CurrentUnitedHealthcarePolicy N/A

Mycapssa (octreotide) — Prior Authorization for Acromegaly

Prior authorization policy for Mycapssa (oral octreotide) for long-term maintenance treatment of acromegaly in members who have previously responded to and tolerated octreotide or lanreotide; applies to UnitedHealthcare coverage programs.

Policy Summary

PayerUnitedHealthcare

PolicyMycapssa (octreotide) — Prior Authorization for Acromegaly

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting diagnosis of acromegaly and prior response and tolerance to octreotide or lanreotide; reauthorization requires documentation of positive clinical response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

prior authorizationprogram type

Mycapssamedication

12 monthsauth duration

prior injectable responserequired prior therapy

Coverage Criteria

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COVERAGE CRITERIA

Covered when ALL of the following are met:

Initial Authorization

Diagnosis of acromegaly
Prior response and tolerance: Patient has responded to and tolerated treatment with Sandostatin (octreotide) or Sandostatin LAR or Somatuline Depot (lanreotide)

Step therapy requirement: Prior treatment with and documented response and tolerance to an injectable somatostatin analog (octreotide or lanreotide) is required before approval of Mycapssa

Coverage may be subject to plan-level restrictions and automated processing. Supply limits may be applied and UnitedHealthcare may use automated approval or re‑approval processes based on prior claim/medication history, diagnosis codes, and claim logic; the use of these automated processes varies by program or therapeutic class.

Medical necessity rules and state, federal, or member‑specific benefit plan language may further restrict approval. Even when coverage criteria are met, UnitedHealthcare may approve initial or reauthorization requests based solely on prior claims, medication history, and diagnosis/claim logic where program rules allow.

Initial Authorization Criteria

Initial Authorization

Initial authorization criteria

Initial: Diagnosis of acromegaly AND prior response and tolerance to octreotide or lanreotide (Sandostatin/Sandostatin LAR or Somatuline Depot)

Authorization issued for 12 months

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial prior authorization must include a documented diagnosis of acromegaly and evidence that the patient previously responded to and tolerated an injectable somatostatin analog (octreotide or lanreotide). Initial approvals are issued for 12 months.

Initial approval period: 12 months
Required documentation: diagnosis of acromegaly; chart evidence of response and tolerance to Sandostatin (octreotide) or Sandostatin LAR, or Somatuline Depot (lanreotide)

Step Therapy

Step / Prior Exposure Requirement

Patients must have previously responded to and tolerated treatment with an injectable somatostatin analog before Mycapssa (oral octreotide) will be authorized. Acceptable prior agents include Sandostatin (octreotide) or Sandostatin LAR, and Somatuline Depot (lanreotide).

Acceptable prior agents: Sandostatin (octreotide) or Sandostatin LAR; Somatuline Depot (lanreotide)
Prior exposure and clinical response must be documented in the medical record

Denial Risk

Reauthorization & Potential Denial Triggers

For reauthorization, documentation of a positive clinical response to Mycapssa therapy is required. Reauthorizations are issued for 12 months. Failure to provide the required diagnosis, prior-treatment documentation, or evidence of ongoing clinical benefit may result in denial.

Reauthorization approval period: 12 months
Documentation required for reauthorization: evidence of positive clinical response to Mycapssa
Potential denial triggers: lack of documented diagnosis of acromegaly; absent documentation of prior response/tolerance to injectable somatostatin analog; failure to show positive clinical response to Mycapssa

Step	Requirement
1	Prior treatment with and documented response and tolerance to an injectable somatostatin analog (Sandostatin [octreotide] or Sandostatin LAR; Somatuline Depot [lanreotide]) is required before Mycapssa approval.
Coverage label	Authorization will be issued for 12 months.

Background

Mycapssa (octreotide) is an oral somatostatin analog indicated for long‑term maintenance treatment of acromegaly in patients who have previously responded to and tolerated injectable somatostatin analogs (octreotide or lanreotide).

This policy applies to Mycapssa when used for maintenance therapy in members with a diagnosis of acromegaly and defines the documentation required for both initial authorization (diagnosis of acromegaly and prior response/tolerance to Sandostatin/Sandostatin LAR or Somatuline Depot) and reauthorization (documentation of positive clinical response to Mycapssa).