CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1515

Um Onc_1515 Radiopharmaceuticals_12272024

Defines accepted indications, inclusion and exclusion criteria, dosing limits, authorization and coding for specified radiopharmaceuticals (Azedra, Lutathera, Pluvicto, Xofigo, Zevalin) for oncology uses, including FDA-approved and certain off-label uses supported by compendia/guidelines; governs utilization management and prior authorization by Evolent for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUm Onc_1515 Radiopharmaceuticals_12272024

Policy CodePolicy UM ONC_1515

Change TypeNo material changes

Effective DateDec 27, 2024

Next Review Date

Key ActionEvolent is responsible for processing medication requests from network ordering providers; requests must be supported by FDA labeling, CMS compendia, NCCN/ASCO guidance, or peer-reviewed literature per CMS requirements.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

5Radiopharmaceuticals addressed

3Prostate cancer agent rules

6Dosing/threshold entries

Coverage Summary

This policy defines accepted indications, inclusion/exclusion criteria, dosing limits, authorization and coding for specified radiopharmaceuticals — Azedra, Lutathera, Pluvicto, Xofigo, and Zevalin — used in oncology, and applies to prior authorization and utilization management for Neighborhood Health Plan of Rhode Island.

Use of these agents must be supported by authoritative evidence per policy: FDA product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements. Evolent’s utilization management processes govern prior authorization and reimbursement determinations for requests involving these radiopharmaceuticals.

Dosing & Laboratory Thresholds

Azedra single dose (weight ≤62.5 kg)296 MBq/kg (8 mCi/kg) per dose; total of 2 doses

Azedra single dose (weight >62.5 kg)18,500 MBq (500 mCi) total (for 2 doses)

Lutathera cumulative activity limit7.4 GBq (200 mCi)

Pluvicto cumulative activity & duration7.4 GBq (200 mCi); treatment duration must not exceed 36 weeks (up to 6 doses)

Xofigo dose and duration55 kBq/kg (1.49 microcurie/kg); maximum duration 6 cycles

Zevalin dose32 mCi per treatment

Azedra hematologic lab thresholdsPlatelet count ≥ 80,000/mcL and absolute neutrophil count ≥ 1,200/mcL required

Initial Therapy Criteria (Agent-specific)

Gastrointestinal and Pancreatic Neuroendocrine Tumors (GEP-NET) - Lutathera

Covered when ALL of the following are met:

ALL of the following

Member is ≥ 12 years of age (pediatric and adult members eligible).
Diagnosis of metastatic, locally advanced, or unresectable gastrointestinal OR pancreatic neuroendocrine tumor (GEP‑NET).
Somatostatin receptor positive disease documented by peptide receptor imaging (e.g., Ga‑68 DOTA‑PET/CT or equivalent).
Somatostatin receptor positivity must be documented on imaging of the lesions intended for treatment.
Prior treatment: member has received somatostatin analog therapy (e.g., octreotide LAR and/or lanreotide) with documented disease progression on one or both agents, OR there is clinical justification for use without prior somatostatin analogs (must be documented).
Planned dosing does not exceed the maximum cumulative single‑course dose: 7.4 GBq (200 mCi) per dose, and total treatment does not exceed 4 doses (maximum duration per FDA labeling).
Ensure administered activity and number of doses adhere to prescribing information.

Pheochromocytoma/Paraganglioma - Azedra

Covered when ALL of the following are met:

ALL of the following

Member is ≥ 12 years of age (pediatric and adult members eligible).
Diagnosis of unresectable, locally advanced, or metastatic pheochromocytoma or paraganglioma.
Positive MIBG (meta‑iodobenzylguanidine) scan demonstrating uptake in tumor lesions planned for treatment (iobenguane scan).
A positive MIBG scan is defined as sufficient tumor uptake relative to background to permit targeted iobenguane therapy; document imaging report and representative images as available.
Laboratory parameters: platelet count ≥ 80,000/mcL AND absolute neutrophil count (ANC) ≥ 1,200/mcL prior to treatment initiation.

Continuation Therapy Criteria

Continuation Requests Exemption

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

No progression: The member has not experienced disease progression on the requested medication
Recent use with limited lapse: The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
No additional meds: Additional medication(s) are not being added to the continuation request

Provider Actions & Operational Requirements

Prior Authorization

Utilization Management authorization required

Evolent is responsible for processing all medication requests from network ordering providers. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Evolent processes medication requests and unauthorized medications may be not reimbursable.

Documentation Required

Support for off-label use required

Use must be supported by FDA approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Denial Risk

Denial for disease progression

Requests are excluded if there is disease progression while taking the requested radiopharmaceutical.

Documentation Required

Azedra MIBG scan requirement

For Azedra, a positive MIBG scan must be documented.

Definition: Positive MIBG scan — Meta-iodobenzylguanidine scan demonstrating uptake in tumor lesions; required for Azedra eligibility.

Billing Rule

Dose limits must be observed

Claims exceeding specified single-dose, cumulative activity, or duration limits may be excluded.

Affected HCPCS codes: A9590, A9513, A9607, A9606, A9543
Observe the dosing thresholds documented in the Coverage/Exclusion section (single-dose, cumulative activity, and duration limits per agent).

Clinical Evidence & Guidance

Key cited trials and guidance include the NETTER‑1 trial (177Lu‑Dotatate for midgut NETs), the VISION trial (lutetium‑177‑PSMA‑617 in mCRPC), data on high‑specific‑activity I‑131 MIBG for pheochromocytoma/paraganglioma, and referenced NCCN and ASCO guidance alongside each agent’s prescribing information.

Key Definitions

Positive MIBG scanMeta-iodobenzylguanidine scan demonstrating uptake in tumor lesions; required for Azedra eligibility

PSMA-positiveConfirmed PSMA expression on metastatic lesions by PSMA PET/CT scan; required for Pluvicto eligibility

Background

This policy is maintained by the Utilization Management program and approved by the Evolent Specialty Services Clinical Guideline Review Committee; final authorization decisions are made through the Utilization Management Department and Committee.

It governs accepted indications for radiopharmaceuticals including FDA‑approved and selected off‑label uses when supported by the required authoritative sources, and assigns utilization management responsibilities — including prior authorization processing, documentation requirements, dosing and coding limits, and approval authority — to Evolent as described in the policy.