CurrentCignaPolicy N/A

prior_authorization_form_onivyde

This document is a Cigna prior authorization request form to collect patient, prescriber, and clinical information needed to review coverage for Onivyde (irinotecan liposome) for oncology indications including pancreatic adenocarcinoma, ampullary adenocarcinoma, and biliary tract cancer; it includes logistics for submission, urgency attestation, and distribution channels for medication.

Policy Summary

PayerCigna

Policyprior_authorization_form_onivyde

Policy CodePolicy N/A

Change TypeOperational form (no material change)

Effective Date

Next Review Date

Key ActionFax the completed form to (855) 840-1678 or submit online via CoverMyMeds or SureScripts and include all required asterisked fields.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes reported.

1Form pages

5Standard response time (business days)

1Preferred specialty pharmacy (Accredo)

Policy overview

This is a Cigna prior authorization request form to collect patient, prescriber, and clinical information needed to review coverage for Onivyde (irinotecan liposome) for oncology indications including pancreatic adenocarcinoma, ampullary adenocarcinoma, and biliary tract cancer. The form captures patient identifiers (name, Cigna ID, DOB, contact and address), prescriber details (physician name, specialty, DEA/NPI/TIN, office contact and phone/fax), and request specifics (medication requested — Onivyde 43mg/10ml, ICD-10 diagnosis, dose, frequency, and duration). It also records where the medication will be obtained (including Accredo Specialty Pharmacy as Cigna’s nationally preferred specialty pharmacy, hospital outpatient, retail, home infusion, or physician office stock) and facility/dispensing details. Submission logistics include faxing the completed form to (855) 840-1678 or submitting online via CoverMyMeds or SureScripts; for urgent requests prescribers should call (800) 882-4462 to attest urgent need.

Operational metadata

Form pages1

Standard response time (business days)5

Preferred specialty pharmacy (Accredo)Accredo (preferred)

StatusCURRENT

SubjectOnivyde (irinotecan liposome) prior authorization form

PayerCigna

Information requested on the prior authorization form

Information requested to support prior authorization decision

Form fields and conditional clinical questions prescribers must complete to support a coverage decision for Onivyde

ALL of the following

Patient identifying information: Physician name, specialty, DEA/NPI/TIN, patient name, Cigna ID, DOB, patient/street/city/state/zip, contact phone/fax
Complete all asterisked items to allow fax response
Request details: medication requested (Onivyde 43mg/10ml), ICD-10 code, dose, frequency, duration
Site of medication obtainment: select one or more of Accredo Specialty Pharmacy, Hospital Outpatient, Retail pharmacy, Other, Home Health/Home Infusion vendor, Physician's office stock
Accredo is Cigna's nationally preferred specialty pharmacy
Diagnosis selection: Diagnosis related to use: select one or more: Ampullary adenocarcinoma; Biliary tract cancer; Pancreatic adenocarcinoma; Other

Clinical specifics if pancreatic adenocarcinoma

Combination and staging: Is medication given in combination with both fluorouracil (5-FU) and leucovorin? Yes/No; Does the patient have metastatic disease? Yes/No; Will the medication be given as first line therapy? Yes/No
If first line, further combination question applies
First-line combination: If given as first line therapy: Will it be given in combination with oxaliplatin, 5-FU, and leucovorin? Yes/No
Conditional on first-line = Yes
Prior therapy if not first-line: If not first line therapy: Was the patient previously treated with either a gemcitabine-based therapy, or a fluoropyrimidine-based therapy and no prior irinotecan? Yes/No; If previously treated: Did the patient have disease progression after therapy? Yes/No
Conditional on first-line = No
ECOG and prior regimens:

Clinical specifics if ampullary adenocarcinoma

Prior therapies: Was the patient previously treated with a gemcitabine-based therapy, fluoropyrimidine-based therapy if no prior irinotecan, or oxaliplatin-based therapy if no prior irinotecan? Yes/No; If previously treated: Did the patient have disease progression after therapy? Yes/No
Treatment initiation and contraindications: Has the patient already been started on Onivyde? Yes/No; If not already started: Baseline neuropathy? Yes/No; If not already started: Has the patient experienced an inadequate response, significant intolerance OR does the patient have a contraindication for irinotecan IV infusion? Yes/No

Clinical specifics if biliary tract cancer

Disease status: Does the patient have unresectable or resected gross residual (R2) disease, or metastatic disease? Yes/No
Progression after prior systemic therapy: Did the patient have progression of disease during or after previous systemic treatments? Yes/No

Additional information and attestation: Additional pertinent information and prescriber attestation and signature/date

Provider must attest accuracy; plan may audit and request records

The form flow is conditional: after basic patient and request details, diagnosis selection triggers disease-specific clinical questions. For pancreatic adenocarcinoma the form asks about metastatic status, whether Onivyde is first-line or subsequent therapy, combination with 5-FU/leucovorin (and if first-line, with oxaliplatin), prior therapies (gemcitabine- or fluoropyrimidine-based without prior irinotecan), ECOG performance status (0–4) with follow-up branching (e.g., if ECOG 0–1 ask about prior gemcitabine; if no gemcitabine ask about fluoropyrimidine without irinotecan), and whether the patient has already started Onivyde, baseline neuropathy, progression after prior therapy, or intolerance/contraindication to irinotecan. For ampullary and biliary tract indications analogous conditional items capture prior gemcitabine/fluoropyrimidine/oxaliplatin exposure, disease progression, unresectable or metastatic status (biliary), current Onivyde start, neuropathy, and intolerance/contraindication. The form concludes with additional pertinent information and a prescriber attestation and signature/date.

Codes referenced on the form

Medication product referenced on formmixed

Onivyde 43mg/10ml

irinotecan liposome formulation and vial size as listed on form

Diagnosis selections (ICD-10 codes to be supplied by prescriber)ICD-10

	Ampullary adenocarcinoma (ICD-10 code to be provided by prescriber)
	Biliary tract cancer (ICD-10 code to be provided by prescriber)
	Pancreatic adenocarcinoma (ICD-10 code to be provided by prescriber)

What providers must do

Prior Authorization

Submit completed prior authorization form

Fax the completed form or submit electronically and be sure all required asterisked fields are completed so the plan can respond. Include the completed prior authorization form and required asterisked fields when submitting.

Fax number: (855) 840-1678
Online portals: CoverMyMeds (www.covermymeds.com/...) or SureScripts in your EHR

Prior Authorization

Urgent requests

For urgent requests call to attest that applying the standard review timeframe may seriously jeopardize the individual's life, health, or ability to regain maximum function. Our standard response time for prescription drug coverage requests is 5 business days.

Documentation Required

Clinical documentation required

Complete the disease-specific clinical questions on the form (prior therapies, ECOG performance status, combination regimen details, baseline neuropathy, progression) and sign the prescriber attestation. The plan may perform a routine audit and request medical records to verify the accuracy of the information provided.

Plan may audit and request medical records to verify accuracy

Billing Rule

Specialty pharmacy preference

Accredo is Cigna's nationally preferred specialty pharmacy for this medication. Medication orders can be placed with Accredo (e-prescribe, fax, or verbal) but prescribers may choose alternate acquisition sites if desired.

Accredo contact options listed on the form (e-prescribe, Fax 888.302.1028, Verbal 866.759.1557)

Background and definitions

Background: This operational prior authorization form is used by Cigna to obtain the clinical details necessary to evaluate coverage for Onivyde in gastrointestinal malignancies. It guides providers through disease-specific prior treatment history, combination regimen use, performance status (ECOG), neuropathy and progression questions, and requires prescriber attestation; the plan may audit and request medical records to verify the information.

Definitions

ECOG (performance status)Eastern Cooperative Oncology Group performance status (0-4) as listed on the form

Policy Summary

PayerCigna

Policyprior_authorization_form_onivyde

Policy CodePolicy N/A

Change TypeOperational form (no material change)

Effective Date

Next Review Date

Key ActionFax the completed form to (855) 840-1678 or submit online via CoverMyMeds or SureScripts and include all required asterisked fields.

SourceLink

On This Page

ECOG performance status: select 0/1/2/3/4; If ECOG 0 or 1: Has the patient tried a gemcitabine-based regimen? Yes/No; If no gemcitabine: Has the patient tried a fluoropyrimidine-based regimen, but without irinotecan? Yes/No; If ECOG 0,1,2: Will the medication be used for subsequent therapy? Yes/No

ECOG definitions per form

Treatment initiation and contraindications: If none of the above prior regimens: Has the patient already been started on Onivyde? Yes/No; If not already started: Baseline neuropathy? Yes/No; If not already started: Has the patient experienced an inadequate response, significant intolerance OR does the patient have a contraindication for irinotecan IV infusion? Yes/No

Conditional on prior regimen answers

OpenPayer

prior_authorization_form_onivyde

Policy overview

Information requested on the prior authorization form

Codes referenced on the form

What providers must do

Background and definitions

Revision history