Drug prices increased twice as quickly than expected during shortage

1. Drug prices increased twice as quickly than expected during shortage

Manufacturers suspected of exploiting shortage to charge more for drugs in demand

Abstract: http://annals.org/aim/article/doi/10.7326/M18-1137

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Prices for drugs under shortage between 2015 and 2016 increased more than twice as quickly as they were expected to in the absence of a shortage. While researchers could not assess reasons for the increases, manufacturers were suspected of exploiting shortages to charge more for drugs in high demand. A brief research report is published in Annals of Internal Medicine.

Prescription drug shortages cause an estimated $230 million in additional costs each year because of the rising prices of drugs under shortage and the higher costs of substitution drugs. This public health crisis may require attention from policymakers.

Researchers from the University of Pittsburgh School of Pharmacy, UPMC Health Plan and Harvard Medical School used the U.S. Food and Drug Administration (FDA) drug shortages database to identify an active shortage of 917 drugs between December 2015 and December 2016. They then used pricing data from AnalySource to extract monthly wholesale acquisition costs for each drug in the month of the shortage began and the 12 months before and after. In the 11 months after the shortage began, the expected price increase for all drugs was 20 percent compared with 9 percent in the absence of a shortage. The researchers speculate that price increases reflect manufacturers' opportunistic behavior during shortages, when the imbalance between supply and demand increases willingness to pay.

Media contact: For an embargoed PDF, please contact Lauren Evans at laevans@acponline.org. To interview the lead author, Inmaculada Hernandez PharmD, PhD, please contact Ned Schano at schanoe@upmc.edu.

2. Evidence lacking to compare safety and efficacy of common skin cancer treatments

More high-quality studies are needed to inform both clinical decision-making and health care policy

Abstract: http://annals.org/aim/article/doi/10.7326/M18-0678

Editorial: http://annals.org/aim/article/doi/10.7326/M18-2286

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Basal cell carcinoma (BCC) is the most common cancer in the U.S., with millions of patients treated every year. Despite its prevalence, most commonly-used treatment interventions have not been rigorously studied. Evidence is lacking to compare the safety and efficacy of the common skin cancer interventions used to treat BCC. Sparse available evidence suggests that excisional surgery, including Mohs micrographic surgery, works well. However, it is less clear how other treatments work as there are so few studies examining them. Findings from a systematic review and network meta-analysis of these treatments are published in Annals of Internal Medicine.

Researchers from Women's College Hospital in Toronto, Ontario, Canada and Brown University in Providence, RI reviewed 40 randomized controlled trials and five nonrandomized comparative studies of common BCC treatments to evaluate a variety of outcomes including tumor recurrence, cosmetic appearance, quality of life, mortality and costs. The results supported the known effectiveness of commonly-used treatment options including surgery, external beam radiation, and topical creams, but found a lack of evidence to support choices between the interventions. According to the authors, these results confirmed recent guidelines from the American Academy of Dermatology, which called out the scarcity of evidence and randomized controlled trials conducted on these treatments.

The researchers conclude that future studies will need to investigate the comparative effectiveness of BCC treatments through randomized controlled trials. In addition, future research should address the cost to the health care system of treating BCC. Currently, a large amount of money is spent treating BCC without concrete knowledge about the value of choosing one treatment over another.

Media contact: For an embargoed PDF, please contact Lauren Evans at laevans@acponline.org. To interview the lead author, Aaron Drucker, MD, ScM, FRCPC, please contact Sarah Warr at Sarah.Warr@wchospital.ca.

3. Tailoring FIT positivity thresholds by age and sex may help to optimize colorectal cancer screening programs

Abstract: http://annals.org/aim/article/doi/10.7326/M18-0244

Editorial: http://annals.org/aim/article/doi/10.7326/M18-2257

URLs go live when the embargo lifts

Tailoring fecal immunochemical test (FIT) positivity thresholds by age and sex may help to optimize population-based colorectal cancer screening programs. Findings from a community-based cohort study are published in Annals of Internal Medicine.

Quantitative FITs directly measure human hemoglobin concentrations in the stool and are commonly used for colorectal cancer screening. Despite demographic variations in stool hemoglobin concentrations, few data exist regarding optimal positivity thresholds by age and sex.

Researchers from Kaiser Permanente Division of Research in Oakland, Calif. studied health records for more than 640,000 adults aged 50 to 75 years to quantify the sensitivity of FIT over several rounds of testing, as well as the potential effect of various positivity thresholds on a screening program, in a cohort representing a community-based, diverse population. They found that programmatic sensitivity for colorectal cancer detection increased modestly with decreasing positivity thresholds, from 74.3 percent at 20 uμ/g, to 76 percent at 15 uμ/g, and 79 percent at 10 uμ/g. The number of positive test results per cancer case detected over 2 years increased with decreasing positivity thresholds, especially those below the conventional 20 μg/g. The performance of FIT varied by age and sex, with lower programmatic sensitivity and specificity with increasing age and higher programmatic sensitivity and lower specificity in men than women.

According to the researchers, screening programs wishing to increase cancer detection by lowering their positivity threshold will require substantial additional colonoscopy and financial resources. Additional research is needed to assess the cost-effectiveness of this type of change and its practicality across settings with different resources.

Media contact: For an embargoed PDF, please contact Lauren Evans at laevans@acponline.org. To interview the lead author, Kevin Selby, MD, MAS, please contact Janet Byron at Janet.L.Byron@kp.org.

4. Quarterly canakinumab administration associated with significantly reduced risk for gout attacks

Abstract: http://annals.org/aim/article/doi/10.7326/M18-1167

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Quarterly administration of canakinumab, an interleukin-1β blocker, was found to be associated with significantly reduced risk for gout attacks without any change in serum uric acid (SUA) levels. However the authors note that the high cost of the drugs could be an issue. Findings from a secondary analysis of a randomized controlled trial are published in Annals of Internal Medicine.

Gout is the most common inflammatory arthritis in adults, and its prevalence has increased substantially over the past several decades. Effective therapies exist for acute gout attacks, and long-term prevention has focused on decreasing concentrations of SUA. No trial data support the long-term prevention of gout attacks with agents that do not target SUA lowering. Studies have shown that interleukin-1B inhibitors can shorten gout attacks, but whether they can prevent gout attacks from occurring is unclear.

Researchers from Brigham and Women's Hospital in Boston, Mass. conducted a post hoc analysis of data from CANTOS (Canakinumab Antiinflammatory Thrombosis Outcome Study) to examine the relationship among canakinumab, SUA, and the incidence of gout attacks. Rates of gout attacks were compared across patients with different baseline concentrations of SUA and in different intervention groups in the randomized controlled study. The researchers found that canakinumab was associated with a reduced risk for the incidence of gout attacks by approximately 50 percent at three different doses administered quarterly, without altering SUA concentrations. Canakinumab also had the added benefit of reducing the risk for cardiovascular events, a common comorbid condition in patients with gout.

According to the researchers, these findings suggest that in the future, canakinumab, if it were available at a lower price, or other inhibitors of interleukin-1β, may be considered a viable therapeutic option for patients with refractory gout who are also at risk for cardiovascular events

Media contact: For an embargoed PDF, please contact Lauren Evans at laevans@acponline.org. To interview the lead author, Daniel H. Solomon, MD, please contact Haley Bridger at hbridger@bwh.harvard.edu.

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Shoshana J. Herzig, MD, MPH
Hospitalist Inpatient Notes
Abstract: http://annals.org/aim/article/doi/10.7326/M18-2295

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Cathryn J. Lapedis, MD, MPH
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Abstract: http://annals.org/aim/article/doi/10.7326/M18-1398