Drug Infusion/Injection Site of Care Policy

This page outlines the Site of Care for Specialty Drug Administration policy and the medications to which this policy applies. It provides the criteria used to determine the medical necessity of hospital outpatient administration as the site of service for identified specialty medications.

This policy applies to the following therapies administered by health care professionals:

Actemra IV formulation effective 1/1/2019
Adakveo-effective 2/13/2020
Aduhelm effective 8/3/2021
Aldurazyme effective 1/1/2020
Alpha 1 proteinase inhibitors (Glassia, Prolastin C, Aralast NP, Zemaira) effective 1/1/2020
Amondys 45 effective 6/1/2021
Avsola (infliximab-axxq) effective 9/1/2020
Bavencio effective 7/1/2020
Benlysta IV formulation effective 7/1/2019
Cerezyme effective 1/1/2020
Cinqair effective 9/1/2020
Cinryze effective 1/1/2020
Crysvita effective 7/13/2018
Elaprase effective 1/1/2020
Elelyso effective 1/1/2020

Enjaymo – effective 4/29/2022

Entyvio effective 1/1/2019
Evkeeza effective 5/7/21
Exondys 51 effective 1/11/2017
Fabrazyme effective 1/1/2020
Fasenra (provider-administered) effective 9/1/2020
Givlaari effective 2/13/2020
Imfinzi effective 7/1/2020
Immune Globulins effective 1/1/2017
Inflectra (infliximab-dyyb) effective 7/1/2017
Inflectra - Psoriasis and Psoriatic Arthritis: Targeted Immune Modulators effective 7/1/2017
Jemperli effective 7/1/2021
Kanuma effective 1/1/2020
Keytruda effective 7/1/2020
Lemtrada effective 7/1/2017
Libtayo effective 7/1/2020
Lumizyme effective 1/1/2020
Luxturna* effective 3/9/2018
Mepsevii effective 1/1/2020
Naglazyme effective 1/1/2020
Nexviazyme effective 10/7/2021
Nucala (provider-administered) effective 9/1/2020
Ocrevus effective 05/23/2017
Onpattro effective 08/23/2018
Opdivo effective 7/1/2020

Opdualag effective 6/1/2022

Orencia IV formulation effective 1/1/2019
Oxlumo effective date 3/17/2021
Radicava (edaravone) effective 7/20/2017
Remicade (infliximab) effective 7/1/2017
Remicade - Psoriasis and Psoriatic Arthritis: Targeted Immune Modulators effective 7/1/2017
Renflexis (infliximab-abda) effective 9/1/2017
Renflexis - Psoriasis and Psoriatic Arthritis: Targeted Immune Modulators effective 9/1/2017
Saphnelo effective 10/7/2021
Simponi Aria effective 1/1/2019
Soliris effective 1/1/2017
Spinraza# effective 7/1/2021
Tecentriq effective 7/1/2020
Tepezza effective 7/1/2020
Tezspire effective 3/23/2022
Tysabri effective 7/1/2017
Ultomiris effective 3/15/2019
Uplizna effective 9/1/20
Viltepso effective 11/10/20
Vimizim effective 1/1/2020
Vpriv effective 1/1/2020
Vyepti effective 7/1/2020
Vyondys 53 effective 3/1/2019
Xolair effective 9/1/2020
Yervoy effective 7/1/2020
Zolgensma** effective 7/1/2019

*Product is available for administration at Aetna Gene Therapy Designated Centers identified below:

Baylor Eye Center – Houston, TX
Cincinnati Children’s Hospital – Cincinnati, OH
Massachusetts Eye and Ear – Boston, MA
The Vision Center at Children's Hospital – Los Angeles, CA
Children’s Hospital of Philadelphia – Philadelphia, PA
Oregon Health & Science University Hospital - Casey Eye Institute – Portland, OR
University of Iowa Hospital and Clinics – Iowa City, IA
University Of Michigan Medical Center – Kellogg Eye Center – Ann Arbor, MI

**Product is available for administration at Aetna Gene Therapy Designated Centers identified below:

Akron Children's Hospital – Akron, OH
Boston Children's Hospital – Boston, MA
Children's Healthcare of Atlanta - Scottish Rite Hospital/Egleston Children's Hospital – Atlanta, GA
Children's Hospital and Medical Center – Omaha, NE
Children's Hospital of Colorado – Aurora, CO
Children's Hospital of Dallas – Dallas, TX
Children’s Hospital of the Kings Daughters – Norfolk, VA
Children's Hospital Los Angeles – Los Angeles, CA
Children’s Hospital of Michigan – Detroit and Grand Blanc, MI
Children’s Hospital of New Orleans – New Orleans, LA
Children's Hospital of Philadelphia – Philadelphia, PA
Children's Mercy Hospital – Kansas City, MO
Cincinnati Children’s Hospital and Medical Center – Cincinnati, OH
Columbia University Medical Center – New York, NY
Cook Children’s Medical Center – Fort Worth, TX
Doernbecher Children’s Hospital – Portland, OR
Gillette Children’s Specialty Healthcare – Saint Paul, MN
Goryeb Children’s Hospital at Morristown Medical Center – Morristown, NJ
Integris Southwest Medical Center – Oklahoma City, OK
Jackson Memorial Hospital – Miami, FL
Joe DiMaggio Children's Hospital – Hollywood, FL
Lucile Packard Children's Hospital – Palo Alto, CA
Massachusetts General Hospital – Boston, MA
Memorial Hospital Regional – Hollywood, FL
Milton Hershey Medical Center Pennsylvania State University – Hershey, PA
Nemours Children’s Hospital Delaware – Wilmington, DE
Nemours Children’s Hospital – Orlando, FL
Nicklaus Children's Hospital – Miami, FL
Oregon Health & Science University Hospital – Doernbecher Children's Hospital – Portland, OR
OU Medicine – Children’s Hospital – Oklahoma City, OK
Rady Children’s Hospital San Diego – San Diego, CA
Ronald Reagan UCLA Medical Center – Los Angeles, CA
Seattle Children’s Hospital – Seattle, WA
Stanford Medical Center – Standford, CA
Texas Children’s Clinic – Houston, TX
University of Iowa Hospital and Clinics – Iowa City, IA
University of Kansas, Kansas City, KS
University of Kentucky – Lexington, KY
University Of Michigan Medical Center – C S Mott Children's Hospital – Ann Arbor, MI
University of Rochester Medical Center Health System – Strong Memorial Hospital – Rochester, NY
University of Wisconsin Hospital and Clinics – Madison, WI

***Product is available for administration at Aetna Gene Therapy Designated Centers:

Banner University Medical Center Tucson Campus – Tucson, AZ
Banner University Medical Center Phoenix Campus – Phoenix, AZ
Boston Children's Hospital – Boston, MA
Diamond Children’s Hospital, part of Banner University Tucson Campus – Tucson, AZ
Children's Healthcare of Atlanta – Scottish Rite Hospital/Egleston Children's Hospital – Atlanta, GA
Children's Hospital and Medical Center – Omaha, NE
Children’s Hospital Colorado – Aurora, CO
Children’s Hospital Los Angeles (The Vision Center) – Los Angeles, CA
Children’s Hospital of the Kings Daughters – Norfolk, VA
Children’s Hospital of Michigan – Grand Blanc, MI
Children’s Hospital of Michigan – Detroit, MI
Children’s Hospital of Philadelphia – Philadelphia, PA
Children’s Medical Center of Dallas – Dallas, TX
Children’s Mercy Hospital – Kansas City, MO
Children's National Medical Center – Washington, DC
Cincinnati Children’s Hospital – Cincinnati, OH
Cook Children’s Medical Center – Fort Worth, TX
Gillette Children’s Specialty Hospital – St. Paul, MN
Goryeb Children's Hospital at Morristown Medical Center – Morristown, NJ
Joe DiMaggio Children's Hospital – Hollywood, FL
Memorial Hospital Regional – Hollywood, FL
Milton Hershey Medical Center Pennsylvania State University – Hershey, PA
Lucile Packard Children's Hospital – Palo Alto, CA
Nemours Children’s Hospital Delaware – Wilmington, DE
Nemours Children’s Hospital – Orlando, FL
Nicklaus Children's Hospital – Miami, FL
Ohio State University Hospital – Columbus, OH
Oregon Health & Science University Hospital - Doernbecher Children's Hospital – Portland, OR
OU Medicine – Children’s Hospital – Oklahoma City, OK
Rady Children’s Hospital San Diego – San Diego, CA
Seattle Children’s Hospital – Seattle, WA
Stanford Medical Center – Standford, CA
University of Iowa Hospital and Clinics – Iowa City, IA
University of Kansas – Kansas City, KS
University Of Michigan Medical Center – C S Mott Children's Hospital – Ann Arbor, MI
University of Wisconsin Hospital and Clinics – Madison, WI

Site of care

The starting dose(s) of the medications subject to this policy may be given at the physician’s facility of choice only when multiple administrations are required and provided that the medication is available and not subject to limited distribution. For identified gene and cellular therapies, Aetna Gene Therapy Designated Centers listed in the policy apply.

This includes hospital outpatient facilities, non-hospital outpatient facilities and home care. In the event the therapy is represented by a single administration, the policy applies to the first administration.

All subsequent doses will be subject to the Aetna Site of Care for Drug Administration policy, which requires the use of non-hospital outpatient facilities or home care.

Clinical rationale and documentation must be provided for review of Medical Necessity exceptions.

This policy provides coverage for administration of therapy in an outpatient hospital setting for up to 45 days* when ANY of the following criteria are met:

The member is new to therapy or reinitiating therapy after not being on therapy for at least 6 months. For Xolair only, the member is new to therapy or reinitiating therapy after not being on therapy for at least 3 months.
The member is switching to a product that he/she has not received before.**
The member has experienced a gap in therapy.***

This policy provides coverage for provider administered therapies in an outpatient hospital setting when ANY of the following criteria are met:

The member has experienced an adverse reaction that did not respond to conventional interventions (eg, acetaminophen, steroids, diphenhydramine, fluids or other pre-medications) or a severe adverse event (anaphylaxis, anaphylactoid reactions, myocardial infarction, thromboembolism, or seizures) during or immediately after administration.
The member either has immunoglobulin A (IgA) deficiency with anti-IgA antibodies† or has developed anti-drug antibodies††† which increases the risk for infusion related reactions.
The member is medically unstable (eg respiratory, cardiovascular, or renal conditions).
The member has severe venous access issues that require the use of a special intervention.††
The member has significant behavioral issues and/or physical or cognitive impairment that would impact the safety of the administration AND the patient does not have access to a caregiver.
For members receiving an immune checkpoint inhibitor (Bavencio, Imfinzi, Jemperli, Keytruda, Libtayo, Opdivo, Opdualag, Tecentriq, and Yervoy), ANY of the following additional criteria also apply:

a. The member is within the initial 6 months of starting therapy;

b. The member is continuing on a maintenance regimen that includes provider administered combination chemotherapy including but not limited to: i. Tecentriq used in combination with bevacizumab for non-small cell lung cancer (NSCLC); ii. Tecentriq used in combination with paclitaxel protein-bound for breast cancer; iii. Keytruda in combination with pemetrexed for NSCLC;

c. The member is experiencing severe toxicity requiring continuous monitoring (e.g. Grade 2-4 bullous dermatitis, transaminitis, pneumonitis, Stevens-Johnson syndrome, acute pancreatitis, primary adrenal insufficiency aseptic meningitis, encephalitis, transverse myelitis, myocarditis, pericarditis, arrhythmias, impaired ventricular function, conduction abnormalities).

REQUIRED DOCUMENTATION

The following information is necessary to initiate the site of care prior authorization review (where applicable): 

Medical records supporting the member has experienced an adverse reaction that did not respond to conventional interventions or a severe adverse event during or immediately after administration
Medical records supporting the member has IgA antibodies or has developed anti-drug antibodies
Medical records supporting the member is medically unstable
Medical records supporting the member has severe venous access issues that require specialized interventions only available in the outpatient hospital setting
Medical records supporting the member has behavioral issues and/or physical or cognitive impairment and no access to a caregiver
Medical records supporting the member is receiving provider administered combination chemotherapy.

For situations where administration of the medication does not meet the criteria for outpatient hospital administration, coverage for the medication is provided when administered in alternative sites such as; physician office, home infusion or ambulatory care.

*A duration greater than 45 days will be allowed for members initiating therapy for any of the following drugs and corresponding indications:

Drug	Indication	Days allowed
Actemra	Rheumatoid arthritis (RA) only	99 days
Actemra	Polyarticular Juvenile Idiopathic Arthritis(PJIA) only	99 days
Actemra	Systemic Juvenile Idiopathic Arthirits (SJIA) only	50 days
Actemra	Castleman's disease	50 days
Actemra	Immunotherapy-related inflammatory arthritis only	99 days
Aldurazyme	Mucopolysaccharidosis I	54 days
Elaprase	Hunter syndrome	54 days
Fabrazyme	Fabry disease	106 days
Infliximab	Takayasu only	85 days
Kanuma	LAL deficiency	50 days
Lumizyme	Pompe disease	106 days
Mepsveii	Mucopolysacaridosis VII	50 days
Naglazyme	Mucopolysacaridosis VI	54 days
Nexviazyme	Pompe disease	106 days
Oxlumo	Primary hyperoxaluria type I	60 days
Vimizim	Mucopolysacaridosis IVA	82 days
Vpriv	Gaucher disease type I	50 days
Vyepti	Migraine prevention	50 days
Xolair	Asthma, chronic idiopathic urticaria	60 days
Immune Checkpoint Inhibitors (Bavencio, Imfinzi, Jemperli, Keytruda, Libtayo, Opdivo, Opdualag, Tecentriq, and Yervoy)	All indications	6-month initial authorization, then up to 45 day renewal

Drug	Actemra
Indication	Rheumatoid arthritis (RA) only
Days allowed	99 days

Drug	Actemra
Indication	Polyarticular Juvenile Idiopathic Arthritis(PJIA) only
Days allowed	99 days

Drug	Actemra
Indication	Systemic Juvenile Idiopathic Arthirits (SJIA) only
Days allowed	50 days

Drug	Actemra
Indication	Castleman's disease
Days allowed	50 days

Drug	Actemra
Indication	Immunotherapy-related inflammatory arthritis only
Days allowed	99 days

Drug	Aldurazyme
Indication	Mucopolysaccharidosis I
Days allowed	54 days

Drug	Elaprase
Indication	Hunter syndrome
Days allowed	54 days

Drug	Fabrazyme
Indication	Fabry disease
Days allowed	106 days

Drug	Infliximab
Indication	Takayasu only
Days allowed	85 days

Drug	Kanuma
Indication	LAL deficiency
Days allowed	50 days

Drug	Lumizyme
Indication	Pompe disease
Days allowed	106 days

Drug	Mepsveii
Indication	Mucopolysacaridosis VII
Days allowed	50 days

Drug	Naglazyme
Indication	Mucopolysacaridosis VI
Days allowed	54 days

Drug	Nexviazyme
Indication	Pompe disease
Days allowed	106 days

Drug	Oxlumo
Indication	Primary hyperoxaluria type I
Days allowed	60 days

Drug	Vimizim
Indication	Mucopolysacaridosis IVA
Days allowed	82 days

Drug	Vpriv
Indication	Gaucher disease type I
Days allowed	50 days

Drug	Vyepti
Indication	Migraine prevention
Days allowed	50 days

Drug	Xolair
Indication	Asthma, chronic idiopathic urticaria
Days allowed	60 days

Drug	Immune Checkpoint Inhibitors (Bavencio, Imfinzi, Jemperli, Keytruda, Libtayo, Opdivo, Opdualag, Tecentriq, and Yervoy)
Indication	All indications
Days allowed	6-month initial authorization, then up to 45 day renewal

**Applies only to IVIG, infliximab and alpha-1-anti-trypsin products

***^†Applies only to IVIG, Tysabri, and infliximab products

^†Applies only to IVIG, HyQvia, Alpha 1 proteinase inhibitors

^††Does not apply to drugs administered by subcutaneous injection

^†††§Applies only to Tysabri, Infliximab, Elaprase, Kanuma, Aldurazyme, Cerezyme, Fabrazyme, Lumizyme, and Nexviazyme

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J3590, J0491, NDC 00310-3040-00 (Saphnelo)
J3590, J0219, NDC 58468-0426-01 (Nexviazyme)
J3590, NDC 80203-347-01 (Enjaymo)
J3490, J9999, NDC 00003-7125-11 (Opdualag)

Actemra [prescribing information]. South San Francisco, CA: Genentech, Inc.; March 2021.

Adakveo [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; July 2021.

Aduhelm [prescribing information]. Cambridge, MA: Biogen; April 2022.

Aldurazyme [prescribing information]. Novato, CA: BioMarin Pharmaceutical Inc.; December 2019.

American Academy of Allergy, Asthma and Immunology. Guidelines for the Site of Care for Administration of IGIV Therapy. December 2011.

Amondys 45 [package insert]. Cambridge, MA: Sarepta Therapeutics; February 2021.

Aralast NP [package insert]. Lexington, MA: Baxalta US Inc.; December 2018.

Asceniv [prescribing information.] Kankakee, IL: CSL Behring LLC; April 2019.

Avsola [prescribing information]. Thousand Oaks, CA: Amgen Inc.; December 2019.

Bavencio [prescribing information]. Rockland, MA: EMD Serono, Inc; November 2020.

Bivigam [prescribing information]. Boca Raton, FL: Biotest Pharmaceuticals Corporation; July 2019.

Benlysta [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; March 2021.

Bonilla FA. Intravenous immunoglobulin: adverse reactions and management. J Allergy Clin Immunol. 2008;122(6):1238-1239.

Cerezyme [prescribing information]. Cambridge, MA: Genzyme Corporation.; April 2018.

Cinqair [prescribing information]. Frazer, PA: Teva Respiratory, LLC; February 2020.

Cinryze [prescribing information]. Lexington, MA: Shire ViroPharma Biologics Inc.; January 2021.

Crysvita [prescribing information]. Novato, CA: Ultragenyx Pharmaceutical Inc; June 2020.

Cutaquig [package insert]. Hoboken, NJ: Octapharma USA Inc; July 2020.

Cuvitru [package insert]. Lexington, MA: Baxalta USA Inc.; March 2021.

Elaprase [prescribing information]. Lexington, MA: Shire Human Genetic Therapies, Inc.; September 2021.

Elelyso [prescribing information]. NY, NY: Pfizer Inc.; July 2021.

Enjaymo [package insert]. Waltham, MA: Bioverativ USA Inc Inc.; February 2022.

Entyvio [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; March 2020.

Evkeeza [prescribing information]. Tarrytown, NY: Regeneron Pharmaceuticals Inc; February 2021.

Exondys 51 [prescribing information]. Cambridge, MA: Sarepta Therapeutics, Inc.; January 2022.

Fabrazyme [prescribing information]. Cambridge, MA: Genzyme Corporation.; March 2021.

Fasenra [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021.

Flebogamma 10% DIF [prescribing information]. Barcelona, Spain: Instituto Grifols, SA; November 2019.

Flebogamma 5% DIF [prescribing information]. Barcelona, Spain: Instituto Grifols, SA; November 2019.

Gammagard Liquid [prescribing information]. Lexington, MA: Baxalta US Inc; March 2021.

Gammagard S/D IgA less than 1 mcg/mL [package insert]. Lexington, MA: Baxalta US Inc; March 2021.

Gammaked [package insert]. Research Triangle Park, NC: Grifols Therapeutics Inc.; January 2020.

Gammaplex 5% [package insert]. Durham, NC: Bio Products Laboratory Inc; September 2019.

Gammaplex 10% [package insert]. Durham, NC: Bio Products Laboratory Inc; October 2019.

Gamunex-C [package insert]. Research Triangle Park, NC: Grifols Therapeutics Inc.; January 2020.

Givlaari [prescribing information]. Cambridge, MA: Alnylam Pharmaceuticals.; December 2020.

Glassia [package insert]. Lexington, MA: Baxter US Inc.; June 2017.

Hizentra [package insert]. Kankakee, IL: CSL Behring LLC; April 2021.

HyQvia [package insert]. Lexington, MA: Baxalta USA Inc.; March 2021.

Imfinzi [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021.

Inflectra [prescribing information]. Lake Forest, IL: Celltrion, Inc.; August 2020.

Jemperli [prescribing information]. Philadelphia, PA: GlaxoSmithKline LLC; August 2021.

Kanuma [prescribing information]. Cheshire, CT: Alexion Pharmaceuticals Inc.; November 2021.

Katzberg H, Rasutis V, Bril V Home iVIG for CIDP: A Focus on Patient Centred Care Can J Neurol Sci. 2013; 40: 384-388.

Keytruda [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; July 2021.

Lemtrada [prescribing information]. Cambridge, MA: Genzyme Corp.; January 2022.

Libtayo [prescribing information]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; February 2021.

Lumizyme [prescribing information]. Cambridge, MA: Genzyme Corporation; February 2020.

Luxturna [prescribing information]. Philadelphia, PA: Spark Therapeutics, Inc.; December 2019.

MCG Care Guidelines, 19^th Edition, 2015, Home Infusion Therapy: CMT: CMT-0009

Mepsevii [prescribing information]. Novato, CA: Ultragenyx Pharmaceutical Inc.; December 2020.

Naglazyme [prescribing information]. Novato, CA: BioMarin Pharmaceutical Inc; December 2019.

Nexviazyme [prescribing information]. Cambridge, MA: Genzyme Corporation; August 2021.

Nucala [package insert]. Research Triangle Park, NC: GlaxoSmithKline, Inc.; January 2022.

Ocrevus [prescribing information]. Genentech, Inc. South San Francisco, CA.; March 2021.

Octagam 10% [package insert]. Hoboken, NJ: Octapharma USA, Inc.; February 2020.

Octagam 5% [package insert]. Hoboken, NJ: Octapharma USA, Inc.; February 2020

Onpattro (patisiran) [prescribing Information]. Alnylam Pharmaceuticals, Inc. May 2021.

Opdivo [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; March 2022.

Opdualag [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; March 2022.

Orencia [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; June 2020.

Oxlumo [prescribing information]. Cambridge, MA: Alnylam Pharmaceuticals, Inc; November 2020.

Panzyga [package insert]. Lingolsheim, France : Octapharma SAS, Inc; February 2021.

Privigen [package insert]. Bern, Switzerland: CSL Behring AG; March 2019.

Prolastin-C [package insert]. Research Triangle Park, NC: Grifols Therapeutics Inc.; May 2020.

Radicava [prescribing information]. Jersey City, NJ: MT Pharma America, Inc.; March 2021.

Remicade [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; May 2020.

Renflexis [prescribing information]. Kenilworth, NJ: Merck & Co., Inc.; February 2021.

Saphnelo [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; July 2021.

Rigas M, Tandan R, Sterling R. Safety of Liquid Intravenous Immunoglobulin for Neuroimmunologic Disorders in the Home Setting: A Retrospective Analysis of 1085 Infusions. J Clin Neuromusc Dis 2008; 10:52-55

Scheinman SJ and Drezner MK. Hereditary hypophosphatemic rickets and tumor-induced osteomalacia. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed September 2017.

Simponi Aria [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; February 2021.

Soliris [prescribing information]. New Haven, CT: Alexion Pharmaceuticals Inc; November 2020.

Souayah N, Hasan A, Khan H, et. al. The Safety Profile of Home Infusion of Intravenous Immunoglobulin in Patients with Neuroimmunologic Disorders. J Clin Neuromusc Dis 2011; 12:S1-S10

Spinraza [package insert]. Cambridge, MA: Biogen Inc.; June 2020.

Stiehm ER. Adverse effects of human immunoglobulin therapy. Transfus Med Rev. 2013;27(3):171-178.

Tecentriq [prescribing information]. South San Francisco, CA: Genentech, Inc.; April 2021.

Tepezza [package insert]. Dublin, Ireland: Horizon Therapeutics Ireland DAC; October 2021.

Tezspire [package insert]. Thousand Oaks, CA: Amgen; December 2021.

Tysabri [prescribing information]. Cambridge, MA: Biogen Idec Inc.; June 2020.

U.S. Food and Drug Administration (FDA). FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia. Silver Spring, MD: FDA; April 21, 2018. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604810.htm. Accessed April 24, 2018.

Ultomiris [prescribing information]. Boston, MA: Alexion Pharmaceuticals. Inc. June 2021.

Uplizna [prescribing information]. Gaithersburg, MD: Viela Bio, Inc.; July 2021.

Viltepso [prescribing information]. Paramus, NJ: NS Pharma, Inc.; March 2021.

Vimizim [prescribing information]. Novato, CA: BioMarin Pharmaceutical Inc; December 2019.

Vpriv [prescribing information]. Lexington, MA: Shire Human Genetic Therapies Inc; September 2021.

Vyondys 53 [prescribing information]. Cambridge, MA: Sarepta Therapeutics, Inc. February 2021.

Vyepti [package insert]. Bothell, WA: Lundbeck Seattle Bio Pharmaceuticals, Inc; February 2020.

Xembify [package insert]. Research Triangle Park, NC: Grifols Therapeutics LLC; August 2020.

Xolair [package insert]. South San Francisco, CA: Genentech, Inc.; July 2021.

Yervoy [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company. February 2022.

Zemaira [package insert]. Kankakee, IL: CSL Behring LLC.; April 2019.

Zolgensma [prescribing information]. Bannockburn, IL: AveXis, Inc.; October 2021.

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Health benefits and health insurance plans contain exclusions and limitations.

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