CurrentUnitedHealthcarePolicy N/A

Palsonify (paltusotine) — Prior Authorization (Pharmacy)

Prior authorization requirements for Palsonify (paltusotine) for the treatment of adults with acromegaly; applies to UnitedHealthcare pharmacy benefit members where the program is in effect.

Policy Summary

PayerUnitedHealthcare

PolicyPalsonify (paltusotine) prior authorization for adults with acromegaly

Policy CodePolicy N/A

Change TypeNew prior authorization program

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis of acromegaly, patient age ≥18, and inadequate response to or non‑candidacy for surgery.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program established for Palsonify (paltusotine).

12 monthsinitial authorization length

12 monthsreauthorization length

≥18minimum age

Inadequate response OR not candidatesurgical status

Coverage Criteria for Palsonify (paltusotine)

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inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Authorization for Palsonify

Age and diagnosis: Diagnosis of acromegaly; patient >= 18 years old
Surgical criteria: Either inadequate response to surgery OR patient not a candidate for surgery

Initial Therapy: Diagnosis of acromegaly; patient >= 18 years; inadequate response to surgery OR not a candidate for surgery; approval for 12 months.

inv-02: Continuation / Reauthorization — Covered when ALL of the following are met

Covered when ALL of the following are met

Reauthorization for Palsonify: Documentation of positive clinical response to Palsonify therapy.

Authorization will be issued for 12 months

Reauthorization: Documentation of positive clinical response to Palsonify therapy; reauthorization for 12 months.

Patients under 18 years of age are excluded from initial authorization. The policy requires the patient to be ≥ 18 years old as one of the mandatory criteria for approval of Palsonify (paltusotine) for acromegaly; without meeting this age threshold the initial request does not satisfy the coverage criteria.

At reauthorization, approval is contingent on documentation demonstrating a positive clinical response to Palsonify therapy. Failure to provide such documentation is a valid basis for determining the continuation request as not medically necessary and may result in denial of reauthorization.

Initial Therapy

inv-11: Initial Therapy — Initial approval criteria

Initial approval criteria

Initial Therapy: Diagnosis of acromegaly; patient >= 18 years; inadequate response to surgery OR not a candidate for surgery; approval for 12 months.

Continuation / Reauthorization Criteria

inv-12: Reauthorization — Reauthorization requirement

Reauthorization requirement

Reauthorization: Documentation of positive clinical response to Palsonify therapy; reauthorization for 12 months.

Provider Actions and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Palsonify (paltusotine). Initial approvals are granted only when all specified criteria are met: diagnosis of acromegaly, patient is ≥ 18 years old, and either inadequate response to surgery or patient is not a candidate for surgery. Initial authorization duration: 12 months.

Initial approval requires diagnosis of acromegaly, age ≥ 18, and either inadequate surgical response or not a surgical candidate
Authorization duration: 12 months

Note

Additional Authorization Rules

Supply limits, medical necessity review, and automated approval based on prior claim/medication history may apply. UnitedHealthcare may use previous claims, diagnosis codes, and claim logic to approve initial or reauthorization requests; program-specific automated processes vary.

Supply limits may apply
Medical necessity reviews may be required
Automated approval or re-approval may be granted based on prior claim/medication history and diagnosis codes

Documentation Required

Required Documentation

Providers must submit documentation supporting the diagnosis of acromegaly, patient age, and surgical response or candidacy for initial requests. For reauthorization, documentation of a positive clinical response to Palsonify therapy is required. State mandates and member-specific benefit plans may affect required documentation.

Documentation of acromegaly diagnosis (ICD-10)
Documentation of patient age (≥ 18 years)
Evidence of inadequate response to surgery OR documentation that patient is not a surgical candidate
For reauthorization: documentation of positive clinical response to therapy

Denial Risk

Triggers for Denial

Denial is likely if the patient does not meet the eligibility criteria: age < 18, no diagnosis of acromegaly, or lacks documentation of inadequate surgical response or not being a surgical candidate. Denials may also occur if required documentation is not provided or if medical necessity is not established.

Patient is under 18 years of age
No diagnosis of acromegaly documented
No documentation of inadequate response to surgery and patient is not shown to be a surgical candidate
Insufficient clinical documentation to demonstrate medical necessity

Definitions

Inadequate response to surgery — definition entry

TermInadequate response to surgery

DefinitionClinical situation in which acromegaly persists despite prior pituitary surgery, indicated in policy as a criterion for Palsonify when the patient has not achieved adequate disease control after surgery.

Related coverage ruleOne qualifying surgical criterion for initial authorization of Palsonify is 'inadequate response to surgery' (alternative to 'not a candidate for surgery').

Background

Palsonify (paltusotine) is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who have had an inadequate response to surgery or who are not candidates for surgery. The policy’s authorization criteria reflect this indication by requiring a diagnosis of acromegaly, an age of ≥ 18 years, and either evidence of inadequate response to surgery or documentation that the patient is not a candidate for surgery.

Step Therapy

Step	Requirement / Notes
0	No specific step therapy sequencing is detailed in the policy. UnitedHealthcare may use automated approval or re-approval based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic. Supply limits and medical necessity review may apply.

Quantity Limits

Palsonify (paltusotine) — supply limits

DrugPalsonify (paltusotine)

Quantity limit noteSupply limits may be in place for Palsonify; programs may enforce per-month limits.

Approval automationUnitedHealthcare may use previous claim/medication history, diagnosis codes, and automated processes that can affect supply approvals.

Medical necessityMedical necessity review may be applied in addition to supply limits.

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