Pharmacy Medical Policy Interferons Alpha and Gamma

Pharmacy Medical Policy Interferons Alpha and Gamma Table of Contents Policy: Commercial Policy History Endnotes Policy: Medicare Information Pertaining to All Policies Forms Coding Information References Policy Number: 052 BCBSA Reference Number: None Related Policies For coverage of Peginterferon alfa-2a and alfa-2b for the treatment of Hepatitis C, please refer to Medical Policy #344. Quality Care Dosing guidelines apply to the following medications and can be found in Medical Policy #621. Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Note: All requests for outpatient retail pharmacy for indications listed and not listed on the medical policy guidelines may be submitted to BCBSMA Clinical Pharmacy Operations by completing the Prior Authorization Form on the last page of this document. Physicians may also call BCBSMA Pharmacy Operations department at (800)366-7778 to request a prior authorization/formulary exception verbally. Physicians may also submit requests for retail pharmacy exceptions via the web using Express PA which can be found on the BCBSMA provider portal or directly on the web at https://provider.express-path.com. Patients must have pharmacy benefits under their subscriber certificates. Please refer to the chart below for the formulary and step status of the medications affected by this policy. Standard Formulary Drug Actimmune Alferon-N Infergen Intron-A Rebetron Sylatron Formulary Status PA required PA required PA required PA required PA required PA required 1

Interferon alpha We cover interferon alpha for FDA-approved uses including: Hairy cell leukemia Genital warts (condylomata acuminata) Kaposi s sarcoma Chronic hepatitis B 5, 7,10,14 Acute / Chronic hepatitis C Malignant melanoma. 3 We cover interferon alpha for the following off-label uses: 1 Chronic Myelogenous Leukemia (CML) 11 given alone as first-line therapy for patients in the first chronic phase of CML Multiple Myeloma: in previously untreated patients, when given in combination with cytotoxic agents as first-line therapy Multiple Myeloma which has previously responded to first-line therapy: given as maintenance treatment for multiple myeloma Non-Hodgkin s Lymphoma: low-grade (follicular) or intermediate grade type, when given in combination with cytotoxic agents as first-line therapy Polycythemia vera 6 Idiopathic progressive polyneuropathy 6 HIV and AIDS. 8 We cover interferon alpha in accordance with the Massachusetts state mandate for the following off label uses that are listed in the United States Pharmacopeia (USP) 2. However, for some of these cancers, there is evidence that the use of interferon does not improve health, and may worsen quality of life 1. Prior authorization is required. Cancers: bladder 1, kidney 1,4 (renal), cervix 4, brain 4, colorectal 1,4, head and neck 4, ovary 4, pancreas 4, and 'bone (osteosarcoma) 4 Skin cancer4, malignant melanoma1, mycosis fungoides and cutaneous T-cell lymphoma 4 Recurrent respiratory laryngeal papillomatosis and laryngeal papilloma Chronic lymphocytic leukemia (CLL) 1,4 Carcinoid syndrome. 4 Peginterferon alpha-2b (Sylatron ) We cover Sylatron (peginterferon alpha 2b) for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. Interferon gamma We cover interferon gamma 9 only for FDA-approved uses including: Chronic Granulomatous Disease, to reduce the frequency and severity of infections. Conditions not listed above are not covered, because there is not enough scientific data to show that health outcomes will be improved for other conditions. Other Information Blue Cross Blue Shield of Massachusetts (BCBSMA*) members (other than Medex ; Blue MedicareRx, Medicare Advantage plans that include prescription drug coverage) will be required to fill their prescriptions for the above medications at one of the providers in our retail specialty pharmacy network, as listed below: Retail Specialty Pharmacy Contact Information: 2

AcariaHealth. Phone:1-866-892-1202 Fax: 1-866-892-3223 Website: www.acariahealth.com Accredo Health Group Phone: 1-877-988-0058 Fax: 1-866-489-1907 Website: www.accredo.com Caremark, Inc. Phone: 1-866-846-3096 Fax: 1-800-323-2445 Website: www.caremark.com Onco360, the Oncology Pharmacy Phone: 1-877-662-6633 Fax: 1-877-662-6355 Website: www.onco360.com Individual Consideration All our medical policies are written for the majority of people with a given condition. Each policy is based on medical science. For many of our medical policies, each individual s unique clinical circumstances may be considered in light of current scientific literature. Physicians may send relevant clinical information for individual patients for consideration to: Blue Cross Blue Shield of Massachusetts Clinical Pharmacy Department One Enterprise Drive Quincy, MA 02171 Tel: 1-800-366-7778 Fax: 1-800-583-6289 Managed Care Authorization Instructions Prior authorization is required for all out patient sites of service For retail pharmacy requests, physicians may call BCBSMA Pharmacy Operations department to request a review for prior authorization for patients. Pharmacy Operations: (800)366-7778 For all outpatient sites of service, physicians may also fax or mail the attached form to the address above. The Formulary Exception/Prior Authorization form is included as part of this document for physicians to submit for patients. For all outpatient sites of service, physicians may also submit requests for retail pharmacy exceptions via the web using Express PAth which can be found on the BCBSMA provider portal or directly on the web at https://provider.express-path.com PPO and Indemnity Authorization Instructions Prior authorization is required when these medications are processed under the retail pharmacy benefit and home infusion therapy benefit. Prior authorization is not required when these drugs are purchased by the physician and administered in the office in accordance with this medical policy. For retail pharmacy requests, physicians may call BCBSMA Pharmacy Operations department to request a review for prior authorization for patients. 3

Pharmacy Operations: (800)366-7778 Physicians may also fax or mail the attached form to the address above. The Formulary Exception/Prior Authorization form is included as part of this document for physicians to submit for patients. Physicians may also submit requests for retail pharmacy exceptions via the web using Express PAth which can be found on the BCBSMA provider portal or directly on the web at https://provider.expresspath.com CPT Codes / HCPCS Codes / ICD-9 Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member. A draft of future ICD-10 Coding related to this document, as it might look today, is included below for your reference. Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. CPT Codes There is no specific CPT code for this service. HCPCS Codes HCPCS codes: Code Description J9212 Injection, interferon Alfacon-1, recombinant, 1 mcg (Infergen) J9214 Injection, interferon, alfa-2b, recombinant, 1 million units (Intron A, Rebetron Kit) J9215 Injection, interferon, alfa-n3, (human leukocyte derived), 250,000 IU (Alferon N) J9216 Injection, interferon, gamma 1-b, 3 million units (Actimmune) Diagnosis coding ICD-9-CM diagnosis codes: Code Description 042 Human immunodeficiency virus [HIV] disease 070.22 Chronic viral hepatitis B with hepatic coma without hepatitis delta 070.23 Chronic viral hepatitis B with hepatic coma with hepatitis delta 070.32 Chronic viral hepatitis B without mention of hepatic coma without mention of hepatitis delta 070.33 Chronic viral hepatitis B without mention of hepatic coma with hepatitis delta 070.41 Acute hepatitis C with hepatic coma 070.44 Chronic hepatitis C with hepatic coma 070.49 Other specified viral hepatitis with hepatic coma 070.51 Acute hepatitis C without mention of hepatic coma 070.54 Chronic hepatitis C without mention of hepatic coma 070.70 Unspecified viral hepatitis C without hepatic coma 070.71 Unspecified viral hepatitis C with hepatic coma 078.11 Condyloma acuminatum 154.0 Malignant neoplasm of rectosigmoid junction 157.0 Malignant neoplasm of head of pancreas 157.1 Malignant neoplasm of body of pancreas 157.2 Malignant neoplasm of tail of pancreas 157.3 Malignant neoplasm of pancreatic duct 157.4 Malignant neoplasm of islets of langerhans 4

157.8 Malignant neoplasm of other specified sites of pancreas 157.9 Malignant neoplasm of pancreas, part unspecified 172.0 Malignant melanoma of skin of lip 172.1 Malignant melanoma of skin of eyelid, including canthus 172.2 Malignant melanoma of skin of ear and external auditory canal 172.3 Malignant melanoma of skin of other and unspecified parts of face 172.4 Malignant melanoma of skin of scalp and neck 172.5 Malignant melanoma of skin of trunk, except scrotum 172.6 Malignant melanoma of skin of upper limb, including shoulder 172.7 Malignant melanoma of skin of lower limb, including hip 172.8 Malignant melanoma of other specified sites of skin 172.9 Melanoma of skin, site unspecified 173.00 Unspecified malignant neoplasm of skin of lip 173.01 Basal cell carcinoma of skin of lip 173.02 Squamous cell carcinoma of skin of lip 173.09 Other specified malignant neoplasm of skin of lip 173.10 Unspecified malignant neoplasm of eyelid, including canthus 173.11 Basal cell carcinoma of eyelid, including canthus 173.12 Squamous cell carcinoma of eyelid, including canthus 173.19 Other specified malignant neoplasm of eyelid, including canthus 173.20 Unspecified malignant neoplasm of skin of ear and external auditory canal 173.21 Basal cell carcinoma of skin of ear and external auditory canal 173.22 Squamous cell carcinoma of skin of ear and external auditory canal 173.29 Other specified malignant neoplasm of skin of ear and external auditory canal 173.30 Unspecified malignant neoplasm of skin of other and unspecified parts of face 173.31 Basal cell carcinoma of skin of other and unspecified parts of face 173.32 Squamous cell carcinoma of skin of other and unspecified parts of face 173.39 Other specified malignant neoplasm of skin of other and unspecified parts of face 173.40 Unspecified malignant neoplasm of scalp and skin of neck 173.41 Basal cell carcinoma of scalp and skin of neck 173.42 Squamous cell carcinoma of scalp and skin of neck 173.49 Other specified malignant neoplasm of scalp and skin of neck 173.50 Unspecified malignant neoplasm of skin of trunk, except scrotum 173.51 Basal cell carcinoma of skin of trunk, except scrotum 173.52 Squamous cell carcinoma of skin of trunk, except scrotum 173.59 Other specified malignant neoplasm of skin of trunk, except scrotum 173.60 Unspecified malignant neoplasm of skin of upper limb, including shoulder 173.61 Basal cell carcinoma of skin of upper limb, including shoulder 173.62 Squamous cell carcinoma of skin of upper limb, including shoulder 173.69 Other specified malignant neoplasm of skin of upper limb, including shoulder 173.70 Unspecified malignant neoplasm of skin of lower limb, including hip 173.71 Basal cell carcinoma of skin of lower limb, including hip 173.72 Squamous cell carcinoma of skin of lower limb, including hip 173.79 Other specified malignant neoplasm of skin of lower limb, including hip 173.80 Unspecified malignant neoplasm of other specified sites of skin 173.81 Basal cell carcinoma of other specified sites of skin 173.82 Squamous cell carcinoma of other specified sites of skin 173.89 Other specified malignant neoplasm of other specified sites of skin 173.90 Unspecified malignant neoplasm of skin, site unspecified 173.91 Basal cell carcinoma of skin, site unspecified 173.92 Squamous cell carcinoma of skin, site unspecified 173.99 Other specified malignant neoplasm of skin, site unspecified 176.0 Kaposi's sarcoma, skin 5

176.1 Kaposi's sarcoma, soft tissue 176.2 Kaposi's sarcoma, palate 176.3 Kaposi's sarcoma, gastrointestinal sites 176.4 Kaposi's sarcoma, lung 176.5 Kaposi's sarcoma, lymph nodes 176.8 Kaposi's sarcoma, other specified sites 176.9 Kaposi's sarcoma, unspecified site 180.0 Malignant neoplasm of endocervix 180.1 Malignant neoplasm of exocervix 180.8 Malignant neoplasm of other specified sites of cervix 180.9 Malignant neoplasm of cervix uteri, unspecified site 183.0 Malignant neoplasm of ovary 189.0 Malignant neoplasm of kidney, except pelvis 191.0 Malignant neoplasm of cerebrum, except lobes and ventricles 191.1 Malignant neoplasm of frontal lobe 191.2 Malignant neoplasm of temporal lobe 191.3 Malignant neoplasm of parietal lobe 191.4 Malignant neoplasm of occipital lobe 191.5 Malignant neoplasm of ventricles 191.6 Malignant neoplasm of cerebellum nos 191.7 Malignant neoplasm of brain stem 191.8 Malignant neoplasm of other parts of brain 191.9 Malignant neoplasm of brain, unspecified 195.0 Malignant neoplasm of head, face, and neck 200.20 Burkitt's tumor or lymphoma, unspecified site, extranodal and solid organ sites 200.21 Burkitt's tumor or lymphoma, lymph nodes of head, face, and neck 200.22 Burkitt's tumor or lymphoma, intrathoracic lymph nodes 200.23 Burkitt's tumor or lymphoma, intra-abdominal lymph nodes 200.24 Burkitt's tumor or lymphoma, lymph nodes of axilla and upper limb 200.25 Burkitt's tumor or lymphoma, lymph nodes of inguinal region and lower limb 200.26 Burkitt's tumor or lymphoma, intrapelvic lymph nodes 200.27 Burkitt's tumor or lymphoma, spleen 200.28 Burkitt's tumor or lymphoma, lymph nodes of multiple sites 200.30 Marginal zone lymphoma, unspecified site, extranodal and solid organ sites 200.31 Marginal zone lymphoma, lymph nodes of head, face, and neck 200.32 Marginal zone lymphoma, intrathoracic lymph nodes 200.33 Marginal zone lymphoma, intraabdominal lymph nodes 200.34 Marginal zone lymphoma, lymph nodes of axilla and upper limb 200.35 Marginal zone lymphoma, lymph nodes of inguinal region and lower limb 200.36 Marginal zone lymphoma, intrapelvic lymph nodes 200.37 Marginal zone lymphoma, spleen 200.38 Marginal zone lymphoma, lymph nodes of multiple sites 200.40 Mantle cell lymphoma, unspecified site, extranodal and solid organ sites 200.40 Mantle cell lymphoma, unspecified site, extranodal and solid organ sites 200.41 Mantle cell lymphoma, lymph nodes of head, face, and neck 200.42 Mantle cell lymphoma, intrathoracic lymph nodes 200.43 Mantle cell lymphoma, intra-abdominal lymph nodes 200.44 Mantle cell lymphoma, lymph nodes of axilla and upper limb 200.45 Mantle cell lymphoma, lymph nodes of inguinal region and lower limb 200.46 Mantle cell lymphoma, intrapelvic lymph nodes 200.47 Mantle cell lymphoma, spleen 200.48 Mantle cell lymphoma, lymph nodes of multiple sites 202.10 Mycosis fungoides, unspecified site, extranodal and solid organ sites 6

202.11 Mycosis fungoides, lymph nodes of head, face, and neck 202.12 Mycosis fungoides, intrathoracic lymph nodes 202.13 Mycosis fungoides, intra-abdominal lymph nodes 202.14 Mycosis fungoides, lymph nodes of axilla and upper limb 202.15 Mycosis fungoides, lymph nodes of inguinal region and lower limb 202.16 Mycosis fungoides, intrapelvic lymph nodes 202.17 Mycosis fungoides, spleen 202.18 Mycosis fungoides, lymph nodes of multiple sites 202.40 Leukemic reticuloendotheliosis, unspecified site, extranodal and solid organ sites 202.41 Leukemic reticuloendotheliosis, lymph nodes of head, face, and neck 202.42 Leukemic reticuloendotheliosis, intrathoracic lymph nodes 202.43 Leukemic reticuloendotheliosis, intra-abdominal lymph nodes 202.44 Leukemic reticuloendotheliosis, lymph nodes of axilla and upper arm 202.45 Leukemic reticuloendotheliosis, lymph nodes of inguinal region and lower limb 202.46 Leukemic reticuloendotheliosis, intrapelvic lymph nodes 202.47 Leukemic reticuloendotheliosis, spleen 202.48 Leukemic reticuloendotheliosis, lymph nodes of multipes sites 202.80 Other malignant lymphomas, unspecified site, extranodal and solid organ sites 202.81 Other malignant lymphomas, lymph nodes of head, face, and neck 202.82 Other malignant lymphomas, intrathoracic lymph nodes 202.83 Other malignant lymphomas, intra-abdominal lymph nodes 202.84 Other malignant lymphomas, lymph nodes of axilla and upper limb 202.85 Other malignant lymphomas, lymph nodes of inguinal region and lower limb 202.86 Other malignant lymphomas, intrapelvic lymph nodes 202.87 Other malignant lymphomas, spleen 202.88 Other malignant lymphomas, lymph nodes of multiple sites 203.00 Multiple myeloma, without mention of having achieved remission 203.01 Multiple myeloma, in remission 203.02 Multiple myeloma, in relapse 204.10 Chronic lymphoid leukemia, without mention of having achieved remission 204.11 Chronic lymphoid leukemia, in remission 204.12 Chronic lymphoid leukemia, in relapse 205.10 Chronic myeloid leukemia, without mention of having achieved remission 205.11 Chronic myeloid leukemia, in remission 205.12 Chronic myeloid leukemia, in relapse 212.1 Benign neoplasm of larynx 238.4 Polycythemia vera 259.2 Carcinoid syndrome 288.1 Functional disorders of polymorphonuclear neutrophils V08 Asymptomatic human immunodeficiency virus [HIV] infection status Facility coding ICD-9-CM procedure codes: Code Description 99.28 Injection or infusion of biological response modifier [BRM] as an antineoplastic agent ICD-10 Diagnosis Codes ICD-10-CM Diagnosis codes: Code Description A63.0 Anogenital (venereal) warts B17.10 Acute hepatitis C without hepatic coma 7

B17.11 Acute hepatitis C with hepatic coma B17.8 Other specified acute viral hepatitis B18.0 Chronic viral hepatitis B with delta-agent B18.1 Chronic viral hepatitis B without delta-agent B18.2 Chronic viral hepatitis C B19.20 Unspecified viral hepatitis C without hepatic coma B19.21 Unspecified viral hepatitis C with hepatic coma B20 Human immunodeficiency virus [HIV] disease C19 Malignant neoplasm of rectosigmoid junction C25.0 Malignant neoplasm of head of pancreas C25.1 Malignant neoplasm of body of pancreas C25.2 Malignant neoplasm of tail of pancreas C25.3 Malignant neoplasm of pancreatic duct C25.4 Malignant neoplasm of endocrine pancreas C25.7 Malignant neoplasm of other parts of pancreas C25.8 Malignant neoplasm of overlapping sites of pancreas C25.9 Malignant neoplasm of pancreas, unspecified C43.0 Malignant melanoma of lip C43.10 Malignant melanoma of unspecified eyelid, including canthus C43.11 Malignant melanoma of right eyelid, including canthus C43.12 Malignant melanoma of left eyelid, including canthus C43.20 Malignant melanoma of unspecified ear and external auricular canal C43.21 Malignant melanoma of right ear and external auricular canal C43.22 Malignant melanoma of left ear and external auricular canal C43.30 Malignant melanoma of unspecified part of face C43.31 Malignant melanoma of nose C43.39 Malignant melanoma of other parts of face C43.4 Malignant melanoma of scalp and neck C43.51 Malignant melanoma of anal skin C43.52 Malignant melanoma of skin of breast C43.59 Malignant melanoma of other part of trunk C43.60 Malignant melanoma of unspecified upper limb, including shoulder C43.61 Malignant melanoma of right upper limb, including shoulder C43.62 Malignant melanoma of left upper limb, including shoulder C43.70 Malignant melanoma of unspecified lower limb, including hip C43.71 Malignant melanoma of right lower limb, including hip C43.72 Malignant melanoma of left lower limb, including hip C43.8 Malignant melanoma of overlapping sites of skin C43.9 Malignant melanoma of skin, unspecified C44.00 Unspecified malignant neoplasm of skin of lip C44.01 Basal cell carcinoma of skin of lip C44.02 Squamous cell carcinoma of skin of lip C44.09 Other specified malignant neoplasm of skin of lip C44.101 Unspecified malignant neoplasm of skin of unspecified eyelid, including canthus C44.102 Unspecified malignant neoplasm of skin of right eyelid, including canthus C44.109 Unspecified malignant neoplasm of skin of left eyelid, including canthus C44.111 Basal cell carcinoma of skin of unspecified eyelid, including canthus C44.112 Basal cell carcinoma of skin of right eyelid, including canthus C44.119 Basal cell carcinoma of skin of left eyelid, including canthus C44.121 Squamous cell carcinoma of skin of unspecified eyelid, including canthus C44.122 Squamous cell carcinoma of skin of right eyelid, including canthus 8

C44.129 Squamous cell carcinoma of skin of left eyelid, including canthus C44.191 Other specified malignant neoplasm of skin of unspecified eyelid, including canthus C44.192 Other specified malignant neoplasm of skin of right eyelid, including canthus C44.199 Other specified malignant neoplasm of skin of left eyelid, including canthus C44.201 Unspecified malignant neoplasm of skin of unspecified ear and external auricular canal C44.202 Unspecified malignant neoplasm of skin of right ear and external auricular canal C44.209 Unspecified malignant neoplasm of skin of left ear and external auricular canal C44.211 Basal cell carcinoma of skin of unspecified ear and external auricular canal C44.212 Basal cell carcinoma of skin of right ear and external auricular canal C44.219 Basal cell carcinoma of skin of left ear and external auricular canal C44.221 Squamous cell carcinoma of skin of unspecified ear and external auricular canal C44.222 Squamous cell carcinoma of skin of right ear and external auricular canal C44.229 Squamous cell carcinoma of skin of left ear and external auricular canal C44.291 Other specified malignant neoplasm of skin of unspecified ear and external auricular canal C44.292 Other specified malignant neoplasm of skin of right ear and external auricular canal C44.299 Other specified malignant neoplasm of skin of left ear and external auricular canal C44.300 Unspecified malignant neoplasm of skin of unspecified part of face C44.301 Unspecified malignant neoplasm of skin of nose C44.309 Unspecified malignant neoplasm of skin of other parts of face C44.310 Basal cell carcinoma of skin of unspecified parts of face C44.311 Basal cell carcinoma of skin of nose C44.319 Basal cell carcinoma of skin of other parts of face C44.320 Squamous cell carcinoma of skin of unspecified parts of face C44.321 Squamous cell carcinoma of skin of nose C44.329 Squamous cell carcinoma of skin of other parts of face C44.390 Other specified malignant neoplasm of skin of unspecified parts of face C44.391 Other specified malignant neoplasm of skin of nose C44.399 Other specified malignant neoplasm of skin of other parts of face C44.40 Unspecified malignant neoplasm of skin of scalp and neck C44.41 Basal cell carcinoma of skin of scalp and neck C44.42 Squamous cell carcinoma of skin of scalp and neck C44.49 Other specified malignant neoplasm of skin of scalp and neck C44.500 Unspecified malignant neoplasm of anal skin C44.501 Unspecified malignant neoplasm of skin of breast C44.509 Unspecified malignant neoplasm of skin of other part of trunk C44.510 Basal cell carcinoma of anal skin C44.511 Basal cell carcinoma of skin of breast C44.519 Basal cell carcinoma of skin of other part of trunk C44.520 Squamous cell carcinoma of anal skin C44.521 Squamous cell carcinoma of skin of breast C44.529 Squamous cell carcinoma of skin of other part of trunk C44.590 Other specified malignant neoplasm of anal skin C44.591 Other specified malignant neoplasm of skin of breast C44.599 Other specified malignant neoplasm of skin of other part of trunk C44.601 Unspecified malignant neoplasm of skin of unspecified upper limb, including shoulder C44.602 Unspecified malignant neoplasm of skin of right upper limb, including shoulder C44.609 Unspecified malignant neoplasm of skin of left upper limb, including shoulder C44.611 Basal cell carcinoma of skin of unspecified upper limb, including shoulder C44.612 Basal cell carcinoma of skin of right upper limb, including shoulder C44.619 Basal cell carcinoma of skin of left upper limb, including shoulder 9

C44.621 Squamous cell carcinoma of skin of unspecified upper limb, including shoulder C44.622 Squamous cell carcinoma of skin of right upper limb, including shoulder C44.629 Squamous cell carcinoma of skin of left upper limb, including shoulder C44.691 Other specified malignant neoplasm of skin of unspecified upper limb, including shoulder C44.692 Other specified malignant neoplasm of skin of right upper limb, including shoulder C44.699 Other specified malignant neoplasm of skin of left upper limb, including shoulder C44.701 Unspecified malignant neoplasm of skin of unspecified lower limb, including hip C44.702 Unspecified malignant neoplasm of skin of right lower limb, including hip C44.709 Unspecified malignant neoplasm of skin of left lower limb, including hip C44.711 Basal cell carcinoma of skin of unspecified lower limb, including hip C44.712 Basal cell carcinoma of skin of right lower limb, including hip C44.719 Basal cell carcinoma of skin of left lower limb, including hip C44.721 Squamous cell carcinoma of skin of unspecified lower limb, including hip C44.722 Squamous cell carcinoma of skin of right lower limb, including hip C44.729 Squamous cell carcinoma of skin of left lower limb, including hip C44.791 Other specified malignant neoplasm of skin of unspecified lower limb, including hip C44.792 Other specified malignant neoplasm of skin of right lower limb, including hip C44.799 Other specified malignant neoplasm of skin of left lower limb, including hip C44.80 Unspecified malignant neoplasm of overlapping sites of skin C44.81 Basal cell carcinoma of overlapping sites of skin C44.82 Squamous cell carcinoma of overlapping sites of skin C44.89 Other specified malignant neoplasm of overlapping sites of skin C44.90 Unspecified malignant neoplasm of skin, unspecified C44.91 Basal cell carcinoma of skin, unspecified C44.92 Squamous cell carcinoma of skin, unspecified C44.99 Other specified malignant neoplasm of skin, unspecified C46.0 Kaposi's sarcoma of skin C46.1 Kaposi's sarcoma of soft tissue C46.2 Kaposi's sarcoma of palate C46.3 Kaposi's sarcoma of lymph nodes C46.4 Kaposi's sarcoma of gastrointestinal sites C46.50 Kaposi's sarcoma of unspecified lung C46.51 Kaposi's sarcoma of right lung C46.52 Kaposi's sarcoma of left lung C46.7 Kaposi's sarcoma of other sites C46.9 Kaposi's sarcoma, unspecified C53.0 Malignant neoplasm of endocervix C53.1 Malignant neoplasm of exocervix C53.8 Malignant neoplasm of overlapping sites of cervix uteri C53.9 Malignant neoplasm of cervix uteri, unspecified C56.1 Malignant neoplasm of right ovary C56.2 Malignant neoplasm of left ovary C56.9 Malignant neoplasm of unspecified ovary C64.1 Malignant neoplasm of right kidney, except renal pelvis C64.2 Malignant neoplasm of left kidney, except renal pelvis C64.9 Malignant neoplasm of unspecified kidney, except renal pelvis C71.0 Malignant neoplasm of cerebrum, except lobes and ventricles C71.1 Malignant neoplasm of frontal lobe C71.2 Malignant neoplasm of temporal lobe C71.3 Malignant neoplasm of parietal lobe 10

C71.4 Malignant neoplasm of occipital lobe C71.5 Malignant neoplasm of cerebral ventricle C71.6 Malignant neoplasm of cerebellum C71.7 Malignant neoplasm of brain stem C71.8 Malignant neoplasm of overlapping sites of brain C71.9 Malignant neoplasm of brain, unspecified C76.0 Malignant neoplasm of head, face and neck C82.50 Diffuse follicle center lymphoma, unspecified site C82.51 Diffuse follicle center lymphoma, lymph nodes of head, face, and neck C82.52 Diffuse follicle center lymphoma, intrathoracic lymph nodes C82.53 Diffuse follicle center lymphoma, intra-abdominal lymph nodes C82.54 Diffuse follicle center lymphoma, lymph nodes of axilla and upper limb C82.55 Diffuse follicle center lymphoma, lymph nodes of inguinal region and lower limb C82.56 Diffuse follicle center lymphoma, intrapelvic lymph nodes C82.57 Diffuse follicle center lymphoma, spleen C82.58 Diffuse follicle center lymphoma, lymph nodes of multiple sites C82.59 Diffuse follicle center lymphoma, extranodal and solid organ sites C83.10 Mantle cell lymphoma, unspecified site C83.11 Mantle cell lymphoma, lymph nodes of head, face, and neck C83.12 Mantle cell lymphoma, intrathoracic lymph nodes C83.13 Mantle cell lymphoma, intra-abdominal lymph nodes C83.14 Mantle cell lymphoma, lymph nodes of axilla and upper limb C83.15 Mantle cell lymphoma, lymph nodes of inguinal region and lower limb C83.16 Mantle cell lymphoma, intrapelvic lymph nodes C83.17 Mantle cell lymphoma, spleen C83.18 Mantle cell lymphoma, lymph nodes of multiple sites C83.19 Mantle cell lymphoma, extranodal and solid organ sites C83.70 Burkitt lymphoma, unspecified site C83.71 Burkitt lymphoma, lymph nodes of head, face, and neck C83.72 Burkitt lymphoma, intrathoracic lymph nodes C83.73 Burkitt lymphoma, intra-abdominal lymph nodes C83.74 Burkitt lymphoma, lymph nodes of axilla and upper limb C83.75 Burkitt lymphoma, lymph nodes of inguinal region and lower limb C83.76 Burkitt lymphoma, intrapelvic lymph nodes C83.77 Burkitt lymphoma, spleen C83.78 Burkitt lymphoma, lymph nodes of multiple sites C83.79 Burkitt lymphoma, extranodal and solid organ sites C83.80 Other non-follicular lymphoma, unspecified site C83.81 Other non-follicular lymphoma, lymph nodes of head, face, and neck C83.82 Other non-follicular lymphoma, intrathoracic lymph nodes C83.83 Other non-follicular lymphoma, intra-abdominal lymph nodes C83.84 Other non-follicular lymphoma, lymph nodes of axilla and upper limb C83.85 Other non-follicular lymphoma, lymph nodes of inguinal region and lower limb C83.86 Other non-follicular lymphoma, intrapelvic lymph nodes C83.87 Other non-follicular lymphoma, spleen C83.88 Other non-follicular lymphoma, lymph nodes of multiple sites C83.89 Other non-follicular lymphoma, extranodal and solid organ sites C84.00 Mycosis fungoides, unspecified site C84.01 Mycosis fungoides, lymph nodes of head, face, and neck C84.02 Mycosis fungoides, intrathoracic lymph nodes C84.03 Mycosis fungoides, intra-abdominal lymph nodes 11

C84.04 Mycosis fungoides, lymph nodes of axilla and upper limb C84.05 Mycosis fungoides, lymph nodes of inguinal region and lower limb C84.06 Mycosis fungoides, intrapelvic lymph nodes C84.07 Mycosis fungoides, spleen C84.08 Mycosis fungoides, lymph nodes of multiple sites C84.09 Mycosis fungoides, extranodal and solid organ sites C84.90 Mature T/NK-cell lymphomas, unspecified, unspecified site C84.91 Mature T/NK-cell lymphomas, unspecified, lymph nodes of head, face, and neck C84.92 Mature T/NK-cell lymphomas, unspecified, intrathoracic lymph nodes C84.93 Mature T/NK-cell lymphomas, unspecified, intra-abdominal lymph nodes C84.94 Mature T/NK-cell lymphomas, unspecified, lymph nodes of axilla and upper limb C84.95 Mature T/NK-cell lymphomas, unspecified, lymph nodes of inguinal region and lower limb C84.96 Mature T/NK-cell lymphomas, unspecified, intrapelvic lymph nodes C84.97 Mature T/NK-cell lymphomas, unspecified, spleen C84.98 Mature T/NK-cell lymphomas, unspecified, lymph nodes of multiple sites C84.99 Mature T/NK-cell lymphomas, unspecified, extranodal and solid organ sites C84.A0 Cutaneous T-cell lymphoma, unspecified, unspecified site C84.A1 Cutaneous T-cell lymphoma, unspecified lymph nodes of head, face, and neck C84.A2 Cutaneous T-cell lymphoma, unspecified, intrathoracic lymph nodes C84.A3 Cutaneous T-cell lymphoma, unspecified, intra-abdominal lymph nodes C84.A4 Cutaneous T-cell lymphoma, unspecified, lymph nodes of axilla and upper limb C84.A5 Cutaneous T-cell lymphoma, unspecified, lymph nodes of inguinal region and lower limb C84.A6 Cutaneous T-cell lymphoma, unspecified, intrapelvic lymph nodes C84.A7 Cutaneous T-cell lymphoma, unspecified, spleen C84.A8 Cutaneous T-cell lymphoma, unspecified, lymph nodes of multiple sites C84.A9 Cutaneous T-cell lymphoma, unspecified, extranodal and solid organ sites C84.Z0 Other mature T/NK-cell lymphomas, unspecified site C84.Z1 Other mature T/NK-cell lymphomas, lymph nodes of head, face, and neck C84.Z2 Other mature T/NK-cell lymphomas, intrathoracic lymph nodes C84.Z3 Other mature T/NK-cell lymphomas, intra-abdominal lymph nodes C84.Z4 Other mature T/NK-cell lymphomas, lymph nodes of axilla and upper limb C84.Z5 Other mature T/NK-cell lymphomas, lymph nodes of inguinal region and lower limb C84.Z6 Other mature T/NK-cell lymphomas, intrapelvic lymph nodes C84.Z7 Other mature T/NK-cell lymphomas, spleen C84.Z8 Other mature T/NK-cell lymphomas, lymph nodes of multiple sites C84.Z9 Other mature T/NK-cell lymphomas, extranodal and solid organ sites C85.10 Unspecified B-cell lymphoma, unspecified site C85.11 Unspecified B-cell lymphoma, lymph nodes of head, face, and neck C85.12 Unspecified B-cell lymphoma, intrathoracic lymph nodes C85.13 Unspecified B-cell lymphoma, intra-abdominal lymph nodes C85.14 Unspecified B-cell lymphoma, lymph nodes of axilla and upper limb C85.15 Unspecified B-cell lymphoma, lymph nodes of inguinal region and lower limb C85.16 Unspecified B-cell lymphoma, intrapelvic lymph nodes C85.17 Unspecified B-cell lymphoma, spleen C85.18 Unspecified B-cell lymphoma, lymph nodes of multiple sites C85.19 Unspecified B-cell lymphoma, extranodal and solid organ sites C85.20 Mediastinal (thymic) large B-cell lymphoma, unspecified site C85.21 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of head, face, and neck C85.22 Mediastinal (thymic) large B-cell lymphoma, intrathoracic lymph nodes 12

C85.23 Mediastinal (thymic) large B-cell lymphoma, intra-abdominal lymph nodes C85.24 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of axilla and upper limb C85.25 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of inguinal region and lower limb C85.26 Mediastinal (thymic) large B-cell lymphoma, intrapelvic lymph nodes C85.27 Mediastinal (thymic) large B-cell lymphoma, spleen C85.28 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of multiple sites C85.29 Mediastinal (thymic) large B-cell lymphoma, extranodal and solid organ sites C85.80 Other specified types of non-hodgkin lymphoma, unspecified site C85.81 Other specified types of non-hodgkin lymphoma, lymph nodes of head, face, and neck C85.82 Other specified types of non-hodgkin lymphoma, intrathoracic lymph nodes C85.83 Other specified types of non-hodgkin lymphoma, intra-abdominal lymph nodes C85.84 Other specified types of non-hodgkin lymphoma, lymph nodes of axilla and upper limb C85.85 Other specified types of non-hodgkin lymphoma, lymph nodes of inguinal region and lower limb C85.86 Other specified types of non-hodgkin lymphoma, intrapelvic lymph nodes C85.87 Other specified types of non-hodgkin lymphoma, spleen C85.88 Other specified types of non-hodgkin lymphoma, lymph nodes of multiple sites C85.89 Other specified types of non-hodgkin lymphoma, extranodal and solid organ sites C85.90 Non-Hodgkin lymphoma, unspecified, unspecified site C85.91 Non-Hodgkin lymphoma, unspecified, lymph nodes of head, face, and neck C85.92 Non-Hodgkin lymphoma, unspecified, intrathoracic lymph nodes C85.93 Non-Hodgkin lymphoma, unspecified, intra-abdominal lymph nodes C85.94 Non-Hodgkin lymphoma, unspecified, lymph nodes of axilla and upper limb C85.95 Non-Hodgkin lymphoma, unspecified, lymph nodes of inguinal region and lower limb C85.96 Non-Hodgkin lymphoma, unspecified, intrapelvic lymph nodes C85.97 Non-Hodgkin lymphoma, unspecified, spleen C85.98 Non-Hodgkin lymphoma, unspecified, lymph nodes of multiple sites C85.99 Non-Hodgkin lymphoma, unspecified, extranodal and solid organ sites C86.0 Extranodal NK/T-cell lymphoma, nasal type C86.1 Hepatosplenic T-cell lymphoma C86.2 Enteropathy-type (intestinal) T-cell lymphoma C86.3 Subcutaneous panniculitis-like T-cell lymphoma C86.4 Blastic NK-cell lymphoma C88.4 Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue [MALT-lymphoma] C90.00 Multiple myeloma not having achieved remission C90.01 Multiple myeloma in remission C90.02 Multiple myeloma in relapse C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission C91.11 Chronic lymphocytic leukemia of B-cell type in remission C91.12 Chronic lymphocytic leukemia of B-cell type in relapse C91.40 Hairy cell leukemia not having achieved remission C91.41 Hairy cell leukemia, in remission C91.42 Hairy cell leukemia, in relapse C92.10 Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission C92.11 Chronic myeloid leukemia, BCR/ABL-positive, in remission C92.12 Chronic myeloid leukemia, BCR/ABL-positive, in relapse D03.0 Melanoma in situ of lip D03.10 Melanoma in situ of unspecified eyelid, including canthus D03.11 Melanoma in situ of right eyelid, including canthus 13

D03.12 Melanoma in situ of left eyelid, including canthus D03.20 Melanoma in situ of unspecified ear and external auricular canal D03.21 Melanoma in situ of right ear and external auricular canal D03.22 Melanoma in situ of left ear and external auricular canal D03.30 Melanoma in situ of unspecified part of face D03.39 Melanoma in situ of other parts of face D03.4 Melanoma in situ of scalp and neck D03.51 Melanoma in situ of anal skin D03.52 Melanoma in situ of breast (skin) (soft tissue) D03.59 Melanoma in situ of other part of trunk D03.60 Melanoma in situ of unspecified upper limb, including shoulder D03.61 Melanoma in situ of right upper limb, including shoulder D03.62 Melanoma in situ of left upper limb, including shoulder D03.70 Melanoma in situ of unspecified lower limb, including hip D03.71 Melanoma in situ of right lower limb, including hip D03.72 Melanoma in situ of left lower limb, including hip D03.8 Melanoma in situ of other sites D03.9 Melanoma in situ, unspecified D14.1 Benign neoplasm of larynx D45 Polycythemia vera D71 Functional disorders of polymorphonuclear neutrophils E34.0 Carcinoid syndrome Z21 Asymptomatic human immunodeficiency virus [HIV] infection status ICD-10 Procedure Codes ICD-10-PCS procedure codes: 3E00X0M 3E01305 3E0130M 3E01329 3E02305 3E0230M 3E02329 3E03003 3E0300M 3E03303 3E03305 3E0330M 3E03329 3E04003 3E0400M 3E04303 3E04305 3E0430M 3E04329 3E05003 3E0500M Code Description Introduction of Monoclonal Antibody into Skin and Mucous Membranes, External Approach Introduction of Other Antineoplastic into Subcutaneous Tissue, Percutaneous Approach Introduction of Monoclonal Antibody into Subcutaneous Tissue, Percutaneous Approach Introduction of Other Anti-infective into Subcutaneous Tissue, Percutaneous Approach Introduction of Other Antineoplastic into Muscle, Percutaneous Approach Introduction of Monoclonal Antibody into Muscle, Percutaneous Approach Introduction of Other Anti-infective into Muscle, Percutaneous Approach Introduction of Low-dose Interleukin-2 into Peripheral Vein, Open Approach Introduction of Monoclonal Antibody into Peripheral Vein, Open Approach Introduction of Low-dose Interleukin-2 into Peripheral Vein, Percutaneous Approach Introduction of Other Antineoplastic into Peripheral Vein, Percutaneous Approach Introduction of Monoclonal Antibody into Peripheral Vein, Percutaneous Approach Introduction of Other Anti-infective into Peripheral Vein, Percutaneous Approach Introduction of Low-dose Interleukin-2 into Central Vein, Open Approach Introduction of Monoclonal Antibody into Central Vein, Open Approach Introduction of Low-dose Interleukin-2 into Central Vein, Percutaneous Approach Introduction of Other Antineoplastic into Central Vein, Percutaneous Approach Introduction of Monoclonal Antibody into Central Vein, Percutaneous Approach Introduction of Other Anti-infective into Central Vein, Percutaneous Approach Introduction of Low-dose Interleukin-2 into Peripheral Artery, Open Approach Introduction of Monoclonal Antibody into Peripheral Artery, Open Approach 14

3E05303 3E05305 3E0530M 3E05329 3E06003 3E06005 3E0600M 3E06303 3E06305 3E0630M 3E06329 3E0930M 3E0970M 3E09X0M 3E0A30M 3E0B30M 3E0B70M 3E0BX0M 3E0C305 3E0C30M 3E0C329 3E0C70M 3E0CX05 3E0CX0M 3E0CX29 3E0D30M 3E0D70M 3E0DX0M 3E0E30M 3E0E70M 3E0E80M 3E0F30M 3E0F70M 3E0F80M 3E0G30M 3E0G70M 3E0G80M 3E0H30M 3E0H70M 3E0H80M 3E0J30M 3E0J70M Introduction of Low-dose Interleukin-2 into Peripheral Artery, Percutaneous Approach Introduction of Other Antineoplastic into Peripheral Artery, Percutaneous Approach Introduction of Monoclonal Antibody into Peripheral Artery, Percutaneous Approach Introduction of Other Anti-infective into Peripheral Artery, Percutaneous Approach Introduction of Low-dose Interleukin-2 into Central Artery, Open Approach Introduction of Other Antineoplastic into Central Artery, Open Approach Introduction of Monoclonal Antibody into Central Artery, Open Approach Introduction of Low-dose Interleukin-2 into Central Artery, Percutaneous Approach Introduction of Other Antineoplastic into Central Artery, Percutaneous Approach Introduction of Monoclonal Antibody into Central Artery, Percutaneous Approach Introduction of Other Anti-infective into Central Artery, Percutaneous Approach Introduction of Monoclonal Antibody into Nose, Percutaneous Approach Introduction of Monoclonal Antibody into Nose, Via Natural or Artificial Opening Introduction of Monoclonal Antibody into Nose, External Approach Introduction of Monoclonal Antibody into Bone Marrow, Percutaneous Approach Introduction of Monoclonal Antibody into Ear, Percutaneous Approach Introduction of Monoclonal Antibody into Ear, Via Natural or Artificial Opening Introduction of Monoclonal Antibody into Ear, External Approach Introduction of Other Antineoplastic into Eye, Percutaneous Approach Introduction of Monoclonal Antibody into Eye, Percutaneous Approach Introduction of Other Anti-infective into Eye, Percutaneous Approach Introduction of Monoclonal Antibody into Eye, Via Natural or Artificial Opening Introduction of Other Antineoplastic into Eye, External Approach Introduction of Monoclonal Antibody into Eye, External Approach Introduction of Other Anti-infective into Eye, External Approach Introduction of Monoclonal Antibody into Mouth and Pharynx, Percutaneous Approach Introduction of Monoclonal Antibody into Mouth and Pharynx, Via Natural or Artificial Opening Introduction of Monoclonal Antibody into Mouth and Pharynx, External Approach Introduction of Monoclonal Antibody into Products of Conception, Percutaneous Approach Introduction of Monoclonal Antibody into Products of Conception, Via Natural or Artificial Opening Introduction of Monoclonal Antibody into Products of Conception, Via Natural or Artificial Opening Endoscopic Introduction of Monoclonal Antibody into Respiratory Tract, Percutaneous Approach Introduction of Monoclonal Antibody into Respiratory Tract, Via Natural or Artificial Opening Introduction of Monoclonal Antibody into Respiratory Tract, Via Natural or Artificial Opening Endoscopic Introduction of Monoclonal Antibody into Upper GI, Percutaneous Approach Introduction of Monoclonal Antibody into Upper GI, Via Natural or Artificial Opening Introduction of Monoclonal Antibody into Upper GI, Via Natural or Artificial Opening Endoscopic Introduction of Monoclonal Antibody into Lower GI, Percutaneous Approach Introduction of Monoclonal Antibody into Lower GI, Via Natural or Artificial Opening Introduction of Monoclonal Antibody into Lower GI, Via Natural or Artificial Opening Endoscopic Introduction of Monoclonal Antibody into Biliary and Pancreatic Tract, Percutaneous Approach Introduction of Monoclonal Antibody into Biliary and Pancreatic Tract, Via Natural or Artificial Opening 15

3E0J80M 3E0K30M 3E0K70M 3E0K80M 3E0L30M 3E0L70M 3E0M30M 3E0M70M 3E0N30M 3E0N70M 3E0N80M 3E0P30M 3E0P70M 3E0P80M 3E0Q30M 3E0Q70M 3E0R303 3E0R30M 3E0S303 3E0S30M 3E0U30M 3E0V30M 3E0W30M 3E0Y30M 3E0Y70M Introduction of Monoclonal Antibody into Biliary and Pancreatic Tract, Via Natural or Artificial Opening Endoscopic Introduction of Monoclonal Antibody into Genitourinary Tract, Percutaneous Approach Introduction of Monoclonal Antibody into Genitourinary Tract, Via Natural or Artificial Opening Introduction of Monoclonal Antibody into Genitourinary Tract, Via Natural or Artificial Opening Endoscopic Introduction of Monoclonal Antibody into Pleural Cavity, Percutaneous Approach Introduction of Monoclonal Antibody into Pleural Cavity, Via Natural or Artificial Opening Introduction of Monoclonal Antibody into Peritoneal Cavity, Percutaneous Approach Introduction of Monoclonal Antibody into Peritoneal Cavity, Via Natural or Artificial Opening Introduction of Monoclonal Antibody into Male Reproductive, Percutaneous Approach Introduction of Monoclonal Antibody into Male Reproductive, Via Natural or Artificial Opening Introduction of Monoclonal Antibody into Male Reproductive, Via Natural or Artificial Opening Endoscopic Introduction of Monoclonal Antibody into Female Reproductive, Percutaneous Approach Introduction of Monoclonal Antibody into Female Reproductive, Via Natural or Artificial Opening Introduction of Monoclonal Antibody into Female Reproductive, Via Natural or Artificial Opening Endoscopic Introduction of Monoclonal Antibody into Cranial Cavity and Brain, Percutaneous Approach Introduction of Monoclonal Antibody into Cranial Cavity and Brain, Via Natural or Artificial Opening Introduction of Low-dose Interleukin-2 into Spinal Canal, Percutaneous Approach Introduction of Monoclonal Antibody into Spinal Canal, Percutaneous Approach Introduction of Low-dose Interleukin-2 into Epidural Space, Percutaneous Approach Introduction of Monoclonal Antibody into Epidural Space, Percutaneous Approach Introduction of Monoclonal Antibody into Joints, Percutaneous Approach Introduction of Monoclonal Antibody into Bones, Percutaneous Approach Introduction of Monoclonal Antibody into Lymphatics, Percutaneous Approach Introduction of Monoclonal Antibody into Pericardial Cavity, Percutaneous Approach Introduction of Monoclonal Antibody into Pericardial Cavity, Via Natural or Artificial Opening Policy History Date Action 7/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/2015. 2/2014 Updated Onco360 name and removed Curascript in Specialty Pharmacy section. 1/2014 Updated ExpressPAth language and remove Blue Value. 6/2013 Update to correct ICD-9 list to include 288.1 (chronic granulomatous disease) 11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. 1/2012 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 1/2012 Updated to move criteria for Pegasys and PegIntron from policy and include in new Pharmacy Medical Policy #344 Hepatitis C medications. 10/2011 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. 16

7/2011 Updated to include coverage criteria for new FDA approved medication Sylatron and to update Specialty Pharmacy contact information. 1/2011 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 11/2010 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. 9/2010 Reviewed - Medical Policy Group - Hematology and Oncology. 1/2010 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 11/2009 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. 9/2009 Reviewed - Medical Policy Group - Hematology and Oncology. 10/2009 Updated to remove Medicare Part D from policy and to reflect UM requirements. 1/2009 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 11/2008 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. 10/2008 Reviewed - Medical Policy Group - Hematology and Oncology. 2/2008 Updated to include additional retail pharmacy specialty network information. 1/2008 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 11/2007 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. 9/2007 Reviewed - Medical Policy Group - Hematology and Oncology. 6/2007 Updated to include information regarding retail pharmacy specialty network for medications commonly prescribed for oncology. 5/2007 Updated to remove covered indications, prior authorization, coding and footnotes 6, 7, 12 and 15 related to Interferon Beta based upon Pharmacy Services recommendations and development of retail pharmacy specialty network. 1/2007 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 10/21/1988 New policy, effective 10/21/1988, describing covered and non-covered indications. References 1. Davis GL, Esteban-Mur R, Rustgi V et al. Interferon alfa-2b alone or in combination with ribavirin for the treatment of relapse of chronic hepatitis C. N Engl J Med 1998; 339(21):1493-9. 2. McHutchison JG, Gordon SC, Schiff ER et al. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. N Engl J Med 1998; 339(21):1485-92. 3. Liang TJ. Combination therapy for hepatitis C infection. N Engl J Med 1998; 339(21):1549-50. 4. Scott LJ, Perry CM. Interferon alpha 2b plus ribavirin: a review of its use in the management of chronic hepatitis C. Drugs 2002; 62(3):507-56. 5. Lindsay KL, Trepo C, Heintges T et al. A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C. Hepatology 2001; 34(2):395-403. 17

6. Reddy KR, Wright TL, Pockros PJ et al. Efficacy and safety of pegylated (40-kd) interferon alpha-2a compared with interferon alpha-2a in noncirrhotic patients with chronic hepatitis C. Hepatology 2001; 33(2):433-48. 7. Glue P, Rouzier-Panis R, Raffanel C et al. A dose-ranging study of pegylated interferon alfa-2b and ribavirin in chronic hepatitis C. The Hepatitis C Intervention Therapy Group. Hepatology 2000; 32(3):646-53. 8. Cornberg M, Wedemeyer H, Manns MP. Treatment of chronic hepatitis C with PEGylated interferon and ribavirin. Curr Gastroenterol Rep 2002; 4(1):23-30. 9. Shiffman ML, Di Bisceglie AM, Lindsay KL et al. Peginterferon alfa-2a and ribavirin in patients with chronic hepatitis C who have failed prior treatment. Gastroenterology 2004; 126(4):1015-23. 10. Chung RT, Andersen J, Volberding P et al. Peginterferon alfa-2a plus ribavirin versus interferon alfa- 2a plus ribavirin for chronic hepatitis C in HIV-coinfected persons. N Engl J Med 2004; 351(5):451-9. 11. Torriani FJ, Rodriguez-Torres M, Rockstroh JK et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med 2004; 351(5):438-50. 12. Muir AJ, Bornstein JD, Killenberg PG. Peginterferon alfa-2b and ribavirin for the treatment of chronic hepatitis C in blacks and non-hispanic whites. N Engl J Med 2004; 350(22):2265-71. 13. Pockros PJ, Carithers R, Desmond P et al. Efficacy and safety of two-dose regimens of peginterferon alpha-2a compared with interferon alpha-2a in chronic hepatitis C: a multicenter, randomized controlled trial. Am J Gastroenterol 2004; 99(7):1298-305. 14. Van Vlierberghe H, Leroux-Roels G, Adler M et al. Daily induction combination treatment with alpha 2b interferon and ribavirin or standard combination treatment in naïve chronic hepatitis C patients. A multicentre randomized controlled trial. J Viral Hepat 2003; 10(6):460-6. 15. Portal I, Bourliere M, Halfon P et al. Retreatment with interferon and ribavirin vs interferon alone according to viraemia in interferon responder-relapse hepatitis C patients: a prospective multicentre randomized controlled study. J Viral Hepat 2003; 10(3):215-23. 16. Poynard T, Marcellin P, Bissery A et al. Reinforced interferon alpha-2b and ribavirin is more effective than standard combination therapy in the retreatment of chronic hepatitis C previously nonresponse to interferon: a randomized trial. J Viral Hepat 2003; 10(3):197-204. 17. Hadziyannis SJ, Sette H, Morgan TR et al. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med 2004; 140(5):346-55. 18. Fried MW, Shiffman M, Sterling RK et al. A multicenter, randomized trial of daily high-dose interferonalfa 2b for the treatment of chronic hepatitis C: pretreatment stratification by viral burden and genotype. Am J Gastroenterol 2000; 95(11):3225-9. Endnotes 1. Revised 9/95 to include the 9/95 Technology Evaluation Center s Medical Advisory Panel consensus assessing medical literature from 1985 to June 1995 which addressed IFN,, and for off-label uses in lymphomas, leukemias, and plasma cell tumors, and for off-label uses in solid tumors. 2. Revised 12/95 to include off label uses listed in the United States Pharmacopeia (USP) Drug Information, 16th Edition. 3. Revised 1/30/96 to include the December 5, 1995 FDA-approved indication of alpha interferon for malignant melanoma in patients 18 years of age or older with primary or recurrent malignant melanoma who are free of disease but at a high risk for systemic disease. 4. Effective 4/1/96. Revised 4/1/96 in accordance with local Medicare regulations section 2050.5 of the Carriers manual. See also: Medicare newsletter, April 1994 p. 21. 5. See Randomised trial of effects of IFN-alpha on incidence of hepatocellular carcinoma in chronic active hepatitis C with cirrhosis. Nishiguchi S et al. Lancet 1995 October 21;346:1051-5. 6. In accordance with CMS regulations, published in the February/March 1998 newsletter, pages 27-28. 7. Infergen TM (Interferon alfacon-1) is covered for indication specified by the FDA. Currently, Infergen is FDA-approved for chronic hepatitis C. 8. Off-label use in the treatment of AIDS and HIV as required by law. 9. New England Journal of Medicine, Vol.341, No. 17, October 1999, Ziesche 1999: 10. Lancet 1998 Jan 10;351:83-7. Randomised, double-blind, placebo-controlled trial of interferon alpha- 2b with and without ribavirin for chronic hepatitis C. Lancet 1998 Jan 10; 351:78-9 18