GRANIX, Tbo-Filgrastim ZARXIO, Filgrastim-sndz NEUPOGEN, Filgrastim NIVESTYM, Filgrastim-aafi Form

Filgrastim (Neupogen®) and its biosimilars, filgrastim-sndz (Zarxio®), filgrastim-aafi (Nivestym™), filgrastim-ayow (Releuko®), and tbo-filgrastim (Granix®), are human granulocyte colony-stimulating factors. FDA Approved Indication(s) Granix is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia (FN). Neupogen, Nivestym, and Zarxio are indicated to mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. Neupogen, Nivestym, Releuko, and Zarxio are indicated to: • Decrease the incidence of infection‚ as manifested by FN‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever. • Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML). • Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ FN, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT). • Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia. Neupogen is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Granix, Neupogen,
Nivestym, Releuko, and Zarxio are medically necessary when the following criteria are met:
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Filgrastim, Filgrastim-sndz, Filgrastim-aafi,
Filgrastim-ayow, Tbo-filgrastim I. Initial Approval Criteria
A. Chemotherapy-Induced Neutropenia (must meet all):

1. Diagnosis of non-myeloid malignancy (i.e., solid tumor and lymphoid malignancies) or AML;
2. Prescribed for use following myelosuppressive chemotherapy;
   
   3. For Neupogen, Nivestym, Releuko, or Granix requests, member meets one of the following (a or b): a. Member must use Zarxio, unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required for Zarxio b. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);
3. The requested medication will not be prescribed concurrently with other colony stimulating factors (e.g., pegfilgrastim, Leukine®) within any chemotherapy cycle;
4. For members receiving palliative chemotherapy, provider attestation that chemotherapy dose reduction has been considered;
5. Dose does not exceed 30 mcg/kg per day [IV] or 24 mcg/kg per day [SC] (see Appendix F for dose rounding guidelines).
   Approval duration:
   Medicaid/HIM – 6 months
   Commercial – 6 months or to the member’s renewal date, whichever is longer B. Bone Marrow Transplantation (must meet all):
6. Diagnosis of non-myeloid malignancy (i.e., solid tumor and lymphoid malignancies);
   2. Member is undergoing myeloablative chemotherapy followed by BMT;
   3. For Neupogen, Nivestym, Releuko, or Granix requests, member meets one of the following (a or b):
      a. Member must use Zarxio, unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required for Zarxio b. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);
7. The requested medication will not be prescribed concurrently with other colony stimulating factors (e.g., pegfilgrastim, Leukine®) within any chemotherapy cycle;
8. Dose does not exceed 10 mcg/kg per day [IV or SC] (see Appendix F for dose rounding guidelines). Approval duration:
   Medicaid/HIM – 6 months
   Commercial – 6 months or to the member’s renewal date, whichever is longer C. Peripheral Blood Progenitor Cell Collection (must meet all):
9. Prescribed for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis;

10. The prescribed drug will be initiated before leukapheresis (e.g., prescribed for 6 to 7 days with leukapheresis on days 5, 6 and 7); Page 2 of 15

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11. For Neupogen, Nivestym, Releuko, or Granix requests, member meets one of the following (a or b):
    a. Member must use Zarxio, unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required for Zarxio b. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);
12. The requested medication will not be prescribed concurrently with other colony stimulating factors (e.g., pegfilgrastim, Leukine®) within any chemotherapy cycle;
13. Request meets one of the following (a or b): a. Dose does not exceed 10 mcg/kg per day [IV or SC] (see Appendix F for dose rounding guidelines); b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN. Approved duration:
    Medicaid/HIM – 1 month
    Commercial – 6 months or to the member’s renewal date, whichever is longer D. Chronic Neutropenia (must meet all):
14. Prescribed for use in symptomatic (e.g., fever‚ infections‚ oropharyngeal ulcers) severe chronic neutropenia caused by congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia;
15. For Neupogen, Nivestym, Releuko, or Granix requests, member meets one of the following (a or b):
    a. Member must use Zarxio, unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required for Zarxio b. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);
16. The requested medication will not be prescribed concurrently with other colony stimulating factors (e.g., pegfilgrastim, Leukine®) within any chemotherapy cycle;
17. Dose does not exceed: 30 mcg/kg per day [IV] or 24 mcg/kg per day [SC] (see Appendix F for dose rounding guidelines). Approved duration: Medicaid/HIM – 6 months
    Commercial – 6 months or to the member’s renewal date, whichever is longer E. Acute Radiation Syndrome (must meet all):
18. Prescribed for use following suspected or confirmed acute exposure to myelosuppressive doses of radiation;

19. For Neupogen, Nivestym, Releuko, or Granix requests, member meets one of the following (a or b):
    a. Member must use Zarxio, unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required for Zarxio Page 3 of 15

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    Filgrastim-ayow, Tbo-filgrastim b. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);

20. The requested medication will not be prescribed concurrently with other colony stimulating factors (e.g., pegfilgrastim, Leukine®) within any chemotherapy cycle;
    4. Dose does not exceed 10 mcg/kg per day [SC] (see Appendix F for dose rounding guidelines). Approved duration:
       Medicaid/HIM – 6 months
       Commercial – 6 months or to the member’s renewal date, whichever is longer F. Myelodysplastic Syndrome (off-label) (must meet all):
21. Diagnosis of myelodysplastic syndrome with symptomatic anemia without del (5q) abnormality;
22. Current (within the past 30 days) serum erythropoietin level ≤ 500 mU/mL;
    3. For Neupogen, Nivestym, Releuko, or Granix requests, member meets one of the following (a or b):
       a. Member must use Zarxio, unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required for Zarxio b. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);
23. The requested medication will not be prescribed concurrently with other colony stimulating factors (e.g., pegfilgrastim, Leukine®) within any chemotherapy cycle;
24. Request meets one of the following (a or b): a. Dose does not exceed 2 mcg/kg twice a week [SC] (see Appendix F for dose rounding guidelines); b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Approved duration: Medicaid/HIM – 6 months
    Commercial – 6 months or to the member’s renewal date, whichever is longer G. Wilms Tumor (off-label) (must meet all):
25. Diagnosis of Wilms tumor (nephroblastoma);
    2. Request is for supportive care for member receiving a regimen of cyclophosphamide and etoposide, or cyclophosphamide, doxorubicin, and vincristine in Regimen M and Regimen I (see Appendix D);

26. For Neupogen, Nivestym, Releuko, or Granix requests, member meets one of the following (a or b):
    a. Member must use Zarxio, unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required for Zarxio b. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E); Page 4 of 15

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27. The requested medication will not be prescribed concurrently with other colony stimulating factors (e.g., pegfilgrastim, Leukine®) within any chemotherapy cycle;
28. Request meets one of the following (a or b): a. Dose does not exceed 30 mcg/kg per day [IV] or 24 mcg/kg per day [SC] (see Appendix F for dose rounding guidelines); b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Approved duration: Medicaid/HIM – 6 months
    Commercial – 6 months or to the member’s renewal date, whichever is longer H. Other diagnoses/indications (must meet all):
29. For Neupogen, Nivestym, Releuko, or Granix requests, member meets one of the following (a or b): a. Member must use Zarxio, unless contraindicated or clinically significant adverse effects are experienced;
    Prior authorization may be required for Zarxio b. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);
30. Member must meet one of the following (a or b): a. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (i or ii): i. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or ii. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or b. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. II. Continued Therapy A. All Indications in Section I (must meet all):

31. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B); Page 5 of 15

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32. Member is responding positively to therapy;
    3. For Neupogen, Nivestym, Releuko, or Granix requests, member meets one of the following (a or b): a. Member must use Zarxio, unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required for Zarxio b. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);
33. The requested medication will not be prescribed concurrently with other colony stimulating factors (e.g., pegfilgrastim, Leukine®) within any chemotherapy cycle;
34. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed the FDA-approved maximum recommended dose for the relevant indication in Section V (see Appendix F for dose rounding guidelines); b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Approval duration:
    Medicaid/HIM – 6 months
    Commercial – 6 months or to the member’s renewal date, whichever is longer B. Other diagnoses/indications (must meet 1 and 2):
35. For Neupogen, Nivestym, Releuko, or Granix requests, member meets one of the following (a or b): a. Member must use Zarxio, unless contraindicated or clinically significant adverse effects are experienced;
    Prior authorization may be required for Zarxio b. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E);

36. Member must meet one of the following (a or b): a. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (i or ii): i. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or ii. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or b. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. Page 6 of 15

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    Filgrastim, Filgrastim-sndz, Filgrastim-aafi,
    Filgrastim-ayow, Tbo-filgrastim III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key AML: acute myeloid leukemia ANC: absolute neutrophil count BMT: bone marrow transplantation Appendix B: Therapeutic Alternatives Not applicable FDA: Food and Drug Administration
    FN: febrile neutropenia G-CSF: granulocyte colony-stimulating factor Appendix C: Contraindications/Boxed Warnings
    • Contraindication(s): history of serious allergic reactions • Boxed warning(s): none reported Appendix D: General Information • Zarxio is not recommended in patients requiring direct administration of less than 0.3 mL due to the potential for dosing errors. The spring-mechanism of the needle guard apparatus affixed to the prefilled syringe interferes with the visibility of the graduation markings on the syringe barrel corresponding to 0.1 mL and 0.2 mL. The visibility of these markings is necessary to accurately measure doses of Zarxio less than 0.3 mL (180 mcg). • Neutropenia is defined as an absolute neutrophil count (ANC) of < 500 neutrophils/mcL or an ANC of < 1,000 neutrophils/mcL and a predicted decline to ≤ 500 neutrophils/mcL over the next 48 hours. Neutropenia can progress to FN, defined as a single temperature of ≥ 38.8ºC orally or ≥ 38.0ºC over 1 hour. • The development of febrile neutropenia is a common dose-limiting toxicity of many chemotherapy regimens. This risk is directly related to the intensity of the chemotherapy regimen. Chemotherapy regimens that have an incidence of febrile neutropenia greater than 20% in clinical trials in chemotherapy naïve patients are considered by the National Comprehensive Cancer Network (NCCN) panel at high risk. Prophylaxis with myeloid growth factors is recommended at this level of risk (Category 1 recommendation). NCCN Compendium recommend prophylaxis be considered in intermediate-risk (10-20% overall risk of FN) patients (Category 2A recommendation). In addition to chemotherapy regimens, other risk factors such as: treatment-related, patient related, cancer-related, and co-morbidities have also been associated with an increased risk of febrile neutropenia.
    Therefore, the type of chemotherapy regimen is only one component of the risk assessment.
    • For chemotherapy patients, continuing filgrastim until the ANC has reached 10,000/mm3 following the expected chemotherapy-induced neutrophil nadir (as specified in the G- Page 7 of 15

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    Filgrastim-ayow, Tbo-filgrastim CSF package insert), is known to be safe and effective. However, a shorter duration of administration that is sufficient to achieve clinically adequate neutrophil recovery is a reasonable alternative, considering issues of patient convenience and cost.5
    • Evidence supports dose reduction of pegylated interferon according to FDA approved labeling as treatment for neutropenia occurring in hepatitis C patients treated with combination therapy (pegylated interferon + ribavirin). Treatment with filgrastim is not FDA approved or recommended by current hepatitis C treatment guidelines except in patients with decompensated cirrhosis. • There are insufficient data to support the use of filgrastim to treat febrile neutropenia in • patients who have received prophylactic Neulasta. In a randomized, double-blind, multi-center safety and efficacy study of 218 breast cancer patients receiving chemotherapy with a high risk of neutropenia, Zarxio was non- inferior to Neupogen on the primary endpoint of duration of severe neutropenia (1.17 days for Zarxio and 1.20 days for Neupogen). • NCCN guidelines for myelodysplastic syndrome list filgrastim with a category 2A recommendation for use as initial treatment of symptomatic anemia in lower risk disease with no del (5q), serum erythropoietin levels ≤500 mU/mL, and ring sideroblasts ≥15%. Filgrastim may also be considered for the treatment of symptomatic anemia in lower risk disease with serum erythropoietin levels ≤500 mU/mL, and ring sideroblasts <15% when these is no response or erythroid response followed by loss of response to epoetin or darbepoetin alone (category 2A recommendation). • For patients with a latex allergy, Granix (tbo-filgrastim) and Nivestym (filgrastim-aafi) are considered to be latex free. For Neupogen (filgrastim), and Zarxio (filgrastim-sndz), the presence of latex definitively be ruled out.
    • According to the ASCO, 2006 Clinical Practice Guideline for the Use of White Blood Cell Growth Factors, dose reduction or delay remains an appropriate strategy for the palliative treatment of cancer, as there is no evidence that dose maintenance or escalation improves clinically important outcomes in this setting. The 2015 updates to this guideline found no new data supporting the use of colony-stimulating factors (CSFs) to maintain dose-intensity in the treatment of metastatic disease, and the review found no demonstrable benefit in the use of myeloid growth factors to in patients with metastatic lung, small-cell lung, colorectal, hormone-refractory prostate, or breast cancer. To date, there have been no improvements in disease-free or OS reported for any common cancer with the use of CSFs to maintain dose-intensity, instead of dose reduction. The ASCO Panel recognizes that there may be individual patients who will not tolerate effective doses of chemotherapy without CSFs. Medical Oncologists making the decision to use prophylactic MGFs, or not, may need to consider not only the optimal chemotherapy regimen, but also the individual member risk factors and the intention of treatment; that is, curative, prolongation of life, or symptom control and palliation. • For mobilization of hematopoietic progenitor cells in the autologous setting, NCCN myeloid growth factor treatment guidelines include a dosing range from 10 to 32 mcg/kg/day by subcutaneous injection, in daily or twice-daily dosing, when used as a single-agent growth factor.
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    Filgrastim-ayow, Tbo-filgrastim • Chemotherapy regimens used in the treatment of Wilms Tumor for which filgrastim supportive care may be considered: o Regimen M: 9 doses of vincristine, 5 doses of dactinomycin, 5 doses of doxorubicin (cumulative dose 150 mg/m2), 4 courses of 5 daily doses of cyclophosphamide, and 4 courses of 5 daily doses of etoposide over 24 weeks. Dactinomycin and doxorubicin are given together, and cyclophosphamide and etoposide are given together. o Regimen I: 9 doses of vincristine, 4 doses of doxorubicin (cumulative dose 180 mg/m2), 7 courses of 3 to 5 daily doses of cyclophosphamide, and 3 courses of 5 daily doses of etoposide. Doxorubicin and 3 daily doses of cyclophosphamide are given together, and 5 daily doses of cyclophosphamide and etoposide are given together. Appendix E: States with Regulations against Redirections in Certain Oncology Settings State Step Therapy Prohibited? Yes Yes FL GA IA LA NV OH PA TN TX Yes Yes Yes Yes Yes Yes Yes Notes For stage 4 metastatic cancer and associated conditions. For stage 4 metastatic cancer. Redirection does not refer to review of medical necessity or clinical appropriateness. For standard of care stage 4 cancer drug use, supported by peer- reviewed, evidence-based literature, and approved by FDA. For stage 4 advanced, metastatic cancer or associated conditions. Exception if “clinically equivalent therapy, contains identical active ingredient(s), and proven to have same efficacy. Stage 3 and stage 4 cancer patients for a prescription drug to treat
    the cancer or any symptom thereof of the covered person Applies to Commercial and HIM requests only For stage 4 metastatic cancer and associated conditions For stage 4 advanced, metastatic cancer For advanced metastatic cancer and associated conditions For stage 4 advanced, metastatic cancer and associated conditions Appendix F: Dose Rounding Guidelines Weight-based Dose Range Vial Quantity Recommendation ≤ 314.99 mcg 1 vial of 300 mcg/1 mL 315-503.99 mcg 1 vial of 480 mcg/1.6 mL
    315-629.99 mcg 2 vials of 300 mcg/1 mL 630-944.99 mcg 3 vials of 300 mcg/1 mL 945-1,007.99 mcg 2 vials of 480 mcg/1.6 mL
    3 vials of 480 mcg/1.6 mL
    1,008-1,511.99 mcg This is part of a dose rounding guideline on select drug classes as part of an initiative conducted on a larger scale with multiple references and prescriber feedback.
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    Filgrastim, Filgrastim-sndz, Filgrastim-aafi,
    Filgrastim-ayow, Tbo-filgrastim Chemotherapy- induced neutropenia V. Dosage and Administration
    Drug Name Indication Filgrastim (Neupogen), filgrastim- sndz (Zarxio) , filgrastim- aafi (Nivestym), filgrastim- ayow (Releuko) Chronic neutropenia BMT Peripheral blood progenitor cell collection Patients acutely exposed to myelosuppressive doses of radiation Myelosuppressive chemotherapy Tbo- filgrastim (Granix) Dosing Regimen 5 mcg/kg SC or IV QD Dose may be increased in increments of 5 mcg/kg for each chemotherapy cycle, according to the duration and severity of the ANC nadir Do not administer 24 hours before and after chemotherapy Congenital: 6 mcg/kg SC BID Idiopathic or cyclic: 5 mcg/kg SC QD 10 mcg/kg IV or SC infusion QD 10 mcg/kg SC bolus or continuous infusion QD Maximum Dose 30 mcg/kg/day [IV] or 24 mcg/kg/day [SC] 30 mcg/kg/day [IV] or 24 mcg/kg/day [SC] 10 mcg/kg/day 10 mcg/kg/day 10 mcg/kg SC QD 10 mcg/kg/day 5 mcg/kg SC or IV QD 5 mcg/kg/day VI. Product Availability
    Drug Filgrastim (Neupogen) Filgrastim-sndz (Zarxio) Filgrastim-aafi (Nivestym) Filgrastim- ayow (Releuko Tbo-filgrastim (Granix) Availability
    Single-dose prefilled syringes for injection: 300 mcg/0.5 mL, 480 mcg/0.8 mL Single-dose vials for injection: 300 mcg/mL, 480 mcg/1.6 mL Single-dose prefilled syringes for injection: 300 mcg/0.5 mL, 480 mcg/0.8 mL Single-dose prefilled syringes for injection: 300 mcg/0.5 mL, 480 mcg/0.8 mL Single-dose vials for injection: 300 mcg/mL, 480 mcg/1.6 mL Single-dose vials for injection: 300 mcg/mL, 480 mcg/1.6 mL Single-dose prefilled syringes for injection: 300 mcg/0.5 mL, 480 mcg/0.8 mL
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    Single-dose vials for injection: 300 mcg/mL, 480 mcg/1.6 mL VII.