Medical Policy
Effective Date:05/01/2020 Title:Padcev (enfortumab vendotin-ejfv)
Revision Date:07/01/2020 Document:BI646:00
CPT Code(s):J9177
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)    Padcev (enfortumab vedotin-ejfv) requires prior authorization.

2)    Padcev is used to treat advanced urothelial cancer.

3)    Padcev is a specialty drug covered under the medical benefit.
Medical Statement

Padcev (enfortumab vedotin-ejfv) is considered medically necessary for patients 18 years of age and older who meet the following criteria:

 

1)    Diagnosis of locally advanced or metastatic urothelial carcinoma AND

2)    Patient has previously received a platinum-containing chemotherapy regimen in the neoadjuvant/adjuvant, locally advanced, or metastatic setting AND

3)    Patient has received a PD-1 inhibitor (e.g., Keytruda, Opdivo, Libtayo) or PD-L1 inhibitor (e.g., Tecentriq, Bavencio, Imfinzi).
Limits
Intentially left empty
Reference

1)    Padcev Prescribing Information. Northbrook, IL; Astellas Pharma US, Inc.; December 2019.

2)    NCCN Drugs & Biologics Compendium. Accessed online 3/16/20.
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.