HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES

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1 Generic Brand HICL HCN Exception/Other PALIVIZUMAB SYNAGIS Synagis may be covered during the RSV season from October 15, 2017 and March 31, If the PA is received prior to October 15, 2017, proactive approvals should include a start date of 10/15/2017. GUIDELINES FOR USE 1. Does the patient have hemodynamically significant cyanotic or acyanotic congenital heart disease (including those with moderate to severe pulmonary hypertension and those who are receiving medication to control congestive heart failure)? If yes, continue to #3. If no, continue to #2. 2. Does the patient have chronic lung disease (CLD) and has received medical therapy (supplemental oxygen, bronchodilator, diuretic, or chronic corticosteroid therapy) for CLD within 6 months before the start of RSV season (since 4/15/2017)? If yes, continue to #3. If no, continue to #4. 3. Is the patient less than 24 months of age? medication is only covered for patients less than 24 months of age with an increased risk of severe Respiratory Syncytial Virus (RSV) infection due to either chronic lung disease or congenital heart disease. The patient is over 24 months of age and therefore the request was not approved. 4. Does the patient have significant congenital abnormalities of the airways or a neuromuscular disease that compromises the handling of respiratory tract secretions? If yes, continue to #5. If no, continue to #6. Page 1

2 5. Is the patient less than 12 months of age at the start of RSV season? medication is only covered for patients with significant congenital abnormalities of the airways or a neuromuscular disease that compromises the handling of respiratory tract secretions who are less than 12 months of age at the start of RSV season. The patient is or will be 12 months of age or older at the start of RSV season and therefore the request was not approve. 6. Was the patient born prior to 35 weeks gestational age? If yes, continue to #7. medication is only covered for patients with an increased risk of severe Respiratory Syncytial Virus (RSV) infection based on certain medical conditions including chronic lung disease, congenital heart disease, congenital abnormalities of the airway, neuromuscular disease, or premature birth with or without certain environmental factors. The physician did not indicate that the patient is at an increased risk of severe RSV infection and therefore the request was not approved. 7. Was the patient born at or prior to '28 weeks, 6 days' gestational age and is less than 12 months of age at the start of RSV season? If no, continue to #8. 8. Was the patient born at '29 weeks, 0 days' through '31 weeks, 6 days' gestational age and is less than 6 months of age at the start of RSV season? If no, continue to #9. Page 2

3 9. Was the patient born at '32 weeks, 0 days' through '34 weeks, 6 days' gestational age and is less than 3 months old at the start of RSV season? If yes, continue to #10. medication is only covered for infants with an increased risk of severe Respiratory Syncytial Virus (RSV) infection based on their gestational age at birth and chronological age at the start of RSV season. Synagis is covered for patients who are born at less than 29 weeks gestational age and are less than 12 months of age at the start of RSV season, patients who are born at 29 weeks through 31 weeks, 6 days gestational age and are less than 6 months of age at the start of RSV season, and patients who are born at 32 weeks through 34 weeks, 6 days gestational age and are less than 3 months old at the start of RSV season. The patient's gestational age at birth and chronological age do not meet these requirements and therefore the request was not approved. 10. Does the infant attend child care/daycare? If yes, continue to #13. If no, continue to # Does the infant have a sibling younger than 5 years of age living permanently in the home (multiple births younger than 1 year of age do not qualify)? If yes, continue to #13. medication is only covered for a patients who was born at 32 weeks through 34 weeks, 6 days gestational age and is less than 3 months old at the start of RSV season if the patient is either attending child care/daycare or has a sibling younger than 5 years of age living permanently in the home (multiple births younger than 1 year of age do not qualify). The patient does not meet this requirement and therefore the request was not approved. Page 3

4 12. Approve up to 5 doses by HICL AND up to 5 fills. Please enter a minimum days supply of 28 and maximum # of vials per fill of 2 for patients < 20 kg (44 lbs). For patients 20 kg, please enter a minimum days supply of 28 and maximum # of vials per fill of 3. The number of approved doses is dependent on the month when the child starts prophylaxis: Child born before the start of RSV season: starting on October 15, 2017, approve up to 5 doses through 3/31/2018; fill count = 5. Infant born in November: approve up to 5 doses through 3/31/2018; fill count = 5. Infant born in December: approve up to 4 doses through 3/31/2018; fill count = 4. Infant born in January: approve up to 3 doses through 3/31/2018; fill count = 3. Infant born in February: approve up to 2 doses through 3/31/2018; fill count = 2. Infant born in March: approve 1 dose through 3/31/2018; fill count = 1. Additional doses are dependent on RSV virology persisting after March. Please use status code #057 and the approval text provided. PAC NOTE: Please forward a copy of the approval letter to CVS Specialty (Fax: APPROVAL TEXT: Synagis has been approved for your condition for [# of approved doses] doses to be ordered between October 15, 2017 and March 31, Approve up to 3 doses by HICL AND up to 3 fills. Please enter a minimum days supply of 28 and maximum # of vials per fill of 2 for patients < 20 kg (44 lbs). For patients 20 kg, please enter a minimum days supply of 28 and maximum # of vials per fill of 3. The number of approved doses is dependent on the month when the child starts prophylaxis: Child born before the start of RSV season: starting on October 15, 2017, approve up to 3 doses through 3/31/2018; fill count = 3. Infant born in November: approve up to 3 doses through 3/31/2018; fill count = 3. Infant born in December: approve up to 3 doses through 3/31/2018; fill count = 3. Infant born in January: approve up to 3 doses through 3/31/2018; fill count = 3. Infant born in February: approve up to 2 doses through 3/31/2018; fill count = 2. Infant born in March: approve 1 dose through 3/31/2018; fill count = 1. Additional doses are dependent on RSV virology persisting after March. Please use status code #057 and the approval text provided. PAC NOTE: Please forward a copy of the approval letter to CVS Specialty (Fax: APPROVAL TEXT: Synagis has been approved for your condition for [# of approved doses] doses to be ordered between October 15, 2017 and March 31, Page 4

5 RATIONALE To ensure the optimal use of palivizumab in high-risk patients for the prophylaxis of RSV. FDA APPROVED INDICATIONS For the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease. Safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD), infants with a history of premature birth ( 35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD). REFERENCES MedImmune, Inc. Synagis package insert. Gaithersburg, MD. April 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(6): American Academy of Pediatrics. Policy statement modified recommendations for use of palivizumab for prevention of respiratory syncytial virus infections. Pediatrics 2009; 124: American Academy of Pediatrics, Subcommittee on Diagnosis and Management of Bronchiolitis. Pediatrics 2006; 118; American Academy of Pediatrics, Committee on Infectious Diseases and Bronchiolitis Guidelines Committee. Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infections. Pediatrics 2014:134: Reducing RSV hospitalizations. AAP modifies recommendations for use of palivizumab in high-risk infants, young children. AAP News 2009; 30:1. Thomas Healthcare. Palivizumab. DRUGDEX System [database online]. Greenwood Village, CO. [Accessed: August ]. Created: 08/21/12 Effective: 09/18/17 Client Approval: 09/12/17 P&T Approval: 09/11/17 Page 5

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