Paltusotine (Palsonify) for acromegaly
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Defines medical necessity and prior authorization requirements for paltusotine (Palsonify) in adults with acromegaly for Centene-affiliated health plans (Commercial, HIM, Medicaid) and specifies approval durations and step therapy expectations.
No material clinical or coverage changes in this revision.
Coverage Criteria for Paltusotine (Palsonify)
inv-01: Initial Therapy — Acromegaly — Covered when ALL of the following are met:
Covered when ALL of the following are met:
Prior authorization required; approval durations: Medicaid/HIM 12 months; Commercial 6 months or to renewal date.
inv-02: Continuation Therapy — Acromegaly — For continued therapy, ALL of the following must be met:
For continued therapy, ALL of the following must be met:
Approval durations: Medicaid/HIM 12 months; Commercial 6 months or to renewal date.
inv-03: Other Diagnoses / Indications — Other uses not specifically covered by criteria:
Other uses not specifically covered by criteria:
References to specific Centene policy numbers provided in policy text.
Non-FDA approved indications that are not specifically addressed by this policy are not authorized for coverage unless the request includes sufficient documentation of efficacy and safety consistent with the applicable off-label use policy or the member’s evidence of coverage document.
Requests for use of paltusotine for non-FDA approved indications that lack adequate supporting documentation per the applicable off-label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, or CP.PMN.53 for Medicaid) are considered not authorized (not medically necessary) under this policy.
Product Availability and Dosing / Coding
| NDC/HCPCS not specified | No specific NDC or HCPCS codes listed in policy; product strengths: Tablets 20 mg and 30 mg |
| Paltusotine dosing - initial | Initial: 40 mg PO QD (may be temporarily reduced to 20 mg PO QD during initiation based on tolerability) |
| Paltusotine dosing - maintenance | Maintenance: after 2–4 weeks of 40 mg PO QD, may titrate to 60 mg PO QD based on IGF‑1 levels |
| Maximum daily dose | 60 mg per day; dosing guidance indicates maximum 2 tablets per day (per policy thresholds) |
Prior Authorization, Documentation, and Step Therapy Requirements
Prior Authorization Required
Prior authorization is required. Submit documentation demonstrating diagnostic criteria for acromegaly, evidence of endocrinologist involvement, age ≥ 18 years, prior treatments (including surgical resection or pituitary irradiation status), and other supporting clinical information.
- Required documentation: office chart notes, laboratory results (e.g., IGF-I, GH with oral glucose tolerance test), imaging or operative reports, and consultation notes.
- Approval durations: Medicaid/HIM — 12 months; Commercial — 6 months or to the member's renewal date, whichever is longer.
State-specific Step Therapy Exception (Illinois HIM)
For Illinois HIM (health insurance marketplace) requests, the Sandostatin LAR Depot (octreotide acetate) step therapy requirement does not apply beginning 1/1/2026 per Illinois HB 5395.
- Effective date of exception: 2026-01-01
- Scope: Illinois HIM requests only
Step Therapy Requirement — Octreotide LAR
Step therapy: prior failure of Sandostatin LAR Depot (octreotide acetate) is required before approval of Palsonify (paltusotine) unless the member has a contraindication to Sandostatin LAR or experienced clinically significant adverse effects.
- If Sandostatin LAR Depot is contraindicated or produced intolerable adverse effects, document the specific contraindication or adverse event.
- Prior authorization for Sandostatin LAR Depot may be required; document prior use and response when available.
Required Clinical Documentation
Provider must submit documentation (such as office chart notes, lab results, imaging, operative reports, or other clinical information) supporting that the member meets all approval criteria.
- Documentation should confirm diagnosis criteria (e.g., elevated pre-treatment IGF-I for age/gender or GH ≥ 1 µg/L post-OGTT), endocrinologist involvement, age ≥ 18, prior surgical or radiation treatment status, and prior medication history.
- Ensure documentation of dosing and therapeutic response or adverse effects to prior therapies when applicable.
Unsupported Indication or Missing Documentation
Requests for non-FDA approved (off-label) indications that are not addressed by this policy will not be authorized unless sufficient documentation is provided per applicable off-label use policies.
- Commercial off-label policy: CP.CPA.09
- HIM off-label policy: HIM.PA.154
- Medicaid off-label policy: CP.PMN.53
- Provide clinical evidence of efficacy and safety or evidence of coverage documentation to support approval for an unsupported indication.
Background
Paltusotine (Palsonify) is a somatostatin receptor agonist indicated for adults with acromegaly who have had an inadequate response to surgical resection or who are not surgical candidates. Clinical response is assessed by changes in growth hormone (GH) and insulin-like growth factor I (IGF‑I)
Diagnostic Criteria and Definitions
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