CLEVIPREX^® (clevidipine)
Health Economics and Value Team

Discover the potential clinical and economic outcomes of using CLEVIPREX

The CLEVIPREX Value Model

Choosing IV antihypertensives depends on clinical context and patient factors. The CLEVIPREX Value Model uses ISPOR methodology to provide valuable information to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health economics analysis, carrying out responsibilities for the selection of drugs for coverage or reimbursement.

CLEVIPREX Value Model goals

Foster an understanding of IV antihypertensive options and patient outcomes, dosing, adverse event rates, and potential cost implications

Quantify costs and health impact from the unique perspective of US institutions, including hospitals, cardiac suites, emergency departments, and integrated delivery networks

Estimate the clinical outcomes and economic impact of using CLEVIPREX over a 1- to 3-year time horizon in relevant patient populations

CLEVIPREX Value Model inputs and outputs*

Content in this section is intended specifically for US population health decision makers supporting multiple acute hypertensive patient types.

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The CLEVIPREX Value Model addresses patients undergoing cardiac surgery and experiencing perioperative hypertension, patients experiencing a neuroemergency with acute hypertension, and patients with acute severe hypertension in the emergency room or critical care setting.

The outputs in this model are subject to assumptions and methodology described within the model and the data the user selects or decides to input in the model. Calculations are based on patients in acute care settings who, per the treating clinician, require an intravenous antihypertensive.

Graphic showing the CLEVIPREX customer values, evidence-based impacts, and other considerations. Customer values include impacts of IV blood pressure management and administration strategies, standardization and impact on quality initiatives, and clinical decisions relative to total cost of care. Evidence-based impacts include BP variability, low-volume dosing, percent of patients reaching BP target, surgery and intubation duration, extubation and ICU costs, polypharmacy, pharmacy budget, and total cost of care. Other considerations include neuro or stroke quality initiatives, stroke guideline committee support, cardiovascular quality initiatives, cardiovascular surgery committee support, and ERAS^® protocol committee support.

^†CLEVIPREX has not been studied or proven to impact fluid overload.

^‡CLEVIPREX is not indicated for the prevention or treatment of stroke.

*In the neuroemergency module and acute hypertension module, CLEVIPREX has not been studied head-to-head with any of the comparators. Further prospective research is warranted.

The CLEVIPREX Value Model is considered health economics and value information. It is important to note that overall economic impact is dependent on specific patient populations, institutional practices, and local cost structures.

BP=blood pressure; CV=cardiovascular; ERAS=Enhanced Recovery After Surgery; ICU=intensive care unit; ISPOR=International Society for Pharmacoeconomics and Outcomes Research; IV=intravenous.

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This information can be provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of the health economics analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement.

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Important Safety Information

CLEVIPREX^® (clevidipine) Injectable Emulsion is contraindicated in patients with:

Allergies to soybeans, soy products, eggs, or egg products;
Defective lipid metabolism seen in conditions such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and
Severe aortic stenosis.

CLEVIPREX^® is intended for intravenous use. Use aseptic technique and discard any unused product within 12 hours of stopper puncture.

Hypotension and reflex tachycardia are potential consequences of rapid upward titration of CLEVIPREX^®. If either occurs, decrease the dose of CLEVIPREX^®. There is limited experience with short-duration therapy with beta-blockers as a treatment for CLEVIPREX^®-induced tachycardia. Beta-blocker use for this purpose is not recommended.

CLEVIPREX^® contains approximately 0.2 g of lipid per mL (2.0 kcal). Lipid intake restrictions may be necessary for patients with significant disorders of lipid metabolism.

Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.

CLEVIPREX^® is not a beta-blocker, does not reduce heart rate, and gives no protection against the effects of abrupt beta-blocker withdrawal. Beta-blockers should be withdrawn only after a gradual reduction in dose.

Patients who receive prolonged CLEVIPREX^® infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped.

There is no information to guide use of CLEVIPREX^® in treating hypertension associated with pheochromocytoma.

Most common adverse reactions for CLEVIPREX^® (>2%) are headache, nausea, and vomiting.

Indication

CLEVIPREX^® (clevidipine) is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure (BP) when oral therapy is not feasible or not desirable.

Please see Full Prescribing Information.

CLEVIPREX® (clevidipine)Health Economics and Value Team