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\"Groundbreaking research has given us many remarkable new medicines, but America's drug evaluation process, once the envy of the world, is being seriously compromised. Under pressure from drugmakers, the FDA has been lowering its approval standards and has let poorly effective or risky products enter the market--while our prescription prices, the highest in the world, put crucial treatments beyond the reach of many. In Rethinking Medications, Dr. Jerry Avorn explains how we got here and what we can do to ensure that our medicines are dependably effective, safe, and affordable\"-- Provided by publisher.

For expensive specialty drugs, it’s unclear how quickly substantial price competition among generics manufacturers can be achieved. Even if generic specialty drugs have far lower list prices than brand-name versions, savings may not accrue to Medicare beneficiaries.

Polypharmacy is a serious health issue for older adults worldwide, including in Japan, which has a rapidly aging society. The “Proper Medication Guideline for Older Adults” was published for healthcare providers in May 2018, and polypharmacy reduction incentives were initiated for medical facilities in April 2016 and April 2018. This study identified the long-term reduction in polypharmacy prescriptions focusing on older adults aged 75 years and above from April 2015 to March 2019. The national health insurance claims database, which covers most reimbursement claims in Japan, was selected as the primary data source. In this study, polypharmacy was defined as the simultaneous prescription of seven or more medications or multi-psychotropic medications. The primary outcome was the polypharmacy reduction ratio, which indicates the decrease in polypharmacy proportion based on the number of medications on an outpatient prescription. A total polypharmacy reduction of 19.3% for the “75–89 years” subgroup and 16.5% for the “90 years and above” subgroup was observed over four years. Based on prefecture analysis, the mean values of polypharmacy proportion showed a statistically significant reduction over four years. This study showed a successful nationwide reduction in polypharmacy prescriptions after implementing the polypharmacy management guidelines for older adults and incentive-based policies.

The FDA is developing guidance on the use of “real-world evidence” — health care information from atypical sources, including electronic health records, billing databases, and product and disease registries — to assess the safety and effectiveness of drugs and devices. The term “real-world evidence” is widely used by those who develop medical products or who study, deliver, or pay for health care, but its specific meaning is elusive. We believe it refers to information on health care that is derived from multiple sources outside typical clinical research settings, including electronic health records (EHRs), claims and billing data, product and disease registries, and data gathered through personal devices and health applications. 1 , 2 Key to understanding the usefulness of real-world evidence is an appreciation of its potential for complementing the knowledge gained from traditional clinical trials, whose well-known limitations make it difficult . . .

The use of brand rather than generic names for medications can increase health care costs. However, little is known at a national level about how often physicians refer to drugs using their brand or generic names. To evaluate how often physicians refer to drugs using brand or generic terminology. We used data from the 2003 National Ambulatory Medical Care Survey (NAMCS), a nationally representative survey of 25,288 community-based outpatient visits in the United States. After each visit, patient medications were recorded on a survey encounter form by the treating physician or transcribed from office notes. Our main outcome measure was the frequency with which medications were recorded on the encounter form using their brand or generic names. For 20 commonly used drugs, the median frequency of brand name use was 98% (interquartile range, 81-100%). Among 12 medications with no generic competition at the time of the survey, the median frequency of brand name use was 100% (range 92-100%). Among 8 medications with generic competition at the time of the survey (\"multisource\" drugs), the median frequency of brand name use was 79% (range 0-98%; P < .001 for difference between drugs with and without generic competition). Physicians refer to most medications by their brand names, including drugs with generic formulations. This may lead to higher health care costs by promoting the use of brand-name products when generic alternatives are available.

The debate regarding step therapy reflects a tension between two important policy goals: safeguarding patients’ access to high-quality care and constraining spending on prescription drugs, including by limiting the overuse of costly medications with uncertain efficacy.

New hepatitis C virus (HCV) medicines have markedly improved treatment efficacy and regimen tolerability. However, their high prices have limited access, prompting wide debate about fair and affordable prices. This study systematically compared the price and affordability of sofosbuvir and ledipasvir/sofosbuvir across 30 countries to assess affordability to health systems and patients. Published 2015 ex-factory prices for a 12-wk course of treatment were provided by the Pharma Price Information (PPI) service of the Austrian public health institute Gesundheit Österreich GmbH or were obtained from national government or drug reimbursement authorities and recent press releases, where necessary. Prices in Organisation for Economic Co-operation and Development (OECD) member countries and select low- and middle-income countries were converted to US dollars using period average exchange rates and were adjusted for purchasing power parity (PPP). We analysed prices compared to national economic performance and estimated market size and the cost of these drugs in terms of countries' annual total pharmaceutical expenditure (TPE) and in terms of the duration of time an individual would need to work to pay for treatment out of pocket. Patient affordability was calculated using 2014 OECD average annual wages, supplemented with International Labour Organization median wage data where necessary. All data were compiled between 17 July 2015 and 25 January 2016. For the base case analysis, we assumed a 23% rebate/discount on the published price in all countries, except for countries with special pricing arrangements or generic licensing agreements. The median nominal ex-factory price of a 12-wk course of sofosbuvir across 26 OECD countries was US$42,017, ranging from US$37,729 in Japan to US$64,680 in the US. Central and Eastern European countries had higher PPP-adjusted prices than other countries: prices of sofosbuvir in Poland and Turkey (PPP$101,063 and PPP$70,331) and of ledipasvir/sofosbuvir in Poland (PPP$118,754) were at least 1.09 and 1.63 times higher, respectively than in the US (PPP$64,680 and PPP$72,765). Based on PPP-adjusted TPE and without the cost of ribavirin and other treatment costs, treating the entire HCV viraemic population with these regimens at the PPP-adjusted prices with a 23% price reduction would amount to at least one-tenth of current TPE across the countries included in this study, ranging from 10.5% of TPE in the Netherlands to 190.5% of TPE in Poland. In 12 countries, the price of a course of sofosbuvir without other costs was equivalent to 1 y or more of the average annual wage of individuals, ranging from 0.21 y in Egypt to 5.28 y in Turkey. This analysis relies on the accuracy of price information and infection prevalence estimates. It does not include the costs of diagnostic testing, supplementary treatments, treatment for patients with reinfection or cirrhosis, or associated health service costs. Current prices of these medicines are variable and unaffordable globally. These prices threaten the sustainability of health systems in many countries and prevent large-scale provision of treatment. Stakeholders should implement a fairer pricing framework to deliver lower prices that take account of affordability. Without lower prices, countries are unlikely to be able to increase investment to minimise the burden of hepatitis C.

Eosinophilic esophagitis (EoE) has rapidly become a major cause of upper GI morbidity, but health-care costs related to EoE have not been described. This study aimed to estimate EoE-related health-care costs and utilization in the United States. We performed a study on health-care utilization of EoE cases compared with age- and sex-matched controls using administrative claims data, representative of the commercially insured population in the United States. Cases of EoE were identified using a previously validated definition. We assessed inpatient, outpatient, emergency department, outpatient prescription, and endoscopy-related costs for patients with EoE, and estimated total costs related to EoE extrapolated to the US population. We identified 8,135 cases of EoE and 32,540 controls. The median total annual cost per EoE case was $3,304 compared with $1,001 for controls (P<0.001). For EoE, the median costs included $2,508/year for outpatient visits, $157 for endoscopies, and $325 for pharmacy claims, compared with $699, $0, and $76 for controls (P<0.001 for all). The overall median cost associated with EoE was $2,302/year/patient. Total costs in the United States ranged from $503 million to $1.36 billion/year, depending on the prevalence estimate, with costs attributable to EoE ranging from $350 to $947 million/year. Patients with EoE have an estimated annual health-care cost of as much as $1.4 billion in the United States. This represents a remarkable burden of disease for an entity that was essentially unknown two decades ago. These cost data can be used by policy makers to guide resource allocation.