CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Doxil (liposomal doxorubicin) — Coverage Criteria

Defines accepted indications, continuation and exclusion criteria, and authorization expectations for Doxil (liposomal doxorubicin) for members of Neighborhood Health Plan of Rhode Island (managed by Evolent UM).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDoxil (liposomal doxorubicin) — Coverage Criteria

Policy CodePolicy N/A

Change TypeMinor review — no material changes

Effective DateMay 31, 2024

Next Review DateN/A

Key ActionSubmit medication requests to Evolent Utilization Management with supporting evidence per FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

May 08, 2024Approval date

2024-05-31Effective date

16Committee review dates

4Covered indications

4Single-dose limits specified

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Coverage Criteria — Indications and Limits

Indication-specific Coverage Criteria

Covered when criteria for each indication are met as specified below:

Kaposi's Sarcoma (AIDS-related): Doxil will be used for the treatment of HIV-related Kaposi's sarcoma as a single agent or in combination with antiretroviral therapy, as initial or subsequent line systemic therapy.

Multiple Myeloma: The member has relapsed or refractory multiple myeloma and Doxil will be used in combination with bortezomib (if not previously received) with or without dexamethasone following one prior therapy.

Ovarian Cancer: Doxil used in combination with carboplatin for platinum-sensitive relapsed/recurrent ovarian cancer OR as a single agent or in combination with bevacizumab (or bevacizumab biosimilar) for platinum-resistant relapsed/recurrent ovarian cancer.

Hodgkin Lymphoma: Doxil may be used in combination with gemcitabine and vinorelbine as second-line and subsequent therapy in members with relapsed or refractory Hodgkin lymphoma.

Continuation Requests Exemption: Continuation requests exempt from policy if medication was used within the last year AND the member has not experienced disease progression or intolerance AND additional medication(s) are not being added to the continuation request.

Breast Cancer - Not supported: Doxil is not supported for the treatment of recurrent, unresectable, or metastatic breast cancer due to lack of Level 1 evidence showing superiority over conventional doxorubicin; refer to alternative regimens recommended by Evolent.

Coverage exclusions include disease progression while receiving Doxil (liposomal doxorubicin), instances where dosing exceeds the specified single-dose mg/m2 limits for the indicated diagnosis, and investigational or off-label uses that lack sufficient evidence or are not generally accepted by the medical community. The single-dose limits are 50 mg/m2 for ovarian cancer, 20 mg/m2 for Kaposi's sarcoma, 30 mg/m2 for multiple myeloma, and 15 mg/m2 for Hodgkin lymphoma. Investigational/off-label requests will be considered unsupported if they are not backed by CMS-recognized compendia or acceptable peer-reviewed literature meeting the policy's evidence standards (for example: adequate representation of patient characteristics and regimens, clinically meaningful outcomes, and appropriate study design).

Doxil is not supported by this policy for the treatment of recurrent, unresectable, or metastatic breast cancer. This position reflects the absence of Level 1 evidence (randomized trials or meta-analyses) demonstrating superior outcomes with liposomal doxorubicin compared with conventional doxorubicin (e.g., Adriamycin). Providers should refer to Evolent-recommended alternative agents and regimens when treating these breast cancer presentations.

Coding and Quantity Limits

Single dose limits (mg/m2) by indication

Ovarian cancerSingle-dose limit 50 mg/m2

Multiple myelomaSingle-dose limit 30 mg/m2

Hodgkin lymphomaSingle-dose limit 15 mg/m2

Doxil (liposomal doxorubicin) — single‑dose mg/m2 limits

Doxil — Ovarian cancerSingle‑dose limit 50 mg/m2

Doxil — Multiple myelomaSingle‑dose limit 30 mg/m2

Doxil — Hodgkin lymphomaSingle‑dose limit 15 mg/m2

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required. All medication requests for Doxil (liposomal doxorubicin) must be processed through Evolent's Utilization Management (UM) workflow; final approval authority rests with the Neighborhood Health Plan of Rhode Island Utilization Management Committee. Medications not authorized by Evolent may be deemed not approvable and non-reimbursable.

Processed by Evolent UM — contact Evolent per standard UM procedures for prior auth submission and clinical review.
Final approval authority: Utilization Management Committee (Neighborhood Health Plan of Rhode Island).

Documentation Required

Continuation Exemption Criteria

Continuation (exemption) — continuation requests for a medication that would otherwise be not approvable may be exempt from the Evolent prior authorization policy only when ALL of the following are met: the medication was used within the last year; the member has not experienced disease progression and/or intolerance to the medication; and no additional medications are being added to the continuation request.

Continuation Therapy Criteria

Continuation Therapy

Continuation exemption for previously used, not-approvable medication requests

Continuation exemption: Requested medication was used within the last year AND the member has not experienced disease progression and/or intolerance AND additional medication(s) are not being added to the continuation request.

Continuation request — definition and operational elements

DefinitionA continuation request is a request to continue a medication previously used within the last year without disease progression or intolerance and without adding new medications.

Operational criterion 1Requested medication was used within the last year

Operational criterion 2Member has not experienced disease progression or intolerance while on the medication

Background

Doxil (pegylated liposomal doxorubicin) is a liposomal formulation of the anthracycline doxorubicin designed to alter drug distribution and pharmacokinetics. It is used in multiple oncology settings addressed by this policy, including HIV‑related Kaposi's sarcoma, certain relapsed ovarian cancers (platinum‑sensitive and platinum‑resistant scenarios), relapsed or refractory multiple myeloma in combination with bortezomib (± dexamethasone), and as part of salvage regimens for relapsed or refractory Hodgkin lymphoma. Appropriate use must align with FDA labeling or recognized oncologic compendia and guidelines.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDoxil (liposomal doxorubicin) — Coverage Criteria

Policy CodePolicy N/A

Change TypeMinor review — no material changes

Effective DateMay 31, 2024

Next Review DateN/A

Key ActionSubmit medication requests to Evolent Utilization Management with supporting evidence per FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

On This Page

Used within the last year
No disease progression and/or intolerance
No additional medications added to the continuation request

Documentation Required

Supportive Evidence Required

Supportive evidence standards required for approval: requests must be supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards. If relying on peer-reviewed literature, evidence should adequately represent the patient and regimen, report clinically meaningful outcomes (e.g., ASCO-recommended thresholds such as HR < 0.80 and ≥3 months survival benefit for OS/PFS where applicable), and be of sufficient study design; case reports and meeting abstracts without full articles are generally insufficient.

Acceptable sources: FDA labeling; CMS-approved compendia; NCCN/ASCO guidelines; peer-reviewed literature meeting CMS standards.
Peer-reviewed evidence must represent the patient population and regimen, show clinically meaningful outcomes, and be of appropriate study design; single case reports and abstracts without full publications are generally inadequate.

Denial Risk

Denial Triggers / Exclusion Criteria

Denial triggers — requests will be denied if they meet any exclusion criteria such as documented disease progression on Doxil, dosing that exceeds specified single-dose limits, or investigational/off‑label uses lacking sufficient evidence or general acceptance in the medical community per CMS compendia or acceptable peer‑reviewed literature.

Disease progression while on Doxil.
Dosing exceeds single-dose limits: 50 mg/m2 (ovarian cancer); 20 mg/m2 (Kaposi sarcoma); 30 mg/m2 (multiple myeloma); 15 mg/m2 (Hodgkin lymphoma).
Investigational or off-label indications without sufficient supporting evidence (see supportive evidence standards).

Operational criterion 3No additional medications are being added to the regimen