CurrentAvMedPolicy Pub. 100-2

Carvykti (ciltacabtagene autoleucel) — Medical Prior Authorization (Part B)

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This form governs prior authorization and step-edit requests for Carvykti (ciltacabtagene autoleucel) as a medical (Part B) infusion product for AvMed members and specifies clinical criteria, documentation, and administrative requirements for providers.

Policy Summary

PayerAvMed

PolicyCarvykti (ciltacabtagene autoleucel) medical prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization for Carvykti (J9999/C9399) with prescriber signature and complete supporting documentation including labs, diagnostics, and chart notes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 dosequantity limit per member (up to)

18+minimum member age for eligibility

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CurrentAvMedPolicy Pub. 100-2

Carvykti (ciltacabtagene autoleucel) — Medical Prior Authorization (Part B)

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Get alerted when Policy Pub. 100-2 changes without checking for updates manually.

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Policy Summary

PayerAvMed

PolicyCarvykti (ciltacabtagene autoleucel) medical prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization for Carvykti (J9999/C9399) with prescriber signature and complete supporting documentation including labs, diagnostics, and chart notes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 dosequantity limit per member (up to)

18+minimum member age for eligibility

Coverage and Clinical Criteria

Initial Therapy

Covered when ALL of the following are met

Initial Authorization: Member is 18 years of age or older; Provider is an oncologist and the administrating healthcare facility has enrolled in the Carvykti REMS Program with training for management of cytokine release syndrome (CRS) and neurological toxicities; Member has NOT received prior CAR-T therapy; Member has NOT received prior allogeneic hematopoietic stem cell transplantation (HSCT) within 6 months of therapy; Member does NOT have a clinically significant active systemic infection or inflammatory disorder; Member has NOT received live vaccines within 6 weeks prior to lymphodepleting chemotherapy, during treatment, and will not receive live vaccines until immune recovery following treatment; Member has been screened for CMV, HBV, HCV, and HIV prior to leukapheresis per clinical guidelines; Prophylaxis for infection has been followed according to local guidelines or clinical practice; Provider attests Carvykti will be used as single-agent therapy (not counting lymphodepleting or interim chemotherapy); Member does NOT have known central nervous system involvement with myeloma; Member does NOT have active or history of plasma cell leukemia; Member has an ECOG performance status of 0-1; Member has a diagnosis of multiple myeloma AND has received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent; Multiple myeloma is refractory to lenalidomide (if indicated).

All checklist items on the form must be supported with documentation (lab results, diagnostics, and/or chart notes).

Reauthorization

Reauthorization: Coverage cannot be renewed (reauthorization not allowed).

No continuation approvals per form.

The following conditions are exclusionary for Carvykti authorization: the member has known central nervous system (CNS) involvement with myeloma (including history or presence of clinically relevant CNS pathology) or the member has active or a history of plasma cell leukemia. Requests that indicate either condition do not meet the clinical eligibility criteria and should be denied.

The use of drug samples to initiate therapy is not acceptable for meeting the preauthorization/step-edit requirements. Authorization requests that document initiation with samples do not meet the criteria and will not be approved.

Initial Therapy Requirements

Initial authorization requires all criteria below to be met and documented.

Initial: See Initial Therapy: patient age >= 18; REMS-enrolled oncologist and facility with training for CRS and neurologic toxicity management; no prior CAR-T therapy; no allogeneic HSCT within 6 months; no clinically significant active systemic infection or inflammatory disorder; no live vaccines within 6 weeks prior to lymphodepletion and until immune recovery; screening for CMV, HBV, HCV, and HIV prior to leukapheresis; infection prophylaxis per local guidelines; Carvykti to be used as single-agent therapy (excluding lymphodepleting/interim chemotherapy); no known CNS involvement with myeloma; no active or history of plasma cell leukemia; ECOG performance status 0-1; diagnosis of multiple myeloma with at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent; refractory to lenalidomide if applicable.

Documentation required for each listed item (lab results, diagnostics, chart notes).

Step Therapy / Prior Treatments

Step	Requirement
1
Member must have received at least 1 prior line of therapy, including a proteasome inhibitor (e.g., bortezomib) and an immunomodulatory agent (e.g., lenalidomide, thalidomide)

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J9999	Carvykti (ciltacabtagene autoleucel) — unclassified biologics
C9399	Unclassified biologic or drug — Carvykti

Maximum dose

Maximum Dose1 dose of up to 100 million autologous CAR-positive viable T-cells

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for Carvykti billed as J9999/C9399 (medical). The prescribing physician must sign and clearly print their name on the medical prior authorization/step-edit request form (preprinted stamps are not valid). All required supporting documentation must be provided — including lab results, diagnostics, and chart notes — or the request may be denied. Fax completed request and documentation to 1-877-535-1391. For Medicare members, ensure compliance with Pub. 100-2, Chapter 15 §50 and any applicable NCDs/LCDs.

Prior authorization required for Carvykti billed as J9999/C9399 (medical)
Prescribing physician must sign and clearly print name on PA request form (preprinted stamps not valid)
Fax completed request and all supporting documentation (labs, diagnostics, chart notes) to 1-877-535-1391
For Medicare members, comply with Pub. 100-2 Chapter 15 §50 and applicable NCDs/LCDs

Provider Responsibilities and Documentation

Documentation Required

Provide supporting documentation for each checked criterion

Submit documentation to support each clinical criterion checked on the form; this includes laboratory results, diagnostic studies, and chart notes. Prior therapies may be verified through pharmacy paid claims or submitted chart documentation.

All documentation, including lab results, diagnostics, and/or chart notes, must be provided or request may be denied.
Previous therapies will be verified through pharmacy paid claims or submitted chart notes.

Denial Risk

Incomplete or illegible submissions may delay or cause denials

Authorization can be delayed if the information provided is not complete, correct, or legible; requests may be denied if required supporting documentation (labs, diagnostics, chart notes) is not provided.

Administration Location Requirements

Note

Infusion center must be REMS-enrolled and site must be provided

The administering healthcare facility must be enrolled in the Carvykti REMS Program and provide the location/site of drug administration or indicate use of the specialty pharmacy (Proprium Rx); for urgent reviews contact AvMed Pre-Authorization Department as directed on the form.

Authorization criteria require the provider be an oncologist and the administrating facility enrolled in the Carvykti REMS Program with appropriate training.
Medication being provided by: indicate location/site of drug administration (include NPI or DEA of administering location) or select Specialty Pharmacy - Proprium Rx.
For urgent reviews, practitioner should call AvMed Pre-Authorization Department per form instructions.

Quantity Limits

inv-15: Carvykti (ciltacabtagene autoleucel) — 1 dose

Carvykti dose limit1 dose per course

Dose contentUp to 100 million autologous CAR-positive viable T-cells per dose

Quantity limit sourceHCPCS/NDC quantity limits as stated in policy

Program Enrollment and Safety Requirements

inv-12: REMS program enrollment and training

REMS enrollment requirementProvider is an oncologist and the administrating healthcare facility must be enrolled in the Carvykti REMS Program

Training requirementTraining has been given to providers on the management of cytokine release syndrome (CRS) and neurological toxicities

Facility responsibilityAdministering facility must maintain REMS program compliance for Carvykti administration

Background

Carvykti (ciltacabtagene autoleucel) is an autologous CAR‑T cell therapy supplied as a manufactured cellular product for infusion. Administration must occur at a facility and by providers enrolled in the Carvykti REMS Program with documented training in management of cytokine release syndrome (CRS) and neurologic toxicities. These REMS and training requirements are mandatory components of eligibility for treatment.