CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Short Granulocyte Colony Stimulating Factors: Nivestym, Neupogen, Granix, Releuko, Zarxio

Medical benefit coverage and prior authorization criteria for short-acting G-CSF products (filgrastim and tbo-filgrastim biosimilars/brands) for Medicaid, Commercial, and Medicare-Medicaid Plan members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyShort Granulocyte Colony Stimulating Factors: Nivestym, Neupogen, Granix, Releuko, Zarxio

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, ANC when required, and trial/failure/contraindication/intolerance to preferred agent Zarxio when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5G-CSF products named

4 codesHCPCS/CPT codes listed

Medicaid, Commercial, MMPPayer scopes covered

Up to 14 daysTypical covered duration

Coverage Criteria

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inv-01: Initial criteria

Covered when ALL of the following are met:

Root

Indication
- PBPC: Peripheral Blood Progenitor Cell (PBPC) mobilization and transplant (Nivestym/Neupogen ONLY)
- BMT: Bone marrow transplant (BMT)
- PBSC: Peripheral Blood Stem Cell (PBSC) mobilization and transplant (Granix ONLY)
ANC requirement: Patient must have an absolute neutrophil count (ANC)
Severe chronic neutropenia
- Congenital neutropenia
- Idiopathic neutropenia
- Cyclic neutropenia
- BMT failure: Bone marrow transplantation failure or engraftment delay
Preferred agent trial: Patients must have documented failure, contraindication, or intolerance to Zarxio (filgrastim-sndz) OR patients currently on Nivestym, Neupogen, Releuko, or Granix may remain on treatment; MMP members with prior receipt within 365 days are not subject to therapy requirements.

Investigational use: therapies used at doses or for conditions not recognized as medically accepted indications in standard compendia are considered investigational and not covered. Standard compendia referenced include AHFS, Micromedex DrugDex, Clinical Pharmacology, Lexi-Drugs, or peer‑reviewed literature demonstrating sufficient evidence to support the use. Neighborhood does not provide coverage for therapies when used for investigational purposes.

Use outside the policy guidelines or investigational uses are considered not covered and may not be paid unless approved under an exception process. Coverage of short-acting Colony Stimulating Factors is reviewed prospectively via the authorization process and requests must meet the clinical criteria and documentation requirements in this policy.

Initial Therapy

inv-12: Initial therapy coverage criteria (detailed nested criteria)

Initial therapy coverage criteria

Initial therapy: See 'Initial Criteria' group: indication match, ANC documented, and preferred-agent requirement as specified below.

Indication detail

PBPC detail: Peripheral Blood Progenitor Cell (PBPC) mobilization and transplant — coverage limited to Nivestym or Neupogen (filgrastim products).
BMT detail: Bone marrow transplant (BMT).
PBSC detail: Peripheral Blood Stem Cell (PBSC) mobilization and transplant — coverage limited to Granix (tbo-filgrastim).

ANC documentation: Absolute neutrophil count (ANC) must be documented where clinically required for the indication.

Severe chronic neutropenia specifics

Congenital neutropenia.
Idiopathic neutropenia.
Cyclic neutropenia.
BMT failure: Bone marrow transplantation failure or engraftment delay.

Step therapy / preferred agent: Patient must have documented failure, contraindication, or intolerance to the preferred agent Zarxio (filgrastim-sndz) prior to coverage of other short-acting G-CSFs, unless the patient is currently maintained on Nivestym, Neupogen, Releuko, or Granix, or is an MMP member with prior receipt within the past 365 days who is exempt from the trial requirement.

Zarxio is the preferred short-acting G-CSF.

Continuation Therapy

inv-13: Continuation/maintenance therapy criteria

Continuation/maintenance rule

Continuation: Members currently receiving Nivestym (filgrastim-aafi), Neupogen (filgrastim), Releuko (filgrastim-ayow), or Granix (tbo-filgrastim) may remain on their current treatment without meeting the Zarxio trial requirement; MMP members who received the medication within the past 365 days are also exempt from the step requirement.

Step Therapy / Preferred Agent

No results

Prior Authorization

Prior authorization and documentation

Prior authorization and documentation required. For non‑preferred short‑acting G‑CSFs, include clinical rationale showing trial and failure/intolerance/contraindication to Zarxio, or documentation that the request is for continuation of an existing regimen or within 365 days of prior receipt.

Include prior authorization submission with clinical records supporting trial and outcome with Zarxio.
If member is currently on Nivestym, Neupogen, Releuko, or Granix, indicate date therapy initiated to permit continuation without step requirement.
If member received the medication within the past 365 days, note prior receipt to bypass step requirement.

Step Therapy

Biosimilar preference and exceptions

Biosimilar preference noted: Zarxio is preferred. Requests for other biosimilars or reference products require documentation of failure, intolerance, or contraindication to Zarxio, unless the request is for continuation of an existing non‑preferred product.

Zarxio (filgrastim‑sndz) is the preferred biosimilar short‑acting G‑CSF.
Other filgrastim products (including biosimilars) require documentation of trial and failure/intolerance/contraindication to Zarxio to be approved.
Continuation of an existing non‑preferred product is acceptable when documented.

Provider Actions & Authorization

Prior Authorization

Prior authorization required

Coverage of short-acting Colony Stimulating Factors is reviewed prospectively via the prior authorization process and will be approved only when the request meets the clinical criteria set forth in the policy.

Authorization is required before coverage is provided under the Medical Benefit.
Requests must meet all procedure and clinical criteria in the policy.

Documentation Required

Required clinical documentation for authorization

Requests must include the diagnosis, absolute neutrophil count (ANC) when required, and documentation of prior trial, failure, contraindication, or intolerance to the preferred agent (Zarxio) when applicable, plus indication-specific supporting information per the procedure section.

Diagnosis that matches one of the covered indications (e.g., PBPC mobilization, BMT, PBSC mobilization, severe chronic neutropenia).
ANC value when the indication requires it.
Evidence of documented failure/contraindication/intolerance to Zarxio or documentation of current maintenance on an alternative agent if applicable.

Denial Risk

Non-guideline or investigational use may be denied

Use outside the policy guidelines or investigational uses may result in non-payment; such uses are reviewed via authorization and must meet the criteria to be covered.

Investigational uses (doses or conditions not recognized in standard compendia) are not covered.
Non-guideline use may be denied or not paid unless approved through an exception process.

Coding & Billing

Applicable HCPCS/CPT codesHCPCS

Q5101	Injection, filgrastim-sndz, biosimilar; (Zarxio)
J1442	Injection, filgrastim (G-CSF), excludes biosimilar, 1 microgram
J1447	Injection, tbo-filgrastim, 1 microgram
Q5110	Injection, filgrastim-aafi, biosimilar, (Nivestym), 1 microgram

Maximum billable units per day by indication (billable unit = 1 mcg)

BMT / PBPC (per day)Maximum billable units = 1200 units/day (dose: 10 mcg/kg daily for up to 14 days)

Severe chronic neutropeniaMaximum billable units = 1380 units/day (dose example: 6 mcg/kg twice daily for congenital/idiopathic/cyclic cases)

All other indicationsMaximum billable units = 600 units/day (dose example: 5 mcg/kg daily for up to 14 days)

Quantity Limits

filgrastim / tbo-filgrastim products — quantity limits by indication

BMT / PBPCQuantity limit = 1200 billable units per day (1 mcg = 1 billable unit); dosing described as 10 mcg/kg daily for up to 14 days)

Severe chronic neutropeniaQuantity limit = 1380 billable units per day (1 mcg = 1 billable unit); dosing examples include 6 mcg/kg twice daily for severe congenital/idiopathic/cyclic neutropenia)

Other indicationsQuantity limit = 600 billable units per day (1 mcg = 1 billable unit); typical dosing ~5 mcg/kg daily for up to 14 days)

Site of Care

Note

Covered sites of care (medical benefit)

Short-acting Colony Stimulating Factors are covered under the medical benefit for administration in hospital outpatient settings, infusion centers, physician offices, or the home; authorization is reviewed prospectively.

Covered settings: hospital outpatient, infusion center, office, and home.
Coverage is under the medical benefit and requires prior authorization per the procedure section.

Definitions

Definitions — drugs that stimulate production/function of neutrophils

DefinitionShort-acting granulocyte colony-stimulating factors (G-CSFs) — drugs that stimulate the production and function of neutrophils (examples: filgrastim, tbo-filgrastim)

Clinical effectReduce duration and severity of chemotherapy-induced neutropenia and related complications such as febrile neutropenia and hospitalization)

Common adverse reactionsBone pain, injection site reactions, and mild-to-moderate musculoskeletal symptoms)

Background

Short-acting granulocyte colony-stimulating factors (G-CSFs) stimulate the production and function of neutrophils, reducing the duration and severity of chemotherapy-induced neutropenia and lowering the incidence of febrile neutropenia, hospitalizations, and need for IV antibiotics. Common adverse reactions include bone pain and injection site reactions. These agents are dosed and billed by microgram; example dosing regimens noted in the policy include up to 14 days for many indications with indication-specific maximum billable units per day (see coding/quantity limits).

Biosimilar Information

Prior Authorization

Filgrastim products: Zarxio preferred

Zarxio (filgrastim-sndz) is the preferred filgrastim product; coverage of other filgrastim or tbo-filgrastim products requires documented failure, contraindication, or intolerance to Zarxio before approval, except where continuation rules apply.

Preferred product: Zarxio (filgrastim-sndz).
Other filgrastim/tbo-filgrastim agents require documented inability to use Zarxio for coverage to be approved.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyShort Granulocyte Colony Stimulating Factors: Nivestym, Neupogen, Granix, Releuko, Zarxio

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, ANC when required, and trial/failure/contraindication/intolerance to preferred agent Zarxio when applicable.

SourceLink

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