Hypercholesterolemia Agents Prior Authorization
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Defines prior authorization requirements for select cholesterol-lowering medications including indications, age, dosing limits, documentation, and renewal criteria for Kansas Medicaid.
No material clinical or coverage changes in this revision.
Coverage Criteria and Authorization Rules
Initial Prior Authorization
Covered when ALL of the following are met
All elements required
Renewal Prior Authorization
Covered on renewal when ALL of the following are met
All elements required
Drugs that already have prior authorization requirements but later receive new FDA-approved indications, dosages, or age expansions will not be automatically covered under existing PA criteria. Such requests will be reviewed against the product package insert for the specific indication, age, dose, and any prerequisite treatment requirements relevant to that new approval. Providers should be prepared to supply documentation consistent with the package insert when seeking coverage for these new or modified uses.
Clinical Thresholds and Coding-Related Criteria
Provider Requirements, Documentation, and Denial Triggers
Prior authorization required for listed agents
Prior authorization is required for all current and future dose forms of the listed hypercholesterolemia agents and approval is contingent on meeting the drug-specific indication, age, and dosing limits in Table 1; the preferred PDL agent must be used when applicable unless non-preferred criteria are met.
- PA required for all listed agents and dose forms.
- Approval requires indication, age, and dosing per Table 1.
- Preferred PDL agent must be used when applicable unless non-preferred criteria are met.
Agent-specific prior therapy requirements (PCSK9 trial)
For lomitapide and evinacumab, the prescriber must document a trial of a PCSK9 inhibitor of at least 28 consecutive days with an inadequate response defined as LDL‑C ≥ 70 mg/dL prior to approval; additionally, inclisiran may not be used concurrently with a PCSK9 inhibitor.
- Lomitapide and evinacumab: PCSK9 inhibitor trial ≥ 28 consecutive days with LDL‑C ≥ 70 mg/dL.
- Inclisiran: not to be used concurrently with a PCSK9 inhibitor.
Statin-first and response requirements
The patient must have had an adequate trial of maximally tolerated statin therapy (per Table 2) and either an inadequate response to statins (often after adding ezetimibe) or a documented contraindication to listed statins; renewal requires documented LDL improvement (see renewal thresholds).
- Adequate trial of maximally tolerated statin therapy is required (Table 2).
- Inadequate response may be defined by prespecified LDL goals or failure after statin ± ezetimibe.
- Renewal requires documented LDL improvement (≥50% reduction or achievement/maintenance of initial LDL goal).
Required documentation on initial request
On the initial prior authorization request the prescriber must provide the patient’s baseline LDL‑C and a prespecified LDL goal (one of: <55 mg/dL, <70 mg/dL, or <100 mg/dL) and include documentation of prior therapies (e.g., trials of statins, ezetimibe, and PCSK9 inhibitors when required).
- Provide baseline LDL‑C and prespecified LDL goal (<55, <70, or <100 mg/dL).
- Document prior therapy trials (statins, ezetimibe, and PCSK9 inhibitor trial when applicable).
Triggers for denial
Requests will be denied if the patient does not meet the Table 1 indication, age, or dosing limits; if a required preferred PDL drug was not used when applicable and non-preferred criteria are unmet; or if disease-specific criteria (ASCVD, HeFH, HoFH) or required prior therapy trials (including statins and PCSK9 where specified) are not documented.
- Failure to meet indication, age, or dosing limits in Table 1.
- Failure to use preferred PDL agent when required and non-preferred criteria not met.
- Insufficient documentation of disease-specific criteria (ASCVD, HeFH, HoFH) or required prior therapy trials (statins, ezetimibe, PCSK9 where applicable).
Diagnostic Definitions
Background and Context
These agents are nonstatin therapies intended to lower low‑density lipoprotein cholesterol (LDL‑C) and reduce cardiovascular risk in patients with established ASCVD, heterozygous familial hypercholesterolemia (HeFH), or homozygous familial hypercholesterolemia (HoFH). The policy requires documentation of an adequate trial of maximally tolerated statin therapy (unless contraindicated) and specifies response thresholds and disease‑specific diagnostic criteria that must be met for initial approval and renewal.
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