Palsonify (paltusotine) — Coverage Criteria (Arkansas PASSE)
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Defines prior authorization requirements and coverage criteria for Palsonify (paltusotine) for adult members with acromegaly under the pharmacy benefit for CareSource Arkansas PASSE.
New policy for Palsonify created.
Coverage Criteria for Palsonify (paltusotine)
Initial Therapy
Covered when ALL of the following are met for initial authorization
If all requirements met, approve for 6 months.
Continuation/Reauthorization
Covered for reauthorization when the following is met
If met, approve for an additional 12 months.
Palsonify (paltusotine) is considered not medically necessary for treatment of conditions not listed in this document. For any indication other than those explicitly covered here, providers should follow the payer's Off‑Label policy and obtain prior authorization as appropriate.
Use of Palsonify for indications other than acromegaly is considered not medically necessary. Requests for other diagnoses must be directed to and justified under the Off‑Label policy; coverage will not be granted based on this policy for non‑acromegaly indications.
Initial Therapy Requirements and Dosing
Initial therapy
Initial dosing and approval
Approval granted for 6 months if criteria met.
Reauthorization / Continuation Criteria
Reauthorization
Reauthorization requirement
Diagnostic and Monitoring Criteria
Quantity and Supply Limits
What Providers Must Do
Prior Authorization Required
Prior authorization is required for Palsonify (paltusotine). Initial approvals are granted for 6 months when all initial criteria are met; reauthorizations are granted for 12 months when reauthorization criteria are met.
- Initial approval: 6 months
- Reauthorization: 12 months
- Benefit type: Pharmacy
- Prior authorization required
No Step Therapy
No step therapy (failure of prior pharmaceutical agents) is required for Palsonify. The key provider requirement is documentation that surgery was inadequate or that the patient is not a surgical candidate.
- No step therapy required
- Prescriber: endocrinologist or in consultation with an endocrinologist
Required Documentation
Document the diagnosis of acromegaly with an elevated IGF-1 level, evidence of inadequate response to surgery or documentation that surgery is not an option, prescriber specialty (endocrinologist or consultation), and dosing/quantity information (initial 40 mg once daily, titrate to 60 mg once daily after 2–4 weeks as indicated; limit 60 tablets per 30 days). For reauthorization, include chart notes demonstrating normalized or improved (decreased) IGF-1.
- Diagnosis: acromegaly with elevated IGF-1
- Evidence of inadequate surgical response OR documentation surgery is not an option
- Prescribed by or in consultation with an endocrinologist
- Initial dosing: 40 mg once daily; titrate to 60 mg once daily after 2–4 weeks based on IGF-1
- Quantity limit: 60 tablets per 30 days
- Reauthorization: chart notes showing normalized or decreased IGF-1
Denial Triggers
Prior authorization is required and requests that do not meet the documented criteria may be denied. Common denial triggers include: patient age <18 years, absence of endocrinologist involvement or consultation, lack of documented elevated IGF-1, and missing documentation of inadequate surgical response or that surgery is not an option.
- Denial triggers: age < 18 years
- No endocrinologist involvement/consultation documented
- No documented elevated IGF-1
- No documentation of inadequate response to surgery or surgery not an option
- Failure to follow dosing/quantity limits
Key Definitions
Background and Rationale
Acromegaly results from growth hormone–secreting pituitary adenomas; surgical resection is preferred when possible as it offers the best chance for cure. Palsonify (paltusotine) is a somatostatin receptor agonist approved to treat adults with acromegaly who have had an inadequate response to surgery or for whom surgery is not an option. For reauthorization, chart notes must demonstrate normalized or improved (decreased) IGF‑1 to qualify for an additional 12 months of therapy.
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