CurrentColorado Rocky Mountain Health PlansPolicy N/A

Mycapssa (octreotide) — Prior Authorization and Medical Necessity Criteria

Defines prior authorization and medical necessity criteria for Mycapssa (octreotide) for long-term maintenance treatment of acromegaly for eligible members and prescribers.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyMycapssa (octreotide) prior authorization and medical necessity criteria

Policy CodePolicy N/A

Change TypeMaterial revisions and clarifications

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation of diagnosis and prior response/tolerance to octreotide or lanreotide (or document current Mycapssa therapy) and ensure prescriber is or consults with an endocrinologist.

SourceLink

POLICY UPDATE CHANGES

For initial authorization, removed requirements for previous surgery, radiation, or bromocriptine; added Lanreotide Injection as an example of lanreotide; noted injectable somatostatin analogs may be subject to additional benefit and coverage review requirements; and added prescriber requirement.

For reauthorization, added example of positive clinical response.

Added exclusion footnote noting Mycapssa is typically excluded from coverage for some plans; tried/failed criteria may be in place; refer to plan specifics.

Updated background and references and provided updated wording of criteria without change in clinical intent.

12 monthsauthorization duration

2 pathwaysinitial authorization options

positive IGF-1example reauthorization evidence

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Mycapssa (octreotide) Coverage Criteria

Initial Authorization (new start, prior injectable response required)

Covered when ALL of the following are met:

Initial Authorization (Pathway 1): (a) Diagnosis of acromegaly confirmed by either: serum GH > 1 ng/mL after a 2-hour OGTT at time of diagnosis OR elevated age- and gender-adjusted IGF-1 (as documented by the provider).> 1 ng/mL after 2-hour OGTT

See diagnostic testing documentation; provider must submit evidence of diagnostic test results.

Initial Authorization (Pathway 1): (b) Patient has responded to and tolerated treatment with octreotide (e.g., Sandostatin, Sandostatin LAR) OR lanreotide (e.g., Lanreotide Injection, Somatuline Depot).

Coverage of injectable somatostatin analogs may be subject to additional benefit/coverage review requirements.

Initial Authorization (Pathway 1): (c) Provider has submitted clinical justification why the patient cannot be maintained on current octreotide or lanreotide therapy (documentation of intolerance, inadequate access, or other clinical reason).

Operational reviewers will evaluate documentation explaining the need to switch to oral therapy.

Initial Authorization (Pathway 1): (d) Prescribed by or in consultation with an endocrinologist.

Prescriber requirement must be documented in the request.

Initial Authorization (current Mycapssa therapy)

Covered when BOTH of the following are met:

Initial Authorization (Pathway 2): (a) Patient is currently receiving Mycapssa therapy for acromegaly.

Document current therapy on the prior authorization request.

Initial Authorization (Pathway 2): (b) Prescribed by or in consultation with an endocrinologist.

Allows continuation of existing Mycapssa therapy without repeating prior injectable requirements.

Reauthorization

Reauthorization covered when the following is documented:

Reauthorization: Documentation of positive clinical response to Mycapssa therapy (example: normalized serum IGF-1 level).

Authorization will be issued for 12 months when criteria are met; include recent laboratory results demonstrating response.

Coverage for Mycapssa (octreotide) varies by member benefit plan. Mycapssa is typically excluded from coverage for some plans; certain plans may apply tried/failed or step therapy requirements before Mycapssa will be considered. Refer to the specific member benefit plan to determine exclusion status and any additional benefit or coverage review requirements.

When Mycapssa is considered under a plan that permits coverage, prior authorization requirements apply and the policy expects documentation of diagnostic criteria and prior response/tolerance to injectable somatostatin analogs (octreotide or lanreotide) unless the member is already receiving Mycapssa. Authorization, when issued, is typically for 12 months.

Diagnostic and Coding Thresholds

OGTT GH threshold

OGTT GH threshold> 1 ng/mL after 2-hour OGTT

Test type2-hour oral glucose tolerance test (OGTT)

TimingMeasured at time of diagnosis

Diagnostic criteria for acromegaly

Confirmatory biochemical criteriaSerum GH > 1 ng/mL after a 2-hour OGTT

Alternative biochemical criteriaElevated serum IGF-1 above age- and gender-adjusted normal range

Associated drug indicationMycapssa (octreotide) indicated for long-term maintenance in patients who have responded to and tolerated octreotide or lanreotide

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approval is granted when the diagnosis of acromegaly is documented and prior response and tolerance to injectable somatostatin analogs is shown.

Authorization duration: 12 months
Prescribed by or in consultation with an endocrinologist

Step Therapy

Step Therapy Expectations

Step therapy: Members must have trialed and shown response and tolerance to an injectable somatostatin analog prior to approval of oral Mycapssa, unless exceptions are documented and justified by the provider.

Accepted prior agents: Octreotide (e.g., Sandostatin, Sandostatin LAR)
Accepted prior agents: Lanreotide (e.g., Lanreotide Injection, Somatuline Depot)
If patient cannot be maintained on injectable therapy, provider must submit clinical justification

Initial Therapy — Conditions for Starting Mycapssa

Initial therapy

Initial therapy approval conditions

Initial therapy options: Either: (1) prior documented response and tolerance to octreotide or lanreotide with clinical justification for switching to Mycapssa; OR (2) patient is already on Mycapssa therapy.

Prescriber must be or consult with an endocrinologist; injectable somatostatin analog coverage may be subject to separate review.

Continuation / Alternative Pathway

Continuation therapy

Continuation/initial-therapy alternative pathway

Current Mycapssa users: Patient currently on Mycapssa therapy and prescribed by or in consultation with an endocrinologist.

Allows approval without repeating prior injectable therapy requirements.

Step Therapy Expectations and Prior Treatment

Step	Requirement	Notes
1	Prior response and tolerance to an injectable somatostatin analog (octreotide OR lanreotide) documented	Examples: Octreotide (e.g., Sandostatin, Sandostatin LAR) or Lanreotide (e.g., Lanreotide Injection, Somatuline Depot). Injectable products may be subject to additional benefit and coverage review requirements.
2	Provider submits clinical justification why the patient cannot be maintained on current octreotide or lanreotide therapy	Required for patients switching from injectables to Mycapssa; justification must explain inability to continue injectable therapy.
3	Prescription by or in consultation with an endocrinologist	Prescriber requirement applies to initial authorization; allows special consideration for current Mycapssa users when consult documented.
Exception	Patient is currently on Mycapssa therapy	If member is already receiving Mycapssa and prescribed by or in consultation with an endocrinologist, prior injectable requirement is not required.
Coverage note	Mycapssa may be excluded from coverage for some plans; tried/failed criteria may apply	Refer to member specific benefit plan; state mandates and other policies may impact coverage and authorization duration (authorization issued for 12 months when criteria met).

Supply, Site-of-Care, and Coverage Limits

Note

Site-of-care and coverage limits may be affected by supply limits, mandates, and plan benefits

Supply limits, state mandates, federal requirements, and the member's specific benefit plan may affect coverage and site-of-care rules; Mycapssa is typically excluded from coverage for some plans—refer to plan specifics.

Authorizations are issued for 12 months when criteria are met; state mandates and member-specific benefit plans may alter coverage (chunk 6).
Supply limits may be in place; other policies and utilization programs may apply (chunk 7).
Mycapssa is typically excluded for some plans and tried/failed criteria may apply—check plan exclusions (chunk 6).

Background and Indication

Mycapssa (octreotide) is an oral somatostatin analog indicated for long-term maintenance treatment of acromegaly in patients who have responded to and tolerated treatment with injectable somatostatin analogs such as octreotide or lanreotide. Clinical monitoring for acromegaly typically includes growth hormone assessment (for example, GH measurement after a 2‑hour oral glucose tolerance test) and measurement of age‑ and gender‑adjusted serum IGF‑1.

The policy requires prior authorization for Mycapssa. Initial approval is generally granted when diagnosis is confirmed (for example GH >1 ng/mL after a 2‑hour OGTT or elevated age/gender‑adjusted IGF‑1) and there is documentation of prior response and tolerance to injectable octreotide or lanreotide, or when the member is already on Mycapssa and the medication is prescribed by or in consultation with an endocrinologist. Reauthorization requires documentation of positive clinical response (for example normalized serum IGF‑1) and, when approved, authorizations are issued for 12 months.

Definitions and Diagnostic Criteria

Diagnostic criteria for acromegaly

Confirmatory biochemical criteriaSerum GH > 1 ng/mL after a 2-hour OGTT

Alternative biochemical criteriaElevated serum IGF-1 above age- and gender-adjusted normal range

Associated drug indicationMycapssa (octreotide) for long-term maintenance in patients who responded to and tolerated injectable somatostatin analogs