Pharmacy Prior Authorization Criteria

Roszet (rosuvastatin/ezetimibe) - ST, NF

For diagnosis of Non-familial hyperlipidemia
Indicated as an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C).
For diagnosis of Homozygous familial hypercholesterolemia (HoFH)
Indicated alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Step Therapy

Length of Approval: 12 Month(s)

Requested drug is being used for a Food and Drug Administration (FDA)-approved indication

AND

Trial and failure (of a minimum 30 day supply) or intolerance to one of the following generics:

Non Formulary (Initial Authorization)

Length of Approval: 6 Month(s)

Submission of medical records (e.g., chart notes) documenting one of the following diagnoses:

AND

Submission of medical records (e.g., chart notes) documenting history of a trial and failure (of a minimum 30 day supply) or intolerance to two of the following:

AND

Submission of medical records (e.g., chart notes) documenting history of trial and failure (of a minimum 30 day supply) or intolerance to ezetimibe

AND

Physician has provided rationale for needing to use fixed-dose combination therapy with Roszet instead of taking individual products in combination

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)

Submission of medical records (e.g., chart notes) documenting positive clinical response to therapy

2023-06-07, 2022-05-31, 2021-11-01, 2021-09-08, 2021-06-17

Roszet Prescribing Information. Althera Pharmaceuticals LLC. Morristown, NJ. June 2021.
Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2019; 73:e285-e350.
Cuchel M, Bruckert E, Ginsberg HN, et al. Homozygous familial hypercholesterolaemia: new insights and guidance for clinicians to improve detection and clinical management. A position paper from the Consensus Panel on Familial Hypercholesterolaemia of the European Atherosclerosis Society. Eur Heart J. 2014;35:2146-57.

2023-06-07: Annual Review - Update to t/f verbiage to remove "contraindication"
2022-05-31: Annual Review - Diagnosis verification added to ST section
2021-11-01: Added ABA as target
2021-09-08: Retired PA program. Added new ST program.
2021-06-17: New Program