CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Systemic Immunomodulator Criteria

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New Hampshire Medicaid Fee-for-Service prior authorization for systemic immunomodulators and their FDA-approved indications, including specialty-prescriber, indication, step-therapy, renewal, and denial requirements.

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicySystemic Immunomodulator Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests only for listed FDA-approved indications and ensure the medication is prescribed by an appropriate specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7Disease-specific approval criteria groups

8Explicit denial or exclusion conditions

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CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Systemic Immunomodulator Criteria

Customize your policy alerts

Sign up for all New Hampshire Department of Health and Human Services policy alerts

Know when New Hampshire Department of Health and Human Services releases new policies or updates existing guidance.

Monitor payer policy activity

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Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicySystemic Immunomodulator Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests only for listed FDA-approved indications and ensure the medication is prescribed by an appropriate specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7Disease-specific approval criteria groups

8Explicit denial or exclusion conditions

Crohn's disease or ulcerative colitis initial approval

1 yearOther indications initial approval

3 monthsUlcerative colitis azathioprine or mercaptopurine prerequisite

Coverage Criteria

General approval requirements

Coverage requires ALL of the following:

General approval requirements: The request must be for an approved FDA indication listed in the policy, and the drug must be prescribed by a rheumatologist, gastroenterologist, or dermatologist based on the approved FDA indication.

Ankylosing spondylitis

Coverage requires ALL of the following:

Ankylosing spondylitis: The member must have a trial and failure with a nonsteroidal anti-inflammatory drug (NSAID).

Juvenile idiopathic arthritis

Coverage requires ANY ONE of the following:

JIA methotrexate prerequisite

There must be a trial and failure of methotrexate.
Methotrexate must be contraindicated.
The member must have had an adverse reaction to methotrexate.

Moderately to severely active Crohn's disease

Coverage requires the applicable corticosteroid prerequisite:

Crohn's disease corticosteroid prerequisite

For moderate to severe Crohn's disease, the member must have a trial and failure of a compliant regimen of oral corticosteroids, unless contraindicated.
For severe and fulminant Crohn's disease, or when the member fails to respond to oral corticosteroids, the member must have a trial and failure of intravenous corticosteroids.

Moderately to severely active ulcerative colitis

Coverage requires ALL of the following:

Ulcerative colitis prerequisites

Aminosalicylate trial: The member must have a trial and failure of a compliant regimen of oral or rectal aminosalicylates, such as sulfasalazine or mesalamine.2 consecutive months
Corticosteroid trial
- For moderate to severe ulcerative colitis, the member must have a trial and failure of a compliant regimen of oral corticosteroids, unless contraindicated.
- For severe and fulminant ulcerative colitis, or when the member fails to respond to oral corticosteroids, the member must have a trial and failure of intravenous corticosteroids.

Moderate to severe chronic plaque psoriasis

Coverage requires ALL of the following:

Plaque psoriasis prerequisite: The member must have a previous failure on a topical psoriasis agent.

Psoriatic arthritis

Coverage requires ALL of the following:

Psoriatic arthritis prerequisite: The member must have a trial and failure with methotrexate first, or in combination with methotrexate if appropriate.

Rheumatoid arthritis

Coverage requires ALL of the following:

Rheumatoid arthritis prerequisites

Methotrexate requirement
- There must be a trial and failure of methotrexate.
- Methotrexate must be contraindicated.
- The member must have had an adverse reaction to methotrexate.
The member must have a trial and failure of at least one other disease-modifying antirheumatic drug (DMARD), such as sulfasalazine, hydroxychloroquine, or minocycline.At least 1 other DMARD

Continuation and renewal

Continuation or renewal requires ALL of the following:

Renewal requirements

Medical records must support response to therapy.
Prescription history must be reviewed.

Coverage may be denied for moderate to severe heart failure classified as NYHA Functional Class III/IV, active infection, or current or recent malignancy. Additional exclusions include pregnancy for Arava requests, concomitant use with another systemic immunomodulator, and concurrent irritable bowel syndrome for Cosentyx requests. Non-preferred drugs on the Preferred Drug List require additional prior authorization.

Live vaccines should not be administered concurrently with systemic immunomodulator therapy; requests may be denied when concurrent live-vaccine administration is identified.

Requests for Remicade, Avsola, Inflectra, or Renflexis are denied when the member is receiving concomitant azathioprine or 6-mercaptopurine, due to the increased risk of fatal hepatosplenic T-cell lymphoma.

Provider Requirements and Action Items

Prior Authorization

FDA Indication and Specialist Prescriber Required

Prior authorization will only be granted for an approved FDA indication listed in the policy and must be prescribed by the appropriate specialist based on that indication.

Rheumatologist, gastroenterologist, or dermatologist must prescribe according to the approved FDA indication.

Prior Authorization

Additional Authorization for Non-Preferred Drugs

Non-preferred drugs listed on the Preferred Drug List (PDL) require additional prior authorization beyond the standard coverage requirements.

Verify the product’s PDL status before submitting the request.
Submit additional authorization documentation for non-preferred products.

Policy Background

This policy addresses systemic immunomodulators, including biologic agents, targeted synthetic agents, and other immunomodulatory therapies used for inflammatory, autoimmune, dermatologic, gastrointestinal, rheumatologic, and autoinflammatory conditions. Coverage is limited to listed FDA-approved indications and requires prescribing by an appropriate specialist, with disease-specific prerequisite treatment requirements before authorization.

Definitions and Abbreviations

Definitions

AbbreviationJIA

MeaningJuvenile idiopathic arthritis

Former terminologyPreviously listed as juvenile rheumatoid arthritis (JRA)

Definitions

AbbreviationCD

MeaningCrohn's disease

Policy descriptionModerately to severely active Crohn's disease

Initial Therapy Criteria

Initial therapy requirements

Initial therapy requires ALL of the following:

Initial systemic immunomodulator authorization

The request must be for a listed FDA-approved indication.
The prescriber must be a rheumatologist, gastroenterologist, or dermatologist appropriate to the FDA-approved indication.
Disease-specific prerequisite: The applicable prerequisite must be met: NSAID trial and failure for ankylosing spondylitis; methotrexate trial and failure, contraindication, or adverse reaction for juvenile idiopathic arthritis; corticosteroid trial and failure for Crohn's disease; aminosalicylate, corticosteroid, and azathioprine or mercaptopurine trials and failures for ulcerative colitis; topical psoriasis-agent failure for chronic plaque psoriasis; methotrexate trial and failure for psoriatic arthritis; or methotrexate plus at least one additional DMARD trial and failure, as applicable, for rheumatoid arthritis.

Continuation and Renewal Criteria

Renewal and continuation

Renewal and continuation require ALL of the following:

Continuation therapy

Medical records must support response to therapy.
Prescription history must be reviewed.

Indication-Specific Step Therapy

Step	Indication	Required prior therapy	Duration
1	Ankylosing spondylitis	Trial and failure with a nonsteroidal anti-inflammatory drug (NSAID).	Not specified

Step	Indication	Required prior therapy	Duration
1	Juvenile idiopathic arthritis (JIA)	Trial and failure of, contraindication to, or adverse reaction to methotrexate.	Not specified

Step	Indication	Required prior therapy	Duration
1	Moderately to severely active Crohn's disease	Trial and failure of a compliant regimen of oral corticosteroids for moderate to severe disease unless contraindicated, or intravenous corticosteroids for severe and fulminant disease or failure to respond to oral corticosteroids.	Not specified

Step	Indication	Required prior therapy	Duration
1	Moderately to severely active ulcerative colitis	Trial and failure of a compliant regimen of oral or rectal aminosalicylates, such as sulfasalazine or mesalamine.	2 consecutive months

Step	Indication	Required prior therapy	Duration
2	Moderately to severely active ulcerative colitis	Trial and failure of a compliant regimen of oral corticosteroids for moderate to severe ulcerative colitis unless contraindicated, or intravenous corticosteroids for severe and fulminant ulcerative colitis or failure to respond to oral corticosteroids.	Not specified

Step	Indication	Required prior therapy	Duration
3	Moderately to severely active ulcerative colitis	Trial and failure of a compliant regimen of azathioprine or mercaptopurine.	3 consecutive months

Step	Indication	Required prior therapy	Duration
1	Moderate to severe chronic plaque psoriasis	Previous failure on a topical psoriasis agent.	Not specified

Step	Indication	Required prior therapy	Duration
1	Psoriatic arthritis	Trial and failure with methotrexate first or in combination with methotrexate if appropriate.	Not specified

Step	Indication	Required prior therapy	Duration
1	Rheumatoid arthritis	Trial and failure of, contraindication to, or adverse reaction to methotrexate, plus trial and failure of at least one other DMARD, such as sulfasalazine, hydroxychloroquine, or minocycline.	At least 1 other DMARD; duration not specified

Biosimilar Information

Note

Renflexis biosimilar identification

Renflexis is identified as a biosimilar to infliximab. The policy does not state a preferred-product rule for Renflexis.

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicySystemic Immunomodulator Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests only for listed FDA-approved indications and ensure the medication is prescribed by an appropriate specialist.

SourceLink

On This Page

Immunomodulator trial:

The member must have a trial and failure of a compliant regimen of azathioprine or mercaptopurine.

3 consecutive months

Complete Indication-Specific Step Therapy

Document the required disease-specific prerequisite therapy, including compliant treatment trials and required duration, before requesting authorization.

Ankylosing spondylitis: trial and failure of an NSAID.
JIA: trial and failure of, contraindication to, or adverse reaction to methotrexate.
Moderately to severely active Crohn’s disease: trial and failure of compliant oral corticosteroids for moderate to severe disease, unless contraindicated; use intravenous corticosteroids for severe or fulminant disease or failure to respond to oral corticosteroids.
Moderately to severely active ulcerative colitis: trial and failure of compliant oral or rectal aminosalicylates (such as sulfasalazine or mesalamine) for two consecutive months; oral corticosteroids for moderate to severe disease unless contraindicated, or intravenous corticosteroids for severe or fulminant disease or failure to respond to oral corticosteroids; and azathioprine or mercaptopurine for three consecutive months.
Moderate to severe chronic plaque psoriasis: previous failure of a topical psoriasis agent.
Psoriatic arthritis: trial and failure of methotrexate first or in combination with methotrexate when appropriate.
Rheumatoid arthritis: trial and failure of, contraindication to, or adverse reaction to methotrexate and at least one other DMARD, such as sulfasalazine, hydroxychloroquine, or minocycline.

Documentation Required

Document Response for Renewal

Renewal authorization requires medical records supporting response to therapy and review of the member’s prescription history. Renewal approval is generally for one year.

Initial approval is three months for Crohn’s disease or ulcerative colitis.
Initial approval is one year for all other indications.
Submit records demonstrating clinical response and continued medical necessity.

Documentation Required

Document Prior Treatments and Exceptions

Document all prerequisite treatment history, including prior trials and failures, contraindications, adverse reactions, and applicable treatment durations. The documentation must support the disease-specific requirement for the requested therapy.

Include the medication or therapy tried, treatment dates or duration, outcome, and reason for discontinuation.
For requirements allowing exceptions, clearly document the contraindication or adverse reaction.
For ulcerative colitis, document each required prerequisite regimen and the applicable two- or three-month duration.

Denial Risk

Review Clinical Denial Conditions

Authorization may be denied when any applicable clinical exclusion is present or when required safety conditions are not met.

Moderate to severe heart failure: NYHA Functional Class III or IV.
Live vaccines must not be administered concurrently.
Active infection.
Current or recent malignancy.
Concomitant azathioprine or 6-mercaptopurine for Remicade®, Avsola®, Inflectra®, or Renflexis® requests, due to increased risk of fatal hepatosplenic T-cell lymphoma.
Pregnancy for Arava® requests.
Concomitant use with other systemic immunomodulators.
Concurrent irritable bowel syndrome diagnosis for Cosentyx® requests.

Prior Authorization

Non-Preferred PDL Products

Non-preferred products on the Preferred Drug List require an additional prior authorization.

Identify whether the requested product is preferred or non-preferred on the PDL.
For a non-preferred product, submit the additional prior authorization request and supporting rationale.

Definitions

AbbreviationUC

MeaningUlcerative colitis

Policy descriptionModerately to severely active ulcerative colitis

Definitions

AbbreviationPP

MeaningPlaque psoriasis

Policy descriptionModerate to severe chronic plaque psoriasis

Definitions

AbbreviationPsA

MeaningPsoriatic arthritis

Treatment contextMethotrexate trial and failure is required first or in combination with methotrexate if appropriate

Definitions

AbbreviationRA

MeaningRheumatoid arthritis

Treatment contextCoverage requires methotrexate and at least one other DMARD, such as sulfasalazine, hydroxychloroquine, or minocycline

Definitions

AbbreviationNYHA

MeaningNew York Heart Association Functional Class III or IV heart failure

Coverage consequenceModerate to severe heart failure in NYHA Functional Class III/IV is a criterion for denial