CurrentCignaPolicy IP0491

Octreotide delayed-release capsules (Mycapssa) for acromegaly

Defines medical necessity, reauthorization, authorization duration, non-covered uses, and employer/individual plan non-covered product criteria for octreotide delayed-release capsules (Mycapssa) for treatment of acromegaly under Cigna benefit plans.

Policy Summary

PayerCigna

PolicyOctreotide delayed-release capsules (Mycapssa) for acromegaly

Policy CodePolicy IP0491

Change TypeAnnual Revision — No Criteria Changes

Effective DateJul 15, 2025

Next Review Date

Key ActionProvide documentation that the individual has responded to one octreotide acetate injection product or Somatuline Depot (lanreotide injection) and pretreatment IGF-1 above lab-specific ULN; continuation requires documentation of beneficial response.

POLICY UPDATE CHANGES

Annual Revision, Summary of Changes = No Criteria Changes.

1Indication covered

1Non-covered (other uses)

12 monthsAuthorization duration (initial & reauth)

Coverage Summary

Coverage stance: covered_with_criteria for Octreotide delayed-release capsules (Mycapssa) for acromegaly. Scope summary: Defines medical necessity, reauthorization, authorization duration, non-covered uses, and employer/individual plan non-covered product criteria for octreotide delayed-release capsules (Mycapssa) for treatment of acromegaly under Cigna benefit plans. Authorization duration: 12 months for both initial and reauthorization. Policy effective date and last review: 7/15/2025 (policy effective date remains in force until updated or retired).

Initial Therapy Criteria (Medical Necessity)

Medical Necessity - Initial Therapy (Acromegaly)

Octreotide delayed-release capsules (Mycapssa) are considered medically necessary when ALL of the following are met:

Pretreatment IGF-1: Documentation of a pretreatment insulin-like growth factor 1 (IGF-1) level above the upper limit of normal based on age and gender for the reporting laboratory.above the upper limit of normal based on age and gender for the reporting laboratory
Response to injectable therapy: Documentation that the individual has responded to one octreotide acetate injection product or Somatuline Depot (lanreotide injection).
Prescriber: The medication is prescribed by, or in consultation with, an endocrinologist.
Non-Covered Product Criteria is met, refer to below table(s).
Employer Group and Individual and Family Plan non-covered product criteria described in policy.

Non-Covered Product Criteria: defined as Employer Group and Individual and Family Plan-specific criteria that allow coverage when member previously started Mycapssa or is unable to use Somatuline Depot (lanreotide) injection. Some employer/group and individual plan-specific allowances exist that permit coverage when the member has previously started Mycapssa or cannot use lanreotide injection; these allowances may require prior authorization and vary by plan.

Continuation / Reauthorization Criteria

Reauthorization Criteria (Continuation Therapy)

Continuation of Mycapssa is considered medically necessary when ALL of the following are met:

Initial criteria: Above medical necessity criteria are met (see Initial Therapy criteria).
Refer to Medical Necessity - Initial Therapy (Acromegaly).
Beneficial response: There is documentation of beneficial response.
Policy requires documentation of clinical or biochemical improvement while on therapy (policy does not define specific metrics).

Beneficial response: defined as documentation of clinical or biochemical improvement while on therapy (policy requires documentation but does not define specific metrics). The policy requires documentation of beneficial response for continuation but does not specify exact measurement thresholds or metrics.

Provider Actions & Operational Notes

Prior Authorization

Prior authorization may be required for lanreotide inability documentation

If coverage depends on documentation that the individual is unable to use Somatuline Depot (lanreotide) injection, prior authorization may be required per plan rules.

Documentation Required

Documentation of response to injectable therapy required

Provide documentation that the individual has responded to one octreotide acetate injection product or Somatuline Depot (lanreotide injection) and pretreatment IGF-1 above lab-specific upper limit of normal; continuation requires documentation of beneficial response.

Billing Rule

Receipt of sample product not acceptable for coverage

Receipt of sample product does not satisfy any criteria requirements for coverage.

Operational impact: prescribing must be by, or in consultation with, an endocrinologist as a condition of medical necessity; plans may require documentation and prior authorization for certain Non-Covered Product Criteria. Employer- and plan-specific exceptions exist for Non-Covered Product Criteria (for example, prior use of Mycapssa or documented inability to use Somatuline Depot), and these exceptions may have additional prior authorization or documentation requirements per the applicable benefit plan.

Clinical Evidence & Guidelines

Evidence: Mycapssa prescribing information (Amryt; March 2022) and Endocrine Society Clinical Practice Guideline for Acromegaly (2014) are cited. Clinical studies and the product label report that Mycapssa maintained growth hormone (GH) and insulin-like growth factor 1 (IGF-1) levels in patients with acromegaly. Guidelines endorse injectable somatostatin analogs (octreotide and lanreotide) as first-line medical therapies after surgery; oral octreotide is considered suitable for patients who have demonstrated biochemical response to injectable formulations.

Background & Definitions

Background: Mycapssa is an oral somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated injectable octreotide or lanreotide. It maintained GH and IGF-1 levels in clinical studies. Clinical guidelines recommend injectable somatostatin analogs as first-line medical therapy after surgery, and oral octreotide is appropriate for patients who have demonstrated biochemical response to injectables.

Term	Definition
Beneficial response	Documentation of clinical or biochemical improvement while on therapy (policy requires documentation but does not define specific metrics).
Non-Covered Product Criteria	Employer Group and Individual and Family Plan-specific criteria that allow coverage when member previously started Mycapssa or is unable to use Somatuline Depot (lanreotide) injection. For Employer Group and Individual and Family Plan: documentation of ONE of the following: 1) individual has previously started on or is currently receiving Mycapssa capsules; or 2) documentation the individual is unable to use Somatuline Depot (lanreotide) injection (may require prior authorization).

Term

Definition

Beneficial response

Documentation of clinical or biochemical improvement while on therapy (policy requires documentation but does not define specific metrics).

Non-Covered Product Criteria

Employer Group and Individual and Family Plan-specific criteria that allow coverage when member previously started Mycapssa or is unable to use Somatuline Depot (lanreotide) injection. For Employer Group and Individual and Family Plan: documentation of ONE of the following: 1) individual has previously started on or is currently receiving Mycapssa capsules; or 2) documentation the individual is unable to use Somatuline Depot (lanreotide) injection (may require prior authorization).