romiplostim (Nplate)

Romiplostim (Nplate)

Policy ID: I-9004-02

Section: Injections

Effective Date: October 01, 2019

Revised Date: September 09, 2020

Revision Effective Date: October 01, 2020

Last Reviewed: September 21, 2020

Description

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.

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:

The individual has a diagnosis of immune (idiopathic) thrombocytopenia (ITP); and
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 had an insufficient response to a splenectomy; or
- The individual has tried and had an inadequate response to corticosteroids or immunoglobulins (IVIg or anti-D); or
- The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to corticosteroids; and
ONE of the following:
- The individual is NOT being treated with another thrombopoietin receptor agonist (e.g., Doptelet, Mulpleta, Promacta, Tavalisse); or
- The individual is currently being treated with another thrombopoietin receptor agonist AND will discontinue prior to initiating romiplostim (Nplate); and
The prescriber has provided the individual's weight.

Initial Length of Approval: 4 months

Renewal Criteria

Romiplostim (Nplate) maybe renewed when the following are met:

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

J2796

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.

Diagnosis Codes

D69.3

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 9-26-2019 Annual Review

Internal Medical Policy Committee 9-21-2020 Annual Review; criteria updated

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.

Section: Injections

Effective Date: October 01, 2019

Revised Date: September 30, 2019

Archived Date: September 30, 2020

Description

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

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

Procedure Codes

J2796

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

D69.3

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