CurrentColorado Rocky Mountain Health PlansPolicy N/A

PCSK9 inhibitors prior authorization (Praluent, Repatha)

Form-based prior authorization questions and documentation requirements for prescribing PCSK9 inhibitors (Praluent and Repatha) for Colorado Rocky Mountain Health Plans members; affects prescribers requesting PA.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPCSK9 inhibitors prior authorization (Praluent, Repatha)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionAttach LDL lab results before and after statin treatment and documentation of 90 days of high‑dose atorvastatin or rosuvastatin (or documented significant statin intolerance) when submitting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20+form items

>70LDL eligibility

>190Severe hyperlipidemia LDL

≥18/≥10Age criteria (Praluent/Repatha)

90 daysRequired prior statin duration

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPCSK9 inhibitors prior authorization (Praluent, Repatha)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Initial Authorization Criteria

Covered when ALL of the following are met:

General prerequisites: Beneficiary has completed 90 days of maximal-dose atorvastatin or rosuvastatin for age OR has documented clinically significant statin intolerance; LDL laboratory results before and after statin therapy are attached; LDL after statin therapy is > 70 mg/dL; Provider indicates whether high‑dose atorvastatin or rosuvastatin will be continued with the PCSK9 inhibitor.See thresholds: 90 days; LDL > 70 mg/dL

Derived from general PSCK9 clinical questions (items 1–7).

Agent-specific diagnosis and age: Praluent: beneficiary age ≥ 18 AND diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH) OR clinical atherosclerotic cardiovascular disease OR Severe Primary Hyperlipidemia (LDL‑C > 190 mg/dL). Repatha: beneficiary age ≥ 10 AND diagnosis of HeFH OR Homozygous Familial Hypercholesterolemia (HoFH) OR clinical atherosclerotic cardiovascular disease OR Severe Primary Hyperlipidemia (LDL‑C > 190 mg/dL).Age and LDL thresholds apply (Praluent ≥18; Repatha ≥10; Severe Primary Hyperlipidemia LDL‑C >190 mg/dL)

From agent-specific clinical questions (Praluent items 8–12; Repatha items 13–17).

Continuation Therapy

Continuation criteria (Praluent and Repatha):

Continuation prerequisites: Provider must submit documentation indicating a positive clinical response to therapy; confirm whether the beneficiary is continuing other lipid‑lowering therapy; and confirm the beneficiary is not receiving more than one PCSK9 inhibitor.Positive response documented

See continuation questions 18–20 on the form.

For the purposes of prior authorization for PCSK9 inhibitors, statin intolerance that is limited to fatigue, cognitive impairment, or mild aches is not considered clinically significant. Clinically significant statin intolerance must be more severe (for example, severe muscle pain, significant liver abnormalities, or rhabdomyolysis) and documentation of such intolerance should be attached to the prior authorization request.

Key Numeric and Administrative Thresholds

Required duration of statin therapy — 90 days

Required durationBeneficiary must have completed 90 days of treatment with maximal-dose atorvastatin or rosuvastatin (for age)

ContextQuestion 1 on the form confirms 90 days of statin therapy is required

DocumentationDocumentation of 90 days of therapy may be required for prior authorization

LDL threshold after statin for PCSK9 consideration — > 70 mg/dL

LDL threshold after statin> 70 mg/dL (LDL >70 mg/dL required after at least 90 days of atorvastatin or rosuvastatin)

Form locationQuestion 2 asks whether LDL is >70 mg/dL after statin therapy

Evidence neededAttach LDL lab results before and after statin treatment

LDL threshold for Severe Primary Hyperlipidemia — > 190 mg/dL

Severe Primary Hyperlipidemia definitionLDL-C > 190 mg/dL

Form questionsPraluent (Q12) and Repatha (Q17) ask whether beneficiary has Severe Primary Hyperlipidemia defined as LDL-C >190 mg/dL

ImplicationMeets agent-specific diagnosis criterion when LDL-C >190 mg/dL

Praluent age criterion — ≥ 18 years

Age requirementPraluent is for beneficiaries aged ≥ 18 years

Form locationQuestion 8 asks if beneficiary is 18 years of age or older

Agent-specificAge ≥18 is required in addition to diagnosis criteria for Praluent

Repatha age criterion — ≥ 10 years

Age requirementRepatha is for beneficiaries aged ≥ 10 years

Form locationQuestion 15 asks if beneficiary is 10 years or older

Agent-specificAge ≥10 is required in addition to diagnosis criteria for Repatha

Prior Authorization & Documentation Requirements

Prior Authorization

Administrative request data

Prior authorization requests must include full administrative request data. Provide beneficiary name, ID number, date of birth, gender, prescriber NPI, prescriber fax, requester contact name, phone and extension, drug name, strength, quantity per 30 days, and requested length of therapy. Include the prescriber signature and date on the request form.

Beneficiary name, ID #, DOB, gender
Prescribing provider NPI and provider fax number
Requester contact name, phone, and extension
Drug name, strength, quantity per 30 days, and length of therapy requested
Prescriber signature and date

Denial Risk

Missing required documentation

Requests missing required documentation will be at risk for denial. Ensure LDL lab results (baseline before statin and after statin treatment) are attached and documentation confirming completion of at least 90 days of high-dose atorvastatin or rosuvastatin is provided, or clear documentation of clinically significant statin intolerance.

Attach baseline LDL prior to statin therapy and LDL after at least 90 days of high-dose atorvastatin or rosuvastatin
Attach documentation confirming ≥90 days of treatment with high-dose atorvastatin or rosuvastatin OR documentation of clinically significant statin intolerance
Missing LDL labs or 90-day statin documentation may result in denial

Documentation Required

Statin optimization requirement

The provider must confirm statin optimization prior to approval. Document that the beneficiary is currently taking the maximum tolerated dose for their age of atorvastatin or rosuvastatin and has completed at least 90 days of therapy, unless there is documented clinically significant intolerance or allergy.

Confirm current max-dose atorvastatin or rosuvastatin for the beneficiary's age and ≥90 days of therapy
If unable to tolerate max-dose, attach documentation of clinically significant intolerance (e.g., severe muscle pain, significant liver abnormalities, rhabdomyolysis — not mild aches, fatigue, or cognitive complaints)

Denial Risk

Incomplete form or missing signature

Incomplete forms or missing prescriber signature will delay processing and may cause denial. Ensure all ID fields, contact information, and the prescriber's dated signature are completed on the prior authorization form before submission.

Complete all beneficiary ID fields on the form
Include prescriber signature and date
Ensure requester contact and prescriber NPI are provided

Background and Clinical Context

PCSK9 inhibitors (Praluent, Repatha) are used as adjunctive therapy for patients who have inadequate LDL-C lowering despite maximally tolerated statin therapy. The prior authorization form requests confirmation that the beneficiary has completed 90 days of high‑dose atorvastatin or rosuvastatin (or has documented clinically significant statin intolerance), and requires LDL lab results both before and after statin treatment to demonstrate an on‑statin LDL > 70 mg/dL before considering a PCSK9 inhibitor.

Definitions and Diagnostic Thresholds

Severe Primary Hyperlipidemia — defined as LDL-C > 190 mg/dL

DefinitionSevere Primary Hyperlipidemia is defined as LDL-C > 190 mg/dL

Where usedAppears in Praluent (Q12) and Repatha (Q17) clinical questions

RelevanceCounts as an agent-specific diagnosis criterion for PCSK9 inhibitor coverage

Clinically significant statin intolerance — included and excluded findings

Included signs of clinically significant intoleranceSevere muscle pain, significant liver abnormalities, or rhabdomyolysis

Excluded symptomsFatigue, cognitive impairment, or mild aches are not considered clinically significant intolerance

Form locationQuestion 3 asks about significant intolerance and provides examples and exclusions

OpenPayer

PCSK9 inhibitors prior authorization (Praluent, Repatha)

Coverage Criteria for PCSK9 Inhibitors

Key Numeric and Administrative Thresholds

Prior Authorization & Documentation Requirements

Background and Clinical Context

Definitions and Diagnostic Thresholds