PARTNERSHIP HEALTHPLAN OF CALIFORNIA
POLICY / PROCEDURE
Policy/Procedure Number: : MPRG4025 (previously MPRC4025,
RC100425)
Lead Department: Health Services
Policy/Procedure Title: Palivizumab (Synagis) Guidelines
Original Date:
12/13/1999 – Medi-Cal
07/24/2008 – Healthy Kids
Applies to:
Medi-Cal
External Policy
Internal Policy
Next Review Date: 10/1/2016
Last Review Date: 10/1/2015
Healthy Kids
Employees
Reviewing
Entities:
IQI
P&T
QUAC
OPERATIONS
EXECUTIVE
COMPLIANCE
DEPARTMENT
Approving
Entities:
BOARD
COMPLIANCE
FINANCE
PAC
CEO
COO
CREDENTIALING
Approval Signature: Robert L. Moore, MD, MPH
DEPT. DIRECTOR/OFFICER
Approval Date: 10/1/2015
I.
RELATED POLICIES: N/A
II.
IMPACTED DEPTS.:
III.
DEFINITIONS: N/A
IV.
ATTACHMENTS:
A. Synagis Enrollment Packet – see enclosed sample
V.
PURPOSE:
To define the use of palivizumab (Synagis prophylaxis in infants and young children at increased risk of
hospitalization for respiratory syncytial virus (RSV) infection.
VI.
POLICY / PROCEDURE:
A. One or more of the following criteria must be met for infants to receive prophylaxis administration of
Synagis in the prevention of respiratory syncytial virus (RSV) infection:
1. Infant born before 29 weeks, 0 days’ gestation who are younger than 12 months at the start of RSV
season
2. Infants younger than 12 months of age with chronic lung disease (CLD) of prematurity defined as
gestational age <32 weeks, 0 days and a requirement of >21% oxygen for at least the first 28 days
after birth
3. Infants age 12 months to 24 months who satisfy the definition of CLD of prematurity AND continue
to require medical support ( chronic corticosteroid therapy, bronchodilator therapy, or supplemental
oxygen) during the six month period before the start of RSV season
4. Infants age 12 months or younger with hemodynamically significant congenital heart disease
(CHD). This category includes infants with acyanotic heart disease who are receiving medication to
control congestive heart failure and will require cardiac surgical procedures and infants with
moderate to severe pulmonary hypertension.
5. Infants younger than 12 months of age with cyanotic heart defects and request is made in
conjunction with a pediatric cardiologist
6. Children younger than 24 months who undergo cardiac transplantation during the RSV season
7. Infants younger than 12 months of age with neuromuscular disease or congenital anomaly that
impairs the ability to clear secretions from the upper airways will be evaluated on a case by case
basis.
8. Infants and children with severe immunodeficiencies will be evaluated on a case by case basis.
Page 1 of 3
Policy/Procedure Number: MPRG4025 (previously
MPRC4025, RC100425)
Lead Department: Health Services
☒External Policy
☐Internal Policy
Original Date: 12/13/1999 – Medi-Cal
Next Review Date: 10/1/2016
07/24/2008 – Healthy Kids Last Review Date: 10/1/2015
☒ Healthy Kids
☐ Employees
Applies to: ☒ Medi-Cal
Policy/Procedure Title: Palivizumab (Synagis) Guidelines
B. Administration schedule of injections:
1. In Northern California RSV season typically runs from early November to mid-April.
2. Administration is every 30 days beginning in November just before the onset of RSV season.
3. Four (4) subsequent monthly doses for a total of five (5) doses are sufficient to provide protection
during the entire season. Five (5) monthly doses will provide more than 6 months (>24 weeks) of
protection.
4. Qualifying infants born during the RSV season may require fewer doses.
5. Palivizumab does not interfere with responses to vaccines. The vaccine schedule should not be
altered if palivizumab is administered
C. Palivizumab (Synagis) requires prior authorization approval and are processed through PHC designated
Specialty Pharmacy (see attachment). Designated Specialty Pharmacy is also responsible for processing
and timely monthly distribution of approve palivizumab requests to providers.
D. For all children enrolled in a California Children Services (CCS) program, PHC will follow CCS criteria
for Palivizumab (Synagis)
E. PHC Pharmacy tracks palivizumab (Synagis) approvals and monthly distribution by Specialty Pharmacy.
Additional screens may be done if there is a specific reason to suspect an incorrectly processed claim for
a specific drug or provider. The review is not limited to, but will include:
1. Eligibility
2. Reimbursement/Pricing
3. Invalid claims
4. Benefit exclusion
5. Formulary compliance
6. Informing Pharmacy Benefits Manager (PBM) – identify problems and submit report to PHC and
PBM for a corrective action plan if necessary.
VII.
REFERENCES:
A. American Academy of Pediatrics (AAP) Updated Guidance for Palivizumab Prophylaxis Among,
Infants and Young Children at Increased Risk of Hospitalizations for Respiratory Syncytial Virus
Infection. Pediatrics Vol. 134, Number 2, August 2014, pp 415 - 420
VIII.
DISTRIBUTION:
A. PHC Department Directors,
B. PHC Provider and Practitioner Manuals,
C. SharePoint
IX.
POSITION RESPONSIBLE FOR IMPLEMENTING PROCEDURE:
A. Pharmacy Services Director
X.
REVISION DATES:
Medi-Cal
04/05/01 archived 10/01; 10/03/02; 08/20/03; 10/20/04; 07/24/08; 09/24/09; 10/28/10; 01/16/14; 08/14/14;
10/1/2015
Healthy Kids
07/24/08; 09/24/09; 10/28/10; 01/16/14; 08/14/14; 10/1/2015
Page 2 of 3
Policy/Procedure Number: MPRG4025 (previously
MPRC4025, RC100425)
Lead Department: Health Services
☒External Policy
☐Internal Policy
Original Date: 12/13/1999 – Medi-Cal
Next Review Date: 10/1/2016
07/24/2008 – Healthy Kids Last Review Date: 10/1/2015
☒ Healthy Kids
☐ Employees
Applies to: ☒ Medi-Cal
Policy/Procedure Title: Palivizumab (Synagis) Guidelines
PREVIOUSLY APPLIED TO:
PartnershipAdvantage:
MPRC4025 – 09/24/2009 to 01/16/2014
MPRG4025 – 01/16/2014 to 01/01/2015
Healthy Families:
MPRC4025 - 10/28/2010 to 03/01/2013
XI.
POLICY DISCLAIMER:
A. In accordance with the California Health and Safety Code, Section 1363.5, this policy was developed with
involvement from actively practicing health care providers and meets these provisions:
1. Consistent with sound clinical principles and processes;
2. Evaluated and updated at least annually;
3. If used as the basis of a decision to modify, delay or deny services in a specific case, the criteria will be
disclosed to the provider and/or enrollee upon request.
B. The materials provided are guidelines used by PHC to authorize, modify or deny services for persons with
similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the
benefits covered under PHC.
Page 3 of 3