The class of drugs known as granulocyte colony stimulating factors (G-CSFs) include: filgrastim (Neupogen®), filgrastim-sndz, (Zarxio®), filgrastim-aafi (Nivestym®), pegfilgrastim (Neulasta®) (Neulasta® Onpro®), pegfilgrastim-jmdb (Fulphila™), pegfilgrastim-cbqv (Udenyca™), pegfilgrastim-bmez (Ziextenzo™), tbo-filgrastim (Granix®) and sargramostim (Leukine®). These drugs are used for the prevention of severe neutropenia, reduce the duration of the neutropenia, prevent febrile neutropenia (FN), and possible infection-related complications in individuals with cancer. FN is defined as a single temperature equal to or greater than 38.3°C, or a temperature equal to or greater than 38.0°C over 1 hour, and neutrophils less than 500 mcL.
G-CSFs are a blood growth factor that stimulates the bone marrow to produce more infection-fighting white blood cells known as neutrophils. These neutrophils are then released into the blood stream where they aid in fighting infection. When neutrophil levels drop and an individual becomes neutropenic, the body is less able to fight off infection. Individuals at high risk to develop these types of conditions may be clinically indicated for the administration of G-CSFs.
Delaware Mandate
Effective September 1, 2017, 18 Delaware Code §§3338B and 3555B, require that no individual policy or contract of health insurance, or certificate issued thereunder, which is delivered, issued for delivery, renewed, modified, altered, or amended in this State by any health insurer, health service corporation or health maintenance organization that directly or indirectly covers the treatment of cancer shall limit or exclude coverage for a drug approved by the United States Food and Drug Administration by mandating that the insured shall first be required to fail to successfully respond to a different drug or drugs or prove a history of failure of such drug or drugs; provided, however that the use of such drug or drugs is consistent with best practices for the treatment of stage 4 advanced, metastatic cancer or, in the case of other cancers, the use of the drug is supported by national clinical guidelines, national standards of care, or peer reviewed medical literature for the treatment of the cancer, or in the case of targeted therapy, the target at issue.
Note: Risk assessment for use of G-CSFs includes (not an all-inclusive list) disease type, chemotherapy regimen (high-dose, dose-dense, or standard-dose), risk factors, and treatment intent (curative/adjuvant vs. palliative). Independent clinical judgment should be exercised based on the individual’s situation.
Filgrastim (Neupogen) may be considered medically necessary for ANY of the following indications:
Food and Drug Administration (FDA) Indications:
National Comprehensive Cancer Network (NCCN) Indications:
J1442 |
|
|
|
|
|
|
Note: Filgrastim (Neupogen), J1442, excludes biosimilar reference in its definition and should therefore be reported with code Q5101 or Q5110 to report the biosimilarity of filgrastim.
Filgrastim-sndz (Zarxio) may be considered medically necessary for ANY of the following indications:
FDA Indications
NCCN Indications:
Q5101 |
|
|
|
|
|
|
Note: Filgrastim (Neupogen), J1442, excludes biosimilar reference in its definition and should therefore be reported with code Q5101 or Q5110 to report the biosimilarity of filgrastim.
Filgrastim-aafi (Nivestym) may be considered medically necessary for ANY of the following:
FDA Indications:
Q5110 |
|
|
|
|
|
|
Note: Filgrastim (Neupogen), J1442, excludes biosimilar reference in its definition and should therefore be reported with code Q5101 or Q5110 to report the biosimilarity of filgrastim.
Pegfilgrastim (Neulasta) and (Neulasta Onpro) may be considered medically necessary for ANY of the following:
FDA Indications:
NCCN Indications:
J2505 |
96377 |
|
|
|
|
|
Note: Pegfilgrastim (Neulasta), J2505, excludes biosimilar reference in its definition and should therefore be reported with code Q5108 or Q5111 to report the biosimilarity of pegfilgrastim.
Pegfilgrastim-jmdb (Fulphila) may be considered medically necessary for the following:
FDA Indication:
Q5108 |
|
|
|
|
|
Note: Pegfilgrastim (Neulasta), J2505, excludes biosimilar reference in its definition and should therefore be reported with code Q5108 or Q5111 to report the biosimilarity of pegfilgrastim.
Note: Pegfilgrastim-jmdb (Fulphila) is not indicated for the mobilization or peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Pegfilgrastim-cbqv (Udenyca) may be considered medically necessary for the following:
FDA Indication:
Q5111 |
|
|
|
|
|
|
Note: Pegfilgrastim (Neulasta), J2505, excludes biosimilar reference in its definition and should therefore be reported with code Q5108 or Q5111 to report the biosimilarity of pegfilgrastim.
Note: Pegfilgrastim-cbqv (Udenyca) is not indicated for the mobilization or peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Pegfilgrastim-bmez (Ziextenzo) may be considered medically necessary for the following:
FDA Indication:
J3590 |
|
|
|
|
|
|
Note: Pegfilgrastim-bmez (Ziextenzo) is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Tbo-filgrastim (Granix) may be considered medically necessary for ANY of the following:
FDA Indication:
· To reduce the duration of severe neutropenia in adult and pediatric individuals one (1) month and older with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of FN.
NCCN Indications:
· MDS:
o Treatment of lower risk* disease associated with symptomatic anemia, without del(5q) with or without other cytogenetic abnormalities, serum erythropoietin levels less than or equal to 500 mU/mL, and ring sideroblasts greater than or equal to 15%:
§ In combination with epoetin alfa or darbepoetin alfa; or
§ In combination with lenalidomide and epoetin alfa, or lenalidomide and darbepoetin alfa if no response to hematopoietic cytokines alone; or
o Consider in combination with epoetin alfa or darbepoetin alfa for lower risk* disease associated with symptomatic anemia, without del(5q), with or without cytogenetic abnormalities, with serum erythropoietin levels less than or equal to 500 mU/mL, ring sideroblasts less than 15%, and no response to epoetin alfa or darbepoetin alfa alone.
· Myeloid Growth Factors:
o Prophylaxis of chemotherapy-induced FN or other dose-limiting neutropenic events in high-risk (greater than 20% overall risk of FN) individuals with solid tumors and nonmyeloid malignancies receiving treatment in the curative/adjuvant or palliative settings; or
o Prophylaxis of chemotherapy-induced FN or other dose-limiting neutropenic events in intermediate-risk (10% to 20% overall risk of FN) individuals with solid tumors and nonmyeloid malignancies receiving treatment in the curative/adjuvant or palliative settings who have one (1) or more of the following risk factors (see Table 1):
§ Prior chemotherapy or radiation therapy
§ Persistent neutropenia
§ Bone marrow involvement by tumor
§ Recent surgery and/or open wounds
§ Liver dysfunction (bilirubin greater than 2.0)
§ Renal dysfunction (CrCl less than 50 mL/min)
§ Age greater than 65 years receiving full chemotherapy dose intensity; or
o Treatment of chemotherapy-induced FN in individuals who have been receiving prophylactic tbo-filgrastim (Granix); or
o Used in hematopoietic cell transplant for:
§ Mobilization of hematopoietic progenitor cells in the autologous setting as a single agent, following combination chemotherapy; or
§ Mobilization of hematopoietic progenitor cells in combination with plerixafor (Mozobil) in the autologous setting for individuals with non-Hodgkin lymphoma or multiple myeloma; or
§ Mobilization of donor hematopoietic progenitor cells or for granulocyte transfusion in the allogeneic setting; or
§ Supportive care in the post-transplant setting.
J1447 |
|
|
|
|
|
|
Sargramostim (Leukine) may be considered medically necessary for ANY of the following indications:
FDA Indications:
· Individuals 55 years and older with AML following induction chemotherapy to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death; or
· Adult individuals undergoing mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation; or
· Individuals 2 years of age or older for the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation; or
· Individuals 2 years or age or older for the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation; or
· Individuals 2 years or age or older for treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation; or
· Individuals acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) to increase survival.
NCCN Indications
· Myeloid Growth Factors:
o Treatment of chemotherapy-induced FN in individuals who have not received prophylactic G-CSFs but who have one or more risk factors for an infection-associated complication (see Table 2):
§ Sepsis syndrome
§ Age greater than 65 years
§ ANC less than 100/mcL
§ Duration of neutropenia expected to be greater than 10 days
§ Pneumonia or other clinically documented infections
§ Invasive fungal infection
§ Hospitalization at the time of fever
§ Prior episode of febrile neutropenia; or
o Used in hematopoietic cell transplant for the mobilization of hematopoietic progenitor cells in combination with filgrastim or filgrastim-sndz in the autologous setting.
The safety and efficacy of sargramostim (Leukine) have not been assessed in individuals with AML less than 55 years of age.
Liquid solutions containing benzyl alcohol (including liquid sargramostim or lyophilized Leukine reconstituted with bacteriostatic water for injection, USP (0.9% benzyl alcohol)) should not be administered to neonates.
J2820 |
|
|
|
|
|
|
The use of G-CSFs are considered not medically necessary for ANY of the following:
· For uses not meeting the criteria above; or
· As prophylaxis for FN, except when criteria above are met; or
· As treatment of neutropenia in individuals who are afebrile, except when criteria above are met; or
· As adjunctive therapy in individuals with uncomplicated FN, defined as: fever less than ten (10) days duration, no evidence of pneumonia, cellulitis, abscess, sinusitis, hypotension, multi-organ dysfunction, or invasive fungal infection; and no uncontrolled malignancies; or
· Chemo sensitization of myeloid leukemias; or
· As prophylaxis for FN during concomitant chemotherapy and radiation therapy; or
· Continued use if no response is seen within 28-42 days (individuals who have failed to respond within this time frame are considered non-responders).
J1442 |
J1447 |
J2505 |
J2820 |
J3590 |
Q5101 |
Q5108 |
Q5110 |
Q5111 |
|
|
|
|
|
C9058 |
|
|
|
|
|
|
NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.
*Note: Lower risk defined as IPSS-R (Very Low, Low, Intermediate), IPSS (Low/Intermediate-1), and WPSS (Very Low, Low, Intermediate).
**Note: Language derived from National Comprehensive Cancer Network (NCCN) guidelines
Covered diagnosis codes for J1442
B20 |
C92.00 |
C92.02 |
C92.10 |
C92.40 |
C92.42 |
C92.50 |
C92.52 |
C92.60 |
C92.62 |
C92.90 |
C92.92 |
C92.A0 |
C92.A2 |
C93.00 |
C93.02 |
C93.10 |
C94.00 |
C94.02 |
C94.20 |
C94.22 |
D46.0 |
D46.1 |
D46.20 |
D46.21 |
D46.22 |
D46.4 |
D46.9 |
D46.A |
D46.B |
D46.C |
D46.Z |
D47.1 |
D47.4 |
D61.1 |
D61.2 |
D61.3 |
D61.89 |
D70.0 |
D70.1 |
D70.2 |
D70.3 |
D70.4 |
D70.8 |
D70.9 |
T45.1X5A |
T45.1X5D |
T45.1X5S |
Z41.8 |
Z48.290 |
Z51.11 |
Z51.12 |
Z51.89 |
Z52.001 |
Z52.011 |
Z52.091 |
Z76.82 |
Z92.21 |
Z92.3 |
Z94.81 |
Z94.84 |
|
|
Covered diagnosis codes for Q5101
B20 |
C92.00 |
C92.02 |
C92.10 |
C92.40 |
C92.42 |
C92.50 |
C92.52 |
C92.60 |
C92.62 |
C92.90 |
C92.92 |
C92.A0 |
C92.A2 |
C93.10 |
D46.0 |
D46.1 |
D46.20 |
D46.21 |
D46.22 |
D46.4 |
D46.9 |
D46.A |
D46.B |
D46.C |
D46.Z |
D47.1 |
D47.4 |
D61.1 |
D61.2 |
D61.3 |
D61.89 |
D70.0 |
D70.1 |
D70.2 |
D70.3 |
D70.4 |
D70.8 |
D70.9 |
T45.1X5A |
T45.1X5D |
T45.1X5S |
Z41.8 |
Z48.290 |
Z51.11 |
Z51.12 |
Z51.89 |
Z52.001 |
Z52.011 |
Z52.091 |
Z76.82 |
Z92.21 |
Z92.3 |
Z94.81 |
Z94.84 |
|
Covered diagnosis codes for Q5110
C92.00 |
C92.02 |
C92.10 |
C92.40 |
C92.42 |
C92.50 |
C92.52 |
C92.60 |
C92.62 |
C92.90 |
C92.92 |
C92.A0 |
C92.A2 |
D61.1 |
D61.2 |
D61.3 |
D61.89 |
D70.0 |
D70.1 |
D70.2 |
D70.3 |
D70.4 |
D70.8 |
D70.9 |
Z41.8 |
Z48.290 |
Z51.11 |
Z51.12 |
Z51.89 |
Z52.001 |
Z52.011 |
Z52.091 |
Z76.82 |
Z92.21 |
Z92.3 |
Z94.81 |
|
|
|
|
|
|
Covered diagnosis codes for J2505, 96377
D70.1 |
D70.2 |
D70.3 |
T45.1X5A |
T45.1X5D |
T45.1X5S |
Z41.8 |
Z48.290 |
Z51.11 |
Z51.12 |
Z51.89 |
Z52.001 |
Z52.011 |
Z52.091 |
Z92.3 |
Z94.81 |
Z94.84 |
|
|
|
|
Covered diagnosis codes for Q5108
D70.1 |
D70.2 |
|
|
|
|
|
Covered diagnosis codes for Q5111
D70.1 |
D70.2 |
|
|
|
|
|
Covered diagnosis codes for J1447
C93.10 |
D46.0 |
D46.1 |
D46.20 |
D46.21 |
D46.4 |
D46.9 |
D46.A |
D46.B |
D46.Z |
D70.1 |
D70.2 |
T45.1X5A |
T45.1X5D |
T45.1X5S |
Z41.8 |
Z51.11 |
Z51.89 |
Z52.001 |
Z52.011 |
Z52.091 |
Z94.81 |
Z94.84 |
|
|
|
|
|
Covered diagnosis codes for J2820
C92.00 |
C92.02 |
C92.10 |
C92.40 |
C92.42 |
C92.50 |
C92.52 |
C92.60 |
C92.62 |
C92.90 |
C92.92 |
C92.A0 |
C92.A2 |
C93.10 |
D61.1 |
D61.2 |
D61.3 |
D61.89 |
D70.0 |
D70.1 |
D70.2 |
D70.3 |
D70.4 |
D70.8 |
D70.9 |
T45.1X5A |
T45.1X5D |
T45.1X5S |
Z48.290 |
Z51.11 |
Z51.12 |
Z51.89 |
Z52.001 |
Z52.011 |
Z52.091 |
Z76.82 |
Z92.21 |
Z92.3 |
Z94.81 |
Z94.84 |
|
|
Covered Diagnosis Codes for J3590, C9058
D61.810 |
D61.811 |
D61.818 |
D70.1 |
D70.2 |
D70.9 |
T45.1X5A |
T45.1X5D |
T45.1X5S |
T66.XXXA |
T66.XXXD |
T66.XXXS |
W88.1XXA |
W88.1XXD |
W88.1XXS |
W88.8XXA |
W88.8XXD |
W88.8XXS |
Z41.8 |
Z48.290 |
Z51.11 |
Z51.12 |
Z51.89 |
Z52.011 |
Z76.89 |
Z94.81 |
Z94.84 |
|
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract, and subject to the applicable laws of your state.
Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you need these services, contact the Civil Rights Coordinator.
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.