CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Interferon alfa-2b (Intron A) — Coverage Criteria for Indications and Authorization Durations

Defines covered indications (FDA and compendial) for interferon alfa-2b (Intron A) and the authorized initial and continuation approval durations for each indication for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInterferon alfa-2b (Intron A) — Coverage Criteria for Indications and Authorization Durations

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionProviders must request prior authorization matching the specific indication and document clinical rationale and absence of exclusions.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthscommon initial authorization length for many indications

6 monthsinitial authorization length for hairy cell leukemia and CML

16 weeksinitial authorization length for chronic hepatitis B and C

52 wks (up to 96)continuation authorization for chronic hepatitis C

12 months

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Coverage Criteria for Interferon alfa-2b (Intron A)

Initial Covered Indications

Covered when the indication is one of the following FDA-approved or compendial uses and all approval criteria are met and the member has no exclusions to the prescribed therapy.

Covered Indications (FDA-approved): Malignant melanoma; Condylomata acuminata; Hairy cell leukemia; AIDS-related Kaposi sarcoma; Chronic hepatitis B virus infection; Chronic hepatitis C virus infection; Follicular non-Hodgkin's lymphoma.

Authorization durations vary by indication (see Initial Authorization Durations).

Compendial Uses: Adult T-cell leukemia/lymphoma (ATLL); Renal cell carcinoma; Chronic myeloid leukemia (CML); Ocular surface neoplasia (conjunctival and corneal neoplasm).

All other indications are considered experimental/investigational and not medically necessary.

Initial Authorization Durations

Initial authorization durations by indication.

Malignant melanoma: Authorization of 12 months may be granted for treatment of malignant melanoma.12 months

Adult T-cell leukemia/lymphoma (ATLL) (with zidovudine): Authorization of 12 months may be granted for treatment of ATLL when the requested medication is used in combination with zidovudine.12 months

Combination therapy requirement noted.

Hairy cell leukemia: Authorization of 6 months may be granted for treatment of hairy cell leukemia.6 months

Follicular non-Hodgkin's lymphoma (clinically aggressive): Authorization of 12 months may be granted for treatment of follicular lymphoma (clinically aggressive).12 months

Renal cell carcinoma (with bevacizumab): Authorization of 12 months may be granted for treatment of renal cell carcinoma when the requested medication will be used in combination with bevacizumab.12 months

Combination therapy requirement noted.

Condylomata acuminata: Authorization of 12 months may be granted for treatment of condylomata acuminata.12 months

AIDS-related Kaposi sarcoma: Authorization of 12 months may be granted for treatment of AIDS-related Kaposi sarcoma.12 months

Chronic myeloid leukemia (CML): Authorization of 6 months may be granted for treatment of CML.6 months

Chronic hepatitis C: Authorization of 16 weeks may be granted for treatment of chronic hepatitis C virus infection.16 weeks

Chronic hepatitis B (including hepatitis D co-infection): Authorization of 16 weeks may be granted for treatment of chronic hepatitis B (including hepatitis D virus co-infection).16 weeks

Ocular surface neoplasia (conjunctival and corneal neoplasm): Authorization of 12 months may be granted for treatment of ocular surface neoplasia (conjunctival and corneal neoplasm).12 months

Other listed indications continued treatment: Authorization of 12 months may be granted for continued treatment for indications in Section II other than hairy cell leukemia, chronic hepatitis C and chronic hepatitis B when no unacceptable toxicity or disease progression is present.12 months

Excludes certain indications with separate continuation limits.

Continuation/Reauthorization Criteria

Continuation (reauthorization) criteria and maximum durations when clinical benefit and acceptable toxicity are present.

Chronic Hepatitis C continuation: Authorization of 52 weeks, up to a total of 96 weeks, may be granted for continued treatment when the member is receiving clinical benefit and there is no evidence of unacceptable toxicity while on the current regimen.up to 96 weeks total

Requires documentation of clinical benefit and acceptable toxicity.

Chronic Hepatitis B continuation: Authorization of up to a total of 24 weeks may be granted for continued treatment when the member is receiving clinical benefit and there is no evidence of unacceptable toxicity while on the current regimen.up to 24 weeks total

Requires documentation of clinical benefit and acceptable toxicity.

Hairy Cell Leukemia continuation: Authorization of up to a total of 6 months may be granted for continued treatment when the member is receiving clinical benefit and there is no evidence of unacceptable toxicity while on the current regimen.

Continued Treatment Reauthorization

Authorization of 12 months may be granted for continued treatment when ALL of the following are met:

Reauthorization conditions: Indication is listed in Section II (excluding hairy cell leukemia, chronic hepatitis C, and chronic hepatitis B); there is no evidence of unacceptable toxicity; there is no evidence of disease progression while on the current regimen.

Applies to reauthorization requests only.

All indications beyond the FDA-approved and listed compendial uses are treated as experimental/investigational and are not medically necessary under this policy. Coverage is limited to the FDA-approved indications and the compendial uses specifically listed in Section I; requests for uses outside those listings should be considered noncovered.

The 12-month reauthorization provision does not apply to hairy cell leukemia, chronic hepatitis C, and chronic hepatitis B. These indications have separate continuation limits and are excluded from the general 12-month continued-treatment reauthorization described for other listed indications.

Use of interferon alfa-2b for any indication that is not listed in Section I (the FDA-approved indications and the listed compendial uses) is considered not medically necessary and will be denied as experimental/investigational.

Provider Requirements and Authorization Actions

Prior Authorization

Indication-specific prior authorization required

Prior authorization is required and must be requested for each specific indication for interferon alfa-2b (Intron A). Providers must document the exact FDA-approved or compendial indication when requesting authorization; approvals are issued with indication-specific durations (see Indications and Authorization Durations).

Drug: INTRON A (interferon alfa-2b)
Document the requested indication (FDA approval or compendial use) on the prior authorization request

Denial Risk

Experimental / Investigational exclusions

Use of interferon alfa-2b for any indication not listed as an FDA-approved or compendial use in this policy is considered experimental and investigational and is not medically necessary. Requests for non-listed indications will be denied.

Covered Combination Regimens

Regimen	Indication	Authorization
Interferon alfa-2b used in combination with zidovudine
Adult T-cell leukemia/lymphoma (ATLL)
Authorization of 12 months may be granted

Regimen	Indication	Authorization
Interferon alfa-2b when used in combination with bevacizumab
Renal cell carcinoma
Authorization of 12 months may be granted

Background

Interferon alfa-2b (Intron A) is indicated for multiple malignant, viral, and ocular surface conditions when those indications are FDA-approved or supported by recognized compendia. This policy defines the covered FDA-approved indications and specified compendial uses and ties coverage to the documented indication and approval criteria. For continued treatment, a general provision allows authorization of 12 months for listed indications when there is no evidence of unacceptable toxicity or disease progression; however, certain diagnoses (for example, hairy cell leukemia, chronic hepatitis C, and chronic hepatitis B) have separate continuation rules and are excluded from that 12-month reauthorization allowance.

Definitions

Covered indication — definition

DefinitionAn indication listed under the policy’s FDA‑Approved Indications or Compendial Uses for which coverage may be granted when all approval criteria are met and the member has no exclusions to the prescribed therapy.

Included FDA‑Approved IndicationsMalignant melanoma; Condylomata acuminata; Hairy cell leukemia; AIDS‑related Kaposi sarcoma; Chronic hepatitis B; Chronic hepatitis C; Follicular non‑Hodgkin's lymphoma.

Included Compendial UsesAdult T‑cell leukemia/lymphoma (ATLL); Renal cell carcinoma; Chronic myeloid leukemia (CML); Ocular surface neoplasia (conjunctival and corneal neoplasm).

Coverage conditionCoverage is granted only when all approval criteria in the policy are met and the member has no exclusions to the prescribed therapy.

ExclusionsIndications not listed in the FDA‑Approved or Compendial sections are considered experimental/investigational and not medically necessary.