CurrentCignaPolicy N/A

Somatostatin Analogs - Mycapssa Prior Authorization Policy

Cigna coverage and prior authorization requirements for Mycapssa (octreotide delayed-release capsules) for treatment of acromegaly for members of Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicySomatostatin Analogs - Mycapssa Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateApr 8, 2026

Key ActionObtain prior authorization and document baseline IGF-1 and prior response to an injectable somatostatin analog; approvals are provided for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yrapproval duration

Acromegalyindications covered

Endocrinologistprescriber requirement

Other uses NMIexclusions

Consensus/Endoguidance cited

Coverage Criteria for Mycapssa (octreotide delayed-release capsules)

FDA-Approved Indication — Acromegaly

Covered when ALL of the following are met:

Acromegaly indication and prerequisites: A) Patient has (or had) a pretreatment (baseline) insulin-like growth factor 1 (IGF-1) level above the upper limit of normal based on age and gender for the reporting laboratory; AND B) According to the prescriber, patient has responded to one octreotide acetate injection product or Somatuline Depot (lanreotide injection); AND C) The medication is prescribed by or in consultation with an endocrinologist.IGF-1 above the upper limit of normal for age and gender for the reporting laboratory

Approve for 1 year when all conditions met

Mycapssa® (octreotide delayed-release capsules) is considered not medically necessary for ANY other use(s) outside the indications and criteria described in this policy.

Use of Mycapssa for indications other than acromegaly as specified in this policy is not medically necessary and will not be approved unless and until criteria are updated based on new published data.

Coding and Laboratory Requirements

Policy Summary

PayerCigna

PolicySomatostatin Analogs - Mycapssa Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateApr 8, 2026

Key ActionObtain prior authorization and document baseline IGF-1 and prior response to an injectable somatostatin analog; approvals are provided for 1 year when criteria are met.

SourceLink

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Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Mycapssa. Approvals are provided for 1 year when all coverage criteria are met. Because of the specialized skills required for evaluation and diagnosis and for monitoring, Mycapssa must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Approval duration: 1 year
Prescriber requirement: prescribed by or in consultation with an endocrinologist

Prior Authorization

Response to Injectables Required

Patient must have responded to an injectable somatostatin analog prior to approval. Documented response to one octreotide acetate injection product or Somatuline Depot (lanreotide injection) is required.

Required prior therapy: response to one octreotide acetate injection product or Somatuline Depot (lanreotide)
This is an actionable requirement for approval

Documentation Required

Required Supporting Documentation

Provide supporting documentation with the prior authorization request to demonstrate eligibility and clinical response.

Baseline (pretreatment) IGF-1 level above the upper limit of normal for age and gender (reporting laboratory reference range)
Documentation of response to an injectable somatostatin analog (prescriber statement or objective measures)
Prescriber specialty or documentation of consultation with an endocrinologist

Denial Risk

Denial Risk for Unmet Criteria

Requests that do not meet all required criteria or that are for any other uses are considered not medically necessary and will be denied.

Denial risk if baseline IGF-1 not documented
Denial risk if no documented response to injectable somatostatin analog
Denial risk if prescriber is not an endocrinologist or no consultation is documented
Mycapssa is not medically necessary for any other uses outside the listed criteria

Background

Acromegaly is typically managed with surgery when feasible, with medical therapy using somatostatin analogs as first-line pharmacologic treatment when surgery is not curative or appropriate. Mycapssa is an oral formulation of octreotide indicated for long-term maintenance in patients who have responded to and tolerated injectable octreotide or lanreotide. Within this policy, coverage for Mycapssa is limited to the FDA-approved acromegaly indication when the specified prerequisites are met (including a pretreatment IGF-1 above the upper limit of normal for the reporting laboratory, documented response to an injectable somatostatin analog, and endocrinologist prescribing or consultation); approvals are issued for 1 year when criteria are satisfied.

OpenPayer

Somatostatin Analogs - Mycapssa Prior Authorization Policy

Coverage Criteria for Mycapssa (octreotide delayed-release capsules)

Coding and Laboratory Requirements

Provider Actions, Prior Authorization, and Documentation

Definitions

Background