precision of the procedure's predictions were then tested against a database containing the timing of generic entry for 170 top-selling drugs that lost market exclusivity between 2000 and 2012, on the basis of Medicaid data.Results: Overall, the procedure predicted a median market exclusivity period of 12.5 years (interquartile range [IQR] 7.25-14.5) compared with the median actual period of 12.5 years (IQR 8.5-14.75 years). Among the 131 drugs (77%) with active ingredient patents, the median predicted market exclusivity was 12.25 years (IQR 7.5-14.5) compared with a median actual period of 13.0 years (IQR 10.0-14.75). Among the 38 (22%) drugs protected only by secondary patents, the median predicted market exclusivity was 16.0 years (IQR 6.75-19.5), but the median actual market exclusivity was only 8.25 years (IQR 6.25-13.5).Conclusions: The procedure approximated median actual exclusivity with reasonable accuracy and precision for drugs with active ingredient patents, but substantially overestimated exclusivity for drugs with only secondary patents. [ABSTRACT FROM AUTHOR]

Differential pricing-manufacturers varying prices for on-patent pharmaceuticals across markets-can, in theory, lead to increased patient access and improved research and development (R&D) incentives compared with charging a uniform price across markets. Theoretical models of price discrimination and Ramsey pricing support differentials based inversely on price elasticities, which are plausibly related to average per capita income. However, these models do not address absolute price levels and dynamic efficiency. Value-based differential pricing theory incorporates insurance coverage and addresses static and dynamic efficiency. Limited empirical evidence indicates a weak positive relationship between prices and gross domestic product (GDP) per capita. External referencing and parallel trade undermine differential pricing. We discuss previously neglected factors that undermine differential pricing in practice. High price growth relative to GDP in the USA leads to widening differentials between the USA and other countries. Concerns over the effects of confidential rebating challenges acceptance of this approach to implementing price differentials. The growth of branded generics in low- and middle-income countries leads to complex markets with product and price differentiation. [ABSTRACT FROM AUTHOR]

Introduction: Multiple Criteria Decision Analysis (MCDA) is increasingly used in health care mainly because it moves decision-making from ad hoc to an evidence-based and comprehensive process. Developing countries with more restricted financial and human research capacities, however, should consider their own methods of MCDA development and implementation. Areas covered: An MCDA framework to improve procurement decisions of off-patent pharmaceuticals was developed for developing countries and adapted to Indonesia, Kazakhstan and Vietnam during three policy workshops. Based on the experience of these workshops and one joint workshop with international experts and decision makers from multiple developing countries, general recommendations were formulated on how to implement MCDA specifically in developing countries. We provide 17 practical MCDA implementation recommendations in four major areas, including (1) MCDA objectives; (2) technical considerations of MCDA tool; (3) development and customization of MCDA tool and (4) policy implementation of MCDA in decision-making. Expert commentary: These practical MCDA recommendations for developing countries contribute to feasible, transparent, stepwise, iterative and standardized decision-making in health care. [ABSTRACT FROM AUTHOR]

In the second of three articles, Angus Thompson continues his reflections on the differences in prescribing and medicines management between the UK and Australia, this time looking at prescription costs, quantities and generics. [ABSTRACT FROM AUTHOR]

Background: Increasing generic drug use, due to potential for cost savings and drug access, is a viable consideration for Medicare prescription drug plans to achieve high star ratings and improve quality of plan offerings for Medicare beneficiaries.Objective: To examine the association between contract-level proportion of generic drugs dispensed (pGDD) and Medicare Part D star ratings.Methods: This was a retrospective study of linked 2011 Medicare Part D star rating data with contract-level pGDD data. A total of 477 individual Medicare prescription contracts were included, representing 75% of total Prescription Drug Plans and more than 65% of total Medicare Advantage Prescription Drug Plans available by the end of 2010. Primary outcomes were Medicare Part D summary and domain star ratings (1-5 indicating lowest to highest performance), incorporating a range of quality measures for access, cost, beneficiary satisfaction, and health services outcomes and processes. Ordinal logistic regression models were used to examine associations between pGDD and Medicare Part D summary and domain star ratings, controlling for contract type and number of beneficiary enrollment.Results: Higher pGDD was associated with higher summary star ratings (adjusted odds ratio 1.08 with 95% confidence interval 1.04-1.12) and higher "member experience with drug plan" domain ratings (adjusted odds ratio 1.07 with 95% confidence interval 1.03-1.11).Conclusions: Prescription formulary benefit design targeting increasing generic drug use appears to be associated with improved member experience and higher plan star ratings. Consideration may be given to incorporating pGDD into Medicare Part D star rating measures to improve quality of prescription plans. [ABSTRACT FROM AUTHOR]

Importance: Brand-name combination drugs can be more expensive than the sum of their components, especially when the constituent products are available as generic medications. The potential savings that could be achieved using generic components is not known.Objective: To estimate the additional cost to Medicare of prescribing brand-name combination medications instead of generic constituents.Design, Setting, and Participants: Retrospective analysis for 2011 through 2016 using the Medicare data set of Part D beneficiaries prescribed any of the 1500 medications that accounted for the highest total spending in 2015. Brand-name combination drugs that had identical or therapeutically equivalent generic constituents were included.Exposures: Brand-name, oral combination medications with constituents available either as generic drugs or therapeutically equivalent generic substitutes.Main Outcomes and Measures: The estimated difference between the amount spent by Medicare on brand-name combination drugs and the estimated amount that would have been spent on substitutable generic components.Results: Among the 1500 medications evaluated, 29 brand-name combination medications were separated into 3 mutually exclusive categories: constituents available as generic medications at identical doses (n = 20), generic constituents at different doses (n = 3), and therapeutically equivalent generic substitutes (n = 6). For the constituents available as generic medications at identical doses category, total spending by Medicare in 2016 on the brand-name combination products was $303 million and the estimated spending for the generic constituents would have been $68 million, which is an estimated difference of $235 million. For the generic constituents at different doses category, total spending by Medicare in 2016 on the brand-name combination products was $232 million and the estimated spending for the generic constituents would have been $13 million, which is an estimated difference of $219 million. For the therapeutically equivalent generic substitutes category, total spending by Medicare in 2016 on the brand-name combination products was $491 million and the estimated spending for the generic constituents would have been $20 million, which is an estimated difference of $471 million. In 2016, the estimated spending for the generic constituents for these 29 drugs would have been $925 million less than the estimated spending for the brand-name combinations. For the 10 most costly combination products available during the entire study period, the listed Medicare spending could have been an estimated $2.7 billion lower between 2011 and 2016 if the generic constituents had been prescribed.Conclusions and Relevance: In 2016, the difference between the amount that the Medicare drug benefit program reported spending on brand-name combination medications and the estimated spending for generic constituents for the same number of doses was $925 million. Promoting generic substitution and therapeutic interchange through prescriber education and more rational substitution policies may offer important opportunities to achieve substantial savings in the Medicare drug benefit program. [ABSTRACT FROM AUTHOR]

Aim: To give an overview of the pharmaceutical policy in the largest medical center in Morocco, a developing country in socio-economic transition.Methods: This is an analytical descriptive study of the drug formulary and the purchasing process carried out at the Ibn Sina University Medical Center.Results: Our formulary included 830 drugs belonging to 14 classes according to the Anatomical, Therapeutic and Chemical (ATC) Classification System. There was a respective predominance of class N (21.8%), class B (13.5%), and class J (12.6%). Injectable route was dominant (46%). Drugs had a significant actual benefit in 70% (according to the French Data), reimbursable in 42.8%, essential in 29.2% according to World Health Organization (WHO) list, and in 36.9% according to the Moroccan list. The calls for tenders included 542 drugs representing 65% of the formulary, and the attribution rate was 71%. The main reason for non-attribution was the lack of offers. Generics accounted for 45% by volume and 26.5% by value.Conclusion: With this first study, we were able to identify key indicators on drugs used in the largest medical center in Morocco. The current challenge is to introduce pharmacoeconomics in decision making concerning the updates of the drug formulary. [ABSTRACT FROM AUTHOR]

This paper investigates and quantifies the impact of parallel trade in markets for pharmaceuticals. The paper develops a structural model of demand and supply using data on price, sales, and the characteristics of statins in Denmark and simulates outcomes under a complete ban of parallel imports, keeping other regulatory schemes unchanged. There are two sets of key results. The first set focuses on price effects. On average, prices increase more in markets where the molecule has lost patent protection; wholesale prices for both generic and original products increase after competition from parallel importers is removed, but the final price paid by consumers (after deducting reimbursement) increases more for original products than for generics because most changes in wholesale prices are absorbed by the prevailing reimbursement rules. The second set of results reports the effects on market participants. My model takes into consideration consumers' preferences, allowing them to substitute between products. Prohibiting parallel imports induces consumers to substitute towards original products for which they have stronger preferences. In sum, banning parallel imports leads to (a) an increase in variable profits for original producers and a decrease for generic firms, (b) an increase in governmental health-care expenditures, and (c) a decrease in the welfare of Danish patients and firms. [ABSTRACT FROM AUTHOR]

The article reports on the increase in prescription drug expenditures in the U.S. in 2021, the projected growth in 2022, and the three areas of opportunity from an employer perspective. Topics discussed include prescription drug affordability, use of low value medications, and equitable access to specialty drugs.

Objectives: This study looks at market exclusivity time for the top selling originator drugs in Canada. Total sales for drugs without competition were also calculated.Methods: A list of the top selling originator drugs by dollar sales from 2009 to 2015 inclusive, except for 2010, was compiled along with their annual sales. Health Canada databases were used to extract the following information: generic name, date of Notice of Compliance (NOC, date of marketing authorization), whether the product was a small molecule drug or a biologic, and date of NOC for a generic or biosimilar. Market exclusivity time was calculated in days for drugs.Results: A total of 121 drugs were identified. There were 96 small molecule drugs (63 with a generic competitor and 33 with no generic competitor) and 25 biologics (none with a biosimilar competitor). The 63 drugs with a competitor had a mean market exclusivity time of 4478 days (12.3 years) (95% CI 4159-4798). The 58 drugs without competition had total annual sales of Can$8.59 billion and were on the market for a median of 5357 days (14.7 years) (interquartile range 3291-6679) as of January 31, 2017.Conclusions: Top selling originator drugs in Canada have a considerably longer period of market exclusivity than the 8 to 10 years that the research-based pharmaceutical industry claims. [ABSTRACT FROM AUTHOR]

Escalating drug prices have catalysed the generation of numerous “value frameworks” with the aim of informing payers, clinicians and patients on the assessment and appraisal process of new medicines for the purpose of coverage and treatment selection decisions. Although this is an important step towards a more inclusive Value Based Assessment (VBA) approach, aspects of these frameworks are based on weak methodologies and could potentially result in misleading recommendations or decisions. In this paper, a Multiple Criteria Decision Analysis (MCDA) methodological process, based on Multi Attribute Value Theory (MAVT), is adopted for building a multi-criteria evaluation model. A five-stage model-building process is followed, using a top-down “value-focused thinking” approach, involving literature reviews and expert consultations. A generic value tree is structured capturing decision-makers' concerns for assessing the value of new medicines in the context of Health Technology Assessment (HTA) and in alignment with decision theory. The resulting value tree (Advance Value Tree) consists of three levels of criteria (top level criteria clusters, mid-level criteria, bottom level sub-criteria or attributes) relating to five key domains that can be explicitly measured and assessed: (a) burden of disease, (b) therapeutic impact, (c) safety profile (d) innovation level and (e) socioeconomic impact. A number of MAVT modelling techniques are introduced for operationalising (i.e. estimating) the model, for scoring the alternative treatment options, assigning relative weights of importance to the criteria, and combining scores and weights. Overall, the combination of these MCDA modelling techniques for the elicitation and construction of value preferences across the generic value tree provides a new value framework (Advance Value Framework) enabling the comprehensive measurement of value in a structured and transparent way. Given its flexibility to meet diverse requirements and become readily adaptable across different settings, the Advance Value Framework could be offered as a decision-support tool for evaluators and payers to aid coverage and reimbursement of new medicines. [ABSTRACT FROM AUTHOR]

Background: Official drug prices have been set by the government and revised every other year in Japan. However, most drug prices are revised based on the price divergence rate of official and delivery prices every other year. This paper overviews how the drug price revision process works and reveals factors associated with price cutting, based on the price divergence rate. Methods: Drugs approved as new molecular entities from 2005 to 2014 were selected for price cutting analysis, based on the price divergence rate. Logistic regression assessed the determinants of whether drugs were targeted for price cutting in 2016. Additionally, generic drugs approved from 2009 to 2013 and their off-patent drugs were also analyzed by multiple linear regression analysis to reveal determinants related to price divergence rates. Results: From the targeted on-patent drugs, 90% were targeted for price revision based on the price divergence rate. Of these drugs, 23% were targeted for price cutting. Drugs whose characteristics are larger sales, lower cost/patient, being followers, and being longer in the market were more likely to be targeted for price cutting. The number of generic manufacturers is directly proportional to the price cutting of both generic and off-patent branded drugs. Conclusions: As drug price revision policy is under reconstruction in Japan, the characteristics of drugs targeted for price cutting shown in this study should be considered for establishing drug price revision policies that reflect market conditions adequately. [ABSTRACT FROM AUTHOR]

Objectives: To analyze how value is determined within the scope of the German Pharmaceutical Restructuring Act, which came into effect in 2011.Methods: Using data from all pharmaceuticals that had undergone assessment, appraisal, and price negotiations in Germany before June 30, 2016, we applied generalized linear model regression to analyze the impact of added benefit on the difference between negotiated prices and the prices of comparators. Data were extracted from the Federal Joint Committee's appraisals and price databases. We specified added benefit in various ways. In all models, we controlled for additional criteria such as size of patient population, European price levels, and whether the comparators were generic.Results: Our regression results confirmed the descriptive results, with price premiums reflecting the extent of added benefit as appraised by the Federal Joint Committee. On the substance level, an added benefit was associated with an increase in price premium of 227.2% (P < 0.001) compared with no added benefit. Moreover, we saw increases in price premium of 377.5% (P < 0.001), 90.0% (P < 0.001), and 336.8% (P < 0.001) for added benefits that were "considerable," "minor," and "not quantifiable," respectively. Beneficial effects on mortality were associated with the greatest price premium (624.3%; P < 0.001), followed by such effects on morbidity (174.7%; P < 0.001) and adverse events (93.1%; P = 0.019).Conclusions: Price premiums, or "value," are driven by health gain, the share of patients benefiting from a pharmaceutical, European price levels, and whether comparators are generic. No statement can be made, however, about the appropriateness of the level of price premiums. [ABSTRACT FROM AUTHOR]

Background: A Food and Drug Administration (FDA) Generic Drug User system, Generic Drug User Fee Amendment of 2012 (GDUFA), started October 1, 2012, and has been in place for over 3 years. There is controversy about the GDUFA fee structure but no analysis of GDUFA data that we could find.Objective: To look at the economic impact of the GDUFA fee structure.Methods: We compared the structure of GDUFA with that of other FDA Human Drug User fees. We then, using FDA-published information, analyzed where GDUFA facility and Drug Master File fees are coming from. We used the Orange Book to identify the sponsors of all approved Abbreviated New Drug Applications (ANDAs) and the S&P Capital IQ database to find the ultimate parent companies of sponsors of approved ANDAs.Results: The key differences between the previous structure for Human Drug User fees and the GDUFA are as follows: GDUFA has no approved product fee and no first-time or small business fee exemptions and GDUFA charges facility fees from the time of filing and charges a foreign facility levy. Most GDUFA fees are paid by or on behalf of foreign entities. The top 10 companies hold nearly 50% of all approved ANDAs but pay about 14% of GDUFA facility fees.Conclusions: We conclude that the regressive nature of the GDUFA fee structure penalizes small, new, and foreign firms while benefiting the large established firms. A progressive fee structure in line with other human drug user fees is needed to ensure a healthy generic drug industry. [ABSTRACT FROM AUTHOR]

The article discusses a study that determines if disparities in drug pricing, pharmacy services, and community pharmacy access exist in Shelby County, Tennessee with a predominantly minority population. Topics covered include the role of insurance status in health disparities and medication access, the proximity of an individual's residence to a community pharmacy, and racial disparities in some aspects of healthcare and healthcare outcomes.

Objectives: Prior research suggests that authorized generic drugs increase competition and decrease prices, but little empirical evidence supports this conclusion. This study evaluated the impact of authorized generic marketing on brand and generic prices.Design: Longitudinal analysis of the household component of the Medical Expenditure Panel Survey.Setting: Interview panels over 12 years, with a new panel each year. For each panel, 5 rounds of household interviews were conducted over 30 months.Patients or Participants: Nationally representative sample of the U.S. civilian noninstitutionalized population, focusing on people using 1 of 5 antidepressant drugs that became generically available between 2000 to 2011.Intervention: Drugs and dose/formulations with versus without an authorized generic drug marketed.Main Outcome Measures: Multiple linear regression models with lagged variables evaluated the effect of an authorized generic on average inflation-adjusted brand and generic price, adjusting for payment sources, generic entry time, competitor price, and year.Results: During 2000-2011, annual brand antidepressant utilization decreased from 51.47 to 7.52 million prescriptions, and generic antidepressant utilization increased from 0 to 88.83 million prescriptions. Over time, payment per prescription for brand prescriptions increased 25% overall, and generic payments decreased 70% for all payer types. With unadjusted data, after generic entry the average brand price decreased $0.59 per year with and $3.62 per year without an authorized generic in the market. Average generic prices decreased $10.30 per year with and $8.47 per year without an authorized generic in the market. In multiple regression models with lagged variables adjusted for heteroscedasticity, payer source, time since generic entry, competitor price, and year, authorized generics significantly reduced average payment for generic (-$3.03) and brand (-$60.64) prescriptions, and over time this price change slowly diminished.Conclusion: Availability of an authorized generic was associated with reduced average generic and brand price in the antidepressant market, supporting prior evidences. [ABSTRACT FROM AUTHOR]

The article discusses branded and nominally branded generic versions of prescription writing. Topics discussed include study by Singal et al comparing branded and nominally branded generic versions of the same drug manufactured and formulated by the same company; notification by Medical Council of India (MCI) for doctors in India to prescribe drugs by their generic name and quality control of drugs by the U.S. Food and Drug Administration (FDA).

Background: Canada's universal health care system does not include universal coverage of prescription drugs. We sought to estimate the effects of adding universal public coverage of an essential medicines list to existing public drug plans in Canada.Methods: We used administrative and market research data to estimate the 2015 shares of the volume and cost of prescriptions filled in the community setting that were for 117 drugs on a model list of essential medicines for Canada. We compared prices of these essential medicines in Canada with prices in the United States, Sweden and New Zealand. We estimated the cost of adding universal public drug coverage of these essential medicines based on anticipated effects on medication use and pricing.Results: The 117 essential medicines on the model list accounted for 44% of all prescriptions and 30% of total prescription drug expenditures in 2015. Average prices of generic essential medicines were 47% lower in the US, 60% lower in Sweden and 84% lower in New Zealand; brand-name drugs were priced 43% lower in the US. Estimated savings from universal public coverage of these essential medicines was $4.27 billion per year (range $2.72 billion to $5.83 billion; 28% reduction) for patients and private drug plan sponsors, at an incremental government cost of $1.23 billion per year (range $373 million to $1.98 billion; 11% reduction).Interpretation: Our analysis showed that adding universal public coverage of essential medicines to the existing public drug plans in Canada could address most of Canadians' pharmaceutical needs and save billions of dollars annually. Doing so may be a pragmatic step forward while more comprehensive pharmacare reforms are planned. [ABSTRACT FROM AUTHOR]

Introduction: The price, availability and affordability of drugs used in the prevention and treatment of cardiovascular disease (CVD) when purchased from online pharmacies in China is currently unknown. Objective: Our objective was to estimate the availability, price and affordability of drugs for the prevention and treatment of CVDs on the basis of information from online pharmacies in China and to provide evidence-based support for improvements to medicine-related policies. Methods: We estimated the availability, price and affordability of 17 drugs, including their originator brand (OB) and the lowest-priced generic equivalent (LPGE) using the standardized survey method recommended by the World Health Organization and Health Action International. Drug availability was measured as the proportion of online pharmacies providing information on the drug on the day of data collection. We assessed prices by measuring the median price ratio (MPR). Drug affordability was defined as the ratio between the cost of a 30-day supply at the median price and the lowest daily wage of an unskilled government non-technician employee. Results: The mean availability of OBs and LPGEs from online pharmacies was 47.35 and 70.18 %, and the mean MPR of OBs and LPGEs was 14.7 and 3.4, respectively. In terms of drug affordability, 90 % of OBs had an affordability ratio of >1, whereas 82 % of LPGs had an affordability ratio of <1. Conclusion: This study provides insight into the availability, price and affordability of 17 drugs for the prevention and treatment of CVDs on the basis of information from 20 online pharmacies in China. Our findings suggest the price of some drugs, especially of OBs, may still be too high. The affordability of OBs is poor, whereas the affordability of most LPGs is good. The government should establish an online payment system and permit patients to pay for online drugs using funds from their healthcare insurance system account. Measures, such as limiting the highest price, should be instituted to regulate the price of OBs. Narrowing the quality gap between OBs and generics is necessary to increase competition. Anti-monopoly laws should be considered to control drug prices. [ABSTRACT FROM AUTHOR]

The article presents an analysis of regional variation in Medicare and pharmaceutical expenditure and utilization. It mentions that beneficiary-level regressions with controls for demographics and health status were used in the development of standardized measures for pharmaceutical and medical spending and utilization. It shows that areas with higher medical expenditure tend to have low spending for drug.

In the period 2005-13 the US prescription drug market grew at an average annual pace of only 1.8 percent in real terms on an invoice price basis (that is, in constant dollars and before manufacturers' rebates and discounts). But the growth rate increased dramatically in 2014, when the market expanded by 11.5 percent--which raised questions about future trends. We determined the impact of manufacturers' rebates and discounts on prices and identified the underlying factors likely to influence prescription spending over the next decade. These include a strengthening of the innovation pipeline; consolidation among buyers such as wholesalers, pharmacy benefit managers, and health insurers; and reduced incidence of patent expirations, which means that fewer less costly generic drug substitutes will enter the market than in the recent past. While various forecasts indicate that pharmaceutical spending growth will moderate from its 2014 level, the business tension between buyers and sellers could play out in many different ways. This suggests that future spending trends remain highly uncertain. [ABSTRACT FROM AUTHOR]

Importance: The increasing cost of prescription drugs in the United States has become a source of concern for patients, prescribers, payers, and policy makers.Objectives: To review the origins and effects of high drug prices in the US market and to consider policy options that could contain the cost of prescription drugs.Evidence: We reviewed the peer-reviewed medical and health policy literature from January 2005 to July 2016 for articles addressing the sources of drug prices in the United States, the justifications and consequences of high prices, and possible solutions.Findings: Per capita prescription drug spending in the United States exceeds that in all other countries, largely driven by brand-name drug prices that have been increasing in recent years at rates far beyond the consumer price index. In 2013, per capita spending on prescription drugs was $858 compared with an average of $400 for 19 other industrialized nations. In the United States, prescription medications now comprise an estimated 17% of overall personal health care services. The most important factor that allows manufacturers to set high drug prices is market exclusivity, protected by monopoly rights awarded upon Food and Drug Administration approval and by patents. The availability of generic drugs after this exclusivity period is the main means of reducing prices in the United States, but access to them may be delayed by numerous business and legal strategies. The primary counterweight against excessive pricing during market exclusivity is the negotiating power of the payer, which is currently constrained by several factors, including the requirement that most government drug payment plans cover nearly all products. Another key contributor to drug spending is physician prescribing choices when comparable alternatives are available at different costs. Although prices are often justified by the high cost of drug development, there is no evidence of an association between research and development costs and prices; rather, prescription drugs are priced in the United States primarily on the basis of what the market will bear.Conclusions and Relevance: High drug prices are the result of the approach the United States has taken to granting government-protected monopolies to drug manufacturers, combined with coverage requirements imposed on government-funded drug benefits. The most realistic short-term strategies to address high prices include enforcing more stringent requirements for the award and extension of exclusivity rights; enhancing competition by ensuring timely generic drug availability; providing greater opportunities for meaningful price negotiation by governmental payers; generating more evidence about comparative cost-effectiveness of therapeutic alternatives; and more effectively educating patients, prescribers, payers, and policy makers about these choices. [ABSTRACT FROM AUTHOR]

Purpose. Historical trends and factors likely to influence future pharmaceutical expenditures are discussed, and projections are made for drug spending in 2016 in nonfederal hospitals, clinics, and overall (all sectors). Methods. Drug expenditure data through calendar year 2015 were obtained from the IMS Health National Sales Perspectives database and analyzed. Other factors that may influence drug spending in hospitals and clinics in 2016, including new drug approvals and patent expirations, were also reviewed. Expenditure projections for 2016 were based on a combination of quantitative analyses and expert opinion. Results. Total U.S. prescription sales in the 2015 calendar year were $419.4 billion, which was 11.7% higher than sales in 2014. Prescription expenditures in clinics and nonfederal hospitals totaled $56.7 billion (a 15.9% increase) and $33.6 billion (a 10.7% increase), respectively, in 2015. In nonfederal hospitals, growth in spending was driven primarily by increased prices for existing drugs. The hepatitis C combination drug ledipasvir-sofosbuvir was the top drug overall in terms of 2015 expenditures ($14.3 billion); in both clinics and nonfederal hospitals, infliximab was the top drug. Individual drugs with the greatest increases in expenditures in 2015 were specialty agents and older generics; these agents are likely to continue to influence total spending in 2016. Conclusion. We project an 11-13% increase in total drug expenditures overall in 2016, with a 15-17% increase in clinic spending and a 10-12% increase in hospital spending. Health-system pharmacy leaders should carefully examine local drug utilization patterns in projecting their own organization's drug spending in 2016. [ABSTRACT FROM AUTHOR]

Background: Several countries recently reassessed the roles of drug prescribing and dispensing, either by enlarging pharmacists' rights to prescribe (e.g. the US and the United Kingdom) or by limiting physicians' rights to dispense (e.g. Taiwan and South Korea). While integrating the two roles might increase supply and be convenient for patients, concern is that drug mark-ups incite providers to prescribe unnecessary drugs. We aimed to assess the association of physician dispensing (PD) in Switzerland on various outcomes.Methods: We performed a retrospective cohort study, using health care claims data for patients in the year 2013. The analysis of the association of PD was perfomed using a large patient level dataset and several target variables, including the number of different chemical agents, share of generic drugs, number of visits to physicians and expenditures. Different multivariate econometric models were applied in order to capture the association PD on the target variables.Results: A total of 101'784 patients were enrolled in 2013, whereas 54 % were PD patients. We find that PD is associated with lower pharmaceutical expenditure per patient, which can be explained by an increased use of generic drugs. The decrease is compensated by higher use of physician services. We find no significant impact of physician dispensing on total health care expenditure.Conclusions: Our study offers insights for policy makers who are (re-)considering the separation between drug prescribing and dispensing, either by allowing physicians to dispense or pharmacists to prescribe certain drugs. In terms of total health care expenditures, we find no difference between the two systems, so we are doubtful that changing dispensing rights are a good measure to contain cost, at least in Switzerland. [ABSTRACT FROM AUTHOR]

The article discusses the results of an analysis of the data released by the Centers for Medicare and Medicaid Services (CMS) in May 2015 aimed at understanding the breakdown of cost and benefits for prescription drugs and evaluating the effects of prescribing practices on individuals and the system. Findings reveal that Medicare Part D patients were paying more than ten times the copay of two brand-name drugs, Nexium and Crestor, versus generic drugs.

The Trans-Pacific Partnership (TPP) Agreement is a proposed free trade agreement between the US and 11 other countries in Asia and South America covering many consumer goods, including prescription medicines. This review describes how the TPP could affect international laws governing intellectual property rights for prescription drugs, focusing on patents and exclusivity protections for test data, including their effect on reimbursement decisions by national health care authorities responsible for health priority setting. We conclude that the TPP could affect low-income patients' access to medicines in signatory countries. [ABSTRACT FROM AUTHOR]

Objective: The aim of the present study was to better understand the views and experiences of New Zealand patients on switching between brands of prescription medicines and on alternative funding options for the provision of medicines, including an increase in copayments. Methods: A self-administered questionnaire was offered to selected patients through participating community pharmacies. Pharmacies were stratified according to level of deprivation of the community served before random selection and invitation for involvement in the study. Patient understanding of and rationale for brand substitution was assessed. Preference for different copayment options was elicited, together with demographic and other explanatory information. Results: In all, 194 patient-completed questionnaires were returned. Some gaps in patient knowledge and understanding of brand changes were evident. Most respondents indicated a preference for the existing subsidy arrangements with little desire expressed for alternatives. Around half were willing to contribute towards paying for a choice of brand other than the subsidised brand; however, the maximum contribution nominated was disproportionately lower than real cost differences between originator brand and generics. Conclusion: The findings of the present study suggest that although most patients have experienced brand changes without any problems occurring, a lack of knowledge about substitution does persist. There may be some additional gain in ensuring New Zealanders are aware of the full cost of their medicines at the point of dispensing to reinforce the benefits of the Pharmaceutical Management Agency (PHARMAC) purchasing model. [ABSTRACT FROM AUTHOR]

The high cost of patent-protected brand-name drugs can strain budgets and curb the widespread use of new medicines. An example is the case of direct-acting antiviral drugs for the treatment of hepatitis C. While prices for these drugs have come down in recent months, they still create barriers to treatment. Additionally, prescribing restrictions imposed by insurers put patients at increased risk of medical complications and contribute to transmission of the hepatitis C virus. We propose that the federal government invoke its power under an existing "government patent use" law to reduce excessive prices for important patent-protected medicines. Using this law would permit the government to procure generic versions of patented drugs and in exchange pay the patent-holding companies reasonable royalties to compensate them for research and development. This would allow patients in federal programs, and perhaps beyond, to be treated with inexpensive generic medicines according to clinical need--meaning that many more patients could be reached for no more, and perhaps far less, money than is currently spent. Another benefit would be a reduction in the opportunity for companies to extract monopoly profits that far exceed their risk-adjusted costs of research and development. [ABSTRACT FROM AUTHOR]