Long-Acting Colony Stimulating Factors (pegfilgrastim and efbemalenograstim biosimilars)
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Policy governing prior authorization and pharmacy benefit coverage of FDA-approved long-acting granulocyte colony-stimulating factor products for members of Mass General Brigham Health Plan.
Policy updated to indicate it no longer applies to the medical benefit and to require trial and failure with Fulphila and Neulasta/Onpro for reauthorization of nonpreferred agents.
Ryzneuta (efbemalenograstim) and several recently approved biosimilars were added as nonpreferred products.
Clarified that members new to the plan with coverage effective date 3C= 90 days require submission of medical records documenting current treatment to authorize medication.
Coverage Criteria
The requested medication must not be used in combination with other colony stimulating factors within any chemotherapy cycle. Members receiving concurrent chemotherapy and radiation therapy are not eligible for coverage under these criteria. Additionally, the product will not be administered with weekly chemotherapy regimens.
Use of long‑acting pegfilgrastim products in settings that do not meet the policy's specified primary or secondary prophylaxis criteria is not supported. Specifically, requests for regimens that do not meet the febrile neutropenia risk thresholds described in Appendix A (≥20%) or Appendix B (10–19%), or uses outside the listed FDA‑approved or compendial indications, are not consistent with the coverage criteria and may be considered not medically necessary.
| Regimen (Appendix A) | Cancer type / notes | FN risk threshold / coverage stance |
|---|---|---|
| Dose dense MVAC (methotrexate, vinblastine, doxorubicin, cisplatin) | Bladder cancer | >=20% — covered (primary prophylaxis) |
| CBDCa/Pac (carboplatin, paclitaxel) | Bladder cancer | >=20% — covered (primary prophylaxis) |
| VAI; VDC-IE; Cisplatin/doxorubicin; VDC; VIDE | Bone cancer (various combination regimens) | >=20% — covered (primary prophylaxis) |
| Docetaxel + trastuzumab; Dose-dense AC + paclitaxel; TAC; AT; Doc; TC; TCH | Breast cancer (multiple high-risk regimens) | >=20% — covered (primary prophylaxis) |
| FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, irinotecan) | Colorectal cancer | >=20% — covered (primary prophylaxis) |
| Docetaxel/cisplatin/fluorouracil; TPF (docetaxel, cisplatin, fluorouracil) | Esophageal and gastric cancers; Head and neck SCC | >=20% — covered (primary prophylaxis) |
| Brentuximab vedotin + AVD; Escalated BEACOPP | Hodgkin lymphoma | >=20% — covered (primary prophylaxis) |
| Doxorubicin/gemcitabine | Kidney cancer | >=20% — covered (primary prophylaxis) |
| Dose-adjusted EPOCH; ICE; Dose-dense CHOP-14 + rituximab; MINE; DHAP; ESHAP; HyperCVAD + rituximab; VAPEC-B | Non-Hodgkin's lymphoma (multiple high-risk regimens) | >=20% — covered (primary prophylaxis) |
| Dacarbazine-based combination with IL-2, interferon alpha | Melanoma | >=20% — covered (primary prophylaxis) |
| DT-PACE / VTD-PACE | Multiple myeloma | >=20% — covered (primary prophylaxis) |
| Topotecan or Docetaxel | Ovarian cancer | >=20% — covered (primary prophylaxis) |
| FOLFIRINOX (fluorouracil, leucovorin, irinotecan, oxaliplatin) | Pancreatic cancer | >=20% — covered (primary prophylaxis) |
| MAID; Doxorubicin; Ifosfamide/doxorubicin | Soft tissue sarcoma | >=20% — covered (primary prophylaxis) |
| Topotecan; CAV (cyclophosphamide, doxorubicin, vincristine) | Small cell lung cancer | >=20% — covered (primary prophylaxis) |
| VelP; VIP; TIP | Testicular cancer | >=20% — covered (primary prophylaxis) |
Covered Chemotherapy Regimens (Appendices)
| Appendix | Selected example regimens (non‑exhaustive) | Typical applicability / guidance |
|---|---|---|
| Appendix A | Dose-dense MVAC; FOLFOXIRI; TAC; FOLFIRINOX; VDC-IE; Escalated BEACOPP; DT-PACE; MAID; Topotecan-based regimens | Regimens with FN incidence >20% — primary prophylaxis indicated per policy |
| Appendix A | Dose-adjusted EPOCH; ICE; Dose-dense CHOP-14 + rituximab; VAI; VIDE; Cisplatin/doxorubicin | High-risk hematologic regimens — primary prophylaxis indicated per policy |
| Appendix A | Docetaxel + trastuzumab; Dose-dense AC + paclitaxel; TAC; TCH | Breast cancer regimens with >20% FN risk — primary prophylaxis indicated per policy |
| Appendix B | Docetaxel; CHOP (including liposomal doxorubicin variants); Carboplatin/paclitaxel; Cisplatin/paclitaxel; Paclitaxel q21 | Regimens with 10–19% FN risk — may be considered for prophylaxis per policy (see policy note) |
| Appendix B | FOLFOX; FL; CPT-11 (irinotecan); Etoposide/carboplatin; BEP | Additional 10–19% risk regimens — consideration for prophylaxis based on clinical judgment and policy criteria |
Risk Thresholds and Coding
Provider Actions and Requirements
Prior authorization required under the pharmacy benefit
Prior authorization is required under the pharmacy benefit for long‑acting colony stimulating factors; approvals are based on diagnosis‑specific criteria for prevention of chemotherapy‑induced neutropenia, secondary prophylaxis, or other allowed indications. Submit a prior authorization request per pharmacy benefit procedures before dispensing.
Trial/failure of preferred agents required for nonpreferred products
Nonpreferred pegfilgrastim and efbemalenograstim products require prior trial and failure of preferred agents. For initial and continuation approvals of Ziextenzo, Udenyca, Udenyca Onbody, Ryzneuta, Stimufend, Fylnetra, and Nyvepria, the member must have had an adverse reaction, intolerance, or contraindication to Neulasta/Neulasta Onpro AND Fulphila before the nonpreferred product will be authorized.
- Reauthorization for nonpreferred agents requires documented adverse reaction/intolerance/contraindication to Neulasta/Neulasta Onpro and Fulphila.
Provide medical records for members new to the plan (≤ 90 days)
If the member is new to the plan (coverage effective date ≤ 90 days), submit medical records demonstrating the member is currently receiving treatment with the requested drug; records from samples or manufacturer's patient assistance programs do not satisfy this requirement.
- Coverage effective date ≤ 90 days triggers requirement.
- Do not submit documentation consisting only of samples or manufacturer's patient assistance program records.
Denial risk if prophylaxis criteria are not met
Requests that do not meet the policy's diagnosis‑specific criteria for primary or secondary prophylaxis (including regimen febrile neutropenia risk thresholds per Appendix A/B or documented prior febrile neutropenia/dose‑limiting neutropenic event) are at risk for denial.
- Primary prophylaxis requires regimen FN risk ≥20% (Appendix A) or 10–19% (Appendix B) where applicable.
- Secondary prophylaxis requires prior FN or dose‑limiting neutropenic event from a prior similar chemotherapy cycle with same dose and schedule.
Insufficient documentation for new-to-plan members may lead to denial
For members new to the plan (coverage effective date ≤ 90 days), failure to provide the required medical records documenting current treatment with the requested drug may result in denial of the request.
- Ensure submitted records document current receipt of the requested medication (not samples or manufacturer assistance).
- Include treatment details sufficient to verify indication (primary vs secondary prophylaxis) and regimen FN risk when applicable.
Line of Therapy
first-line
Background
Long‑acting pegfilgrastim products are indicated to decrease the incidence of infection manifested by febrile neutropenia in patients with non‑myeloid malignancies who are receiving myelosuppressive chemotherapy. Coverage is defined for primary prophylaxis when the planned chemotherapy regimen is expected to result in a febrile neutropenia risk of ≥20% (Appendix A) or may be considered for regimens with a 10–19% risk (Appendix B), and for secondary prophylaxis when a patient experienced a prior febrile neutropenic complication or dose‑limiting neutropenic event on a similar chemotherapy regimen with the same dose and schedule.
Definitions
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