PCSK9 Inhibitor Prior Authorization / Request Form (Coverage Criteria)
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This document is a pharmacy prior authorization/request form collecting patient, prescriber, diagnosis, treatment history, and documentation to support coverage decisions for lipid-lowering therapy (notably PCSK9 inhibitors). It affects prescribers requesting coverage or renewals from Blue Cross Blue Shield - Alabama.
No material clinical or coverage changes in this revision.
Coverage Criteria and Required Form Fields
Coverage criteria checklist (informational — form fields)
Information requested to establish medical necessity (form prompts provider to confirm ALL of the following as applicable):
From diagnostic checklist on form
Dutch score and family xanthoma questions on form
ASCVD events listed on form
Questions 2 and 3
Questions 4 and 5
Questions 6 and 7
Question 8 and medication history fields
Renewal section
The form does not list any explicit exclusions. However, requests lacking required documentation will be incomplete and may not meet criteria for approval. Examples of missing information that can preclude approval include absence of a recent LDL-C value within the past 90 days, no documentation of diagnosis confirmation (clinical or genetic criteria for HoFH/HeFH), or missing details about prior and current lipid-lowering therapies. Providers should submit the completed form with all requested fields to avoid delays or denial.
The form does not use explicit “not medically necessary” language. Instead, medical necessity is established by the presence of required clinical data: documented diagnosis criteria, recent LDL-C results, and appropriate prior therapy history. If the form does not show evidence of need—for example, no LDL-C within 90 days, no trial of or intolerance to statins, or missing information about prior PCSK9 or other lipid-lowering medication trials—the request may be determined not medically necessary.
Laboratory Thresholds and Coding-Relevant Criteria
Prior Authorization Documentation & Provider Responsibilities
Prior authorization documentation requirements
Prior authorization requests must document the patient's diagnosis and how it is confirmed: specify HoFH or HeFH and indicate supporting genetic or clinical criteria (e.g., genetic confirmation of one or two mutant alleles at LDLR/APOB/PCSK9/LDLRAP1, tendon xanthoma before age 10, or historical LDL‑C thresholds). Also include statin therapy history (intensity and adherence for the past 90 days or documented intolerance) and a current LDL‑C measured within the past 90 days.
- Select diagnosis: HoFH or HeFH and mark confirmation method (genetic confirmation, tendon xanthoma, or specified LDL‑C thresholds).
- Document statin therapy: high‑intensity vs low/moderate, adherence for past 90 days or intolerance (≥2 statins or FDA contraindication as applicable).
- Provide LDL‑C value obtained within the past 90 days.
Step therapy and trial documentation
The form requires documentation of prior trials and failures of other lipid‑lowering therapies and a clear rationale for selecting the requested agent over alternatives; it also expects that standard statin therapy has been addressed (adherence or documented intolerance) before approval.
- List prior lipid‑lowering medications tried and reasons for failure or intolerance.
- Explain why the requested agent and dosing were chosen instead of alternatives (contraindication, allergy, adverse reaction, lower dose tried).
- Confirm whether the patient is currently on a PCSK9 inhibitor and whether it will be discontinued before starting the requested agent.
Required documentation to support request
Submit the completed prior authorization form including patient demographics, prescriber information, diagnosis confirmation, prior and current lipid therapies, recent LDL‑C, treatment start date if already on the requested medication, and physician signature for renewals.
- Patient name and date of birth; prescriber NPI/contact per form header.
- Diagnosis confirmation details (HoFH/HeFH and selected supporting criteria).
- List of prior and concurrent lipid‑lowering therapies and start dates; indicate if another PCSK9 inhibitor is being used and plan for discontinuation.
- Most recent LDL‑C value within 90 days and whether a 50% reduction from baseline was achieved on maximally tolerated statin.
- For renewals: documentation of clinical benefit and adherence for the past 90 days plus physician signature and date.
Documentation omissions that may lead to denial
Requests missing key elements risk denial: common omissions include absent or outdated LDL‑C (not within 90 days), lack of documented statin use/adherence or intolerance, and failure to report prior PCSK9 inhibitor use.
- No LDL‑C value within the past 90 days or failure to indicate whether LDL‑C ≥70 mg/dL.
- No documentation of statin therapy intensity and 90‑day adherence or documented intolerance.
- Missing history of prior PCSK9 inhibitor use or whether it will be discontinued prior to the requested therapy.
Policy Background and Scope
This prior authorization/request form is designed to assess patients with familial hypercholesterolemia (heterozygous or homozygous) or atherosclerotic cardiovascular disease who may require additional LDL-C–lowering therapy such as a PCSK9 inhibitor. It captures diagnosis confirmation, current and prior lipid-lowering treatments, adherence over the past 90 days, whether the patient achieved a 50% reduction in LDL‑C on maximally tolerated statin therapy, and whether the most recent LDL‑C is ≥ 70 mg/dL within the past 90 days. The completed form and supporting data are required to evaluate medical necessity and process the request.
Key Diagnostic Definitions
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