Prior authorization and quantity limit requirements for antihyperlipidemic agents
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Governs prior authorization (PA) and quantity limit (QCD) requirements for specified antihyperlipidemic medications for BCBSMA commercial members; affects providers requesting coverage under pharmacy or medical benefits.
Addition of Tryngolza.
Updated remove trial of three (3) statins for Praluent and Repatha.
QCD added to Juxtapid.
Coverage Criteria for Antihyperlipidemic Agents
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 request
Covered when ALL of the following are met
Initial approval duration: 3 months (encompassing one 6-month shot)
Leqvio - Continuation
Covered when ALL of the following are met
Continued coverage duration: 12 months
Nexletol / Nexlizet - Medical necessity
Covered when ALL of the following are met
Praluent (alirocumab) - Initiation and continuation
Initiation covered when ALL of the following are met
Initial approval duration: 3 months
Continued coverage duration: 12 months
Repatha (evolocumab) - Initiation and continuation
Initiation covered when ALL of the following are met
Initial approval duration: 3 months
Repatha - Initiation
Repatha may be considered medically necessary and covered when ALL of the following are met:
Initial approval duration: 3 months.
Repatha - Continuation
Repatha continuation requests require ALL of the following:
Continued coverage duration: 12 months.
Tryngolza - Initiation
Tryngolza may be considered medically necessary and covered when ALL of the following are met:
Initial approval duration: 3 months.
Tryngolza - Continuation
Tryngolza continuation requests require ALL of the following:
Continued coverage duration: 12 months.
Certain commonly used antihyperlipidemic agents listed on the BCBSMA formulary do not have coverage requirements under this policy. These medications include Atorvastatin, Colesevelam, Colestipol, Ezetimibe, and Ezetimibe‑Simvastatin. Providers do not need to meet the prior authorization criteria in this document to prescribe these listed agents.
There are no additional explicit exclusions in this policy beyond the requirement that prior use, step therapy and formulary processes be followed where applicable. When a provider asserts a clinical reason preventing trial of a formulary alternative, the submission must include documentation of the name and strength of alternatives tried and failed (with dates if available) and specific details about the treatment failure or clinical rationale for not switching to a formulary alternative.
Repatha (evolocumab) will not meet medical necessity unless the member satisfies the stated initiation requirements. Specifically, requests for Repatha must be supported by a confirmed qualifying diagnosis (HeFH, HoFH, or established cardiovascular disease), evidence of evaluation in a lipid program staffed by a board-certified cardiologist or endocrinologist, and recent LDL laboratory values within 12 months. In addition, Repatha is intended as an adjunct to diet and maximally tolerated statin therapy in combination with ezetimibe where applicable; use without meeting these initiation criteria would be considered not medically necessary.
Coding and Clinical Parameter Summary
| Evkeeza (evinacumab) | Covered, PA; PA required. |
| Juxtapid (lomitapide) | Covered, PA, QCD; PA required. |
| Nexletol (bempedoic acid) | Covered, PA, QCD; PA required. |
| Nexlizet (bempedoic acid and ezetimibe) | Covered, PA, QCD; PA required. |
| Leqvio (inclisiran) | Covered, PA; PA required. *SPBO - Pharmacy benefit coverage only. |
| Repatha (evolocumab) | Covered, PA, QCD; PA required. *SPBO - Pharmacy benefit coverage only. |
| Praluent (alirocumab) | NFNC, PA, QCD; PA and Non formulary criteria required. *SPBO - Pharmacy benefit coverage only. |
| Tryngolza (olezarsen) | Covered, PA, QCD; PA required. *SPBO - Pharmacy benefit coverage only. |
Provider Requirements, Prior Authorization, and Documentation
Prior Authorization Required
Prior authorization is required for the antihyperlipidemic agents listed in this policy. Requests that do not meet prior authorization requirements or that fail to document required prior treatment/criteria may be denied.
- Prior Authorization required for listed agents
- Contact Pharmacy Operations: 1-800-366-7778; Fax: 1-800-583-6289
Repatha prior authorization requirements
Repatha (evolocumab) requires prior authorization and is covered when initiation and continuation criteria in this policy are met, including a documented diagnosis (HeFH, HoFH, or established cardiovascular disease), evaluation in a lipid program staffed by a board-certified cardiologist or endocrinologist, recent LDL labs (within 12 months for initiation; within 3 months for continuation), and use as adjunct to diet and maximally tolerated statin therapy with ezetimibe or documented treatment failure per policy.
- Initiation: Confirmed diagnosis (HeFH, HoFH, or established CVD); lipid program evaluation; recent LDL (<12 months); adjunct to diet + maximally tolerated statin + ezetimibe.
- Continuation: adherence verified via claims; current labs within 3 months showing maintained LDL improvement; continued coverage duration 12 months.
Prior use documentation required
The plan uses prescription claim records to establish prior use/trial of formulary alternatives within the previous 130 days. If claims data are not available or do not demonstrate required prior use or step-therapy failure, the provider must supply supporting documentation.
- Prior use window: previous 130 days (claims data used to support).
- When claims are insufficient, provider must document prior trials and failures or clinical reasons preventing trials.
Required provider documentation for prior use and exceptions
Providers must document the name and strength of formulary alternatives tried and failed (include dates if available) and specific details regarding the treatment failure. If a clinical reason prevented trial of a formulary alternative, provide specific clinical rationale and supporting documentation (e.g., clinical notes, lab data, literature or guideline references). Recent cholesterol/LDL or triglyceride labs should be provided (typically within 12 months for initiation; continuation often requires labs within 3 months).
- Document names/strengths of alternatives tried and failed, dates if available, and specifics of failure.
- Provide clinical rationale if a formulary alternative was not tried (e.g., contraindication, adverse effect).
- Include recent labs: cholesterol/LDL (initiation ≤12 months; continuation often ≤3 months) or fasting triglycerides as applicable.
Step therapy / treatment failure
For non-covered medications or when step therapy applies, members must have had treatment failure with, or a documented contraindication to, at least two covered formulary alternatives when available. The plan may verify required trials using prescription claims; if claims do not establish failure or contraindication, provider documentation of trials/failures or clinical justification is required.
- Step therapy requirement: failure of at least two covered formulary alternatives (or documented contraindication) when available.
- Plan will use claims to verify trials; if insufficient, provider must supply documentation of trials/failures and dates if available.
Background
This policy governs prior authorization and quantity limit requirements for multiple antihyperlipidemic agents, including PCSK9 inhibitors (e.g., Repatha, Praluent), ANGPTL3 inhibitors (e.g., Evkeeza), bempedoic acid (Nexletol/Nexlizet), lomitapide (Juxtapid), and newer antisense/oligonucleotide therapies (e.g., Leqvio). Criteria require confirmation of diagnosis for specified indications (such as HeFH or HoFH), documentation of recent lipid labs (typically within 12 months for initiation and 3 months for continuation where specified), evidence of specialist evaluation in a lipid program for certain agents, and prior trials or intolerance of other lipid‑lowering therapies when required.
Key Definitions
Policy Revision History
Quantity change (QCD) was added to Juxtapid (lomitapide).
Tryngolza was added to the policy.
Removed trial of three (3) statins requirement for Praluent (alirocumab) and Repatha (evolocumab).
Nexletol and Nexlizet were added to the policy with a new indication.
Repatha was added to the formulary and Praluent was designated NFNC.
Policy was reformatted.
Policy reformatted and medical necessity language updated to align with 118E MGL § 51A; Leqvio indication updated to include primary hyperlipidemia.
Policy was reformatted.
Kynamro (mipomersen) was removed from the policy following market withdrawal.
Leqvio (inclisiran) was added to the policy.
Evkeeza (evinacumab) was added to the policy and Praluent clinical indication updated.
Specified which medications are required to be filled at an in‑network specialty pharmacy.
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