Synagis MHCP Policy and PA Criteria

Drug - Synagis [palivizumab]

August 2023

2023-2024 RSV Season

Prior authorization is required for all patients

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

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 1 to March 31 OR is determined in real time by identifying the first week of two consecutive weeks that RSV RT-PCR test positivity is greater than or equal to 3% or antigen detection positivity is greater than or equal to 10% (according to CDC RSV Surveillance for Minnesota).
• Up to eight doses will be allowed per member over the course of the RSV season. Some patients will be eligible for fewer doses, depending on their gestational and chronological age. The number of requested doses must be clearly stated on the prior authorization request form.
• 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, use Table 1 to determine dosage. Table 1 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 or 100 mg vial

Criteria

Infant or Child with Pulmonary Dysfunction

Any infant or child younger 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 younger 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 eight (8) monthly doses will be approved.

Any infant or child younger than or equal to 12 months of age, at the time of request, with a diagnosis of one or more of the following that impacts pulmonary function:

• Interstitial Lung Disease
• Neuromuscular disease
• Congenital airway abnormality

Up to eight (8) monthly doses will be approved.

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

Any infant younger than 12 months of age, at the time of request, 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 eight (8) 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 eight (8) 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 eight (8) 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

Addendum C

During the 2023-2024 RSV season, prior authorization request may be approved if the patient meets applicable clinical criteria AND one of the following:

• Patient has a contraindication to the RSV immunization (nirsevimab-alip, Beyfortus [Sanofi]) OR
• Patient is unable to receive the RSV immunization (nirsevimab-alip, Beyfortus [Sanofi]) 

Questions?

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