CurrentMass General Brigham Health PlanPolicy N/A

Brineura (cerliponase alfa) — Coverage Criteria for CLN2

This policy governs prior authorization and coverage criteria for Brineura (cerliponase alfa) for members of Mass General Brigham Health Plan and MassHealth UPPL, including initial and continuation authorization rules and quantity/approval limits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyBrineura (cerliponase alfa) — Coverage Criteria for CLN2

Policy CodePolicy N/A

Change TypeMaterial—age eligibility revised

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document CLN2 diagnosis confirmed by TPP1 deficiency or genetic testing and that the prescriber is a neurologist.

SourceLink

POLICY UPDATE CHANGES

Removed requirement that member is at least three years of age to align with updated FDA-approved package labeling.

6 monthsApproval duration

90 daysNew-to-plan allowance

NeurologistRequired prescriber

TPP1/genetic testDiagnosis confirmation

Coverage and Medical Necessity Criteria

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inv-01: Initial Therapy — Authorization may be granted when ALL of the following are met

Authorization may be granted when ALL of the following are met:

Initial Authorization: Documented diagnosis of neuronal ceroid lipofuscinosis type 2 (CLN2) confirmed by TPP1 deficiency or genetic testing.

Initial Authorization: Prescribing provider is a neurologist.

Members new to the plan within the past 90 days who are currently receiving treatment with the requested medication may be authorized; this allowance excludes treatment obtained only as manufacturer samples or via the manufacturer's patient assistance programs.

inv-02: Continuation Therapy — Requests for reauthorization will be approved when the following criteria are met

Requests for reauthorization will be approved when the following criteria are met:

Continuation Therapy: (Continuation criteria not itemized in source document.)6 months approval

Initial approvals and reauthorizations are granted for 6 months when continuation criteria are met.

Authorization exclusions: treatment courses that are obtained solely as manufacturer samples or provided through a manufacturer patient assistance program are excluded from coverage considerations and are not eligible under the policy’s 90‑day new‑to‑plan allowance.

The following are considered not medically necessary under this policy: when a diagnosis of neuronal ceroid lipofuscinosis type 2 (CLN2) is not documented by TPP1 deficiency or genetic testing, or when the prescribing provider does not meet the required specialty (the policy requires the prescribing provider to be a neurologist).

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals and reauthorizations will be for 6 months. Members who are new to the plan (within the past 90 days) and are currently receiving the medication may have an existing authorization continued (excludes product obtained as samples or via manufacturer's patient assistance programs).

Initial and reauthorization duration: 6 months
New-to-plan continuation: members within 90 days of plan enrollment and currently receiving treatment (excludes samples or manufacturer assistance)

Step Therapy

No step therapy requirements specified for this medication.

Documentation Required

Required Documentation

Documented diagnosis of neuronal ceroid lipofuscinosis type 2 (CLN2) confirmed by TPP1 deficiency testing or genetic testing is required. Include documentation of prior treatment and response as applicable. The prescribing provider must be a neurologist.

Required diagnostic confirmation: TPP1 deficiency or genetic testing showing CLN2
Prescriber requirement: neurologist
Include prior treatment history and response when applicable

Denial Risk

Denial Triggers / Risks

Authorization may be denied if documentation does not confirm CLN2 (TPP1 deficiency or genetic testing), if the prescriber is not a neurologist, or if the request is for members not meeting the new-to-plan continuation criteria and lacking necessary diagnostic documentation.

Missing or non-confirmatory CLN2 diagnostic testing
Prescriber is not a neurologist
Member does not meet new-to-plan continuation conditions and lacks required documentation

Definitions

CLN2 — Definition and relation to TPP1 deficiency

DefinitionNeuronal ceroid lipofuscinosis type 2 (CLN2) is a lysosomal storage disorder caused by deficiency of the enzyme tripeptidyl peptidase 1 (TPP1).

SynonymAlso referred to as TPP1 deficiency.

Clinical relevanceBrineura (cerliponase alfa) is an intraventricular enzyme replacement therapy indicated to slow loss of ambulation in symptomatic pediatric patients with CLN2 (TPP1 deficiency).

Diagnostic requirement for coveragePolicy requires documented CLN2 confirmed by TPP1 deficiency or genetic testing for authorization.

Prescriber requirementAuthorization criteria specify the prescribing provider must be a neurologist (per policy).