Colony Stimulating Factors
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Policy governs prior authorization, preferred and targeted colony stimulating factor products, and coverage criteria for Blue Cross Blue Shield - Iowa members requesting CSF therapy.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy (Rolvedon)
Authorization of 6 months may be granted when ALL of the following are met
Do not use with concurrent CSFs or weekly chemo; approval for 6 months.
Other Indications
Authorization of 6 months may be granted for members with any of the following indications
Approval duration: 6 months.
Targeted short-acting products - Exception Criteria
Coverage for targeted short-acting products (Neupogen, Filkri, Granix, Nypozi, Releuko) is provided when ONE of the following is met
Approval for 6 months.
Leukine and targeted long-acting products - Exception Criteria
Coverage for targeted products Leukine, and certain long-acting targeted products is provided when specified criteria are met
Approval for 6 months.
Approval for 6 months.
Policy note: Rolvedon requires meeting both exception criteria and the initial/continuation criteria when applicable.
Continuation Therapy
Continuation of therapy
If criteria are not met, Rolvedon is considered not medically necessary.
Indications based on chemotherapy regimen risk and patient risk factors
Covered when chemotherapy regimen or patient risk factors indicate intermediate to high risk of febrile neutropenia
Appendices enumerate specific regimens by cancer type.
Patient risk factor considerations
Covered when patient has additional risk factors that increase FN risk
List is not all-inclusive.
This policy may not apply to the Federal Employee Program (FEP). Benefit determinations for FEP members are made by the Federal Employee Program and may differ from the coverage rules described here; providers should verify member benefits and applicable contract language for FEP enrollees.
The policy appendices list chemotherapy regimens associated with intermediate and high risk of febrile neutropenia but explicitly note that these lists are not comprehensive. No additional explicit exclusions are provided in the extracted appendix sections; clinicians should use the appendices as illustrative guidance and document regimen-specific risk when requesting coverage.
Per the coverage criteria, Rolvedon is considered not medically necessary when the patient does not meet the stated initial or continuation authorization requirements. Continuation requests (including those from new members) must satisfy all initial authorization criteria for Rolvedon; failure to meet those criteria supports a determination of not medically necessary.
Within the extracted sections reviewed there are no additional, specific scenarios listed beyond the general statement that therapy not meeting the policy criteria is not medically necessary. The document’s appendices and Appendix C provide regimen lists and patient risk factors to inform clinical judgment, but they do not enumerate other explicit 'not medically necessary' cases in these excerpts.
Coding
| C9399 | Unclassified drugs or biologicals |
| C9173 | Injection, filgrastim-txid (Nypozi), biosimilar, 1 microgram (cancelled 7/1/2025) |
| J1442 | Injection, filgrastim (g-csf), excludes biosimilars, 1 microgram (Neupogen) |
| J1447 | Injection, tbo-filgrastim, 1 mcg |
| J1449 | Injection, eflapegrastim-xnst, (Rolvedon) 0.1 mg (effective 4/1/2023) |
| J2820 | Injection, sargramostim (gm-csf), 50 micrograms (Leukine) |
| J3590 | Unclassified biologicals |
| J9361 | Injection, efbemalenograstim alfa-vuxw, 0.5 mg (Ryzneuta) |
| Q5108 | Injection, pegfilgrastim-jmdb, biosimilar, (Fulphila), 0.5mg |
| Q5111 | Injection, pegfilgrastim-cbqv, biosimilar, (Udenyca), 0.5mg |
Provider Actions & Requirements
Prior authorization required for targeted (non-preferred) products
Prior authorization is required for non-preferred (targeted) colony stimulating factor products; coverage is granted only when the member meets applicable exception criteria or the clinical criteria for the requested product (e.g., documented failure/intolerance to preferred products or other specified exception reasons). Approval duration is generally 6 months for targeted products when criteria are met.
- Policy states targeted products are covered based on clinical circumstances and an exception process (chunk 3).
- Exception criteria for targeted short-acting products require documented failure/intolerance to all preferred products or latex allergy with inadequate response to preferred product (chunk 6).
- Exception criteria for Leukine and targeted long-acting products require documented inadequate response or intolerable adverse effect to preferred products; approvals noted for 6 months (chunk 7).
- Rolvedon-specific initial/continuation clinical criteria must also be met when requesting Rolvedon (chunk 12).
Use listed HCPCS/J/Q and reporting codes for authorization and claims
When requesting authorization or submitting claims, providers must use the specific HCPCS/J/Q and unclassified codes listed in the policy for the product administered; unclassified codes (C9399, J3590) are available but specific product codes are provided and should be used when applicable.
Step/exception pathway: document failure or intolerance to preferred products
Coverage for targeted products is contingent on documented failure or intolerable adverse effect to all preferred products, or other specified exception reasons (for example, documented latex allergy with need for latex‑free vials); providers must supply documentation of the prior trial and the adverse event or inadequate response.
- Targeted short-acting products: member must have failed all preferred products due to documented intolerable adverse event not attributable to the active ingredient, or have documented latex allergy with inadequate response to Nivestym (chunk 6).
- Targeted long-acting products and Leukine: member must have documented inadequate response or intolerable adverse effect to preferred products (chunk 7).
- Policy states targeted products are covered based on clinical circumstances and previous product use; exception process applied (chunk 3).
No additional explicit step therapy sequence specified
No additional explicit step therapy sequence beyond the documented failure/intolerance exception criteria is specified in these extracted sections.
- The policy notes required documentation for exceptions but does not describe a separate step-by-step prior authorization sequence in the extracted content (chunk 24).
Documentation required for primary prophylaxis requests
For primary prophylaxis requests, provide documentation of the member's diagnosis and chemotherapeutic regimen; if the regimen has an intermediate FN risk (10–19%), also document patient-specific risk factors that confirm high risk for febrile neutropenia.
- Documentation must include member diagnosis and the chemotherapeutic regimen (chunk 10).
- If regimen risk is intermediate (see Appendix B), document patient risk factors that place the member at high risk for FN (chunk 10).
- Initial authorization criteria for Rolvedon and other products reference regimen- and patient-level risk thresholds that must be supported in documentation (chunk 12).
Report services with listed CPT/HCPCS/Revenue/ICD codes
Providers must report services using the appropriate CPT, HCPCS (J- and Q-codes), revenue, and ICD diagnostic codes referenced in the policy when billing for colony stimulating factors; specific HCPCS/J/Q codes listed in the policy should be used where applicable.
- Policy instructs use of appropriate CPT, HCPCS, revenue, and ICD codes to report provider services (chunk 23).
- The policy lists specific HCPCS/J/Q and unclassified codes to report CSF products (chunk 24).
Denial risk: therapy not covered if initial/continuation criteria not met
Rolvedon will be considered not medically necessary if the member does not meet the stated initial authorization criteria or continuation requirements; continuation requests must meet all initial authorization criteria.
- Continuation of therapy requires that all initial authorization criteria are met; if not met, Rolvedon is considered not medically necessary (chunk 14).
- Initial authorization criteria include restrictions such as not combining with other CSFs, not with concurrent chemo/radiation, not with weekly regimens, and meeting regimen/patient risk thresholds (chunk 12).
Billing/coding requirement: use specific listed product codes when available
Use the appropriate CPT/HCPCS/Revenue/ICD codes when reporting services; while unclassified codes (C9399, J3590) exist, the policy provides specific HCPCS/J/Q codes for many CSF products and these product-specific codes should be used when available.
Background
Colony stimulating factors (short- and long-acting) are used to prevent or treat neutropenia in patients receiving myelosuppressive chemotherapy and for other indications such as stem cell transplantation and radiation-induced myelosuppression. Use includes primary prophylaxis to prevent febrile neutropenia based on chemotherapy regimen risk and patient-level risk factors, and secondary prophylaxis after a prior neutropenic complication or dose-limiting neutropenia when the same dose and schedule are planned.
Definitions
Initial Therapy Criteria
Initial therapy (Rolvedon)
Initial approval for prevention of neutropenia in cancer patients receiving myelosuppressive chemotherapy
Rolvedon-specific usage restrictions apply; approval duration: 6 months.
Initial therapy guidance
Initial use considerations
Appendices provide lists of specific regimens by cancer type; lists are not comprehensive.
Continuation Criteria
Continuation of therapy
Continuation requirement
If not met, therapy is not medically necessary.
Step Therapy
| Requirement | Details |
|---|---|
| Documented failure or intolerable adverse event to all preferred products | |
| Member has failed treatment with all preferred products due to a documented intolerable adverse event (adverse event not an expected adverse event attributed to the active ingredient as described in prescribing information). Approval typically for 6 months. | |
| Documented latex allergy with need for latex-free vial | |
| Prescriber documents member has a latex allergy requiring latex-free vials and member had inadequate response or intolerable adverse effect to Nivestym. Approval typically for 6 months. | |
| Documented inadequate response or intolerable adverse effect to preferred products for Leukine | |
| Coverage for Leukine provided when member has documented inadequate response or intolerable adverse effect to any preferred products; Leukine also covered for uveal melanoma with immunoembolization. Approval typically for 6 months. | |
| Documented inadequate response or intolerable adverse effect to preferred products for targeted long-acting agents (including Rolvedon, Ryzneuta, Armlupeg, Fylnetra, Nyvepria, Stimufend, Udenyca, Udenyca Onbody, Ziextenzo) | |
| Coverage provided when member has failed treatment with all preferred products due to a documented intolerable adverse effect not attributable to the active ingredient. Approval typically for 6 months. |
| Statement | Details |
|---|---|
| No explicit step therapy sequence specified | |
| The extracted sections do not describe a step-by-step sequence; instead the policy uses exception criteria to permit coverage of targeted products when documented failure or intolerance to preferred products is shown. |
Site of Care
No site-of-care restrictions specified; outpatient administration codes provided
No site-of-care restrictions are specified in the extracted policy sections; billing codes provided pertain to outpatient administration settings such as office, infusion center, or hospital outpatient.
- Policy lists HCPCS/J/Q codes for products and does not impose site-of-care limitations in the provided sections.
Biosimilar Products
Preferred short-acting filgrastim: Nivestym and Zarxio
Preferred short-acting filgrastim products are Nivestym and Zarxio; document attempts or failures with these preferred products when seeking exceptions for targeted short-acting agents.
- Exception criteria for targeted short-acting products require documented failure or intolerable adverse event to all preferred products (Nivestym, Zarxio).
Preferred long-acting pegfilgrastim: Fulphila, Neulasta, Neulasta Onpro
Preferred long-acting pegfilgrastim products are Fulphila, Neulasta, and Neulasta Onpro; coverage of targeted long-acting products requires documented failure or intolerable adverse effect to preferred long-acting products.
- Targeted long-acting exception criteria list specific products and require documented inadequate response or intolerable adverse effect to preferred products.
Use the specific HCPCS/Q-code corresponding to the biosimilar product administered
The policy lists specific HCPCS/Q-codes for Neulasta, Neupogen, and multiple biosimilar filgrastim/pegfilgrastim products; when billing, use the HCPCS/Q-code that corresponds to the exact biosimilar product administered.
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