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:
Oral Corticosteroids:
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Immunological Agents – Corticosteroids |
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Immunological Agents – Immunosuppressants |
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Immunological Agents – Interleukin Antagonists |
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Immunological Agents – Janus Kinase (JAK) Inhibitors |
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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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| # | This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization 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. |
| ^ | This drug is available through the health care professional who administers the drug. MassHealth does not pay for this drug to be dispensed through a retail pharmacy. |
II. Therapeutic Uses
FDA-approved, for example:
- Acute lymphoblastic leukemia – Xatmep
- Ankylosing spondylitis – Cimzia, Cosentyx, Enbrel, Humira, Inflectra, Remicade, Renflexis, Simponi, Simponi Aria, Taltz
- Crohn’s disease – Cimzia, Entyvio, Humira, Stelara
- Crohn’s disease (including fistulizing disease) – Inflectra, Remicade, Renflexis
- Cytokine release syndrome – Actemra
- Duchenne muscular dystrophy (DMD) – Emflaza
- Familial cold autoinflammatory syndrome – Arcalyst, Ilaris
- Familial Mediterranean fever – Ilaris
- Giant cell arteritis – Actemra
- Hidradenitis Suppurativa – Humira
- Hyperimmunoglobulin D syndrome/Mevalonate kinase deficiency – Ilaris
- Inflammatory, allergic, or immunological disorders – dexamethasone tablet pack, prednisolone ODT, prednisolone oral solution, Rayos
- Muckle-Wells syndrome – Arcalyst, Ilaris
- Multicentric Castleman's Disease – Sylvant
- Neonatal-onset multisystem inflammatory disease – Kineret
- Non-infectious uveitis – Humira
- Non-radiographic axial spondyloarthritis – Cimzia
- Oral ulcers associated with Behçet’s Disease – Otezla
- Osteoarthritis pain of the knee – Zilretta
- Plaque psoriasis – calcipotriene cream, ointment, calcitriol ointment, Sorilux
- Plaque psoriasis, moderate-to-severe – Cimzia, Cosentyx, Enbrel, Humira, Ilumya, Inflectra, Otezla, Remicade, Renflexis, Siliq, Skyrizi, Stelara, Taltz, Tremfya
- Polyarticular juvenile idiopathic arthritis – Xatmep
- Polyarticular juvenile idiopathic arthritis, moderate-to-severe – Actemra, Enbrel, Humira, Orencia, Otrexup, Rasuvo
- Prevention of rejection of kidney allografts – Envarsus XR, Nulojix
- Prevention of rejection of kidney, heart, or liver allografts – azathioprine 75 mg and 100 mg tablet, mycophenolic acid, Prograf granules
- Psoriasis, severe, recalcitrant, disabling – Otrexup, Rasuvo
- Psoriatic arthritis – Cimzia, Cosentyx, Enbrel, Humira, Inflectra, Orencia, Otezla, Remicade, Renflexis, Simponi, Simponi Aria, Stelara, Taltz, Xeljanz, Xeljanz XR
- Rheumatoid arthritis – Actemra, Cimzia, Enbrel, Humira, Inflectra, Kevzara, Kineret, Olumiant, Orencia, Otrexup, Rasuvo, Remicade, Renflexis, Rinvoq, Simponi, Simponi Aria, Xeljanz, Xeljanz XR
- Systemic juvenile idiopathic arthritis – Actemra, Ilaris
- Tumor necrosis factor receptor associated periodic syndrome – Ilaris
- Ulcerative colitis – Entyvio, Humira, Inflectra, Remicade, Renflexis, Simponi, Stelara, Xeljanz, Xeljanz XR
Note: The above list may not include all 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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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 the member’s condition and requested medication (see below).
Actemra for cytokine release syndrome
- Documentation of the following is required:
- an 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:
- an appropriate diagnosis; and
- member is ≥ 18 years of age; and
- appropriate dosing; and
- an inadequate response or adverse reaction to one systemic glucocorticoid or contraindication to all systemic glucocorticoids; and
- an inadequate response or adverse reaction to one systemic immunosuppressive therapy or contraindication to all systemic immunosuppressive therapy.
Actemra for polyarticular juvenile idiopathic arthritis
- Documentation of the following is required:
- an appropriate diagnosis; and
- member is ≥ two years of age; and
- appropriate dosing; and
- one of the following:
- an inadequate response or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; or
- an inadequate response, adverse reaction, or contraindication to Humira.
Actemra for systemic juvenile idiopathic arthritis
- Documentation of the following is required:
- an appropriate diagnosis; and
- member is ≥ two years of age; and
- appropriate dosing; and
- an inadequate response, adverse reaction, or contraindication to methotrexate.
Actemra, Cimzia, Enbrel, Humira, Inflectra, Kevzara, Orencia, Remicade, Renflexis, Simponi, and Simponi Aria for rheumatoid arthritis (RA)
- Documentation of the following is required:
- an appropriate diagnosis; and
- appropriate dosing; and
- for Actemra, and Kevzara, member is ≥ 18 years of age; and
- an inadequate response or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; or
- an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for RA.
Arcalyst and Ilaris for familial cold autoinflammatory syndrome (FCAS) or Muckle-Wells syndrome (MWS)
- Documentation of the following is required:
- an appropriate diagnosis; and
- appropriate age (for Arcalyst member is ≥ 12 years of age, for Ilaris member is ≥ four years of age); and
- appropriate treatment dose and frequency; 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.
azathioprine 75 mg, 100 mg tablet
- Documentation of the following is required:
- an appropriate diagnosis; and
- medical necessity for the use of the 75 mg or 100 mg tablets over 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/month
- 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/month.
calcitriol ointment, and Sorilux
- Documentation of the following is required:
- diagnosis of plaque psoriasis; and
- member is ≥ 18 years of age; and
- an inadequate response, adverse reaction, or contraindication to a topical corticosteroid; and
- an inadequate response, adverse reaction, or contraindication to calcipotriene cream, ointment or solution; and
- for Sorilux, one of the following:
- request is for the 60 gram tube; or
- clinical rationale for the use of > 60 grams/month.
Cimzia for ankylosing spondylitis and non-radiographic axial spondyloarthritis
- Documentation of the following is required:
- an appropriate diagnosis; and
- appropriate dosing; and
- an inadequate response or adverse reaction to two NSAIDs or contraindication to all NSAIDs.
Cimzia, Cosentyx, Enbrel, Humira, Inflectra, Orencia, Otezla, Remicade, Renflexis, Simponi, Simponi Aria, Stelara, and Taltz for psoriatic arthritis
- Documentation of the following is required:
- an appropriate diagnosis; and
- appropriate dosing; and
- for Cosentyx, Otezla, Stelara, and Taltz, member is ≥ 18 years of age; and
- for Otezla, quantity requested is ≤ 60 tablets/30 days; and
- an inadequate response or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; or
- an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for psoriatic arthritis.
Cimzia, Entyvio, Humira, Inflectra, Remicade, and Renflexis for Crohn’s disease
- Documentation of the following is required for moderate-to-severe Crohn's disease (see below for fistulizing Crohn's disease):
- an appropriate diagnosis; and
- appropriate dosing; and
- one of the following:
- an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for Crohn's disease; or
- an inadequate response, adverse reaction, or contraindication to all of the following:
- an aminosalicylate; and
- an antibiotic; and
- a corticosteroid; and
- an immunomodulator (e.g., azathioprine, 6-mercaptopurine, or methotrexate).
- For Inflectra, Remicade, and Renflexis for fistulizing Crohn's disease, documentation of the following is required:
- an appropriate diagnosis; and
- appropriate dosing; and
- one of the following:
- an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for Crohn's disease; or
- an inadequate response, adverse reaction, or contraindication to one immunomodulator (e.g., azathioprine or 6-mercaptopurine); or
- clinical rationale for use over oral immunomodulator.
Cimzia, Cosentyx, Enbrel, Humira, Ilumya, Inflectra, Otezla, Remicade, Renflexis, Siliq, Skyrizi, Stelara, Taltz, and Tremfya for moderate-to-severe plaque psoriasis
- Documentation of the following is required:
- an appropriate diagnosis; and
- for Cosentyx, Ilumya, Otezla, Siliq, Skyrizi, and Tremfya, member is ≥ 18 years of age; and
- for Stelara, member is ≥ 12 years of age; and
- for Taltz, member is ≥ 6 years of age; and
- for Otezla, quantity requested is ≤ 60 tablets/30 days; and
- appropriate dosing; and
- one of the following:
- an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for plaque psoriasis; or
- an inadequate response or adverse reaction to two conventional therapies (as defined in appendix below) in any one of the following combinations:
- one topical agent plus one systemic agent; or
- one topical agent plus one phototherapy; or
- one systemic agent plus one phototherapy; or
- two systemic agents; or
- a contraindication to all conventional therapies (topical agents, phototherapy, and systemic agents).
Cosentyx, Enbrel, Humira, Inflectra, Remicade, Renflexis, Simponi, Simponi Aria, and Taltz for ankylosing spondylitis
- Documentation of the following is required:
- an appropriate diagnosis; and
- appropriate dosing; and
- an inadequate response or adverse reaction to two NSAIDs or contraindication to all NSAIDs; and
- for Cosentyx and Taltz, both of the following:
- member is ≥ 18 years of age; and
- an inadequate response or adverse reaction to one anti-TNF agent that is FDA-approved for ankylosing spondylitis.
dexamethasone tablet pack
- Documentation of the following is required:
- an appropriate diagnosis; and
- one of the following:
- clinical rationale for requested medication; or
- requested medication provides a significant or unique therapeutic advantage over the conventionally packaged formulation.
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
- one of the following:
- 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
- dose is appropriate for weight (~0.9 mg/kg/day) (current dose and current weight must be provided); and
- for suspension formulation, medical necessity for use of the suspension formulation instead of the tablet formulation.
- 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
- one of the following:
- prescriber is a neuromuscular neurologist; or
- consult notes from a neuromuscular neurology office are provided; and
- dose is appropriate 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.
Enbrel, Humira, and Orencia for polyarticular juvenile idiopathic arthritis
- Documentation of the following is required:
- an appropriate diagnosis; and
- appropriate dosing; and
- an inadequate response or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; or
- an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for polyarticular juvenile idiopathic arthritis.
Entyvio, Humira, Inflectra, Remicade, Renflexis, Simponi, Stelara, Xeljanz, and Xeljanz XR for ulcerative colitis
- Documentation of the following is required:
- an appropriate diagnosis; and
- appropriate dosing; and
- for Xeljanz, member is ≥ 18 years of age and quantity requested is ≤ 60 tablets/30 days; and
- for Xeljanz XR, member is ≥ 18 years of age and quantity requested is ≤ 30 tablets/30 days; and
- an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for ulcerative colitis; or
- an inadequate response, adverse reaction, or contraindication to all of the following:
- an aminosalicylate; and
- a corticosteroid; and
- an immunomodulator (e.g., azathioprine, 6-mercaptopurine or methotrexate).
Envarsus XR
- Documentation of the following is required:
- an appropriate diagnosis; and
- clinical rationale why tacrolimus capsules may not be appropriate.
SmartPA: Claims for Envarsus XR will usually process and pay at the pharmacy without a prior authorization if the member has paid claims for at least 90 days of therapy out of the last 120 days.†
Humira for 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.
Humira for non-infectious uveitis
- Documentation of the following is required:
- an appropriate diagnosis; and
- appropriate dosing; and
- an inadequate response or adverse reaction to one topical or systemic glucocorticoid, or a contraindication to all topical and systemic glucocorticoids; and
- an inadequate response or adverse reaction to one systemic immunosuppressive therapy, or a contraindication to all systemic immunosuppressive therapies (e.g., methotrexate, azathioprine, mycophenolate, cyclosporine, tacrolimus, cyclophosphamide).
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 treatment dose and frequency; 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 sJIA
- Documentation of the following is required:
- an appropriate diagnosis; and
- member is ≥ two years of age; and
- an inadequate response, adverse reaction, or contraindication to one NSAID; and
- an inadequate response, adverse reaction, or contraindication to one corticosteroid; and
- an inadequate response, adverse reaction, or contraindication to Kineret; and
- appropriate treatment dose and frequency.
Kineret for neonatal-onset multisystem inflammatory disease (NOMID)
- Documentation of the following is required:
- an appropriate diagnosis; and
- appropriate dosing.
Kineret for RA
- Documentation of the following is required:
- an appropriate diagnosis; and
- member is ≥ 18 years of age; and
- appropriate dosing; and
- an inadequate response or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; and
- an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for RA, or a contraindication to all biologic DMARDs that are FDA-approved for RA.
mycophenolic acid
- Documentation of the following is required:
- an appropriate diagnosis; and
- an inadequate response, adverse reaction, or contraindication to mycophenolate mofetil.
SmartPA: Claims for mycophenolic acid 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.†
Nulojix
- Documentation of the following is required:
- an appropriate diagnosis; and
- member is ≥ 18 years of age.
Olumiant and Rinvoq for RA
- Documentation of the following is required:
- an appropriate diagnosis; and
- member is ≥ 18 years of age; and
- an inadequate response or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; and
- an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for RA, or a contraindication to all biologic DMARDs that are FDA-approved for RA; and
- an inadequate response, adverse reaction, or contraindication to Xeljanz or Xeljanz XR; and
- quantity requested is ≤ 30 tablets/30 days.
Otezla for oral ulcers associated with Behçet’s disease
- Documentation of the following is required:
- an appropriate diagnosis; and
- member is ≥ 18 years of age; and
- appropriate dosing; and
- quantity requested is ≤ 60 tablets/30 days.
Otrexup
- Documentation of the following is required:
- an appropriate diagnosis; and
- an inadequate response, adverse reaction, or contraindication to oral methotrexate; and
- an inadequate response or adverse reaction to Rasuvo; and
- one of the following:
- an inadequate response, adverse reaction, or contraindication to intramuscular methotrexate; or
- medical necessity for prefilled methotrexate injector as noted by one of the following:
- physical disability; or
- visual impairment; or
- cognitive impairment.
prednisolone 10 mg/5 mL oral solution, prednisolone 20 mg/5 mL oral solution, and prednisolone orally disintegrating tablet
- Documentation of the following is required:
- an appropriate diagnosis; and
- compelling clinical rationale why the requested prednisolone product would offer a therapeutic advantage over generically available, less costly alternatives.
Prograf granules
- Documentation of the following is required:
- an appropriate diagnosis; and
- clinical rationale why tacrolimus capsules may not be appropriate.
- For recertification, documentation of continued medical necessity of dosage form is required.
Rasuvo
- Documentation of the following is required:
- an appropriate diagnosis; and
- an inadequate response, adverse reaction, or contraindication to oral methotrexate; and
- one of the following:
- an inadequate response, adverse reaction, or contraindication to intramuscular methotrexate; or
- medical necessity for prefilled methotrexate injector as noted by one of the following:
- physical disability; or
- visual impairment; or
- cognitive impairment.
Rayos
- Documentation of the following is required:
- an appropriate diagnosis; and
- medical records documenting inadequate response or adverse reaction to generic prednisone immediate-release tablets.
Stelara for Crohn’s disease
- Documentation of the following is required for moderate-to-severe Crohn's disease:
- an appropriate diagnosis; and
- member is ≥ 18 years of age; and
- appropriate dosing; and
- an inadequate response or adverse reaction to one biologic DMARD that is FDA-approved for Crohn's disease, or a contraindication to all biologic DMARDs that are FDA-approved for Crohn's disease; and
- an inadequate response, adverse reaction, or contraindication to all of the following:
- an aminosalicylate; and
- an antibiotic; and
- a corticosteroid; and
- an immunomodulator (e.g., azathioprine, 6-mercaptopurine or methotrexate).
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.
Xatmep
- Documentation of the following is required:
- an appropriate diagnosis; and
- member is < 13 years of age; and
- member's current body surface area; and
- clinical rationale why generic injectable methotrexate may not be appropriate; and
- clinical rationale why generic methotrexate tablets may not be appropriate.
Xeljanz and Xeljanz XR for psoriatic arthritis and RA
- Documentation of the following is required:
- an appropriate diagnosis; and
- member is ≥ 18 years of age; and
- an inadequate response or adverse reaction to one traditional DMARD or contraindication to traditional DMARDs; and
- quantity requested is within quantity limits (for Xeljanz ≤ 60 tablets/30 days, for Xeljanz XR ≤ 30 tablets/30 days).
Zilretta
- Documentation of the following is required:
- an appropriate diagnosis; and
- one of the following:
- an inadequate response or adverse reaction to two different intra-articular corticosteroid injection preparations; or
- a contraindication to all other intra-articular corticosteroid injection preparations; and
- appropriate dosing.
Appendix:
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Conventional Therapies for Plaque Psoriasis |
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Phototherapy |
Topical Agents |
Systemic Agents |
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ultraviolet A and topical psoralens (topical PUVA) |
emollients |
Traditional DMARDs: |
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ultraviolet A and oral psoralens (systemic PUVA) |
keratolytics |
methotrexate |
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narrow band UV-B (NUVB) |
corticosteroids |
sulfasalazine |
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calcipotriene |
cyclosporine |
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tazarotene |
tacrolimus |
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acitretin |
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mycophenolate mofetil |
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azathioprine |
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hydroxyurea |
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leflunomide |
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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: 05/2020
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Last updated 05/19/20