Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Beyfortus (nirsevimab-alip) requires prior authorization.

2)    Beyfortus is indicated for the prevention of RSV lower respiratory tract disease in 1) neonates and infants born during or entering their first RSV season and 2) children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

3)    Befortus is covered under the medical benefit.

Beyfortus (nirsevimab-alip) is considered medically necessary when the following criteria are met:

Initial Approval Criteria

1.    Preterm, Late Preterm, or term infant (must meet all):

a.    Age at onset of RSV season < 12 months;

b.    Request is for RSV prophylaxis;

c.    Medical justification supports request for RSV prophylaxis beyond September through May

*Elevated interseasonal activity has been observed since March 2021, the Centers for Disease Control and Prevention (CDC) has indicated that at this time it is not possible to anticipate the likely spread, peak, or duration of activity with any certainty; requests for RSV prophylaxis outside of the typical season by region may be considered. Traditionally RSV season onset was defined by consecutive weeks when RSV antigen-based tests exceeded 10% positivity. Due to the increased use of PCR testing, alternative statistical methods are used to determine seasonality in real time. Local and State health departments should be consulted to determine the real-time RSV season. Additional information on RSV trends by state can be found by visiting: https://www.cdc.gov/surveillance/nrevss/rsv/state.html.

d.    Member has not previously received Beyfortus or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination;

e.    If member previously received Synagis for the current RSV season, < 5 Synagis doses were administered;

f.     Member has not been hospitalized or previously infected with RSV disease during the current RSV season;

g.    Dose not exceed a single dose of one of the following (i or ii):

i.      Body weight < 5kg: 50mg

ii.    Body weight >5 kg: 100mg

Approval duration: 4 weeks (1 dose per lifetime)

2.    Chronic Lung Disease of Prematurity (must meet all):

a.    Diagnosis of CLD of prematurity (i.e., bronchopulmonary dysplasia [BPD]) defined as both of the following (i and ii):

i.     GA < 32 weeks;

ii.    Requirement for > 21% oxygen for > 28 days after birth;

b.    Medical management (i.e., supplemental oxygen, bronchodilators, diuretics, or chronic corticosteroid therapy) of CLD was required within the previous 6 months;

c.    One of the following (i. or ii.):

i.      Age at onset of RSV season < 12 months;

ii.    Age < 24 months and request is for members entering their second RSV season;

d.    Request is for RSV prophylaxis;

e.    Medical justification supports requests for RSV prophylaxis extending beyond September through May;

f.     Member has not previously received any RSV vaccine, including maternal RSV vaccination;

g.    Member has not previously received > 2 doses of Beyfortus;

h.    If member previously received Synagis, one of the following (i. or ii.):

i.      Request for Beyfortus is not within the same RSV season in which Synagis was administered;

ii.    < 5 Synagis doses were administered or previously infected with RSV disease during the current RSV season;

i.      Member has not been hospitalized or previously infected with RSV disease during the current RSV season;

j.      Dose does not exceed one of the following (i. or ii.):

i.      First RSV season, a single dose of one of the following (a or b): a) Weight < 5kg: 50mg; b) Weight > 5kg: 100mg)

ii.    Second RSV season: 200mg single dose.

Approval duration: 12 months (2 doses per lifetime)

3.    Congenital Heart Disease (must meet all):

a.    Diagnosis of hemodynamically significant CHD and one of the following (i. or ii.)

i.      CHD is unoperated or partially corrected;

ii.    Presence of acyanotic cardiac lesions and one of the following:

·         Pulmonary hypertension with > 40mm Hg measured pressure in the pulmonary artery;

·         Requirement of daily medication therapy to manage CHD;

b.    Request is for RSV prophylaxis;

c.    Medical justification supports requests for RSV prophylaxis extending beyond September through May;

*Elevated interseasonal activity has been observed since March 2021, the CDC has indicated that at this time it is not possible to anticipate the likely spread, peak, or duration of activity with any certainty; requests for RSV prophylaxis outside of the typical season by region may be considered. Traditionally RSV season onset was defined by consecutive weeks when RSV antigen-based tests exceeded 10% positivity. Due to the increased use of PCR testing, alternative statistical methods are used to determine seasonality in real time. Local and State health departments should be consulted to determine the real-time RSV season. Additional information on RSV trends by state can be found by visiting: https://www.cdc.gov/surveillance/nrevss/rsv/state.html.

d.    Member has not previously received any RSV vaccine, including maternal RSV vaccination;

e.    Member has not previously received > 2 doses of Beyfortus;

f.     If member previously received Synagis, one of the following (i. or ii.):

i.      Request for Beyfortus is not within the same RSV season in which Synagis was administred;

ii.    < 5 Synagis doses were administered for the current RSV season;

g.    Member has not been hospitalized or previously infected with RSV disease during the current RSV season;

h.    Dose does not exceed one of the following (i., ii., or iii):

i.      First RSV season, a single dose of one of the following::

·         Weight < 5kg: 50mg;

·         Weight > 5kg: 100mg

ii.    Second RSV season: 200mg single dose

Approval Duration: 12 months (2 doses total per lifetime)

4.    Anatomic Pulmonary Abnormalities, Neuromuscular Disorders, Infants Profoundly Immunocompromised (off-label) (must meet all):

a.    Age and diagnosis at onset of RSV season (i. or ii.):

i.      Age < 12 months and diagnosis of an anatomic pulmonary abnormality or neuromuscular disorder that impairs the ability to clear secretions from the upper airway (e.g.  due to ineffective cough);

ii.    Age < 24 months and will be profoundly  immunocompromised during the RSV season (e.g., due to solid organ or hematopoietic stem cell transplantation, chemotherapy, severe combined immunodeficiency, chronic granulomatous disease);

b.    Request is for RSV prophylaxis;

c.    Medical justification supports requests for RSV prophylaxis extending beyond September through May;

*Elevated interseasonal activity has been observed since March 2021, the CDC has indicated that at this time it is not possible to anticipate the likely spread, peak, or duration of activity with any certainty; requests for RSV prophylaxis outside of the typical season by region may be considered. Traditionally RSV season onset was defined by consecutive weeks when RSV antigen-based tests exceeded 10% positivity. Due to the increased use of PCR testing, alternative statistical methods are used to determine seasonality in real time. Local and State health departments should be consulted to determine the real-time RSV season. Additional information on RSV trends by state can be found by visiting: https://www.cdc.gov/surveillance/nrevss/rsv/state.html.

d.    Member has not previously received any RSV vaccine, including maternal RSV vaccine;

e.    Member has not previously received > 2 doses of Beyfortus;

f.     If member previously received Synagis, one of the following:

i.      Request for Beyfortus is not within the same RSV season in which Synagis was administered ;

ii.    < 5 Synagis doses were administered for the current RSV season;

g.    Member has not been hospitalized or previously infected with RSV disease during the current RSV season;

h.    Dose does not exceed one of the following:

i.      First RSV season, a single dose of one of the following:

·         Weight < 5kg: 50mg;

·         Weight > 5kg: 100mg;

ii.    Second RSV season: 200mg single dose.

5.    Cystic Fibrosis (off-label) (must meet all):

a.    Diagnosis of cystic fibrosis and one of the following:

i.      Clinical evidence of nutritional compromise;

ii.    Diagnosis of CLD of prematurity defined as both of the following:

·         GA < 32 weeks

·         Requirement for > 21% oxygen for > 28 days after birth

b.    Age at onset of RSV season (i. or ii.):

i.      Age < 12 months;

ii.    Age < 24 months and both of the following:

·         Manifestations of severe lung disease (e.g., previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest radiography or chest computed tomography that persist when stable):

·         Weight for length < 10th percentile

c.    Request is for RSV prophylaxis

d.    Medical justification supports requests for RSV prophylaxis extending beyond May through September;

*Elevated interseasonal activity has been observed since March 2021, the CDC has indicated that at this time it is not possible to anticipate the likely spread, peak, or duration of activity with any certainty; requests for RSV prophylaxis outside of the typical season by region may be considered. Traditionally RSV season onset was defined by consecutive weeks when RSV antigen-based tests exceeded 10% positivity. Due to the increased use of PCR testing, alternative statistical methods are used to determine seasonality in real time. Local and State health departments should be consulted to determine the real-time RSV season. Additional information on RSV trends by state can be found by visiting: https://www.cdc.gov/surveillance/nrevss/rsv/state.html.

e.    Member has not previously received any RSV vaccine, including maternal RSV vaccination;

f.     Member has not previously received > 2 doses of Beyfortus;

g.    If member previously received Synagis, one of the following (i. or ii.):

i.      Request for Beyfortus is not within the same RSV season in which Synagis was administered;

ii.    < 5 Synagis doses were administered for the current RSV season;

h.    Member has not been hospitalized or previously infected with RSV disease during the current RSV season;

i.      Dose does not exceed on of the following:

i.      First RSV season, a single dose of one of the following:

·         Weight < 5kg: 50mg;

·         Weight > 5kg: 100mg;

ii.    Second RSV season: 200mg single dose

Approval Duration: 12 months (2 dose per lifetime)

Continued Therapy

Continued therapy will not be authorized as Beyfortus is indicated to be dosed once, unless member is at increased risk of sever disease, in which case an additional dose may be administered (2 doses total per lifetime).

Codes Used In This BI:

1)    90380 – Beyfortus 50mg/0.5ml Solution; Respiratory syncytial virus, monoclonal antibody, seasonal dose; 0.5ml dosage, for intramuscular use

2)    90381 – Beyfortus 100mg/ml Solution; Respiratory syncytial virus, monoclonal antibody, seasonal dose; 1ml dosage, for intramuscular use

1)    Beyfortus Prescribing Information. Södertälje, Sweden: AstraZeneca AB. July 2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761328s000lbl.pdf. Accessed August 7, 2023.

2)    American Academy of Pediatrics Committee on Infectious Diseases. and American Academy of Pediatrics Bronchiolitis Guidelines Committee. “Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection.” Pediatrics vol. 134,2 (2014): e620-38. doi:10.1542/peds.2014-1666

3)    ClinicalTrials.gov. A Phase 2b Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody with an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants.  Last updated October 14, 2019. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02878330. Accessed November 29, 2022.

4)    ClinicalTrials.gov. A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody with an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY). Last updated September 2, 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT03979313. Accessed November 15, 2022.

5)    ClinicalTrials.gov. A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody with an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY). Last updated August 22, 2022. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03959488. Accessed November 28, 2022.

6)    Domachowske J, Madhi SA, Simões EAF, et al. Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity. N Engl J Med. 2022 Mar 3;386(9):892-894.

7)    Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec; 9(12): e1644-e1645.

8)    Griffin MP, Yuan Y, Takas T, et al. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. N Engl J Med. 2020 Jul 30;383(5):415-425.

9)    Hammitt LL, Dagan R, Yuan Y, et al. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022 Mar 3;386(9):837-846.

10) Kieffer A, Beuvelet M, Sardesai A, et al. Expected Impact of Universal Immunization with Nirsevimab against RSV-Related Outcomes and Costs Among All US Infants in Their First RSV Season: A Static Model. Journal of Infectious Diseases. 2022 August 15; 226(Suppl 2): S282-S292.

11) Respiratory syncytial virus infection (RSV): Trends and surveillance. Centers for Disease Control and Prevention website. Content source: National Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases. Available at http://www.cdc.gov/rsv/research/us-surveillance.html. Page last reviewed: December 18, 2020. Accessed February 21, 2022.

12) Rha B, Curns AT, Lively JY, et al. Respiratory Syncytial Virus-Associated Hospitalizations Among Young Children: 2015-2016. Pediatrics. 2020 Jul; 146(1): e20193611.

13) Rose EB, Wheatley A, Langley G, Gerber S, Haynes A. Respiratory Syncytial Virus Seasonality — United States, 2014–2017. MMWR Morb Mortal Wkly Rep 2018;67:71–76. DOI: http://dx.doi.org/10.15585/mmwr.mm6702a4.

14) Centers for Disease Control and Prevention [Presentation]: Proposed Clinical Consideration Updates for Nirsevimab. August 3, 2023. Available at: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-08-3/04-RSV-Jones-508.pdf. Accessed August 7, 2023.

15) ACIP and AAP Recommendations for Nirsevimab. Red Book Online. August 15, 2023. Available at: https://publications.aap.org/redbook/resources/25379/ACIP-and-AAP-Recommendations-for-Nirsevimab?searchresult=1?autologincheck=redirected. Accessed August 21, 2023.