CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

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

This document describes covered indications, compendial uses, and authorization/reauthorization timeframes for Intron A (interferon alfa-2b) for members of the plan when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

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

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document clinical benefit and absence of unacceptable toxicity or disease progression for reauthorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 months12-month authorization (many indications)

6 months6-month authorization (hairy cell leukemia, CML)

16 weeksInitial hepatitis B/C authorization

up to 96 wksMax chronic hepatitis C

12 monthsMax reauthorization period

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Coverage and Authorization Criteria

Initial therapy — indication-specific criteria

Covered when ALL of the following are met for the specific indication:

General: Requested use is for an indication listed as FDA‑approved or compendial in this document and the member has no exclusions to the prescribed therapy.

See 'INDICATIONS' section for full list.

Indication-specific authorization durations: Authorization durations vary by indication (examples: malignant melanoma — 12 months; adult T‑cell leukemia/lymphoma — 12 months when used with zidovudine; hairy cell leukemia — 6 months; follicular lymphoma (clinically aggressive) — 12 months; renal cell carcinoma — 12 months when used with bevacizumab; condylomata acuminata — 12 months; AIDS‑related Kaposi sarcoma — 12 months; chronic myeloid leukemia — 6 months; chronic hepatitis C — 16 weeks; chronic hepatitis B — 16 weeks; ocular surface neoplasia — 12 months).

See individual indication entries in policy (chunks 3–14).

Combination requirements: When specified for an indication, interferon alfa‑2b must be used in combination with the named agent to qualify for authorization (e.g., ATLL with zidovudine; renal cell carcinoma with bevacizumab).

Chunks 4 and 7.

Reauthorization/continued therapy

Reauthorization/continued treatment covered when ALL of the following are met:

Clinical benefit: Member is receiving clinical benefit from the current regimen.

See reauthorization guidance (chunks 15–17).

Toxicity: There is no evidence of unacceptable toxicity while on the current regimen.

Assessment by treating clinician; see chunks 15–17.

Duration limits: Specific maximums for continued treatment depend on indication (examples: chronic hepatitis C — authorization of 52 weeks, up to a total of 96 weeks; chronic hepatitis B — up to a total of 24 weeks; hairy cell leukemia — up to a total of 6 months).

Chunks 15–17.

Reauthorization for Other Indications

Authorization of 12 months may be granted for continued treatment for indications listed in Section II, other than specified exclusions, when the following are met:

Eligible indication: Member is receiving treatment for an indication listed in Section II and the indication is not one of the excluded diagnoses (hairy cell leukemia, chronic hepatitis C, chronic hepatitis B).

See Section II for eligible indications (chunk 2); exclusions listed in chunk 18.

Safety: There is no evidence of unacceptable toxicity while on the current regimen.

Unacceptable toxicity as assessed by treating clinician (chunk 18).

Disease control: There is no evidence of disease progression while on the current regimen.

Documented lack of progression required for continued authorization (chunk 18).

Indications that are not listed in Sections A (FDA-approved indications) or B (compendial uses) are considered experimental/investigational and not medically necessary. Requests for interferon alfa-2b for these non-listed indications will not be approved.

The 12-month reauthorization provision does not apply to members receiving treatment for hairy cell leukemia, chronic hepatitis C, or chronic hepatitis B. These indications are specifically excluded from the up-to-12-month reauthorization allowance.

Use of interferon alfa-2b for indications other than those listed among the FDA-approved indications or compendial uses in this document is not medically necessary and is considered investigational; such uses are not eligible for coverage.

Provider Requirements and Authorization Details

Prior Authorization

Authorization Durations by Indication

Prior authorization is required. Authorization durations are specified below by indication — requests must include diagnosis and supporting documentation. Durations listed are the maximum initial authorization periods and reauthorization rules apply as noted.

Authorization durations are indication-specific (see bullets).
Prior authorization required before dispensing.

Prior Authorization

Durations by Indication (detailed)

Authorization durations (maximum initial approval):

Malignant melanoma — up to 12 months.
Adult T‑cell leukemia/lymphoma (ATLL) — up to 12 months when used in combination with zidovudine.
Hairy cell leukemia — up to 6 months.
Follicular lymphoma (clinically aggressive) — up to 12 months.
Renal cell carcinoma — up to 12 months when used in combination with bevacizumab.

Approved Combination Regimens and Indication Mapping

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

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

Regimen	Indication	Initial Authorization	Reauthorization / Total Duration	Coverage Status
Interferon alfa-2b
Hairy cell leukemia
Authorization of 6 months may be granted for treatment of hairy cell leukemia.
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.
Covered

Drug Coding and Reference

Drug referencemixed

Intron A (interferon alfa-2b)

Reference number(s) 1703-A

Line of Therapy Guidance

Line-of-therapy rules

ATLL combination: Authorization of 12 months may be granted for adult T‑cell leukemia/lymphoma (ATLL) when interferon alfa‑2b is used in combination with zidovudine.

Chunk 4.

Renal cell carcinoma combination: Authorization of 12 months may be granted for renal cell carcinoma when interferon alfa‑2b is used in combination with bevacizumab.

Chunk 7.

Definitions and Covered Indication Summary

Covered indications — summary

ScopeIndications listed in this document (FDA‑approved and compendial uses) are considered covered benefits when all approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA‑approved indications (examples)Malignant melanoma; Condylomata acuminata; Hairy cell leukemia; Chronic hepatitis B; AIDS‑related Kaposi sarcoma; Chronic hepatitis C; Follicular non‑Hodgkin's lymphoma.

Coverage conditionCoverage applies only when the requested use is for an indication included in the policy and all indication‑specific approval criteria (including any combination‑therapy requirements and authorization durations) are met.

Documentation requirementMember must have no exclusions to the prescribed therapy; prescriber must meet any indication‑specific documentation and prior authorization requirements per the policy.

Background

Interferon alfa-2b (Intron A) is an immunomodulatory agent used across certain viral infections and multiple malignancies. This policy defines the specific FDA-approved and compendial indications considered a covered benefit when approval criteria are met, and it outlines authorization durations and reauthorization conditions (including exclusions). Uses outside the listed indications are classified as experimental/investigational and are not medically necessary.