CurrentCignaPolicy N/A

Cigna Healthcare Gene Therapy Prior Auth Request Form

Prior authorization form and required documentation checklist for requesting Hemgenix (gene therapy for hemophilia B) through Cigna, including clinical eligibility checkpoints, documentation requirements, administration/setting details, and attestation. It is a submission form rather than a standalone coverage policy.

Policy Summary

PayerCigna

PolicyCigna Healthcare Gene Therapy Prior Auth Request Form

Policy CodePolicy N/A

Change TypeInformational

Effective Date

Next Review Date

Key ActionProviders must complete and fax the Gene Therapy Prior Authorization form with required clinical documentation (chart notes, labs, genetic test results, claims history) to Fax# 833-910-1625; failure to complete form may delay processing or result in adverse determination.

POLICY UPDATE CHANGES

No material clinical/coverage changes noted.

1Gene therapy product referenced

ManyRequired documentation items

ConditionalCoverage determination

Policy snapshot & scope

This is Cigna's Gene Therapy Prior Authorization Request Form for Hemgenix, intended as a submission checklist rather than a standalone coverage policy. Cigna designates Hemgenix as a gene therapy product included in its Gene Therapy Provider Network and directs providers to submit clinical documentation to support medical necessity. Providers must complete and fax the form and supporting records to Fax# 833-910-1625. The prescriber must also sign an attestation that the information provided is true and accurate as part of the submission process.

Medical necessity & documentation criteria for Hemgenix

Medical Necessity / Documentation Criteria for Hemgenix

Hemgenix is considered medically necessary when the following criteria are met; documentation is required as indicated.

ALL of the following

Documentation: Documentation is required for use of Hemgenix as noted in the criteria (e.g., chart notes, laboratory results, medical test results, claims records, prescription receipts, and/or other information).
Marked [documentation required] where applicable.
Demographics / Prior therapy / Disease severity
- Patient is male*
- Patient is ≥ 18 years of age
- Patient has not received a gene therapy for hemophilia B in the past [verification in claims history required]
- If no claim for Hemgenix or Beqvez is present (or if claims history is not available), prescribing physician confirms patient has not previously received Hemgenix or Beqvez (fidanacogene elaparvovec-dzkt intravenous infusion).
- Patient has moderately severe or severe hemophilia B as evidenced by a baseline (without Factor IX replacement therapy) Factor IX level ≤ 2% of normal≤ 2% of normal
  [documentation required]
Clinical history requirements (ONE of i, ii, iii)
- i
  - Patient has a history of life-threatening hemorrhage
  - On-demand use of Factor IX therapy was required for this life-threatening hemorrhage
- ii
  - a: Patient has a history of life-threatening hemorrhage
  - b: On-demand use of Factor IX therapy was required for this life-threatening hemorrhage
- iii
Safety and laboratory prerequisites (multiple grouped checks)
- Factor IX inhibitor titer testing has been performed within the past 30 days
  [documentation required]
- Patient is negative for Factor IX inhibitors
  [documentation required]
- Patient does not have an active infection with hepatitis B virus or hepatitis C virus
  [documentation required]
- Patient is not currently receiving antiviral therapy for a prior hepatitis B virus or hepatitis C virus exposure
  [documentation required]
- According to the prescribing physician, the patient does not have uncontrolled human immunodeficiency virus infection
If any requirements are not met and provider feels Hemgenix is medically necessary, provide clinical support and rationale (including recent H&P, labs, disease stage, prior therapy, performance status, names/doses/schedule of concurrent agents).
Any other use is considered experimental, investigational, or unproven unless clinical rationale is provided.

Exclusions / Trial exclusions noted

Exclusions / Trial Exclusions Noted

Clinical trial exclusions from pivotal studies that may impact coverage consideration; if present, clinical rationale required.

ANY of the following

Prior receipt of gene therapy (was a reason for patient exclusion in the pivotal study).
Patient with a history of Factor IX inhibitors (was a reason for patient exclusion in the pivotal trial).

The form identifies exclusions observed in pivotal studies (for example, prior receipt of gene therapy and history of Factor IX inhibitors) but notes that presence of these exclusions does not automatically preclude consideration. If an exclusion applies, the provider should supply clinical support and rationale (recent history and physical, labs, prior therapy, etc.) to justify medical necessity.

Submission steps, documentation, and billing actions

Prior Authorization

Submit completed prior authorization form and supporting documentation

Submit the completed Gene Therapy Prior Authorization form and include all required supporting clinical documentation (chart notes, labs, genetic test results, claims history). Fax the form and documents to Fax# 833-910-1625. Failure to complete the form in its entirety or to provide required documentation may delay processing or result in an adverse determination for insufficient information.

Documentation Required

Provide specific laboratory and clinical evidence

Provide specific laboratory and clinical evidence as indicated on the form and mark items noted as [documentation required]. Required items include: baseline Factor IX level (≤ 2% of normal) and Factor IX inhibitor testing performed within the past 30 days (and negative inhibitor status); liver function tests within the past 30 days (ALT, AST, total bilirubin, alkaline phosphatase — each ≤ two times the upper limit of normal); platelet count within the past 30 days (≥ 50 x 10^9/L); renal function (estimated creatinine clearance ≥ 30 mL/min or creatinine ≤ two times the upper limit of normal); documentation of prior exposures to Factor IX (e.g., ≥150 exposure days) and current body weight within the past 30 days. Mark all items indicated as [documentation required].

Factor IX level (baseline) ≤ 2% of normal [documentation required]
Factor IX inhibitor testing within 30 days and negative inhibitor status [documentation required]
Liver function tests within 30 days: ALT, AST, total bilirubin, alkaline phosphatase ≤ 2x ULN [documentation required]
Platelet count within 30 days ≥ 50 x 10^9/L [documentation required]
Renal function: estimated creatinine clearance ≥ 30 mL/min or creatinine ≤ 2x ULN [documentation required]
Prior Factor IX exposures (e.g., ≥ 150 exposure days) and prior therapies
Current body weight within past 30 days [documentation required]

Documentation Required

Confirm prior gene therapy/Beqvez exposure

Verify prior receipt of Hemgenix or Beqvez via claims history. If no claim is present or claims history is not available, the prescribing physician must confirm that the patient has not previously received Hemgenix or Beqvez (fidanacogene elaparvovec-dzkt).

Documentation Required

Specialist prescribing requirement

The medication must be prescribed by a hemophilia specialist physician per the form instructions.

Billing Rule

Provide associated CPT/administration codes after medical necessity determination

After medical necessity has been determined, include all associated CPT and administration codes for Hemgenix with the submission (additional CPT and administration codes may be provided following medical necessity determination).

Documentation Required

Attestation

The prescriber must sign the attestation affirming that the information provided is true and accurate. The form also asks whether you and the patient agree to share any required plan-specific outcome measures (Yes/No).

Required laboratory thresholds and timing

Eligibility thresholds (discrete)

Baseline Factor IX level≤ 2% of normal

Factor IX therapy exposure days≥ 150 exposure days

Platelet count≥ 50 x 10^9/L

Platelet count timingwithin past 30 days

Creatinine clearance≥ 30 mL/minute

ALT/AST/Total bilirubin/Alkaline phosphatase≤ two times the upper limit of normal (within past 30 days)

Safety prerequisites require documentation that Factor IX inhibitor titer testing was performed within the past 30 days and that the patient is negative for Factor IX inhibitors. The form also requires that the patient does not have an active hepatitis B or hepatitis C infection and is not currently receiving antiviral therapy for prior hepatitis exposure; additionally, the prescribing physician must attest the patient does not have uncontrolled HIV infection.

Policy Summary

PayerCigna

PolicyCigna Healthcare Gene Therapy Prior Auth Request Form

Policy CodePolicy N/A

Change TypeInformational

Effective Date

Next Review Date

On This Page

ALL of the following

Alanine aminotransferase (ALT) ≤ two times the upper limit of normal≤ two times the upper limit of normal
[documentation required]
Aspartate aminotransferase (AST) ≤ two times the upper limit of normal≤ two times the upper limit of normal
[documentation required]
Total bilirubin ≤ two times the upper limit of normal≤ two times the upper limit of normal
[documentation required]
Alkaline phosphatase ≤ two times the upper limit of normal≤ two times the upper limit of normal
[documentation required]

OpenPayer

Cigna Healthcare Gene Therapy Prior Auth Request Form

Policy snapshot & scope

Medical necessity & documentation criteria for Hemgenix

Exclusions / Trial exclusions noted

Submission steps, documentation, and billing actions

Codes to include with submission

Required laboratory thresholds and timing

Key terms

Document history & changes