CurrentBlue Cross Blue Shield - TennesseePolicy N/A

Pasireotide (Signifor LAR) — Coverage Criteria

Defines prior authorization, documentation, and coverage criteria for pasireotide (Signifor LAR) for treatment of acromegaly and Cushing's disease for BlueCross BlueShield of Tennessee members.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyPasireotide (Signifor LAR) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 31, 202649d

Next Review DateN/A

Key ActionSubmit prior authorization with required laboratory reports (pretreatment IGF-1 for acromegaly or pretreatment cortisol testing for Cushing's) to support approval up to 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period for initial and continuation approvals

2FDA-approved covered indications (acromegaly, Cushing's disease)

RequiredStep therapy applies per guide

TennesseeState off-label coverage compliance citation

Coverage Criteria

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Initial therapy — Acromegaly

Authorization of 12 months may be granted for the treatment of acromegaly when all of the following criteria are met:

Acromegaly initial criteria: Member meets one of the following: (1) high pretreatment IGF-1 level for age and/or gender based on the laboratory reference range; AND (2) member had an inadequate or partial response to surgery OR surgery is not an option for the member.

12-month authorization if met

Continuation therapy — Acromegaly

Authorization of 12 months may be granted for continuation of therapy for acromegaly when:

Acromegaly continuation criteria: Member's IGF-1 level has decreased or normalized since initiation of therapy (provide laboratory report showing current IGF-1).

12-month authorization if met

Initial therapy — Cushing's Disease

Authorization of 12 months may be granted for the treatment of Cushing's disease when:

Cushing initial criteria: Member has had pituitary surgery that was not curative OR the member is not a candidate for surgery. For initial requests, provide pretreatment cortisol measured by one of the following: urinary free cortisol (UFC), late‑night salivary cortisol, 1 mg overnight dexamethasone suppression test (DST), or longer low‑dose DST (2 mg per day for 48 hours).

12-month authorization if met; laboratory report required for initial request

Continuation therapy — Cushing's Disease

Authorization of 12 months for continuation of therapy may be granted when one of the following is met:

Cushing continuation criteria: Either (1) lower cortisol levels since the start of therapy as measured by one of: urinary free cortisol (UFC), late‑night salivary cortisol, 1 mg overnight DST, or longer low‑dose DST (2 mg per day for 48 hours); OR (2) improvement in signs and symptoms of Cushing's disease.

12-month authorization if met; provide laboratory report or documentation of clinical improvement

Initial Therapy

Initial therapy — Initial approval criteria for covered indications

Initial approval criteria for covered indications

Acromegaly initial: Elevated pretreatment IGF-1 for age/gender AND inadequate/partial response to surgery or surgery not an option; provide laboratory report and chart notes. Authorization up to 12 months.

Laboratory report and chart notes required

Cushing initial: Pituitary surgery not curative OR member is not a candidate for surgery; provide pretreatment cortisol via UFC, late‑night salivary cortisol, 1 mg overnight DST, or low‑dose DST (2 mg/day for 48 hours). Authorization up to 12 months.

Laboratory report required for initial request

Continuation Therapy

Continuation therapy — Continuation therapy criteria and duration

Continuation therapy criteria and duration

Acromegaly continuation: IGF-1 decreased or normalized since initiation of therapy; provide laboratory report showing current IGF-1. Authorization up to 12 months.

Cushing continuation: Lower cortisol levels by specified tests (UFC, late‑night salivary cortisol, 1 mg overnight DST, or longer low‑dose DST) OR clinical improvement in signs/symptoms; provide laboratory report or clinical documentation. Authorization up to 12 months.

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Authorization Period

Prior authorization is required. Approvals may be granted for up to 12 months when all clinical criteria are met for initial and continuation requests.

Authorization period: up to 12 months for initial and continuation requests when criteria are met
Applies to: acromegaly and Cushing's disease (FDA‑approved indications only)

Step Therapy

Step Therapy Requirement

Step therapy applies per the 'Step Therapy Requirements for Provider Administered Specialty Medications' guide. Providers must follow the referenced guide.

See: Step Therapy Requirements for Provider Administered Specialty Medications guide

Documentation Required

Required Documentation

Submit relevant laboratory reports and chart notes to support initial and continuation requests.

Acromegaly — Initial: pretreatment IGF-1 elevated for age/gender; chart notes documenting inadequate or partial response to surgery or that surgery is not an option
Acromegaly — Continuation: laboratory report showing IGF-1 decreased or normalized since initiation of therapy or chart notes documenting same
Cushing's Disease — Initial: pretreatment cortisol level measured by one of: urinary free cortisol (UFC), late‑night salivary cortisol, 1 mg overnight dexamethasone suppression test (DST), or low‑dose DST (2 mg/day for 48 hours)
Cushing's Disease — Continuation: laboratory report showing decreased cortisol from baseline by one of the listed tests or documentation of improvement in signs and symptoms

Denial Risk

Non‑Covered Indications

Requests for indications other than the FDA‑approved indications (acromegaly and Cushing's disease) are considered experimental/investigational and are not covered.

FDA‑approved indications: acromegaly (after inadequate response to surgery or when surgery not an option) and Cushing's disease (when pituitary surgery not an option or not curative)
All other indications: experimental/investigational — not medically necessary

Required prior step	Notes / criteria
Follow PAD Step Therapy Guide ('Step Therapy Requirements for Provider Administered Specialty Medications')	Providers must follow the referenced document for required prior steps before pasireotide (Signifor LAR) will be authorized; see https://www.bcbst.com/docs/providers/Comm_BC_PAD_Step_Therapy_Guide.pdf

Site of Care

Note

Provider‑administered specialty medication — follow PAD Step Therapy and site‑of‑care guidance

Pasireotide is a provider‑administered specialty medication; follow the PAD Step Therapy Guide for step therapy requirements and the payer's site‑of‑care guidance when administering in an infusion center.

Medication is provider‑administered specialty (infusion/clinic setting).
Adhere to step therapy and site‑of‑care guidance in the referenced PAD Step Therapy Guide.

Definitions and Tests

inv-12: IGF-1

DefinitionInsulin-like growth factor-1 (IGF-1) laboratory measurement used to assess disease activity and response in acromegaly.

Initial approval requirementDocument a high pretreatment IGF-1 level for age/gender based on the laboratory reference range.

Continuation requirementProvide laboratory report showing IGF-1 has decreased or normalized since initiation of therapy for continuation approvals (authorization up to 12 months).

Required documentationSubmit laboratory reports and chart notes indicating inadequate/partial response to surgery or that surgery is not an option for initial requests.

inv-13: Cortisol testing

DefinitionCortisol testing includes urinary free cortisol (UFC), late-night salivary cortisol, the 1 mg overnight dexamethasone suppression test (DST), or a longer low-dose DST (2 mg per day for 48 hours).

Initial approval requirementFor Cushing's initial requests, provide a pretreatment cortisol measured by one of the listed tests (UFC, late-night salivary cortisol, 1 mg overnight DST, or longer low-dose DST).

Continuation requirementFor continuation, provide laboratory report showing current cortisol has decreased from baseline by one of the listed tests or documentation of clinical improvement (authorization up to 12 months).

Monitoring examplesTests listed for monitoring response: UFC, late-night salivary cortisol, 1 mg overnight DST, or longer low-dose DST (2 mg/day for 48 hours).

Background

Pasireotide (Signifor LAR) is indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery or for whom surgery is not an option, and for patients with Cushing's disease when pituitary surgery is not an option or has not been curative. The policy requires documentation of baseline biochemical disease activity (for example, pretreatment IGF-1 for acromegaly; cortisol testing such as urinary free cortisol, late‑night salivary cortisol, or dexamethasone suppression testing for Cushing's disease) to support initial authorization and objective improvement or normalization on follow-up testing to support continuation.