Coverage Policies

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INDEX:



Effective Date: 06/01/2023	Title: Pluvicto
Revision Date:	Document: BI717:00
CPT Code(s): A9607
Public Statement
*Effective Date:* a) This policy will apply to all services performed on or after the above revision date which will become the new effective date. b) For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply. 1) Pluvicto requires prior authorization. 2) Pluvicto is used to treat prostate cancer.
Medical Statement
Pluvicto is considered medically necessary for members meeting the following criteria: Metastatic Castration-resistant Prostate Cancer (must meet all): 1. Diagnosis of metastatic CRPC; 2. Documentation of disease progression despite bilateral orchiectomy or other androgen deprivation therapy (ADT); 3. Documentation of PSMA-positive disease confirmed on a GA-PSMA-11 or piflufolastat F-18 positive emission tomography (PET) or computed tomography (CT) scan; 4. Prescribed by or in consultation with an oncologist or urologist; 5. Age ≥ 18 years; 6. Member will use a gondatropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy; 7. Failure of both of the following, unless contraindicated or clinically significant adverse effects are experienced or all are contraindicated a. A taxane-based regimen (e.g. docetaxel, cabazitaxel); b. Abiraterone (Zytiga®), unless member has previously failed Yonsa® (abiraterone) or Xtandi® (enzalutamide); 8. Pluvicto is not prescribed concurrently with cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy; 9. Request meets one of the following (a or b): a. Dose does not exceed 7.4 GBq (200 mCi) every 6 weeks for up to 6 doses; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Approval Duration: 6 months (up to a total of 6 doses) Continued Therapy 1) Member is responding positively to therapy; 2) Member has not received ≥ 6 doses (infusions) of Pluvicto; Codes Used In This BI: 1) A9607 – lutetium lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie
Reference
1) Pluvicto Prescribing Information. Millburn, NJ: Novartis AG.; October 2022. Available at https://www.novartis.com/us-en/sites/novartis_us/files/pluvicto.pdf. Accessed January 6, 2023. 2) National Comprehensive Cancer Network. Prostate Cancer Version 1.2023. Available at https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed January 11, 2023 3) ClinicalTrials.gov. Study of 177Lu-PSMA-617 in Metastatic Castrate-Resistant Prostate Cancer (VISION). Available at https://clinicaltrials.gov/ct2/show/NCT03511664. Accessed April 15, 2022 4) IPD Analytics. NOC Code Guide: Pluvicto (lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous use by Advanced Accelerator Applications USA, Inc. Published April 2022 5) IPD Analytics. New Drug Review: Pluvicto (lutetium Lu 177 vipivotide tetraxetan). Published April 6, 2022 6) Virgo KS, Rumble B, de Wit R, et al. Initial Management of Non-Castrate Advanced, Recurrent or Metastatic Prostate Cancer. American Society of Clinical Oncology (ASCO). Published ahead of print January 26, 2021, DOI: 10.1200/JCO.20.03256. Available at: https://www.asco.org/practice-patients/guidelines/genitourinary-cancer#/9521. Accessed January 11, 2023. 7) Basch E, Loblaw DA, Oliver TK, et al. Systemic Therapy in Men with Metastatic CastrationResistant Prostate Cancer (CRPC). American Society of Clinical Oncology (ASCO). Published online before print September 8, 2014. Available at: https://ascopubs.org/doi/full/10.1200/JCO.2013.54.8404. Accessed January 11, 2023. 8) Garje R, Rumble B, Parikh RA. Systemic Therapy Update on 177Lutetium-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer: ASCO Rapid Recommendation. Journal of Clinical Oncology 2022. 40(31): 3664-3666. Available at: https://www.asco.org/practicepatients/guidelines/genitourinary-cancer#/9496. 9) Sartor O, de Bono J, Chi KN, et al. Lutetium-177-PSMA-617 for Metastatic CastrationResistant Prostate Cancer. N Engl J Med. 2021 Sep 16; 385(12): 1091-1103.
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.

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