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 2/1/2020
Aldurazyme-effective 1/1/2020
Alpha 1 proteinase inhibitors (Glassia, Prolastin C, Aralast NP, Zemaira)-effective 1/1/2020
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
Entyvio - effective 1/1/2019
Exondys 51 - effective 1/11/2017
Fabrazyme-effective 1/1/2020
Fasenra (provider-administered) – effective 9/1/2020
Givlaari-effective 2/1/2020
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
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
Nucala (provider-administered) – effective 9/1/2020
Ocrevus - effective 05/23/2017
Onpattro - effective 08/23/2018
Opdivo - effective 7/1/2020
Orencia IV formulation - effective 1/1/2019
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
Simponi Aria - effective 1/1/2019
Soliris - effective 1/1/2017
Tecentriq - effective 7/1/2020
Tepezza – effective 7/1/2020
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:
^Product is available for administration at Aetna Gene Therapy Designated Centers identified below:
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.
I. CRITERIA FOR APPROVAL FOR ADMINISTRATION IN OUTPATIENT-HOSPITAL SETTING
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:
A. 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.
B. The member is switching to a product that he/she has not received before.**
C. 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:
A. 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.
B. 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.
C. The member is medically unstable (eg respiratory, cardiovascular, or renal conditions).
D. The member has severe venous access issues that require the use of a special intervention.†††
E. 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.
F. For members receiving an immune checkpoint inhibitor (Bavencio, Imfinzi, Keytruda, Libtayo, Opdivo, Tecentriq, and Yervoy), 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:
a. Tecentriq used in combination with bevacizumab for non-small cell lung cancer (NSCLC)
b. Tecentriq used in combination with paclitaxel protein-bound for breast cancer
c. 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)
II. REQUIRED DOCUMENTATION
The following information is necessary to initiate the site of care prior authorization review (where applicable):
A. 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
B. Medical records supporting the member has IgA antibodies or has developed anti-drug antibodies
C. Medical records supporting the member is medically unstable
D. Medical records supporting the member has severe venous access issues that require specialized interventions only available in the outpatient hospital setting
E. Medical records supporting the member has behavioral issues and/or physical or cognitive impairment and no access to a caregiver
F. 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:
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 |
Vimizim |
Mucopolysacaridosis IVA |
82 days |
Vpriv |
Gaucher disease type I |
50 days |
Vyepti | Migraine prevention |
90 days |
Xolair | Asthma, chronic idiopathic urticaria |
60 days |
Immune Checkpoint Inhibitors (Bavencio, Imfinzi, Keytruda, Libtayo, Opdivo, Tecentriq, and Yervoy) |
All indications |
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 and Lumizyme
Applicable codes
References
Actemra [prescribing information]. South San Francisco, CA: Genentech, Inc.; May 2020.
Adakveo [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; November 2019.
Aldurazyme [prescribing information]. Novato, CA: BioMarin Pharmaceutical Inc.; December 2018.
American Academy of Allergy, Asthma and Immunology. Guidelines for the Site of Care for Administration of IGIV Therapy. December 2011.
Avsola [prescribing information]. Thousand Oaks, CA: Amgen Inc.; December 2019.
Bavencio [prescribing information]. Rockland, MA: EMD Serono, Inc; June 2020.
Benlysta [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; September 2020.
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 [package insert]. Frazer, PA: Teva Respiratory, LLC; January 2019.
Cinryze [prescribing information]. Lexington, MA: Shire ViroPharma Biologics Inc.; June 2018.
Crysvita [prescribing information]. Novato, CA: Ultragenyx Pharmaceutical Inc; June 2020.
Elaprase [prescribing information]. Lexington, MA: Shire Human Genetic Therapies, Inc.; November 2018.
Elelyso [prescribing information]. NY, NY: Pfizer Inc.; October 2019.
Entyvio [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; March 2020.
Exondys 51 [prescribing information]. Cambridge, MA: Sarepta Therapeutics, Inc.; October 2018.
Fabrazyme [prescribing information]. Cambridge, MA: Genzyme Corporation.; December 2018.
Fasenra [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019.
Givlaari [prescribing information]. Cambridge, MA: Alnylam Pharmaceuticals.; November 2019.
Imfinzi [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; June 2020.
Inflectra [prescribing information]. Lake Forest, IL: Celltrion, Inc.; Nov. 2016.
Kanuma [prescribing information]. Cheshire, CT: Alexion Pharmaceuticals Inc.; December 2015.
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 2020.
Lemtrada [prescribing information]. Cambridge, MA: Genzyme Corp.; November 2019.
Libtayo [prescribing information]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; November 2020.
Lumizyme [prescribing information]. Cambridge, MA: Genzyme Corporation; May 2019.
Luxturna [prescribing information]. Philadelphia, PA: Spark Therapeutics, Inc.; December 2017.
MCG Care Guidelines, 19th Edition, 2015, Home Infusion Therapy: CMT: CMT-0009
Mepsevii [prescribing information]. Novato, CA: Ultragenyx Pharmaceutical Inc.; November 2017.
Naglazyme [prescribing information]. Novato, CA: BioMarin Pharmaceutical Inc; March 2013.
Nucala [package insert]. Research Triangle Park, NC: GlaxoSmithKline, Inc.; September 2019.
Ocrevus [prescribing information]. Genentech, Inc. South San Francisco, CA.; July 2019.
Onpattro (patisiran) [prescribing Information]. Alnylam Pharmaceuticals, Inc. 8/2018.
Opdivo [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; June 2020.
Orencia [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; March 2019.
Radicava [prescribing information]. Jersey City, NJ: MT Pharma America, Inc.; August 2018.
Remicade [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; May 2020.
Renflexis [prescribing information]. Kenilworth, NJ: Merck & Co., Inc.; February 2020.
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.; September 2019.
Soliris [prescribing information]. New Haven, CT: Alexion Pharmaceuticals Inc; June 2019.
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
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 2020.
Tepezza [package insert]. Dublin, Ireland: Horizon Therapeutics Ireland DAC; January 2020.
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. October 2020.
Uplizna [prescribing information]. Gaithersburg, MD: Viela Bio, Inc.; June 2020.
Viltepso [prescribing information]. Paramus, NJ: NS Pharma, Inc.; August 2020.
Vimizim [prescribing information]. Novato, CA: BioMarin Pharmaceutical Inc; February 2014.
Vpriv [prescribing information]. Lexington, MA: Shire Human Genetic Therapies Inc; November 2019.
Vyondys 53 [prescribing information]. Cambridge, MA: Sarepta Therapeutics, Inc. December 2019.
Vyepti [package insert]. Bothell, WA: Lundbeck Seattle Bio Pharmaceuticals, Inc; February 2020
Xolair [package insert]. South San Francisco, CA: Genentech, Inc.; May 2019.
Yervoy [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company. October 2020.
Zolgensma [prescribing information]. Bannockburn, IL: AveXis, Inc.; May 2019.
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