ModifiedKaiser PermanentePolicy N/A

Kaiser Foundation Health Plan of Washington - Vipivotide Tetraxetan and Dotatate Clinical Review Criteria

Clinical review criteria for medical necessity determinations for Lutetium Lu 177 dotatate (Lutathera) for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) for progressive metastatic castration-resistant prostate cancer (mCRPC) for Kaiser Foundation Health Plan of Washington members (non-Medicare criteria applied when Medicare coverage guidance absent).

Policy Summary

PayerKaiser Permanente

PolicyKaiser Foundation Health Plan of Washington - Vipivotide Tetraxetan and Dotatate Clinical Review Criteria

Policy CodePolicy N/A

Change TypeModified (criteria additions and clarifications)

Effective DateJun 1, 2023

Next Review DateApr 1, 2025

Key ActionVerify authorization requirements via Pre-authorization Code Check and provide required imaging, labs, ECOG status, and treatment history to support approval (Pluvicto typically approved for 4 doses if initial criteria met).

SourceLink

POLICY UPDATE CHANGES

MPC approved coverage criteria for Pluvicto (Lutetium Lu 177 vipivotide tetraxetan) for Prostate Cancer; required 60-day notice with effective date June 01, 2023.

Clarified language related to radiologic_response under renewal criteria.

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

2Radiopharmaceuticals covered

2HCPCS codes listed

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Key initial inclusion requirements (Pluvicto)

11Initial inclusion/exclusion items (Pluvicto)

Coverage Summary

Scope: Clinical review criteria for medical necessity determinations for Lutetium Lu 177 dotatate (Lutathera) for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) for progressive metastatic castration-resistant prostate cancer (mCRPC) for Kaiser Foundation Health Plan of Washington members (Non‑Medicare criteria applied when Medicare guidance absent).

Coverage stance: mixed (radiopharmaceuticals covered when specific clinical criteria are met).

Effective/Review dates: Effective: 2023-06-01; Last review: 2024-08-05; Next review: 2025-04-01.

Key thresholds & definitions

68Ga-DOTATATE PET/CT recencywithin last 3 months

PSMA PET/CT recencywithin past 3 months

Baseline CT/bone scan recencywithin prior 2 months

WBC / ANC>= 2.5 K/uL or ANC >= 1.5 K/uL

Hemoglobin> 9 mg/dL (no transfusion within 30 days)

Platelets> 100 K/uL

Total bilirubin< 1.5 x ULN (<= 3 x ULN for Gilbert's)

AST/ALT< 3 x ULN (or < 5 x ULN if liver metastases)

Serum creatinine / CrClcreatinine < 1.5 x ULN and CrCl > 50 mL/min (Cockcroft-Gault)

Albumin> 3.0 g/dL

ECOG PS0-2

Pluvicto lesion size exclusions - visceral<= 1 cm

Pluvicto lesion size exclusions - lymph node<= 2.5 cm

Pluvicto lesion size exclusions - bone<= 1 cm

Definition listmCRPC: metastatic castration-resistant prostate cancer; GEP-NET: gastroenteropancreatic neuroendocrine tumors; ECOG PS: Eastern Cooperative Oncology Group performance status

Medical Necessity Criteria

Dotatate (Lutathera) - Initial Criteria (Non-Medicare Members)

Candidates must meet ALL of the following:

ALL of the following

Presence of metastasized or locally advanced, unresectable (with curative intent) gastroenteropancreatic neuroendocrine tumors (GEP-NET)
Ki-67 protein < 20% (patients with higher-grade disease need to be evaluated on case-by-case basis)
Progressive disease under somatostatin analog therapy (SSA)
At least 18 years of age

Coding

Applicable HCPCS Codes (considered medically necessary when criteria met)HCPCSCovered

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

Provider Actions

Prior Authorization

Authorization required when criteria met

Verify authorization requirements for specific HCPCS codes by plan type using the Pre-authorization Code Check. When the Pluvicto initial eligibility criteria are met, approval is typically granted for four doses; follow the renewal criteria to consider continuation.

A9607
A9513

Documentation Required

Imaging and laboratory documentation

Provide recent imaging and laboratory documentation to support medical necessity: include receptor-targeted imaging and baseline anatomic imaging within the specified recency windows; document ECOG performance status and prior systemic treatments (androgen-receptor inhibitors, taxane chemotherapy) as applicable.

68Ga-DOTATATE PET/CT within last 3 months (Lutathera)
PSMA PET/CT within past 3 months and baseline CT/bone scan within prior 2 months (Pluvicto)

Background & Evidence

Background: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are rare but increasing in incidence; midgut NETs are the most common malignant gastrointestinal NETs and survival is poor for metastatic disease. Lutetium-177 radiolabeled somatostatin analog therapy (Lutathera) targets somatostatin receptors on tumor cells to deliver beta/gamma radiation and is FDA-approved for somatostatin receptor-positive GEP-NETs in adults.

Prostate cancer background: A subset (about 10–20%) of prostate cancers progress to metastatic castration-resistant prostate cancer (mCRPC) with frequent bone, nodal, and visceral metastases; PSMA-targeted radioligand therapies (including 177-Lu PRLT such as Pluvicto) have been evaluated for mCRPC.

Kaiser policy use: In the absence of active CMS National or Local Coverage Determinations, Kaiser Permanente uses its own Clinical Review Criteria (Non‑Medicare criteria) for medical necessity determinations for Pluvicto and Lutathera.

Evidence summary: For Lutathera, one RCT (NETTER-1) with moderate risk of bias supports efficacy versus octreotide LAR, with additional non-comparative studies suggesting effectiveness and safety. For Pluvicto/177-Lu PRLT, multiple RCTs and numerous observational studies (hundreds to thousands of patients) show PSA declines, higher response rates, and improvements in survival and/or progression outcomes versus comparators in many trials, though certainty ranges from moderate to low due to heterogeneity and study limitations.

Key evidence summaries

NETTER-1 RCT (Lutathera)One randomized trial (NETTER-1) with moderate risk of bias showed Lu-Dotatate more effective than octreotide LAR for somatostatin receptor–positive GEP-NETs; octreotide had fewer adverse events.

Definitions

mCRPCMetastatic castration-resistant prostate cancer

GEP-NETGastroenteropancreatic neuroendocrine tumors

ECOG PSEastern Cooperative Oncology Group performance status (scale used to assess functional status; policy requires ECOG 0-2)

Revision History

01/10/2023approval

MPC approved coverage criteria for Pluvicto (Lutetium Lu 177 vipivotide tetraxetan) for prostate cancer; 60-day notice required with effective date June 01, 2023.

01/23/2023administrative

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

03/22/2023revision

Policy Summary

PayerKaiser Permanente

PolicyKaiser Foundation Health Plan of Washington - Vipivotide Tetraxetan and Dotatate Clinical Review Criteria

Policy CodePolicy N/A

Change TypeModified (criteria additions and clarifications)

Effective DateJun 1, 2023

Next Review DateApr 1, 2025

SourceLink

On This Page

Target lesions overexpressing somatostatin receptors as demonstrated on 68Ga-DOTATATE PET/CT scan within last 3 months

Monitoring labs must be conducted: baseline within the first 4 weeks of injection; 4-6 weeks after each Lutathera injection and 2 days to subsequent Lutathera injections

Dotatate (Lutathera) - Contraindications / Exclusions

Not appropriate when any of the following are present:

ANY of the following

Women who are or may be pregnant (pregnancy category X)
pregnancy/breastfeeding exclusion
Women who are breastfeeding
pregnancy/breastfeeding exclusion
Pediatric patients (<18 years of age)
age exclusion
Recent surgery, radioembolization, chemoembolization, radiofrequency ablation or chemotherapy within 4 weeks prior to initiation of Lutathera
Known brain metastases unless treated and stabilized
Uncontrolled congestive heart failure (NYHA II, III, IV)
Inability to interrupt short-acting SSA for 24 hours before Lutathera or long-acting (LAR) SSA that cannot be interrupted for at least 4 weeks before initiation
Prior external beam radiation therapy to >25% of the bone marrow
Current spontaneous urinary incontinence making it unsafe to administer Lutathera

Pluvicto (Vipivotide Tetraxetan) - Initial Criteria (Non-Medicare Members)

Given every 6 weeks for 4-6 cycles and considered medically necessary when ALL of the following are met:

ALL of the following

Patient age 18 years or older
Baseline CT and/or bone scan of chest/abdomen/pelvis within the prior 2 months with at least one visible lesionwithin prior 2 months
Have been treated with one or more androgen-receptor pathway inhibitors (e.g., enzalutamide and/or abiraterone)
Previously received at least 1 taxane-based chemotherapy regimen (e.g., docetaxel, cabazitaxel) for mCRPC, for at least 2 cycles
PSMA status: PSMA-positive mCRPC defined as at least one tumor lesion with uptake greater than normal liver within the past 3 monthswithin past 3 months
No excessive PSMA-negative disease by size
- Visceral metastases <= 1 cm<= 1 cm
  document uses 'ZIcm'
- Lymph node metastases <= 2.5 cm<= 2.5 cm
  document uses '22.5cm'
- Bone metastases <= 1 cm<= 1 cm
  document uses 'ZIcm'
At least 30 days out from starting bisphosphonate or denosumab (if applicable)>= 30 days
No radium-223 within last 6 monthswithin last 6 months
No chemotherapy, immunotherapy, or biologics within 28 days of treatmentwithin 28 days
No impending cord compression
Prior CNS metastases acceptable if stable; must not be on steroids for CNS metastases treatment and must be neurologically intact
No NYHA class 3-4 heart failure; no active B/C , uncontrolled infection
Birth control if partner has child-bearing potential
Laboratory and performance status requirements
- WBC at least 2.5 K/uL and/or ANC at least 1.5 K/uL>= 2.5 K/uL or ANC >= 1.5 K/uL
- Hemoglobin (Hgb) > 9 mg/dL and no transfusion within 30 days> 9 mg/dL
  no transfusion within 30 days
- Platelets > 100 K/uL> 100 K/uL
- Total bilirubin < 1.5 x ULN (3x for Gilbert's)< 1.5 x ULN (or <= 3x ULN for Gilbert's)

Pluvicto - Maximum/Total Doses

ALL of the following

If initial criteria are met, approve x4 dosesx4 doses approval
Approval guidance: approve 4 doses if initial criteria met
If initial criteria are not met, do not approve
Pluvicto treatment greater than a total of 6 doses as per the Food and Drug Administration-approved regimen is ...max 6 doses (FDA)
Source text truncated; implies adherence to FDA max of 6 doses

Laboratory thresholds: WBC ≥ 2.5 K/uL or ANC ≥ 1.5 K/uL; Hgb > 9 mg/dL (no transfusion within 30 days); Platelets > 100 K/uL; Total bilirubin < 1.5 x ULN (≤ 3x ULN for Gilbert's); AST/ALT < 3 x ULN (< 5 x ULN if liver metastases); Serum creatinine < 1.5 x ULN and CrCl > 50 mL/min; Albumin > 3.0 g/dL; ECOG PS 0-2

Billing Rule

Code-based billing

Report the therapeutic radiopharmaceutical HCPCS codes per mCi as applicable and verify authorization requirements by plan type; codes listed may not be all-inclusive.

A9513
A9607

Denial Risk

Denial if criteria not met

Claims will not be approved if the initial eligibility criteria are not fully met. Common reasons for denial include lack of required prior therapies, absent or insufficient receptor-positive imaging, failure to meet laboratory or performance thresholds, or presence of PSMA-negative lesions exceeding size limits.

Insufficient prior therapies (e.g., no prior androgen-receptor inhibitors or taxane chemotherapy where required)
Missing or non-concordant receptor positivity on 68Ga-DOTATATE or PSMA imaging
Laboratory thresholds not met (see documented WBC, Hgb, platelets, liver and renal function limits)
Lesion-size exclusions exceeded (visceral > 1 cm; lymph node > 2.5 cm; bone > 1 cm)

Pluvicto evidence - RCT summaryMultiple RCTs (total >800 mCRPC patients across key trials) show 177-Lu PRLT reduces PSA, increases response rates, and improves OS/PFS versus comparators; overall evidence certainty rated moderate for key RCTs but downgraded for heterogeneity and other limitations.

Pluvicto evidence - observational dataNumerous observational studies (thousands of mCRPC patients) report PSA declines in 55–85% and variable radiologic responses; observational evidence rated low certainty due to design limitations.

Safety and certaintyRCT evidence had moderate risk of bias and was downgraded for inconsistency/indirectness/imprecision; serious AEs (anemia, marrow suppression, thrombocytopenia) reported in RCTs and observational studies.

Clarified language related to Medical Oncologist recommending this treatment (administrative clarification noted in revision history).

06/05/2023revision

Removed language related to Medical Oncologist recommending Pluvicto treatment (administrative revision noted in revision history).

06/01/2023effective_date

Effective date for MPC-approved Pluvicto coverage criteria (per 60-day notice from 01/10/2023).

08/05/2024clarificationLatest

Updated/clarified radiologic_response parentheticals to clarify intent under renewal criteria for Pluvicto.

AST/ALT < 3 x ULN (5x if liver metastases)< 3 x ULN (or < 5 x ULN if liver metastases)

document lists 'Sx if liver metastases' interpreted as 5x

Serum creatinine < 1.5 x ULN and creatinine clearance > 50 mL/min (Cockcroft-Gault with actual body weight)Cr < 1.5 x ULN; CrCl > 50 mL/min

Albumin > 3.0 g/dL> 3.0 g/dL

ECOG Performance Status 0-2 (consider PS2 carefully)ECOG 0-2