CurrentHawaii Medical Service Association (HMSA)Policy N/A

Prior authorization for short-acting colony-stimulating factor (G-CSF) products

Form and criteria used by CVS Caremark (for HMSA members) to determine prior authorization for short-acting colony-stimulating factor (G-CSF) products including Granix, Leukine, Neupogen, Nivestym, Releuko, and Zarxio; affects prescribers and pharmacy/specialty benefit adjudication for HMSA members.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyPrior authorization for short-acting colony-stimulating factor (G-CSF) products

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is required for non-preferred short-acting G-CSF products; use Zarxio (preferred) when clinically appropriate to avoid PA.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6products listed on form

1preferred biosimilar (no PA required)

8exception / question steps on form

300 mcgdose threshold referenced

Coverage Criteria

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Exception criteria / Authorization logic

Coverage/exemption logic follows the numbered questionnaire on the form. Authorization for non-preferred products is allowed only when the questions below are satisfied.

Initial gating: Requested product is one of: Granix, Leukine, Neupogen, Nivestym, Releuko (Zarxio is the preferred product and does not require prior authorization).

If Zarxio requested, no PA required.

Approved indications: Product requested is for one of: neutropenia associated with myelosuppressive anti-cancer therapy; neutropenia due to chemotherapy for acute myeloid leukemia; neutropenia associated with myeloablative chemotherapy after bone marrow transplant for a non-myeloid cancer; autologous stem cell mobilization; severe chronic congenital, cyclic, or idiopathic neutropenia.

If No, the form stops (No Further Questions).

Dose check: Dose of requested product is NOT less than 300 mcg.<300 mcg

If dose <300 mcg, form indicates 'No Further Questions'.

Preferred product step: Can the patient be switched to the plan's preferred product (Zarxio)? If Yes, no PA is required; if No, continue to failure/intolerance assessment for non-preferred product.

If Zarxio acceptable, stop — no PA required.

Failure or intolerance to Zarxio: Prescriber documents either (A) failure to Zarxio due to inadequate response or (B) failure due to an intolerable adverse event (e.g., rash, nausea, vomiting). Supporting chart notes required when asserting inadequate response or when adverse event is not an expected adverse reaction to the active ingredient.

If neither documented, no exception criteria met.

Attestation: Prescriber or authorized signer attests that the information is accurate and that supporting documentation is available upon request.

Form must be signed and dated.

Requests for non-preferred products (Granix, Leukine, Neupogen, Nivestym, Releuko and others listed on the form) require documentation that the patient cannot use the preferred biosimilar. Prior authorization for a non-preferred product is permitted only when the prescriber documents either failure to Zarxio (inadequate response) or intolerance to Zarxio (intolerable adverse event), and supporting chart notes should be attached when asserting inadequate response or when the adverse event is not a known/expected reaction.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for non-preferred short-acting G-CSF products (Granix, Leukine, Neupogen, Nivestym, Releuko). The biosimilar Zarxio is the preferred product and is exempt from prior authorization.

Affected products: Granix, Leukine, Neupogen, Nivestym, Releuko
Exempt product (no PA required): Zarxio
Send completed PA form and supporting documentation to CVS Caremark Specialty Programs Fax: 1-866-237-5512

Step Therapy

Step Therapy — Try Zarxio First

Step therapy requires trying the preferred biosimilar Zarxio before coverage of non-preferred short-acting G-CSF products will be approved. If the patient can be switched to Zarxio, no prior authorization is required for that product.

If the patient's treatment can be switched to Zarxio, select Zarxio and no PA is required
If Zarxio was tried and the patient experienced treatment failure or intolerance, document per failure criteria to proceed with non-preferred product request

Documentation Required

Prescribers must provide the diagnosis and may need to attach chart notes to support claims of failure or intolerance to Zarxio. Attestation that documentation is available for review is required on the PA form.

Required documentation: diagnosis for the requested indication (e.g., chemotherapy-associated neutropenia, stem cell mobilization, severe chronic neutropenia)
If requesting a non-preferred product due to inadequate response or intolerable adverse event with Zarxio, attach supporting chart notes
If an adverse event is claimed, indicate whether it is an expected adverse reaction per prescribing information; if not, attach chart notes

Denial Risk

Denial Triggers / Things That May Delay Approval

Requests may be denied if the product is not requested for an approved indication, if dosing exceeds established thresholds, or if step therapy requirements are not met (e.g., Zarxio not tried or failure not documented).

Denial triggers: product requested for an indication not listed in criteria
Denial triggers: requested dose ≥ 300 mcg when criteria specify lower dosing limits
Denial triggers: lack of documentation of trial and failure/intolerance of Zarxio when required

Requirement	Details
Failure or intolerance to the preferred biosimilar (Zarxio)
Prescriber must document that the patient failed treatment with Zarxio due to an inadequate response or experienced an intolerable adverse event (e.g., rash, nausea, vomiting). Supporting chart notes must be attached when asserting inadequate response or when the adverse event is not an expected adverse reaction for both brand and biosimilar.

Site of Care

Note

Site of care: indicate dispensing and administration locations

The form asks the prescriber to indicate where the drug will be dispensed and where it will be administered (options include office, outpatient, hospital); the form does not state explicit site-of-care restrictions.

Indicate where the drug is being dispensed (Office, Outpatient, Hospital) on the form.
Indicate where the drug will be administered as requested by the form; no explicit prohibition or restriction of site of care is listed.

Definitions & Preferred Biosimilar

Preferred product

Preferred productZarxio (preferred biosimilar)

PA requirement for ZarxioNo prior authorization required for Zarxio; if Zarxio is requested, no further action is needed

Step therapy implicationIf the patient can be switched to Zarxio, no PA is required; inability to switch requires documentation of failure/intolerance to Zarxio

Billing Rule

Preferred biosimilar (Zarxio) — no PA required

Zarxio is the plan's preferred biosimilar and does not require prior authorization; if Zarxio can be used, no PA is needed and no further action is required on the form.

If Zarxio is requested, the form states 'No further action is needed. No PA is required for the preferred product.'

Background

Short-acting granulocyte colony-stimulating factors (G-CSFs) are indicated to prevent or treat neutropenia in several clinical contexts. The form captures use for: neutropenia associated with myelosuppressive anti-cancer therapy; neutropenia due to chemotherapy for acute myeloid leukemia; neutropenia associated with myeloablative chemotherapy after bone marrow transplant for a non-myeloid cancer; autologous stem cell mobilization; and severe chronic congenital, cyclic, or idiopathic neutropenia. The form also incorporates a dosing check and step-to-preferred logic to encourage use of the biosimilar Zarxio when clinically appropriate.