HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-13-017
Topic:
Interferon Alpha
Section:
Injections
Effective Date:
October 1, 2018
Issued Date:
October 1, 2018
Last Revision Date:
September 2018
Annual Review:
May 2016
 
 

Interferon alpha is a family of highly homologous, species-specific proteins that possess antiviral, antineoplastic, and immunomodulating activities. Human interferon alpha is commercially available in the United States as interferon alpha-N3 which is a mixture of naturally occurring human interferon alpha proteins, and as interferon alpha-2a and interferon alpha-2b which are of recombinant DNA origin and exist as single interferon subtype preparations.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

Interferon may be medically necessary for the treatment of ANY of the following conditions for individuals 18 years or older.

 

  • AIDS-related Kaposi's sarcoma; or 
  • Chronic hepatitis B, has compensated disease; or
  • Condyloma acuminata (genital warts, intralesional); or
  • Hairy cell leukemia, relapsed or refractory; or
  • Malignant melanoma; or
  • Multiple myeloma; or
  • Mycosis fungoides; or
  • Non-Hodgkin's lymphoma (follicular); or
  • Papillomatosis, laryngeal; or
  • Renal cell cancer as a debulking agent; or
  • Polycythemia vera (when other treatments have failed); or
    • Oral therapy with hydroxyurea or other myelosuppressive agents are not effective, not tolerated, or is contraindicated; and
    • Phlebotomy is not effective, not tolerated, or contraindicated
      Note: Failure of phlebotomy and or myelosuppresssive agents may be defined as ANY of the following:
      • Lack of hematological control (e.g., hematocrit greater than 45 or platelet count greater than 600 x 10 (9)/L); or
      • Occurrence of intractable symptoms (e.g., headaches, pruitis); or
      • Occurrence of symptoms related to hepatosplenomegaly; or
      • Occurrence of thrombotic of hemorrhagic complications; or
      • Phlebotomy required more often than every 2 months.
  • Chronic phase, Philadelphia chromosome-positive chronic myelogenous leukemia. 

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Chronic Hepatitis C

Initial therapy with Interferon Alpha may be considered medically necessary in individuals with diagnosis of chronic hepatitis C infection. The prescribing clinician must be a gastroenterologist, hepatologist, infectious diseases physician or a liver transplant physician.

  • For individuals with Genotype 1, Interferon alpha may be considered medically necessary if ANY of the following criteria is met:
    • Interferon alpha is being used in combination with sofosbuvir (Sovaldi) and ribavirin; or
    • Interferon alpha is being used in combination with telaprevir (Incivek) and ribavirin; or
    • Interferon alpha is being used in combination with boceprevir (Victrelis) and ribavirin; or
    • Interferon alpha is being used in combination with simeprevir (Olysio) and ribavirin. If the individual is genotype 1a, coverage will be limited to individuals without Q80K polymorphism.
  • For individuals with Genotypes 2, 3, 4, 5, Interferon alpha may be considered medically necessary if ANY of the following criteria is met:
    • Interferon alpha is being used in combination with sofosbuvir (Sovaldi) and ribavirin in treatment naïve individuals or individuals who have previously failed a regimen containing interferon alpha and ribavirin. 

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NOTE: Dosage recommendations per the FDA label.

NOTE:  Interferon alpha is not to be used with ledipasvir/sofosbuvir (Harvoni) or paritaprevir/ritonavir/ombitasvir + dasabuvir (Viekira Pak).

 

Interferon alpha is not to be used in members with Genotype 1 infection and previous failure of an interferon alpha-containing regimen.


Bone Cancer – Giant Cell Tumor of the Bone

  • Used as therapy for ANY of the following:
    • a single agent or combined with denosumab or radiation therapy for localized disease; or
    • a single agent for metastatic disease. 

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Central nervous system Cancers, e.g. leptomeningeal metastases: intracerebrospinal fluid (CSF) treatment

  • as induction therapy for primary treatment of good-risk individuals with normal CSF flow; or
  • as maintenance therapy for individuals with negative CSF cytology or for clinically stable individuals with persistently positive CSF cytology; or
  • as post induction therapy for individuals with positive CSF cytology.

Central Nervous System Cancer, Meningiomas

  • treatment for surgically inaccessible recurrent or progressive meningiomas when further radiation is not possible. 

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Chronic Myelogenous Leukemia (CML)

  • Chronic Myelogenous Leukemia (CML) – follow-up therapy in rare individuals unable to tolerate imatinib, dasatinib, niltinib or bosutinib with ANY of the following:
    • BCR-ABL1 transcript levels >10% at 3 or 6 months; or 
    • partial, minor, or no cytogenetic response or cytogenetic relapse at 12 months; or
    • less than complete cytogenetic response or cytogenetic relapse at 18 months.
  • CML Post transplant follow-up treatment in individuals with ANY of the following:
    • molecular relapse (polymerase chain reaction positive) following complete cytogenetic response; or
    • cytogenetic relapse or those who do not achieve complete cytogenetic response. 

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Kidney Cancer

  • First-line therapy in combination with bevacizumab for relapse or for surgically unresectable stage IV disease with predominant clear cell histology. 

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Melanoma

  • Intralesional therapy for ANY of the following:
    • unresectable stage III in-transit metastases, particularly superficial cutaneous or dermal lesions; or
    • local/satellite and/or in-transit unresectable recurrence.
  • Adjuvant treatment for ANY of the following:
    • stage IIB or C disease following wide excision; or
    • stage III disease with nodal metastases following wide excision and/or lymph node dissection; or
    • stage III in-transit disease following primary treatment; or
    • local/satellite and/or in-transit recurrence following initial treatment; or
    • nodal recurrence following complete lymph node dissection.
  • Therapy for metastatic or unresectable disease in combination with cisplatin and vinblastine with either dacarbazine or temozolomide and with interleukin-2 for ANY of the folloiwng:
    • first-line therapy for BRAF V600 wild type disease if clinical deterioration is anticipated in ≤12 week; or
    • second-line or subsequent therapy for disease progression of BRAF V600 wild type disease for individuals with performance status (PS) 0-2; or
    • second-line or subsequent therapy for BRAF V600 mutant disease if clinical deterioration is anticipated in ≤12 weeks for disease progression or following maximum clinical benefit from BRAF targeted therapy for individuals with PS 0-2. 

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Multiple myeloma              

  • Maintenance therapy as a single agent for ANY of the following:
    • for active (symptomatic) myeloma responding to primary myeloma therapy; or
    • for stable or responsive disease following stem cell transplant; or
    • with second tandem transplant for stable or responsive disease following autologous stem cell transplant.         
  • Multiple Myeloma - Systemic Light Chain Amyloidosis
    • primary treatment in combination with dexamethasone

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NHL - Adult T-Cell Leukemia/Lymphoma

  • Used in combination with zidovudine for chronic, smoldering, or acute disease for ANY of the following:
    • first-line therapy; or
    • additional therapy following response to first-line therapy; or
    • additional therapy for acute disease in nonresponders if not previously received.

NHL - Hairy Cell Leukemia

  • Single-agent therapy in individuals with the indication  for treatment for ANY of the following: 
    • refractory disease; or
    • relapse within one year of complete response.

NHL - Mycosis Fungoides (MF)/Sezary Syndrome (SS)

  • Systemic biologic therapy for ANY of the following:
    • single agent or in combination with skin-directed therapy for stage I-IIA and stage III MF with blood involvement; or
    • single agent or in combination with skin-directed therapies for stage I-IIA MF with histologic evidence of folliculotropic or large cell transformation or stage IIB MF with limited extent tumor disease; or
    • single agent or in combination with systemic retinoids, phototherapy, or photopheresis (with or without systemic retinoids) for stage IA-IIB MF with histologic evidence of folliculotropic or large cell transformation, or stage IIB MF with generalized extent tumor, transformed, and/or folliculotropic disease, with or without skin-directed therapy; or
    • as a single agent or in combination with systemic retinoids, phototherapy, or photopheresis (with or without systemic retinoids) for SS; or
    • May be used as adjuvant systemic biologic therapy after total skin electron beam therapy for stage IIB MF generalized extent tumor, transformed, and/or folliculotropic disease or after chemotherapy for stage IV non-Sezary or visceral disease; or
      o Systemic biologic therapy as a single agent or in combination with systemic retinoids, phototherapy, or photopheresis (with or without systemic retinoids), with or without skin-directed therapy for refractory or progressive stage I-III MF.

 NHL - Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders

  • Single-agent therapy for primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions for ANY of the following:
    • primary treatment; or

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Soft Tissue Sarcoma - Desmoid Tumors (Aggressive Fibromatosis)

  • Low-dose single agent for primary, recurrent, or progressive disease for ANY of the following:
    • initial treatment for resectable disease; or
    • adjuvant treatment for gross residual disease; or
    • initial treatment for unresectable disease or for disease for which surgery would be unacceptably morbid. 

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Related Policies

See Medical Policy Bulletin G-16 for information on Chemotherapy for Malignant Disease.


Covered Diagnosis Codes

B17.10

B18.2

B19.20

C32.1

C43.10

C43.111

C43.112

C43.121

C43.122

C43.20

C43.21

C43.22

C43.30

C43.31

C43.39

C43.4

C43.51

C43.52

C43.59

C43.60

C43.61

C43.62

C43.70

C43.71

C43.72

C43.8

C43.9

C45.9

C51.0

C51.1

C51.9

C52

C60.0

C63.9

C64.1

C64.2

C64.9

C65.1

C65.2

C65.9

C69.40

C69.41

C69.42

C69.60

C69.61

C69.62

C70.0

C70.1

C70.9

C79.00

C79.01

C79.02

C79.31

C79.32

C79.40

C79.49

C79.82

C79.89

C79.9

C80.0

C80.1

C82.00

C82.09

C82.10

C82.19

C82.20

C82.29

C82.30

C82.39

C82.40

C82.49

C82.60

C82.69

C82.80

C82.89

C82.90

C82.99

C83.00

C83.01

C83.02

C83.03

C83.04

C83.05

C83.06

C83.07

C83.08

C83.09

C83.31

C83.35

C83.37

C83.80

C83.81

C83.82

C83.83

C83.84

C83.85

C83.86

C83.87

C83.88

C83.89

C83.90

C83.91

C83.92

C83.93

C83.94

C83.95

C83.96

C83.97

C83.98

C83.99

C85.10

C85.11

C85.12

C85.13

C85.14

C85.15

C85.16

C85.17

C85.18

C85.19

C85.80

C85.81

C85.82

C85.83

C85.84

C85.85

C85.86

C85.87

C85.88

C85.89

C85.90

C85.91

C85.92

C85.93

C85.94

C85.95

C85.96

C85.97

C85.98

C85.99

C86.0

C86.1

C86.2

C86.3

C86.4

C86.5

C86.6

C88.2

C88.3

C88.8

C88.9

C90.00

C90.01

C90.02

C90.10

C90.20

C90.21

C90.30

C90.31

C91.30

C91.32

C91.40

C91.41

C91.42

C91.50

C91.52

C91.60

C91.62

C91.A0

C91.A2

C91.Z0

C91.Z2

C92.10

C92.11

C92.12

C96.0

C96.2

C96.4

C96.9

C96.A

C96.Z

D00.00

D00.01

D00.02

D00.03

D00.04

D00.05

D00.06

D00.07

D00.08

D02.0

D03.0

D03.10

D03.111

D03.112

D03.121

D03.122

D03.20

D03.21

D03.22

 

 

 



Place of Service: Outpatient

The administration of Interferon Alpha is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.



Links






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.

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:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • 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:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • 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.