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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.

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
Bavencio-effective 7/1/2020
Benlysta IV formulation - effective 7/1/2019  
Cerezyme-effective 1/1/2020
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
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
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
Tysabri - effective 7/1/2017
Ultomiris- effective 3/15/2019
Vimizim -effective 1/1/2020
Vpriv - effective 1/1/2020
Vyondys 53 - effective 3/1/2019
Yervoy - effective 7/1/2020
Zolgensma^ – effective 7/1/2019

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

 

  • Bascom Palmer Eye Institute – Miami, FL
  • Baylor Eye Center – Houston, TX
  • Massachusetts Eye and Ear – Boston, MA
  • Penn Medicine, Scheie Eye Institute – Philadelphia, PA
  • The Vision Center at Children's Hospital – Los Angeles, CA
     

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

  • Akron Children's Hospital (Children's Hospital Medical Center of Akron) – Akron, OH
  • Children's Hospital of Colorado – Aurora, CO
  • Children's Hospital of Dallas – Dallas, TX
  • Children's Hospital Los Angeles – Los Angeles, CA
  • Children’s Hospital of Michigan – Detroit, MI
  • 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
  • Hershey Medical Center Pennsylvania State University Pediatric – Hershey, PA
  • Integris Southwest Medical Center – Oklahoma City, OK
  • Massachusetts General Hospital – Boston, MA
  • Nationwide Children’s Hospital – Columbus, OH
  • Rady Children’s Hospital San Diego – San Diego, CA
  • Ronald Reagan UCLA Medical Center – Los Angeles, CA
  • Texas Children Clinic – Houston, TX
  • University of Kentucky – Lexington, KY
  • University of Rochester Medical Center Health System, Strong Memorial Hospital – Rochester, NY

 

 

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.  

Criteria for Medical Necessity

  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.
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:

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

Vimizim

Mucopolysacaridosis IVA

82 days

Vpriv

Gaucher disease type I

50 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

  • J0585
  • J3490, J3590, C9399 NDC 00078-0883-61 Adakveo (crizanlizumab)
  • J3490, J3590, C9399 NDC 71336-1001-01 Givlaari (givosiran)
  • J3490, J3590, C9399 NDC 60923-0465-02 Vyondys 53 (golodirsen)
  • J1300
  • J1301
  • J1428
  • J1459
  • J1460
  • J1555
  • J1556
  • J1557
  • J1559
  • J1560
  • J1561
  • J1566
  • J1568
  • J1569
  • J1572
  • J1575
  • J1599
  • J2350
  • J3262
  • J3380
  • Q5103
  • J0202
  • J3398
  • J0490
  • J3490, C9399 NDC 71336-1000-1 Onpattro (patisiran)
  • J0129
  • J1745
  • Q5104
  • J1602
  • J2323
  • J3490, J3590, C9399 NDC 25682-022-01 (Ultomiris)
  • J0598
  • J0256
  • S9346
  • J0180
  • J0220
  • J0221
  • J1322
  • J1458
  • J1743
  • J1786
  • J1931
  • J2840
  • J3060
  • J3385
  • J3397
  • J9228
  • J9023
  • J9173
  • J9271
  • J9119
  • J9299
  • J9022

References

Actemra [prescribing information]. South San Francisco, CA: Genentech, Inc.; May 2018.

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; May 2019.

Benlysta [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; September 2019.

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

Cinryze [prescribing information]. Lexington, MA: Shire ViroPharma Biologics Inc.; June 2018.

Crysvita [prescribing information]. Novato, CA: Ultragenyx Pharmaceutical Inc; October 2019.

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.; April 2014.

Exondys 51 [prescribing information]. Cambridge, MA: Sarepta Therapeutics, Inc.; October 2018.

Fabrazyme [prescribing information]. Cambridge, MA: Genzyme Corporation.; December 2018.

Givlaari [prescribing information]. Cambridge, MA: Alnylam Pharmaceuticals.; November 2019.

Imfinzi [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; August 2019.

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.; January 2020.

Lemtrada [prescribing information]. Cambridge, MA: Genzyme Corp.; Nov. 2014.

Libtayo [prescribing information]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; March 2019.

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.

Ocrevus (ocrelizumab) [prescribing information]. Genentech, Inc.  South San Francisco, CA.  March 2017.  Available online at:https://www.gene.com/download/pdf/ocrevus_prescribing.pdf. Accessed on May 16, 2017.

Onpattro (patisiran) [prescribing Information]. Alnylam Pharmaceuticals, Inc. 8/2018.

Opdivo [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; September 2019.

Orencia [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; June 2017.

Radicava [prescribing information]. Jersey City, NJ: MT Pharma America, Inc.; May 2017.

Remicade [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; Oct. 2015.

Renflexis [prescribing information]. Kenilworth, NJ: Merck & Co., Inc.; April 2017.

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.; Oct. 2017.

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

Tecentriq [prescribing information]. South San Francisco, CA: Genentech, Inc.; December 2019.

Tysabri [prescribing information]. Cambridge, MA: Biogen Idec Inc.; May 2016.

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 2019.

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.

Yervoy [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company. May 2019.

Zolgensma [prescribing information]. Bannockburn, IL: AveXis, Inc.; May 2019.

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