Somatostatin Analogs - Mycapssa
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Cigna's coverage policy for Mycapssa (octreotide delayed-release capsules) specifying prior authorization, prescribing clinician requirements, and medical necessity criteria for treatment of acromegaly in members of Cigna-administered health plans.
Changed documentation wording to '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'.
Changed response documentation requirement wording to 'According to the prescriber, patient has responded to one octreotide acetate injection product or Somatuline Depot (lanreotide injection)'.
Preferred product criteria updated to require trial of ONE of octreotide ER injectable suspension, Somatuline Depot, or lanreotide subcutaneous injection.
Policy title updated from 'Mycapssa' to 'Somatostatin Analogs - Mycapssa'.
Coverage Criteria
Initial Therapy (Acromegaly)
Mycapssa is considered medically necessary when ALL of the following are met; approve for 1 year:
ALL of the following
- 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.
- Note: 'Pretreatment (baseline)' refers to the IGF-1 level prior to the initiation of a somatostatin analog (examples include: Mycapssa [octreotide delayed-release capsules], octreotide acetate injections such as Sandostatin LAR Depot or generics, Signifor LAR, Somatuline Depot [lanreotide injection], dopamine agonists, or pegvisomant). Reference ranges for IGF-1 vary among laboratories.
- B: According to the prescriber, patient has responded to one octreotide acetate injection product or Somatuline Depot (lanreotide injection).
- C: The medication is prescribed by or in consultation with an endocrinologist.
- D: Preferred product criteria is met: patient has tried ONE of octreotide ER injectable suspension (Sandostatin LAR Depot or generic), Somatuline Depot, or lanreotide subcutaneous injection; for a Cipla lanreotide product use preferred billing J1930, NDC 69097-0906-67.
Use of Mycapssa (octreotide delayed-release capsules) for any indication other than acromegaly is considered not medically necessary.
Mycapssa for any other use is considered not medically necessary; criteria will be updated as new published data are available.
Coding and Key Clinical Values
| J1930 | Cipla lanreotide product preferred billing code noted |
| NDC: 69097-0906-67 | Preferred NDC for Cipla lanreotide product |
Provider Actions & Requirements
Prior authorization required for Mycapssa (approve for 1 year when criteria met)
Prior authorization is required for benefit coverage of Mycapssa. If criteria are met, approvals are provided for 1 year; the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated (endocrinologist).
- Approve for 1 year when all FDA‑approved indication criteria are met (see coverage criteria).
- Specialty prescriber requirement: prescribed by or in consultation with an endocrinologist.
Step therapy: trial of one injectable somatostatin analog required
Before Mycapssa may be approved, the patient must have tried ONE injectable somatostatin analog: octreotide ER injectable suspension (Sandostatin LAR Depot or generic), Somatuline Depot (lanreotide), or lanreotide subcutaneous injection.
- Trial of ONE injectable somatostatin analog is required prior to Mycapssa.
- If requesting a Cipla lanreotide product, preferred billing code is J1930 with NDC 69097-0906-67.
Required clinical documentation: baseline IGF‑1 and prescriber attestation of response
Documentation must indicate the patient has (or had) a pretreatment (baseline) IGF-1 level above the upper limit of normal based on age and gender for the reporting laboratory, and that, according to the prescriber, the patient has responded to one octreotide acetate injection product or Somatuline Depot (lanreotide).
- State the pretreatment (baseline) IGF‑1 value and the reporting laboratory’s age‑ and gender‑specific reference range.
- Include prescriber attestation that the patient responded to one injectable octreotide acetate product or Somatuline Depot.
Definition: pretreatment (baseline) IGF‑1 — timing and applicable injectables
'Pretreatment (baseline)' refers to the IGF‑1 level measured prior to initiation of a somatostatin analog (examples include Mycapssa, octreotide acetate injection products such as Sandostatin or Sandostatin LAR Depot, Signifor LAR, Somatuline Depot [lanreotide], dopamine agonists, or Somavert). Reference ranges for IGF‑1 vary among laboratories.
- Report the IGF‑1 value obtained before starting any somatostatin analog.
- List the injectable product(s) to which the pretreatment measurement applies (e.g., octreotide injectables, Somatuline Depot).
Coding and prior authorization requirement — claims lacking covered codes will be denied
Claims submitted without covered diagnosis/procedure codes or not meeting the policy criteria will be denied; prior authorization is required and approvals are time‑limited to the duration specified in the policy. When requesting a Cipla lanreotide product, use preferred coding (J1930, NDC 69097-0906-67) as noted in the preferred product table.
- Claims lacking covered codes under this Coverage Policy will be denied as not covered.
- Prior authorization must be obtained and approvals are provided for the duration stated (e.g., 1 year when criteria are met).
- Preferred product coding: J1930; NDC 69097-0906-67 for the Cipla lanreotide product.
Background
Mycapssa (octreotide delayed-release capsules) is approved for long-term maintenance treatment of acromegaly in patients who have responded to and tolerated injectable octreotide or lanreotide; somatostatin analogs are a first-line medical therapy for persistent or non-surgically managed acromegaly with goals of normalizing IGF-1, controlling symptoms, and preventing tumor growth.
Definitions
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