CurrentCignaPolicy N/A

Mycapssa (octreotide delayed-release) quantity management — quantity limits and dose-based exceptions

Defines quantity limits and medical-necessity exceptions for Mycapssa (octreotide delayed-release capsules) for Cigna-administered health benefit plans; affects providers prescribing and pharmacists dispensing Mycapssa.

Policy Summary

PayerCigna

PolicyMycapssa (octreotide delayed-release) quantity management — quantity limits and dose-based exceptions

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateFeb 5, 2026

Key ActionSubmit requests that meet the dose-based exception criteria to obtain an approved quantity (approvals are provided for 1 year).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

56Retail maximum (standard)

168Home delivery maximum (standard)

8460 mg/day retail

25260 mg/day home

11280 mg/day retail

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Coverage Criteria

inv-01: Quantity limit exceptions (dose-based)

Exceptions to standard quantity limits are covered as medically necessary when ONE of the following dose-based criteria is met:

60 mg/day dose: Patient requires 60 mg per dayApprove 84 capsules per 28 days (retail) or 252 capsules per 84 days (home delivery)

Supports approval for increased quantity only for documented clinical need for 60 mg/day dosing.

80 mg/day dose: Patient requires 80 mg per dayApprove 112 capsules per 28 days (retail) or 336 capsules per 84 days (home delivery)

Supports approval for increased quantity only for documented clinical need for 80 mg/day dosing.

Any exception to the quantity limits not meeting the listed dose-based criteria is considered not medically necessary.

Requests for quantities exceeding the listed maximums that do not meet the specified dose-based exception criteria are considered not medically necessary.

Coding

Product description (no billing codes provided)mixed

N/A	No specific procedure, HCPCS, CPT, ICD-10, or NDC codes listed in policy text; product described by strength and form (20 mg capsules)

Maximum recommended dose

Maximum recommended dose80 mg per day

Starting dose20 mg twice daily (20 mg BID) with titration based on IGF-1 and symptoms

Titration incrementsIncrease by 20 mg daily increments as needed

Provider Actions

Prior Authorization

Required submission and approval duration

Providers must submit prior authorization requests in accordance with applicable coverage policy criteria. All approvals are provided for 1 year from the date of approval.

Submit requests per Cigna clinical policy requirements
Approvals = 1 year

Denial Risk

Quantity limits and exception prior authorization

Quantity limits apply at the point of service. If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the criteria in this policy; claims exceeding quantity limits may be denied unless an exception is approved.

Retail maximum: 56 capsules per 28 days (2 wallets)
Home delivery maximum: 168 capsules per 84 days (6 wallets)

Background

Mycapssa (oral octreotide delayed-release) is a somatostatin analog indicated for long-term maintenance treatment of acromegaly in patients who have responded to and tolerated octreotide or lanreotide. The initial recommended dosing is 20 mg twice daily with titration based on IGF‑1 levels and clinical symptoms up to a maximum recommended dose of 80 mg per day.

Definitions

Mycapssa — product description and indication

ProductMycapssa (octreotide delayed-release) 20 mg oral capsules

IndicationLong-term maintenance treatment of acromegaly in patients who have responded to and tolerated octreotide or lanreotide

Dosing notesInitiate at 20 mg BID; titrate by IGF-1 and symptoms; specific administration guidance for 60 mg/day and 80 mg/day dosing in prescribing information

Initial Therapy Criteria

inv-12: Dosing

Dosing and titration guidance from prescribing information.

Starting dose: Initial recommended dose is 20 mg administered twice daily (BID); titrate based on IGF-1 levels and signs/symptoms; increase in 20 mg daily increments up to a maximum of 80 mg/day20 mg BID starting; max 80 mg/day

For 60 mg/day administer as 40 mg in the morning and 20 mg in the evening; for 80 mg/day administer as 40 mg twice daily.

Continuation / Approval Duration

inv-13: Approval duration

Approvals are provided for continuation up to 1 year when criteria are met.

Continuation approval duration: All approvals are provided for 1 year in duration1 year

Renewal must meet same criteria or applicable plan terms.

Quantity Limits

Standard quantity limits (retail)

Retail standard maximum quantity56 capsules per 28 days (2 wallets)

Strength and form20 mg capsules (28 capsules per wallet)

Home delivery standard maximum quantity168 capsules per 84 days (6 wallets)

Standard quantity limits (home delivery)

Home delivery standard maximum quantity168 capsules per 84 days (6 wallets)

Retail standard maximum quantity56 capsules per 28 days (2 wallets)

Strength and form

Policy Summary

PayerCigna

PolicyMycapssa (octreotide delayed-release) quantity management — quantity limits and dose-based exceptions

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateFeb 5, 2026

Key ActionSubmit requests that meet the dose-based exception criteria to obtain an approved quantity (approvals are provided for 1 year).

SourceLink

On This Page

Documentation Required

Exceptions to quantity limits

Exceptions to the stated quantity limits are covered as medically necessary only when the policy’s exception criteria are met. Any request that does not meet the exception criteria is considered not medically necessary and may be denied.

Exceptions allowed only when documented criteria are satisfied
Requests failing to meet exception criteria = Not medically necessary

Denial Risk

Denial risk for exceeding quantity limits

Providers should be aware of denial risk when prescribing quantities above the Drug Quantity Management limits; ensure documentation supports any exception request and submit supporting records with the prior authorization.

Ensure clinical documentation supports medical necessity for exceptions
Include supporting records with prior authorization submission to avoid denial

20 mg capsules (28 capsules per wallet)

Exception quantity — 60 mg/day (retail)

Exception — 60 mg/day (retail)84 capsules per 28 days

RationaleApproved when patient requires 60 mg per day

Administration guidanceFor 60 mg/day: administer 40 mg in morning and 20 mg in evening (per dosing guidance)

Exception quantity — 60 mg/day (home delivery)

Exception — 60 mg/day (home delivery)252 capsules per 84 days

RationaleApproved when patient requires 60 mg per day

Corresponding retail equivalent84 capsules per 28 days

Exception quantity — 80 mg/day (retail)

Exception — 80 mg/day (retail)112 capsules per 28 days

RationaleApproved when patient requires 80 mg per day

Administration guidanceFor 80 mg/day: administer as 40 mg twice daily (40 mg BID)

Exception quantity — 80 mg/day (home delivery)

Exception — 80 mg/day (home delivery)336 capsules per 84 days

RationaleApproved when patient requires 80 mg per day

Corresponding retail equivalent112 capsules per 28 days