Table 5: Immunological Agents
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Drug Category: Immunological Agents
Medication Class/Individual Agents: Anti-TNF-Alpha, Corticosteroid, Immunosuppressant, Interleukin Antagonist, Miscellaneous, Topical
I. Prior-Authorization Requirements
Immunological Agents – Anti-TNF-Alpha |
Clinical Notes |
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Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself. For PA drugs, one of the following FDA-approved indications must be met. For unlabeled uses, approval is considered based on current medical evidence. Immunological agents warnings and precautions:
Monoclonal antibodies warning and precautions:
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Immunological Agents – Corticosteroids |
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Immunological Agents – Immunosuppressants |
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Immunological Agents – Interleukin (IL)-1 Antagonist |
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Immunological Agents – Interleukin (IL)-12/23 Antagonist |
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Immunological Agents – Interleukin (IL)-13 Antagonist |
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Immunological Agents – Interleukin (IL)-17A Antagonists |
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Immunological Agents – Interleukin (IL)-23 Antagonists |
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Immunological Agents – Interleukin (IL)-36 Antagonist |
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Immunological Agents – Interleukin (IL)-6 Antagonists |
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Immunological Agents – Janus Kinase (JAK) Inhibitors |
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Immunological Agents – Miscellaneous Interleukin Antagonists |
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Immunological Agents – Not Otherwise Classified |
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Immunological Agents – Selective T-Cell Costimulation Blocker |
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Immunological Agents – Topical Agents |
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Immunological Agents – Tyrosine Kinase 2 (TYK2) Inhibitor |
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| # | This designates a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent. |
| BP | Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent. |
| PD | Preferred Drug. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. |
| MB | This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable. |
| A90 | Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply. |
II. Therapeutic Uses
FDA-approved, for example:
- Acute Graft Versus Host Disease Prophylaxis – Orencia
- Acute lymphoblastic leukemia – Xatmep
- Adult Onset Still's Disease (AOSD) – Ilaris
- Adrenocortical Insufficiency – Alkindi
- Alopecia Areata, severe – Litfulo, Olumiant
- Ankylosing spondylitis – Abrilada, Amjevita, Avsola, Cimzia, Cosentyx, Cyltezo, Enbrel, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Inflectra, Remicade, Renflexis, Rinvoq, Simponi, Simponi Aria, Taltz, unbranded adalimumab generics, unbranded infliximab, Xeljanz, Yuflyma, Yusimry
- Atopic Dermatitis, moderate-to-severe – Adbry, Cibinqo, Rinvoq
- Crohn’s disease, moderate-to-severe – Abrilada, Amjevita, Avsola, Cimzia, Cyltezo, Entyvio, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Inflectra, Remicade, Renflexis, Rinvoq, Skyrizi, Stelara, unbranded adalimumab generics, unbranded infliximab, Yuflyma, Yusimry
- Crohn’s disease (including fistulizing disease), moderate-to-severe – Avsola, Inflectra, Remicade, Renflexis, unbranded infliximab
- Cytokine release syndrome – Actemra
- Deficiency of Interleukin-1 Receptor Antagonist (DIRA) – Arcalyst, Kineret
- Duchenne muscular dystrophy (DMD) – Emflaza
- Enthesitis-related arthritis – Cosentyx
- Familial cold autoinflammatory syndrome – Arcalyst, Ilaris
- Familial Mediterranean fever (FMF) – Ilaris
- Generalized Pustular Psoriasis Flares – Spevigo
- Giant cell arteritis – Actemra
- Hidradenitis Suppurativa, moderate-to-severe – Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Humira, Hyrimoz, Idacio, unbranded adalimumab generics, Yuflyma, Yusimry
- Hyperimmunoglobulin D syndrome (HIDS)/Mevalonate kinase deficiency (MKD)– Ilaris
- Immunoglobulin A nephropathy (IgAN) – Tarpeyo
- Inflammatory, allergic, or immunological disorders – dexamethasone tablet pack, prednisolone ODT, prednisolone oral solution, Rayos
- Lupus Nephritis – Lupkynis
- Muckle-Wells syndrome – Arcalyst, Ilaris
- Multicentric Castleman's Disease – Sylvant
- Multiple myeloma – Hemady
- Neonatal-onset multisystem inflammatory disease – Kineret
- Non-infectious uveitis – Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Humira, Hyrimoz, Idacio, unbranded adalimumab generics, Yuflyma, Yusimry
- Non-radiographic axial spondyloarthritis – Cimzia, Cosentyx, Rinvoq, Taltz
- Oral ulcers associated with Behçet’s Disease – Otezla
- Osteoarthritis pain of the knee – Zilretta
- Plaque psoriasis – calcipotriene cream, ointment, calcipotriene foam, calcitriol ointment, Otezla
- Plaque psoriasis, moderate-to-severe – Abrilada, Amjevita, Avsola, Cimzia, Cosentyx, Cyltezo, Enbrel, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Ilumya, Inflectra, Otrexup, Rasuvo, Reditrex, Remicade, Renflexis, Siliq, Skyrizi, Sotyktu, Stelara, Taltz, Tremfya, unbranded adalimumab generics, unbranded infliximab, Yuflyma, Yusimry
- Polyarticular juvenile idiopathic arthritis – Otrexup, Rasuvo, Reditrex, Xatmep
- Polyarticular juvenile idiopathic arthritis, moderate-to-severe – Abrilada, Amjevita, Actemra, Cyltezo, Enbrel, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Orencia, Simponi Aria, unbranded adalimumab generics, Xeljanz, Yuflyma, Yusimry
- Polymyalgia rheumatica – Kevzara
- Prevention of rejection of heart transplant – Prograf granules, Sandimmune solution
- Prevention of rejection of kidney transplant – azathioprine 75 mg and 100 mg tablets, Envarsus XR, Nulojix, Prograf granules, Sandimmune solution
- Prevention of rejection of liver transplant – Prograf granules, Sandimmune solution
- Prevention of rejection of lung transplant – Prograf granules
- Psoriatic arthritis – Abrilada, Amjevita, Avsola, Cimzia, Cosentyx, Cyltezo, Enbrel, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Inflectra, Orencia, Otezla, Remicade, Renflexis, Rinvoq, Simponi, Simponi Aria, Skyrizi, Stelara, Taltz, Tremfya, unbranded adalimumab generics, unbranded infliximab, Xeljanz, Xeljanz XR, Yuflyma, Yusimry
- Recurrent pericarditis – Arcalyst
- Rheumatoid arthritis – azathioprine 75 mg and 100 mg tablets, Otrexup, Rasuvo, Reditrex
- Rheumatoid arthritis, moderate-to-severe – Abrilada, Amjevita, Actemra, Avsola, Cimzia, Cyltezo, Enbrel, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Inflectra, Kevzara, Kineret, Olumiant, Orencia, Remicade, Renflexis, Rinvoq, Simponi, Simponi Aria, unbranded adalimumab generics, unbranded infliximab, Xeljanz, Xeljanz XR, Yuflyma, Yusimry
- Systemic juvenile idiopathic arthritis (sJIA) – Actemra, Ilaris
- Systemic sclerosis-associated interstitial lung disease – Actemra
- Tumor necrosis factor receptor associated periodic syndrome – Ilaris
- Ulcerative colitis, moderate-to-severe – Abrilada, Amjevita, Avsola, Cyltezo, Entyvio, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Inflectra, Remicade, Renflexis, Rinvoq, Simponi, Stelara, unbranded adalimumab generics, unbranded infliximab, Xeljanz, Xeljanz XR, Yuflyma, Yusimry, Zeposia
Non-FDA-approved, for example:
- Acute gout – Kineret
- Acute lymphoblastic leukemia in adult members – Xatmep
- Adult Onset Still's Disease (AOSD) – Kineret
- Alopecia Areata – Xeljanz, Xeljanz XR
- Behçet’s Disease (BD) – Avsola, Enbrel, Humira, Inflectra, Remicade, Renflexis, unbranded infliximab
- Familial cold autoinflammatory syndrome – Kineret
- Fistulizing Crohn’s disease – Stelara
- Hidradenitis Suppurativa – Xeljanz, Xeljanz XR
- Hidradenitis Suppurativa, moderate-to-severe – Avsola, Cosentyx, Inflectra, Kineret, Remicade, Renflexis, Stelara, unbranded infliximab
- Hyperimmunoglobulin D syndrome (HIDS) – Kineret
- Lichen Planus – Otezla
- Muckle-Wells syndrome – Kineret
- Mycosis fungoides – Xatmep
- Neurologic Sarcoidosis – Avsola, Inflectra, Remicade, Renflexis, unbranded infliximab
- Pityriasis rubra pilaris (PRP) – Cosentyx, Ilumya, Siliq, Skyrizi, Stelara, Taltz, Tremfya
- Plaque psoriasis, moderate-to-severe – Xatmep, Xeljanz, Xeljanz XR
- Polymyalgia Rheumatica (PMR) – Actemra, Kevzara
- Pulmonary Sarcoidosis – Avsola, Humira, Inflectra, Remicade, Renflexis, unbranded infliximab
- Recurrent Pericarditis – Kineret
- Relapsed or refractory non-Hodgkin lymphoma – Xatmep
- Rheumatoid arthritis – Xatmep
- Synovitis-acne-pustulosis-hyperostosis-osteitis (SAPHO) syndrome – Avsola, Cosentyx, Enbrel, Humira, Inflectra, Kineret, Remicade, Renflexis, Stelara, unbranded infliximab
- Scleritis – Actemra, Avsola, Humira, Inflectra, Remicade, Renflexis, unbranded infliximab
- Systemic juvenile idiopathic arthritis (sJIA) – Kineret
- Takayasu Arteritis – Avsola, Enbrel, Humira, Inflectra, Remicade, Renflexis, unbranded infliximab
- Uveitis – Actemra, Avsola, Inflectra, Remicade, Renflexis, unbranded infliximab
Note: The above lists may not include all FDA-approved and non-FDA approved indications.
III. Evaluation Criteria for Approval
Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.
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All PA requests must include clinical diagnosis, drug name, dose, and frequency.
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Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply.
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A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
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For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
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Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.
Abrilada, Amjevita, Avsola, Cyltezo, Enbrel, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Inflectra, Remicade, Renflexis, Simponi, Simponi Aria, unbranded adalimumab generics, unbranded infliximab, Yuflyma, and Yusimry for ankylosing spondylitis
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- inadequate response or adverse reaction to two or contraindication to all NSAIDs; and
- for Avsola, Cimzia, Inflectra, Remicade, Renflexis, Simponi, Simponi Aria, and unbranded infliximab, both of the following:
- clinical rationale for the use of the requested agent instead of Enbrel; and
- clinical rationale for the use of the requested agent instead of Humira; and
- for Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry, and unbranded adalimumab generics, one of the following:
- clinical rationale for use of the requested agent instead of Humira; or
- medical records documenting an inadequate response or adverse reaction to Humira; and
- for Inflecta or Renflexis, clinical rationale for use of the requested agent instead of Avsola and unbranded infliximab; and
- for brand name Cyltezo, Hulio, Hyrimoz 40 mg/0.4 mL syringe and pen, and Idacio 40 mg/0.8 mL pen, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective therapeutically equivalent generic; and
- for brand name Remicade, the prescriber must provide medical records documenting an inadequate response or adverse reaction to unbranded infliximab.
Abrilada, Amjevita, Avsola, Cyltezo, Enbrel, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Inflectra, Remicade, Renflexis, unbranded adalimumab generics, unbranded infliximab, Yuflyma, and Yusimry for Crohn’s disease
- Documentation of the following is required for moderate-to-severe Crohn's disease (see below for fistulizing Crohn's disease):
- appropriate diagnosis; and
- appropriate dosing; and
- for Avsola, Cimzia, Inflectra, Remicade, Renflexis, and unbranded infliximab, clinical rationale for the use of the requested agent instead of Humira; and
- for Inflectra or Renflexis, clinical rationale for use of the requested agent instead of Avsola and unbranded infliximab; and
- for Entyvio, inadequate response or adverse reaction to one or contraindication to all anti-TNF agents that are FDA-approved for Crohn’s disease; and
- For Skyrizi, both of the following:
- inadequate response, adverse reaction, or contraindication to Stelara; and
- inadequate response or adverse reaction to one or contraindication to all anti-TNF agents that are FDA-approved for Crohn's disease; and
- for Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry, and unbranded adalimumab generics, one of the following:
- clinical rationale for use of the requested agent instead of Humira; or
- medical records documenting an inadequate response or adverse reaction to Humira; and
- for brand name Cyltezo, Hulio, Hyrimoz 40 mg/0.4 mL syringe and pen, and Idacio 40 mg/0.8 mL pen, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective therapeutically equivalent generic; and
- for brand name Remicade, the prescriber must provide medical records documenting an inadequate response or adverse reaction to unbranded infliximab.
- For Avsola, Inflectra, Remicade, Renflexis, and unbranded infliximab for fistulizing Crohn's disease, documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- for Inflectra or Renflexis, clinical rationale for use of the requested agent instead of Avsola and unbranded infliximab; and
- for brand name Remicade, the prescriber must provide medical records documenting an inadequate response or adverse reaction to unbranded infliximab.
Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Yuflyma, Yusimry, and unbranded adalimumab generics for moderate-to-severe hidradenitis suppurativa
- Documentation of the following is required:
- diagnosis of moderate-to-severe hidradenitis suppurativa (Hurley Stage II or Hurley Stage III disease); and
- appropriate dosing; and
- for Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry, and unbranded adalimumab generics, one of the following:
- clinical rationale for use of the requested agent instead of Humira; or
- medical records documenting an inadequate response or adverse reaction to Humira; and
- for brand name Cyltezo, Hulio, Hyrimoz 40 mg/0.4 mL syringe and pen, and Idacio 40 mg/0.8 mL pen, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective therapeutically equivalent generic.
Abrilada, Amjevita, Cyltezo, Enbrel, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Orencia, Simponi Aria, unbranded adalimumab generics, Yuflyma, and Yusimry for moderate-to-severe PJIA
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- one of the following:
- inadequate response or adverse reaction to one or contraindication to all traditional DMARDs; or
- inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for PJIA; and
- for Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry, and unbranded adalimumab generics, one of the following:
- clinical rationale for use of the requested agent instead of Humira; or
- medical records documenting an inadequate response or adverse reaction to Humira; and
- for Simponi Aria, both of the following:
- clinical rationale for the use of the requested agent instead of Enbrel; and
- clinical rationale for the use of the requested agent instead of Humira; and
- for brand name Cyltezo, Hulio, Hyrimoz 40 mg/0.4 mL syringe and pen, and Idacio 40 mg/0.8 mL pen, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective therapeutically equivalent generic.
Abrilada, Amjevita, Avsola, Cimzia, Cyltezo, Cosentyx, Enbrel, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Ilumya, Inflectra, Remicade, Renflexis, Siliq, Skyrizi, Stelara, Taltz, Tremfya, unbranded adalimumab generics, unbranded infliximab, Yuflyma, and Yusimry for moderate-to-severe plaque psoriasis
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- one of the following:
- inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for plaque psoriasis; or
- inadequate response or adverse reaction to one or contraindication to all conventional therapies (topical agents, phototherapy, and systemic agents as defined in appendix below); and
- for Avsola, Cimzia, Inflectra, Remicade, Renflexis, and unbranded infliximab, both of the following:
- clinical rationale for the use of the requested agent instead of Enbrel; and
- clinical rationale for the use of the requested agent instead of Humira; and
- for Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry, and unbranded adalimumab generics, one of the following:
- clinical rationale for use of the requested agent instead of Humira; or
- medical records documenting an inadequate response or adverse reaction to Humira; and
- for Cosentyx, Iluymya, Siliq, Skyrizi, and Tremfya, clinical rationale for the use of the requested agent instead of Stelara and Taltz; and
- for Inflectra or Renflexis, clinical rationale for use of the requested agent instead of Avsola and unbranded infliximab; and
- for brand name Cyltezo, Hulio, Hyrimoz 40 mg/0.4 mL syringe and pen, and Idacio 40 mg/0.8 mL pen, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective therapeutically equivalent generic; and
- for brand name Remicade, the prescriber must provide medical records documenting an inadequate response or adverse reaction to unbranded infliximab.
Abrilada, Amjevita, Actemra, Avsola, Cimzia, Cyltezo, Enbrel, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Inflectra, Kevzara, Orencia, Remicade, Renflexis, Simponi, Simponi Aria, unbranded adalimumab generics, unbranded infliximab, Yuflyma, and Yusimry for moderate-to-severe rheumatoid arthritis (RA)
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- one of the following:
- inadequate response or adverse reaction to one or contraindication to all traditional DMARDs; or
- inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for RA; and
- for Avsola, Cimzia, Inflectra, Remicade, Renflexis, Simponi, Simponi Aria, and unbranded infliximab, both of the following:
- clinical rationale for the use of the requested agent instead of Enbrel; and
- clinical rationale for the use of the requested agent instead of Humira; and
- for Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry, and unbranded adalimumab generics, one of the following:
- clinical rationale for use of the requested agent instead of Humira; or
- medical records documenting an inadequate response or adverse reaction to Humira; and
- for Inflectra or Renflexis, clinical rationale for use of the requested agent instead of Avsola and unbranded infliximab; and
- for brand name Cyltezo, Hulio, Hyrimoz 40 mg/0.4 mL syringe and pen, and Idacio 40 mg/0.8 mL pen, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective therapeutically equivalent generic; and
- for brand name Remicade, the prescriber must provide medical records documenting an inadequate response or adverse reaction to unbranded infliximab.
Abrilada, Amjevita, Avsola, Cyltezo, Entyvio, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Inflectra, Remicade, Renflexis, Simponi, Stelara, unbranded adalimumab generics, unbranded infliximab, Yuflyma, and Yusimry for moderate-to-severe ulcerative colitis
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- for Avsola, Inflectra, unbranded infliximab, Remicade, Renflexis, and Simponi, clinical rationale for use of the requested agent instead of Humira; and
- for Stelara, an inadequate response or adverse reaction to one or contraindication to all biologic DMARDs that are FDA-approved for ulcerative colitis; and
- for Entyvio, inadequate response or adverse reaction to one or contraindication to all anti-TNF agents that are FDA-approved for ulcerative colitis; and
- for Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry, and unbranded adalimumab generics, one of the following:
- clinical rationale for use of the requested agent instead of Humira; or
- medical records documenting an inadequate response or adverse reaction to Humira; and
- for Inflectra or Renflexis, clinical rationale for use of the requested agent instead of Avsola and unbranded infliximab; and
- for brand name Cyltezo, Hulio, Hyrimoz 40 mg/0.4 mL syringe and pen, and Idacio 40 mg/0.8 mL pen, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective therapeutically equivalent generic; and
- for brand name Remicade, the prescriber must provide medical records documenting an inadequate response or adverse reaction to unbranded infliximab.
Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Yuflyma, Yusimry, and unbranded adalimumab generics for non-infectious uveitis
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- inadequate response or adverse reaction to one topical or systemic glucocorticoid, or contraindication to all topical and systemic glucocorticoids; and
- inadequate response or adverse reaction to one or contraindication to all systemic immunosuppressive therapies (e.g., methotrexate, azathioprine, mycophenolate, cyclosporine, tacrolimus, cyclophosphamide); and
- for Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry, and unbranded adalimumab generics, one of the following:
- clinical rationale for use of the requested agent instead of Humira; or
- medical records documenting an inadequate response or adverse reaction to Humira; and
- for brand name Cyltezo, Hulio, Hyrimoz 40 mg/0.4 mL syringe and pen, and Idacio 40 mg/0.8 mL pen, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective therapeutically equivalent generic.
Abrilada, Amjevita, Avsola, Cimzia, Cosentyx, Cyltezo, Enbrel, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Inflectra, Orencia, Otezla, Remicade, Renflexis, Simponi, Simponi Aria, Skyrizi, Stelara, Taltz, Tremfya, unbranded adalimumab generics, unbranded infliximab, Yuflyma, and Yusimry for psoriatic arthritis
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- for Avsola, Cimzia, Inflectra, Remicade, Renflexis, Simponi, Simponi Aria, and unbranded infliximab, both of the following:
- clinical rationale for the use of the requested agent instead of Enbrel; and
- clinical rationale for the use of the requested agent instead of Humira; and
- for Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry, and unbranded adalimumab generics, one of the following:
- clinical rationale for use of the requested agent instead of Humira; or
- medical records documenting an inadequate response or adverse reaction to Humira; and
- for Orencia, an inadequate response or adverse reaction to one or contraindication to all anti-TNF agents that are FDA-approved for psoriatic arthritis; and
- for Otezla, requested quantity is ≤ two tablets/day; and
- for Inflectra or Renflexis, clinical rationale for use of the requested agent instead of Avsola and unbranded infliximab; and
- for brand name Cyltezo, Hulio, Hyrimoz 40 mg/0.4 mL syringe and pen, and Idacio 40 mg/0.8 mL pen, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective therapeutically equivalent generic; and
- for brand name Remicade, the prescriber must provide medical records documenting an inadequate response or adverse reaction to unbranded infliximab; and
- for Cosentyx, Skyrizi, and Tremfya, both of the following:
- inadequate response, adverse reaction, or contraindication to Stelara and Taltz; and
- inadequate response or adverse reaction to one or contraindication to all anti-TNF agents that are FDA-approved for psoriatic arthritis.
Adbry for moderate-to-severe atopic dermatitis
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- prescriber is a specialist (i.e., allergist/immunologist or dermatologist) or consult notes from a specialist are provided; and
- member is ≥ 18 years of age; and
- inadequate response or adverse reaction to one or contraindication to all superpotent or potent topical corticosteroids; and
- inadequate response or adverse reaction to one or contraindication to both of the following: Eucrisa, topical tacrolimus.
Actemra for Polymyalgia Rheumatica (PMR)
- Documentation of the following is required:
- appropriate diagnosis; and
- one of the following:
- inadequate response or adverse reaction to one or contraindication to all systemic corticosteroids; and
- inadequate response, adverse reaction or contraindication to methotrexate.
Actemra for cytokine release syndrome
- Documentation of the following is required:
- appropriate diagnosis; and
- concurrent therapy with CAR T-cell therapies (request must include anticipated date of administration); and
- appropriate dosing.
Actemra for giant cell arteritis
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- inadequate response or adverse reaction to one or contraindication to all systemic glucocorticoids.
Actemra for moderate-to-severe polyarticular juvenile idiopathic arthritis (PJIA)
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- one of the following:
- inadequate response or adverse reaction to one or contraindication to all traditional DMARDs; or
- inadequate response, adverse reaction, or contraindication to Humira.
Actemra for systemic juvenile idiopathic arthritis (sJIA)
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- one of the following:
- inadequate response or adverse reaction to one or contraindication to all traditional DMARDs; or
- inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for systemic juvenile idiopathic arthritis.
Actemra for systemic sclerosis-associated interstitial lung disease
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- inadequate response or adverse reaction to one or contraindication to both of the following: cyclophosphamide, mycophenolate.
Actemra, Avsola, Humira, Inflectra, Remicade, Renflexis, and unbranded infliximab for scleritis
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response, adverse reaction, or contraindication to both of the following:
- ophthalmic, oral, or injectable glucocorticoids; and
- oral or injectable immunosuppressive therapy; and
- for Actemra, inadequate response, adverse reaction, or contraindication to Rituxan; and
- for Inflectra or Renflexis, clinical rationale for use of the requested agent instead of Avsola and unbranded infliximab; and
- for brand name Remicade, the prescriber must provide medical records documenting an inadequate response or adverse reaction to unbranded infliximab.
Actemra, Avsola, Inflectra, Remicade, Renflexis, and unbranded infliximab for uveitis
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response, adverse reaction, or contraindication to both of the following:
- ophthalmic, oral, or injectable glucocorticoids; and
- oral or injectable immunosuppressive therapy; and
- one of the following:
- inadequate response, adverse reaction, or contraindication to Humira; or
- clinical rationale for use of the requested agent instead of Humira; and
- for Inflecta or Renflexis, clinical rationale for use of the requested agent instead of Avsola and unbranded infliximab; and
- for brand name Remicade, the prescriber must provide medical records documenting an inadequate response or adverse reaction to unbranded infliximab.
Alkindi
- Documentation of the following is required:
- appropriate diagnosis; and
- member is < 18 years of age; and
- one of the following:
- medical necessity for the granule formulation; or
- medical records documenting inadequate response or adverse reaction to hydrocortisone immediate-release tablets.
Arcalyst and Ilaris for familial cold autoinflammatory syndrome (FCAS) or Muckle-Wells syndrome (MWS)
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate age (for Arcalyst member is ≥ 12 years of age, for Ilaris member is ≥ four years of age); and
- appropriate dosing; and
- one of the following:
- evidence of symptoms indicative of the disease; or
- confirmation of diagnosis through genetic testing; and
- for Arcalyst, an inadequate response, adverse reaction, or contraindication to Ilaris.
Arcalyst and Kineret for Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
- Documentation of the following is required:
- appropriate diagnosis; and
- confirmation of diagnosis through genetic testing; and
- appropriate dosing; and
- for Arcalyst, an inadequate response, adverse reaction, or contraindication to Kineret.
Arcalyst for recurrent pericarditis
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- member is ≥ 12 years of age; and
- inadequate response or adverse reaction to one or contraindication to both of the following: aspirin, NSAIDs; and
- inadequate response or adverse reaction to one or contraindication to all corticosteroids; and
- inadequate response, adverse reaction, or contraindication to both of the following: colchicine, Kineret.
Avsola, Enbrel, Humira, Inflectra, Remicade, Renflexis, and unbranded infliximab for Behçet’s Disease (BD)
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response or adverse reaction to one or contraindication to all topical corticosteroids; and
- inadequate response or adverse reaction to one or contraindication to all systemic corticosteroids; and
- inadequate response or adverse reaction to one or contraindication to all of the following: azathioprine, colchicine, cyclophosphamide, cyclosporine, methotrexate, Otezla; and
- for infliximab agents, clinical rationale for use of the requested agent instead of Enbrel and Humira; and
- for Inflectra or Renflexis, clinical rationale for use of the requested agent instead of Avsola and unbranded infliximab; and
- for brand name Remicade, the prescriber must provide medical records documenting an inadequate response or adverse reaction to unbranded infliximab.
Avsola, Enbrel, Humira, Inflectra, Remicade, Renflexis, and unbranded infliximab for Takayasu arteritis
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response, adverse reaction, or contraindication to both of the following: systemic glucocorticoids, one traditional DMARD; and
- for Avsola, Inflectra, Remicade, Renflexis, or unbranded infliximab, one of the following:
- inadequate response, adverse reaction, or contraindication to Humira and Enbrel; or
- clinical rationale for use of Avsola, Inflectra, Remicade, Renflexis, or unbranded infliximab instead of Humira and Enbrel; and
- for Inflecta or Renflexis, clinical rationale for use of the requested agent instead of Avsola and unbranded infliximab; and
- for brand name Remicade, the prescriber must provide medical records documenting an inadequate response or adverse reaction to unbranded infliximab.
Avsola, Cosentyx, Inflectra, Kineret, Remicade, Renflexis, Stelara, and unbranded infliximab for moderate-to-severe hidradenitis suppurativa
- Documentation of the following is required:
- diagnosis of moderate-to-severe hidradenitis suppurativa (Hurley Stage II or Hurley Stage III disease); and
- inadequate response or adverse reaction to one or contraindication to all oral antibiotics; and
- for Avsola, Inflectra, Kineret, Remicade, Renflexis, or unbranded infliximab, inadequate response, adverse reaction, or contraindication to Humira; and
- for Inflectra or Renflexis, clinical rationale for use of the requested agent instead of Avsola and unbranded infliximab; and
- for Stelara, both of the following:
- inadequate response, adverse reaction, or contraindication to Humira; and
- inadequate response or adverse reaction to one or contraindication to all of the following: Avsola, Inflectra, Kineret, Remicade, Renflexis, or unbranded infliximab; and
- for Cosentyx, all of the following:
- inadequate response, adverse reaction, or contraindication to Humira; and
- inadequate response or adverse reaction to one or contraindication to all of the following: Avsola, Inflectra, Kineret, Remicade, Renflexis, or unbranded infliximab; and
- inadequate response, adverse reaction, or contraindication to Stelara; and
- for brand name Remicade, the prescriber must provide medical records documenting an inadequate response or adverse reaction to unbranded infliximab.
Avsola, Cosentyx, Enbrel, Humira, Inflectra, Kineret, Remicade, Renflexis, Stelara, and unbranded infliximab for Synovitis-acne-pustulosis-hyperostosis-osteitis (SAPHO) syndrome
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response or adverse reaction to one or contraindication to all NSAIDs; and
- inadequate response or adverse reaction to one or contraindication to all systemic corticosteroids; and
- for infliximab agents, clinical rationale for use of the requested agent instead of Enbrel and Humira; and
- for Inflectra or Renflexis, clinical rationale for use of the requested agent instead of Avsola and unbranded infliximab; and
- for brand name Remicade, the prescriber must provide medical records documenting an inadequate response or adverse reaction to unbranded infliximab; and
- for Cosentyx, clinical rationale for use of the requested agent instead of Stelara.
Avsola, Inflectra, Remicade, Renflexis, and unbranded infliximab for Neurologic Sarcoidosis
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response or adverse reaction to one or contraindication to all systemic corticosteroids; and
- inadequate response or adverse reaction to two or contraindication to all of the following: azathioprine, cyclophosphamide, leflunomide, methotrexate, mycophenolate mofetil; and
- for Inflectra or Renflexis, clinical rationale for use of the requested agent instead of Avsola and unbranded infliximab; and
- for brand name Remicade, the prescriber must provide medical records documenting an inadequate response or adverse reaction to unbranded infliximab.
Avsola, Humira, Inflectra, Remicade, Renflexis, and unbranded infliximab for Pulmonary Sarcoidosis
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response, adverse reaction, or contraindication to both of the following: systemic glucocorticoids, one traditional DMARD; and
- for Avsola, Inflectra, Remicade, Renflexis, or unbranded infliximab, one of the following:
- inadequate response, adverse reaction or contraindication to Humira; or
- clinical rationale for use of Avsola, Remicade, Inflectra, Renflexis, or unbranded infliximab, instead of Humira; and
- for Inflectra or Renflexis, clinical rationale for use of the requested agent instead of Avsola and unbranded infliximab; and
- for brand name Remicade, the prescriber must provide medical records documenting an inadequate response or adverse reaction to unbranded infliximab.
azathioprine 75 mg, 100 mg tablet
- Documentation of the following is required:
- appropriate diagnosis; and
- medical necessity for the use of the 75 mg or 100 mg tablets instead of the 50 mg tablets.
SmartPA: Claims for azathioprine 75 mg and 100 mg tablets will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for the requested agent and the member has a history of MassHealth medical claims for organ transplant, complications of transplanted organs, or paid MassHealth pharmacy claims for sirolimus in the past 365 days.†
calcipotriene cream, ointment > 60 grams/30 days
- Documentation of the following is required:
- diagnosis of plaque psoriasis; and
- member is ≥ 18 years of age; and
- clinical rationale for the use of > 60 grams/30 days.
calcipotriene foam and calcitriol ointment
- Documentation of the following is required:
- diagnosis of plaque psoriasis; and
- one of the following:
- for calcitriol ointment, member is ≥ two years of age; or
- for calcipotriene foam, member is ≥ four years of age; and
- inadequate response or adverse reaction to one or contraindication to all topical corticosteroids; and
- inadequate response or adverse reaction to one or contraindication to all of the following: calcipotriene cream, ointment, and scalp solution; and
- for calcipotriene foam, one of the following:
- requested quantity is 60 grams; or
- clinical rationale for the use of > 60 grams/30 days.
Cibinqo for moderate-to-severe atopic dermatitis
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- prescriber is a specialist (i.e., allergist/immunologist or dermatologist) or consult notes from a specialist are provided; and
- member is ≥ 12 years of age; and
- inadequate response or adverse reaction to one superpotent or potent topical corticosteroid, or contraindication to all superpotent or potent topical corticosteroids; and
- inadequate response or adverse reaction to one or contraindication to both of the following: Eucrisa, topical tacrolimus; and
- inadequate response, adverse reaction, or contraindication to Dupixent; and
- requested quantity is ≤ one tablet/day; and
- for the 200 mg tablet, inadequate response (defined as ≥ 12 weeks of therapy) to the 100 mg dose.
Cimzia and Taltz for ankylosing spondylitis
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- inadequate response or adverse reaction to two or contraindication to all NSAIDs; and
- for Cimzia, both of the following:
- clinical rationale for the use of the requested agent instead of Enbrel; and
- clinical rationale for the use of the requested agent instead of Humira.
Cimzia and Taltz for non-radiographic axial spondyloarthritis
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- inadequate response or adverse reaction to two or contraindication to all NSAIDs.
Cosentyx, Rinvoq, Xeljanz and Xeljanz XR for ankylosing spondylitis
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- inadequate response or adverse reaction to two or contraindication to all NSAIDs; and
- inadequate response or adverse reaction to one or contraindication to all anti-TNF agents that are FDA-approved for ankylosing spondylitis; and
- for Cosentyx, inadequate response, adverse reaction, or contraindication to Taltz; and
- for Rinvoq, inadequate response or adverse reaction to one or contraindication to both of the following: Xeljanz, Xeljanz XR; and
- one of the following:
- for Xeljanz, requested quantity is ≤ two tablets/day; or
- for Rinvoq and Xeljanz XR, requested quantity is ≤ one tablet/day.
Cosentyx for Enthesitis-Related Arthritis
- Documentation of the following is required:
- appropriate diagnosis; and
- member is ≥ four years and < 18 years of age; and
- appropriate dosing.
Cosentyx and Rinvoq for non-radiographic axial spondyloarthritis
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- inadequate response or adverse reaction to two or contraindication to all NSAIDs; and
- inadequate response or adverse reaction to one or contraindication to all anti-TNF agents; and
- inadequate response, adverse reaction, or contraindication to Taltz; and
- for Rinvoq, requested quantity is ≤ one tablet/day.
Cosentyx for psoriatic arthritis in pediatric members
- Documentation of the following is required:
- appropriate diagnosis; and
- member is ≥ two years and < 18 years of age; and
- inadequate response or adverse reaction one or contraindication to both of the following: Enbrel, Humira; and
- appropriate dosing.
Cosentyx, Ilumya, Siliq, Skyrizi, Stelara, Taltz, and Tremfya for Pityriasis rubra pilaris (PRP)
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response or adverse reaction to one or contraindication to all topical corticosteroids; and
- for Cosentyx, Ilumya, Siliq, Skyrizi, and Tremfya, clinical rationale for use of the requested agent instead of Stelara and Taltz.
dexamethasone tablet pack
- Documentation of the following is required:
- appropriate diagnosis; and
- one of the following:
- clinical rationale for requested medication; or
- requested medication provides a significant or unique therapeutic advantage instead of the conventionally packaged formulation; or
- medical records documenting an inadequate response or adverse reaction to dexamethasone tablets.
Emflaza
- Documentation of the following is required:
- genetically confirmed mutation in the dystrophin gene representative of DMD; and
- member is ≥ two years of age; and
- prescriber is a neuromuscular neurologist or consult notes from a neuromuscular neurology office are provided; and
- trial of prednisone and experienced significant weight gain [e.g., crossing two major percentiles and/or reaching the 98th percentile for body mass index (BMI) for age and gender] that was not alleviated with at least a 25% dose reduction (~0.56 mg/kg/day); and
- appropriate dosing for weight (~0.9 mg/kg/day) (current dose and current weight must be provided); and
- for suspension formulation, one of the following:
- medical necessity for use of the suspension formulation instead of the tablet formulation; or
- member is not utilizing other solid oral formulations.
- For recertification, documentation of the following is required:
- genetically confirmed mutation in the dystrophin gene representative of DMD; and
- member is ≥ two years of age; and
- prescriber is a neuromuscular neurologist or consult notes from a neuromuscular neurology office are provided; and
- appropriate dosing for weight (~0.9 mg/kg/day) (current dose and current weight must be provided); and
- medical records to support improvement from baseline in steroid-specific side-effects after treatment with the requested agent; and
- for suspension formulation, one of the following:
- continued medical necessity for use of the suspension formulation instead of the tablet formulation; or
- member is not utilizing other solid oral formulations.
Envarsus XR
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response, adverse reaction, or contraindication to tacrolimus capsules.
SmartPA: Claims for Envarsus XR will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 days of therapy out of the last 120 days.†
Hemady, prednisolone 10 mg/5 mL oral solution, prednisolone 20 mg/5 mL oral solution, prednisolone orally disintegrating tablet, and prednisolone tablet
- Documentation of the following is required:
- appropriate diagnosis; and
- one of the following:
- compelling clinical rationale why the requested agent would offer a therapeutic advantage instead of less-costly alternatives available without PA; or
- medical records documenting an inadequate response or adverse reaction to an oral corticosteroid available without PA.
Ilaris for familial Mediterranean fever (FMF), Hyperimmunoglobulin D syndrome (HIDS)/Mevalonate kinase deficiency (MKD), or Tumor necrosis factor receptor associated periodic syndrome (TRAPS)
- Documentation of the following is required:
- an appropriate diagnosis; and
- appropriate dosing; and
- one of the following:
- evidence of symptoms indicative of the disease; or
- confirmation of diagnosis through genetic testing; and
- for diagnosis of FMF, an inadequate response, adverse reaction, or contraindication to colchicine.
Ilaris for Adult Onset Still's Disease (AOSD) and sJIA
- Documentation of the following is required:
- appropriate diagnosis; and
- member is ≥ two years of age; and
- inadequate response or adverse reaction to one or contraindication to all corticosteroids; and
- inadequate response, adverse reaction, or contraindication to Kineret; and
- appropriate dosing.
Kevzara for Polymyalgia Rheumatica (PMR)
- Documentation of the following is required:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- inadequate response or adverse reaction to one or contraindication to all systemic corticosteroids; and
- inadequate response, adverse reaction, or contraindication to methotrexate; and
- appropriate dosing.
Kineret for acute gout
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response, adverse reaction, or contraindication to all of the following: colchicine, NSAIDs, oral or intraarticular glucocorticoids.
Kineret for Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA)
- Documentation of the following is required:
- diagnosis of one of the following:
- AOSD; or
- SJIA; and
- inadequate response or adverse reaction to one or contraindication to all corticosteroids; and
- requested dose is 1 to 2 mg/kg once daily (maximum initial dose of 100 mg); if no response, dose may be titrated up to 4 mg/kg once daily (maximum dose of 200 mg).
- diagnosis of one of the following:
Kineret for familial cold autoinflammatory syndrome (FCAS) or Muckle-Wells syndrome (MWS)
- Documentation of the following is required:
- diagnosis of one of the following:
- FCAS; or
- MWS; and
- requested dose is 1 mg/kg/day subcutaneously (maximum, 100 mg).
- diagnosis of one of the following:
Kineret for Hyperimmunoglobulin D Syndrome (HIDS)
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response or adverse reaction to one or contraindication to all NSAIDs; and
- inadequate response or adverse reaction to one or contraindication to all systemic corticosteroids.
Kineret for neonatal-onset multisystem inflammatory disease (NOMID)
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing.
Kineret for moderate-to-severe RA
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- inadequate response or adverse reaction to one or contraindication to all traditional DMARDs; and
- inadequate response or adverse reaction to one or contraindication to all biologic DMARDs that are FDA-approved for RA.
Kineret for recurrent pericarditis
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response or adverse reaction to one or contraindication to both of the following: aspirin, NSAIDs; and
- inadequate response or adverse reaction to one corticosteroid, or contraindication to all corticosteroids; and
- inadequate response, adverse reaction, or contraindication to colchicine; and
- requested dose is 100 mg subcutaneously once daily.
Litfulo and Olumiant for severe alopecia areata
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- prescriber is a dermatologist or consult notes from a dermatologist are provided; and
- one of the following:
- for Litfulo, member is ≥ 12 years of age; or
- for Olumiant, member is ≥ 18 years of age; and
- inadequate response or adverse reaction to one or contraindication to all topical corticosteroids; and
- inadequate response or adverse reaction to one or contraindication to all intralesional corticosteroids; and
- inadequate response or adverse reaction to one or contraindication to both of the following: Xeljanz, Xeljanz XR; and
- requested quantity is ≤ one unit/day.
Lupkynis
- Documentation of the following is required:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- member is receiving concurrent immunosuppressive therapy, excluding cyclophosphamide and biologics; and
- appropriate dosing.
Nulojix
- Documentation of the following is required:
- appropriate diagnosis; and
- member is ≥ 18 years of age.
Olumiant, Rinvoq, Xeljanz, and Xeljanz XR for moderate-to-severe RA
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- inadequate response or adverse reaction to one or contraindication to all anti-TNF agents that are FDA-approved for RA; and
- for Olumiant and Rinvoq, inadequate response or adverse reaction to one or contraindication to both of the following: Xeljanz, Xeljanz XR; and
- one of the following:
- for Xeljanz, requested quantity is ≤ two tablets/day; or
- for Olumiant, Rinvoq, and Xeljanz XR, requested quantity is ≤ one tablet/day.
Orencia for Acute Graft Versus Host Disease (aGVHD) prophylaxis
- Documentation of the following is required:
- appropriate diagnosis; and
- member is ≥ two years of age; and
- requested agent will be used in combination with both a calcineurin inhibitor and methotrexate; and
- appropriate dosing.
Otezla for Lichen Planus
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response or adverse reaction to one high-potency or super high potency topical corticosteroid or contraindication to all high-potency or super high potency topical corticosteroids; and
- inadequate response or adverse reaction to one or contraindication to all intralesional corticosteroids; and
- inadequate response or adverse reaction to two or contraindication to all of the following: phototherapy, acitretin, cyclosporine, dapsone, hydroxychloroquine, hydroxyzine, methotrexate, metronidazole, mycophenolate mofetil, sulfasalazine, systemic glucocorticoids.
Otezla for plaque psoriasis (all severity levels)
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- inadequate response or adverse reaction to one or contraindication to all conventional therapies (topical agents, phototherapy, and systemic agents as defined in appendix below); and
- requested quantity is ≤ two tablets/day.
Otezla for oral ulcers associated with Behçet’s disease
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- requested quantity is ≤ two tablets/day.
Otrexup, Rasuvo, and Reditrex for moderate-to-severe plaque psoriasis in adults or RA
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response, adverse reaction, or contraindication to oral methotrexate; and
- for Otrexup, inadequate response or adverse reaction to Rasuvo or Reditrex; and
- medical necessity for prefilled methotrexate injector as noted by one of the following:
- physical disability; or
- visual impairment; or
- cognitive impairment.
Otrexup, Rasuvo, and Reditrex for moderate-to-severe plaque psoriasis in pediatrics or PJIA
- Documentation of the following is required:
- appropriate diagnosis; and
- for Otrexup, inadequate response or adverse reaction to Rasuvo or Reditrex; and
- medical necessity for prefilled methotrexate injector as noted by one of the following:
- physical disability; or
- visual impairment; or
- cognitive impairment.
Prograf granules
- Documentation of the following is required:
- appropriate diagnosis; and
- one of the following:
- inadequate response, adverse reaction, or contraindication to tacrolimus capsules; or
- medical necessity for tacrolimus granules as noted by one of the following:
- member is < 13 years of age; or
- requested dose cannot be obtained from capsule formulation; or
- member utilizes tube feeding (J-tube, G-tube); or
- member has a swallowing disorder.
- For recertification, documentation of continued medical necessity for the requested formulation is required.
Rayos
- Documentation of the following is required:
- appropriate diagnosis; and
- medical records documenting inadequate response or adverse reaction to prednisone immediate-release tablets available without PA.
Rinvoq for Crohn’s disease
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- inadequate response or adverse reaction to one or contraindication to all anti-TNF agents that are FDA-approved for Crohn’s disease; and
- requested quantity is ≤ one tablet/day.
Rinvoq for moderate-to-severe atopic dermatitis
- Documentation of the following is required:
- appropriate diagnosis; and
- prescriber is a specialist (e.g., allergist/immunologist or dermatologist), or consult notes from a specialist office are provided; and
- member is ≥ 12 years of age; and
- for members ≥ 12 years and < 18 years of age, weight is ≥ 40 kg; and
- inadequate response or adverse reaction to one superpotent or potent topical corticosteroid, or contraindication to all superpotent and potent topical corticosteroids; and
- inadequate response or adverse reaction to one or contraindication to both of the following: Eucrisa, topical tacrolimus; and
- inadequate response, adverse reaction, or contraindication to Dupixent; and
- appropriate dosing; and
- requested quantity is ≤ one tablet/day.
Rinvoq, Xeljanz, and Xeljanz XR for psoriatic arthritis
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- inadequate response or adverse reaction to one or contraindication to all traditional DMARDs; and
- inadequate response or adverse reaction to one or contraindication to all anti-TNF agents that are FDA-approved for psoriatic arthritis; and
- for Rinvoq, an inadequate response or adverse reaction to one or contraindication to both of the following: Xeljanz, Xeljanz XR; and
- one of the following:
- for Xeljanz, requested quantity is ≤ two tablets/day; or
- for Rinvoq or Xeljanz XR, requested quantity is ≤ one tablet/day.
Rinvoq, Xeljanz, and Xeljanz XR for ulcerative colitis
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- inadequate response or adverse reaction to one or contraindication to all anti-TNF agents that are FDA-approved for ulcerative colitis; and
- for Rinvoq, inadequate response or adverse reaction to one or contraindication to both of the following: Xeljanz, Xeljanz XR; and
- one of the following:
- for Xeljanz, requested quantity is ≤ two tablet/day; or
- for Rinvoq or Xeljanz XR, requested quantity is ≤ one tablets/day.
Sandimmune solution
- Documentation of the following is required:
- appropriate diagnosis; and
- one of the following:
- inadequate response, adverse reaction, or contraindication to cyclosporine capsules; or
- medical necessity for cyclosporine solution as noted by one of the following:
- member is < 13 years of age; or
- requested dose cannot be obtained from capsule formulation; or
- member utilizes tube feeding (J-tube, G-tube); or
- member has a swallowing disorder.
- For recertification, documentation of continued medical necessity for the requested formulation is required.
Sotyktu for moderate-to-severe plaque psoriasis
- Documentation of the following is required:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- appropriate dosing; and
- requested quantity is ≤ one tablet/day; and
- inadequate response or adverse reaction to one of the following or contraindication to both of the following: one biologic DMARD that is FDA-approved for plaque psoriasis, Otezla.
Spevigo for generalized pustular psoriasis flares
- Documentation of the following is required:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- appropriate dosing.
Stelara for fistulizing Crohn’s disease
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response or adverse reaction to one or contraindication to all anti-TNF agents; and
- appropriate dosing.
Sylvant
- Documentation of the following is required:
- diagnosis of multicentric Castleman's disease (MCD); and
- member is ≥ 18 years of age; and
- member is HIV negative and HHV-8 negative; and
- member's current weight; and
- results from hematological laboratory tests at baseline showing all of the following:
- absolute neutrophil count ≥ 1.0x109/L; and
- platelet count ≥75x109/L; and
- hemoglobin <17 g/dL.
Tarpeyo
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- prescriber is a nephrologist or consult notes from a nephrologist are provided; and
- one of the following:
- both of the following:
- inadequate response (defined as ≥ 90 days of therapy) to the maximally tolerated dose of an ACE inhibitor or ARB; and
- medical records documenting intolerance to an ACE inhibitor or ARB at a dose above the maximally tolerated dose; or
- inadequate response (defined as ≥ 90 days of therapy) to the maximum FDA-approved dose of an ACE inhibitor or ARB; and
- both of the following:
- medical records documenting one of the following despite treatment with a maximally tolerated dose of an ACE inhibitor or ARB for ≥ 90 days:
- urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g; or
- proteinuria >1.0 g/day; and
- medical necessity for delayed-release formulation instead of other glucocorticoid formulations.
Xatmep for acute lymphoblastic leukemia in members < 18 years or PJIA
- Documentation of the following is required:
- appropriate diagnosis; and
- member is < 18 years of age; and
- member's current body surface area; and
- one of the following:
- inadequate response, adverse reaction, or contraindication to methotrexate tablets; or
- medical necessity for methotrexate oral solution as noted by one of the following:
- member is < 13 years of age; or
- member has a swallowing disorder or condition affecting ability to swallow; or
- requested dose cannot be obtained from tablet formulation; or
- member utilizes tube feeding (G-tube/J-tube).
Xatmep for acute lymphoblastic leukemia in members ≥ 18 years, moderate-to-severe plaque psoriasis, relapsed or refractory non-Hodgkin lymphoma, or RA
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response, adverse reaction, or contraindication to methotrexate injection; and
- one of the following:
- inadequate response, adverse reaction, or contraindication to methotrexate tablets; or
- medical necessity for methotrexate oral solution as noted by one of the following:
- member is < 13 years of age; or
- member has a swallowing disorder or condition affecting ability to swallow; or
- requested dose cannot be obtained from tablet formulation; or
- member utilizes tube feeding (G-tube/J-tube).
Xeljanz and Xeljanz XR for Alopecia Areata
- Documentation of the following is required:
- appropriate diagnosis; and
- prescriber is a dermatologist or consult notes from a dermatologist are provided; and
- inadequate response or adverse reaction to one or contraindication to all topical corticosteroids; and
- inadequate response or adverse reaction to one or contraindication to all intralesional corticosteroids
- one of the following:
- for Xeljanz, requested quantity is ≤ two tablets/day; or
- for Xeljanz XR, requested quantity is ≤ one tablet/day; or
- for Xeljanz solution, requested quantity is ≤ 20 mL/day; and
- for Xeljanz solution, medical necessity for the use of a solution formulation as noted by one of the following:
- member utilizes tube feeding (G-tube/J-tube); or
- member has a swallowing disorder or condition affecting ability to swallow; or
- member is < 13 years of age; or
- requested dose is < 5 mg.
Xeljanz and Xeljanz XR for Hidradenitis Suppurativa (HS)
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response, adverse reaction, or contraindication to Humira; and
- for Xeljanz solution, medical necessity for the use of a solution formulation as noted by one of the following:
- member utilizes tube feeding (G-tube/J-tube); or
- member has a swallowing disorder or condition affecting ability to swallow; or
- member is < 13 years of age; or
- requested dose is < 5 mg; and
- one of the following:
- for Xeljanz, requested quantity is ≤ two tablets/day; or
- for Xeljanz XR, requested quantity is ≤ one tablet/day; or
- for Xeljanz solution, requested quantity is ≤ 20 mL/day.
Xeljanz and Xeljanz XR for moderate-to-severe plaque psoriasis
- Documentation of the following is required:
- appropriate diagnosis; and
- one of the following:
- inadequate response or adverse reaction to one or contraindication all conventional therapies (topical agents, phototherapy, and systemic agents as defined in appendix below); and
- inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for plaque psoriasis; and
- for Xeljanz solution, medical necessity for the use of a solution formulation as noted by one of the following:
- member utilizes tube feeding (G-tube/J-tube); or
- member has a swallowing disorder or condition affecting ability to swallow; or
- member is < 13 years of age; or
- requested dose is < 5 mg; and
- one of the following:
- for Xeljanz, requested quantity is ≤ two tablets/day; or
- for Xeljanz XR, requested quantity is ≤ one tablet/day; or
- for Xeljanz solution, requested quantity is ≤ 20 mL/day.
Xeljanz for moderate-to-severe PJIA
- Documentation of the following is required:
- appropriate diagnosis; and
- appropriate dosing; and
- inadequate response or adverse reaction to one or contraindication to all anti-TNF agents; and
- one of the following:
- for solution, requested quantity is ≤ 20 mL/day; or
- for tablets, requested quantity is ≤ two tablets/day.
Xeljanz solution for off-label indications
- Documentation of the following is required:
- PA criteria for Xeljanz or Xeljanz XR must be met, depending on indication; and
- medical necessity for the use of a solution formulation as noted by one of the following:
- member utilizes tube feeding (G-tube/J-tube); or
- member has a swallowing disorder or condition affecting ability to swallow; or
- member is < 13 years of age; or
- requested dose is < 5 mg; and
- requested quantity is ≤ 20 mL/day.
Zeposia for moderate-to-severe ulcerative colitis
- Documentation of the following is required:
- appropriate diagnosis; and
- prescriber is a gastroenterologist or consult notes from a gastroenterologist are provided; and
- inadequate response or adverse reaction to one or contraindication to all anti-TNF agents that are FDA-approved for ulcerative colitis; and
- inadequate response, adverse reaction, or contraindication to Entyvio; and
- appropriate dosing; and
- member is not currently receiving concomitant therapy with immunomodulators or biologic agents; and
- requested quantity is ≤ one capsule/day.
Zilretta
- Documentation of the following is required:
- appropriate diagnosis; and
- inadequate response or adverse reaction to two different intra-articular corticosteroid injection preparations or contraindication to all other intra-articular corticosteroid injection preparations; and
- appropriate dosing.
Appendix:
|
Conventional Therapies for Plaque Psoriasis |
||
|
Phototherapy |
Topical Agents |
Systemic Agents |
|
ultraviolet A and topical psoralens (topical PUVA) |
emollients |
Traditional DMARDs: |
|
ultraviolet A and oral psoralens (systemic PUVA) |
keratolytics |
methotrexate |
|
narrow band UV-B (NUVB) |
corticosteroids |
sulfasalazine |
|
|
calcipotriene |
cyclosporine |
|
|
tazarotene |
tacrolimus |
|
|
|
acitretin |
|
|
|
mycophenolate mofetil |
|
|
|
azathioprine |
|
|
|
hydroxyurea |
|
|
|
leflunomide |
|
|
|
6-thioguanine |
† Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.
Original Effective Date: 09/2003
Last Revised Date: 03/2024
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Last updated 04/01/24