Cochrane Database of Systematic Reviews

2017

DOI: 10.1002/14651858.cd009868.pub3

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Fixed-dose combination therapy for the prevention of atherosclerotic cardiovascular diseases

Ehete Bahiru¹,

Angharad N de Cates

²

,

Matthew R. B. Farr

³

et al.

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Therapy-related Factors1

Expected Benefits Of Polypills In Lmics1

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Cited by 65 publications

(88 citation statements)

References 163 publications

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“…21 A 2017 Cochrane review concluded that the benefits of combination products on mortality or cardiovascular events were uncertain. 22 In contrast, the larger co-payments that are often seen with more expensive products have been demonstrated to reduce adherence and worsen clinical outcomes. 23,24 A substantial potential reduction in spending would have been associated with the 6 combination products for which inclass generic therapeutic substitution was possible.…”

Section: Discussionmentioning

confidence: 99%

Medicare Spending on Brand-name Combination Medications vs Their Generic Constituents

¹

,

²

,

³

et al. 2018

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IMPORTANCE Brand-name combination drugs can be more expensive than the sum of their components, especially when the constituent products are available as generic medications. The potential savings that could be achieved using generic components is not known.OBJECTIVE To estimate the additional cost to Medicare of prescribing brand-name combination medications instead of generic constituents. DESIGN, SETTING, AND PARTICIPANTSRetrospective analysis for 2011 through 2016 using the Medicare data set of Part D beneficiaries prescribed any of the 1500 medications that accounted for the highest total spending in 2015. Brand-name combination drugs that had identical or therapeutically equivalent generic constituents were included.EXPOSURES Brand-name, oral combination medications with constituents available either as generic drugs or therapeutically equivalent generic substitutes. MAIN OUTCOMES AND MEASURESThe estimated difference between the amount spent by Medicare on brand-name combination drugs and the estimated amount that would have been spent on substitutable generic components.RESULTS Among the 1500 medications evaluated, 29 brand-name combination medications were separated into 3 mutually exclusive categories: constituents available as generic medications at identical doses (n = 20), generic constituents at different doses (n = 3), and therapeutically equivalent generic substitutes (n = 6). For the constituents available as generic medications at identical doses category, total spending by Medicare in 2016 on the brand-name combination products was $303 million and the estimated spending for the generic constituents would have been $68 million, which is an estimated difference of $235 million. For the generic constituents at different doses category, total spending by Medicare in 2016 on the brand-name combination products was $232 million and the estimated spending for the generic constituents would have been $13 million, which is an estimated difference of $219 million. For the therapeutically equivalent generic substitutes category, total spending by Medicare in 2016 on the brand-name combination products was $491 million and the estimated spending for the generic constituents would have been $20 million, which is an estimated difference of $471 million. In 2016, the estimated spending for the generic constituents for these 29 drugs would have been $925 million less than the estimated spending for the brand-name combinations. For the 10 most costly combination products available during the entire study period, the listed Medicare spending could have been an estimated $2.7 billion lower between 2011 and 2016 if the generic constituents had been prescribed. CONCLUSIONS AND RELEVANCEIn 2016, the difference between the amount that the Medicare drug benefit program reported spending on brand-name combination medications and the estimated spending for generic constituents for the same number of doses was $925 million. Promoting generic substitution and therapeutic interchange through prescriber education and more ...

“…21 A 2017 Cochrane review concluded that the benefits of combination products on mortality or cardiovascular events were uncertain. 22 In contrast, the larger co-payments that are often seen with more expensive products have been demonstrated to reduce adherence and worsen clinical outcomes. 23,24 A substantial potential reduction in spending would have been associated with the 6 combination products for which inclass generic therapeutic substitution was possible.…”

Section: Discussionmentioning

confidence: 99%

Medicare Spending on Brand-name Combination Medications vs Their Generic Constituents

¹

,

²

,

³

et al. 2018

View full text Add to dashboard Cite

IMPORTANCE Brand-name combination drugs can be more expensive than the sum of their components, especially when the constituent products are available as generic medications. The potential savings that could be achieved using generic components is not known.OBJECTIVE To estimate the additional cost to Medicare of prescribing brand-name combination medications instead of generic constituents. DESIGN, SETTING, AND PARTICIPANTSRetrospective analysis for 2011 through 2016 using the Medicare data set of Part D beneficiaries prescribed any of the 1500 medications that accounted for the highest total spending in 2015. Brand-name combination drugs that had identical or therapeutically equivalent generic constituents were included.EXPOSURES Brand-name, oral combination medications with constituents available either as generic drugs or therapeutically equivalent generic substitutes. MAIN OUTCOMES AND MEASURESThe estimated difference between the amount spent by Medicare on brand-name combination drugs and the estimated amount that would have been spent on substitutable generic components.RESULTS Among the 1500 medications evaluated, 29 brand-name combination medications were separated into 3 mutually exclusive categories: constituents available as generic medications at identical doses (n = 20), generic constituents at different doses (n = 3), and therapeutically equivalent generic substitutes (n = 6). For the constituents available as generic medications at identical doses category, total spending by Medicare in 2016 on the brand-name combination products was $303 million and the estimated spending for the generic constituents would have been $68 million, which is an estimated difference of $235 million. For the generic constituents at different doses category, total spending by Medicare in 2016 on the brand-name combination products was $232 million and the estimated spending for the generic constituents would have been $13 million, which is an estimated difference of $219 million. For the therapeutically equivalent generic substitutes category, total spending by Medicare in 2016 on the brand-name combination products was $491 million and the estimated spending for the generic constituents would have been $20 million, which is an estimated difference of $471 million. In 2016, the estimated spending for the generic constituents for these 29 drugs would have been $925 million less than the estimated spending for the brand-name combinations. For the 10 most costly combination products available during the entire study period, the listed Medicare spending could have been an estimated $2.7 billion lower between 2011 and 2016 if the generic constituents had been prescribed. CONCLUSIONS AND RELEVANCEIn 2016, the difference between the amount that the Medicare drug benefit program reported spending on brand-name combination medications and the estimated spending for generic constituents for the same number of doses was $925 million. Promoting generic substitution and therapeutic interchange through prescriber education and more ...

“…The data for the polypill’s efficacy in promoting adherence are mostly related to primary prevention of CAD. A recent Cochrane analysis concluded that while there is clear improvement in self-reported adherence with the polypill, evidence of benefit in terms of hard outcomes has thus far been elusive [66]. For example, a 2015 study of the polypill in primary prevention found a greater percentage of patients in the polypill arm of the study reported adherence with combination primary prevention therapy; however, no differences in blood pressure or cholesterol were observed between the groups [67].…”

Section: Therapy-related Factorsmentioning

confidence: 99%

Recent Approaches to Improve Medication Adherence in Patients with Coronary Heart Disease: Progress Towards a Learning Healthcare System

Levy¹,

²

,

³

et al. 2018

Curr Atheroscler Rep

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Purpose of Review Non-adherence to medications for the secondary prevention of myocardial infarction (MI) is a major contributor to morbidity and mortality in these patients. This review describes recent advances in promoting adherence to therapies for coronary artery disease (CAD). Recent Findings Two large randomized controlled trials to “incentivize” adherence were somewhat disappointing; neither financial incentives nor “peer pressure” successfully increased rates of adherence in the post-MI population. Patient education and provider engagement appear to be critical aspects of improving adherence to CAD therapies, where the provider is a physician, pharmacist, or nurse and follow-up is performed in person or by telephone. Fixed-dose combinations of CAD medications, formulated as a so-called “polypill,” have shown some early efficacy in increasing adherence. Technological advances that automate monitoring and/or encouragement of adherence are promising but seem universally dependent on patient engagement. For example, medication reminders via text message perform better if patients are required to respond. Multifaceted interventions, in which these and other interventions are combined together, appear to be most effective. Summary There are several available types of proven interventions through which providers, and the health system at large, can advance patient adherence to CAD therapies. No single intervention to promote adherence will be successful in all patients. Further study of multifaceted interventions and the interactions between different interventions will be important to advancing the field. The goal is a learning healthcare system in which a network of interventions responds and adapts to patients’ needs over time.

“…The current literature is clear about the fact that polypills increase adherence to medication . Nonadherence to medication has been shown to be more prevalent in LMICs.…”

Section: Expected Benefits Of Polypills In Lmicsmentioning

confidence: 99%

“…Polypills are generally made of a fixed combination of one or two antihypertensive agents, a lipid‐lowering medicine and sometimes an antiplatelet drug. Several studies have demonstrated that cardiovascular polypills may simplify treatment algorithms, improve patients’ adherence, increase accessibility, and reduce cardiovascular events and associated costs as compared with usual care . However, cardiovascular polypills have not gained much popularity when compared with fixed‐dose combinations for other diseases such as HIV, tuberculosis, and malaria.…”

Section: Introductionmentioning

confidence: 99%

Fixed‐dose combination therapy to reduce the growing burden of cardiovascular disease in low‐ and middle‐income countries: feasibility and challenges

¹

,

²

,

Kamtchum‐Tatuene

³

et al. 2018

J of Clinical Hypertension

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Cardiovascular disease (CVD) has become a major concern in low-and middle-income countries, which bear about 80% of the cardiovascular mortality worldwide. Curbing the burden of CVD implies the management and control of many cardiovascular risk factors that act synergistically to increase cardiovascular mortality. Such actions may require expensive polymedications in a context of limited resources. Therefore, alternative solutions for CVD prevention in low-and middle-income countries are urgently needed. In this context, the concept of a fixed-dose combination therapy, a polypill composed of drugs known to effectively treat or prevent CVD, has been proposed as a scalable strategy to overcome nonadherence to polymedications and reduce costs.While this has recently been approved in more than 30 countries across America and Europe, there is a crucial need to analyze the potential benefits and challenges related to cardiovascular polypills implementation and vulgarization in low-and middle-income countries, the epicenter of CVD.

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