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.
Initial Criteria
Romiplostim (Nplate) may be considered medically necessary when
ALL
of the following criteria are met:
- ONE
of the following:
-
The individual has a diagnosis of hematopoietic syndrome of acute radiation syndrome (HS-ARS);
or
-
The individual has a diagnosis of immune (idiopathic) thrombocytopenia (ITP)
AND ALL
of the following:
- ONE
of the following:
-
The individual is between the ages of 1 and 17 years old
AND
the diagnosis has lasted for at least six (6) months;
or
-
The individual is 18 years old or over;
and
- ONE
of the following:
-
The individual has a platelet count less than or equal to 30 X 10
9
/L;
or
-
The individual has a platelet count greater than 30 X 10
9
/L but less than 50 x 10
9
/L AND has symptomatic bleeding and/or an increased risk for bleeding;
and
- ONE
of the following:
-
The individual has tried and had an inadequate response to ONE corticosteroid used for the treatment of ITP;
or
-
The individual has an intolerance or hypersensitivity to ONE corticosteroid used for the treatment of ITP;
or
-
The individual has an FDA labeled contraindication to ALL corticosteroids used for the treatment of ITP;
or
-
The individual has tried or had an inadequate response to immunoglobulins (IVIg or anti-D);
or
-
The individual has had an inadequate response to a splenectomy;
or
-
The individual has tried and had an inadequate response to rituximab;
or
-
The individual has another FDA approved indication for romiplostim (Nplate);
or
-
The individual has another indication supported in compendia for romiplostim (Nplate);
and
-
If the individual has an FDA approved diagnosis,
ONE
of the following:
-
The individual's age is within FDA labeling for the requested indication for romiplostim (Nplate);
or
-
The prescriber has provided information in support of using romiplostim (Nplate) for the individual's age for the requested indication;
and
- ONE
of the following:
-
The individual has a diagnosis of hematopoietic syndrome of acute radiation syndrome (HS-ARS);
or
- The individual will NOT receive romiplostim (Nplate) in combination with another thrombopoietin receptor agonist (e.g., Doptelet, Promacta, or Tavalisse).
Initial Length of Approval: One (1) time for HS-ARS
Four (4) months for ITP
Six (6) months for all other indications
Reauthorization Criteria
Continuation of therapy with romiplostim (Nplate) may be considered medically necessary when
ALL
of the following are met:
-
The individual has been previously approved for romiplostim (Nplate) through the Blue Cross Blue Shield of North Dakota approval process
NOTE:
if requested diagnosis is hematopoietic syndrome of acute radiation syndrome (HS-ARS) should always be reviewed under initial criteria;
and -
ONE of the following:
-
The individual has a diagnosis of immune (idiopathic) thrombocytopenia (ITP)
AND ONE
of the following:
-
The individual has a platelet count greater than or equal to 50 x 10
9
/L;
or
-
The individual's platelet count has increased sufficiently to avoid clinically important bleeding;
or
-
The individual has another indication for romiplostim (Nplate) AND has shown clinical improvement (i.e., decreased symptom severity and/or frequency);
and
-
The individual will
NOT
receive romiplostim (Nplate) in combination with another thrombopoietin receptor agonist (e.g., Doptelet, Promacta, or Tavalisse).
The use of romiplostim (Nplate) 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.
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