CurrentUnitedHealthcarePolicy N/A

Antihyperlipidemics PCSK9 Inhibitors (Washington) Prior Authorization Form - Community Planopen_in_new

Prior authorization request form and coverage checklist for PCSK9 inhibitors for members in Washington (community plan). Captures required clinical criteria for heterozygous/homozygous familial hypercholesterolemia, primary hypercholesterolemia with ASCVD, risk reduction in established CVD, concomitant statin therapy requirements, LDL thresholds, documentation of prior therapies, and continuation criteria. Used to submit PA via fax with required patient/provider/medication information and clinical attachments.

Policy Summary

PayerUnitedHealthcare

PolicyAntihyperlipidemics PCSK9 Inhibitors (Washington) Prior Authorization Form - Community Planopen_in_new

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionFax the entire completed prior authorization form plus any pertinent clinical information to 866-940-7328 and allow at least 24 hours for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

5Key clinical indications listed

3LDL numeric thresholds specified

6Required statin trial duration (weeks)

Coverage Summary

This is a prior authorization (PA) request form and coverage checklist for PCSK9 inhibitors for UnitedHealthcare Community Plan members in Washington. The document reflects a covered_with_criteria stance — requests are approved only when the specified clinical criteria are met.

The form captures the requested indication (HeFH, HoFH, primary hypercholesterolemia with ASCVD, or risk reduction in established CVD), documentation of a trial of the highest-tolerated statin regimen for ≥6 consecutive weeks or statin intolerance, LDL thresholds and percent reduction (including ≥50% LDL reduction from baseline and persistent LDL thresholds of ≥100 mg/dL or ≥130 mg/dL depending on indication), prior therapies and reasons for discontinuation, specialist involvement, and continuation criteria (including documentation of continued clinical benefit). The form is submitted by fax and includes required patient/provider/medication information and clinical attachments to support the request.

Thresholds

Statin trial duration>= 6 consecutive weeks on highest-tolerated statin regimen

LDL reduction for initial approval>= 50% reduction from baseline (while on highest-tolerated statin for >=6 consecutive weeks)

LDL persistent threshold (general)>= 100 mg/dL (since being on highest-tolerated statin >=6 consecutive weeks)

LDL persistent threshold (some indications)>= 130 mg/dL (since being on highest-tolerated statin >=6 consecutive weeks)

HeFH age-based LDL thresholdsAge >=20: LDL >=190 mg/dL on maximally tolerated statin; Age <20: LDL >=160 mg/dL on maximally tolerated statin

HoFH historic thresholdUntreated LDL >=500 mg/dL with xanthoma before age 10

Continuation clinical benefit>= 30% LDL reduction from initiation of PCSK9 inhibitor (or achievement of patient-specific goal)

Medical Necessity Criteria

ALL REQUESTS

Covered when ALL of the following are met:

Patient diagnosis is one of the listed indications (HeFH; Primary hypercholesterolemia with ASCVD; HoFH; reducing risk of MI/stroke/coronary revascularization in adults with established CVD) or other specified diagnosis

Form requires checking the applicable diagnosis box

Patient has concomitant therapy with the highest-tolerated statin regimen for at least 6 consecutive weeks or is statin intolerant>= 6 consecutive weeks on highest-tolerated statin regimen

If yes, complete medication info including dose, date of trial, and reason for discontinuation (Section D)

Has the patient's LDL achieved at least 50% reduction from baseline since being on the highest-tolerated statin regimen for at least 6 consecutive weeks?>= 50% reduction from baseline

If yes, provider to list LDL reduction from baseline on form

LDL thresholds (conditional on indication): Patient's LDL has remained ≥100 mg/dL since being on highest-tolerated statin regimen for at least 6 consecutive weeks OR patient's LDL has remained ≥130 mg/dL since being on highest-tolerated statin regimen for at least 6 consecutive weeks (appears for some indications)≥100 mg/dL; ≥130 mg/dL

Form asks to list current LDL when checked

Requested medication will not be used in combination with another PCSK9 inhibitor, lomitapide (Juxtapid), or mipomersen (Kynamro) unless explicitly indicated

Checkboxes provided on form to indicate combination

Requested medication is prescribed by or in consultation with a provider specializing in lipid management (e.g., cardiologist, lipid specialist, endocrinologist)

Form asks provider specialty and whether prescribing or consulting provider is a specialist

Has the patient demonstrated failure or intolerance to one preferred Antihyperlipidemics - PCSK9 Inhibitor?

Form includes checkbox to indicate prior failure/intolerance to preferred agent; if yes, complete medication info including dose, date of trial, and reason for discontinuation

Heterozygous Familial Hypercholesterolemia (HeFH) Requests

Diagnosis must be defined by ONE of the following:

Clinical diagnosis using diagnostic tools such as US MedPed, Simon Broome Register Group, or Dutch Lipid Panel List diagnostic tool

Form provides checkbox for clinical diagnostic tool

Age ≥20 and LDL ≥190 mg/dL on maximally tolerated statin therapy prior to adding a PCSK9 inhibitorAge >=20: LDL >=190 mg/dL

Form requests listing age, LDL, statin and dose

Age <20 and LDL ≥160 mg/dL on maximally tolerated statin therapy prior to adding a PCSK9 inhibitorAge <20: LDL >=160 mg/dL

Form requests listing age, LDL, statin and dose

Genetic testing confirming presence of familial hypercholesterolemia genes

Homozygous Familial Hypercholesterolemia (HoFH) Requests

Diagnosis must be defined by ONE of the following:

History of untreated LDL ≥500 mg/dL with a xanthoma before 10 years of ageUntreated LDL >=500 mg/dL; xanthoma before age 10

Form requests listing LDL and age of xanthoma

Evidence of heterozygous familial hypercholesterolemia in both parents

Checkbox provided on form

Genetic testing confirming presence of familial hypercholesterolemia genes

Checkbox provided on form

None of the above (open field to list alternative evidence)

Primary hypercholesterolemia with ASCVD and Risk Reduction in Established CVD

Requests require documentation of history of at least one atherosclerotic cardiovascular event:

Myocardial infarction (MI), presumed to be of atherosclerotic origin

Checkbox provided

Acute coronary syndrome (ACS), presumed to be of atherosclerotic origin

Checkbox provided

Severe angina, presumed to be of atherosclerotic origin

Checkbox provided

Stroke, presumed to be of atherosclerotic origin

Checkbox provided

Transient ischemic attack (TIA), presumed to be of atherosclerotic origin

Continuation of Therapy

For ongoing treatment, ALL of the following are requested:

Patient continues to receive the maximum tolerated dose of statin unless contraindicated or intolerantmax tolerated statin dose

Provider to list statin and dose on form

There is documentation of continued clinical benefit (e.g., at least a 30% reduction in LDL from initiation of PCSK9 inhibitor or achievement of patient-specific goal)>= 30% LDL reduction from initiation of PCSK9 inhibitor

Form asks to list clinical benefit

Required Provider Actions

Prior Authorization

Submit completed PA form and supporting documentation

Fax the entire completed prior authorization form and any pertinent clinical information to 866-940-7328. Allow at least 24 hours for review.

Prior medication trials and doses
LDL values (baseline, on-statin, current) and percent reduction
Genetic testing results (if applicable)
Diagnostic tool results (e.g., US MedPed, Simon Broome, Dutch Lipid Panel)

Documentation Required

Document statin trial and intolerance

Provide documentation that the patient was treated with the highest-tolerated statin regimen for at least 6 consecutive weeks OR document the reason for statin intolerance. Include the statin name, dose, and start/stop or trial dates.

Statin name
Dose (highest-tolerated)
Dates of trial (start and end) or duration (≥6 consecutive weeks)
Reason for discontinuation/intolerance (if applicable)

Documentation Required

Provide LDL measurements and percent reduction

Report baseline LDL, LDL while on the highest-tolerated statin, percent LDL reduction from baseline, and current LDL values as applicable. Indicate if LDL has remained at or above specified thresholds since being on the highest-tolerated statin regimen for at least 6 consecutive weeks.

Baseline LDL (pre-statin)
On-statin LDL (after ≥6 weeks on highest-tolerated statin)
Percent LDL reduction from baseline (report if ≥50% when on statin)
Current LDL value
Flag if LDL remained ≥100 mg/dL
Flag if LDL remained ≥130 mg/dL (when applicable to indication)

Documentation Required

Specialist involvement

Indicate whether the requested medication is being prescribed by or in consultation with a provider specializing in lipid management (for example, cardiologist, lipid specialist, or endocrinologist). Provide supporting specialty documentation when applicable.

Prescribing provider specialty
Documentation of consultation or specialty involvement (if applicable)

Billing Rule

Delivery coordination and signature requirement

A physician signature is required on the form and complete provider and patient information must be provided to facilitate dispensing and delivery coordination. Ensure delivery destination and administration setting are indicated.

Physician signature on the medication/prescription section
Complete Provider Information (name, address, phone, fax, specialty, provider ID)
Complete Patient Information (name, DOB, address, phone)
Specify delivery coordination: Ship to physician's office or patient's address; indicate date medication is needed and administration setting (self-administered, home health, LTC, physician's office)

Background

This document is a specialty medication prior authorization request form for PCSK9 inhibitors for UnitedHealthcare Community Plan Washington. It collects patient and provider demographics, medication details (including ICD-10 code and physician signature), diagnosis and indication selection, prior therapy history and reasons for discontinuation, LDL measurements and percent reductions, and other clinical evidence such as genetic testing or diagnostic tool results.

The form requires a physician signature and complete provider and patient information to facilitate dispensing and delivery coordination. It also supports submission of pertinent clinical attachments and directs providers to fax the completed form (allow at least 24 hours for review) and coordinate delivery per the delivery instructions on the form.

Definitions

HeFHHeterozygous familial hypercholesterolemia (diagnosed by clinical tools like US MedPed/Simon Broome/Dutch Lipid Panel, age-based LDL criteria, or genetic testing)

HoFHHomozygous familial hypercholesterolemia (diagnosed by history of untreated LDL >=500 mg/dL with xanthoma before age 10, parental evidence, or genetic testing)

ASCVDAtherosclerotic cardiovascular disease (history of MI, ACS, severe angina, stroke, TIA, coronary revascularization, or peripheral arterial disease)

PCSK9 inhibitorProprotein convertase subtilisin/kexin type 9 inhibitor (antihyperlipidemic class requiring prior authorization and documentation of statin therapy/LDL criteria)

OpenPayer

Antihyperlipidemics PCSK9 Inhibitors (Washington) Prior Authorization Form - Community Planopen_in_new

Coverage Summary

Medical Necessity Criteria

Required Provider Actions

Coding

Background

Revision History