Comparing Adoption of Breakthrough and “Me-too” Drugs Among Medicare Beneficiaries: a Case Study of Dipeptidyl Peptidase-4 Inhibitors

Hernandez, Inmaculada; Zhang, Yuting

doi:10.1007/s12247-017-9277-x

Cited by 5 publications

(6 citation statements)

References 12 publications

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“…This is a conservative estimation since drug adoption often takes two to three years, and thus it is likely that utilization trends would have continued to increase. 11 We calculated the difference between actual varenicline use through 2016, when the warnings were lifted. Finally, we estimated lives lost due to lost smoking cessation opportunities over the eight years of varenicline warnings.…”

Section: Methodsmentioning

confidence: 99%

Varenicline and Nicotine Replacement Use Associated With US Food and Drug Administration Drug Safety Communications

et al. 2019

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Importance Drug safety communications released by the Food and Drug Administration (FDA) are often based on limited evidence on safety signals post-approval. Varenicline constitutes an interesting case study, because it was the target of several FDA communications in 2008 and 2009; ultimately the EAGLES trial dismissed safety concerns on increased suicidal thoughts and aggressive and erratic behavior in 2016. Objective To examine the association between FDA drug safety communications and the utilization of varenicline. Design/ Setting/ Participants/ Exposures Retrospective longitudinal study of 2002–2018 VHA outpatient data and 2006–2018 Medicaid drug state utilization data. Main Outcomes/Measures We extracted prescribing records for varenicline and nicotine replacement therapy (NRT) in VHA and measured the number of unique varenicline and NRT users in VHA per quarter. We implemented an interrupted time-series analysis to describe the association between FDA safety warnings and the utilization of varenicline and of NRT. To test the generalizability of our findings, we duplicated similar analyses using the number of prescriptions reimbursed for varenicline by Medicaid every quarter in 2006–2018. Results After its addition to VHA national drug formulary in January 2007, varenicline presented a rapid uptake growing from 70 to over 50,000 prescriptions by the end of the year. Within 12 months of the 2008 public health advisory, quarterly varenicline utilization decreased by 68.7% from 32,581 to 10,182 patients (p-value for trend change<0.001), while NRT utilization increased by 32.1%, from 55,728 to 73,629 patients (p-value for trend change<0.001). In Medicaid, varenicline utilization decreased by 38.0% from 109,308 to 67,761 prescriptions within 12 months of the 2008 public health advisory (p-value for trend change<0.001). Twelve months after the publication of the EAGLES trial, which showed no significant increase in psychiatric/behavioral effects with varenicline relative to nicotine replacement therapy (NRT), utilization increased by 42.7% in VHA patients (p-value for trend change=0.01), and by 26.0% in Medicaid (p-value for trend change=0.26). Conclusions and Relevance Using varenicline as a case study, we found that early communications from the FDA and VHA followed by a labelling change was associated with a considerable decrease in drug utilization, which may have been associated with negative public health consequences.

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Section: Methodsmentioning

confidence: 99%

Varenicline and Nicotine Replacement Use Associated With US Food and Drug Administration Drug Safety Communications

et al. 2019

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“…We used this definition because previous literature has estimated that adoption of new drugs takes two to three years, on average. 5,6 To identify specialty medications, we used a list of specialty medications obtained from a national pharmacy benefit manager, 7 as the Department of Human and Health Services previously used such a list to study pharmaceutical pricing. 8 All drug products were identified at the National Drug Code level.…”

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confidence: 99%

The Contribution Of New Product Entry Versus Existing Product Inflation In The Rising Costs Of Drugs

et al. 2019

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It is unknown to what extent rising drug costs are due to inflation in the prices of existing drugs versus the entry of new products. We used pricing data from First Databank and pharmacy claims from UPMC Health Plan to quantify the contribution of new versus existing drugs to the changes in costs of oral and injectable drugs used in the outpatient setting in 2008-16. The costs of oral and injectable brand-name drugs increased annually by 9.2 percent and 15.1 percent, respectively, largely driven by existing drugs. For oral and injectable specialty drugs, costs increased 20.6 percent and 12.5 percent, respectively, with 71.1 percent and 52.4 percent of these increases attributable to new drugs. Costs of oral and injectable generics increased by 4.4 percent and 7.3 percent, respectively, driven by new drug entry. The rising costs of generic and specialty drugs were mostly driven by new product entry, whereas the rising costs of brand-name drugs were due to existing drug price inflation. R ising drug costs are a pressing concern for the US health care system. Annual increases in drug costs have consistently exceeded general inflation in the past ten years. 1 Drug prices increased annually by nearly 10 percent in the period 2013-15-over six times the rate of general inflation. 1,2 Several studies have evaluated cost increases for different drug classes, finding that specialty drugs experienced the largest inflation, followed by brand-name drugs. 1,3,4 However, these studies examined inflation only within existing pharmaceuticals-that is, for each time period they estimated the average change in prices for drugs that were already in the market at the beginning of the period. 1,3,4 Although this approach is appropriate for estimating inflation, it does not address a broader question: To what extent are rising drug costs due to inflation in the prices of existing products versus the market entry of new, more expensive drug products? Answering this question is critical in the development of policies to improve the affordability of medications in the US. In this study we used pricing data from First Databank and pharmacy claims from UPMC Health Plan for the period 2005-16 to quantify the contribution of new versus existing drug products in the rising costs of prescription drugs used in the outpatient setting in the US.

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“…So far, the effect of withdrawal and prescription restrictions have been studied, but the effect of the inclusion of a higher-cost me-too drug remains unexplored, me-too drugs being defined as new pharmaceuticals with the same mechanism of action of an existing drug and are considered less innovative than breakthrough drugs. 14 Traditionally, HDFs have been built up on the basis of medicines effectiveness and costs at a hospital level, without taking into account the repercussions that they may have on primary care. 15,16 This is especially delicate in cases where drug companies make large discounts in order to introduce their medications into HDFs, while at the same time maintaining high costs at an out-of-hospital level.…”

Section: Introductionmentioning

confidence: 99%

“…Other contextual factors such as the commercialization of new drugs or the expiration of patents could also play an important role. So far, the effect of withdrawal and prescription restrictions have been studied, but the effect of the inclusion of a higher‐cost me‐too drug remains unexplored, me‐too drugs being defined as new pharmaceuticals with the same mechanism of action of an existing drug and are considered less innovative than breakthrough drugs 14 …”

Section: Introductionmentioning

confidence: 99%

Impact on In‐ and Out‐of‐Hospital Drug Prescriptions of Including a More Expensive Me‐Too Antidepressant in a Hospital Drug Formulary: a Controlled Longitudinal Study

Carracedo-Martínez

Vázquez-Mourelle

Figueiras

et al. 2022

Pharmacoepidemiology and Drug

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Background: The effect of the inclusion of a more expensive me-too medicine in a hospital drug formulary (HDF) on both in-and out-of-hospital utilization, and the contextual factors which influence this type of induction is rarely studied. Accordingly, this work aimed to quantify the effect of the decision of a hospital of including a more expensive me-too antidepressant in its HDF.Methods: A controlled longitudinal study was carried out in a Regional Health Service of Spain. We performed a segmented regression analysis with control group. We used the following dependent variables: defined daily doses (DDD) per 1000 inhabitants per day, DDD per 100 bed days, and cost per DDD.Results: At a hospital level, the modification in the formulary led to utilization changes: (1) an increase in immediate consumption of the newly included me-too drug; and, (2) an annual 25.96% [95% CI: 2.96%-48.95%] decrease in the adjusted trend of the already existing parent antidepressant. The adjusted trend of the cost per DDD of the sum of all medications in the therapeutic group increased by 20.03% annually [95% CI: 3.24%-36.82%]. In the out-of-hospital setting utilization changes were: (1) the adjusted trend of the newly included me-too drug rose by 12.14% annually [95% CI: 4.97%-19.30%]; and, (2) that of the parent drug underwent a negative change in trend of 4.18% annually [95% CI: 0.00%-8.36%]. Conclusions:The inclusion of a more expensive me-too drug in the HDF led to increased consumption of this more expensive me-too drug both in-and out-ofhospital.

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Comparing Adoption of Breakthrough and “Me-too” Drugs Among Medicare Beneficiaries: a Case Study of Dipeptidyl Peptidase-4 Inhibitors

Cited by 5 publications

References 12 publications

Varenicline and Nicotine Replacement Use Associated With US Food and Drug Administration Drug Safety Communications

Varenicline and Nicotine Replacement Use Associated With US Food and Drug Administration Drug Safety Communications

The Contribution Of New Product Entry Versus Existing Product Inflation In The Rising Costs Of Drugs

Impact on In‐ and Out‐of‐Hospital Drug Prescriptions of Including a More Expensive Me‐Too Antidepressant in a Hospital Drug Formulary: a Controlled Longitudinal Study

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