MPRG4025: Synagis Guidelines - Partnership HealthPlan of California

PARTNERSHIP HEALTHPLAN OF CALIFORNIA
GUIDELINE / PROCEDURE
Policy Number: MPRG4025 (previously MPRC4025, RC100425)
Lead Department: Health Services
Policy Title: Palivizumab (Synagis) Guidelines
Original Date:
12/13/1999 – Medi-Cal
9/24/2009- PartnershipAdvantage Revision Date: (Medi-Cal: 4/05/01 archived 10/01;
10/3/02, 8/20/03; 10/20/04); (MC, PA, HK - 7/24/08;
7/24/2008 – Healthy Kids
9/24/09); (MC, PA, HK, HF - 10/28/10); 1/16/14; 8/14/14
10/28/2010 to 03/01/2013 – Healthy Families
Applies to:
5 Medi-Cal
5 Healthy Kids
PartnershipAdvantage
Reviewing Entities:
CREDENTIALING
Approving Entities:
BOARD
Approval Signature:
CEO
IQI
P&T
COMPLIANCE
Robert L. Moore, MD, MPH
QUAC
FINANCE
PAC
Approval Date: 08/14/2014
RELATED POLICIES: None
DEFINITIONS: N/A
I.
ATTACHMENTS:
A.
Synagis Enrollment Packet – see enclosed sample
II.
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.
III.
GUIDELINE / 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:
•
•
•
•
•
•
•
•
Infant born before 29 weeks, 0 days’ gestation who are younger than 12 months at the start of
RSV season
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
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
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.
Infants younger than 12 months of age with cyanotic heart defects and request is made in
conjunction with a pediatric cardiologist
Children younger than 24 months who undergo cardiac transplantation during the RSV season
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
Infants and children with severe immunodeficiencies will be evaluated on a case by case basis.
Page 1 of 2
Policy Number: MPRG4025 (previously MPRC4025, RC100425)
Lead Department: Health Services
Policy Title: Palivizumab (Synagis) Guidelines
Original Date:
12/13/1999 – Medi-Cal
9/24/2009- PartnershipAdvantage
Last Revision Date: 8/14/14
7/24/2008 – Healthy Kids
10/28/2010 to 03/01/2013 – Healthy Families
Applies to:
5 Medi-Cal
5 Healthy Kids
PartnershipAdvantage
B.
Administration schedule of injections:
•
•
•
•
•
IV.
In Northern California RSV season typically runs from early November to mid-April.
Administration is every 30 days beginning in November just before the onset of RSV season.
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.
Qualifying infants born during the RSV season may require fewer doses.
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.
REFERENCES:
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
V.
DISTRIBUTION:
PHC Department Directors, PHC Provider and Practitioner Manuals.
Page 2 of 2
October 2014
PHC PRIMARY VENDOR FOR SYNAGIS
Dear PHC Provider:
Partnership HealthPlan of California’s (PHC) primary vendor for all providers who administer Synagis to PHC
high-risk children in the prevention of respiratory syncytial virus (RSV) is Diplomat Specialty Pharmacy (DSP)
and the contact information is as follows:
DIPLOMAT SPECIALTY PHARMACY
Call toll-free: 1-877-319-6337
Fax toll-free: 1-877-905-6337
Please follow this procedure to obtain Synagis for office administration to PHC members:
 Contact Diplomat Specialty Pharmacy (DSP) with the member’s information and your prescription for
Synagis
 DSP will request that you complete and return a PHC Synagis Enrollment form (attached) to assist them
in completing the Treatment Authorization Request (TAR)
 DSP will fax the completed TAR and PHC Synagis Enrollment form to PHC for review
 PHC reviews the TAR and notifies DSP within one business day of the determination. Determination is
based on PHC’s Prior Authorization Criteria (attached), which is adapted from the current 2014 American
Academy of Pediatrics (AAP) Guidelines. These are the new, current criteria for which infants need RSV
prophylaxis:
o In the first year of life, infants born before 29 weeks, 0 days gestation.
o In the first year of life, infants born before 32 weeks, 0 days AND with chronic lung disease
(CLD) of prematurity (defined as >= 28 days of > 21% oxygen after birth). In the second year of
life those infants who still require medical intervention for their CLD (supplemental oxygen,
chronic corticosteroid or diuretic therapy) may also qualify.
o In the first year of life, infants with hemodynamically significant congenital heart disease (CHD).
For patients with cyanotic heart disease a recommendation should come from their cardiologist.
o In the first year of life, children with pulmonary abnormalities or neuromuscular disease that
impairs airway clearance may qualify.
o Children younger than 24 months who are profoundly immunocompromised.
 Approved TARs-DSP will ship Synagis to the provider’s office once a month throughout the RSV season.
A representative will contact the provider’s office prior to shipping to confirm the member’s weight and
appropriate dose.
 DSP will bill PHC for the cost of the Synagis through PHC’s pharmacy benefit manager, MedImpact
If you have any questions regarding this information, you may contact the PHC Pharmacy Department at
(707) 863-4414.
Sincerely,
Robert L. Moore, MD, MPH
Chief Medical Officer
Attachments:
Gary Louie, Pharm.D.
Pharmacy Director
PHC Non-Formulary Medication Authorization Criteria for Synagis
Synagis Enrollment Form-Attachment A
4665 Business Center Drive, Fairfield, California 94534
 (707) 863-4414  fax (707) 419-7900
Toll Free Phone 877.319.6337
Toll Free Fax 877.905.6337
4100 S. Saginaw Street
Flint, MI 48507
Patient Information (please fax copy of insurance card front and back)
Patient: ______________________________________________ Male
Female
Last
First
Is infant a participant in the CCS program? Yes
DOB:________________ Patient ID/CIN#: ____________________
Age at the beginning of RSV season: ___________________________
No
Address: _____________________________________________________________________________________________________________________
Street
City
Primary Phone Number: ____________________
Cell
Caregiver: __________________________________________
State
Alternate Phone Number: _____________________________
Alergies: _______________________________________
Zip
Cell
NKDA
Clinical Information (please include chart notes)
Diagnosis/ICS-9:
745.0-747.0 (congenital heart disease)
770.7 (chronic lung disease of prematurity)
748.0-748.9 (congenital anomalies of the respiratory system)
770.0-770.9 (other respiratory
765.21-765.22 (≤ 24 completed weeks of gestation)
conditions of fetus & newborn)
765.23 (25-26 completed weeks of gestation)
Other (please specify):
765.24 (27-28 completed weeks of gestation)
Secondary diagnosis, if applicable (please specify)
Medical Criteria for Determination of High-Risk Indication:
______________________________________________
Infant born before 29 weeks 0 days gestation that is < 12 months of age at the start of the RSV season
CLD of prematurity (gestational age < 32 weeks, 0 days and a requirement for > 21% oxygen for at least the first 28 days after birth)
First season prophylaxis
Second season prophylaxis; please indicate which treatment(s) the patient has received during the
6-month period before the start of the second RSV season
Date(s)
Oxygen _________________________________
Corticosteroids __________________________
Date(s)
Bronchodilator ______________________________
Diuretics ___________________________________
Hemodynamically significant CHD in a child ≤ 12 months of age
Acyanotic heart disease, receving medication to treat CHF, and will require cardiac surgical procedures
Please list all medications the patient is receiving for treatment of this condition (attach documentation if needed):
_____________________________________________________________________
Last Date Received: _________________________
Moderate to severe pulmonary hypertension
Cyanotic heart defect (pediatric cardiology consult required)
Other Relevant Information for Consideration:
Diagnosis of Down syndrome with qualifying heart disease, CLD, airway clearance issues,
or prematurity ( < 29 weeks, 0 days gestation)
< 12 months of age with neuromuscular disease or congenital anomaly impairing airway secretion clearing
< 12 months of age with CF and clinical evidence of CLD and/or nutritional compromise
< 24 months of age and undergoing cardiac transplantation during RSV season
< 24 months of age and profoundly immunocompromised during RSV season
Other (please specify): _________________________________________________________________________________________
Did the patient spend time in the NICU/PICU/special care nursery?
Yes
No
If yes, please attach the disharge summary
Was Synagis ® (palivizumab administered in the NICU/hospital?
Yes
No
Date(s): ____________________________________
EXPECTED DATE OF FIRST/NEXT DOSE: ______________ Dose already given?
Yes
No
Date(s): ______________________
Please complete month and day to indicate if next dose is to be given:
Month: ________ Date: ________ Year: ________
Agency Nurse to visit home for injection:
Yes
No
Agency Name: __________________________________
Prescription
Synagis® (palivizumab) 50 mg and/or 100 mg vials
Directions:
Inject 15mg/kg instramuscularly once per month
Please select the number of refills:
Epinephrine 1 : 1000 amp.
Directions:
Inject 0.01 mg/kg. subcutaneously as directed
Quantity:
1
2
Quantity:
Quantity sufficient to achieve 15 mg/kg dose
3
4
Quantity sufficient to achieve 0.01 mg/kg dose
Refills: 0
Prescriber + Shipping Information
Prescriber (print): __________________________________________________________________ Contact: _______________________________________________
Ship to:
Patient
Office
Alternate: _________________________________________________________________________________________
Street
City
State
Zip
Office Address: ____________________________________________________________________________________________________________________________________
Phone: _________________________
Fax: ____________________________
NPI: _________________________
DEA: _______________________
Prescribers Signature: ____________________________________________________________________________ Date: ___________________________________
I authorize Diplomat Specialty Pharmacy and its representatives to act as an agent to initiate and execute prior authorization process.
Confidentiality Statement: This message is intended only for the individual or entity to which it is addressed. It may contain information which may be propritary and confidential. It may also contain privilaged, confidential information which is exempt from disclosure under applicable laws, including the Health Insurance Portability and
Accountability Act (HIPAA). if you are not the intended recipient, please note that you are strictly prohibited from disseminating or distributing this information (other than to the intended recipient) or copying this information. If you received this communication in error, please notify the sender immediately by calling (810) 768-9178 or by
emailing [email protected] to obtain instructions as to the proper distruction of the transmitted material. Thank you. Copyright© 2014 by Diplomat Pharmacy Inc. All rights reserved. Diplomat is a trademark of Diplomat Pharmacy Inc. 002693-0914
877.905.6337
PHONE: 877.319.6337
FAX:
Synagis Enrollment
®
1. Is this infant a participant in the California Children Services (CCS) program?
Yes
No
If Yes: Does this infant have a CCS eligible condition that may worsen with RSV infection?
Yes
2. Is this request from the CCS approved Special Care Center authorized to treat the child’s CCS
eligible condition?
Yes
No
Please note: PHC follows CCS Criteria for requests submitted on children with CCS eligible conditions.
Worksheet for Synagis dosing:
Dose #
Date
Approx.Weight
No. of 100mg Vials
1
2
3
4
5
Total No. of Vials Required:
Name:
PER ENROLLMENT FORM BY
PHYSICIAN, WEIGHT ON
/
/
IS
RPh ADDED
KG TO COMPENSATE
FOR WEIGHT GAIN BETWEEN
/
/
AND
/
/
Date of Birth:
No. of 50mg Vials
No

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