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Policy effects This table lists the policies that are in effect in various parts of the world, their effects and their unintended consequences. EU: European Union, USA: United States of America, DTCA: direct-to-consumer advertising, UK: United Kingdom, LMIC: Low- and Middle-Income Countries.
Source publication
Context
Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines.
Method
A systematic review of Pubmed, the Financial Times, the New York Times, the Wall Street Journal and the G...
Citations
... Similarly, a practice called 'evergreening' sees 'minor alteration to an existing invention [generate profit from] a secondary patent…[with] 78% of new [OD] patents correspond[ing] to drugs already on the market' [23]. Existing policy also enables (bio)pharmaceutical manufacturers to profit from new licences with minimal R&D outlay by making 'minor chemical variations relative to a drug already on the market within a given therapeutic class' [40] -labelled 'me-too' drugs. Here, in '1,345 [EU] new drug approvals between 2000 and 2014… 51% [were] modified versions of existing medicines…[yet] only 1% were considered a therapeutic advancement' [23]. ...
Rare disease prevalence rates are increasing rapidly worldwide, as are the cost of orphan indication drugs used to treat them, posing significant strain on many healthcare systems. In response, a set of tensions have arisen within academic, activist, advocacy, industry, and policy circles over orphan drug pricing. Yet there has to date been no unifying review of the literature engaging critically with these tensions. Addressing this gap, the article examines the narratives in circulation around orphan pricing, the traditions and epistemic bases they draw on, and their points of contestation/coalescence. It does so through a meta-narrative literature review, finding three core narratives. One involves dispute over outlay costs for developing new orphan drugs, often drawing on normative health economics with a base in practical idealism. It argues that (bio)pharmaceutical manufacturers misuse policy incentives to profit excessively through monopoly capitalism. A second narrative draws on both empirical and normative health economics (often steeped in empiricism paired with a utilitarian standpoint). It contends that high orphan drug prices signify a healthy market and justifiably support longer-term innovation while promoting wider equity of access. A third (midway) narrative draws on the sociology of health and innovation studies alongside normative health economics and health policy studies to suggest alternative models of innovation and valuation. As a unifying meta-narrative, the review finds a sustained call for reform, centred on welfare economics and resource allocation, where current incentives and regulations are held to be insufficient. Overall, the article recommends that regulators look to alternative models of innovation steeped in social science thinking to modify reviewing appraisal, coverage, and reimbursement processes for orphan drugs. Also, that greater patient inclusion and transparency would help include a wider range of intangible social factors that rare disease patients face in accessing high priced orphan drugs.
... Expenses on health care are rising dramatically across the globe, largely due to the cost of medication. 1 High prescription charges have become a common ground for complaints among the public and in the media. 2 Politically, governments and health insurers must act to offset the surging costs of new prescription drugs; 3,4 one seemingly obvious way to do this is to curb physicians' overspending on unnecessary medications. In USA, the annual cost of prescribing unnecessary medication is considered as much as $226 billion with conservative estimate of waste to account for more than 20% of total health spending. ...
... 7 Therefore, re-evaluating approaches to prescribing medication to factor in cost considerations is crucial, even for more advanced health-care systems. 2 Saudi Arabia has one of the largest pharmaceutical markets in the Middle East and the largest among Gulf Cooperation Council (GCC) countries. 8 As physicians make 80% of the decisions related to healthcare expenditures, the current shift toward containing money spent on medication is therefore focused on physicians. ...
Background
Physicians are responsible for most decisions related to resource allocation and healthcare expenditures, and should consider cost in their decision-making approach.
Objective
To measure cost consciousness among dermatologists, evaluate their understanding of cost-related concepts, and explore what prevents them from factoring cost into their daily practice decisions.
Methods
This cross-sectional survey-based study involved dermatologists from different practice types and work environments. The survey is split into four sections, focusing on participants’ (1) demographic and workplace information; (2) knowledge of cost-related terms; (3) personal cost-consciousness level; and (4) perceived barriers to factoring cost into clinical decisions.
Results
Overall, 132 practicing dermatologists participated in the survey. Approximately 82% of them had heard of cost-effectiveness, but only 10% really understood how to indicate, interpret, and calculate it, while most had never heard of cost-consciousness or cost-containment. The majority agreed that it is the responsibility of physicians to contain medication costs, and almost all agreed that physicians need to do more to limit the prescription of unnecessary medications. Sex, long work experience, mixed administrative and clinical roles, and working in a mixed practice setting were all associated with cost consciousness. Multivariate regression analysis showed a significant association between having a mixed clinical and administrative professional role and cost consciousness.
Conclusion
Although most dermatologists agree that it is the responsibility of physicians to contain the cost when deciding on medication, they have limited understanding of cost-related concepts. Having a mixed clinical and administrative roles was a significant predictor of cost conscious behavior.
... One of the causes is the increasing number of expensive medicines each year and projections suggest that the growing percentage of healthcare budgets required will eventually crowd out other types of healthcare [1,2]. The balance between access to innovative yet expensive medicines and sustainable access to generic healthcare is delicate [3][4][5][6]. Each country in the EU tries to manage this balance in its own way, which may cause inequalities in access to medicines for European citizens [7,8]. ...
Objectives
Solidarity-based healthcare systems are being challenged by the incremental costs of new and expensive medicines for cancer and rare diseases. To regulate reimbursement of such drugs, the Dutch government introduced a policy instrument known as the Coverage Lock (CL) in 2015. Little is known about the public opinion regarding such policy instruments and their consequences, i.e., reimbursement of some, but not all, expensive medicines. We aimed to identify the preferences of Dutch citizens regarding the reimbursement of expensive medicines, and to investigate the views of the public on the use of the CL as a healthcare policy instrument and their input for improvement.
Methods
Web-based survey of a representative sample of 1999 Dutch citizens aged 18 years and older (panel of research company Kantar Public). Potential respondents were approached via e-mail. Several policy measures, real-life cases and statements related to the CL were presented in the survey to respondents. Their responses were analysed by tabulating descriptive statistics (proportions and percentages).
Results
1179 individuals (response rate 59%) filled in the questionnaire. Although a majority considered the CL policy unjustified, they preferred it to the alternative policy measures that were presented. In four real-life case descriptions of patients in need of expensive medicines, respondents most often indicated effectiveness, lack of availability of alternative treatment and improved quality of life due to treatment as reasons for a positive reimbursement decision. An unfavourable cost-benefit ratio was their main reason to be against reimbursement. Some argued that withholding reimbursement was a way of informing manufacturers that extremely high prices are unacceptable.
Conclusion
There is public support for patients in need of expensive medicine. Many respondents supported the CL as a reimbursement policy. However, there is a wish to optimize the interpretation of the assessment criteria and the weight these are attributed in decision making about reimbursement of expensive innovative medicine for patients.
... carpio) (Pattanayak et al., 2020). This has a very serious consequence to human beings and other animals (Nhinh et al., 2021).Antimicrobial resistance (AMR) refers to the emergence of bacterial defense mechanisms against antibiotics (Marston et al., 2016).The management of these diseases is becoming more complex, and higher dosages mean higher costs (Gronde et al., 2017).Genetic mutations have been found to exert a significant influence on the development and dissemination of bacterial resistance mechanisms in a number of animal species. In domestic animals, antibiotic resistance is constantly happening (Christaki et al., 2017).Antibiotic-resistant infections are ever more widespread and, with such limited effective options for treatment available, it represents a problems of global proportion (Darby et al., 2023).By the year 2050, Brüssow (2024) suggests that the search for novel antibiotics or the upgrading of current ones will be a necessity if effective antibiotics for disease management are to continue being available. ...
This study sought to isolate and identify Aeromonas species and assess their antibiotic resistance. The inquiry centered on 56 dubious fish contaminated with Aeromonas germs from Basra. The fish weighed between 20 and 44 grams and were thereafter placed in individual tanks. This research was undertaken at the Fish Breeding and Nutrition Laboratory within Fish and Marine Resources, College of Agriculture, University of Basra. Specimens were obtained from the ulcerated dermal regions, kidneys, liver, and spleen. A homogenous bacterial isolation was subsequently conducted and confirmed leading to identification of Gram-negative bacteria. ID-GN demonstrated that clinical isolates, including A. hydrophila, A. sobria, and A. caviae, aligned with the fundamental biochemical assays and employed by Vitec 2. The Clinical and Laboratory Standards Institute (CLSI, 2021) was used to evaluate the antibiotic susceptibility of Aeromonas isolates responsible for carp infections using the Kirby-Bauer disk diffusion method. We are looking at how resistant three types of bacteria are to oxytetracycline, erythromycin and ampicillin after exposed to them. The results show differing levels of resistance to various antibiotics A. hydrophila has an 11% resistance to oxytetracycline, 33% to erythromycin and a significant 95% to ampicillin. A. sobria exhibits a 10% resistance to oxytetracycline, 45% to erythromycin and 75% resistance to ampicillin. A. caviae shows 8% resistance to oxytetracycline, 50% to erythromycin and 77% resistance to ampicillin. The mean antimicrobial resistance (MAR) for three Aeromonas species studied is around 80 percent to ampicillin with moderate resistance to erythromycin observed in fifty percent of cases. Oxytetracycline demonstrates the greatest sensitivity and a low resistance rate of ten percent among the isolates.
... As a special commodity, pharmaceuticals have both economic and social attributes, which makes them different from the general goods on the market, but also increases the difficulty of the government to effectively regulate the price of drugs. In terms of its attributes, drug price regulation belongs to the category of social regulation, which has been one of the important contents of the government's regulatory function [1][2]. Along with China's economy from a production-oriented gradually transitioning to a consumption-oriented, the market mechanism also gradually penetrated the pharmaceutical industry. ...
Setting reasonable drug prices is the fundamental goal of drug price elasticity analysis, and the game theory method can play a role in drug pricing by analyzing the behaviors of multiple game subjects to give a plan that meets the best interests of all parties. The optimal pricing strategies under different threshold conditions are summarized by establishing four model assumptions and solving them based on the basic model of game theory and the bidding process. Accordingly, the drug pricing of Pharmaceutical Company F was analyzed, and it was found that its optimal pricing was 21.3yuan, at which time the profit was 132.74% higher than the original pricing profit. After applying this pricing, it was found that the implementation of the new pricing increased the mean score of the company’s profitability by 0.16738 to 0.19504 as compared to before the optimized drug pricing strategy, indicating that the pricing strategy improved by the game theory model is able to provide the company’s level of profitability and is feasible.
... 20,21 Apart from the scarcity of essential medicines, the high cost of medications presents a formidable challenge in delivering adequate health services. 22 Affordability concerns regarding medicines are particularly pronounced in LMICs, where as much as 90% of the population acquires medications through out-of-pocket payments, greatly affecting their ability to afford treatment and affecting disease outcomes. 23,24 Ethiopia, among other developing nations, grapples with the severe consequences stemming from the lack of availability and affordability of medicines. ...
Objectives
This study aims to assess access to essential medicines used in the management of noncommunicable diseases through analysis of the availability, prices, and affordability of these essential medicines in Arba Minch town, Gamo Zone, Southern Ethiopia.
Methods
A cross-sectional design was carried out using the World Health Organization/health action international methodology between 2 March and 2 May 2023, within public and private healthcare facilities located in Arba Minch town, Southern Ethiopia. The median price ratio served as a metric. Statistical tests like the Shapiro-Wilk and Kolmogorov-Smirnov were utilized to assess the normal distribution of price data. The Wilcoxon-Mann-Whitney U test was also employed to compare median buyer’s prices (patient prices) between public and private healthcare institutions. Treatment affordability was determined by estimating the number of days’ wages required by the lowest-paid government employee in Ethiopia to afford the prescribed medication regimen.
Results
Among 23 health facilities surveyed, the pooled availability of essential medicine used in the management of noncommunicable diseases was 18.7% (range: 0%–30.1%), with the public and private facilities contributing 16.3% and 38.3%, respectively. The overall percentage of availability originator brand versions was 1.1% for overall health sectors, 0.6% for public sectors, and 1.2% for private sectors. The overall percent availability of lowest price generics was 36.2% (range: 0%–26.2%; public: 32.0%; private: 37.1%). Only seven lowest price generics satisfied the World Health Organization target of 80% and above. The overall median price of lowest price generic medicines in private was two times higher than in public sectors. The top five median price scorers were amlodipine, furosemide, insulin, beclomethasone, and salbutamol. The Mann-Whitney U test showed that 11.6% of lowest price generics medicines had a statistically significant median price disparity between the public and private sectors (p < 0.05). The overall percent of unaffordability was found to be 100.0%, (public: 70.4; private: 100.0%).
Conclusions
This study revealed the limited availability and potential financial burdens on patients seeking essential noncommunicable disease medications. Limited availability suggests the need for better supply chain management and consistent stock availability. The price disparities and affordability challenges identified underscore the necessity for policy interventions such as price regulation and subsidized programs to ensure equitable access to essential noncommunicable disease medications in Arba Minch town, Southern Ethiopia.
... • Regulations governing pharmaceutical prices: By promoting the use of biosimilar and generic medications and controlling Reforms in pharmaceutical pricing are necessary to rein down the rising expense of cancer drugs. Essential cancer medications can be more affordably priced and more widely available to patients through policies that encourage pricing transparency and competition among pharmaceutical companies [8]. • Patient education and advocacy: It is essential to inform patients about their illness, available funding sources, and workable treatment options. ...
... Based on their systematic review on pricing of medicines, Van der Gronde et al. concluded that value-based pricing and outcomebased pricing are the most promising long-term developments (Van der Gronde et al., 2017). Moreover, value-based pricing has emerged as a preferred alternative to prices determined to what the market will bear (Kaltenboeck, 2020) or other alternatives such as price referencing (Drummond et al., 1997). ...
Health authorities use value-based pricing models to determine the value of innovative drugs and to establish a price. Pharmaceutical companies prefer value-based pricing over cost-based pricing. It is ambiguous whether value-based pricing has the same meaning to these stakeholders. We aimed to identify the elements that attribute to value-based pricing of innovative drugs from a pharmaceutical industry’s perspective and as possible starting point for (value-based) contracting of drugs. We performed a scoping review of publications available in scientific databases with terms such as ‘value-based pricing’, ‘pharmacoeconomics’, ‘drug cost’, ‘innovative drug’ and ‘drug therapy’. We included 31 publications, covering value elements of innovative drugs from a pharmaceutical industry’s perspective. Overall, all found elements of value-based pricing were congruent with the elements of value-based pricing from a health authority’s perspective. However, the emphasis placed on the elements differed. The most frequently mentioned elements in our review were economic considerations and cost aspects. Least mentioned were elements regarding cost-effectiveness, disease characteristics and patient characteristics. Although all elements in the drug value framework were present which indicate congruity, there seems controversy on the importance of cost-effectiveness as an element of value. Consequently, establishing a coherent and to all stakeholders’ acceptable framework to value and price innovative drugs seems complicated. Mutual understanding can be found in the value elements societal considerations and healthcare process benefits. Our results supported the importance of economic and cost aspects regarding determination of prices of innovative drugs. Further research is required to quantify the weights of all relevant elements in the drug value framework, observe their possible interlinkages, and to weigh them over time.
... It has been observed that drug development is now focused in the biologic and targeted medicines space. With this shift, drug budgets are escalating at rates not seen in the past, in many cases to unsustainable levels [9]. The future sustainability of medicines budgets and overall healthcare budgets may become more dependent upon the successful uptake of biosimilar medicines and the consequential cost savings [10]. ...
Biosimilars represent an opportunity to realise savings against the costs of innovative medicines. Despite efforts made by stakeholders, there are numerous barriers to the uptake of biosimilars. To realise the promise of biosimilars reducing costs, barriers must be identified, understood, and overcome, and enablers magnified. The aim of this systematic review is to summarise the enablers and barriers affecting uptake of biosimilars through the application of a classification system to organise them into healthcare professional (HCP), patient, or systemic categories.
A systematic literature search was performed in PubMed, Scopus, CINAHL, eConlit, and Embase. Included were primary research studies published in English between Jan 2017 through June 2023 focused on enablers and barriers affecting uptake of biosimilars. Excluded studies comprised comparisons of biosimilar efficacy and safety versus the reference biologic. One reviewer extracted data that included classification of barriers or enablers, the sub-classification, and the identification of the degree of agency associated with the actor through their role and associations as a mediator within their network, through the application of Actor Network Theory. The data were validated by a second reviewer (PV).
Of the 94 studies included, 59 were cross-sectional, 20 were qualitative research, 12 were cohort studies, and three were economic evaluations. Within the review, 51 of the studies included HCP populations and 35 included patients. Policies and guidelines were the most cited group of enablers, overall. Systemic enablers were addressed in 29 studies. For patients, the most frequently cited enabler was positive framing of a biosimilar, while for HCPs, cost benefit was the most frequently noted enabler. The most frequently discussed systemic barrier to biosimilar acceptance was lack of effective policies or guidelines, followed by lack of financial incentives, while the most significant barriers for HCPs and patients, respectively, were their lack of general knowledge about biosimilars and concerns about safety and efficacy. Systemic actors and HCPs most frequently acted with broad degree of agency as mediators, while patient most frequently acted with a narrow degree of agency as mediators within their networks.
Barriers and enablers affecting uptake of biosimilars are interconnected within networks, and can be divided into systemic, HCP, and patient categories. Understanding the agency of actors within networks may allow for more comprehensive and effective approaches. Systemic enablers in the form of policies appear to be the most effective overall levers in affecting uptake of biosimilars, with policy makers advised to give careful consideration to appropriately educating HCPs and positively framing biosimilars for patients.
... As other authors have already pointed out, the various confidentiality elements of the MAH process prevent other possible cost-containment policies from being used. Meanwhile, in Romania, some of these policies are also used (biosimilars/generic stimulation for prescription, reference pricing, protocols and guidelines for prescriptions, some open tenders for exclusivity) while others are waiting to be implemented (price ceilings, value-based pricing, pay for performance, etc.) [23] Looking at the future development of MEA in Romania, there are plans to expand from simple cost-volume contracts to other types of MEA, including the payment for performance mechanisms. For this aspect, there will be a need for merging patient-level data with drug-patient data, yet not generally available in Romania at the health system level, but only in some of the hospitals, and the definition and the confidentiality of these patient outcomes will be a new issue during the implementation [24,25]. ...
Background and Aim: Health technology assessment for drugs is a necessary step in developing health policies that are focused on patients and getting the best value for scarce resources. One important feature of health technology assessment is transparency. In many countries, health technology assessment is followed by negotiations between pharmaceutical companies and health authorities to determine whether a drug will be publicly funded. These negotiations often result in Managed Entry Agreements, which typically include confidentiality clauses covering the final price of the drug. Methods: We reviewed Romanian legislation starting in 2014 to assess the level of confidentiality and transparency in drug pricing and reimbursement. Results: We found that for drugs with Managed Entry Agreements, the level of discounts is confidential, the public does not know how much the government is paying for each of these drugs, the volumes (units) of drugs are not transparently published by the payer, the outcomes, in terms of patients treated by therapeutic area, therapeutic success, and resource utilization, are confidential. Conclusions: We consider that too much confidentiality can prevent the public from knowing if the government is getting good value for money, but too little confidentiality can lead to higher drug prices or a lack of drugs from the market.
