CurrentHawaii Medical Service Association (HMSA)Policy N/A

PCSK9 inhibitor prior authorization for Praluent (alirocumab)

Prior authorization form and criteria for coverage of PCSK9 inhibitor therapy (Praluent) for members whose prescription benefit is administered by CVS Caremark for HMSA; intended for prescribers to document indication, prior therapies, and supporting information required for PA determination.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyPCSK9 inhibitor prior authorization for Praluent (alirocumab)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed prior authorization form and supporting documentation to CVS Caremark Specialty Programs by fax to 1-866-237-5512.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1prior authorization form (single document)

3primary diagnostic categories listed

>=3mminimum statin therapy duration referenced

Faxsubmission method / specialty fax

Coverage Criteria

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyPCSK9 inhibitor prior authorization for Praluent (alirocumab)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed prior authorization form and supporting documentation to CVS Caremark Specialty Programs by fax to 1-866-237-5512.

SourceLink

On This Page

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Indication: Patient has one of: prevention of cardiovascular events, primary hyperlipidemia including heterozygous familial hypercholesterolemia (HeFH), or homozygous familial hypercholesterolemia (HoFH).

Document ICD-10 and check appropriate diagnosis box on the form.

Preferred product / step therapy: If the plan's preferred product is Repatha (evolocumab), determine whether the patient's treatment can be switched to Repatha. If not, document a prior inadequate response or intolerable adverse event to Repatha and attach supporting chart notes.

If Yes to switching, obtain and submit the PA for the preferred product per form instructions.

Prior lipid-lowering therapy and baseline LDL-C: Provide current LDL-C level and indicate diagnosis category (ASCVD, HeFH, HoFH). For HeFH/HoFH report untreated (pre-therapy) LDL-C where requested. Document current use of high-intensity statin therapy (e.g., rosuvastatin 20 mg or atorvastatin 40 mg) and duration.>= 3 months for high-intensity statin where required

If on high-intensity statin plus ezetimibe, document combination and duration; if not on high-intensity statin, complete statin intolerance evaluation per form.

Statin intolerance or contraindication: Statin intolerance may be documented by meeting any of the following: SAMS-CI score >=7; statin-associated CK elevation >= 10x ULN during prior statin therapy; or contraindication to statins (active liver disease, pregnancy/planning pregnancy, or nursing).SAMS-CI >=7; CK >=10x ULN

If one of these is documented, some statin requirements may be waived per the form.

Requests for use of the product for indications other than those listed on the prior authorization form — prevention of cardiovascular events, primary hyperlipidemia (including heterozygous familial hypercholesterolemia), or homozygous familial hypercholesterolemia — are outside the scope of this form and require separate justification. If the answer to the indication question on the form is No, the form instructs the provider to skip to the criteria questions, and additional documentation or a different authorization pathway will be necessary.

Coding and Clinical Thresholds

High-intensity statin therapy duration

Minimum durationHigh-intensity statin therapy: at least 3 months

Example high-intensity dosesRosuvastatin 20 mg daily; Atorvastatin 40 mg daily

Combination with ezetimibeIf used, high-intensity dose plus ezetimibe should be for at least 3 months

Statin-associated CK elevation threshold

CK elevation threshold>= 10 times upper limit of normal (ULN)

Clinical implicationIf CK >=10x ULN during prior statin, statin requirements may be waived (no further questions)

Assessment contextDocumented statin-associated CK increase is captured on the PA form (yes/no)

Initial Therapy

Initial therapy requests must document baseline LDL-C and prior statin therapy.

Baseline LDL-C and diagnosis: Provide ICD-10 code and current LDL-C level; indicate diagnosis category (ASCVD, HeFH, HoFH). For HeFH/HoFH include untreated (pre-therapy) LDL-C when requested.

Complete the diagnosis and LDL-C fields on the PA form.

Statin therapy requirement: Patient is receiving a high-intensity statin daily (examples: rosuvastatin 20 mg or atorvastatin 40 mg) for at least 3 months, with or without ezetimibe; OR documents statin intolerance per form criteria.>= 3 months

If not on high-intensity statin, the form guides evaluation of intolerance and history of moderate-intensity statin with duration and ezetimibe use.

Continuation Therapy

Continuation requests require documentation of maintained benefit.

Continuation of PCSK9 inhibitor: For continuation, provider must indicate whether the patient achieved or maintained LDL-C reduction (for example, LDL-C at goal or robust LDL-C reduction) as a result of PCSK9 inhibitor therapy.

If Yes, no further questions per the form; document current LDL-C and response on the PA form.

Step Therapy / Preferred Product

Step	Requirement / Provider action	Supporting documentation
If the plan's preferred product is Repatha	Provider must indicate on the form whether the patient's treatment can be switched to Repatha. If Yes, obtain and submit the PA form for the preferred product (Repatha).	N/A
When patient cannot be switched to Repatha	Provider must select 'No' and document that the patient has had a documented inadequate response or intolerable adverse event to Repatha and that the provider does not expect the same event to occur with the requested drug.	Attach supporting chart note(s) documenting inadequate response or intolerable adverse event to Repatha.

Provider Actions and Submission Instructions

Prior Authorization

Prior Authorization Submission

Send the completed prior authorization form and ALL supporting documentation to CVS Caremark Specialty Programs by fax: 1-866-237-5512. Include the correct ICD-10 diagnosis code and current LDL-C levels on the form. Failure to submit a completed form with required supporting documentation may result in denial or processing delays.

Fax: 1-866-237-5512
Include ICD-10 code on form
Include current LDL-C level(s)

Step Therapy

Plan Preference / Step Therapy

HMSA’s preferred product is Repatha. If the patient’s treatment can be switched to the preferred product, obtain and submit the prior authorization form for Repatha rather than for the requested non-preferred product.

Preferred product: Repatha
If switchable: submit PA for Repatha

Documentation Required

Supporting Documentation for Preferred Product Failure/Intolerance

If the request is for a non-preferred product because Repatha failed or caused intolerance, attach supporting chart notes documenting the inadequate response or intolerable adverse event. Chart documentation should show the specific adverse event or objective evidence of inadequate LDL-C lowering on Repatha and state why the provider does not expect the same event to occur with the requested drug.

Attach chart notes documenting Repatha failure or intolerance
Document objective LDL-C response and adverse events
Explain why the same event is not expected with requested drug

Documentation Required

Required Form Fields and Attestation

Ensure the prescriber (or authorized signer) signs and dates the form and includes the prescriber name, specialty, NPI, office phone and fax. By signing, the prescriber attests that the information is accurate and that supporting documentation is available for review if requested by CVS Caremark or the plan sponsor.

Prescriber signature and date required (attestation)
Include prescriber name, specialty, NPI, office phone and fax
Attestation: documentation available upon request

Site of Care

Note

Select site of care (dispense and administration) on the form

Indicate on the form where the drug will be dispensed and where it will be administered by selecting from the provided options (Office, Pharmacy, Home, Outpatient Hospital, Inpatient Hospital, Infusion Center, etc.).

Dispensed location options include: Office, Pharmacy, Other facility options listed on form.
Administration location options include: Home, Office, Outpatient Hospital, Inpatient Hospital, Pharmacy, Ambulatory surgical, etc.

Definitions

ASCVD — clinical examples

ASCVD definition (term)Clinical atherosclerotic cardiovascular disease (ASCVD)

ExamplesAcute coronary syndrome; Myocardial infarction; Stable or unstable angina; Coronary or other arterial revascularization (e.g., PTCA, CABG)

Additional examplesStroke of presumed atherosclerotic origin; Transient ischemic attack (TIA); Non-cardiac peripheral arterial disease of presumed atherosclerotic origin (e.g., carotid artery stenosis, lower extremity PAD)

HeFH / HoFH definitions

HeFHHeterozygous familial hypercholesterolemia (HeFH)

HoFHHomozygous familial hypercholesterolemia (HoFH)

Form requirementIndicate diagnosis category on PA form (check HeFH or HoFH and provide untreated LDL‑C for HeFH/HoFH when requested)

Background

The prior authorization form is designed to support authorization of PCSK9 inhibitor therapy by collecting the indication, prior lipid‑lowering therapy and response, and documentation needed for a coverage determination. It asks the prescriber to confirm the diagnostic category (e.g., ASCVD, HeFH, HoFH), indicate whether the plan’s preferred product is Repatha and whether the patient can be switched, and to report any documented inadequate response or intolerable adverse event to the preferred product — with an explicit instruction to attach supporting chart note(s) if such failure or intolerance is asserted.