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Published on: November 10, 2017
Clinical Considerations for Healthcare Provider-Administered Lipid-Lowering Medications
Barry D Bertolet1, Katherine P Cabral2,3, Lance Sullenberger3
1Cardiology Associates of North Mississippi, 499 Gloster Creek Village, Suite A-2, Tupelo, MS, USA. bbert@nmhs.net.
Insights
Healthcare provider-administered therapies like inclisiran can improve adherence for atherosclerotic cardiovascular disease (ASCVD) patients. The buy-and-bill model offers potential benefits for managing LDL-C goals and cardiovascular outcomes.
Area of Science:
- Cardiology
- Pharmacology
- Health Economics
Background:
- Atherosclerotic cardiovascular disease (ASCVD) poses a significant global health burden.
- Achieving low-density lipoprotein cholesterol (LDL-C) goals is critical for ASCVD management, yet many patients do not attain target levels.
- Suboptimal adherence and utilization of lipid-lowering therapies (LLTs) contribute to poor outcomes, influenced by factors like polypharmacy, side effects, and access.
Purpose of the Study:
- To explore the implications of the buy-and-bill reimbursement model for healthcare provider-administered lipid-lowering therapies in cardiology.
- To provide a practical guide for implementing novel, in-office administered specialty drugs within US clinical practice.
- To assess how in-office administration may enhance patient monitoring, adherence, and cardiovascular outcomes.
Main Methods:
- Discussion of the buy-and-bill process for medical benefit drugs in the US.
- Analysis of inclisiran as a novel, twice-yearly, in-office administered LLT.
- Consideration of infrastructure and process changes for cardiology practices.
Main Results:
- In-office administration of LLTs, such as inclisiran, allows for greater healthcare provider control over drug acquisition, administration, and reimbursement.
- The buy-and-bill model, established in other specialties, can facilitate timely care and potentially improve patient adherence.
- Implementation requires adaptation but may lead to improved cardiovascular outcomes for ASCVD patients.
Conclusions:
- The buy-and-bill model presents an opportunity to optimize LLT delivery and adherence in ASCVD management.
- HCP-administered specialty drugs can enhance patient monitoring and timely treatment initiation.
- Adoption of this model in cardiology may improve the attainment of LDL-C goals and reduce the burden of ASCVD.
Abstract:
Atherosclerotic cardiovascular disease (ASCVD), a leading cause of mortality and morbidity, is associated with a substantial healthcare and economic burden. Reduction of low-density lipoprotein cholesterol (LDL-C) to guideline-recommended goals is crucial in the prevention or management of ASCVD, particularly in those at high risk. Despite the availability of several effective lipid-lowering therapies (LLTs), up to 80% of patients with ASCVD do not reach evidence-based LDL-C goals. This nonattainment may be due to poor adherence to, and lack of timely utilization of, LLTs driven by a range of variables, including polypharmacy, side effects, clinical inertia, costs, and access issues. Inclisiran was approved by the US Food and Drug Administration in 2021 as a novel, twice-yearly, healthcare provider (HCP)-administered LLT. In-office administration allows HCPs more control of drug acquisition, administration, and reimbursement, and may allow for more timely care and increased patient monitoring. In the USA, in-office administered drugs are considered a Medical Benefit and can be acquired and reimbursed using the "buy-and-bill" process. Buy-and-bill is a standard system for medication administration already established in multiple therapeutic areas, including oncology, vaccines, and allergy/immunology. Initiating in-office administration will involve new considerations for clinicians in the cardiovascular specialty, such as the implementation of new infrastructure and processes; however, it could ultimately increase treatment adherence and improve cardiovascular outcomes for patients with ASCVD. This article discusses the potential implications of buy-and-bill for the cardiology specialty and provides a practical guide to implementing HCP-administered specialty drugs in US clinical practice.
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