Pasireotide (Signifor LAR) — Coverage Criteria
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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.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial therapy — Acromegaly
Authorization of 12 months may be granted for the treatment of acromegaly when all of the following criteria are met:
12-month authorization if met
Continuation therapy — Acromegaly
Authorization of 12 months may be granted for continuation of therapy for acromegaly when:
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:
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:
12-month authorization if met; provide laboratory report or documentation of clinical improvement
All indications other than the FDA-approved indications for acromegaly and Cushing's disease are considered experimental/investigational and not medically necessary.
Use of pasireotide (Signifor LAR) for indications outside the listed FDA-approved indications and accepted compendial uses is considered not medically necessary.
Initial Therapy
Initial therapy — Initial approval criteria for covered indications
Initial approval criteria for covered indications
Laboratory report and chart notes required
Laboratory report required for initial request
Continuation Therapy
Continuation therapy — Continuation therapy criteria and duration
Continuation therapy criteria and duration
Provider Actions and Requirements
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 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
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
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
Step Therapy Requirements
| 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
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
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.
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