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 6 months; or
- The individual is 18 years old or over; and
- ONE of the following:
- The individual has a platelet count ≤ 30 X 109/L; or
- The individual has a platelet count > 30 X 109/L but < 50 x 109/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; and
- ONE of the following:
- The individual’s age is within FDA labeling for the requested indication romiplostim (Nplate); or
- The prescriber has provided information in support of using romiplostim (Nplate) for the individual’s age; 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, Mulpleta, Promacta, Tavalisse); and
- The individual does NOT have any FDA labeled contraindications to romiplostim (Nplate).
Initial Length of Approval: 1 time for HS-ARS
4 months for ITP
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
- The individual has a diagnosis of immune (idiopathic) thrombocytopenia (ITP) AND ONE of the following:
- The individual has a platelet count ≥ 50 x 109/L; or
- The individual’s platelet count has increased sufficiently to avoid clinically important bleeding; and
- The individual will NOT receive romiplostim (Nplate) in combination with another thrombopoietin receptor agonist (e.g., Doptelet, Mulpleta, Promacta, Tavalisse); and
- The does NOT have any FDA labeled contraindications to romiplostim (Nplate).
Renewal Length of Approval: 12 months
Romiplostim (Nplate) for any other indication not listed within this policy will be considered experimental/investigational and, therefore, not-covered. Scientific evidence does not support its efficacy or safety for any other indications.
Procedure Codes
