CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1515

Drug Policy: Radiopharmaceuticals

Defines indications, inclusion/exclusion criteria, dosing limits, coding, and utilization management approval authority for specified radiopharmaceutical oncology agents for members of the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Radiopharmaceuticals

Policy CodePolicy UM ONC_1515

Change TypeNo material change

Effective DateDecember 27, 2024

Next Review Date

Key ActionPrior authorization is required for radiopharmaceutical medications and final approval is by the Utilization Management Committee.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5radiopharmaceutical agents covered

36 weeksmax duration Pluvicto/Lutathera

2prior therapies for Pluvicto

Plt<80k/ANC<1kAzedra hematologic thresholds

5HCPCS codes listed

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Coverage Criteria for Radiopharmaceuticals

Lutathera (lutetium Lu 177 dotatate) - Initial Therapy

Covered when ALL of the following are met:

Lutathera initial coverage: Member age ≥ 12 years; metastatic, locally advanced, or unresectable gastrointestinal or pancreatic neuroendocrine tumors (GEP‑NET); confirmed somatostatin receptor positivity on metastatic lesions documented by peptide receptor scintigraphy (e.g., Ga‑DOTA scan or similar); prior treatment with Octreotide LAR or Lanreotide with documented disease progression on one of these agents.

Azedra (iobenguane I-131) - Initial Therapy

Covered when ALL of the following are met:

Azedra initial coverage: Member age ≥ 12 years; unresectable, locally advanced, or metastatic pheochromocytoma or paraganglioma; positive MIBG (meta‑iodobenzylguanidine) scan; Azedra is being used as primary treatment.

Hematologic exclusion thresholds apply (see policy for platelet and ANC criteria).

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) and Xofigo (radium Ra 223) - Initial Therapy

Covered when ALL of the following are met:

Pluvicto initial coverage: PSMA PET/CT confirmation of PSMA‑positive metastatic castration‑resistant prostate cancer; disease progression on or after at least two prior lines of therapy including an androgen receptor pathway inhibitor (e.g., enzalutamide, abiraterone) and a taxane‑based chemotherapy (e.g., docetaxel); intended as monotherapy.

Xofigo initial coverage: Metastatic castration‑resistant prostate cancer with symptomatic bone metastases (e.g., bone pain) and no visceral metastases; must not be combined with abiraterone (Zytiga) due to reported detrimental outcomes.

Zevalin (ibritumomab tiuxetan) - Indications and limitations

Covered when ALL of the following are met:

Zevalin coverage: Used for specified non‑Hodgkin's lymphoma indications supported by available evidence; Zevalin is not supported for Nodal Marginal Zone Lymphoma, Splenic Marginal Zone Lymphoma, Gastric or non‑gastric MALT lymphoma due to lack of Level 1 evidence.

Prior radioimmunotherapy or myeloablative therapy with autologous bone marrow transplant is a contraindication per policy.

Use of radiopharmaceutical agents for indications that are not supported by FDA labeling, CMS‑recognized compendia, or acceptable peer‑reviewed literature is considered investigational/off‑label. The policy defines sufficient evidence by whether the published literature adequately represents the patient and disease characteristics, the treatment regimen, and clinically meaningful outcomes (for example, ASCO‑type thresholds such as a hazard ratio < 0.80 or survival benefit of ≥3 months for OS/PFS). Nonrandomized trials with substantial subject numbers may provide supportive evidence, whereas isolated case reports or meeting abstracts without full peer‑reviewed publication generally do not meet the threshold for accepted use.

An off‑label or investigational request will be considered not medically necessary when the available evidence fails to meet the policy’s criteria for sufficiency or general acceptance. Examples that commonly trigger investigational status include: lack of representation of the clinical population or treatment regimen in the published studies, absence of clinically meaningful outcome measures, reliance on anecdotal case reports or abstracts without full peer‑reviewed publication, or when the request conflicts with explicit exclusion criteria (for example, prior progression on the same radiopharmaceutical, hematologic exclusion thresholds for Azedra, contraindicated concurrent therapies such as Xofigo with abiraterone, or exceeding specified dosing or duration limits).

Initial Therapy Requirements

Initial therapy requirements summary

Covered when ALL of the following are met:

Age and disease-specific confirmation: Member meets age criteria and has the specified diagnosis for the requested agent (e.g., age ≥12 for Lutathera and Azedra; PSMA‑positive mCRPC for Pluvicto; symptomatic bone‑only mCRPC for Xofigo).

Target expression or diagnostic confirmation: Where required, tumor target expression is documented: somatostatin receptor positivity for Lutathera (Ga‑DOTA or similar), positive MIBG scan for Azedra, PSMA PET/CT for Pluvicto.

Providers must supply imaging documentation.

Prior therapy requirements: Required prior therapies and documented progression when specified: prior Octreotide LAR or Lanreotide with progression for Lutathera; progression after ≥2 prior lines including an AR pathway inhibitor and a taxane for Pluvicto.

Safety and contraindications: Requests must not violate agent‑specific contraindications (e.g., do not combine Xofigo with abiraterone; adhere to hematologic thresholds for Azedra; avoid prior radioimmunotherapy/myeloablative therapy for Zevalin).

Dosing and duration limits: Prescribed dosing and total treatment duration must be within policy limits (e.g., Lutathera/Pluvicto single dose 7.4 GBq (200 mCi), maximum duration up to 36 weeks/6 doses; Xofigo 55 kBq/kg, maximum 6 cycles; Azedra total of 2 doses with weight‑based dosing).

Continuation and Renewal Criteria

Continuation Requests

Continuation requests are eligible when ALL of the following are met:

Continuation eligibility: Member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of active authorization; no additional medications are being added to the continuation request.

Continuation requests for a medication that would otherwise be not‑approvable are exempt if these conditions are met.

Quantity and Duration Limits

Azedra — Total dosing limits

Total dosesTotal of 2 doses

Weight > 62.5 kg18,500 MBq (500 mCi) total over 2 doses

Weight ≤ 62.5 kg296 MBq/kg (8 mCi/kg) total over 2 doses

Lutathera — Dose and duration

Single dose7.4 GBq (200 mCi)

Maximum treatment duration36 weeks (up to 6 doses)

Pluvicto — Dose and duration

Single dose7.4 GBq (200 mCi)

Maximum treatment duration36 weeks (up to 6 doses)

Xofigo — Dose and cycle limits

Dosing per kg55 kBq/kg (1.49 microcurie/kg)

Maximum cyclesMaximum 6 cycles

Zevalin — Course dosing

Dose per course32 mCi per course

Course limitSingle course only

Coding and Dosing Details

HCPCS codesHCPCS

A9590	Iodine i-131, iobenguane, millicurie
A9513	Lutetium lu 177, dotatate, therapeutic, millicurie
A9607	Lutetium lu 177 vipivotide tetraxetan, therapeutic, millicurie
A9606	Radium ra-223 dichloride, therapeutic, per microcurie
A9543	Yttrium ibritumomab tiuxetan, therapeutic, per treatment dose, up to 40 millicuries y-90

Azedra dosing by weight

Dosing schemaWeight-based total activity split over 2 doses

If weight > 62.5 kg18,500 MBq (500 mCi) total over 2 doses

If weight ≤ 62.5 kg296 MBq/kg (8 mCi/kg) total over 2 doses

Lutathera single dose

Single dose7.4 GBq (200 mCi)

Indication noteUsed for GEP‑NET with confirmed somatostatin receptor positivity

Pluvicto single dose

Single dose7.4 GBq (200 mCi)

Indication noteUsed as monotherapy for PSMA‑positive mCRPC after ≥2 prior lines including AR pathway inhibitor and taxane

Pluvicto / Lutathera maximum duration

Maximum duration36 weeks (up to 6 doses)

Applies toPluvicto and Lutathera

Xofigo dosing and limits

Dosing per kg55 kBq/kg (1.49 microcurie/kg)

Maximum cyclesMaximum 6 cycles

Contraindication noteDo not combine with abiraterone (Zytiga); avoid concurrent radioisotopes or cytotoxic chemotherapy

Zevalin dose and restrictions

Dose per course32 mCi per course

Treatment limitSingle course only; prior radioimmunotherapy or myeloablative therapy is an exclusion

Provider Requirements and Authorization Workflow

Prior Authorization

Prior Authorization Required

Prior authorization is required for all radiopharmaceutical requests. Final approval is granted by the Utilization Management Committee after review by the UM department.

All requests must be submitted to Evolent for prior authorization.
Final authorization decisions are made by the Utilization Management Committee per policy VI: Approval Authority.

Step Therapy

Preceding Therapy Requirements for Pluvicto

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) requires documented progression on or after two prior lines of therapy, specifically including an Androgen Receptor Pathway Inhibitor and a taxane-based chemotherapy.

Progression must be documented after at least 2 prior systemic therapy lines.
Required prior agents include an AR pathway inhibitor (e.g., enzalutamide, abiraterone) and a taxane (e.g., docetaxel).

Documentation Required

Required Supporting Documentation

Submit supporting documentation that confirms tumor-specific receptor status and other clinical information to support medical necessity.

For Lutathera: documentation of somatostatin receptor positivity (e.g., Ga-DOTATATE PET/CT or equivalent peptide receptor imaging).
For Pluvicto: documentation of PSMA-positive disease on a PSMA PET/CT scan.
For Azedra: positive MIBG scan confirming uptake in tumor lesions.
Clinical history including prior therapies and dates, radiology reports showing progression, and relevant lab values (e.g., platelet count, ANC).
Weight and dosing calculations when applicable to verify dosing limits.

Denial Risk

Triggers for Denial

Requests may be denied when exclusion criteria or dosing/duration limits are met, when required documentation is missing, or when hematologic thresholds are not satisfied.

Denial if disease progression occurred while receiving the requested radiopharmaceutical.
Denial for Azedra if platelet count < 80,000/mcL or absolute neutrophil count below policy threshold.
Denial if dosing exceeds single-dose or cumulative limits (see policy dosing limits per agent, e.g., Lutathera 7.4 GBq/200 mCi; Pluvicto 7.4 GBq/200 mCi; Azedra weight-based limits).
Denial if treatment duration exceeds maximum allowed (e.g., Pluvicto maximum 36 weeks / up to 6 doses; Xofigo maximum 6 cycles; Zevalin single course).
Denial for Xofigo if visceral metastatic disease is present or if combined with abiraterone (Zytiga) or concurrent cytotoxic chemotherapy.
Denial if prior radioimmunotherapy or myeloablative therapy with autologous bone marrow transplant for Zevalin.
Denial if required receptor imaging (PSMA, somatostatin receptor imaging, or MIBG) is not provided or is negative.

Administration Setting and Facility Requirements

Note

Site of care per FDA labeling; UM processes network provider requests

Administration site and facility must follow FDA labeling and facility protocols; the UM department processes medication requests from network ordering providers.

Typical sites of care include infusion centers, hospital outpatient departments, or specialized nuclear medicine facilities per FDA labeling and institutional protocols.
UM processes requests submitted by network ordering providers; consult the FDA package insert for administration details.

Definitions and Diagnostic Confirmation Requirements

Somatostatin receptor positivity (Lutathera)

RequirementSomatostatin receptor positivity must be confirmed by peptide receptor imaging (e.g., Ga‑DOTA scan)

Applies toLutathera eligibility for GEP‑NET

MIBG positivity (Azedra)

RequirementPositive MIBG (meta‑iodobenzylguanidine) scan is required when Azedra is used as primary treatment

Applies toUnresectable, locally advanced, or metastatic pheochromocytoma/paraganglioma

PSMA positivity (Pluvicto)

RequirementPSMA PET/CT confirmation of PSMA‑positive disease is required

Applies toPluvicto eligibility in metastatic castration‑resistant prostate cancer

Prior Therapy and Step Requirements

Agent	Prior lines of therapy required before authorization
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
Disease progression following ≥2 prior lines of therapy including an androgen receptor pathway inhibitor (e.g., enzalutamide, abiraterone) AND a taxane-based chemotherapy (e.g., docetaxel)
Lutathera (lutetium Lu 177 dotatate)
Prior treatment with a somatostatin analogue (Octreotide LAR or Lanreotide) with documented disease progression on one of these agents
Xofigo (radium Ra 223 dichloride)
No prior systemic therapy lines specifically required; eligibility is based on symptomatic bone metastases without visceral metastases (note: must not be combined with abiraterone)
Azedra (iobenguane I-131)
No prior lines required when used as primary treatment for unresectable, locally advanced, or metastatic pheochromocytoma/paraganglioma; requires positive MIBG scan
Zevalin (ibritumomab tiuxetan)
Prior therapy requirements vary by lymphoma indication; use limited to supported non-Hodgkin lymphoma indications per evidence (see criteria) — no universal prior-line count specified in policy

Background

Radiopharmaceuticals are targeted radioactive agents used to treat specific malignancies by delivering therapeutic radioisotopes to tumor‑specific targets (for example, somatostatin receptors, PSMA, or MIBG). Clinical use is typically restricted to disease states where target expression or disease characteristics are confirmed (e.g., peptide receptor imaging for somatostatin receptor positivity before Lutathera, PSMA PET/CT for Pluvicto, or a positive MIBG scan for Azedra). The agents covered by this policy include Azedra, Lutathera, Pluvicto, Xofigo, and Zevalin, and their use is governed by indication‑specific inclusion criteria, laboratory and hematologic thresholds, dosing and duration limits, and contraindications described in the exclusion criteria.

Additional Coding Notes

HCPCS codesHCPCS

A9590	Iodine i-131, iobenguane, millicurie
A9513	Lutetium lu 177, dotatate, therapeutic, millicurie
A9607	Lutetium lu 177 vipivotide tetraxetan, therapeutic, millicurie
A9606	Radium ra-223 dichloride, therapeutic, per microcurie
A9543	Yttrium ibritumomab tiuxetan, therapeutic, per treatment dose, up to 40 millicuries y-90

Revision History

2024-12-12Committee review / approval

Policy was reviewed and approved by the Utilization Management Committee (Evolent Specialty Services Clinical Guideline Review Committee).

2024-12-27Effective dateLatest

Policy became effective for use as written (effective date set by the committee).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Radiopharmaceuticals

Policy CodePolicy UM ONC_1515

Change TypeNo material change

Effective DateDecember 27, 2024

Next Review Date

Key ActionPrior authorization is required for radiopharmaceutical medications and final approval is by the Utilization Management Committee.

SourceLink

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