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High-Cost Generic Drugs — Implications for Patients and Policymakers

November 18, 2014 Comments off

High-Cost Generic Drugs — Implications for Patients and Policymakers
Source: New England Journal of Medicine

It is well known that new brand-name drugs are often expensive, but U.S. health care is also witnessing a lesser-known but growing and seemingly paradoxical phenomenon: certain older drugs, many of which are generic and not protected by patents or market exclusivity, are now also extremely expensive. Take the case of albendazole, a broad-spectrum antiparasitic medication. Albendazole was first marketed by a corporate predecessor to GlaxoSmithKline (GSK) outside the United States in 1982 and was approved by the Food and Drug Administration (FDA) in 1996. Its patents have long since expired, but no manufacturer ever sought FDA approval for a generic version. One reason may be that the primary indications for the drug — intestinal parasites, neurocysticercosis, and hydatid disease — occur relatively rarely in the United States and usually only in disadvantaged populations such as immigrants and refugees. In late 2010, the listed average wholesale price (AWP) for albendazole was $5.92 per typical daily dose in the United States and less than $1 per typical daily dose overseas.

By 2013, the listed AWP for albendazole had increased to $119.58 per typical daily dose.1 We found that at some pharmacies in Minnesota, an uninsured patient requiring 6 months of treatment would have faced costs amounting to tens of thousands of dollars.1 Although the AWP may not reflect the actual cost of the product, Medicaid data show that spending on albendazole increased from less than $100,000 per year in 2008, when the average cost was $36.10 per prescription, to more than $7.5 million in 2013, when the average cost was $241.30 per prescription (see graph).

The albendazole story is not unique. According to the National Average Drug Acquisition Cost pricing file, the price of captopril (12.5 mg), which is used for hypertension and heart failure, increased by more than 2800% between November 2012 and November 2013, from 1.4 cents to 39.9 cents per pill. Similarly, the price of clomipramine (25 mg), a long-established tricyclic antidepressant also used for obsessive–compulsive disorder, increased from 22 cents to $8.32 per pill, and the price of doxycycline hyclate (100 mg), a broad-spectrum antibiotic that has been around since 1967, increased from 6.3 cents to $3.36 per pill.2

Yet many of these drugs remain key therapeutic tools. The number of prescriptions for albendazole has increased dramatically, in part because the drug has increasingly been used to treat parasitic infections in refugees. The Centers for Disease Control and Prevention recommends presumptive treatment of refugees arriving in the United States if they have not had prior treatment. Because the people who need albendazole are generally disadvantaged, the costs resulting from the enhanced demand and associated price increases are largely borne by the patients themselves through substantial out-of-pocket payments or by taxpayers through public insurers such as Medicaid and the Refugee Medical Assistance program.

Voters and the Affordable Care Act in the 2014 Election

October 31, 2014 Comments off

Voters and the Affordable Care Act in the 2014 Election
Source: New England Journal of Medicine

As we approach the 2014 election, we are witnessing an unusual situation. Poll results suggest a low level of public interest and a low projected voter turnout in this election. Only about half (52%) of the public say they are currently paying attention to the election (CBS News–New York Times [CBS-NYT] poll, 2014). On the basis of past nonpresidential-year elections, less than half of U.S. adults are expected to vote.1 At the same time, congressional candidates are raising a number of important national issues, including what should be the future of the Affordable Care Act (ACA) in the years ahead.

Most Democratic candidates hold positions in favor of continuing the next phase of the ACA’s implementation mostly in its current form, whereas most Republican candidates have positions favoring some sort of major scaling back, repeal, or replacement of the legislation. For a number of different reasons, political forecasters see this election’s outcome as being very close. They give at least an even chance that the Republican Party will win majorities in both the House of Representatives and the Senate. The uncertain outcome of this election has importance for health care because of the polarized views held by each party’s candidates on the future of the ACA, federal health spending, and policies regarding federal health care regulation.

This article, which is based on an analysis of data from 27 public opinion polls by 14 organizations, seeks to examine the role of the ACA in the 2014 election and the potential implications for health care depending on the outcome. It examines the following six questions: How important is health care, and specifically the ACA, as an issue in the 2014 election? If a congressional candidate supports the ACA, are voters more or less likely to vote for him or her? What is the current level of voter support for the ACA? How does this support vary according to voters’ partisan affiliation? Do voters currently support a core principle of the ACA that it is the responsibility of the federal government to make sure that all Americans have health care coverage? What do voters want the next Congress to do with the ACA?

Provision of No-Cost, Long-Acting Contraception and Teenage Pregnancy

October 30, 2014 Comments off

Provision of No-Cost, Long-Acting Contraception and Teenage Pregnancy
Source: New England Journal of Medicine

We found that pregnancy, birth, and abortion rates were low among teenage girls and women enrolled in a project that removed financial and access barriers to contraception and informed them about the particular efficacy of LARC methods. The observed rates of pregnancy, birth, and abortion were substantially lower than national rates among all U.S. teens, particularly when compared with sexually experienced U.S. teens. Stratification according to factors known to be associated with sexual behavior and pregnancy risk (age and race)21 showed that this was true among both older teens (18 to 19 years of age) and younger teens, as well as among both white and black teens.

Ebola Virus Disease in West Africa — The First 9 Months of the Epidemic and Forward Projections

October 24, 2014 Comments off

Ebola Virus Disease in West Africa — The First 9 Months of the Epidemic and Forward Projections
Source: New England Journal of Medicine

As of September 14, 2014, a total of 4507 confirmed and probable cases of Ebola virus disease (EVD), as well as 2296 deaths from the virus, had been reported from five countries in West Africa — Guinea, Liberia, Nigeria, Senegal, and Sierra Leone. In terms of reported morbidity and mortality, the current epidemic of EVD is far larger than all previous epidemics combined. The true numbers of cases and deaths are certainly higher. There are numerous reports of symptomatic persons evading diagnosis and treatment, of laboratory diagnoses that have not been included in national databases, and of persons with suspected EVD who were buried without a diagnosis having been made

Ebola Virus Disease in West Africa — The First 9 Months of the Epidemic and Forward Projections

September 24, 2014 Comments off

Ebola Virus Disease in West Africa — The First 9 Months of the Epidemic and Forward Projections
Source: New England Journal of Medicine

A total of 4507 confirmed and probable EVD cases were reported to the WHO between December 30, 2013, and September 14, 2014 — a 37-week period. A total of 718 confirmed and probable cases and 289 deaths were reported in the week of September 8 through September 14 alone. The numbers of confirmed and probable cases reported by each country over time are shown in Figure 1 and Figure 2. Detailed information was available on 3343 confirmed and 667 probable cases; these cases were used in all our analyses, with the exception of projections (results of analyses based on confirmed, probable, and suspected cases are provided in Supplementary Appendix 1). The median age of persons with EVD was 32 years (interquartile range, 21 to 44), and there were no significant differences in the age distribution of persons with EVD among countries. The majority of persons with EVD (60.8%) were between 15 and 44 years of age (this age group makes up only 44% of the population) (Table 1Table 1Demographic Characteristics and Signs and Symptoms in Confirmed and Probable Ebola Case Patients with a Definitive Clinical Outcome in Guinea, Liberia, Nigeria, and Sierra Leone.). There were also no significant differences among countries in the total numbers of male and female persons with EVD reported (49.9% of the total were male patients; within-country differences have not yet been fully investigated). EVD has taken a heavy toll among health care workers in Guinea, Liberia, and Sierra Leone. By September 14, a total of 318 cases, including 151 deaths, had been reported among health care workers.

Health Reform and Changes in Health Insurance Coverage in 2014

August 13, 2014 Comments off

Health Reform and Changes in Health Insurance Coverage in 2014
Source: New England Journal of Medicine

In this analysis of nationally representative survey data from January 2012 through June 2014, we found a significant decline in the uninsured rate among nonelderly adults that coincided with the initial open-enrollment period under the ACA. These changes remained highly significant after adjustment for potential confounders such as employment, demographic characteristics, and income. As compared with the baseline trend, the uninsured rate declined by 5.2 percentage points by the second quarter of 2014, a 26% relative decline from the 2012–2013 period. Combined with 2014 Census estimates of 198 million adults 18 to 64 years of age,19 this corresponds to 10.3 million adults gaining coverage, although depending on the model and confidence intervals, our sensitivity analyses imply a wide range from 7.3 to 17.2 million adults.

The pattern of coverage gains was consistent with the effects of the ACA, with major gains for persons likely to be eligible for expanded Medicaid on the basis of their income and state of residence but smaller and nonsignificant changes for low-income adults in states without Medicaid expansion. Coverage gains were significant both in states with Medicaid expansion and in those without Medicaid expansion for persons with incomes between 139% and 400% of the federal poverty level, which is consistent with tax subsidies under the ACA for private insurance in this income range, regardless of state decisions regarding Medicaid expansion. Absolute gains were largest among young adults and Hispanics, two groups with high uninsured rates at baseline. State-level estimates of coverage gains were significantly associated with official HHS enrollment statistics, showing that each percentage point of the state population enrolling via the marketplaces was associated with a half-point decline in the uninsured rate. Nonetheless, the inherent lack of a control group precludes a causal interpretation for these findings, and other unmeasured factors may have contributed to these changes.

Drug Safety in the Digital Age

July 2, 2014 Comments off

Drug Safety in the Digital Age
Source: New England Journal of Medicine

In this digital age, engaging with new media offers an unparalleled opportunity for medical and public health professionals to find information they need and to interactively reach out to patients and their support networks. One domain where these capabilities may have far-reaching effects that are currently undefined is drug safety. As the volume of health-related information on the Internet has grown, important questions have emerged. How are messages from regulators — for example, warnings against using a drug in a specific patient population — diffused digitally? And are the messages still accurate when they reach the general population?

Despite debates over its credibility, Wikipedia is reportedly the most frequently consulted online health care resource globally: Wikipedia pages typically appear among the top few Google search results and are among the references most likely to be checked by Internet users. We therefore evaluated Google searches and Wikipedia page views for each drug in our sample. We also examined the content of Wikipedia pages, looking specifically for references to safety warnings. To control for secular trends, we examined results from a 120-day window around the date of the announcement (from 60 days before the announcement to 60 days after it) and constructed a baseline period for comparison that ran from 60 days to 10 days before the period of interest began.

We identified safety warnings for 22 prescription drugs that are indicated for a range of clinical conditions, including primary hypertension, chronic myelogenous leukemia, and hepatitis C. Collectively, these drugs triggered 13 million searches on Google and 5 million Wikipedia page views annually during the study period. FDA safety warnings were associated with an 82% increase, on average, in Google searches for the drugs during the week after the announcement and a 175% increase in views of Wikipedia pages for the drugs on the day of the announcement, as compared with baseline trends.

Did users find accurate information on the drugs’ safety? We found that 41% of Wikipedia pages pertaining to the drugs with new safety warnings were updated within 2 weeks after the warning was issued with information provided in the FDA announcements. The Wikipedia pages for drugs that were intended for treatment of highly prevalent diseases (affecting more than 1 million people in the United States) were more likely to be updated quickly (58% were updated within 2 weeks) than were those for drugs designed to treat less-prevalent conditions (20% were updated within 2 weeks, P=0.03; see Fig. S2 in the Supplementary Appendix).

Overall, 23% of Wikipedia pages were updated more than 2 weeks after the FDA warning was issued (average, 42 days), and 36% of pages remained unchanged more than 1 year later (as of January 2014). For example, the FDA issued a safety communication on January 13, 2012, that brentuximab vedotin (Adcetris), used to treat Hodgkin’s lymphoma and systemic anaplastic large-cell lymphoma, had been linked to two cases of progressive multifocal leukoencephalopathy. As a result, the FDA placed a new black-box warning about this risk on the drug label, a move that was followed by a 50% increase in Google searches for the drug during the ensuing week and a 141% increase in views of the drug’s Wikipedia page. However, there was still no mention of the new black-box warning on Wikipedia 2 years later, a discrepancy that substantiates concerns raised by previous studies over the reliability of online drug information.

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