Skip to main content
HealthPartners

Coverage criteria policies

Synagis (palivizumab) injections for respiratory syncytial virus (RSV) prophylaxis – Minnesota Health Care Programs

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Prior authorization is required for Synagis injections for respiratory syncytial virus (RSV) prophylaxis.

Coverage

Synagis injections for respiratory syncytial virus (RSV) prophylaxis are generally covered subject to the indications listed below and per your plan documents.

Indications that are covered

FDA approved indications and usage

  • Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease
  • The RSV season is expected to be November 13 to March 31
  • Up to five doses will be allowed per recipient over the course of the RSV season. Some patients will be eligible for fewer doses, depending on their gestational and chronological age
  • If a dose was administered in an inpatient setting, the date the dose was administered must be included on the request form
Criteria

Infant or Child with Pulmonary Dysfunction

  1. Any infant or child less than or equal to 12 months of age born before 32 weeks, 0 days’ gestation with a diagnosis of Chronic Lung Disease (CLD) of prematurity (defined as supplemental oxygen for at least 28 days after birth.
  2. Any infant or child less than or equal to 24 months of age born before 32 weeks, 0 days’ gestation that required at least 28 days of supplemental oxygen after birth AND having one or more of the following clinical needs during the previous 6 months:
    1. Supplemental oxygen
    2. Recent use of corticosteroid therapy
    3. Regular or intermittent use of diuretics to treat pulmonary disease

*Up to five (5) monthly doses will be approved.

  1. Any infant or child less than or equal to 12 months of age, as of November 6, 2017, with a diagnosis of one or more of the following that impacts pulmonary function:
    1. Interstitial Lung Disease
    2. Neuromuscular disease
    3. Congenital airway abnormality

* Up to five (5) monthly doses will be approved.

Infant with congenital heart disease (CHD) (see also Indications that are not covered)

  1. Any infant less than 12 months of age, as of November 6, 2017, who has a diagnosis of hemodynamically significant congenital heart disease (CHD) and meets any of the following criteria:
    1. Receiving medication to control congestive heart failure (diuretics, antihypertensives)
    2. Moderate to severe pulmonary hypertension
    3. Cyanotic heart disease

* Up to five (5) monthly doses will be approved.

Infants with a history of premature birth

  1. Any infant up to 12 months of age, born at less than 29 weeks, 0 days’ gestation.

* Up to five (5) monthly doses will be approved.

Infants or children who are profoundly immunocompromised

  1. Any infant or child younger than 24 months of age who will be profoundly immunocompromised during the RSV season.

* Up to five (5) monthly doses will be approved.

Indications that are not covered

  1. Patients with CHD who are not candidates for Synagis include:
    1. Hemodynamically insignificant heart disease
    2. Secundum ASD
    3. Small VSD
    4. Pulmonic stenosis
    5. Uncomplicated aortic stenosis
    6. Mild coarctation of the aorta
    7. Patent ductus arteriosus (PDA)
    8. Infants with corrected surgical lesions unless they continue to require medication for CHF
    9. Infants with mild cardiomyopathy who are not receiving medical therapy
  2. There are no guideline or consensus recommendations to support Synagis prophylaxis in patients who have one of the following disorders:
    1. Hematopoietic stem cell transplant (BMT, peripheral blood, placental or cord blood)
    2. Severe combined immunodeficiency syndrome
    3. Children with Down Syndrome
    4. Advanced AIDS
    5. Cystic fibrosis
    6. RSV episode during the current season
    7. Repeated pneumonia
    8. Sickle cell disease
    9. Being one member of a multiple birth, another member of which is approved for Synagis
    10. Apnea or respiratory failure of newborn

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

Vendor

For in-network benefits to apply, item must be received from a contracted vendor or provider.

References

  1. Minnesota Health Care Programs. (2018). Synagis MHCP Policy and PA Criteria.

Go to

Policy activity

  • 09/25/2018 - Date of origin
  • 10/01/2018 - Effective date

Related content