CurrentPremera BluecrossPolicy N/A

PHARMACY MEDICAL POLICY 5.01.548 Pharmacotherapy of Cushing's Disease and Acromegaly

Defines medical necessity coverage criteria, documentation, coding, and benefit routing for multiple pharmacologic agents used to treat Cushing's disease, Cushing's syndrome, acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NETs), carcinoid syndrome, and VIPoma-associated diarrhea. Applies to listed branded and generic drugs (octreotide, lanreotide, pasireotide, pegvisomant, osilodrostat, levoketoconazole, mifepristone, etc.) and describes benefit management (pharmacy vs medical).

Policy Summary

PayerPremera Bluecross

PolicyPHARMACY MEDICAL POLICY 5.01.548 Pharmacotherapy of Cushing's Disease and Acromegaly

Policy CodePolicy N/A

Change TypeCriteria additions, step therapy updates, generic substitutions

Effective Date

Next Review Date

Key ActionProvide office visit notes containing diagnosis, relevant physical evaluation, medication history, and supporting test results (e.g., IGF-1, OGTT, UFC, late-night salivary cortisol, dexamethasone suppression tests).

POLICY UPDATE CHANGES

Added coverage criteria for Somatuline Depot (lanreotide) for acromegaly, GEP-NETs, carcinoid syndrome, and VIPoma-related diarrhea (2021).

Updated criteria for Isturisa (osilodrostat), Signifor (pasireotide), and Signifor LAR to require trial and inadequate response or intolerance to generic ketoconazole first (2022).

Added coverage criteria for Recorlev (levoketoconazole) for endogenous hypercortisolemia in Cushing's syndrome (2022).

Added generic mifepristone coverage and updated Korlym (mifepristone) criteria to require trial and failure with generic mifepristone (2024).

Added generic long-acting octreotide depot with same coverage criteria as Sandostatin LAR Depot and generic lanreotide with identical criteria to Somatuline Depot (2023; 2025).

Clarified medications listed are subject to product FDA dosing and administration and standardized wording changed from 'patient' to 'individual'.

Multiple annual literature reviews (2014–2025) noted; several reviews indicated no policy criteria changes.

Multiple

Coverage Summary

Scope: This policy defines medical necessity coverage criteria, required documentation, coding, and benefit routing for pharmacologic treatment of Cushing's disease/Cushing's syndrome, acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NETs), carcinoid syndrome, and profuse watery diarrhea associated with VIPomas. It applies to listed branded and generic agents including octreotide (generic, Sandostatin, Sandostatin LAR Depot, Bynfezia Pen, Mycapssa), lanreotide (brand/generic, Somatuline Depot), pasireotide (Signifor, Signifor LAR), pegvisomant (Somavert), osilodrostat (Isturisa), levoketoconazole (Recorlev), and mifepristone (Korlym and generic) with indication-specific criteria.

Coverage stance / routing: Coverage is drug- and indication-specific (mixed stance) and requires meeting the policy criteria (age ≥18, documented biochemical diagnosis, prior surgical/radiation status, and step therapy where specified). Certain oral agents (Isturisa, Korlym/generic mifepristone, Mycapssa, Recorlev) are managed through the pharmacy benefit while many injectables (octreotide products, Signifor, Somatuline Depot, Somavert) are managed via pharmacy and/or medical benefit; some long‑acting depot products are managed via the medical benefit per coding guidance.

Effective and administrative notes: Somatuline Depot and octreotide depot / product coverage additions became effective for dates of service on or after 2021-08-06 following 90-day provider notification; many drugs require trial and inadequate response or intolerance to a specified generic alternative (e.g., generic octreotide before brand depot octreotide/lanreotide; generic ketoconazole before Isturisa/Signifor/Signifor LAR and Recorlev; generic mifepristone before Korlym). Non-formulary exception reviews and authorizations may be approved up to 12 months as described in the policy.