Romiplostim (Nplate) is a thrombopoietin receptor agonist that increases platelet production through binding and activation of the thromobpoietin (TPO) receptor, similar in mechanism to endogonous TPO.

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:

• The patient has a diagnosis of immune (idiopathic) thrombocytopenia (ITP); and
• ONE of the following:
  • The patient is between the ages of 1 and 17 years old AND the diagnosis has lasted for at least 6 months; or
  • The patient is 18 years old or over AND has a diagnosis of chronic (defined as lasting for at least 12 months) immune (idiopathic) thrombocytopenia (ITP); and
• ONE of the following:
  • The patient has a platelet count ≤ 30 X 109/L; or
  • The patient 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 patient has had an insufficient response to a splenectomy; or
  • The patient has tried and had an insufficient response to corticosteroids or immunoglobulins (IVIg or anti-D); or
  • BOTH of the following:
    • The patient is NOT a candidate for splenectomy; and
    • The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to BOTH corticosteroids AND immunoglobulins (IVIg or Anti-D); and
• ONE of the following:
  • The patient is NOT being treated with another thrombopoietin receptor agonist (e.g., Doptelet, Mulpleta, Promacta, Tavalisse); or
  • The patient is currently being treated with another thrombopoietin receptor agonist AND will discontinue prior to initiating the requested agent; and
• The prescriber has provided the patient’s weight.

Initial Length of Approval: 4 months

Renewal Criteria

Romiplostim (Nplate) may be renewed when the following are met:

• The patient has been previously approved for the requested agent through the Blue Cross Blue Shield of North Dakota approval process; and
• The patient has a diagnosis of immune (idiopathic) thrombocytopenia (ITP) AND ONE of the following:
  • The patient’s platelet count is ≥50 x 109/L; or
  • The patient’s platelet count has increased sufficiently to avoid clinically important bleeding; and
• ONE of the following:
  • The patient is NOT being treated with another thrombopoietin receptor agonist (e.g., Doptelet, Mulpleta, Promacta, Tavalisse) or
  • The patient is currently being treated with another thrombopoietin receptor agonist AND will discontinue prior to continuing the requested agent; and
• The prescriber has provided the patient’s weight

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

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes