Antihyperlipidemic agents prior authorization and quantity limits
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Governs prior authorization, quantity limit, and formulary requirements for select antihyperlipidemic medications for BCBSMA commercial members; affects providers submitting pharmacy or medical benefit requests.
Addition of Tryngolza to the policy.
Updated removal of trial of three statins requirement for Praluent and Repatha.
Updated to add Repatha indication previously (historic note).
Medication Coverage Criteria
Evkeeza (evinacumab) — Medical necessity
Covered when ALL of the following are met
Juxtapid (lomitapide) — Medical necessity
Covered when ALL of the following are met
Leqvio (inclisiran) — Initial and continuation criteria
Initial request covered when ALL of the following are met
Initial approval duration: 3 months (encompassing one 6-month shot)
Continued coverage duration: 12 months.
Nexletol / Nexlizet (bempedoic acid ± ezetimibe) — Medical necessity
Covered when ALL of the following are met
Praluent (alirocumab) — Initiation and continuation criteria
Initiation requests covered when ALL of the following are met
Initial approval duration: 3 months.
Continued coverage duration: 12 months.
Repatha (evolocumab) — Medical necessity
Covered when ALL of the following are met
Criteria structure referenced in document excerpt.
Repatha — Initiation (medically necessary criteria)
Repatha may be covered when ALL of the following are met:
Repatha — Continuation
Covered when ALL of the following are met for continuation:
Tryngolza — Initiation (medically necessary criteria)
Tryngolza may be covered when ALL of the following are met:
Policy text contains typographical formatting for value.
Initial approval duration: 3 months.
Tryngolza — Continuation
Covered when ALL of the following are met for continuation:
Continued coverage duration: 12 months.
The policy excerpt lists several commonly used statins and other lipid-lowering agents as having no coverage requirements under this policy. Examples explicitly named include Atorvastatin, Colesevelam, Colestipol, Ezetimibe, and Ezetimibe‑Simvastatin.
This excerpt does not provide an exhaustive list of all formulary products; when prior prescription claim data are not available to demonstrate prior use, or when required documentation of trials/failures of formulary alternatives is absent, coverage may be precluded. The plan relies on claims records to establish prior use within the previous 130 days, and providers must supply supporting documentation when claims data are insufficient.
Continuation (renewal) requests must include evidence of adherence from claims data and recent laboratory results showing maintained improvement. Specifically, the policy requires current lab values submitted within 3 months demonstrating maintained LDL or triglyceride improvement as applicable; absence of adherence verification or up-to-date labs may lead to denial of the continuation request.
Lab, Age, and Prior-Use Requirements
Provider Requirements and Submissions
Leqvio prior authorization details
Prior authorization is required for Leqvio (inclisiran). Initial approvals are limited (see criteria) and continuation requires documentation of adherence and recent labs. Requests that do not meet PA criteria or lack required documentation (including documented trials/failures of formulary alternatives when applicable) may be denied.
- Leqvio (inclisiran) is covered with prior authorization; SPBO pharmacy benefit coverage only.
- Initial approval requires meeting initiation criteria (confirmed diagnosis, age >18, evaluation in lipid program by cardiologist/endocrinologist, recent LDL within 12 months, adjunct to diet and maximally tolerated statin ± ezetimibe or documented statin/ezetimibe failures).
- Initial approval duration: 3 months (covers one 6‑month shot as specified).
- Continuation requires evidence of adherence via claims data and submission of current labs (<3 months) demonstrating maintained LDL improvement.
- Continued coverage duration: 12 months.
Requests that do not meet prior authorization
Requests that fail to meet the plan's prior authorization or step therapy requirements, or that lack required provider documentation, risk denial. The plan uses prescription claims to establish prior use/step therapy within the prior 130 days; when claims history is insufficient, the provider must supply supporting documentation.
- Requests without documented failure or contraindication to at least two covered formulary alternatives (when applicable) may be denied.
- If historical prescription claims do not establish prior use or step therapy, additional provider documentation is required.
- Requests not meeting PA requirements or lacking documented failures/contraindications may be denied.
Continuation lab/adherence requirements
For continuation of therapy, submit evidence of adherence and recent labs. Absence of adherence verification or labs within the specified timeframe (<3 months) may result in denial of continued coverage.
- Provide claims-based verification of adherence to current therapy.
- Submit current laboratory results dated within the last 3 months demonstrating maintained improvement in LDL (or triglyceride levels where applicable).
- Lack of adherence evidence or labs <3 months will risk denial for continuation requests.
Provider documentation for trials, failures, and exceptions
Document all trials, failures, and clinical reasons preventing use of formulary alternatives. Include drug names, strengths, dates, and specific rationale for failure or contraindication to support exceptions or approval when prescription claims are insufficient.
- When alternatives were tried, provide name, strength, dates of use (if available), and details of treatment failure.
- If a formulary alternative was not tried for clinical reasons, provide the specific clinical rationale preventing the trial or switch.
- For exception/individual consideration requests, include supporting clinical documentation (notes, literature, guidelines, compendia references).
Step therapy / alternatives required
The plan requires step therapy or documented trial/failure of formulary alternatives when available. The plan may use prescription claims to confirm prior use; if claims do not demonstrate required trials, provide supporting documentation of trials/failures or clinical contraindications.
- Step therapy: member must have prior treatment failure with, or contraindication to, at least two covered formulary alternatives for non‑covered medications when available.
- Plan will check prescription claims to establish prior use/step therapy; absence of claim evidence requires provider-submitted documentation.
- Document the name, strength, dates, and reason for failure for each alternative tried.
Submission form
Use the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm) when submitting PA requests. If eForm submission is not used, print and fax the standard MA Medication Prior Authorization Request form #434 with all supporting documentation.
- Electronic submission: Massachusetts Standard eForm (link on BCBSMA site).
- Paper submission: Print and fax form #434 with supporting clinical documentation to Pharmacy Operations as instructed.
Policy Scope and Applicability
This policy governs prior authorization, quantity limit, and formulary requirements for select antihyperlipidemic agents used to lower LDL cholesterol, including novel agents such as PCSK9 inhibitors, ANGPTL3 inhibitors, and bempedoic acid (with or without ezetimibe). It applies to Boston‑area commercial members enrolled with Blue Cross Blue Shield of Massachusetts and to providers submitting pharmacy or medical benefit prior authorization requests for these agents.
Clinical Definitions
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