This sample is provided for your guidance only. Visit PRALUENT.com to download a copy.
This letter shows the types of information that may be provided when responding to a request from a patient’s insurance company for a
letter of medical necessity for treatment with PRALUENT® (alirocumab) injection. Please see full Prescribing Information available at
www.PRALUENT.com.
Sample Letter of Medical Necessity for PRALUENT
[Date]
ATTN: Medical Review
[Contact name]
[Insurance company]
[Insurance street address]
[Insurance city, state, ZIP]
Re:
[Patient name]
[Date of birth]
[Policy #]
[Group #]
Dear [Contact name]:
I am writing on behalf of [patient name] to document the medical necessity for administering PRALUENT for the treatment of [diagnosis].
This letter provides the clinical history, treatment rationale, and other documents that support the use of PRALUENT for this patient.
Clinical History
Patient name is a [age]-year-old [female/male]. The patient was initially diagnosed with [diagnosis] by [name of referring physician], and
has been in my care since [date]. The diagnosis of [diagnosis] for this patient was based upon [provide details regarding the patient’s
diagnostic workup and history]. Currently the patient [discuss the patient’s current condition (e.g, signs, symptoms, functioning)].
Prior Therapies
[Include other therapies used for the same diagnosis, dosages, and reason for discontinuation.]
Product Description
PRALUENT (alirocumab) is a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) inhibitor antibody indicated as adjunct to diet and
maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic
cardiovascular disease, who require additional lowering of LDL-C.1
The effect of PRALUENT on cardiovascular morbidity and mortality has not been determined.1
Rationale for Initiating PRALUENT
[Highlight factors that led you to recommend the use of PRALUENT, which may include pretreatment LDL level and current LDL level.]
In summary, PRALUENT is medically necessary for [Patient name]. Please contact me at [physician’s telephone number] or
[physician’s email] if additional information is required for approval of this request. Thank you for your immediate attention to this
very important matter.
Sincerely,
[Physician name, MD]
Enclosures [suggested]
PRALUENT FDA approval letter
PRALUENT Prescribing Information
Excerpts of medical records
Use of the information in this letter does not guarantee that the insurance company will provide coverage for PRALUENT and is not
intended to be a substitute for, or an influence on, the independent medical judgment of the physician.
Reference: 1. PRALUENT Prescribing Information. Sanofi/Regeneron Pharmaceuticals, 2015.
©2015, Sanofi and Regeneron Pharmaceuticals, Inc. 07/2015
US.ALI.15.07.092 PRA-0105