CurrentMass General Brigham Health PlanPolicy N/A

Nplate (romiplostim) coverage — prior authorization and medical necessity criteria

Policy governing prior authorization, medical necessity criteria, and coverage limits for romiplostim (Nplate) for Mass General Brigham Health Plan members under medical and pharmacy benefits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyNplate (romiplostim) coverage — prior authorization and medical necessity criteria

Policy CodePolicy N/A

Change TypeOperational revision (SGM → Custom) effective 1/1/2024

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization; authorization requires diagnosis-specific criteria (e.g., inadequate response to prior ITP therapies or specified platelet thresholds) and prescriber specialty when applicable.

SourceLink

POLICY UPDATE CHANGES

Policy was switched from SGM to Custom effective 1/1/2024.

4FDA & compendia indications listed

1-12 moInitial authorization durations

Up to 12 moReauthorization durations

MultiplePlatelet thresholds

Coverage Criteria for Romiplostim (Nplate)

Initial Therapy - ITP

Covered when ALL of the following are met for Immune Thrombocytopenia (ITP):

ITP initial authorization: Member has a diagnosis of immune thrombocytopenia (ITP) and inadequate response or intolerance to prior therapy with corticosteroids, immunoglobulins, or splenectomy

See Section VII for bleeding risk factors

ITP platelet requirement: Untransfused platelet count at any point prior to initiation of the requested medication is <30 x10^9/L OR 30–50 x10^9/L with symptomatic bleeding (e.g., significant mucous membrane bleeding, gastrointestinal bleeding or trauma) or risk factors for bleeding<30 x10^9/L OR 30–50 x10^9/L with symptomatic bleeding

Symptomatic bleeding or bleeding risk factors per policy

Initial Therapy - HSARS

Covered when ALL of the following are met for HSARS:

HSARS initial authorization: Member has hematopoietic syndrome of acute radiation syndrome (acute exposure to myelosuppressive doses of radiation)

FDA indication

Initial Therapy - MDS (compendial)

Covered when ALL of the following are met for Myelodysplastic Syndromes (MDS):

MDS initial authorization: Member has lower-risk MDS defined by IPSS-R (Very Low, Low, Intermediate), IPSS (Low/Intermediate-1), or WPSS (Very Low, Low, Intermediate)per scoring systems

Compendia-supported use

MDS thrombocytopenia requirement: Member has severe or refractory thrombocytopenia following disease progression or lack of response to hypomethylating agents (e.g., azacitidine, decitabine), immunosuppressive therapy, or clinical trial

Compendia-supported use

Initial Therapy - CIT (compendial)

Covered when ANY of the following are met for Chemotherapy-Induced Thrombocytopenia (CIT):

CIT authorization: Platelet count is <100 x10^9/L for at least 3–4 weeks following the last chemotherapy administration<100 x10^9/L for 3–4 weeks

Compendia-supported use; member must not receive concurrent other TPO-RAs or SYK inhibitors and medication must be prescribed by or in consultation with a hematologist/oncologist

CIT authorization - delay: Chemotherapy administration has been delayed due to thrombocytopenia

Member must not receive concurrent other TPO-RAs or SYK inhibitors and medication must be prescribed by or in consultation with a hematologist/oncologist

Continuation Therapy

Continuation therapy covered when benefit demonstrated and platelet goals met as specified:

Continuation - general: Member demonstrates clinical benefit from therapy (e.g., increased platelet counts, decreased bleeding events, reduced need for platelet transfusions)

Applies to MDS, CIT, HSARS and ITP continuation rules specified below

ITP continuation (short): Authorization of 3 months may be granted for members with current platelet count <50 x10^9/L for whom the platelet count is not sufficient to prevent clinically important bleeding and who have not received a maximal Nplate dose for at least 4 weeks<50 x10^9/L

Chunk 9

ITP continuation (12 months): Authorization of 12 months may be granted for any of: current platelet count <50 x10^9/L sufficient to prevent clinically important bleeding; OR platelet count 50–200 x10^9/L; OR platelet count >200 to ≤400 x10^9/L with Nplate dosing adjustments to achieve a platelet count sufficient to avoid clinically important bleeding

Use of romiplostim (Nplate) for indications other than those explicitly listed as covered—specifically the FDA-approved indications and the compendia-supported uses for Chemotherapy‑Induced Thrombocytopenia (CIT) and certain lower‑risk Myelodysplastic Syndromes (MDS)—is considered experimental/investigational and not medically necessary and therefore not covered.

Requests to use romiplostim for conditions outside the listed FDA indications and the specified compendial uses (CIT and lower‑risk MDS as described) will be denied as not medically necessary. Coverage is limited to the named indications and supporting compendia‑based scenarios; therapies for other diagnoses do not meet the plan’s medical necessity criteria.

Regimen	Indication	Coverage status	Key criteria / notes
Romiplostim (compendia-supported)
Myelodysplastic syndromes — lower risk disease (IPSS‑R Very Low/Low/Intermediate; IPSS Low/Intermediate‑1; or WPSS Very Low/Low/Intermediate)
covered
Member has severe or refractory thrombocytopenia following disease progression or no response to hypomethylating agents, immunosuppressive therapy, or clinical trial; compendia-supported use

Regimen	Indication	Coverage status	Key criteria / notes
Romiplostim (compendia-supported)
Chemotherapy‑induced thrombocytopenia (CIT)
covered
Authorization when any of the following are met: platelet count <100 x10^9/L for at least 3–4 weeks after last chemotherapy OR chemotherapy administration delayed due to thrombocytopenia; member must not receive concurrent other TPO‑RAs or SYK inhibitors; medication prescribed by or in consultation with a hematologist/oncologist

Billing and Coding

Codesmixed

N/A	No explicit CPT/HCPCS/ICD-10/NDC codes listed in document

Platelet count thresholds

ITP – initiation thresholdUntransfused platelet count <30 x10^9/L, or 30–50 x10^9/L with symptomatic bleeding or bleeding risk factors

ITP – continuation thresholdsCurrent platelet count <50 x10^9/L (short-term auth) or 50–200 x10^9/L (12-month auth); >200–≤400 x10^9/L with dose adjustments to avoid bleeding

CIT – initiation/continuation thresholdPlatelet count <100 x10^9/L for at least 3–4 weeks after last chemotherapy (or chemotherapy delayed due to thrombocytopenia); target maintenance 100–200 x10^9/L for continuation

General restriction on concomitant agentsMember must not receive concurrent other thrombopoietin receptor agonists or spleen tyrosine kinase inhibitors when on romiplostim

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for this medication. Authorization may be granted for members new to the plan only when the member is currently receiving the requested medication (excludes products obtained solely as samples or through manufacturer patient assistance programs).

New-to-plan continuity: member must be actively receiving the medication at time of request
Samples or manufacturer patient assistance program supplies do not qualify for continuity approval

Prior Authorization

ITP — Prior Therapy Required

For immune thrombocytopenia (ITP), authorization requires documentation of inadequate response or intolerance to prior therapies such as corticosteroids, immunoglobulins, or splenectomy. Additionally, the member must meet platelet-count criteria (untransfused platelet count < 30 x 10^9/L, or 30–50 x 10^9/L with symptomatic bleeding or risk factors for bleeding).

Must show inadequate response or intolerance to corticosteroids, IVIG, or splenectomy
Platelet criteria: < 30 x 10^9/L, or 30–50 x 10^9/L with symptomatic bleeding or bleeding risk factors

Prior Authorization

CIT — Prescriber and Concomitant Therapy Requirements

For chemotherapy-induced thrombocytopenia (CIT), the medication must be prescribed by or in consultation with a hematologist or oncologist. Authorization may be granted when chemotherapy has been delayed due to thrombocytopenia or when platelet count remains < 100 x 10^9/L for at least 3–4 weeks after the last chemotherapy administration. The member must not be receiving concurrent treatment with other thrombopoietin receptor agonists or spleen tyrosine kinase inhibitors.

Prescriber requirement: hematologist or oncologist (or in consultation with one)
CIT timing: platelet count < 100 x 10^9/L for ≥ 3–4 weeks post-chemotherapy or chemotherapy delayed due to thrombocytopenia
No concurrent treatment with other TPO receptor agonists (e.g., eltrombopag, avatrombopag, romiplostim) or spleen tyrosine kinase inhibitors (e.g., fostamatinib)

Covered Regimens and Indication-specific Notes

Regimen	Disease definition	Required criteria	Coverage stance
Romiplostim (compendia-supported)
Lower risk MDS defined by IPSS‑R (Very Low, Low, Intermediate), IPSS (Low/Intermediate‑1), or WPSS (Very Low, Low, Intermediate)
Severe or refractory thrombocytopenia following disease progression or no response to hypomethylating agents, immunosuppressive therapy, or clinical trial
covered

Regimen	Triggering condition	Concurrent therapy restrictions	Coverage stance
Romiplostim (compendia-supported)
Platelet count <100 x10^9/L for at least 3–4 weeks after last chemotherapy OR chemotherapy administration delayed due to thrombocytopenia
No concurrent treatment with other thrombopoietin receptor agonists (e.g., eltrombopag, avatrombopag, lusutrombopag) or spleen tyrosine kinase inhibitors; prescribed by or in consultation with a hematologist or oncologist
covered

Definitions

Lower risk disease (MDS) definitions

IPSS-R definitionLower risk = IPSS-R categories Very Low, Low, or Intermediate

IPSS definitionLower risk = IPSS categories Low or Intermediate-1

WPSS definitionLower risk = WPSS categories Very Low, Low, or Intermediate

Background

Romiplostim is a thrombopoietin receptor agonist with labeled and compendia‑supported uses to increase platelet counts. The policy recognizes its FDA‑approved role in certain hematologic conditions and the compendia‑supported roles in Chemotherapy‑Induced Thrombocytopenia (CIT) and in selected lower‑risk Myelodysplastic Syndromes (MDS) with severe or refractory thrombocytopenia following progression or lack of response to prior disease‑directed therapies.

Revision History

2024-01-01Operational changeLatest

Policy was switched from SGM to Custom effective 1/1/2024.

Policy Summary

PayerMass General Brigham Health Plan

PolicyNplate (romiplostim) coverage — prior authorization and medical necessity criteria

Policy CodePolicy N/A

Change TypeOperational revision (SGM → Custom) effective 1/1/2024

Effective DateJan 1, 2024

Next Review DateN/A

SourceLink

On This Page

HSARS continuation: All members (including new members) requesting continuation of therapy must meet all initial authorization criteria

Chunk 11

MDS continuation: Continued treatment may be granted for members with MDS who experience benefit from therapy (e.g., increased platelet counts, decreased bleeding events, reduced need for platelet transfusions)

Chunk 12

CIT continuation: Continued treatment may be granted for members with CIT who experience benefit from therapy to maintain a target platelet count goal of 100–200 x10^9/L100–200 x10^9/L

Chunk 13