Coverage Policy Manual
Policy #: 2018030
Category: Pharmacy
Initiated: December 2018
Last Review: December 2023
  Site of Care or Site of Service Review

Description:
Many pharmacologic and biologic agents infused historically in a facility (hospital, outpatient hospital, or associated infusion center) setting have been evaluated  and determined to be safe for use in a non-hospital infusion center and through home infusion services.  These alternative settings offer quality services that are often more convenient and less costly to the member and payer as compared to hospital-based services without impeding efficacy or safety.

Policy/
Coverage:
EFFECTIVE December 2022
 
This policy is for determination of whether the site of care (e.g., site of service) meets primary coverage for the infusion and/or injection of the proposed therapy
 
This policy applies to all fully-insured plans, all exchange plans, and most self-insured groups (unless specified otherwise).  
 
An infused or injected pharmacologic/biologic agent should be administered in the least intensive, most cost-effective setting that is appropriate for the infusion and/or injection of the medication subject to ALL the following:
 
    1. The administered pharmacologic/biologic agent must meet primary coverage criteria as defined in the member benefit certificate of coverage or be considered medically necessary for members of plans without primary coverage criteria AND must meet any applicable Arkansas Blue Cross Blue Shield coverage policy AND  must not be an exclusion in the member benefit certificate of coverage; AND
    2. The administered pharmacologic/biologic agent must NOT have a site-of-service restriction per FDA labeling; AND
    3. The member receiving the administered pharmacologic/biologic agent must NOT have any of the following:
a.  History of a prior serious adverse event with the agent necessitating a more intensive level of care during or after the infusion/injection of the agent; OR  
b.  Deemed medically unstable as demonstrated in clinical records (e.g., subject to volume overload in the situation of large infusions); OR
c.  Continuing serious adverse events not mitigated by other interventions (e.g., premedication, altered infusion rate, etc.), OR
d.  Problems with vascular access requiring a more intensive level of care (e.g. children < 13 years old); OR
e.  Absence of caretaker or absence of alternative levels of service.
 
Sites of care (sites of service) include the following:  in-patient hospital, out-patient hospital, hospital affiliated infusion center, in-patient skilled nursing facility, long-term acute care in-patient, physician/provider hospital-affiliated office, and emergency room (hospital affiliated or free standing); less intense, more cost-effective settings include approved ambulatory infusion centers, approved community provider offices,  and home-based setting (including approved nursing home).
 
Any new infused or injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded.  A frequently updated list will be maintained on the Plan’s website.
 
Authorization is specified in letter of agreement and/or coverage policy; however, in no circumstance will a pharmacologic or biologic agent be reviewed less than annually if not otherwise specified.
 
Pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care do not meet primary coverage criteria and may be denied.
 
For members of plans without primary coverage criteria, pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care are considered not medically necessary. Services that are considered not medically necessary are considered exclusions in most member benefit certificates of coverage.
 
EFFECTIVE November 2021 November 2022
 
This policy is for determination of whether the site of care (e.g. site of service) meets primary coverage for the infusion and/or injection of the proposed therapy
 
This policy applies to all fully-insured plans, all exchange plans, and most self-insured groups (unless specified otherwise).  
 
An infused or injected pharmacologic/biologic agent should be administered in the least intensive, most cost-effective setting that is appropriate for the infusion and/or injection of the medication subject to ALL of the following:
 
    1. The administered pharmacologic/biologic agent must meet primary coverage criteria as defined in the member benefit certificate of coverage or be considered medically necessary for members of plans without primary coverage criteria AND must meet any applicable Arkansas Blue Cross Blue Shield coverage policy AND  must not be an exclusion in the member benefit certificate of coverage; AND
    2. The administered pharmacologic/biologic agent must NOT have a site-of-service restriction per FDA labeling; AND
    3. The member receiving the administered pharmacologic/biologic agent must NOT have any of the following:
                • History of a prior serious adverse event with the agent necessitating a more intensive level of care during or after the infusion/injection of the agent, OR
                • Deemed medically unstable as demonstrated in clinical records (e.g. subject to volume overload in the situation of large infusions), OR
                • Continuing serious adverse events not mitigated by other interventions (e.g premedication, altered infusion rate, etc), OR
                • Problems with vascular access requiring a more intensive level of care (e.g. children < 13 y/o), OR
                • Absence of caretaker or absence of alternative levels of service.
 
Sites of care (sites of service) include the following:  in-patient hospital, out-patient hospital, hospital affiliated infusion center, in-patient skilled nursing facility, long-term acute care in-patient, physician/provider hospital-affiliated office, and emergency room (hospital affiliated or free standing); less intense, more cost-effective settings include approved ambulatory infusion centers, approved community provider offices,  and home-based setting (including approved nursing home).
 
Pharmacologic and biologic agents subject to this policy include but are not limited to the below list.  Any new infused or injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded.  A frequently updated list will be maintained on the Plan’s website.
 
Authorization is specified in letter of agreement and/or coverage policy; however, in no circumstance will a pharmacologic or biologic agent be reviewed less than annually if not otherwise specified.
 
Pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care do not meet primary coverage criteria and may be denied.
 
For members of plans without primary coverage criteria, pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care are considered not medically necessary. Services that are considered not medically necessary are considered exclusions in most member benefit certificates of coverage.
 
MEDICATIONS SUBJECT TO THIS POLICY:
 
The following is a list of pharmacologic and biologic agents that are subject to this policy. Please note, this is not an all-inclusive list and is subject to change. Any new infused or injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded. Please also refer to any specific Coverage Policy for additional specific coverage criteria.
 
        • Aldurazyme (Laronidase) J1931
        • Avsola (infliximab-axxq) Q5121
        • Berinert (C1 Esterase, Inhib, Human) J0597
        • Brineura  (Ceroliponase alfa) C9014
        • Cinqair  (Reslizumab)  J2786
        • Cinryze (C1 Esterase, Inhib, Human) J0598
        • Crysvita(Burosumab - twza) J3590
        • Duopa (Levodopa-carpidopa intestinal gel )   J7340
        • Entyvio (vedolizumab)  J3380
        • Evenity (romosozumab-aqqg) J3111
        • Fasenra (Benralizumab)  C9466
        • Firazyr (Icatabant) J1744
        • Galsufase (Nagalzyme) J1458
        • Gamifant (emapalumab-Izsg) J9210
        • Givlaari (givosiran) J0223
        • Glassia (Alpha-1 proteinase inhibitors) J0257
        • Haegarda (C1 Esterase, Inhib, Human)  C9015
        • Idursulfase (Elaprase) J1743
        • Inflectra (infliximab-dyyb)  Q5103
        • IVIG Formulations including, but not limited to:
                • Bivigam - J1556
                • Cuvitru - J1555
                • Flebogamma/Flebogamma Dif - J1572
                • Gammagard liquid - J1569
                • Gammaplex - J1557
                • Gamunex/Gamunex-C/Gammaked – J1561
                • Hizentra – J1559
                • Hyqvia - J1575
                • Immune Globulin (Human) IM - J1460
                • Immune Globulin (Human) IM - J1560
                • Immune Globulin (Human)-klhw - J1558
                • Immune Globulin (Human)-slra - J1564
                • Immune globulin lyophilized powder- J1566
                • Immune globulin nonlyophilized liquid - J1599
                • Octagam - J1568
                • Privigen - J1459
                • Vivaglobin – J1562
        • Ixifi – (infliximab-qbtx) – Q5109
        • Kalbitor  (Ecallantide) J1290
        • Krystexxa (Pegloticase) J2507
        • Lemtrada (Alemtuzumab) J0202
        • Lutathera  (Lutetium Lu 177) A9699, C9031
        • Mepsevii (Vestronidase-Alfa) J3590
        • Myalept (Metreleptin) J3490
        • Nucala (Mepolizumab) J2182
        • Ocrevus (ocrelizumab)  J2350
        • Prolastin (Alpha-1 proteinase inhibitors) J0256
        • Radicava (edaravone)  J1301
        • Reblozyl (luspatercept-aamt) J0896
        • Remicade (infliximab)  J1745
        • Renflexis (infliximab-abda) Q5104
        • Ruconest (C1 Esterase, Inhib, Recombinant) J0596
        • Simponi Aria (golimumab) J1602
        • Soliris (Eculizumab) J1300
        • Spinraza (Nusinersen) C9489
        • Spravato (esketamine) J3490
        • Strensiq (Asfotase alfa) J3490
        • Tepezza (teprotumumab) J3241
        • Tysabri (natalizumab) J2323
        • Ultomiris (ravulizumab-cwyz) J1303
        • Uplizna (inebilizumab) J3590
        • Vimizim (Elosulfase alfa) J1322
        • Xolair (Omalizumab) J2357
        • Zolgensma (onasemnogene abeparvovec-XIOI) J3399
        • Zulresso (brexanolone) J1632
 
EFFECTIVE December 2020 to October 2021
 
This policy is for determination of whether the site of care (e.g. site of service) meets primary coverage for the infusion and/or injection of the proposed therapy
 
This policy applies to all fully-insured plans, all exchange plans, and most self-insured groups (unless specified otherwise).  
 
An infused or injected pharmacologic/biologic agent should be administered in the least intensive, most cost-effective setting that is appropriate for the infusion and/or injection of the medication subject to ALL of the following:
 
    1. The administered pharmacologic/biologic agent must meet primary coverage criteria as defined in the member benefit certificate of coverage or be considered medically necessary for members of plans without primary coverage criteria AND must meet any applicable Arkansas Blue Cross Blue Shield coverage policy AND  must not be an exclusion in the member benefit certificate of coverage; AND
    2. The administered pharmacologic/biologic agent must NOT have a site-of-service restriction per FDA labeling; AND
    3. The member receiving the administered pharmacologic/biologic agent must NOT have any of the following:
                • History of a prior serious adverse event with the agent necessitating a more intensive level of care during or after the infusion/injection of the agent, OR
                • Deemed medically unstable as demonstrated in clinical records (e.g. subject to volume overload in the situation of large infusions), OR
                • Continuing serious adverse events not mitigated by other interventions (e.g premedication, altered infusion rate, etc), OR
                • Problems with vascular access requiring a more intensive level of care (e.g. children < 13 y/o), OR
                • Absence of caretaker or absence of alternative levels of service.
 
Sites of care (sites of service) include the following:  in-patient hospital, out-patient hospital, hospital affiliated infusion center, in-patient skilled nursing facility, long-term acute care in-patient, physician/provider hospital-affiliated office, and emergency room (hospital affiliated or free standing); less intense, more cost-effective settings include approved ambulatory infusion centers, approved community provider offices,  and home-based setting (including approved nursing home).
 
Pharmacologic and biologic agents subject to this policy include but are not limited to the below list.  Any new infused or injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded.  A frequently updated list will be maintained on the Plan’s website.
 
Authorization is specified in letter of agreement and/or coverage policy; however, in no circumstance will a pharmacologic or biologic agent be reviewed less than annually if not otherwise specified.
 
Pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care do not meet primary coverage criteria and may be denied.
 
For members of plans without primary coverage criteria, pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care are considered not medically necessary. Services that are considered not medically necessary are considered exclusions in most member benefit certificates of coverage.
 
MEDICATIONS SUBJECT TO THIS POLICY:
 
The following is a list of pharmacologic and biologic agents that are subject to this policy. Please note, this is not an all-inclusive list and is subject to change. Any new infused or injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded. Please also refer to any specific Coverage Policy for additional specific coverage criteria.
 
        • Aldurazyme (Laronidase) J1931
        • Avsola (infliximab-axxq) Q5121
        • Berinert (C1 Esterase, Inhib, Human) J0597
        • Brineura  (Ceroliponase alfa) C9014
        • Cinqair  (Reslizumab)  J2786
        • Cinryze (C1 Esterase, Inhib, Human) J0598
        • Crysvita(Burosumab - twza) J3590
        • Duopa (Levodopa-carpidopa intestinal gel )   J7340
        • Entyvio (vedolizumab)  J3380
        • Evenity (romosozumab-aqqg) J3111
        • Fasenra (Benralizumab)  C9466
        • Firazyr (Icatabant) J1744
        • Galsufase (Nagalzyme) J1458
        • Gamifant (emapalumab-Izsg) J9210
        • Givlaari (givosiran) J0223
        • Glassia (Alpha-1 proteinase inhibitors) J0257
        • Haegarda (C1 Esterase, Inhib, Human)  C9015
        • Idursulfase (Elaprase) J1743
        • Inflectra (infliximab-dyyb)  Q5103
        • IVIG Formulations including, but not limited to:
                • Bivigam - J1556
                • Cuvitru - J1555
                • Flebogamma/Flebogamma Dif - J1572
                • Gammagard liquid - J1569
                • Gammaplex - J1557
                • Gamunex/Gamunex-C/Gammaked – J1561
                • Hizentra – J1559
                • Hyqvia - J1575
                • Immune globulin lyophilized powder- J1566
                • Immune globulin nonlyophilized liquid - J1599
                • Octagam - J1568
                • Privigen - J1459
                • Vivaglobin – J1562
        • Ixifi – (infliximab-qbtx) – Q5109
        • Kalbitor  (Ecallantide) J1290
        • Krystexxa (Pegloticase) J2507
        • Lemtrada (Alemtuzumab) J0202
        • Lutathera  (Lutetium Lu 177) A9699, C9031
        • Mepsevii (Vestronidase-Alfa) J3590
        • Myalept (Metreleptin) J3490
        • Nucala (Mepolizumab) J2182
        • Ocrevus (ocrelizumab)  J2350
        • Prolastin (Alpha-1 proteinase inhibitors) J0256
        • Radicava (edaravone)  J1301
        • Reblozyl (luspatercept-aamt) J0896
        • Remicade (infliximab)  J1745
        • Renflexis (infliximab-abda) Q5104
        • Ruconest (C1 Esterase, Inhib, Recombinant) J0596
        • Simponi Aria (golimumab) J1602
        • Soliris (Eculizumab) J1300
        • Spinraza (Nusinersen) C9489
        • Spravato (esketamine) J3490
        • Strensiq (Asfotase alfa) J3490
        • Tepezza (teprotumumab) J3241
        • Tysabri (natalizumab) J2323
        • Ultomiris (ravulizumab-cwyz) J1303
        • Uplizna (inebilizumab) J3590
        • Vimizim (Elosulfase alfa) J1322
        • Xolair (Omalizumab) J2357
        • Zolgensma (onasemnogene abeparvovec-XIOI) J3399
        • Zulresso (brexanolone) J1632
 
 
EFFECTIVE JANUARY 1, 2019 to November 2020
 
This policy is for determination of whether the site of care (e.g. site of service) meets primary coverage for the infusion and/or  injection of the proposed therapy
 
This policy applies to all fully-insured plans, all exchange plans, and most self-insured groups (unless specified otherwise).  
 
An infused or injected pharmacologic/biologic agent should be administered in the least intensive, most cost-effective setting that is appropriate for the infusion and/or injection of the medication subject to ALL of the following:
 
    1. The administered pharmacologic/biologic agent must meet primary coverage criteria as defined in the member benefit certificate of coverage or be considered medically necessary for members of plans without primary coverage criteria AND must meet any applicable Arkansas Blue Cross Blue Shield coverage policy AND  must not be an exclusion in the member benefit certificate of coverage; AND
    2. The administered pharmacologic/biologic agent must NOT have a site-of-service restriction per FDA labeling;  AND
    3. The member receiving the administered pharmacologic/biologic agent must NOT have any of the following:
          • History of a prior serious adverse event with the agent necessitating a more intensive level of care during or after the infusion/injection of the agent, OR
          • Deemed medically unstable as demonstrated in clinical records (e.g. subject to volume overload in the situation of large infusions), OR
          • Continuing serious adverse events not mitigated by other interventions (e.g premedication, altered infusion rate, etc), OR
          • Problems with vascular access requiring a more intensive level of care (e.g. children < 13 y/o), OR
          • Absence of caretaker or absence of alternative levels of service.
 
Sites of care (sites of service) include the following:  in-patient hospital, out-patient hospital, hospital affiliated infusion center, in-patient skilled nursing facility, long-term acute care in-patient, physician/provider hospital-affiliated office, and emergency room (hospital affiliated or free standing); less intense, more cost-effective settings include approved ambulatory infusion centers, approved community provider offices,  and home-based setting (including approved nursing home).
 
Pharmacologic and biologic agents subject to this policy include but are not limited to the below list.  Any new infused or injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded.  A frequently updated list will be maintained on the Plan’s website.
 
Authorization is specified in letter of agreement and/or coverage policy; however, in no circumstance will a pharmacologic or biologic agent be reviewed less than annually if not otherwise specified.
 
Pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care do not meet primary coverage criteria and may be denied.
 
For members of plans without primary coverage criteria, pharmacologic and biologic agents subject to this policy administered in an unapproved site-of-care are considered not medically necessary. Services that are considered not medically necessary are considered exclusions in most member benefit certificates of coverage.
 
MEDICATIONS SUBJECT TO THIS POLICY:
 
The following is a list of pharmacologic and biologic agents that are subject to this policy. Please note, this is not an all-inclusive list and is subject to change. Any new infused or injected pharmacologic or biologic agent should be presumed to be subject to this policy unless specifically excluded. Please also refer to any specific Coverage Policy for additional specific coverage criteria.
 
    • Xolair (Omalizumab) J2357
    • Nucala (Mepolizumab) J2182
    • Spinraza (Nusinersen) C9489
    • Brineura  (Ceroliponase alfa) C9014
    • Soliris (Eculizumab) J1300
    • Lemtrada (Alemtuzumab) J0202
    • Strensiq (Asfotase alfa) J3490
    • Myalept (Metreleptin) J3490
    • Haegarda (C1 Esterase, Inhib, Human)  C9015
    • Ruconest (C1 Esterase, Inhib, Recombinant) J0596
    • Berinert (C1 Esterase, Inhib, Human) J0597
    • Cinryze (C1 Esterase, Inhib, Human) J0598
    • Kalbitor  (Ecallantide) J1290
    • Firazyr (Icatabant) J1744
    • Fasenra (Benralizumab)  C9466
    • Cinqair  (Reslizumab)  J2786
    • Lutathera  (Lutetium Lu 177) A9699, C9031
    • Duopa (Levodopa-carpidopa intestinal gel )   J7340
    • Crysvita(Burosumab - twza) J3590
    • Aldurazyme (Laronidase) J1931
    • Idursulfase (Elaprase) J1743
    • Vimizim (Elosulfase alfa) J1322
    • Galsufase (Nagalzyme) J1458
    • Mepsevii (Vestronidase-Alfa) J3590
    • Krystexxa (Pegloticase) J2507
    • Entyvio (vedolizumab)  J3380
    • Inflectra (infliximab-dyyb)  Q5103
    • Remicade (infliximab)  J1745
    • Renflexis (infliximab-abda) Q5104
    • Ixifi – (infliximab-qbtx) – Q5109
    • Ocrevus (ocrelizumab)  J2350
    • Radicava (edaravone)  J1301
    • Simponi Aria (golimumab) J1602
    • Tysabri (natalizumab) J2323
    • Glassia (Alpha-1 proteinase inhibitors) J0257
    • Prolastin (Alpha-1 proteinase inhibitors) J0256
    • IVIG Formulations including, but not limited to:
        • Privigen - J1459
        • Cuvitru - J1555
        • Bivigam - J1556
        • Gammaplex - J1557
        • Hizentra – J1559
        • Gamunex/Gamunex-C/Gammaked – J1561
        • Vivaglobin – J1562
        • Immune globulin lyophilized powder- J1566
        • Octagam - J1568
        • Gammagard liquid - J1569
        • Flebogamma/Flebogamma Dif - J1572
        • Immune globulin nonlyophilized liquid - J1599

Rationale:
Evidence for effectiveness and safety includes a review by Polinski et al., which included 13 relevant studies identified through MEDLINE, EMBASE and Science Citation index search, concluded that patients receiving home infusions were no more likely to experience adverse drug events or side effects (all p >0.05). Patients overwhelmingly preferred receiving infusion at home rather than in a health care facility. The review also showed that home infusion is well suited to medication delivery in clinical areas such as neurology, oncology, hematology, rheumatology and gastroenterology.
 
In a trial evaluating patients with paroxysmal nocturnal hemoglobinuria, after initial 2-5 doses of eculizumab (Soliris), 79 patients received continued infusion with every 14 days in the home setting for the duration of the study – 1-98 months, mean duration of 39 months. The survival of patients treated with eculizumab was not different from age- and sex-matched normal controls (P = .46) but was significantly better than 30 similar patients managed before eculizumab (P = .030). Three patients on eculizumab, all over 50 years old, died of causes unrelated to PNH. Twenty-one patients (27%) had a thrombosis before starting eculizumab (5.6 events per 100 patient-years) compared with 2 thromboses on eculizumab (0.8 events per 100 patient-years; P < .001). Twenty-one patients with no previous thrombosis discontinued warfarin on eculizumab with no thrombotic sequelae. Forty of 61 (66%) patients on eculizumab for more than 12 months achieved transfusion independence. The 12-month mean transfusion requirement reduced from 19.3 units before eculizumab to 5.0 units in the most recent 12 months on eculizumab (P < .001). Eculizumab dramatically alters the natural course of PNH, reducing symptoms and disease complications as well as improving survival to a similar level to that of the general population.
 
2019 Update
Annual policy review completed.
 
2020 Update
Annual policy review completed.
 
2021 Update
Annual policy review completed.
 
2022 Update
Annual policy review completed.
 
2023 Update
Annual policy review completed.

CPT/HCPCS:
A9699Radiopharmaceutical, therapeutic, not otherwise classified
C9399Unclassified drugs or biologicals
J0202Injection, alemtuzumab, 1 mg
J0223Injection, givosiran, 0.5 mg
J0256Injection, alpha 1 proteinase inhibitor (human), not otherwise specified, 10 mg
J0257Injection, alpha 1 proteinase inhibitor (human), (glassia), 10 mg
J0596Injection, c1 esterase inhibitor (recombinant), ruconest, 10 units
J0597Injection, c 1 esterase inhibitor (human), berinert, 10 units
J0598Injection, c 1 esterase inhibitor (human), cinryze, 10 units
J0896Injection, luspatercept aamt, 0.25 mg
J1290Injection, ecallantide, 1 mg
J1300Injection, eculizumab, 10 mg
J1301Injection, edaravone, 1 mg
J1303Injection, ravulizumab cwvz, 10 mg
J1322Injection, elosulfase alfa, 1 mg
J1458Injection, galsulfase, 1 mg
J1459Injection, immune globulin (privigen), intravenous, non lyophilized (e.g., liquid), 500 mg
J1460Injection, gamma globulin, intramuscular, 1 cc
J1554Injection, immune globulin (asceniv), 500 mg
J1555Injection, immune globulin (cuvitru), 100 mg
J1556Injection, immune globulin (bivigam), 500 mg
J1557Injection, immune globulin, (gammaplex), intravenous, non lyophilized (e.g., liquid), 500 mg
J1558Injection, immune globulin (xembify), 100 mg
J1559Injection, immune globulin (hizentra), 100 mg
J1560Injection, gamma globulin, intramuscular, over 10 cc
J1561Injection, immune globulin, (gamunex c/gammaked), non lyophilized (e.g., liquid), 500 mg
J1562Injection, immune globulin (vivaglobin), 100 mg
J1566Injection, immune globulin, intravenous, lyophilized (e.g., powder), not otherwise specified, 500 mg
J1568Injection, immune globulin, (octagam), intravenous, non lyophilized (e.g., liquid), 500 mg
J1569Injection, immune globulin, (gammagard liquid), non lyophilized, (e.g., liquid), 500 mg
J1572Injection, immune globulin, (flebogamma/flebogamma dif), intravenous, non lyophilized (e.g., liquid), 500 mg
J1575Injection, immune globulin/hyaluronidase, (hyqvia), 100 mg immuneglobulin
J1599Injection, immune globulin, intravenous, non lyophilized (e.g., liquid), not otherwise specified, 500 mg
J1602Injection, golimumab, 1 mg, for intravenous use
J1632Injection, brexanolone, 1 mg
J1743Injection, idursulfase, 1 mg
J1744Injection, icatibant, 1 mg
J1745Injection, infliximab, excludes biosimilar, 10 mg
J1931Injection, laronidase, 0.1 mg
J2182Injection, mepolizumab, 1 mg
J2323Injection, natalizumab, 1 mg
J2350Injection, ocrelizumab, 1 mg
J2357Injection, omalizumab, 5 mg
J2507Injection, pegloticase, 1 mg
J2786Injection, reslizumab, 1 mg
J3111Injection, romosozumab aqqg, 1 mg
J3241Injection, teprotumumab trbw, 10 mg
J3380Injection, vedolizumab, 1 mg
J3399Injection, onasemnogene abeparvovec xioi, per treatment, up to 5x10 15 vector genomes
J3490Unclassified drugs
J3590Unclassified biologics
J7340Carbidopa 5 mg/levodopa 20 mg enteral suspension, 100 ml
J9210Injection, emapalumab lzsg, 1 mg
J9999Not otherwise classified, antineoplastic drugs
Q5103Injection, infliximab dyyb, biosimilar, (inflectra), 10 mg
Q5104Injection, infliximab abda, biosimilar, (renflexis), 10 mg
Q5109Injection, infliximab qbtx, biosimilar, (ixifi), 10 mg
Q5121Injection, infliximab axxq, biosimilar, (avsola), 10 mg

References: 1) Polinski JM, Kowal MK, Gagnon M, et al.(2016) Home infusion: safe clinically effective, patient preferred, and cost saving. Healthcare. 2016.

2) Kelly RJ, Hill A, Arnold LM, et al.(2011) Long-term treatment with eculizumab in paroxysmal nocturnal hemoglobinuria: sustained efficacy and improved survival. Blood. 2011;117(25):6786-92.

American Academy of Allergy Asthma and Immunology.(2011) Guidelines for the site of care for administration of IGIV therapy. December 2011. Available at:http://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20Resources/Guidelines-for-thesite-of-care-for-administration-of-IGIV-therapy.pdf.

Basch E, Hesketh PJ, Kris MG, et al.(2011) Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Onc. 2011; 29(31):4189-4198.

Chataway J, Porter B, Riazi A, et al.(2006) Home versus outpatient administration of intravenous steroids for multiplesclerosis relapses: a randomized controlled trial. Lancet Neurol. 2006; 5(7):565-571.

Gutierrez-Aguirre CH, Ruiz-Arguelles G, Cantu-Rodriguez OG, et al.(2010) Outpatient reduced-intensity allogeneic stem cell transplantation for patients with refractory or relapsed lymphomas compared with autologous stem cell transplantation using a simplified method. Annals of Hematology 2010; 89(10):1045-1052.

Mank A, van der Lelie J, de Vos R, Kersten MJ.(2011) Safe early discharge for patients undergoing high dose chemotherapy with or without stem cell transplantation: a prospective analysis of clinical variables predictive for complications after treatment. Journal of Clinical Nursing 2011; 20(3-4):388-395.

Milligan A, Hughes D, Goodwin S, et al.(2006) Intravenous enzyme replacement therapy: better in home or hospital? Br J Nurs. 2006; 15(6):330-333.

NCCN Clinical Practice Guidelines in Oncology®.(2017) © 2018 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Antiemesis (V.2.2018). Revised April 30, 2018. Prevention and Treatment of Cancer-Related Infections. (V.1.2018) Revised December 1, 2017.

Riazi A, Porter B, Chataway J, et al.(2011) A tool to measure the attributes of receiving IV therapy in a home versus hospital setting: the Multiple Sclerosis Relapse management Scale (MSRMS). Health Qual Life Outcomes. 2011;9:80.


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