Criteria
Coverage is subject to the specific terms of the member's benefit plan.
ADAMTS13, recombinant-krhn (Adzynma) may be considered medically necessary for adult and pediatric individuals when the following criteria are met:
-
The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational);
and
-
The requested medication must be prescribed by, or in consult with, a hematologist;
and
-
The diagnosis must be confirmed by both of the following:
-
genetic test confirming biallelic ADAMTS13 mutation (Unless individual has a positive response to Adzynma inpatient and is continuing outpatient treatment, then genetic tests should be provided upon renewal);
and
-
ADAMTS13 activity less than 10% of normal with the absence of an inhibitor (i.e. ADAMTS13 autoantibodies);
and
-
For individuals requesting prophylactic therapy:
-
individual must have a history of at least one of the following:
-
At least one documented TTP event;
or
-
individual is pregnant (approval duration through 6 weeks post-partum);
and
-
The individual must have a documented intolerance to plasma-based therapies;
and
-
For individuals requesting acute (On-Demand) treatment, must have an acute event defined by both of the following:
-
Platelet count less than 150,000/uL or a drop in platelet count greater than 25% of baseline;
and
- Microangiopathic hemolytic anemia (LDH greater than 1.5 x baseline or greater than 1.5 x ULN)
Reauthorization Criteria
Continuation of therapy with ADAMTS13, recombinant-krhn (Adzynma) may be considered medically necessary when the following criteria are met:
-
Prescribed or in consultation with a hematologist, oncologist, intensive care specialist, or specialist in rare genetic hematologic diseases;
and
For individuals receiving prophylaxis, any of the following:
-
Decreased number of acute and subacute TTP events;
or
-
Increased platelet counts (within 25% of baseline or > 150,000/uL);
or
-
Decreased microangiopathic hemolytic anemia episodes (defined as LDH < 1.5 x baseline or < 1.5 x ULN);
and
For individuals receiving On-Demand treatment, both of the following:
-
Increase platelet counts (within 25% of baseline or greater than 150,000/uL, whichever occurs first);
and
- Decreased microangiopathic hemolytic anemia episodes (defined as LDH less than 1.5 x baseline or less than 1.5 x ULN).
The use of ADAMTS13, recombinant-krhn (Adzynma)
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
