CurrentHawaii Medical Service Association (HMSA)Policy N/A

Nplate (romiplostim) Coverage Criteria

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This policy governs Medicare Advantage coverage and prior authorization requirements for Nplate (romiplostim) for immune thrombocytopenia, hematopoietic syndrome of acute radiation syndrome, myelodysplastic syndromes, and chemotherapy-induced thrombocytopenia. Coverage is subject to indication-specific clinical criteria, documentation, authorization durations, and continuation requirements.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyNplate (romiplostim) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateNov 21, 2025

Last ReviewOct 1, 2025

Next Review DateN/A

Key ActionPrecertification is required for Nplate; providers should use the applicable HMSA medical specialty drug policy fax form.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentHawaii Medical Service Association (HMSA)Policy N/A

Nplate (romiplostim) Coverage Criteria

Customize your policy alerts

Sign up for all Hawaii Medical Service Association (HMSA) policy alerts

Know when Hawaii Medical Service Association (HMSA) releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyNplate (romiplostim) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateNov 21, 2025

Last ReviewOct 1, 2025

Next Review DateN/A

Key ActionPrecertification is required for Nplate; providers should use the applicable HMSA medical specialty drug policy fax form.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Covered indication categories

12 monthsMaximum initial authorization for ITP and lower-risk MDS

1 monthInitial authorization for HS-ARS

6 monthsInitial authorization for CIT

RequiredPrecertification requirement

Covered Indications

Initial therapy for immune thrombocytopenia

Covered when both of the following criteria are met.

ITP initial therapy

Pretreatment platelet count
- Platelet count is less than 30 × 10^9/L.<30 × 10^9/L
- Platelet count is 30 × 10^9/L to 50 × 10^9/L and the member has symptomatic bleeding or risk factors for bleeding.30 × 10^9/L to 50 × 10^9/L
  Examples include significant mucous membrane or gastrointestinal bleeding, anticipated blood loss from a procedure, bleeding comorbidities, mandated anticoagulation, or a trauma-prone occupation or lifestyle.
Prior treatment or clinical reason
- Member previously received treatment with an immunoglobulin for ITP.
- Member had an inadequate response to corticosteroids.
- Member has a clinical reason to avoid treatment with both immunoglobulins and corticosteroids.
- Member has undergone a splenectomy.

Hematopoietic syndrome of acute radiation syndrome

Covered when treating hematopoietic syndrome of acute radiation syndrome.

HS-ARS: Member has hematopoietic syndrome of acute radiation syndrome following acute exposure to myelosuppressive doses of radiation.

Authorization may be granted for 1 month.

Initial therapy for myelodysplastic syndromes

Covered when both of the following criteria are met.

MDS initial therapy

Lower-risk disease: Member has lower-risk disease defined as IPSS-R Very Low, Low, or Intermediate; IPSS Low or Intermediate-1; or WPSS Very Low, Low, or Intermediate.
Severe or refractory thrombocytopenia: Member has severe or refractory thrombocytopenia following disease progression or no response to hypomethylating agents such as azacitidine or decitabine, or immunosuppressive therapy.

Initial therapy for chemotherapy-induced thrombocytopenia

Covered when either of the following criteria is met.

CIT initial therapy

Persistent thrombocytopenia after chemotherapy: Platelet count is less than 100 × 10^9/L for at least 3 to 4 weeks following the last chemotherapy administration.<100 × 10^9/L for at least 3 to 4 weeks
Chemotherapy delay: Chemotherapy administration has been delayed related to thrombocytopenia.

Continuation therapy for immune thrombocytopenia

Continuation is covered when all of the following criteria are met.

ITP continuation

Member is currently receiving therapy with Nplate.
Nplate is being used to treat immune thrombocytopenia (ITP).
Qualifying response or maximal-dose trial
- Benefit from therapy
  - Current platelet count is less than 50 × 10^9/L and is sufficient to prevent clinically important bleeding.<50 × 10^9/L
  - Current platelet count is 50 × 10^9/L to 200 × 10^9/L.

Continuation therapy for myelodysplastic syndromes

Continuation is covered when all of the following criteria are met.

MDS continuation: Member is currently receiving therapy with Nplate for myelodysplastic syndromes and is receiving benefit from therapy demonstrated by increased platelet counts, decreased bleeding events, or reduced need for platelet transfusions.

Authorization may be granted for 12 months.

Continuation therapy for chemotherapy-induced thrombocytopenia

Continuation is covered when all of the following criteria are met.

CIT continuation: Member is currently receiving therapy with Nplate for chemotherapy-induced thrombocytopenia, is receiving benefit from therapy demonstrated by increased platelet counts, decreased bleeding events, or reduced need for platelet transfusions, and Nplate is used to maintain the dose schedule and intensity of chemotherapy.

Authorization may be granted for 12 months.

Myelodysplastic syndromes

Nplate use is supported for lower-risk myelodysplastic syndrome when the following clinical circumstances are present.

Lower-risk MDS use

Lower-risk disease with thrombocytopenia: Patient has lower-risk myelodysplastic syndrome with severe or refractory thrombocytopenia.IPSS-R very low, low, or intermediate
Disease course or treatment response
- Disease progression is present.
- There has been no response to hypomethylating agents or immunosuppressive therapy.

Chemotherapy-induced thrombocytopenia

Nplate use is supported for chemotherapy-induced thrombocytopenia when the following platelet-duration and chemotherapy-related circumstances are present.

Patient has chemotherapy-induced thrombocytopenia with platelets less than 100,000/mcL for at least three to four weeks following the last chemotherapy administration.<100,000/mcL for at least 3–4 weeks
Chemotherapy-related circumstance
- The thrombocytopenia follows the last chemotherapy administration.
- Thrombocytopenia has caused delays in chemotherapy initiation.

Clinical Thresholds for Submission

ITP pretreatment platelet count

Platelet count below 30 × 10^9/LUntransfused platelet count at any point before initiation of Nplate is less than 30 × 10^9/L.

Platelet count from 30 × 10^9/L to 50 × 10^9/LUntransfused platelet count is 30 × 10^9/L to 50 × 10^9/L with symptomatic bleeding.

Bleeding-risk conditionsFor a platelet count of 30 × 10^9/L to 50 × 10^9/L, qualifying risk factors include anticipated blood loss from a medical or dental procedure, bleeding comorbidities, mandated anticoagulation, or a trauma-prone occupation or lifestyle.

Chemotherapy-induced thrombocytopenia platelet count

Platelet-count thresholdPlatelet count is less than 100 × 10^9/L.

Required durationThe platelet count must remain below 100 × 10^9/L for at least 3 to 4 weeks.

Authorization and Documentation Requirements

Prior Authorization

Indication-Specific Initial Authorization

Initial authorization is indication-specific and may be granted only when the applicable clinical criteria are met. Authorization duration varies by indication.

Immune thrombocytopenia (ITP): 12 months when the member has an untransfused platelet count before treatment of either <30 x 10⁹/L, or 30–50 x 10⁹/L with symptomatic bleeding or bleeding risk factors, and has previously received immunoglobulin, had an inadequate corticosteroid response, has a clinical reason to avoid both immunoglobulins and corticosteroids, or has undergone splenectomy.
Hematopoietic syndrome of acute radiation syndrome (HS-ARS): 1 month for acute exposure to myelosuppressive doses of radiation.
Myelodysplastic syndromes (MDS): 12 months for lower-risk disease—defined by applicable IPSS-R, IPSS, or WPSS categories—when thrombocytopenia is severe or refractory following disease progression or no response to hypomethylating agents such as azacitidine or decitabine, or immunosuppressive therapy.
Chemotherapy-induced thrombocytopenia (CIT): 6 months when platelet count is <100 x 10⁹/L for at least 3–4 weeks after the last chemotherapy administration, or chemotherapy has been delayed because of thrombocytopenia.

Therapeutic Context

Nplate (romiplostim) increases platelet counts and is used for thrombocytopenic conditions. Under this policy, covered uses include immune thrombocytopenia (ITP), hematopoietic syndrome of acute radiation syndrome (HS-ARS), lower-risk myelodysplastic syndromes (MDS) with severe or refractory thrombocytopenia, and chemotherapy-induced thrombocytopenia (CIT).

Treatment is intended to reduce clinically important or severe bleeding risk by improving or maintaining platelet counts. Depending on the indication, treatment benefit may also be reflected by decreased bleeding events, reduced platelet transfusion needs, or maintenance of chemotherapy dose schedule and intensity.

Clinical Definitions

Lower-risk myelodysplastic syndromes

IPSS-RLower-risk disease includes Revised International Prognostic Scoring System (IPSS-R) categories Very Low, Low, or Intermediate.

IPSSLower-risk disease includes International Prognostic Scoring System (IPSS) categories Low or Intermediate-1.

WPSSLower-risk disease includes WHO classification-based Prognostic Scoring System (WPSS) categories Very Low, Low, or Intermediate.

Benefit from therapy in ITP

Platelet count below 50 × 10^9/LBenefit may be demonstrated when the current platelet count is less than 50 × 10^9/L and sufficient to prevent clinically important bleeding.

Platelet count from 50 × 10^9/L to 200 × 10^9/LA current platelet count of 50 × 10^9/L to 200 × 10^9/L demonstrates benefit from therapy.

Initial Authorization Criteria

ITP initial authorization

ITP initial authorization may be granted for 12 months when both the platelet-count criterion and one prior-treatment or treatment-avoidance criterion are met.

Qualifying pretreatment platelet count: Member has an untransfused platelet count at any point before initiation of Nplate that is less than 30 × 10^9/L, or is 30 × 10^9/L to 50 × 10^9/L with symptomatic bleeding or risk factors for bleeding.<30 × 10^9/L, or 30 × 10^9/L to 50 × 10^9/L with symptomatic bleeding or bleeding risk factors
Prior treatment or clinical reason
- Member previously received treatment with an immunoglobulin for ITP.
- Member had an inadequate response to corticosteroids.

Continuation Authorization Criteria

General continuation requirement

All members, including new members, requesting continuation authorization must be currently receiving Nplate.

Current therapy requirement: Member is currently receiving therapy with Nplate.

This requirement applies to all continuation requests, including requests for new members.

ITP continuation

ITP continuation requires current Nplate therapy, ITP use, and a qualifying response or maximal-dose trial condition.

Member is currently receiving Nplate for ITP.
Qualifying benefit or maximal-dose trial condition
- Benefit from therapy

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyNplate (romiplostim) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateNov 21, 2025

Last ReviewOct 1, 2025

Next Review DateN/A

Key ActionPrecertification is required for Nplate; providers should use the applicable HMSA medical specialty drug policy fax form.

SourceLink

On This Page

50 × 10^9/L to 200 × 10^9/L

Current platelet count is greater than 200 × 10^9/L through 400 × 10^9/L and Nplate dosing will be adjusted to achieve a platelet count sufficient to avoid clinically important bleeding.>200 × 10^9/L to ≤400 × 10^9/L

Insufficient response before maximal dose: Current platelet count is less than 50 × 10^9/L, is not sufficient to prevent clinically important bleeding, and the member has not received a maximal Nplate dose for at least 4 weeks.<50 × 10^9/L; maximal dose for less than 4 weeks

Authorization may be granted for 3 months.

Timing after chemotherapyThe duration is measured following the last chemotherapy administration.

Platelet count and chemotherapy delay

Platelet-count thresholdPlatelets are less than 100,000/mcL.

Required durationThrombocytopenia is present for at least 3–4 weeks following the last chemotherapy administration.

Chemotherapy-delay contextThe criterion also includes delays in chemotherapy initiation related to thrombocytopenia.

Continuation Authorization

For continuation requests, including requests for new members, the member must be currently receiving Nplate. The applicable indication-specific response and treatment requirements below must also be met.

ITP: Authorization may be granted when Nplate is being used for ITP and the member is receiving benefit. A 12-month authorization applies when the current platelet count is <50 x 10⁹/L and sufficient to prevent clinically important bleeding, is 50–200 x 10⁹/L, or is >200 to ≤400 x 10⁹/L with dose adjustment planned to achieve a platelet count sufficient to avoid clinically important bleeding. A 3-month authorization may apply when the current platelet count is <50 x 10⁹/L, insufficient to prevent clinically important bleeding, and the member has not received a maximal Nplate dose for at least 4 weeks.
MDS: 12 months when the member is receiving benefit, demonstrated by increased platelet counts, decreased bleeding events, or reduced need for platelet transfusions.
CIT: 12 months when the member is receiving benefit, demonstrated by increased platelet counts, decreased bleeding events, or reduced need for platelet transfusions, and Nplate is being used to maintain the dose schedule and intensity of chemotherapy.

Denial Risk

Approval Criteria and Exclusions

Coverage is available only when all applicable approval criteria are met and the member has no exclusions to the prescribed therapy.

Verify that the requested use meets the applicable FDA-approved or listed compendial indication criteria.
Confirm that all indication-specific clinical, laboratory, treatment-response, and continuation requirements are satisfied.
Requests that fail to meet the applicable approval criteria or involve an exclusion to the prescribed therapy are not eligible for coverage.

Documentation Required

Other Indications Require Compendial Support

Indications not listed in the policy criteria are assessed individually. Submissions for other indications must include supporting evidence from Medicare-approved compendia.

Provide Medicare-approved compendial support for any requested indication outside ITP, HS-ARS, MDS, or CIT.

Documentation Required

Platelet Count Documentation

For requests involving ITP or CIT, the required platelet-count documentation must be available upon request.

Initial requests: Provide the pretreatment platelet count.
Continuation requests: Provide the current platelet count.

Prior Authorization

Precertification Required

Precertification is required before Nplate is administered. Providers should use the HMSA medical specialty drug policy website to obtain the fax form.

Submit the required precertification request to HMSA.
Refer to the HMSA medical specialty drug policy website for the applicable fax form.

Platelet count above 200 × 10^9/L through 400 × 10^9/LBenefit may be demonstrated when the current platelet count is greater than 200 × 10^9/L to less than or equal to 400 × 10^9/L and Nplate dosing will be adjusted to achieve a platelet count sufficient to avoid clinically important bleeding.

Lower-risk myelodysplastic syndrome

Very low riskIPSS-R category: very low.

Low riskIPSS-R category: low.

Intermediate riskIPSS-R category: intermediate.

Member has a clinical reason to avoid treatment with both immunoglobulins and corticosteroids.

Member has undergone a splenectomy.

HS-ARS initial authorization

HS-ARS initial authorization may be granted for 1 month.

HS-ARS: Member has hematopoietic syndrome of acute radiation syndrome following acute exposure to myelosuppressive doses of radiation.

Authorization may be granted for 1 month.

MDS initial authorization

MDS initial authorization may be granted for 12 months when both lower-risk disease and severe or refractory thrombocytopenia criteria are met.

Lower-risk disease: Member has lower-risk disease defined as IPSS-R Very Low, Low, or Intermediate; IPSS Low or Intermediate-1; or WPSS Very Low, Low, or Intermediate.
Severe or refractory thrombocytopenia: Member has severe or refractory thrombocytopenia following disease progression or no response to hypomethylating agents such as azacitidine or decitabine, or immunosuppressive therapy.

CIT initial authorization

CIT initial authorization may be granted for 6 months when either the persistent thrombocytopenia or chemotherapy-delay criterion is met.

Platelet count is less than 100 × 10^9/L for at least 3 to 4 weeks following the last chemotherapy administration.<100 × 10^9/L for at least 3 to 4 weeks
Chemotherapy administration has been delayed related to thrombocytopenia.

Current platelet count is less than 50 × 10^9/L and is sufficient to prevent clinically important bleeding.<50 × 10^9/L

Current platelet count is 50 × 10^9/L to 200 × 10^9/L.50 × 10^9/L to 200 × 10^9/L

Authorization may be granted for 3 months.

MDS and CIT continuation

MDS and CIT continuation require current Nplate therapy, use for the applicable condition, and documented treatment benefit; CIT also requires maintenance of the chemotherapy dose schedule and intensity.

MDS continuation: Member is currently receiving Nplate for MDS and has increased platelet counts, decreased bleeding events, or reduced need for platelet transfusions.

Authorization may be granted for 12 months.

CIT continuation: Member is currently receiving Nplate for CIT, has increased platelet counts, decreased bleeding events, or reduced need for platelet transfusions, and Nplate is used to maintain the chemotherapy dose schedule and intensity.

Authorization may be granted for 12 months.