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Synagis MHCP Policy and PA Criteria

DrugSynagis [palivizumab]

October 2018 - 2018-2019 RSV Season

Prior authorization is required for all patients

Providers must fax the completed Synagis Authorization Form DHS-6428 (PDF) to the MHCP Prescription Drug Prior Authorization Agent.

MHCP will allow Synagis dispensing to begin November 5, 2018. Qualifying infants born during the RSV season will require fewer doses than the maximum allowed number of 5 doses.

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 12 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

Dosing allowance policy

The calculated dose of Synagis is 15 mg/kg. Because this drug is available only in 50 mg and 100 mg vials, the following table should be followed and shows a 10% difference in allowed dose from the calculated dose.

Table 1.  MN DHS Dosing Allowance - 10% difference from calculated dose

Weight Calculated dose
(max wt) (15mg/kg)
Allowed dose Dispense
0 to 3.6 kg 54  mg 50 mg one 50 mg vial
3.7 to 7.3 kg 110 mg 100 mg one 100 mg vial
7.4 to 11.1 kg 166.5 mg 150 mg one 100 mg one 50 mg vial
11.2 to 14.6 kg 220 mg 200 mg two 100 mg vials
14.7 to 18.1 kg 271.5 mg 250 mg two 100 mg one 50 mg vial

How Supplied

50 mg vial, 100 mg vial

Criteria

Infant or Child with Pulmonary Dysfunction

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.

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:

  • Supplemental oxygen
  • Recent use of corticosteroid therapy
  • Regular or intermittent use of diuretics to treat pulmonary disease

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

Any infant or child less than or equal to 12 months of age, as of November 5, 2018, with a diagnosis of one or more of the following that impacts pulmonary function:

  • Interstitial Lung Disease
  • Neuromuscular disease
  • Congenital airway abnormality

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

Infant with congenital heart disease (CHD) (see also addendum A)

Any infant less than 12 months of age, as of November 5, 2018, who has a diagnosis of hemodynamically significant congenital heart disease (CHD) and meets any of the following criteria:

  • Receiving medication to control congestive heart failure (diuretics, antihypertensives)
  • Moderate to severe pulmonary hypertension
  • Cyanotic heart disease

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

Infants with a history of premature birth

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

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.

Addendum A

Patients with CHD who are NOT candidates for Synagis include:

  • Hemodynamically insignificant heart disease
  • Secundum ASD
  • Small VSD
  • Pulmonic stenosis
  • Uncomplicated aortic stenosis
  • Mild coarctation of the aorta
  • Patent ductus arteriosus (PDA)
  • Infants with corrected surgical lesions unless they continue to require medication for CHF
  • Infants with mild cardiomyopathy who are not receiving medical therapy

Addendum B

There are no guideline or consensus recommendations to support Synagis prophylaxis in patients who have one of the following disorders:

  • Hematopoietic stem cell transplant (BMT, peripheral blood, placental or cord blood)
  • Severe combined immunodeficiency syndrome
  • Children with Down Syndrome
  • Advanced AIDS
  • Cystic fibrosis
  • RSV episode during the current season
  • Repeated pneumonia
  • Sickle cell disease
  • Being one member of a multiple birth, another member of which is approved for Synagis
  • Apnea or respiratory failure of newborn

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411

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