CurrentCignaPolicy N/A

Signifor LAR

This document is a Cigna prior-authorization request form and clinical questionnaire to request coverage of Signifor LAR (pasireotide pamoate) injectable suspension for indications including acromegaly, Cushing's disease, and endogenous Cushing's syndrome. It captures patient/provider info, dosing, prior therapies, specialist involvement, and administration setting to support coverage decisions and claim billing.

Policy Summary

PayerCigna

PolicySignifor LAR

Policy CodePolicy N/A

Change Typeclarified

Effective Date

Next Review Date

Key ActionFax the completed and asterisk-complete prior authorization form to (855) 840-1678 or submit online via covermymeds.com or SureScripts; urgent requests call (800) 882-4462.

SourceLink

POLICY UPDATE CHANGES

Form v040126 provides procedure to fax or submit PA requests and lists clinical questions required to support prior authorization.

3Indications covered on form

2Dose limit tiers

1Specialist requirement

Coverage Summary

This is a Cigna prior-authorization request form and clinical questionnaire to request coverage of Signifor LAR (pasireotide pamoate) injectable suspension for indications including acromegaly, Cushing's disease, and endogenous Cushing's syndrome. The form captures patient and provider identifiers, medication strength and dosing, prior therapies, specialist involvement, baseline laboratory values, and administration/dispensing site information to support coverage decisions and claim processing. Follow submission instructions on the form to fax or submit the request.

Surface thresholds

Signifor LAR dose limit (Acromegaly)Each prescribed dose is 60 mg or less administered intramuscularly no more frequently than once every 28 days.

Signifor LAR dose limit (Cushing's disease)Each prescribed dose is 40 mg or less administered intramuscularly no more frequently than once every 28 days.

Signifor LAR dose limit (Endogenous Cushing's syndrome)Each prescribed dose is 40 mg or less administered intramuscularly no more frequently than once every 28 days.

Baseline IGF-1 requirement (Acromegaly)Pre-treatment (baseline) IGF-1 level above the laboratory upper limit of normal (ULN) for age and gender prior to initiation of any somatostatin analog, dopamine agonist, or pegvisomant.

Medical Necessity Criteria

General prior authorization requirements

Coverage will be considered when ALL of the following administrative and clinical items are provided:

Completed PA form and identifiers: Completed prior authorization form with required patient and provider identifiers (asterisked fields must be completed).
Due to privacy regulations outcome cannot be returned via fax unless all asterisked items are completed.
Medication specified: Medication requested specified (Signifor LAR with selected strength).
New start or continuation: Specify whether new start or continuation of therapy.
If patient has been taking samples, mark 'new start'.
Medication obtain/administration setting: Specify where medication will be obtained and where it will be administered; infusion must occur in least intensive, medically appropriate setting per some Cigna plans.
Include facility/dispensing tax ID and CPT code(s) if applicable. Medication may be obtained from Accredo (preferred specialty pharmacy) or other listed settings.
Submission instructions: Fax completed form to (855) 840-1678 or submit via covermymeds.com / SureScripts; urgent requests call (800) 882-4462.

Acromegaly - clinical criteria

Coverage for acromegaly indication when ALL of the following are met:

Acromegaly clinical criteria

Indication: Acromegaly.
Prior surgery/radiotherapy status
- Inadequate response to surgery/radiotherapy: Patient had an inadequate response to surgery and/or radiotherapy
- Not candidate for surgery/radiotherapy: Patient is not an appropriate candidate for surgery and/or radiotherapy
- Negative side effects due to tumor size: Patient is experiencing negative side effects due to tumor size (e.g., optic nerve compression)

Cushing's Disease - clinical criteria

Coverage for Cushing's disease when ALL of the following are met (branches differ for current vs new patients):

Cushing's disease clinical criteria

Indication: Cushing's disease.
Current vs not currently receiving
- Currently receiving - response documented: If currently receiving Signifor LAR/Signifor: prescriber documents that the patient has responded to Signifor/Signifor LAR as determined by the prescriber (e.g., decrease in mean urinary free cortisol).
- Not currently receiving - surgery status: If not currently receiving Signifor LAR/Signifor: prescriber documents whether patient is a candidate for surgery or whether surgery has been curative.
  For patients awaiting surgery, refer to endogenous Cushing's Syndrome criterion.

Endogenous Cushing's Syndrome - clinical criteria

Coverage for endogenous Cushing's syndrome when ALL of the following are met:

Endogenous Cushing's syndrome clinical criteria

Indication: Endogenous Cushing's syndrome.
Surgery candidacy/waiting/awaiting radiotherapy response
- Not candidate or surgery not curative: Patient is not a candidate for surgery or surgery has not been curative
- Awaiting surgery: Patient is awaiting surgery for endogenous Cushing's syndrome
- Awaiting radiotherapy response: Patient is awaiting therapeutic response after radiotherapy for endogenous Cushing's syndrome

Provider Actions

Prior Authorization

Submit completed PA form

Fax the completed and asterisk-complete prior authorization form or submit online to initiate review. For urgent requests call the phone number provided.

Fax: (855) 840-1678
Online: covermymeds.com or SureScripts (submit via EHR)
Urgent request phone: (800) 882-4462

Documentation Required

Provide baseline labs and prior therapy documentation

Provide documentation to support medical necessity including baseline laboratory values and prior therapy history. Include evidence of pre-treatment (baseline) IGF-1 for acromegaly, documentation of prior trial(s) of specified somatostatin analogs or lanreotide, evidence of response for patients already on therapy, and information about surgical candidacy when applicable.

Pre-treatment (baseline) IGF-1 level (for acromegaly) prior to initiation of any somatostatin analog, dopamine agonist, or pegvisomant
Prior trial of one of: octreotide ER injectable suspension (Sandostatin LAR Depot or generic), Somatuline Depot, or lanreotide subcutaneous injection
Response documentation for ongoing therapy (e.g., decrease in mean urinary free cortisol for Cushing's disease)
Whether patient is a candidate for surgery or surgical candidacy information

Billing Rule

Administration setting and billing site

Indicate where the drug will be obtained and where it will be administered, and provide facility/dispensing tax ID and relevant billing codes to support claims processing.

Specify acquisition site (e.g., Accredo Specialty Pharmacy, Hospital Outpatient, Retail, etc.) and administration site (home, physician office, hospital outpatient)
Provide facility and/or dispensing Tax ID# and facility name/address
Include CPT code(s) for administration on the form
Reference HCPCS/J-code guidance: J1930 noted as referenced preferred product coding for a Cipla lanreotide product

Step Therapy

Prior trial requirement for acromegaly

For acromegaly, the form requires documentation that the patient has tried one of the specified somatostatin therapies prior to Signifor LAR.

Prior trial of one of: octreotide ER injectable suspension (Sandostatin LAR Depot or generic), Somatuline Depot, or lanreotide subcutaneous injection

Coding Guidance

HCPCS / NDC / CPT guidance mentionedmixed

J1930

Referenced preferred product coding for Cipla lanreotide - (note: J1930 mentioned as preferred code for Cipla lanreotide product, NDC 69097-0906-67)

HCPCS / NDC / CPT guidance mentionedmixed

J1930

Referenced preferred product coding for Cipla lanreotide - (note: J1930 mentioned as preferred code for Cipla lanreotide product, NDC 69097-0906-67)

Background

This Cigna specialty drug prior-authorization form collects the clinical rationale and administrative details needed to determine medical necessity and process claims for Signifor LAR. The form requires completion of patient and provider identifiers (asterisked fields), medication requested (name, strength, dosing schedule), and whether the request is a new start or continuation of therapy.

It documents prior therapies and step-therapy history (for example, prior trial of octreotide LAR, Somatuline Depot, or lanreotide), baseline laboratory values (such as pre-treatment IGF-1 for acromegaly), and response documentation for ongoing therapy (for example, decrease in mean urinary free cortisol for Cushing's disease).

The form captures prescribing specialist details (including specialty, DEA/NPI/TIN) and asks whether the medication is prescribed by or in consultation with an endocrinologist or a physician specializing in Cushing's disease/syndrome. It also collects dosing and administration details (dose, frequency, site of administration) and facility/dispensing information (facility name, tax ID, CPT codes, and where the medication will be obtained and administered) to assist with billing and claims.

Submission instructions and contact options are provided (fax the completed form to the number on the form, submit via covermymeds.com or SureScripts, or call the urgent request number) to expedite review and processing.

Pre-treatment (baseline) IGF-1: IGF-1 level prior to initiation of any somatostatin analog, dopamine agonist, or pegvisomant; reference ranges vary by laboratory.

Revision History

v040126clarified

Form v040126 provides procedure to fax or submit PA requests and lists clinical questions required to support prior authorization.

v040126clarified

Fax completed form to (855) 840-1678; urgent requests call (800) 882-4462; online submission available via covermymeds.com or SureScripts.

v040126clarified

Form collects required clinical questions and fields including indication-specific questions (acromegaly, Cushing's disease, endogenous Cushing's syndrome), prior therapy, baseline labs (eg, pre-treatment IGF-1), dosing, prescriber specialty, and administration/dispensing site information to support prior authorization decisions.

Policy Summary

PayerCigna

PolicySignifor LAR

Policy CodePolicy N/A

Change Typeclarified

Effective Date

Next Review Date

Key ActionFax the completed and asterisk-complete prior authorization form to (855) 840-1678 or submit online via covermymeds.com or SureScripts; urgent requests call (800) 882-4462.

SourceLink

On This Page

Baseline IGF-1: Pre-treatment (baseline) IGF-1 level is above the laboratory upper limit of normal (ULN) for age and gender prior to initiation of any somatostatin analog, dopamine agonist, or pegvisomant.

Pre-treatment refers to IGF-1 prior to initiation of any listed therapies; reference ranges vary by laboratory.

Specialist involvement: Prescribed by, or in consultation with, an endocrinologist.

Form asks whether prescriber is an endocrinologist.

Prior trial of somatostatin analog or lanreotide: Patient has tried ONE of octreotide ER injectable suspension (Sandostatin LAR Depot or generic), Somatuline Depot or lanreotide subcutaneous injection.

May require prior authorization for those agents; Cipla lanreotide preferred coding note provided.

Dose limit: Each prescribed dose is 60 mg or less administered intramuscularly no more frequently than once every 28 days.dose <= 60 mg per 28 days

Specialist involvement for new patients: If not currently receiving Signifor LAR/Signifor: medication is prescribed by, or in consultation with, an endocrinologist or physician who specializes in treatment of Cushing's disease.

Dose limit: Each prescribed dose is 40 mg or less administered intramuscularly no more frequently than once every 28 days.dose <= 40 mg per 28 days

Specialist involvement: Medication is prescribed by, or in consultation with, an endocrinologist or a physician who specializes in the treatment of Cushing's syndrome.

Dose limit: Each prescribed dose is 40 mg or less administered intramuscularly no more frequently than once every 28 days.dose <= 40 mg per 28 days