CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cmp_M_Factor_Ix_20240814.Medical

This policy defines clinical coverage criteria for the use of factor IX products Alprolix, Indelvion, and Rebinyn, aligning utilization with FDA labeling and clinical literature; applies to Neighborhood Health Plan of Rhode Island members and INTEGRITY (Medicare-Medicaid Plan) members when no CMS NCD/LCD exists.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCmp_M_Factor_Ix_20240814.Medical

Policy CodePolicy N/A

Change TypeClinical criteria adopted

Effective Date01/01/2020

Next Review Date08/14/2024

Key ActionProviders must submit information demonstrating that the requested factor IX product will be used consistent with FDA-approved labeling and/or relevant clinical literature to support medical necessity; plan will give individual consideration based on submitted prescriber information.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage or policy were made.

3Drugs Reviewed

1P&T Committee Adoption

Coverage Summary

General Coverage Rationale

Coverage is based on alignment with FDA labeling and relevant clinical literature; individual consideration provided when prescriber supplies supporting information.

General Coverage Rationale - Top Level

Medically accepted indication: Use of Alprolix, Idelvion, or Rebinyn is for a medically accepted indication consistent with FDA-approved labeling and/or relevant clinical literature
Supports ensure members use these drugs according to FDA labeling and/or relevant clinical literature
Prescriber and pharmacist input; individual consideration: Prescriber and pharmacist input were used to draft criteria and requests will be individually considered based on information submitted
Plan will give individual consideration to each request based on prescriber-submitted information
INTEGRITY (MMP) caveat: For INTEGRITY (Medicare-Medicaid Plan) members, these criteria apply only in the absence of applicable CMS National Coverage Determination (NCD) or Local Coverage Determination (LCD)
CMS NCDs/LCDs supersede these criteria where applicable

This policy defines clinical coverage criteria for the factor IX products Alprolix, Idelvion, and Rebinyn. Coverage is covered_with_criteria and is intended to align utilization with FDA-approved labeling and relevant clinical literature. The policy applies to Neighborhood Health Plan of Rhode Island members and to INTEGRITY (Medicare‑Medicaid Plan) members only when there is no applicable CMS National Coverage Determination (NCD) or Local Coverage Determination (LCD).

Provider Actions & Authorization

Documentation Required

Support per FDA labeling or clinical literature

Providers must submit information demonstrating that the requested factor IX product will be used consistent with FDA-approved labeling and/or relevant clinical literature to support medical necessity. The plan will give individual consideration to requests based on the prescriber's submitted information.

Prior Authorization

INTEGRITY members and CMS determinations

For INTEGRITY (Medicare-Medicaid Plan) members, ensure there is no applicable CMS National Coverage Determination (NCD) or Local Coverage Determination (LCD); if such CMS determinations exist they supersede this policy and must be followed for coverage decisions.

Applicable Codes

Medicare Part B Administrative Contractors (MAC) jurisdictions referencedmixed

J (10)	MAC Jurisdictions - TN, GA, AL (Contractor = Palmetto GBA)
M (11)	MAC Jurisdictions - NC, SC, WV, VA (Contractor = Palmetto GBA)
L (12)	MAC Jurisdictions - DE, MD, PA, NJ, DC (Contractor = Novitas Solutions, Inc.)
K (13 & 14)	MAC Jurisdictions - NY, CT, MA, RI, VT, ME, NH (Contractor = National Government Services, Inc.)
15	MAC Jurisdictions - KY, OH (Contractor = CGS Administrators, LLC)

Background

Neighborhood Health Plan of Rhode Island's Pharmacy & Therapeutics (P&T) Committee reviewed Alprolix, Idelvion, and Rebinyn and adopted clinical coverage criteria to ensure use according to FDA-approved labeling and relevant clinical literature, to minimize risk of adverse effects, and to encourage use of more cost-effective options when appropriate. The criteria were drafted with input from network prescribers and pharmacists and include provisions for individual consideration of requests based on prescriber-submitted information.

Medicare NCD / LCD

The brief lists entries for CMS determinations (NCD/LCD) but provides no specific NCD or LCD document numbers or effective dates. Where applicable CMS NCDs/LCDs exist they supersede this policy for INTEGRITY (Medicare‑Medicaid Plan) members; requests will be reviewed against relevant NCDs/LCDs as part of the authorization process.