CurrentUnitedHealthcarePolicy N/A

Palsonify (paltusotine) prior authorization

Defines UnitedHealthcare Pharmacy prior authorization and reauthorization criteria for Palsonify (paltusotine) for adults with acromegaly; applies to members and providers subject to UnitedHealthcare pharmacy clinical programs.

Policy Summary

PayerUnitedHealthcare

PolicyPalsonify (paltusotine) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization by documenting diagnosis of acromegaly, patient is ≥18, and either inadequate response to surgery or not a candidate for surgery.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization duration

≥18minimum age

1program number

Prior Authprogram type

Coverage Criteria for Palsonify (paltusotine)

Initial Therapy — Covered when ALL of the following are met

Policy Summary

PayerUnitedHealthcare

PolicyPalsonify (paltusotine) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization by documenting diagnosis of acromegaly, patient is ≥18, and either inadequate response to surgery or not a candidate for surgery.

SourceLink

On This Page

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Covered when ALL of the following are met

Initial Authorization

A: Diagnosis of acromegaly
B: Patient is >= 18 years old
C
- C1: Inadequate response to surgery
- C2: Patient is not a candidate for surgery

Continuation Therapy / Reauthorization — Covered when ALL of the following are met

Covered when ALL of the following are met

Reauthorization

A: Documentation of positive clinical response to Palsonify therapy

The policy document does not list any explicit exclusions for Palsonify (paltusotine). Reviewers should interpret coverage decisions according to the stated authorization criteria and usual UnitedHealthcare pharmacy program rules, but no discrete exclusion provisions are specified in this policy text.

The policy does not contain any explicit statements labeling use of Palsonify (paltusotine) as "not medically necessary." Coverage determinations are governed by the specified authorization criteria rather than by any separate not-medically-necessary language in this document.

Initial Authorization Requirements

Initial Authorization

Initial authorization requirements

A: Diagnosis of acromegaly
B: Patient is >= 18 years old
C
- C1: Inadequate response to surgery
- C2: Patient is not a candidate for surgery

Reauthorization / Continuation Requirements

Reauthorization

Reauthorization requirement

Reauthorization: Documentation of positive clinical response to Palsonify therapy

Authorization will be issued for 12 months

Coding and Age Limits

No specific codes providedmixed

No codes listed

Minimum age

Minimum patient age>= 18 years

Applies toAdults with acromegaly

Related authorization durationInitial authorization issued for 12 months

Provider Responsibilities and Authorization Alerts

Prior Authorization

Prior Authorization Required

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

Initial authorization approval period: 12 months
Required initial criteria: diagnosis of acromegaly; age ≥ 18; inadequate response to surgery OR not a candidate for surgery

Step Therapy

No step therapy specifics are provided in this document. If a step therapy program applies, follow the payer’s separate step therapy requirements or prior authorization pathway.

Document does not specify step therapy agents, sequences, or exemptions
Confirm any applicable step therapy programs via UnitedHealthcare clinical policies or PA portal

Documentation Required

Reauthorization Documentation Requirements

For reauthorization, submit documentation demonstrating a positive clinical response to Palsonify. Reauthorization approvals are issued for 12 months. Lack of required documentation may result in denial.

Reauthorization requirement: documentation of positive clinical response
Reauthorization approval period: 12 months
Include relevant claim/medication history and ICD-10 diagnosis codes as available

Denial Risk

Denial Risk Conditions

Denials may occur if required documentation or criteria are not met. Examples include missing documentation that the patient meets age or diagnosis criteria, no evidence of prior response when required, or absence of necessary claim/medication history. UnitedHealthcare may also deny if supply limits or medical necessity criteria are not satisfied.

Common denial risks: missing proof of diagnosis (acromegaly), missing age documentation (≥ 18), no documentation of inadequate surgical response or ineligibility for surgery, no evidence of positive clinical response for reauthorization
UnitedHealthcare may rely on previous claims/medication history, ICD-10 codes, and automated approval logic — absence of these may affect decisions

Background

Palsonify (paltusotine) is described in the policy as a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. The authorization criteria align with this labeled indication for adult patients.

Definitions

Palsonify (paltusotine)

Drug name (generic)Paltusotine

Brand namePalsonify

Drug class / mechanismSomatostatin receptor agonist

Indication (per policy)Treatment of adults with acromegaly who had an inadequate response to surgery or are not candidates for surgery

Step Therapy Requirements

Step	Requirement
1	No step therapy requirements specified in this document.

Quantity Limits

Supply limits

Quantity/supply limitsSupply limits may be in place

Authorization may considerPrevious claim/medication history, ICD-10 diagnosis codes, and claim logic

Medical necessityMedical necessity rules may apply

Site of Care

Note

No site-of-care requirement specified

The policy does not impose a site-of-care requirement for Palsonify.