CurrentMass General Brigham Health PlanPolicy N/A

Palsonify (paltusotine) prior authorization for acromegaly

Covers prior authorization requirements for Palsonify (paltusotine) under the pharmacy benefit for Mass General Brigham Health Plan commercial/exchange members; describes initial and continuation criteria, specialty fill, and quantity limits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyPalsonify (paltusotine) prior authorization for acromegaly

Policy CodePolicy N/A

Change TypeNew policy

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit prior authorization with diagnosis, pretreatment IGF-1 lab, documentation of surgery status or trial/failure of one SRL, and endocrinology involvement.

SourceLink

POLICY UPDATE CHANGES

New policy establishing prior authorization criteria for Palsonify (paltusotine) effective 05/01/2026.

6 monthsinitial approval duration

12 monthsreauthorization duration

2/dayquantity limit

Commercial/Exchangeplan applicability

Coverage Criteria for Palsonify (paltusotine)

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Initial Authorization

Authorization may be granted when all of the following criteria are met:

Initial Authorization Criteria: 1. Diagnosis of acromegaly

Pretreatment Biochemical Evidence: 2. Submission of laboratory report indicating member has a high pretreatment IGF-1 level for age and/or gender based on the laboratory reference rangehigh pretreatment IGF-1 for age/gender

Attach lab report showing IGF-1 and reference range.

Surgery History / Eligibility

a: Member has had an inadequate or partial response to surgery
Document biochemical or clinical persistence after surgery.
b: Member is not a candidate for surgery
Document clinical reasons surgery is not appropriate.

Prescriber Requirement: 4. Requested medication is prescribed by or in consultation with an endocrinologist

Include prescriber specialty or consultation notes.

Prior SRL Trial Requirement

a: Sandostatin LAR
b: Mycapssa
c: Somatuline Depot

Continuation Therapy

Reauthorization / Continuation of Therapy

Continuation Criteria: 1. Submission of laboratory reports or chart notes indicating member's IGF-1 level has decreased or normalized since initiation of therapy.decreased or normalized IGF-1

Provide recent IGF-1 lab results with reference ranges and dates comparing baseline to on-therapy values.

This policy applies to Commercial/Exchange membership. MassHealth UPPL is not selected for this document. Palsonify (paltusotine) is administered under the pharmacy benefit and is designated as a specialty medication that must be filled at a contracted specialty pharmacy; prior authorization is required for coverage.

Therapy with Palsonify will be considered only when appropriate documentation is submitted. Use of the drug without medical records confirming a diagnosis of acromegaly and a pretreatment laboratory report showing an elevated IGF‑1 for age/gender will be considered not medically necessary. Prior to approval, chart notes must document either an inadequate or partial response to pituitary surgery or that the patient is not a candidate for surgery. The prescriber must be an endocrinologist or document consultation with an endocrinologist. A trial and documented trial and failure, inadequate response, or intolerance to ONE of the listed somatostatin receptor ligands (Sandostatin LAR, Mycapssa, or Somatuline Depot) is required. For members new to the plan (coverage effective date ≤90 days), submit medical records showing the member is currently receiving the requested drug when applicable.

Prescriber and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required under the pharmacy benefit for this specialty medication. These products are designated specialty and must be filled at a contracted specialty pharmacy. Initial approvals will be granted for 6 months; reauthorizations will be granted for 12 months.

Benefit: Pharmacy benefit (specialty fill required at contracted specialty pharmacy)
Initial approval duration: 6 months
Reauthorization duration: 12 months
Contact (Pharmacy Benefit): Phone 800-711-4555; Fax 844-403-1029
Contact (Medical Benefit): Phone 833-895-2611; Fax 888-656-6671

Note

Prescriber Requirement

The requested medication must be prescribed by an endocrinologist or prescribed in consultation with an endocrinologist. Include documentation of the endocrinologist involvement in the medical record or chart notes submitted with the request.

Step Therapy

Step Requirement — ONE Agent

Authorization requires documentation of a trial and failure, inadequate response, or intolerance to ONE of the following somatostatin analog agents before initial approval:

Sandostatin LAR
Mycapssa
Somatuline Depot

Documentation Required

Documentation & Denial Triggers

Submit medical records/chart notes that include: diagnosis of acromegaly; pretreatment IGF-1 laboratory report showing elevated IGF-1 for age/gender per lab reference range; and documentation of prior surgery attempt/response or documentation that surgery is not an option. Failure to submit the required documentation (diagnosis, pretreatment IGF-1, and required prior therapy or surgical documentation) may result in denial.

Required documentation: medical records/chart notes with diagnosis of acromegaly
Required documentation: pretreatment IGF-1 lab report (high for age/gender per reference range)
Required documentation: records indicating inadequate/partial response to surgery OR documentation member is not a surgical candidate
Required documentation: documentation of trial and failure, inadequate response, or intolerance to ONE listed somatostatin analog (if applicable)
Note: New-to-plan members (coverage effective date ≤ 90 days) must submit records showing current treatment with the requested drug (excluding samples or manufacturer assistance program supply)

Background on Paltusotine and Indication

Paltusotine is an oral somatostatin receptor agonist indicated for adults with acromegaly who have had an inadequate response to surgery or who are not candidates for surgery. Authorization requires confirmation of diagnosis and biochemical evidence with a pretreatment elevated IGF‑1, documentation of surgical inadequacy or ineligibility, prescriber endocrinology involvement, and a documented trial and failure or intolerance to one of the listed somatostatin receptor ligands. Initial approvals are granted for 6 months with reauthorizations for 12 months, and dosing is subject to a quantity limit of 2 tablets per day.

Definitions and Clinical Terms

inv-13: Acromegaly definition — description and clinical context (IGF-1, cause, standard treatments)

DefinitionAcromegaly: disorder typically caused by growth hormone–secreting pituitary adenomas leading to elevated IGF-1

Diagnostic requirementAuthorization requires documented diagnosis of acromegaly and a pretreatment IGF-1 laboratory report showing high IGF-1 for age/gender

Typical causesUsually due to growth hormone–secreting pituitary adenomas

Standard treatmentsFirst-line: pituitary surgery; medical options include somatostatin receptor ligands (injectable and oral) and other agents as appropriate

inv-14: Inadequate response / not candidate for surgery — definition and documentation expectations

DefinitionInadequate response to surgery or not a surgical candidate: medical record documentation showing either an inadequate/partial biochemical or clinical response after surgery, or documentation that the patient is not a candidate for surgery

Documentation expected at initial authorizationChart notes or medical records indicating prior surgical outcome (inadequate/partial response) or reasons patient is not a surgical candidate

Additional documentation for authorizationPretreatment IGF-1 laboratory report and records of prior trial and failure, inadequate response, or intolerance to ONE listed somatostatin receptor ligand (Sandostatin LAR, Mycapssa, or Somatuline Depot)

OpenPayer

Palsonify (paltusotine) prior authorization for acromegaly

Coverage Criteria for Palsonify (paltusotine)

Coding and Quantity Limits

Prescriber and Prior Authorization Requirements

Background on Paltusotine and Indication

Definitions and Clinical Terms