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 Aetna Institutes® 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)

For identified gene and cellular therapies, Aetna Institutes® program GCIT Designated Network applies in place of medical necessity exception criteria. (See Aetna Institutes® GCIT Designated Centers below)

Site of care for specialty drug infusion/Injection applicable drug therapy

Actemra IV formulation – effective 1/1/2019

Adakveo – effective 2/13/2020
Adcetris – effective 8/1/2024
Aduhelm – effective 8/3/2021

Adzynma – effective 3/19/2024
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
Beqvez – effective 8/1/2024
Briumvi – effective 4/11/2023
Casgevy^GCIT – effective 3/1/2024
Cerezyme – effective 1/1/2020
Cinqair – effective 9/1/2020
Cinryze – effective 1/1/2020
Cosentyx IV – effective 1/1/2024
Crysvita – effective 7/13/2018
Elaprase – effective 1/1/2020
Elelyso – effective 1/1/2020
Elevidys^GCIT effective 09/14/2023
Elfabrio – effective 8/1/2023

Enjaymo – effective 4/29/2022

Entyvio – effective 1/1/2019
Evkeeza – effective 5/7/2021
Exondys 51 – effective 1/11/2017
Fabrazyme – effective 1/1/2020
Fasenra (provider-administered) – effective 9/1/2020
Givlaari – effective 2/13/2020
Hemgenix^GCIT effective 3/17/2023
Herceptin – effective 8/1/2024
Hercessi – effective 8/1/2024
Herzuma – effective 08/1/2024
Imfinzi – effective 7/1/2020
Immune Globulins – effective 1/1/2017
Inflectra (infliximab-dyyb) – effective 7/1/2017
Jemperli – effective 7/1/2021
Kadcyla – effective 8/1/2024
Kanjinti – effective 8/1/2024
Kanuma – effective 1/1/2020
Keytruda – effective 7/1/2020
Kisunla – effective 10/1/2024
Lamzede – effective 7/1/2023
Lanreotide – effective 9/1/2024
Lemtrada – effective 7/1/2017
Lenmeldy ^GCIT– effective 7/1/2024
Leqembi – effective 04/5/2023
Loqtorzi – effective 3/19/2024
Lumizyme – effective 1/1/2020
Lyfgenia^GCIT – effective 3/1/2024
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
Ogivri – effective 8/1/2024
Onpattro – effective 08/23/2018
Ontruzant – effective 8/1/2024

Opdivo – effective 7/1/2020

Opdualag – effective 6/1/2022

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

Aetna Institutes® GCIT Designated Centers

Beqvez	Qalsody
Casgevy	Roctavian
Elevidys	Skysona
Hemgenix	Spinraza
Lenmeldy	Zolgensma
Lyfgenia	Zynteglo
Luxturna

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

For the GCIT network facility listing, refer to:

GCIT network facility listing (PDF)

GCIT network facility listing - Spanish (PDF)

Criteria for medical necessity

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 they haven’t received before.*
The member’s had a gap in therapy.*

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.
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 (e.g., 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 Perjeta or trastuzumab (Herceptin, Hercessi, Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera), the member is receiving provider-administered combination chemotherapy.
For members receiving Adcetris or rituximab (Riabni, Rituxan, Ruxience, Truxima), the member is receiving provider-administered chemotherapy or other drug therapies at the same visit.
For members receiving Perjeta, trastuzumab, or rituximab, the member is less than 14 years of age.
For members receiving an immune checkpoint inhibitor (Bavencio, Imfinzi, Jemperli, Keytruda, Libtayo, Loqtorzi, Opdivo, Opdualag, Tecentriq, Tevimbra, Yervoy, Zynyz), ANY of the following additional criteria also apply:
1. The member is within the initial 6 months of starting therapy;
2. 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;
3. 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).

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.

Drug	Indication	Days allowed
Tocilizumab	Rheumatoid arthritis (RA) only	99 days
Tocilizumab	Polyarticular Juvenile Idiopathic Arthritis(PJIA) only	99 days
Tocilizumab	Systemic Juvenile Idiopathic Arthirits (SJIA) only	50 days
Tocilizumab	Castleman's disease	50 days
Tocilizumab	Immunotherapy-related inflammatory arthritis only	99 days
Adzynma	Prophylactic treatment of congenital thrombotic thrombocytopenic purpura (cTTP) only	99 days
Aldurazyme	Mucopolysaccharidosis I	54 days
Elaprase	Hunter syndrome	54 days
Elfabrio	Fabry disease	106 days
Fabrazyme	Fabry disease	106 days
Infliximab	Takayasu only	85 days
Kanuma	LAL deficiency	50 days
Lamzede	Alpha-mannosidosis	54 days
Lumizyme	Pompe disease	106 days
Mepsevii	Mucopolysacaridosis VII	50 days
Naglazyme	Mucopolysacaridosis VI	54 days
Nexviazyme	Pompe disease	106 days
Oxlumo	Primary hyperoxaluria type I	60 days
Pombiliti	Pompe disease	106 days
Vimizim	Mucopolysacaridosis IVA	82 days
Vpriv	Gaucher disease type I	50 days
Vyepti	Migraine prevention	50 days
Xenpozyme	Acid sphingomyelinase deficiency (ASMD)	119 days
Xolair	Asthma, chronic idiopathic urticaria	60 days
Immune Checkpoint Inhibitors (Bavencio, Imfinzi, Jemperli, Keytruda, Libtayo, Loqtorzi, Opdivo, Opdualag, Tecentriq, Tevimbra, Yervoy, and Zynyz)	All indications	6-month initial authorization, then up to 45 day renewal

Drug	Tocilizumab
Indication	Rheumatoid arthritis (RA) only
Days allowed	99 days
Drug	Tocilizumab
Indication	Polyarticular Juvenile Idiopathic Arthritis(PJIA) only
Days allowed	99 days
Drug	Tocilizumab
Indication	Systemic Juvenile Idiopathic Arthirits (SJIA) only
Days allowed	50 days
Drug	Tocilizumab
Indication	Castleman's disease
Days allowed	50 days
Drug	Tocilizumab
Indication	Immunotherapy-related inflammatory arthritis only
Days allowed	99 days
Drug	Adzynma
Indication	Prophylactic treatment of congenital thrombotic thrombocytopenic purpura (cTTP) only
Days allowed	99 days
Drug	Aldurazyme
Indication	Mucopolysaccharidosis I
Days allowed	54 days
Drug	Elaprase
Indication	Hunter syndrome
Days allowed	54 days
Drug	Elfabrio
Indication	Fabry disease
Days allowed	106 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	Lamzede
Indication	Alpha-mannosidosis
Days allowed	54 days
Drug	Lumizyme
Indication	Pompe disease
Days allowed	106 days
Drug	Mepsevii
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	Pombiliti
Indication	Pompe disease
Days allowed	106 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	Xenpozyme
Indication	Acid sphingomyelinase deficiency (ASMD)
Days allowed	119 days
Drug	Xolair
Indication	Asthma, chronic idiopathic urticaria
Days allowed	60 days
Drug	Immune Checkpoint Inhibitors (Bavencio, Imfinzi, Jemperli, Keytruda, Libtayo, Loqtorzi, Opdivo, Opdualag, Tecentriq, Tevimbra, Yervoy, and Zynyz)
Indication	All indications
Days allowed	6-month initial authorization, then up to 45 day renewal

Medication billing procedure codes

References

Actemra [prescribing information]. South San Francisco, CA: Genentech, Inc.; December 2022.

Adakveo [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2024.

Adcetris [prescribing information]. Bothell, WA: Seagen Inc.; June 2023.

Aduhelm [prescribing information]. Cambridge, MA: Biogen; August 2023.

Adzynma [prescribing information]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; November 2023.

Aldurazyme [prescribing information]. Novato, CA: BioMarin Pharmaceutical Inc.; December 2023.

Alyglo [package insert]. Teaneck, NJ: GC Biopharma USA, Inc.; December 2023.

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; March 2023.

Amvuttra [package insert]. Cambridge, MA: Alnylam Pharmaceuticals, Inc.; February 2023.

Aralast NP [package insert]. Lexington, MA: Baxalta US Inc.; March 2023.

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; March 2024.

Benlysta [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; February 2023.

Beqvez [prescribing information]. New York, NY: Pfizer Inc.; April 2024.

Bivigam [prescribing information]. Boca Raton, FL: Biotest Pharmaceuticals Corporation; March 2024.

BKEMV [prescribing information]. Thousand Oaks, CA: Amgen Inc.: May 2024.

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

Briumvi [prescribing information]. Morrisville, NC: TG Therapeutics, Inc.; December 2022.

Casgevy [package insert]. Boston, MA: Vertex Pharmaceuticals, Inc.; December 2023.

Cerezyme [prescribing information]. Cambridge, MA: Genzyme Corporation.; December 2022.

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

Cinryze [prescribing information]. Lexington, MA: Shire ViroPharma Biologics Inc.; February 2023.

Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; November 2023.

Crysvita [prescribing information]. Novato, CA: Ultragenyx Pharmaceutical Inc; March 2023.

Cutaquig [package insert]. Hoboken, NJ: Octapharma USA Inc; November 2021.

Cuvitru [package insert]. Lexington, MA: Baxalta USA Inc.; March 2023.

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

Elelyso [prescribing information]. NY, NY: Pfizer Inc.; May 2023.

Elevidys [package insert]. Cambridge, MA: Sarepta Therapeutics, Inc.; June 2023.

Elfabrio [prescribing information]. Cary, NC: Chiesi USA, Inc.; May 2022.

Enjaymo [package insert]. Waltham, MA: Bioverativ USA Inc Inc.; February 2024.

Entyvio [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; September 2023.

Evkeeza [prescribing information]. Tarrytown, NY: Regeneron Pharmaceuticals Inc; March 2023.

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

Fabrazyme [prescribing information]. Cambridge, MA: Genzyme Corporation.; March 2023.

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

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

Flebogamma 5% DIF [prescribing information]. Barcelona, Spain: Instituto Grifols, SA; September 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; November 2021.

Gammaplex 10% [package insert]. Durham, NC: Bio Products Laboratory Inc; November 2021.

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

Givlaari [prescribing information]. Cambridge, MA: Alnylam Pharmaceuticals.; February 2023.

Glassia [package insert]. Lexington, MA: Baxter US Inc.; September 2023.

Hemgenix [package insert]. King of Prussia, PA: CSL Behring LLC; November 2022.

Herceptin [package insert]. South San Francisco, CA: Genentech, Inc.; February 2021.

Hercessi [package insert]. Raleigh, NC: Accord BioPharma Inc.; April 2024.

Herzuma [package insert]. Incheon, Republic of Korea: Celltrion, Inc.; May 2019.

Hizentra [package insert]. Kankakee, IL: CSL Behring LLC; April 2023.

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

Imfinzi [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; June 2023.

Inflectra [prescribing information]. Lake Forest, IL: Celltrion, Inc.; April 2023.

Jemperli [prescribing information]. Philadelphia, PA: GlaxoSmithKline LLC; March 2024.

Kadcyla [package insert]. South San Francisco, CA: Genentech, Inc.; February 2022.

Kanjinti [package insert]. Thousand Oaks, CA: Amgen, Inc.; October 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.

Kisunla [prescribing information]. Indianapolis, IN: Eli Lilly and Company; July 2024.

Kisunla [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; March 2024.

Lamzede [prescribing information]. Cary, NC: Chiesi USA, Inc.; February 2023.

Lanreotide [prescribing information]. Warren, NJ: Cipla USA, Inc.; September 2023.

Lemtrada [prescribing information]. Cambridge, MA: Genzyme Corp.; May 2023.

Lenmeldy [prescribing information]. Boston, MA: Orchard Therapeutics North America; March 2024.

Leqembi [prescribing information]. Nutley, NJ: Eisai Inc.; July 2023.

Libtayo [prescribing information]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; March 2024.

Loqtorzi [prescribing information]. Redwood City, CA: Coherus BioSciences, Inc.; October 2023.

Lumizyme [prescribing information]. Cambridge, MA: Genzyme Corporation; March 2023.

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

Lyfgenia [package insert]. Somerville, MA: Bluebird bio, Inc.; December 2023.

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; September 2023.

Nucala [package insert]. Research Triangle Park, NC: GlaxoSmithKline, Inc.; March 2023.

Ocrevus [prescribing information]. Genentech, Inc. South San Francisco, CA.; January 2024.

Octagam 10% [package insert]. Hoboken, NJ: Octapharma USA, Inc.; March 2022.

Octagam 5% [package insert]. Hoboken, NJ: Octapharma USA, Inc.; April 2022.

Ogivri [package insert]. Morgantown, WV: Mylan Pharmaceuticals Inc.; July 2023.

Onpattro (patisiran) [prescribing Information]. Alnylam Pharmaceuticals, Inc. January 2023.

Ontruzant [package insert]. Incheon, Republic of Korea: Samsung Bioepis Co.; June 2021.

Opdivo [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; March 2024.

Opdualag [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; March 2024.

Orencia [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; May 2024.

Oxlumo [prescribing information]. Cambridge, MA: Alnylam Pharmaceuticals, Inc; September 2023.

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

Perjeta [package insert]. South San Francisco, CA: Genentech, Inc.; February 2021.

Piasky [package insert]. South San Francisco, CA: Genentech, Inc.; June 2024.

Pombiliti [prescribing information]. Philadelphia, PA: Amicus Therapeutics US, LLC; September 2023.

Privigen [package insert]. Bern, Switzerland: CSL Behring AG; March 2022.

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

Qalsody [package insert]. Cambridge, MA: Biogen Inc.; April 2023.

Radicava [prescribing information]. Jersey City, NJ: MT Pharma America, Inc.; November 2022.

Remicade [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; October 2021.

Renflexis [prescribing information]. Kenilworth, NJ: Merck & Co., Inc.; January 2023.

Riabni [package insert]. Thousand Oaks, CA: Amgen Inc.; June 2022.

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

Rituxan [package insert]. South San Francisco, CA: Genentech, Inc.; December 2021.

Rivfloza [package insert]. Lexington, MA: Dicerna Pharmaceuticals, Inc.; October 2022.

Roctavian [package insert]. Novato, CA: BioMarin Pharmaceutical Inc.; June 2023.

Ruxience [package insert]. NY, NY: Pfizer Inc; November 2021.

Saphnelo [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2023.

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.

Skysona [package insert]. Somerville, MA: Bluebird bio.; September 2022.

Soliris [prescribing information]. New Haven, CT: Alexion Pharmaceuticals Inc; March 2024.

Somatuline Depot [prescribing information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.’ February 2023.

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.; February 2023.

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.; May 2023.

Tepezza [package insert]. Dublin, Ireland: Horizon Therapeutics Ireland DAC; July 2023.

Tevimbra [package insert]. San Mateo, CA: BeiGene USA, Inc.; March 2024.

Tezspire [package insert]. Thousand Oaks, CA: Amgen; May 2023.

Tofidence [package insert]. Cambridge, MA: Biogen MA Inc.; October 2023.

Trazimera [package insert]. Cork, Ireland: Pfizer Ireland Pharmaceuticals; November 2020.

Truxima [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.: February 2022.

Tyenne [package insert]. Lake Zurich, IL: Fresenius Kabi USA LLC; March 2024.

Tyruko [package insert]. Princeton, NJ: Sandoz Inc.; August 2023.

Tysabri [prescribing information]. Cambridge, MA: Biogen Idec Inc.; October 2023.

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. March 2024.

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

Veopoz [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals Inc.; March 2024.

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; October 2022.

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

Xenpozyme [prescribing information]. Cambridge, MA: Genzyme Corporation; July 2023.

Xolair [package insert]. South San Francisco, CA: Genentech, Inc.; February 2024.

Yervoy [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company. February 2023.

Yimmugo [package insert]. Dreieich, Germany: Biotest AG. June 2024.

Zemaira [package insert]. Kankakee, IL: CSL Behring LLC.; September 2022.

Zolgensma [prescribing information]. Bannockburn, IL: AveXis, Inc.; February 2023.

Zynteglo [package insert]. Somerville, MA: Bluebird bio; August 2022.

Zynyz [package insert]. Wilmington, DE: Incyte Corporation; March 2023.

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Health benefits and health insurance plans contain exclusions and limitations.

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Drug infusion/Injection site of care policy

Site of care

Site of care for specialty drug infusion/Injection applicable drug therapy

Aetna Institutes® GCIT Designated Centers

Criteria for medical necessity

Medication billing procedure codes

Applicable codes

References

Legal notices

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Drug infusion/Injection site of care policy

Site of care

Site of care for specialty drug infusion/Injection applicable drug therapy

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

Aetna Institutes® GCIT Designated Centers

The drugs listed below are a part of the GCIT Designated Network:

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:

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

Required documentation

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

Medication billing procedure codes

Applicable codes

References

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Legal notices