The effect of generic market entry on antibiotic prescriptions in the United States.
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ABSTRACT:
SUBMITTER: Kallberg C
PROVIDER: S-EPMC8131704 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundIn recent years, the price of many older generic drugs, including numerous antibiotics, has increased substantially. We sought to analyze recent price changes and extent of generic competition within a cohort of commonly prescribed off-patent oral antibiotics.MethodsWe extracted oral antibiotics recommended for common outpatient conditions in the Infectious Diseases Society of America Practice Guidelines. We determined all US Food and Drug Administration-approved manufacturers for each formulation and strength in 2013 and 2016 and the yearly national average drug acquisition cost (NADAC) price between 2013 and 2016. Wilcoxon signed rank test was used to compare changes in drug prices and number of manufacturers from 2013 to 2016. Spearman correlation coefficient was used to assess the association between drug prices and number of manufacturers.ResultsTwenty-two antibiotics (81 formulations and strengths) were analyzed. There was no change in the median NADAC price or the number of manufacturers between 2013 and 2016. However, 11 (14%) formulations increased in price by 90% or more, and 13 (16%) had 2 or fewer manufacturers during all 4 years. Antibiotic prices were negatively associated with the number of available manufacturers.ConclusionsWhile prices and the number of manufacturers for common oral antibiotics were overall stable between 2013 and 2016, reduced manufacturer competition was associated with increased prices. A subset of antibiotics exhibited substantial price increases, and most, but not all, had limited manufacturer competition. Policy solutions are needed to ensure availability of low-cost, essential generic antibiotics.
| S-EPMC5848313 | biostudies-literature
Project description:In April 2020, there were significant reductions in prescription fills of each of the 10 most prescribed outpatient antibiotics in the United States. Monthly azithromycin, amoxicillin-clavulanate, and levofloxacin fills did not rebound significantly from April through July 2020. Coronavirus disease 2019 had an immediate and sustained impact on US outpatient antibiotic prescribing.
| S-EPMC7765437 | biostudies-literature
Project description:BACKGROUND:Some classes of drugs have lower than optimal uptake of generic products. We aimed to understand the determinants of generic drug substitution across classes. METHODS:We conducted a cross-sectional analysis of data from the 2013 MarketScan Commercial Claims and Encounters Database from Truven Health Analytics. We quantified generic substitution rates (GSR) for 26 drug classes, choosing one representative week in November 2013. We used mixed-effects logistic regression to estimate the independent relationship between the determinants of interest and generic substitution for 8 classes with low generic utilization. RESULTS:The GSRs for most classes exceeded 90%, although some were much lower including thyroid hormones (64%), androgens (74%), estrogens (71%), and hydantoin-type anticonvulsants (72%). The determinants of generic substitution varied across classes, albeit with important patterns. Patients using a mail order pharmacy had significantly less generic substitution than patients filling at retail pharmacies for 5 of the 8 studied classes; two additional classes showed no relationship between pharmacy type and generic use. Men relative to women and patients taking more medications were more likely to use generics for most classes. State substitution laws and patient consent laws were largely inconsequential regarding generic substitution. CONCLUSIONS:Policies are needed to support the use of safe, effective and often lower cost generic drugs, when available. Mail order pharmacies, as often required by pharmacy benefits managers, lessen generic use for many classes. These pharmacies may require additional regulatory oversight if this adversely impacts patients.
| S-EPMC7261594 | biostudies-literature
Project description:ObjectivesThe rapid growth of pharmaceutical costs is a major healthcare issue all over the world. The high prices of new drugs, especially those for cancer, are also a concern for stakeholders. Generic drugs are a major price-reducing opportunity and provide more societal value. The aim of this research is to analyse the impact of generic entry on the volume and cost of antineoplastic agents in China.MethodsAn interrupted time-series design examined monthly sales of three antineoplastic drugs (capecitabine, decitabine, imatinib) from 699 public hospitals during January 2011 to June 2016. The first generic entry times (December 2013, December 2012, August 2013, respectively) were regarded as the intervention time points. We estimated changes in volume and cost following the generic entry.ResultsWe found that generic entry was associated with increases in the volume of three antineoplastic agents and decreases in their costs. In terms of volume, generic entry was associated with increases in use of capecitabine, decitabine and imatinib by 815.0 (95% CI -66.5 to 1696.5, p>0.05), 11.0 (95% CI 3.7 to 18.3, p=0.004) and 2145.5 (95% CI 1784.1 to 2506.9, p<0.001) units. The entry of generic antineoplastic drugs reduced the monthly cost trend of three agents by ¥3.1 (95% CI -¥3.6 to -¥2.6, p<0.001), ¥84.7 (95% CI -¥104.7 to -¥64.6, p<0.001) and ¥21.3 (95% CI -¥24.2 to -¥18.4, p<0.001), respectively. The entry of generic drugs attenuated the upward trend in volume of three brand-name drugs and even triggered reductions in the volume of brand-name capecitabine. The entry of generics was accompanied by significant increase of ¥2.6 in monthly brand-name decitabine cost (95% CI ¥0.2 to ¥5.1, p=0.04).ConclusionOur findings suggested that entry of generic drugs impacted use and cost of antineoplastic medicines in China. Generic drugs may improve the availability and the affordability of antineoplastic agents, which would benefit more patients.
| S-EPMC6082476 | biostudies-literature
Project description:BackgroundWe analyzed the cost-effectiveness of treating incident chronic myeloid leukemia in chronic phase (CML-CP) with generic imatinib when it becomes available in United States in 2016. In the year following generic entry, imatinib's price is expected to drop 70% to 90%. We hypothesized that initiating treatment with generic imatinib in these patients and then switching to the other tyrosine-kinase inhibitors (TKIs), dasatinib or nilotinib, because of intolerance or lack of effectiveness ("imatinib-first") would be cost-effective compared with the current standard of care: "physicians' choice" of initiating treatment with any one of the three TKIs.MethodsWe constructed Markov models to compare the five-year cost-effectiveness of imatinib-first vs physician's choice from a US commercial payer perspective, assuming 3% annual discounting ($US 2013). The models' clinical endpoint was five-year overall survival taken from a systematic review of clinical trial results. Per-person spending on incident CML-CP treatment overall care components was estimated using Truven's MarketScan claims data. The main outcome of the models was cost per quality-adjusted life-year (QALY). We interpreted outcomes based on a willingness-to-pay threshold of $100 000/QALY. A panel of European LeukemiaNet experts oversaw the study's conduct.ResultsBoth strategies met the threshold. Imatinib-first ($277 401, 3.87 QALYs) offered patients a 0.10 decrement in QALYs at a savings of $88 343 over five years to payers compared with physician's choice ($365 744, 3.97 QALYs). The imatinib-first incremental cost-effectiveness ratio was approximately $883 730/QALY. The results were robust to multiple sensitivity analyses.ConclusionWhen imatinib loses patent protection and its price declines, its use will be the cost-effective initial treatment strategy for CML-CP.
| S-EPMC4948567 | biostudies-literature
Project description:IntroductionAlthough real-world studies demonstrate that those prescribed nirmatrelvir/ritonavir (and particularly within 5 days of symptom onset) are less likely to experience severe COVID-19 outcomes, prior studies show that only a small fraction of patients with COVID-19 who are eligible for nirmatrelvir/ritonavir receive a prescription. Studies calculating the proportion of nirmatrelvir/ritonavir prescriptions filled and identifying individual- and pharmacy-level correlates of filling nirmatrelvir/ritonavir are lacking.MethodsThis retrospective cohort study included individuals aged ≥ 12 years with a nirmatrelvir/ritonavir prescription ordered at a large national retail pharmacy (December 22, 2021-August 12, 2023). Those taking contraindicated medications were excluded. For those with only one nirmatrelvir/ritonavir prescription ordered, the outcome was whether the prescription was filled (yes/no). In a subanalysis of these individuals, the outcome was whether the prescription was filled within 5 days of symptom onset (yes/no). For those with multiple prescriptions ordered, the outcome was whether > 1 (vs. 0 or 1) prescriptions were filled. A log-binomial regression with generalized estimating equations was used to identify individual (clinical and demographic) and pharmacy-level (percentage of trade area that is non-Hispanic white, urbanicity, US Census region, and tract-level area deprivation index) correlates.ResultsA total of 2,103,570 unique nirmatrelvir/ritonavir prescriptions were ordered for 1,985,990 individuals. Among the 95% of individuals prescribed only one nirmatrelvir/ritonavir course, 88% filled their prescription. Among those with > 1 prescription ordered, 77% (82,993/108,411) filled one and 13% (13,662/108,411) filled > 1. Patients ≥ 50 years of age and those with documented high-risk conditions were slightly more likely to fill prescriptions, regardless of whether one or multiple courses were ordered. Individuals with cancer, asthma, or taking corticosteroids or immunosuppressive medications were more likely to fill multiple prescriptions.ConclusionsMost patients filled their nirmatrelvir/ritonavir prescriptions. Interventions to improve uptake should focus on increasing patient and provider awareness, reducing nirmatrelvir/ritonavir prescribing disparities, and ensuring treatment initiation within 5 days.
| S-EPMC11343940 | biostudies-literature
Project description:In this national cohort of older adults residing long-term in US nursing homes between 2013 and 2017, we calculated period prevalence estimates for antibiotic prescribing, rates of prescribing, and days of therapy. Among 1 375 062 residents, 66.2% were prescribed at least 1 antibiotic during the nursing home stay. The most prevalent antibiotic classes were fluoroquinolones, sulfonamides and related agents, and first-generation cephalosporins. Levofloxacin, ciprofloxacin, and sulfamethoxazole-trimethoprim were the most prevalent antibiotics. These results can inform antibiotic stewardship interventions to reduce antibiotic overprescribing, improve appropriateness, and reduce related adverse outcomes in nursing homes.
| S-EPMC10428191 | biostudies-literature
Project description:BackgroundAtrazine and other triazine herbicides are widely used in US maize and sorghum production, yet the most recent market-level assessment of the economic benefits of atrazine is for market conditions prevalent in the early 1990s, before commercialization of transgenic crops. Grain markets have changed substantially since that time; for example, the size of the US maize market increased by 170% from 1990-1992 to 2007-2009. This paper reports a current assessment of the economic benefits of atrazine.ResultsYield increases and cost changes implied by triazine herbicides are projected to reduce maize prices by 7-8% and sorghum prices by 19-20%. Projected consumer benefits from lower prices range from $US 3.6 to 4.4 × 10(9) annually, with the net projected economic benefit for triazine herbicides to the US economy ranging from $US 2.9 to 3.4 × 10(9) annually because lower prices imply reduced producer income. Productivity gains from triazine herbicides maintain an estimated 270 000-390 000 ha of land in non-crop uses that generate environmental benefits not accounted for in this analysis.ConclusionEven in the current era, with transgenic varieties dominating crop production, atrazine and the other triazine herbicides continue to be a key part of maize and sorghum production and generate substantial economic benefits.
| S-EPMC4282455 | biostudies-literature
Project description:IntroductionThe smokeless tobacco (SLT) industry in the U.S. continues to transform with novel products amid an evolving regulatory environment. We report SLT sales trends in the U.S. by analyzing retail market scanner data from 2011 through 2019.MethodsNational SLT sales data were obtained from Nielsen's Convenience Track System for January 2011 to December 2019. UPC codes were used to classify products by attributes including type, parent company, brand, form, and flavor. Market share was calculated as percentage of total unit sales. Detailed product analysis was presented for moist snuff, snus, and tobacco-free nicotine products.ResultsSLT sales increased by 5.8% between 2011 and 2016 but declined by 3.9% from 2016 to 2019. Moist snuff sales increased by 8.1% between 2011 and 2016 and then declined 7.4% from 2016 to 2019 but still accounted for roughly 90% of the overall market annually. Between 2011 and 2019, snus sales consistently increased while sales of chew, dry snuff, and dissolvables decreased. Tobacco-free nicotine products emerged in 2016 and captured 4.0% of the market by 2019. Portion pouch packaging and flavors showed consistent growth although their popularity varied by the type of smokeless product.ConclusionThis study extends our previous work on U.S. SLT market trends through 2019. Overall sales increased between 2011 and 2016 but there were signs of leveling off including declining sales of moist snuff. Newer products continue to gain market share. Continued monitoring of SLT sales is needed, particularly given the new modified risk status of several products.ImplicationsThis study analyzed the last 9 years of smokeless tobacco market data (2011-2019) to describe recent trends in sales. Overall, the smokeless product category is quite resilient although signs suggest downward trends among some product categories and features. New types of smokeless tobacco products (eg, snus and tobacco-free nicotine pouches) account for a growing share of the market.
| S-EPMC8360632 | biostudies-literature
Project description:The extents of generic-reference and generic-generic average bioequivalence and intra-subject variation of on-market drug products have not been prospectively studied on a large scale.We assessed bioequivalence of 42 generic products of 14 immediate-release oral drugs with the highest number of generic products on the Saudi market. We conducted 14 four-sequence, randomized, crossover studies on the reference and three randomly-selected generic products of amlodipine, amoxicillin, atenolol, cephalexin, ciprofloxacin, clarithromycin, diclofenac, ibuprofen, fluconazole, metformin, metronidazole, paracetamol, omeprazole, and ranitidine. Geometric mean ratios of maximum concentration (Cmax) and area-under-the-concentration-time-curve, to last measured concentration (AUCT), extrapolated to infinity (AUCI), or truncated to Cmax time of reference product (AUCReftmax) were calculated using non-compartmental method and their 90% confidence intervals (CI) were compared to the 80.00%-125.00% bioequivalence range. Percentages of individual ratios falling outside the ±25% range were also determined.Mean (SD) age and body-mass-index of 700 healthy volunteers (28-80/study) were 32.2 (6.2) years and 24.4 (3.2) kg/m2, respectively. In 42 generic-reference comparisons, 100% of AUCT and AUCI CIs showed bioequivalence, 9.5% of Cmax CIs barely failed to show bioequivalence, and 66.7% of AUCReftmax CIs failed to show bioequivalence/showed bioinequivalence. Adjusting for 6 comparisons, 2.4% of AUCT and AUCI CIs and 21.4% of Cmax CIs failed to show bioequivalence. In 42 generic-generic comparisons, 2.4% of AUCT, AUCI, and Cmax CIs failed to show bioequivalence, and 66.7% of AUCReftmax CIs failed to show bioequivalence/showed bioinequivalence. Adjusting for 6 comparisons, 2.4% of AUCT and AUCI CIs and 14.3% of Cmax CIs failed to show bioequivalence. Average geometric mean ratio deviation from 100% was ?3.2 and ?5.4 percentage points for AUCI and Cmax, respectively, in both generic-reference and generic-generic comparisons. Individual generic/reference and generic/generic ratios, respectively, were within the ±25% range in >75% of individuals in 79% and 71% of the 14 drugs for AUCT and 36% and 29% for Cmax.On-market generic drug products continue to be reference-bioequivalent and are bioequivalent to each other based on AUCT, AUCI, and Cmax but not AUCReftmax. Average deviation of geometric mean ratios and intra-subject variations are similar between reference-generic and generic-generic comparisons.ClinicalTrials.gov identifier: NCT01344070 (registered April 3, 2011).
| S-EPMC5721559 | biostudies-literature