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MP 8.01.03 |
Interferon Therapy |
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| Medical Policy | ||
| Section Therapy |
Original Policy Date 12/1/95 |
Last Review Status/Date Reviewed by consensus/1:2004 |
| Issue 1:2004 |
Return to Medical Policy Index |
Disclaimer
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
Description
Interferon comprises approximately 20 naturally occurring proteins. Three classes of interferons have been identified: alpha, beta, and gamma. Each class is chemically unique, is synthesized and released primarily by different sets of cells, and has a specific function.
Interferons play an important role in the immune system. Animal studies and preclinical human tissue studies suggest interferons have antiviral, antiproliferative, antiangiogenic, immunomodulatory, and gene regulatory effects. There are 2 rationales for the use of interferons in clinical oncology. First, evidence suggests that interferons have a direct antiproliferative effect on some cancer cells by increasing the length of the cell cycle by depleting essential intracellular metabolites, and by enhancing cell lysis. Second, interferon may have indirect effects, such as enhancement of cell-surface antigen expression, enhancement of macrophage and lymphocyte cytotoxicity, and induction of antibodies to tumor cells.
Policy
The use of recombinant or natural interferon alfa for the treatment of hematologic malignancies (lymphomas, leukemias, or plasma-cell malignancies) is medically necessary in off-label use for:
- first-line treatment of patients with Philadelphia chromosome-positive CML in first chronic phase;
- as a component of first-line treatment of patients with multiple myeloma, or as maintenance therapy of patients with multiple myeloma that has responded to first-line therapy;
- a combination with cytotoxic agents as first-line therapy of aggressive low-grade (follicular) or intermediate-grade non-Hodgkin’s lymphoma.
- The U. S. Food and Drug Administration (FDA) has licensed 5 forms of interferon (IFN) for clinical use: IFNα-2a, IFNα-2b, IFNα-n3, IFNβ-1b, and IFN-γ. The trade names, manufacturers/vendors, and FDA-licensed indications are as follows:
| Type | Trade Name | Manufacturer | Labeled Indication(s) |
| IFNα-2a | Roferon-A | Hoffman-La Roche | hairy cell leukemia; AIDS-related Kaposi’s sarcoma |
| IFNα-2b | Intron A | Schering-Plough | hairy cell leukemia; condylomatra acuminata; AIDS-related Kaposi’s sarcoma; chronic hepatitis. Primary or recurrent malignant melanoma as adjuvant treatment to surgery in patients 18 years of age or older who are free of disease but at high risk for systemic relapse |
| IFNα-n3 | Alferon N | Purdue Frederick | condyloma acuminata |
| IFNβ-1b | Betaseron | Berlex | multiple sclerosis |
| IFN-γ | Actimmune | Genentech | infections associated with chronic granulomatous disease |
- recombinant or natural interferon alfa is considered investigational for the treatment of any off-label hematologic malignancy other than those specified on the preceding page;
- recombinant interferon beta is considered investigational for the treatment of any hematologic malignancy;
- recombinant interferon gamma is considered investigational for the treatment of any hematologic malignancy; and
- recombinant and human leukocyte-derived interferons are considered investigational for the treatment of any off-label solid tumor indications including, but not limited to, the following:
- bladder cancer
- brain tumors, malignant
- breast cancer
- cancer or precancers of oral cavity
- carcinoid tumor or carcinoid syndromes
- cervical intraepithelial neoplasia II associated with human papillomavirus infection
- colorectal cancer
- cutaneous squamous cell cancer (including actinic keratoses, basal cell carcinomas)
- head and neck cancers, recurrent or metastatic
- lung cancer, non-small-cell
- malignant islet-cell tumors
- medullary thyroid carcinoma
- melanoma
- merkel cell carcinoma
- metastatic apudomas
- neuroendocrine tumors
- osteosarcoma
- ovarian cancer
- pancreatic cancer
- recurrent respiratory papillomatosis
- relapsed adult nephroblastoma
- renal cell carcinoma
- teratoma, testicular, mature-growing
Policy Guidelines
No applicable information
Benefit Application
BlueCard/National Account Issues
See Off-Label Use of Drugs, medical policy No. 8.01.03, under the Prescription Drug section of this manual.
Rationale
A search of the literature was completed through the MEDLINE database for the period of January 1985 through May 1995. The search strategy focused on references containing the following Medical Subject Headings:
- Interferon Linked with Drug Therapy in Conjunction with Neoplasm
- Lymphoma, Leukemia, Multiple Myeloma Combined with Random Allocation or
“Randomized Controls Trials”
Research was limited to English-language journals on humans.
See also:
Current Contents
Abstracts from the following groups:
- American Society for Clinical Oncology
- American Society for Therapeutic and Radiation Oncology
- American Society for Hematology
- Keystone Symposia on Bone Marrow Transplantation
- The American Society for Blood and Marrow Transplantation
- The International Symposia on Bone Marrow Transplantation
TEC Assessments 1995:
Off-Label Oncology indications - Lymphomas, Leukemias, and Plasma-Cell Malignancies -
Tab 16.
Off-Label Oncology Indications - Solid Tumor - Tab 17.
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Codes |
Number |
Description |
| CPT | 90765 | Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour (new code effective 1/1/06) |
| 90766 | each additional hour, up to 8 hours (list separately in addition to code for primary procedure) (new code effective 1/1/06) | |
| ICD-9 Procedure | 99.28 | Injection or infusion of biological response |
| ICD-9 Diagnosis | 202.80–202.88 | Other lymphomas |
| 203.0 | Multiple myeloma | |
| 205.1 | Chronic myelogenous leukemia | |
| HCPCS | J1830 | Interferon beta-1lb, per 0.25 mg |
| J9213 | Interferon alfa-2a, recombinant, 3 million units | |
| J9214 | Interferon alfa-2b, recombinant, 1 million units | |
| J9215 | Interferon alfa-n3, human leukocyte derived | |
| J9216 | Interferon gamma-1b, 3 million units | |
| Type of Service | Therapy | |
| Place of Service | Inpatient Outpatient Home |
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Index
Interferon Therapy for Off-Label Oncology Indications
Off-Label Oncology Indications, Interferon Therapy
Policy History
| Date | Action | Reason |
| 12/1/95 | Add to Therapy section | New policy |
| 10/08/02 | Replace policy | Policy reviewed by consensus; no further review scheduled |
| 02/25/04 | Replace Policy | Policy reviewed without literature search; no further review scheduled |
| 12/14/05 | Replace policy – coding update only | CPT coding updated |
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