CurrentHawaii Department of Human ServicesPolicy FFS-1603 QI-1611

RSV prophylaxis with palivizumab (Synagis) — Hawaii Medicaid QUEST Integration guideline

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Guideline for coverage and authorization of RSV immunoprophylaxis with palivizumab for high-risk infants and children under Hawaii Medicaid QUEST Integration plans during the specified RSV season.

Policy Summary

PayerHawaii Department of Human Services

PolicyRSV prophylaxis with palivizumab (Synagis) — Hawaii Medicaid QUEST Integration guideline

Policy CodePolicy FFS-1603 QI-1611

Change TypeAnnual guideline update (no material clinical changes)

Effective DateAug 5, 2016

Next Review DateN/A

Key ActionObtain prior authorization for palivizumab; doses are covered at 28–35 day intervals during the RSV season.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

15 mg/kgapproved palivizumab dosage

Sep 1, 2016 - Mar 31, 2017coverage period

28-35 daysdose interval

up to 5max doses/season

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CurrentHawaii Department of Human ServicesPolicy FFS-1603 QI-1611

RSV prophylaxis with palivizumab (Synagis) — Hawaii Medicaid QUEST Integration guideline

Customize your policy alerts

Sign up for Hawaii Department of Human Services Policy FFS-1603 QI-1611 alerts

Get alerted when Policy FFS-1603 QI-1611 changes without checking for updates manually.

Monitor payer policy activity

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

Guideline for coverage and authorization of RSV immunoprophylaxis with palivizumab for high-risk infants and children under Hawaii Medicaid QUEST Integration plans during the specified RSV season.

Policy Summary

PayerHawaii Department of Human Services

PolicyRSV prophylaxis with palivizumab (Synagis) — Hawaii Medicaid QUEST Integration guideline

Policy CodePolicy FFS-1603 QI-1611

Change TypeAnnual guideline update (no material clinical changes)

Effective DateAug 5, 2016

Next Review DateN/A

Key ActionObtain prior authorization for palivizumab; doses are covered at 28–35 day intervals during the RSV season.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

15 mg/kgapproved palivizumab dosage

Sep 1, 2016 - Mar 31, 2017coverage period

28-35 daysdose interval

up to 5max doses/season

Coverage Criteria for Palivizumab (Synagis)

Infants <12 months at season start

Covered when ANY one of the following is met for infants less than 12 months chronologic age at start of RSV season (born on or after September 1, 2015):

Infant high-risk criteria

Hemodynamically significant congenital heart disease and/or persistent pulmonary hypertension requiring medical management.
Infants born prematurely under 29 weeks (≤28 + 6 weeks) gestation.
Infants with pulmonary abnormalities or neuromuscular diseases that impair the ability to clear secretions from the upper or lower airways.
Infants born prematurely under 32 weeks (≤31 + 6 weeks) gestation with a history of requiring supplemental oxygen or positive pressure ventilation for the first 28 days after birth.

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Children <24 months at season start

Covered when ANY one of the following is met for children less than 24 months chronologic age at start of RSV season (born on or after September 1, 2014):

Child high-risk criteria

Chronic Lung Disease (CLD) requiring medical management, defined as need for supplemental oxygen, chronic corticosteroid use, or diuretic therapy during the 6-month period prior to the current RSV season.
Severely immunocompromised patients (for example, those undergoing stem cell transplantation or chemotherapy, or with a severe immunocompromised condition) may also be considered for RSV prophylaxis.

Palivizumab (Synagis®) is not covered for infants and children with hemodynamically insignificant heart disease, including but not limited to secundum atrial septal defect (ASD), small ventricular septal defect (VSD), mild coarctation, and patent ductus arteriosus (PDA).

Coverage is also excluded for cardiac lesions that have been adequately corrected by surgery unless the child continues to require ongoing cardiac medication or supplemental oxygen for management of their heart disease, and for mild cardiomyopathy that does not require medical therapy.

Palivizumab is intended for prevention of respiratory syncytial virus (RSV) infection and is not medically necessary for treatment of active RSV disease.

Requests to continue prophylaxis for patients with an active RSV infection or with a documented RSV infection during the current RSV season should be denied and therapy discontinued, as palivizumab is not indicated for treatment.

Provider Requirements and Authorization

Prior Authorization

Prior authorization required for palivizumab

Prior authorization is required for palivizumab and, when approved, will cover doses administered at 28–35 day intervals during the RSV season (September 1, 2016 through March 31, 2017).

Authorization required by MQD for palivizumab
Approved coverage applies to doses given every 28–35 days during the specified RSV season

Step Therapy

No step therapy required

This guideline specifies no step therapy requirements for palivizumab; providers do not need to document failure of alternate prophylaxis steps before requesting authorization.

Definitions and Key Terms

Palivizumab (Synagis) — key definition

AgentPalivizumab (Synagis)

ClassMonoclonal antibody for RSV immunoprophylaxis

Route & doseIntramuscular (IM) injection at 15 mg/kg

Indication (summary)FDA‑approved for RSV prophylaxis in high‑risk infants and children; covered per MQD guidelines with specific high‑risk criteria

Start of RSV season (definition)

RSV season start (this guideline)September 1, 2016

Coverage period (season)

Background

Respiratory syncytial virus (RSV) is a significant cause of respiratory infection risk among high-risk infants and young children. Palivizumab (Synagis®) is used as immunoprophylaxis in eligible pediatric patients to prevent severe RSV disease.

This guideline clarifies exclusions and appropriate use: palivizumab is a preventive monoclonal antibody and should not be used for patients with active or already documented RSV infection during the current RSV season; such patients should have prophylaxis discontinued.