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Palivizumab (Synagis®) a monoclonal antibody, is an intramuscular injection developed to protect high risk infants against the worst effects of respiratory synctial virus, the most common cause of lower respiratory infections such as bronchitis and pneumonia in infancy and early childhood. Synagis® is a genetically engineered antibody against the RSV virus. It is manufactured using human and mouse antibody genes (produced by recombinant DNA technology). Over 125,000 children in the United States are hospitalized each year due to RSV and approximately 500 die. (revised 10-28-2005)

FDA APPROVED INDICATIONS

Palivizumab (Synagis®) is indicated for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease. Safety and efficacy were established in infants less than 24 months of age with bronchopulmonary dysplasia (BPD) and infants with a history of prematurity (35 weeks or less gestational age). (added 9-30-2004) Palivizumab (Synagis®) is also approved for children with hemodynamically significant congenital heart disease. (revised 10-28-2005)

Palivizumab (Synagis®) is considered medically necessary only during RSV season (October-February) for the following indications:

Patients less than 2 years of age at the start of RSV season meeting the following criteria:

• Chronic lung disease (CLD), AND
• Have required medical therapy (supplemental oxygen, bronchodilator, diuretic or corticosteroid therapy) within 6 months before the anticipated start of the RSV season. (added 9-30-2004) (Maximum of 5 doses/season)

  OR

Infants with a history of prematurity <35 weeks meeting the following criteria:

• Infants < 28 weeks of gestation up to 12 months of age at the start of RSV season (Maximum of 5 doses/season), OR
• Infants of 29 - 31 weeks of gestation up to 6 months of age at the start of RSV season (Maximum  of 5 doses/season), OR
• Infants of 32 - 34 weeks of gestation up to 3 months of age at the start of RSV season, if they suffer from 1 or more additional risk factors including: daycare attendance or siblings younger than 5 years of age (Maximum of 3 doses/season), OR
•  Infants < 35 weeks of gestation up to 12 months of age at the start of RSV season if they have either congenital abnormalities of the airway or a neuromuscular condition that compromises handling of respiratory secretions (Maximum of 5 doses/season).

       OR

Infants 24 months of age or less with hemodynamically significant cyanotic or acyanotic congenital heart disease. (Maximum of 5 doses/season)

If one of the above indications is not present, palivizumab (Synagis®) is considered not medically necessary for the following indications:

• Severely immunocompromised infants
• Children who receive monthly IGIV
• Infants and children with hemodynamically insignificant heart disease

None

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

11/1998: Synagis® criteria approved by MPAC; policy merged with RSV and renamed

2/2/2001: Entire "Policy Section" revised

10/26/2001: Infants < 28 weeks of gestation up to 12 months of age "at the start of RSV season" added

1/30/2002: Above statement added to Infants 29-32 weeks and 32-35 weeks

2/14/2002: Investigational definition added

5/2/2002: Type of Service and Place of Service deleted

5/28/2002: Code Reference section updated, CPT 86756 added

11/6/2002: Nova Factor new telephone and fax numbers added. Telephone # 1-800-235-8498 and fax # 1-888-355-6652 deleted.

9/17/2004: Code Reference section updated, CPT 86756, 90780, 90781, 90782 deleted, ICD-9 diagnosis code 460.0 invalid and deleted, ICD-9 diagnosis code range 460-466.0, 478.8-480.0, 493.0-493.1, 765.00-765.19, 770.0-770.9 listed separately, ICD-9 diagnosis code range 493.0-493.1 5th digit added, HCPCS J1565 description revised, HCPCS S9562 added

9/30/2004: Code Reference section updated, ICD-9 diagnosis code 745.10, 745.11, 745.2, 745.4, 745.5, 745.60, 745.61, 745.69, 745.8, 746.02, 746.2, 746.7, 746.81, 746.83, 747.0, 747.10, 747.3, 747.49 added covered codes

10/28/2005:  Description section updated.  FDA approved indications revised.  Policy section updated:  changed preferred provider to Accredo, changed telephone # from 1-866-591-9075 to 1-866-240-3373, changed fax # from 1-866-591-9094 to 1-877-369-3447.  Sources updated;  American Academy of Pediatrics Web Site, Synagis® and RespiGam® added

11/4/2005:  Code Reference section updated, ICD9 diagnosis codes 491.00-491.02, 491.20-491.22, 491.9, 493.20-493.22, 496, 765.20-765.27, V46.2 added; ICD9 procedure code 99.29 added.

11/2005:  Approved by Pharmacy & Therapeutics (P & T) Committee

2/7/2006: Code Reference table updated: The notes under CPT codes 90378 and 90379 and HCPCS code J1565 were updated to include the new intramuscular and IV infusion administration codes (90772, 90765-90766); ICD9 diagnosis codes 079.6, 079.89, 460.0-466.0, 466.11, 478.8-478.9, 480.0-480.9, 487.1, 519.8, 769, 770.0-770.9, 786.9 deleted, V58.65 added

8/22/2006: Respigam deleted from policy due to discontinuation of medication.

11/14/2006: Code Reference section updated: ICD-9 code V04.82 added

1/12/2006: Code reference section updated. ICD-9 codes 491.00, 491.01, and 491.02 deleted. ICD-9 codes 491.0 and 491.1 added.

01/01/2009: Accredo preferred provider information removed. BCBSMS information added.

8/17/2009:  Policy updated: off label uses deleted. Policy statement section updated: deleted RSV season changed from September-March to October-February. Maximum of 5 doses/season added to infant age specifications. Infant age specifications revised.

12/15/2009: Coding Section revised with 2010 CPT4 and HCPCS revisions

• Immune Prophylaxis
• Palivizumab
• Respiratory Synctial Virus
• RSV-IVIg
• Synagis®
• Respigam^TM

Clinical Pharmacology Online, 1998

Micromedix. 1998

FDA Web Site

FDA labeling, based on data submitted to the Food and Drug Administration

Groothuis Jr. 1993, NEJM 329: 1524-30

Ellenberg SS, 1994 NEJM 331: 203-4

The Impact-RSV Study Group. Pediatrics 1998;102:531-37.

American Academy of Pediatrics. Policy Statement: Prevention of Respiratory Syncytial Virus Infections: Indications for the Use of Palivizumab and Update on the Use of RSV-IGIV. November 1998, pp. 1211-1216.

American Academy of Pediatrics. Respiratory syncytial virus immune globulin intravenous: Indications for use. Pediatrics 1997;99:645-50.

American Academy of Pediatrics, Committee on Infectious Diseases and Committee on Fetus and Newborn. Revised Indications for the Use of Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous for the Prevention of Respiratory Syncytial Virus Infections. Pediatrics.2003; 112:1442-1446. (added 9-30-2004)

American Academy of Pediatrics Web Site (added 10-28-2005)

Synagis® Prescribing Information (added 10-28-2005)  

RespiGam® Prescribing Information (added 10-28-2005)

Covered Codes

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