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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 (See Site of Care for Specialty Drug Infusion/Injection applicable drug therapy below).

 

 

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, all doses (including the starting dose(s)) must be administered at an Aetna Institutes™ Gene Based, Cellular and Other Innovative Therapy (GCIT™) Network listed in the policy apply (See GCIT Designated Centers below).

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. (See Criteria for Medical Necessity below)

 

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
Amvuttra – effective 9/22/2022
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
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
LuxturnaGCIT 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 3/17/2021
Radicava (edaravone IV) effective 7/20/2017
Remicade (infliximab) effective 7/1/2017
Renflexis (infliximab-abda) effective 9/1/2017
Saphnelo effective 10/7/2021
Simponi Aria effective 1/1/2019
Soliris effective 1/1/2017
SpinrazaGCIT 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
ZolgensmaGCIT effective 7/1/2019

 

GCITProduct available for administration at Aetna Institutes ™ Gene Based, Cellular and Other Innovative Therapy (GCIT™) Designated Centers.

 

Aetna Institutes GCIT Designated Centers

 

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

 
  • The Children’s Hospital of Alabama – Birmingham, AL
  • Children's Hospital Los Angeles - Los Angeles, CA
  • University of Iowa Hospital and Clinics - Iowa City, IA
  • Massachusetts Eye and Ear Infirmary – Boston, MA
  • University of Michigan Medical Center – Kellogg Eye Center nn Arbor, MI
  • Cincinnati Children's Hospital and Medical Center – Cincinnati, OH
  • Oregon Health & Science University Hospital - Casey Eye Institute – Portland, OR
  • Children's Hospital of Philadelphia – Philadelphia, PA
  • Penn Presbyterian Medical Center (Scheie Eye Institute) – Philadelphia, PA
  • St. Luke's Health Baylor College of Medicine Medical Center – Houston, TX
  • The Children's Hospital of Alabama – Birmingham, AL
  • Banner University Medical Center Tucson Campus – Tucson, AZ
  • Banner University Medical Center Phoenix Campus – Phoenix, AZ
  • Diamond Children’s Hospital, part of Banner University Tucson Campus – Tucson, AZ
  • Children's Hospital Los Angeles - Los Angeles, CA
  • Lucile Packard Children's Hospital - Palo Alto, CA
  • Rady Children's Hospital San Diego - San Diego, CA
  • Stanford Medical Center – Stanford, CA
  • Children's Hospital Colorado – Aurora, CO
  • Connecticut Children's Medical Center – Farmington, CT
  • Children's National Medical Center – Washington, DC
  • MedStar Georgetown University Hospital – Washington, DC
  • Nemours Children’s Hospital Delaware – Wilmington, DE
  • Joe DiMaggio Children's Hospital – Hollywood, FL
  • Memorial Hospital Regional – Hollywood, FL
  • Nemours Children's Hospital – Orlando, FL
  • Nicklaus Children's Hospital – Miami, FL
  • St. Josephs Woman's Hospital (Baycare) – Tampa, FL
  • Memorial Hospital Regional – Hollywood, FL
  • Children's Healthcare of Atlanta - Scottish Rite Hospital – Atlanta, GA
  • Children's Healthcare of Atlanta at Egleston – Atlanta, GA
  • University of Iowa Hospital and Clinics - Iowa City, IA
  • University of Kansas Medical Center - Kansas City, KS
  • Boston Children's Hospital – Boston, MA
  • Children's Hospital of Michigan – Detroit, MI
  • Children's Hospital of Michigan - Grand Blanc, MI
  •  C S Mott Children's Hospital - Ann Arbor , MI
  • University of Michigan Medical Center – Ann Arbor, MI
  • Gillette Children's Specialty Healthcare - Saint Paul, MN
  • The Children's Mercy Hospital - Kansas City, MO
  • Children's Hospital and Medical Center – Omaha, NE
  • Goryeb Children's Hospital at Morristown Medical Center – Morristown, NJ
  • NYU Langone Tisch Hospital – New York, NY
  • NYU Langone Hospital Brooklyn – Brooklyn, NY
  • NYU Langone Hospital Long Island – Mineola, NY
  • Cincinnati Children's Hospital and Medical Center – Cincinnati, OH
  • Nationwide Children's Hospital – Columbus, OH
  • Ohio State University Hospital – Columbus, OH
  • The Children's Hospital at Oklahoma University Medical Center - Oklahoma City, OK
  • Oregon Health & Science University Hospital - Doernbecher Children's Hospital – Portland, OR
  • Children's Hospital of Philadelphia – Philadelphia, PA
  • Milton Hershey Medical Center Pennsylvania State University – Hershey, PA
  • Hospital of The University of Pennsylvania Health System – Philadelphia, PA
  • Vanderbilt University Medical Center – Nashville, TN
  • Monroe Carell, Jr. Children’s Hospital at Vanderbilt – Nashville, TN
  • Cook Children's Medical Center - Fort Worth, TX
  • Children's Medical Center of Dallas – Dallas, TX
  • Primary Children's Hospital - Salt Lake City, UT
  • Children's Hospital of The King's Daughters – Norfolk, VA
  • Seattle Children's Hospital – Seattle, WA
  • University of Wisconsin Hospital and Clinics – Madison, WI
  • The Children's Hospital of Alabama – Birmingham, Al
  • Children's Hospital Los Angeles - Los Angeles, CA
  • Lucile Packard Children's Hospital - Palo Alto, CA
  • Rady Children's Hospital San Diego - San Diego, CA
  • Ronald Reagan UCLA Medical Center - Los Angeles, CA
  • Stanford Medical Center – Stanford, CA
  • Children's Hospital Colorado – Aurora, CO
  • Connecticut Children's Medical Center – Farmington, CT
  • Children's National Medical Center – Washington, DC
  • Nemours Children’s Hospital Delaware – Wilmington, DE
  •  Jackson Memorial Hospital – Miami, FL
  • Joe DiMaggio Children's Hospital – Hollywood, FL
  • Nemours Children's Hospital – Orlando, FL
  • Nicklaus Children's Hospital – Miami, FL
  • St. Josephs Woman's Hospital (Baycare) – Tampa, FL
  •  Memorial Hospital Regional – Hollywood, FL
  • Children's Healthcare of Atlanta at Scottish Rite – Atlanta, GA
  • Children's Healthcare of Atlanta at Egleston – Atlanta, GA
  • University of Iowa Hospital and Clinics - Iowa City, IA
  • Ann and Robert H Lurie Children's Hospital of Chicago – Chicago, IL
  • University of Kansas Medical Center - Kansas City, KS
  • University of Kentucky Hospital – Lexington, KY
  • Children's Hospital New Orleans - New Orleans, LA
  • Massachusetts General Brigham - Boston, MA
  • Children's Hospital of Michigan – Detroit, MI
  • Children's Hospital of Michigan - Grand Blanc, MI
  • C S Mott Children's Hospital – Ann Arbor, MI
  • University of Michigan Medical Center – Ann Arbor, MI
  • Gillette Children's Specialty Healthcare - Saint Paul, MN
  • The Children's Mercy Hospital - Kansas City, MO
  • Children's Hospital and Medical Center – Omaha, NE
  • Goryeb Children's Hospital at Morristown Medical Center – Morristown, NJ
  • Columbia University Medical Center - New York, NY
  • University of Rochester Medical Center Health System - Strong Memorial Hospital – Rochester, NY
  •  NYU Langone Tisch Hospital – New York, NY
  • NYU Langone Hospital Brooklyn – Brooklyn, NY
  • NYU Langone Hospital Long Island – Mineola, NY
  • NYU Langone Orthopedic Hospital – New York, NY
  • Cincinnati Children's Hospital and Medical Center – Cincinnati, OH
  • Nationwide Children's Hospital – Columbus, OH
  • Akron Children's Hospital – Akron, OH
  • Integris Southwest Medical Center - Oklahoma City, OK
  • The Children's Hospital at Oklahoma University Medical Center - Oklahoma City, OK
  • Oregon Health & Science University Hospital - Doernbecher Children's Hospital – Portland, OR
  • Children's Hospital of Philadelphia - Philadelphia , PA
  • Milton Hershey Medical Center Pennsylvania State University – Hershey, PA
  • Vanderbilt University Medical Center – Nashville, TN
  • Monroe Carell, Jr. Children’s Hospital at Vanderbilt – Nashville, TN
  • Cook Children's Medical Center - Fort Worth, TX
  • Children's Medical Center of Dallas - Dallas, TX
  • Children's Hospital of The King's Daughters – Norfolk, VA
  • Seattle Children's Hospital – Seattle, WA
  • University of Wisconsin Hospital and Clinics – Madison, WI

 

For more information on Aetna Institutes ™ Gene Based, Cellular and Other Innovative Therapy (GCIT™) Designated Centers refer to Aetna Institutes™

 

Criteria for medical necessity

 

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:

 

  1. 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.
  2. The member is switching to a product that he/she has not received before.**
  3. 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:

 

  1. The member has experienced an adverse reaction that did not respond to conventional interventions (e.g., 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.
  2. 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.
  3. The member is medically unstable (e.g., respiratory, cardiovascular, or renal conditions).
  4. The member has severe venous access issues that require the use of a special intervention.††
  5. 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.
  6. 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): 

 

  1. 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
  2. Medical records supporting the member has IgA antibodies or has developed anti-drug antibodies
  3. Medical records supporting the member is medically unstable
  4. Medical records supporting the member has severe venous access issues that require specialized interventions only available in the outpatient hospital setting
  5. Medical records supporting the member has behavioral issues and/or physical or cognitive impairment and no access to a caregiver
  6. 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.
 

 

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, Nexviazyme and Xenpozyme

Applicable codes

References

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.

Amvuttra [package insert]. Cambridge, MA: Alnylam Pharmaceuticals, Inc.; June 2022.

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.; September 2021.

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; October 2021.

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

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.; January 2022.

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

Hizentra [package insert]. Kankakee, IL: CSL Behring LLC; April 2022.

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; April 2022.

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.; June 2022.

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, 19th 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.; July 2021.

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

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

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

Orencia [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; December 2021.

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 2022.

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.; October 2021.

Renflexis [prescribing information]. Kenilworth, NJ: Merck & Co., Inc.; January 2022.

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.; January 2022.

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.; December 2021.

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. April 2022.

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; April 2022.

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.

Legal notices

Aetna is the brand name used for products and services provided by one or more of the Aetna group of companies, including Aetna Life Insurance Company and its affiliates (Aetna).

Health benefits and health insurance plans contain exclusions and limitations.

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