CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Intravenous Immune Globulin (IVIG) coverage for cancer-related indications

Defines accepted indications, clinical criteria, coding, contraindications, and utilization management requirements for IVIG in cancer and related immune‑compromised conditions for members whose medication requests are processed by Evolent on behalf of the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIntravenous Immune Globulin (IVIG) coverage for cancer-related indications

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent with required clinical documentation (recent IgG for hypogammaglobulinemia or platelet count for ITP).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

11listed IVIG products mentioned

J1459–J1576HCPCS J-codes range

<600 mg/dLIgG threshold

<30 x10^9/LPlatelet threshold

5LOBs enumerated

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Coverage Criteria for IVIG

ITP Indication

Covered when ALL of the following are met for ITP

ITP indication: Member has a suspected or confirmed diagnosis of Idiopathic Thrombocytopenic Purpura (ITP).

Platelet threshold: Platelet count is less than 30 x 10^9/L.platelets < 30 x 10^9/L

Non-familial/Acquired Hypogammaglobulinemia

Covered when ALL of the following are met for acquired/non-familial hypogammaglobulinemia

Initial requests for acquired hypogammaglobulinemia: Member has Non-familial/Acquired/Secondary hypogammaglobulinemia (eg, associated with B-cell CLL, multiple myeloma, post hematopoietic stem cell transplant, or CAR-T cell therapy) AND a documented IgG level < 600 mg/dL within the last 4 weeks OR a documented history of frequent sinobronchial, skin, or other site bacterial infections, or is clinically felt to be immunocompromised.IgG < 600 mg/dL within 4 weeks OR recurrent bacterial infections

Continuation requests for acquired hypogammaglobulinemia: For continuation requests: member has documented clinical benefit from IVIG (eg, reduced incidence of infections) OR a history of increased recurrent infections within the last 6 months.clinical benefit OR recurrent infections in last 6 months

Intravenous Immune Globulin (IVIG) use for indications not expressly listed as accepted in this policy is considered investigational when the available evidence does not meet recognized standards. Specifically, off‑label uses that are not supported by CMS‑recognized compendia or by acceptable peer‑reviewed literature may be excluded from coverage. The policy applies an evidence standard that evaluates whether patient and disease characteristics, the administered therapy, and reported outcomes are adequately represented in the published evidence and whether study design and clinical meaningfulness (for example, ASCO‑recommended thresholds for survival benefit) are met.

For off‑label requests, case reports, single‑arm anecdotes, and meeting abstracts without a full peer‑reviewed article are considered insufficient to establish an accepted indication. Non‑randomized trials may sometimes provide supportive evidence when subject numbers and design are adequate, but uncontrolled case reports and abstracts alone will generally be deemed inadequate. Providers requesting IVIG for off‑label indications should ensure submitted literature meets the CMS compendia or peer‑reviewed standards described above; otherwise the request may be denied as not medically necessary.

Coding and Clinical Thresholds

Listed HCPCS J-codesHCPCS

J1459	Injection, immune globulin (privigen) , intravenous, non-lyophilized
J1460	Injection, gamma globulin, intramuscular
J1554	Injection, immune globulin (asceniv), 500 mg
J1556	Injection, immune globulin (bivigam), 500 mg
J1557	Injection, immune globulin (gammaplex) , intravenous, non-lyophilized
J1560	Injection, gamma globulin, intramuscular; over 10 cc
J1561	Injection, immune globulin (gamunex-cl/gammaked); non-lyophilized
J1568	Injection, immune globulin (octagam) , intravenous, non-lyophilized, 500 mg
J1569	500 mg
J1572	Injection, immune globulin (flebogamm/flebogamma dif) , intravenous, non-lyophilized

1–10 of 11

1/2

inv-06: IgG level for acquired hypogammaglobulinemia — threshold value

IgG threshold (initial requests)Documented IgG < 600 mg/dL within the last 4 weeks

Alternate initial criteriaOR documented history of frequent sinobronchial, skin, or other bacterial infections, or clinically felt to be immunocompromised

Continuation criteriaDocumented clinical benefit from IVIG (eg, reduced incidence of infections) OR increased recurrent infections in last 6 months

inv-07: Platelet count for ITP — threshold value

Platelet count threshold (ITP)Platelet count < 30 x 10^9/L

Indication contextUsed for suspected or confirmed diagnosis of Idiopathic Thrombocytopenic Purpura (ITP)

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for all Intravenous Immune Globulin (IG) medication requests. Evolent processes medication requests for network ordering providers; medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Applies to all IG products listed in policy (e.g., Asceniv, Bivigam, Flebogamma DIF, Gamastan, Gammagard, Gammaked, Gammaplex, Gamunex C, Octagam, Panzyga, Privigen).
Medication must be supported by FDA approval, ASCO clinical guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

Prior Authorization

Continuation Exemption Criteria

Continuation (renewal) requests for a medication that was previously authorized and is not deemed approvable under new review may be exempt from reauthorization if all exemption criteria are met.

Member has not experienced disease progression on the requested medication.
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.

Definitions

inv-15: Non-familial/Acquired Hypogammaglobulinemia — definition and associated conditions

DefinitionNon‑familial/Acquired Hypogammaglobulinemia: hypogammaglobulinemia associated with B‑cell chronic lymphocytic leukemia, multiple myeloma, post hematopoietic stem cell transplant, or CAR‑T cell therapy

Initial request criteriaDocumented IgG < 600 mg/dL within last 4 weeks OR documented history of frequent sinobronchial, skin, or other bacterial infections, or clinically felt to be immunocompromised

Continuation request criteriaDocumented clinical benefit from IVIG (eg, reduced incidence of infections) OR history of increased recurrent infections within the last 6 months

Background

Intravenous Immune Globulin (IVIG) is used to treat primary and secondary humoral immune deficiencies and immune‑mediated hematologic disorders in oncology populations. In cancer care this includes management of treatment‑associated or disease‑related hypogammaglobulinemia (for example associated with B‑cell chronic lymphocytic leukemia, multiple myeloma, post‑hematopoietic stem cell transplant, or CAR‑T therapy) and management of immune‑mediated cytopenias such as Idiopathic Thrombocytopenic Purpura (ITP). Risks associated with IVIG include thrombosis and renal dysfunction, and individual products differ by excipients (eg, sucrose) that can affect renal risk; these considerations should inform product selection and dosing.