PALSONIFY (paltusotine) prior authorization for acromegaly
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Defines prior authorization requirements and coverage criteria for PALSONIFY (paltusotine) for treatment of acromegaly in adult Mississippi Medicaid members.
No material clinical or coverage changes in this revision.
Coverage Criteria for PALSONIFY (paltusotine)
Initial Authorization
Covered when ALL of the following are met
Re-Authorization
Covered when ALL of the following are met
Coverage for PALSONIFY (paltusotine) requires prior authorization and is limited to adult Mississippi Medicaid members who meet all listed eligibility criteria. Age: the patient must be 18 years or older. Diagnosis: there must be a confirmed diagnosis of acromegaly supported by an elevated IGF-1 above the age‑ and sex‑specific laboratory reference range and compatible clinical signs or symptoms. Surgical history/candidacy: the patient must have had pituitary surgery with inadequate biochemical or clinical response, or be documented as not a surgical candidate. Prior therapy: the patient must have documented ≥6‑month trials with inadequate response, intolerance, or contraindication to both long‑acting injectable somatostatin analogs (octreotide LAR and lanreotide) and a ≥6‑month trial with inadequate response, intolerance, or contraindication to oral octreotide (MYCAPSSA). Prescriber specialty: PALSONIFY must be prescribed by, or in consultation with, an endocrinologist. Dosing requirement: the prescribed dose must not exceed the stated maximum dosing limit.
Requests that exceed the policy's recommended maximum daily dose will not meet coverage criteria. The policy specifies a maximum allowable dose of 60 mg once daily; doses above this threshold are not supported for coverage. Additionally, therapy will not be approved if required prior trials or supporting documentation are absent—specifically, lack of documented trials/intolerance/contraindication to octreotide LAR, lanreotide, and oral octreotide (MYCAPSSA), absence of a confirmed IGF‑1 elevation with clinical correlation, age under 18 years, or missing endocrinology prescriber/consultation documentation are grounds for non‑coverage.
Referenced Drugs, Dosing, and Codes
| PALSONIFY (paltusotine) | Drug referenced in policy (oral paltusotine formulations 20 mg and 30 mg tablets); dosing limited to 60 mg once daily max. |
| MYCAPSSA | Oral octreotide referenced as required prior therapy |
| octreotide LAR | Long-acting injectable somatostatin analog required as prior therapy |
| lanreotide | Long-acting injectable somatostatin analog required as prior therapy |
Provider Requirements and Authorization Process
Prior authorization required — initial approval conditions
Prior authorization is required for PALSONIFY (paltusotine). Initial approvals will be considered for adults (≥18 years) with confirmed acromegaly after inadequate biochemical/clinical response to pituitary surgery or if not a surgical candidate, when prescribed by or in consultation with an endocrinologist, following required prior therapy trials, and when the prescribed dose does not exceed 60 mg once daily. Initial authorization duration: 6 months.
- Patient age ≥18
- Confirmed acromegaly (elevated IGF-1 and clinical symptoms)
- Prior surgery inadequate response or not a surgical candidate
- Prescribed by or in consultation with an endocrinologist
- Dose ≤ 60 mg once daily
- Initial approval length = 6 months
Step therapy: required ≥6-month trials of specified somatostatin analogs
Before PALSONIFY will be approved, document at least one ≥6-month trial with inadequate response, intolerance, or contraindication to each required somatostatin analog: both long-acting injectables (octreotide LAR and lanreotide) and oral octreotide (MYCAPSSA).
- ≥6-month trial with inadequate response/intolerance/contraindication to octreotide LAR
- ≥6-month trial with inadequate response/intolerance/contraindication to lanreotide
- ≥6-month trial with inadequate response/intolerance/contraindication to MYCAPSSA (oral octreotide)
Required documentation to support prior authorization
Submit the Universal PA Form plus supporting clinical documentation demonstrating the coverage criteria are met.
- Completed Universal PA Form
- Diagnosis of acromegaly with IGF-1 lab results (above age/sex reference range)
- Clinical symptom documentation consistent with acromegaly
- Surgical history or rationale if not a surgical candidate
- Records showing ≥6-month trials (or intolerance/contraindication) to octreotide LAR, lanreotide, and oral octreotide (MYCAPSSA)
- Prescribing clinician specialty or endocrinology consultation note
- Prescribed dosing plan showing dose ≤ 60 mg once daily
Denial triggers — failure to meet PA or criteria
Claims or requests lacking an approved prior authorization or missing required documentation/criteria are at risk of denial. Specific denial triggers include patients under 18, absence of documented elevated IGF-1 or clinical symptoms, missing required prior therapy trials or intolerance documentation, and doses exceeding 60 mg once daily.
- No prior authorization obtained
- Patient < 18 years of age
- No documented elevated IGF-1 or clinical symptom evidence of acromegaly
- No documentation of ≥6-month trials (or intolerance/contraindication) to octreotide LAR, lanreotide, and MYCAPSSA
- Prescribed dose > 60 mg once daily
Key Clinical Definitions
Background on PALSONIFY (paltusotine)
PALSONIFY (paltusotine) is an oral somatostatin receptor agonist indicated for the treatment of acromegaly in adults who have had an inadequate response to pituitary surgery or for whom surgery is not an option. The drug is available as 20 mg and 30 mg tablets, with a recommended starting dose of 40 mg once daily, the option to temporarily reduce to 20 mg once daily for tolerability, and the possibility of increasing to 60 mg once daily after 2–4 weeks based on IGF‑1 response. Prior authorization is required and coverage is contingent on meeting the policy's diagnostic, prior‑therapy, prescriber, and dosing criteria.
Policy Revision History
Policy effective date: PALSONIFY (paltusotine) prior authorization criteria became effective.
Initial authorization criteria defined, including age ≥18, confirmed acromegaly with elevated IGF-1 and symptoms, prior pituitary surgery or non‑surgical candidacy, endocrinologist prescriber or consultation, required ≥6‑month trials of octreotide LAR and lanreotide and a ≥6‑month trial of oral octreotide (MYCAPSSA), and maximum dose ≤60 mg once daily (initial approval duration: 6 months).
Re-authorization criteria defined requiring documented clinical response (IGF-1 normalization or meaningful reduction and symptom improvement/stabilization) and continued dosing ≤60 mg once daily (re-authorization duration: 1 year).
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