CurrentKaiser PermanentePolicy N/A

Clinical Review Criteria — Radiopharmaceuticals: Lutathera (Lutetium Lu 177 dotatate) and Pluvicto (Lutetium Lu 177 vipivotide tetraxetan)

Clinical review criteria governing medical necessity determinations for Lutathium Lu 177 dotatate (Lutathera) for somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors and Lutathium Lu 177 vipivotide tetraxetan (Pluvicto) for metastatic castration‑resistant prostate cancer for Kaiser Foundation Health Plan of Washington members and providers.

Policy Summary

PayerKaiser Permanente

PolicyClinical Review Criteria — Radiopharmaceuticals (Lutathera, Pluvicto)

Policy CodePolicy N/A

Change TypeConsolidation and clarificationadded Pluvicto prior therapy requirements

Effective DateJun 1, 2023

Next Review DateApr 7, 2026

Key ActionObtain prior authorization and submit imaging showing receptor uptake (PET within 3 months) and documentation of prior therapies to authorize Pluvicto or Lutathera.

SourceLink

POLICY UPDATE CHANGES

Merged Lutetium Lu 177 dotatate (Lutathera) criteria into the Radiopharmaceuticals page with Lutetium Lu 177 vipivotide tetraxetan (Pluvicto).

Updated radiologic response parentheticals to clarify intent under renewal criteria.

Approved coverage criteria for Pluvicto aligning with clinical trial populations including prior androgen-receptor pathway inhibitor and taxane chemotherapy requirements.

Clarified prior authorization process language regarding authorization quantity: initial approval x4 doses and renewal approval x2 doses when criteria met.

2Radiopharmaceuticals covered

4Initial Pluvicto doses

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Coverage Criteria

inv-01: Lutathera (Lutetium Lu 177 dotatate) Initial Therapy

Covered when ALL of the following are met

Lutathera initial criteria: 1. Presence of metastatic or locally advanced, unresectable gastroenteropancreatic neuroendocrine tumor (GEP‑NET) for which curative intent is not planned; 2. Ki‑67 index ≤ 20% (higher‑grade disease evaluated case‑by‑case); 3. Progressive disease while on somatostatin analog therapy; 4. Patient is ≥ 18 years of age; 5. Target lesions overexpress somatostatin receptors on 68Ga‑DOTATATE PET/CT performed within the prior 3 months; 6. Monitoring laboratory schedule documented: baseline labs within 4 weeks prior to first injection, 4–6 weeks after each Lutathera injection, and labs 2 days prior to subsequent injections.

Do not approve if contraindications present (women who are or may be pregnant; pediatric patients <18 years; recent surgery, radioembolization, chemoembolization, radiofrequency ablation, or chemotherapy within 4 weeks prior to initiation; untreated or unstable brain metastases; uncontrolled congestive heart failure NYHA II–IV; inability to interrupt somatostatin analog therapy as specified; prior external beam radiation to >25% of bone marrow; current spontaneous urinary incontinence).

inv-02: Pluvicto (Lutetium Lu 177 vipivotide tetraxetan) Initial Therapy

Covered when ALL of the following are met

Pluvicto initial criteria: 1. Age ≥ 18 years; 2. Baseline CT and/or bone scan of chest/abdomen/pelvis within the prior 2 months demonstrating at least one visible lesion; 3. Prior treatment with one or more androgen‑receptor pathway inhibitors (e.g., enzalutamide and/or abiraterone); 4. Previously received at least one taxane‑based chemotherapy regimen (e.g., docetaxel, cabazitaxel) for mCRPC for at least 2 cycles; 5. PSMA‑positive metastatic castration‑resistant prostate cancer with at least one tumor lesion showing PSMA tracer uptake greater than normal liver on an FDA‑approved PSMA PET performed within the prior 3 months; 6. No PSMA‑negative lesions exceeding size criteria (no visceral metastasis ≥1 cm, no lymph node metastasis ≥2.5 cm, no bone metastasis ≥1 cm); 7. At least 30 days since starting bisphosphonate or denosumab (if applicable); 8. No radium‑223 within the prior 6 months; 9. No chemotherapy, immunotherapy, or biologic therapy within 28 days of treatment; 10. No impending spinal cord compression; 11. Prior CNS metastases allowed if treated, stable, patient is neurologically intact, and not receiving steroids for CNS disease; 12. No NYHA class 3–4 heart failure, active hepatitis B or C, or uncontrolled infection; 13. Use of appropriate birth control if partner has child‑bearing potential; 14. Laboratory and performance status criteria met: WBC ≥ 2.5 K/µL and/or ANC ≥ 1.5 K/µL; Hgb > 9 g/dL (no transfusion within 30 days); platelets > 100 K/µL; total bilirubin < 1.5× ULN (≤3× ULN for Gilbert's); AST/ALT < 3× ULN (or < 5× ULN if liver metastases); serum creatinine < 1.5× ULN and creatinine clearance > 50 mL/min; albumin > 3.0 g/dL; ECOG performance status 0–2 (consider PS2 carefully).

If initial criteria are met, approve 4 doses; if not met, do not approve.

inv-03: Pluvicto Renewal Therapy

Renewal covered when ALL of the following are met

Pluvicto renewal criteria: 1. Patient has tolerated Pluvicto therapy; 2. Patient has demonstrated evidence of benefit, defined by at least one of: a) PSA response; b) Radiologic response on CT and nuclear medicine bone scan; or c) Clinical benefit as documented by the treating physician.

If renewal criteria are met, approve 2 additional doses; if renewal criteria are not met, do not approve.

Coverage excludes patients with pregnancy and excludes pediatric patients for Lutathera (patients 18 years of age). Lutathera is not covered when there has been recent surgery, radioembolization, chemoembolization, radiofrequency ablation, or chemotherapy within 4 weeks prior to initiation, for known untreated brain metastases, for patients with uncontrolled congestive heart failure (NYHA II–IV), when short‑acting or long‑acting somatostatin analog therapy cannot be appropriately interrupted prior to administration, after prior external beam radiation therapy involving >25% of bone marrow, or for patients with current spontaneous urinary incontinence that makes administration unsafe. For Pluvicto, coverage is denied when there are any PSMA‑negative lesions that exceed the specified size thresholds (see policy), or if the patient has received radium‑223 within the prior 6 months, or has other documented contraindications described in the clinical criteria.

Imaging and timing requirements that are incompatible with coverage are also exclusionary: confirmation of target receptor uptake must be available on the appropriate PET study within 3 months prior to treatment (68Ga‑DOTATATE PET/CT for Lutathera; PSMA PET for Pluvicto). For Pluvicto specifically, patients must be ≥30 days from initiation of bisphosphonate/denosumab when applicable; failure to meet these timing or imaging requirements will render the request not approvable under the applicable criteria.

When a request does not meet the initial eligibility criteria it is considered not medically necessary and will not be approved. For Pluvicto this includes failure to document prior required systemic therapies — specifically at least one androgen‑receptor pathway inhibitor (for example, enzalutamide or abiraterone) and at least one taxane‑based chemotherapy regimen for mCRPC (minimum 2 cycles) — or absence of required baseline imaging showing a visible lesion within the prior 2 months.

Other common non‑approval reasons include insufficient receptor uptake on qualifying PET imaging (no somatostatin receptor overexpression for Lutathera or absence of PSMA‑positive disease on PSMA PET for Pluvicto), presence of disqualifying laboratory or clinical conditions (for example recent radium‑223 within 6 months for Pluvicto, recent chemotherapy within 28 days, or NYHA class 3–4 heart failure), or failure to meet mandatory timing windows (e.g., PET/CT older than 3 months, or bisphosphonate/denosumab started 30 days before planned Pluvicto).

Coding and Test Thresholds

Applicable HCPCS codes when medically necessaryHCPCSCovered

A9513	Lutetium Lu 177, dotatate, therapeutic, 1 mCi
A9607	Lutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 mCi

PSMA-negative lesion size thresholds — disqualifying limits for Pluvicto

Visceral metastases size limitMust be < 1 cm (PSMA-negative visceral metastases ≥1 cm disqualify)

Lymph node metastases size limitMust be < 2.5 cm (PSMA-negative lymph node metastases ≥2.5 cm disqualify)

Bone metastases size limitMust be < 1 cm (PSMA-negative bone metastases ≥1 cm disqualify)

Laboratory minimums required for Pluvicto eligibility

White blood cells / ANCWBC ≥ 2.5 K/µL and/or ANC ≥ 1.5 K/µL

HemoglobinHgb > 9 g/dL (no transfusion within 30 days)

Provider Actions and Authorization Rules

Prior Authorization

Prior authorization and authorized dose counts

Prior authorization required. Initial approval: up to 4 doses of Pluvicto when initial criteria are met. Renewal approval: up to 2 doses when renewal criteria are met.

Approve x4 doses if initial Pluvicto criteria are met; do not approve if not met.
Renewal: approve x2 doses if renewal criteria met (patient tolerated medication and has evidence of response: PSA response, radiologic response, or clinical benefit).

Step Therapy

Prior systemic therapy required for Pluvicto

Pluvicto requires prior systemic therapy before authorization.

Must have been treated with one or more androgen-receptor pathway inhibitors (e.g., enzalutamide and/or abiraterone).
Must have received at least one taxane-based chemotherapy regimen (e.g., docetaxel, cabazitaxel) for mCRPC for at least 2 cycles.

Background

Gastroenteropancreatic neuroendocrine tumors (GEP‑NETs) are uncommon malignancies with rising incidence; they arise from neuroendocrine cells of the gastrointestinal tract and pancreas and frequently require specialized, targeted therapy. Initial management commonly includes somatostatin analogues for symptom control and tumor growth suppression.

Lutetium‑177 somatostatin receptor–targeted therapy (Lutathera) is a radiolabeled somatostatin analogue approved for patients with somatostatin receptor–positive GEP‑NETs who have progressive disease on somatostatin analog therapy and who meet specified histologic and imaging criteria (for example, Ki‑67 ≤ 20% and receptor uptake on 68Ga‑DOTATATE PET/CT within 3 months). These therapies are part of the therapeutic continuum for unresectable or metastatic disease and require monitoring of hematologic and biochemical labs per the policy schedule.

Definitions

Somatostatin receptor–positive — definition for Lutathera

Definition — somatostatin receptor–positiveTumors demonstrating overexpression of somatostatin receptors on 68Ga‑DOTATATE PET/CT consistent with uptake qualifying for Lutathera therapy within the prior 3 months

Imaging requirement timeframe68Ga‑DOTATATE PET/CT must be performed within the last 3 months to confirm receptor overexpression

Disease contextApplies to metastatic or locally advanced, unresectable gastroenteropancreatic neuroendocrine tumors (GEP‑NET) being considered for Lutathera

PSMA-positive mCRPC — definition for Pluvicto

Definition — PSMA-positive mCRPCMetastatic castration‑resistant prostate cancer with at least one lesion showing PSMA tracer uptake greater than normal liver on an FDA‑approved PSMA PET tracer within the prior 3 months

Concurrent PSMA-negative lesion rule

Revision History

2026-04-07next_review

Next scheduled policy review date set.

2025-04-01administrative_update

Document version/date entry recorded (noted in code/date table).

2024-08-05material_revision

Updated radiologic response parentheticals to clarify intent under renewal criteria.