Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the
www.fepblue.org
website.
Nogapendekin alfa inbakicept-pmln (Anktiva) may be considered medically necessary when ALL of the following are met:
-
The individual is at least 18 years of age;
and
-
The individual has a diagnosis of non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (with or without papillary tumors);
and
-
The individual has high-risk disease that is unresponsive to Bacillus Calmette-Guerin (BCG) (defined as persistent disease following adequate BCG therapy [greater than or equal to five (5) of six (6) induction doses plus greater than or equal to two (2) doses of maintenance or of 2nd induction], disease recurrence after an initial tumor-free state following adequate BCG therapy, or Ta/T1 disease following a single induction course of BCG);
and
-
The individual has undergone transurethral resection of bladder tumor (TURBT) to remove all resectable disease (Ta and T1 components) - Note: Individuals with residual carcinoma in situ that is not amenable to complete resection, fulguration, or cauterization is permitted;
and
- The individual does NOT have muscle invasive (T2-T4), locally advanced, metastatic, or extra-vesical (i.e., urethra, ureter, or renal pelvis) urothelial carcinoma.
Initial Approval: 6 months
Reauthorization Criteria
The reauthorization of nogapendekin alfa inbakicept-pmln (Anktiva) may be considered medically necessary when ALL of the following are met:
-
The individual has previously been approved for nogapendekin alfa inbakicept-pmln (Anktiva) through Blue Cross Blue Shield of North Dakota's precertification process;
and
-
The individual continues to meet the universal and indication specific criteria as identified in section III;
and
-
The individual has experienced disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread;
and
-
There is an absence of unacceptable toxicity from the drug;
and
-
If First Renewal:
-
The individual has a complete response (CR) to initial therapy (after three (3) months) defined as a negative result for cystoscopy [with TURBT/biopsies as applicable] and urine cytology;
or
-
The individual has not had a complete response (CR) to initial therapy (after three (3) months) and requires a second course of induction therapy;
and
-
If Subsequent Renewal:
-
The individual has not experienced a high-grade or CIS recurrence;
and
-
For individual at treatment month 25 or later: Individual is experiencing an ongoing (CR) and will require continued treatment;
and
- The individual has not received greater than 37 months of therapy (24 doses as maintenance therapy).
Reauthorization Approval: 6 months
The use of nogapendekin alfa inbakicept-pmln (Anktiva) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
