Decnupaz (pivekimab sunirine-pvzy) prior authorization and coverage
Customize your policy alerts
Sign up for Viva Health Policy IC-0861 alerts
Get alerted when Policy IC-0861 changes without checking for updates manually.
Monitor payer policy activity
Defines prior authorization, dosing limits, clinical criteria, coding, and renewal rules for intravenous Decnupaz (pivekimab sunirine-pvzy) for adults with CD123‑expressing Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). Applies to Viva Health benefit administration.
No material clinical or coverage changes in this revision.
Coverage Criteria for Decnupaz (pivekimab sunirine-pvzy)
Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Dose per dosing section; calculate by actual body weight; recommended 0.045 mg/kg IV once every 21 days until disease progression or unacceptable toxicity.
Continuation/Renewal Therapy — Renewal approval criteria
Renewal approval may be granted when ALL of the following are met:
Prior authorization validity may be renewed every 6 months.
Per policy, patients with active or suspected central nervous system (CNS) disease involvement are excluded from coverage for Decnupaz. The universal criteria explicitly state that the member must not have active or suspected CNS disease involvement as a condition of authorization.
A history of hepatic veno-occlusive disease (VOD) is a contraindication to coverage under this policy. The universal criteria require that the member does not have prior VOD and specify that members must undergo close monitoring for signs and symptoms of VOD, including liver function testing (e.g., ALT, AST, total bilirubin) prior to each dose.
Initial Authorization Criteria (BPDCN)
Initial Therapy (BPDCN)
Initial authorization criteria specific to BPDCN — covered when ALL of the following are met:
Dose: 0.045 mg/kg IV every 21 days; calculate by actual body weight; initial prior authorization valid for 180 days.
Continuation and Renewal Rules
Continuation Therapy
Renewal/continuation approval criteria — continued coverage may be granted when ALL of the following are met:
Prior authorization renewals every 180 days.
Provider Requirements and Administrative Actions
Prior authorization required — initial approvals valid 6 months
Prior authorization is required for Decnupaz for BPDCN in adults; initial authorizations are valid for 6 months (180 days) and may be renewed every 6 months. Indication must be Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) in adults (≥18 years) and used as single‑agent therapy.
- Initial prior authorization validity: 6 months (180 days).
- Renewals may be granted every 6 months (180 days).
- Indication: definitive diagnosis of BPDCN in adults (≥18 years).
- Must be used as single‑agent therapy.
Step therapy: none required
No prerequisite step therapy is required for Decnupaz; it may be used as first‑line therapy for treatment‑naïve de novo BPDCN or as treatment for relapsed/refractory disease as a single agent.
- No prior failed therapy required before initiation.
- Permitted as first‑line (de novo) or for relapsed/refractory BPDCN.
Required clinical documentation and monitoring
Documentation must confirm CD123‑positive disease, absence of prior hepatic veno‑occlusive disease (VOD), and a monitoring plan including liver function testing prior to each dose; dosing must be calculated using actual body weight (0.045 mg/kg IV every 21 days).
- Evidence of CD123‑positive/expression on blasts (detectable CD123).
- Documentation that the member does not have a history of hepatic VOD.
- Plan for close monitoring for VOD signs/symptoms, including LFTs (e.g., ALT, AST, total bilirubin) prior to each dose.
- Dose calculation documented using actual body weight at 0.045 mg/kg IV every 21 days.
Renewal denial risks: unacceptable toxicity or no response
Renewal may be denied for unacceptable toxicity or lack of disease stabilization; examples of unacceptable toxicity include severe hepatotoxicity (including VOD), severe infusion‑related reactions, severe edema, or severe hypersensitivity.
- Renewal requires absence of unacceptable toxicity; presence of listed severe toxicities may result in denial.
- Renewal also requires evidence of disease stabilization or improvement (CR or CRc).
Billing, NDC, and Diagnosis Codes
| 00074-0282-xx | Decnupaz 2 mg lyophilized powder for injection in a single-dose vial |
| C86.40 | Blastic NK-cell lymphoma not having achieved remission |
Quantity and Dosing Limits
| Step | Requirement |
|---|---|
| 1 | No prerequisite step therapy required; Decnupaz may be used as first‑line therapy for treatment‑naïve de novo BPDCN or as therapy for relapsed/refractory BPDCN. |
Site of Care and Billing Context
Infusion center billing: use outpatient HCPCS; hospital outpatient code C9399 referenced
Bill administrations in the outpatient infusion setting using the listed HCPCS/CPT outpatient codes. For hospital outpatient use, reference the unclassified hospital outpatient drug/biological code C9399; J9999 is listed for non‑classified antineoplastic drugs.
Definitions and Key Terms
Background
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare hematologic malignancy characterized by expression of CD123. Decnupaz (pivekimab sunirine-pvzy) is an antibody–drug conjugate that targets CD123 and is used as single‑agent therapy for CD123‑expressing BPDCN. Due to risks observed with this class and the agent, monitoring is required for infusion-related reactions, hypersensitivity reactions, new or worsening edema, and for hepatic veno-occlusive disease (VOD) via liver function tests prior to each dose.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.