Antihyperlipidemic agents prior authorization and quantity limits
Customize your policy alerts
Sign up for Blue Cross Blue Shield - Massachusetts Policy 013 alerts
Get alerted when Policy 013 changes without checking for updates manually.
Monitor payer policy activity
Defines prior authorization, quantity limit, and clinical coverage criteria for specified antihyperlipidemic medications for BCBSMA commercial members (excludes Medicare Advantage). Applies to medications covered under pharmacy and/or medical benefits per formulary status.
Added expanded indication for Repatha.
Addition of Tryngolza to the policy.
Updated to remove trial of three (3) statins for Praluent and Repatha.
Coverage Criteria for Antihyperlipidemic Agents
Evkeeza - Initial therapy
Covered when ALL of the following are met
Juxtapid - Initial therapy
Covered when ALL of the following are met
Leqvio - Initial and continuation
Covered when ALL of the following are met
Initial approval length: 3 months (encompassing one 6-month shot).
Length of approval: 12 months.
Nexletol/Nexlizet - Initial therapy
Covered when ALL of the following are met
Praluent - Initial and continuation
Covered when ALL of the following are met
Length of approval: 12 months.
Repatha - Initial and continuation
Covered when ALL of the following are met
Length of approval: 12 months.
Initial Approval - General
Initial Approval (general lipid-lowering therapies)
From initial approval section
Applies to initial approval
Continuation Therapy
Continuation of therapy (general)
Length of approval: 12 months
Continuation criteria include diet adjunct
Tryngolza Initial Approval
Covered when ALL of the following are met
Required for Tryngolza
Required for Tryngolza
Required for Tryngolza initial approval
Tryngolza adjunct requirement
Specialist and adjunct therapy requirements
Applies to agents that require specialist evaluation
Listed in policy
Listed in policy
Certain commonly used lipid-lowering agents are excluded from the prior authorization requirements in this policy. Specifically, atorvastatin, colesevelam, colestipol, ezetimibe, and ezetimibe‑simvastatin do not have coverage requirements under this policy.
Requests based solely on physician‑supplied samples will not satisfy the documentation requirements for a formulary exception or prior authorization. Providers must submit supporting documentation (for example, chart notes, laboratory results, or other clinical information) to demonstrate that the member meets all approval criteria; prescription claims and other historic medication records may be used to establish prior use or trial-and-failure of formulary alternatives.
If the submitted information indicates the requested therapy is unlikely to be clinically effective for the prescribed purpose, the request may be deemed not medically necessary. In such cases, a provider may request individual consideration for an atypical patient, but the burden of documentation remains with the provider — absence of sufficient clinical documentation (including reasons precluding trials of formulary alternatives) may result in denial.
Coding, Lab Thresholds, and Related Values
| Evkeeza | evinacumab |
| Juxtapid | lomitapide |
| Nexletol | bempedoic acid |
| Nexlizet | bempedoic acid and ezetimibe |
| Leqvio | inclisiran |
| Repatha | evolocumab |
| Praluent | alirocumab |
| Tryngolza | olezarsen |
Provider Requirements, Documentation, and Prior Authorization
Prior authorization required; how to request
Prior authorization is required for multiple antihyperlipidemic agents on the BCBSMA formulary. To request coverage, providers may call Pharmacy Operations (Tel: 1-800-366-7778), fax (1-800-583-6289), or submit the Formulary Exception/Prior Authorization form (Massachusetts Standard Form for Medication Prior Authorization Requests or #434).
PA requires meeting listed clinical criteria
Prior authorization requests must demonstrate that the member meets the applicable initial approval or continuation criteria for the requested medication (diagnosis, recent lipid labs, specialist/lipid program evaluation where required, adherence and diet/statin adjunct requirements).
Document reasons for exceptions to step therapy
If step therapy or formulary alternatives apply, the provider must document the clinical reason preventing trial of formulary alternatives; prescription claims may be used to establish prior use or step completion.
- Provide clinical rationale if switching to a non-formulary agent is contraindicated or inappropriate.
- Claims history may be used to show prior trials; additional documentation required if claims do not establish prior use.
Formulary step and failure documentation for non-covered meds
Formulary and step requirements apply; for non-covered medications the member must have previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available, in addition to meeting prior authorization criteria.
- Non-formulary (NFNC) requests require documented failure or contraindication to ≥2 covered alternatives.
- Higher member cost share may apply if an exception for a non-preferred/non-formulary drug is approved.
Document alternatives tried: names, strengths, dates
Providers must document the name and strength of formulary alternatives tried and failed, including dates if available, and provide specifics regarding the nature of the treatment failure.
- Include medication name, strength, treatment dates (if available), and description of failure or intolerance.
Required supporting documentation and forms
Submit supporting documentation to show the member meets all approval criteria, such as chart notes, lab results, or genetic testing; use the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm) or print and fax form #434.
- Chart notes describing diagnosis and clinical course.
- Recent lipid labs (within required recency: ≤12 months for initial, ≤3 months for continuation where specified).
- Genetic testing results when required (e.g., Tryngolza: familial chylomicronemia syndrome).
Missing documentation may trigger denial
Failure to provide documentation of trial and failure of formulary alternatives or absence of prescription claims demonstrating use of preferred medications may result in denial of the prior authorization request.
Sample-only requests are insufficient
Requests based exclusively on the use of medication samples will not meet coverage criteria for an exception and may be denied if no other supporting documentation is provided.
Background
This policy defines prior authorization, quantity limit, and clinical coverage criteria for selected antihyperlipidemic medications on the BCBSMA formulary. It applies to commercial members (excludes Medicare Advantage) and specifies that prior authorization is required for multiple agents; in addition to meeting specific diagnosis and laboratory thresholds, requests commonly require documentation of prior use or failure of formulary alternatives and submission of supporting clinical records. Providers should use the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm) or form #434 when submitting requests and may request individual consideration for atypical patients with appropriate supporting documentation.
Definitions and Key Terms
Policy Revision History
Added expanded indication for Repatha and updated formatting and references.
Added Tryngolza to the policy (Tryngolza clinical guideline and initial approval criteria included).
Updated criteria to remove requirement for trial of three statins for Praluent and Repatha.
Included Nexletol and Nexlizet with new indication in the policy.
Added Repatha to the formulary and made Praluent non-formulary/clinically managed (NFNC).
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.