Subject:
Intranasal Influenza Virus Vaccine (FluMist Quadrivalent)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Intranasal influenza virus vaccine is a live trivalent vaccine intended for active immunization for the prevention of influenza.
FluMist, the first nasally administered vaccine and the first live attenuated virus influenza vaccine in the U.S., was approved by FDA on June 17, 2003. It is manufactured by MedImmune Vaccines, Inc. The initial indication for Flumist was for individuals 5 to 49 years of age. In September 2007, the FDA revised the indication for Flumist to include individuals as young as 2 years of age. It is indicated for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 2-17 years of age, and healthy adults, 18-49 years of age. Children 2-8 years old, who have never been vaccinated with influenza vaccine, need two doses at least 4 weeks apart while children 2- 8 years old who were previously vaccinated with influenza vaccine and individuals 9-49 years old need one dose. The most common adverse reactions associated with FluMist are nasal congestion, runny nose, sore throat, and fever.
On February 29, 2012, FDA approved FluMist Quadrivalent, a formulation containing two Influenza A subtype viruses and two type B viruses for use in persons 2 through 49 years of age. The effectiveness of FluMist Quadrivalent was based on an evaluation of immune responses in vaccinated persons, as well as the demonstrated effectiveness of the trivalent formulation. Children 2-8 years old, who have never been vaccinated with influenza vaccine, need two doses at least 4 weeks apart while children 2- 8 years old who were previously vaccinated with influenza vaccine and individuals 9-49 years old need one dose.
According to the FDA, FluMist and FluMist Quadrivalent are is not indicated for immunization of individuals less than 2 years of age, or 50 years of age and older. In addition, it is not a treatment for influenza, nor a protection against infections and illness caused by infectious agents other than influenza A or B viruses. As with other live virus vaccines, FluMist and FluMist Quadrivalent should not be given for any reason to people with immune suppression, including those with immune deficiency diseases, such as AIDS or cancer, and people who are being treated with drugs that cause immunosuppression. The safety of FluMist and FluMist Quadrivalent in individuals with asthma or other reactive airway diseases has not been established and thus, it should not be given to those with history of these problems. FluMist and FluMist Quadrivalent should not be given to children or adolescents receiving aspirin, individuals with a history of Guillain-Barré Syndrome that occurred after receiving influenza vaccine, and individuals with a severe allergy to chicken eggs.
Furthermore, the safety of FluMist and FluMist Quadrivalent in individuals with underlying medical conditions that may predispose them to severe disease following wild-type influenza has also not been established. According to the Advisory Committee on Immunization Practices (ACIP), such individuals include, but are not limited to, adults and children with chronic disorders of the cardiovascular and pulmonary systems, including asthma and < 5 years old with recurrent wheezing; pregnant women; adults and children who required regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes), renal dysfunction, or hemoglobinopathies; and adults and children with congenital or acquired immunosuppression caused by underlying disease or immunosuppressive therapy. Intramuscularly administered inactivated influenza vaccines are available to immunize these high-risk individuals.
[INFORMATIONAL NOTE: As per the FDA approved labeling, FluMist and FluMist Quadrivalent are is contraindicated in patients with severe allergic reactions to any component of the FluMist and FluMist Quadrivalent vaccine, including egg protein and in children or adolescents taking concomitant aspirin therapy. Children or adolescents should not be given aspirin for 4 weeks after getting FluMist Quadrivalent unless your healthcare provider tells you otherwise.
Warnings include an increased risk of hospitalization and wheezing in patients younger than 2 years of age, children younger than 5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing after administration of the vaccine, and Guillian- Barre syndrome occurrence within 6 weeks of the vaccine. ]
Policy:
(Note: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
1. Intranasal influenza virus live vaccine (FluMist Quadrivalent) is considered medically necessary in the 2020-2021 flu season in patients aged 2 through 49 years of age for the active immunization and prevention of influenza caused by influenza A subtype viruses and type B viruses contained in the vaccine.
[ INFORMATIONAL NOTE: Per the Center for Disease Control Influenza Surveillance data, the typical flu season begins in October and ends in March. As such, the FluMist Quadrivalent vaccination will be available from September 2020 until March 2021.]
Medicare Coverage
Per MLN SE19022, issued September 9, 2019, FluMist Quadrivalent (CPT code 90672) is covered for the August 1, 2019 through July 31, 2020 season. For additional information and eligibility, refer to MLN Matters Number: SE19022: 2019-2020 Influenza (Flu) Resources for Health Care Professionals. Article Release Date: September 9, 2019. Available at MLN general search page: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNGenInfo/Index.html
FluMist Quadrivalent (CPT code 90672) is also covered for the 2020-2021 influenza season. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/VaccinesPricing
Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Intranasal Influenza Virus Vaccine (FluMist)
FluMist (Intranasal Influenza Virus Vaccine)
Intranasal Influenza Virus Vaccine (FluMist Quadrivalent)
FluMist Quadrivalent (Intranasal Influenza Virus Vaccine)
References:
1. U.S. food and Drug Administration. FDA News: First Nasal Mist Flu Vaccine Approved. June 17, 2003. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00913.html
2. CDC. National Center for Infectious Disease. Recommendations from the Advisory Committee on Immunization Practices (ACIP). http://www.cdc.gov/ncidod/diseases/flu/who.htm (accessed 7/28/2020)
3. Recommendations from the Advisory Committee on Immunization Practices (ACIP). Prevention and Control of Influenza. MMWR 2004 May 28;53(RR-6):1-40.
4. FluMist: An Intranasal Live Influenza Vaccine. Med Lett Drugs Ther 2003 Aug;45(1163):65-66.
5. ECRI. Health Technology Assessment Information Service (HTAIS) Hotline Response: Intranasal Influenza Vaccine (FluMist). Updated 07/10/03.
6. Piedra PA. Safety of the trivalent, cold-adapted influenza vaccine (CAIV-T) in children. Semin Pediatr Infect Dis 2002 Apr;13(2):90-6.
7. Gruber WC. The role of live influenza vaccines in children. Vaccine 2002 May;20 Suppl 2:S66-73.
8. Jackson LA, Holmes SJ, Mendelman PM, et al. Safety of a trivalent live attenuated intranasal influenza vaccine, FluMist, administered in addition to parenteral trivalent inactivated influenza vaccine to seniors with chronic medical conditions. Vaccine 1999 Apr;17(15-16):1905-9.
9. Redding G, Walker RE, Hessel C, et al. Safety and tolerability of cold-adapted influenza virus vaccine in children and adolescents with asthma. Pediatr Infect Dis J 2002;21(1):44-8.
10. Zangwill KM, Droge J, Mendelman P, et al. Prospective, randomized, placebo-controlled evaluation of the safety and immunogenicity of three lots of intranasal trivalent influenza vaccine among young children. Pediatr Infect Dis J 2001;20(8):740-6.
11. American Academy of Pediatrics. Policy Statement: Recommendations for Influenza Immunization of Children. Pediatrics 2004 May;113(5):1441-1447.
12. Belshe RB, Edwards KM, Vesikari T, et al. Live Attenuated versus Inactivated Influenza Vaccine in Infants and Young Children. N Engl J Med 2007;356:685-696.
13. Influenza Vaccine 2006-2007. Med Lett Drugs Ther 2006 Oct;48(1245):81-83.
14. Ohmit SE, Victor JC, Rotthoff JR, et al. Prevention of Antigenically Drifted Influenza by Inactivated and Live Attenuated Vaccines. N Engl J Med 2006;355:2513-2522.
15. Treanor JJ, Kotloff K, Betts RF, et al. Evaluation of trivalent, live, cold-adapted (CAIV-T) and inactivated (TIV) influenza vaccines in prevention of virus infection and illness following challenge of adults with wild-type influenza A (H1N1) , A (H3N2), and B viruses. Vaccine 2000;18(9-10):899-906.
16. Flumist product information. MedImmune Vaccine, Inc. Gaithersburg, MD. 2011-2012 Formula [Available at: http://www.medimmune.com/pdf/products/flumist_pi.pdf (Accessed 02/08/12)]
17. Notice to Readers: Expansion of Use of Live Attenuated Influenza Vaccine (FluMist®) to Children Aged 2-4 Years amd Other FluMist Changes for the 2007-08 Influenza Season. JAMA 2008;299(2):166-167
18. Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2008. MMWR 2008;57(Early Release);1-60 [Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr57e717a1.htm (Accessed 8/5/08)]
19. New Jersey Register. Vol 40, Issue 1. January 7, 2008. 8: 57-4.19 Influenza vaccine.
20. Recommendations from the Advisory Committee on Immunization Practices (ACIP). Prevention and Control of Influenza. MMWR 2009 July 31;58(RR-8):1-52.
21. Clinical Trials Web site. http://clinicaltrials.gov/ct2/results?term=influenza+live (accessed at 02/08/12).
22. Flumist Quadrivalent. Prescribing information. MedImmune, LLC. Gaithersburg, MD. July 2015. Updated 8/2019 [Available at: https://www.azpicentral.com/flumistquadrivalent/flumistquadrivalent.pdf#page=1] (Accessed 9/10/10).
23. CDC. National Center for Infectious Disease. Key Facts About Seasonal Flu Vaccine. 2014. http://www.cdc.gov/flu/protect/keyfacts.htm (accessed at 03/07/12).
24. Grohskopf LA, Olsen SJ, Sokolow LZ et al. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP) - United States, 2014-15 influenza season. MMWR Morb Mortal Wkly Rep. 2014; 63:691-7.
25. Influenza Vaccine 2015-2016. Med Lett Drugs Ther 2015 Oct;48(1245):81-83.
26. Adult Immunization 2015-2016. Med Lett Drugs 2014 Jun;12(142):39-48.
27. Flu vaccines: CDC says FluMist ‘nasal spray’ should not be used this upcoming flu season. Outbreak News Today, June 2016. Available at: http://outbreaknewstoday.com/flu-vaccines-cdc-says-flumist-nasal-spray-should-not-be-used-this-upcoming-flu-season-72228/
28. CDC Panel again advices against FluMist. CNN News. Available at: http://www.cnn.com/2017/06/21/health/flu-shot-flumist-cdc-recommendations/index.html
29. Crawford C. ACIP says no to LAIV for 2017-18 flu season. American Academy of Family Physicians [online]. June 30, 2017. Available at: http://www.aafp.org/news/health-of-the-public/20170630acipjunemtg.html
30. Grohskopf LA, Sokolow LZ, Fry AM, et al. Update: ACIP Recommendations for the Use of Quadrivalent Live Attenuated Influenza Vaccine (LAIV4) - United States, 2018-19 Influenza Season. MMWR Morb Mortal Wkly Rep. 2018;67(22):643-645.
31. AAP News. No flu vaccine preference for 2019-‘20 season. https://www.aappublications.org/news/2019/03/14/fluvaccine031419. Accessed July 18, 2019.
32. AAP Committee on Infectious Diseases. Recommended Childhood and Adolescent Immunization Schedules: United States, 2019. Pediatrics. 2019;143(3):e20190065.
33. Centers for Disease Control and Prevention. Immunization schedules. https://www.cdc.gov/vaccines/schedules/index.html. Accessed July 18, 2019.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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