CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Doxil (liposomal doxorubicin)

Defines accepted indications, continuation and exclusion criteria, dosing limits, evidence standards, and utilization management/approval authority for coverage of Doxil (liposomal doxorubicin) for the payer's lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDoxil (liposomal doxorubicin)

Policy CodePolicy N/A

Change TypeClarified committee review dates

Effective DateMay 31, 2024

Next Review Date

Key ActionAll medication requests must be processed/authorized by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

POLICY UPDATE CHANGES

Committee review dates updated through 05/08/24 and effective date indicated as May 31, 2024.

5Supported Indications

1Not supported (breast)

4Dose limits specified

Coverage Summary

This policy defines the accepted indications and utilization approach for Doxil (liposomal doxorubicin). Doxil is supported for listed FDA‑approved and select off‑label uses when those uses are supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature. Utilization management and authorization decisions for medication requests are performed by Evolent.

Quick points and thresholds

Single-dose limitsOvarian cancer 50 mg/m2; Kaposi's sarcoma 20 mg/m2; Multiple myeloma 30 mg/m2; Hodgkin lymphoma 15 mg/m2

Supported indications5 (HIV-related Kaposi's sarcoma; relapsed/refractory multiple myeloma with bortezomib; platinum-sensitive recurrent ovarian cancer with carboplatin; platinum-resistant ovarian cancer as single agent or with bevacizumab; relapsed/refractory Hodgkin lymphoma in combination regimen)

Not supported indication1 (recurrent, unresectable, or metastatic breast cancer not supported)

Single-dose limits specified (count)4

Authorization authorityAll medication requests processed/authorized by Evolent

Initial / Supported Indications

Approved / supported indications

Doxil (liposomal doxorubicin) is supported for use in the following clinical situations when supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature:

Supported Indications (any of the following)

HIV-related Kaposi's sarcoma: Doxil (liposomal doxorubicin) used as a single agent or in combination with antiretroviral therapy, as initial or subsequent line systemic therapy
Multiple myeloma: Relapsed or refractory multiple myeloma when used in combination with bortezomib (if bortezomib has not previously been received) with or without dexamethasone following one prior therapy
Ovarian cancer — platinum-sensitive: Used in combination with carboplatin for platinum-sensitive relapsed/recurrent ovarian cancer
Ovarian cancer — platinum-resistant: Used as a single agent or in combination with bevacizumab/bevacizumab biosimilar for platinum-resistant relapsed/recurrent ovarian cancer
Hodgkin lymphoma: May be used in combination with gemcitabine and vinorelbine as second-line and subsequent therapy in relapsed or refractory Hodgkin lymphoma

Continuation Therapy / Exemptions

Continuation requests exemption

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following:

Recent use: The requested medication was used within the last AND year
No progression or intolerance: The member has not experienced disease progression and/or no intolerance to the requested medication
No additional medications: Additional medication(s) are not being added to the continuation request

Exclusions / Investigational Criteria

Exclusion criteria / investigational criteria

Doxil is excluded/not approvable when ANY of the following apply:

Exclusion / investigational criteria

Disease progression while taking Doxil (liposomal doxorubicin)
Dosing exceeds single dose limit for the indication
- Ovarian cancer single dose limit: 50 mg/m2
- Kaposi's sarcoma single dose limit: 20 mg/m2
- Multiple myeloma single dose limit: 30 mg/m2
- Hodgkin lymphoma single dose limit: 15 mg/m2
Investigational use: Off-label indication not supported by CMS-recognized compendia or acceptable peer-reviewed literature
Insufficient evidence factors (any of the following weaken support)
- Patient representation: Clinical characteristics of the patient and cancer not adequately represented in published evidence
- Regimen representation: Administered regimen not adequately represented in published evidence
- Outcomes not clinically meaningful: Reported study outcomes do not represent clinically meaningful outcomes (ASCO definitions: e.g., Hazard Ratio >= 0.80 or OS/PFS benefit < 3 months)
- Inappropriate experimental design: Experimental design inappropriate to address the question
- Case reports/abstracts inadequate:

Not supported indication

Evolent does not support the following use:

Not supported indication: Recurrent, unresectable, or metastatic breast cancer: Doxil (liposomal doxorubicin) is not supported due to lack of Level 1 evidence showing superiority to conventional doxorubicin

Provider Actions

Prior Authorization

Medication requests processed by Evolent

All medication requests must be processed/authorized by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Evolent is the authorization authority for medication requests

Documentation Required

Evidence requirement for off-label uses

Off-label uses must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.

FDA approved product labeling
CMS-recognized compendia
NCCN or ASCO clinical guidelines
Acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15

Denial Risk

Denial for investigational or unsupported off-label use

Requests for investigational or off-label indications that lack sufficient evidence based on the listed factors (e.g., inadequate representation of patient/ regimen in published evidence, outcomes not clinically meaningful per ASCO definitions, inappropriate experimental design, reliance on case reports or abstracts without full peer-reviewed articles) are subject to denial.

Insufficient evidence factors include: inadequate representation of clinical characteristics or regimen in published evidence
Reported outcomes not clinically meaningful (ASCO: HR ≥ 0.80 or OS/PFS benefit < 3 months)
Experimental design inappropriate to address the question
Case reports and meeting abstracts without full peer‑reviewed articles are inadequate

Clinical Evidence & References

Key references: Doxil prescribing information (Baxter Healthcare Corporation, 2019); National Comprehensive Cancer Network (NCCN) Cancer Guidelines and Drugs & Biologics Compendium (2023); Pfisterer J, et al., AGO‑OVAR 2.21/ENGOT‑ov 18 (Lancet Oncol. 2020); Bartlett NL et al., CALGB 59804 (Ann Oncol. 2007); Clinical Pharmacology Elsevier Gold Standard (2023); Micromedex Drugdex (2023); AHFS Drug Information (2023); American Society of Clinical Oncology publications and Medicare Benefit Policy Manual Chapter 15.

Background

Background: The policy specifies accepted indications for Doxil including FDA‑approved uses and some off‑label uses supported by CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature. Supported clinical situations include HIV‑related Kaposi's sarcoma; relapsed/refractory multiple myeloma in combination with bortezomib (+/‑ dexamethasone) after one prior therapy; platinum‑sensitive relapsed ovarian cancer in combination with carboplatin; platinum‑resistant relapsed ovarian cancer as single agent or with bevacizumab/bevacizumab biosimilar; and relapsed/refractory Hodgkin lymphoma in combination with gemcitabine and vinorelbine. Utilization management, review, and final approval are conducted by Evolent's Utilization Management Department and Utilization Management Committee; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Not approvable / investigational: Use not supported by CMS compendia or acceptable peer‑reviewed literature; lacks adequate evidence or general acceptance.

Revision History

2012-12-12committee_review

Committee approval date listed: 12/12/12 (part of recurring committee review history).

2013-12-11committee_review

Committee approval date listed: 12/11/13 (part of recurring committee review history).

2015-03-27committee_review

Committee approval date listed: 03/27/15 (part of recurring committee review history).

2016-05-24committee_review

Committee approval date listed: 05/24/16 (part of recurring committee review history).

2020-04-08committee_review

Committee approval date listed: 04/08/20 (part of recurring committee review history).

2021-02-10committee_review

Committee approval date listed: 02/10/21 (part of recurring committee review history).

2021-11-15committee_review

Committee approval date listed: 11/15/21 (part of recurring committee review history).

2022-01-12committee_review

Committee approval date listed: 01/12/22 (part of recurring committee review history).

2022-04-13committee_review

Committee approval date listed: 04/13/22 (part of recurring committee review history).

2022-05-11committee_review

Committee approval date listed: 05/11/22 (part of recurring committee review history).

2022-06-08committee_review

Committee approval date listed: 06/08/22 (part of recurring committee review history).

2022-11-09committee_review

Committee approval date listed: 11/09/22 (part of recurring committee review history).

2023-03-08committee_review

Committee approval date listed: 03/08/23 (part of recurring committee review history).

2023-05-10committee_review

Committee approval date listed: 05/10/23 (part of recurring committee review history).

2024-03-13committee_review

Committee approval date listed: 03/13/24 (part of recurring committee review history).

2024-05-08committee_reviewLatest

Committee approval date listed: 05/08/24 (most recent committee review date).

2024-05-31effective_date

Policy effective date indicated as May 31, 2024 (clarified; no clinical policy statement changes; non-material).