Medical Policies - Prescription Drugs


Interferon alfa-N3 (Alferon N Injection)

Number:RX501.091

Effective Date:07-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Medical policies are a set of written guidelines that support current standards of practice. They are based on current peer-reviewed scientific literature. A requested therapy must be proven effective for the relevant diagnosis or procedure. For drug therapy, the proposed dose, frequency and duration of therapy must be consistent with recommendations in at least one authoritative source. This medical policy is supported by FDA-approved labeling and nationally recognized authoritative references. These references include, but are not limited to: MCG care guidelines, DrugDex (IIb level of evidence or higher), NCCN Guidelines (IIb level of evidence or higher), NCCN Compendia (IIb level of evidence or higher), professional society guidelines, and CMS coverage policy.

Interferon alfa-N3 (Alferon N Injection®)may be considered medically necessaryforintralesional treatment of refractory or recurring external condylomata acuminata (venereal/genital warts) in patients 18 years of age and older.

Interferon alfa-N3 (Alferon N Injection®) is considered experimental, investigational and/or unproven for all other indications.

Description:

Condylomata acuminata, also called genital or venereal warts, are highly contagious, benign epithelial growths in the genital and perianal regions of men and women that are caused by human papillomaviruses (HPVs). It is the most common sexually transmitted disease (STD) in the general population. The U.S. Centers for Disease Control and Prevention (CDC) estimates that approximately 20 million Americans are currently infected with HPV with another 6 million becoming newly infected each year. (1) Both local destruction methods (e.g., surgical excision, electrocautery, cryosurgery, and laser vaporization) and chemical destruction methods using acids have had less than satisfying results, including, scarring, recurrence, local irritation, and uneven effectiveness.

Interferon comprises approximately 20 naturally occurring proteins. Four classes of interferons have been identified: alpha, beta, gamma and omega. (1) Each class is chemically unique, is synthesized and released primarily by different sets of cells, and has a specific function. Interferon alphas stimulate or regulate a wide range of biologic responses such as: 1) interfering with viral multiplication processes (anti-viral), 2) inhibiting tumor growth (antiproliferative), 3) activating the immune system or modifying the immune response (immunomodulatory effects), and 4) stimulating specialization of cells (differentiation-inducing effects). Interferon alfa-N3 has been widely used in the treatment of condylomata acuminatafor its immunomodulatory, antiproliferative and antiviral properties.(2)

Interferon has been shown to protect murine cells against infection with papillomaviruses and to eliminate extrachromosomal viral DNA from infected cells, by binding to specific membrane receptors on the cell surface and then initiating a complex sequence of intracellular events. These intracellular events include the induction of certain enzymes, suppression of cell proliferation, immunomodulating activities such as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells, and inhibition of virus replication in virus-infected cells. (2)

Regulatory Status

Interferon alfa-N3 (Alferon N Injection®) received U.S. Food and Drug Administration approval on October 10, 1989 for the intralesional treatment of refractory or recurring external condyloma acuminata in adults.

Interferon alfa-N3 (Alferon N Injection®) is contraindicated in patients with known hypersensitivity to human interferon proteins or any component of the product, anaphylactic hypersensitivity to mouse immunoglobulin, egg protein, or neomycin. (4)

The recommended dose of interferon alfa-N3 (Alferon N Injection®) for the treatment of condylomata acuminata is 0.05 ml (250,000 IU) per wart administered twice weekly for up to 8 weeks. The maximum dose per treatment session is 0.5ml (2.5 million IU). (4)

Rationale:

Intralesional interferon alfa-N3 (Alferon N Injection®) has been effective in treating condyloma acuminata in both open and controlled studies, including those patients refractory to conventional therapy.

In an open trial of 28 patients with condyloma acuminata, once weekly intralesional administration of interferon alfa-N3 for up to 16 weeks achieved complete or partial resolution of warts in 25 of 28 patients (89%). Of the 154 warts treated, 77% resolved completely. The most frequent side effects were flu-like symptoms.

Additionally, interferon alfa-N3 was shown to be more effective than placebo in a multicenter, randomized, double-blind trial of 156 patients with condyloma acuminata. Patients received a mean dose of 225,000 International Units (IU) per wart twice weekly for 8 weeks; patients had a mean of 5 warts. Overall, 80% (65/81) of interferon alfa-N3-treated patients and 44% (33/75) of placebo-treated patients achieved complete or partial resolution of warts (p less than 0.001), at the end of the treatment period. (4)

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

None

HCPCS Codes

J9215

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Alferon N. Prescribing Information. Philadelphia, PA. Hemispherx Biopharma, Inc. Available at: <http://www.hemispherx.net> (accessed June 16, 2018)

2. Yang J., Pu Y.G., Zeng Z.M., et al. Interferon for the treatment of genital warts: a systematic review.BMC Infect. Dis.2009; 9:156.PMID 19772554

3. FDA – Alferon N Injection (interferon alfa-N3) Food and Drug Administration. Available at: <http://www.accessdata.fda.gov> (accessed June 16, 2018).

4. Interferon Alfa-N3. Micromedex Drug Summary Information. Truven Health Analytics Micromedex Solutions. 2018. Available at: <http://www.microdexsolutions.com> (accessed June 18, 2018).

Policy History:

DateReason
7/15/2018 Reviewed. No changes.
9/1/2017 New medical document. Interferon alfa-N3 (Alferon N Injection®)may be considered medically necessaryforintralesional treatment of refractory or recurring external condylomata acuminata (venereal/genital warts) in patients 18 years of age and older. Interferon alfa-N3 (Alferon N Injection®) is considered experimental, investigational and/or unproven for all other indications.

Archived Document(s):

Title:Effective Date:End Date:
Interferon alfa-N3 (Alferon N Injection)09-01-201707-14-2018
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