CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Onivyde (irinotecan liposome) — Coverage Criteria

Defines coverage criteria, exclusions, coding, and utilization management for Onivyde (liposomal irinotecan) for members receiving cancer treatment, primarily for recurrent/metastatic pancreatic and ampullary adenocarcinoma after prior gemcitabine-based therapy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOnivyde (irinotecan liposome) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 27, 2024

Next Review DateDec 12, 2024

Key ActionSubmit prior authorization requests to Utilization Management demonstrating prior gemcitabine-based therapy and planned use with 5-FU plus leucovorin.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

70 mg/m2single dose maximum

J9205HCPCS code

5-FU + leucovorinrequired regimen

post-gemcitabinerequired prior therapy

Coverage Criteria for Onivyde (irinotecan liposome)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Covered Indication — Pancreatic/Ampullary Adenocarcinoma

Covered when ALL of the following are met

Onivyde for pancreatic/ampullary adenocarcinoma

Prior therapy: Progressed on prior therapy with a gemcitabine-based regimen (e.g., gemcitabine +/- nab-paclitaxel)
Concurrent regimen: Will be used in combination with 5-FU (fluorouracil) and leucovorin

Requests will be excluded (denied) when any of the policy exclusion criteria are met. Key exclusion triggers include: disease progression while taking Onivyde (irinotecan liposome); dosing that exceeds the single dose limit of 70 mg/m2; substitution of Onivyde for non-liposomal irinotecan (irinotecan HCL); known hypersensitivity or contraindication to Onivyde or irinotecan HCL; and investigational or off-label use that lacks sufficient supporting evidence as defined by the policy.

This policy does not support use of Onivyde in combination with oxaliplatin, 5-FU (fluorouracil), and leucovorin for first-line treatment of metastatic pancreatic adenocarcinoma due to the lack of Level 1 evidence demonstrating superior outcomes compared with alternative, Evolent-recommended regimens.

Initial Therapy Criteria

Initial Therapy — initial coverage criteria

Initial coverage criteria

Initial coverage: Adult with recurrent/metastatic pancreatic or ampullary adenocarcinoma; progressed on a gemcitabine-based regimen; to be used in combination with 5-FU and leucovorin.

Continuation Therapy Criteria

Continuation Therapy — continuation requests exempt from policy if all conditions met

Continuation requests exempt from policy if all conditions met

Continuation request criteria: Requested medication was used within the last year; member has not experienced disease progression and/or no intolerance to the requested medication; no additional medications are being added to the continuation request.

Coding and Dosing Limits

HCPCS CodesHCPCS

J9205

Injection, irinotecan liposome, 1 mg

inv-05: Single dose limit — 70 mg/m2

Single dose limit70 mg/m2

Exclusion if dosing exceedsRequests will be denied when dosing exceeds single dose limit of 70 mg/m2

Related denial triggersDose limit breach is listed alongside progression on therapy, hypersensitivity, substitution for non-liposomal irinotecan, and investigational uses

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Requests are processed by Utilization Management and must be authorized by Evolent (on behalf of Neighborhood Health Plan of Rhode Island) before claims will be considered for reimbursement.

Prior authorization is required for initial and continuation requests.
Evolent/Utilization Management will review requests against this policy and supporting documentation.

Documentation Required

Continuation Request Documentation

Continuation (renewal) requests will be approved only when all continuation criteria are met: the medication was used within the last year, there has been no disease progression while on the medication, the member has not experienced intolerance to the medication, and no additional medications are being added to the continuation request.

Medication used within the last year.
No disease progression and no intolerance to the requested medication.
No additional medication(s) added to the continuation request.

Step Therapy

Prior Therapy Requirement

Prior therapy requirement: Onivyde will be considered for adults with recurrent/metastatic adenocarcinoma of the pancreas or ampullary adenocarcinoma only after progression on a gemcitabine-based regimen.

Requires prior exposure and documented progression on a gemcitabine-based regimen (e.g., gemcitabine ± nab-paclitaxel).
Onivyde must be used in combination with 5‑FU and leucovorin as specified.

Documentation Required

Supporting Documentation Required

Supporting documentation must reference one or more accepted sources: FDA product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS Medicare standards. Requests lacking adequate supporting evidence or seeking investigational/off‑label uses not accepted by these sources may be denied.

Cite FDA approved product labeling when applicable.
If using compendia/guidelines, identify the specific recommendation and citation.
For peer‑reviewed literature, include articles that meet CMS Medicare Benefit Policy Manual Chapter 15 standards and address relevance of patient and regimen.
Requests for investigational or off‑label indications must include strong, CMS‑recognized evidence; case reports alone are insufficient.

Denial Risk

Triggers for Denial / Exclusions

Denial triggers and exclusions to approval include: documented disease progression while taking Onivyde, dosing that exceeds the single‑dose limit of 70 mg/m2, substitution of Onivyde for non‑liposomal irinotecan, hypersensitivity/contraindications, and investigational/off‑label uses lacking adequate evidence.

Progression while on Onivyde — not approvable.
Dosing exceeding 70 mg/m2 single dose — will be denied.
Onivyde cannot be substituted for irinotecan HCl (non‑liposomal).
Member hypersensitivity or contraindication to Onivyde/irinotecan HCl — denial.
Investigational or off‑label uses without sufficient CMS‑recognized compendia or acceptable peer‑reviewed evidence — denial.

Definitions

inv-12: Prior therapy — Gemcitabine-based regimen

Required prior therapyProgressed on prior therapy with a gemcitabine-based regimen (e.g., gemcitabine +/- nab-paclitaxel)

Indication contextOnivyde authorized for adults with recurrent/metastatic pancreatic or ampullary adenocarcinoma after gemcitabine-based therapy

Concurrent regimen requirementMust be used in combination with 5-FU (fluorouracil) and leucovorin

Background

Onivyde (irinotecan liposome) is a liposomal formulation of irinotecan indicated for adults with recurrent or metastatic adenocarcinoma of the pancreas or ampullary adenocarcinoma after progression on a prior gemcitabine-based regimen. When authorized for this indication, Onivyde is intended to be used in combination with 5-FU (fluorouracil) and leucovorin.

Step Therapy Requirements

Step	Requirement
1	Member must have received prior gemcitabine-based therapy (e.g., gemcitabine ± nab‑paclitaxel) before Onivyde (irinotecan liposome) is authorized for recurrent/metastatic pancreatic or ampullary adenocarcinoma.

Site of Care

Note

No site‑of‑care restrictions specified

No site‑of‑care or infusion‑center restrictions are specified in this policy document.

Administer in the setting appropriate for the member; policy does not mandate a specific site of care.