Clinical Policy: Paltusotine (Palsonify)
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Defines medical necessity criteria, dosing limits, prior authorization expectations, and approval durations for Palsonify (paltusotine) for adult members with acromegaly across Commercial, HIM, and Medicaid lines of business.
Policy redirects to trial of Mycapssa and one of lanreotide or generic octreotide acetate LAR (or Sandostatin LAR Depot if generic is unavailable) as step therapy prior to Palsonify.
Illinois HIM requests are exempt from certain step therapy requirements per IL HB 5395 effective 1/1/2026.
Coverage Criteria for Paltusotine (Palsonify)
Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met
Step therapy exceptions and prior authorization requirements apply (see policy).
Continuation Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met
Response and continuation assessed per Appendix D.
Non‑FDA approved (off‑label) indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or unless coverage is supported by the member's evidence of coverage documents.
Coverage determinations and the administration of benefits under this clinical policy are governed by the member's coverage documents and applicable law and regulation. This policy is intended to guide medical necessity determinations but does not replace the terms, conditions, exclusions, and limitations contained in the member's evidence of coverage, certificate of coverage, or other contractual documents. Providers must comply with applicable state and federal requirements and Health Plan‑level administrative policies when requesting coverage.
Requests for use of Palsonify (paltusotine) for indications that are not FDA‑approved and are not explicitly covered by this policy require clear, supporting clinical documentation. Providers should follow the Health Plan's referenced off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) and submit evidence of efficacy and safety consistent with those policies. Absent adequate off‑label justification or supporting documentation, requests for non‑FDA indications will be considered not medically necessary and may be denied.
Coding and Dose Limits
| NDCs not listed | Product-specific NDCs not provided in this policy |
Prior Authorization, Documentation, and Step Therapy
Obtain prior authorization and submit required clinical evidence
Prior authorization is required. The provider must document the diagnosis of acromegaly (pre-treatment IGF‑I above lab ULN or serum GH ≥ 1 µg/L after a 2‑hour OGTT), that therapy was prescribed by or in consultation with an endocrinologist, age ≥18, inadequate response to or ineligibility for surgery/pituitary irradiation, prior failure of Mycapssa (unless contraindicated or adverse effects), prior failure of lanreotide or generic octreotide acetate LAR (or Sandostatin LAR if generic unavailable), and that the requested dose does not exceed 60 mg/day and 2 tablets/day.
- Document pre-treatment IGF‑I above lab ULN or GH ≥ 1 µg/L after 2‑hour OGTT
- Document endocrinologist involvement and member age ≥18
- Document inadequate response or not candidate for surgery/pituitary irradiation
- Document failure of Mycapssa (or contraindication/adverse effects) and failure of lanreotide or generic octreotide LAR (or Sandostatin LAR if generic unavailable)
- Document requested dose ≤ 60 mg/day and ≤ 2 tablets/day
Follow Health Plan benefit and administrative rules for prior authorization
Prior authorization requirements and coverage administration are governed by the member's Health Plan medical necessity guidance and applicable benefit documents; providers must follow plan-level administrative policies when requesting coverage or submitting claims.
- Coverage and prior authorization are subject to the Health Plan's coverage documents and administrative policies
- Effective dates and any plan-specific exemptions (e.g., Illinois HIM processing) are determined by the Health Plan
Step therapy: document trials/failures of Mycapssa and long‑acting somatostatin agents
Step therapy redirection requires documented failure of Mycapssa and documented failure of lanreotide or generic octreotide acetate LAR (or Sandostatin LAR if generic unavailable) unless contraindicated or clinically adverse effects occur; Illinois HIM requests are exempt from these step requirements per IL HB 5395 effective 1/1/2026.
- Show trial and failure of Mycapssa prior to Palsonify unless contraindicated or adverse effects
- Show trial and failure of lanreotide OR both generic octreotide acetate LAR (or Sandostatin LAR if generic unavailable) unless contraindicated/adverse effects
- Note IL HIM exemption under IL HB 5395 effective 1/1/2026
Expect plan-level utilization management to be applied
Plan-level utilization management, including step therapy and other utilization controls, may be applied consistent with Health Plan administrative policies when making coverage determinations.
- Utilization management actions are implemented per the Health Plan's administrative procedures
Provide required clinical documentation with requests
Submit supporting clinical documentation with the prior authorization request: office chart notes, relevant lab results (IGF‑I or GH post‑OGTT), documentation of prior therapies and responses, and consultation notes from an endocrinologist as applicable.
- Office chart notes documenting diagnosis and prior treatments
- Pre-treatment IGF‑I or 2‑hour OGTT GH results
- Documentation of trials/failures or contraindications for Mycapssa and listed somatostatin agents
- Endocrinology consultation or prescriber documentation
Comply with Health Plan administrative and billing policies
Providers must follow Health Plan-level administrative policies, coverage documents, and billing procedures when submitting claims or coverage requests; prior authorization and benefit rules are determined by the Health Plan.
- Adhere to evidence of coverage, certificate of coverage, provider billing procedures, and applicable state/federal requirements
Risk of denial for incomplete documentation or non‑covered indications
Requests lacking documentation that the member meets all approval criteria (e.g., missing labs, chart notes, or evidence of prior therapy trials) or requests for non‑FDA indications without adequate off‑label justification may be denied.
- Incomplete documentation of diagnostic criteria or prior therapy trials risks denial
- Non‑FDA indications require sufficient off‑label justification per referenced off‑label policies
Coverage subject to plan terms, exclusions, and administration
Coverage decisions are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable Health Plan administration; failure to meet those terms may result in non‑coverage.
- Coverage is governed by the member's policy documents and applicable laws/regulations
- Clinical policy guidance does not guarantee payment or override contract terms
For Medicaid members, follow state Medicaid provisions when they conflict
For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with this clinical policy; providers should follow the applicable state Medicaid manual and requirements for coverage determinations.
- If state Medicaid rules conflict with this policy, follow state Medicaid provisions
- Refer to the state Medicaid manual for applicable coverage provisions
Background on Paltusotine (Palsonify)
Paltusotine (Palsonify) is a somatostatin receptor agonist used in the management of acromegaly. This clinical policy is developed by licensed health care professionals to guide determination of medical necessity for adults with acromegaly and is based on current standards of medical practice, peer‑reviewed literature, regulatory approvals, and expert clinical input. The policy clarifies required documentation, utilization management expectations, and that coverage decisions remain subject to the member's benefit terms and applicable legal/regulatory requirements.
Definitions and Diagnostic Thresholds
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