Was administration of golimumab (Simponi Aria) and intravenous infusion therapy medically necessary for a patient with rheumatoid arthritis on July 28, 2025, and September 22, 2025?

Medical Necessity Determination for Golimumab (Simponi Aria) in Rheumatoid Arthritis

The golimumab infusions on July 28,2025, and September 22,2025, meet medical necessity criteria for continuation therapy, but the initial treatment course did not fully meet criteria due to inadequate documentation of concurrent methotrexate therapy and incomplete safety screening.

Critical Medical Necessity Gaps Identified

Methotrexate Requirement Not Met

• The FDA label explicitly states that for rheumatoid arthritis, Simponi Aria should be given in combination with methotrexate 1
• The American College of Rheumatology 2021 guidelines strongly recommend that biologic DMARDs like golimumab be used in combination with methotrexate for optimal efficacy 2
• This patient discontinued methotrexate due to widespread rash, but no documentation exists showing attempts at subcutaneous methotrexate administration, which has higher bioavailability and potentially fewer side effects than oral formulation 3, 4
• The patient is currently on hydroxychloroquine (Plaquenil) 200mg twice daily with Simponi Aria, but this does not substitute for the required methotrexate co-therapy 3

Incomplete Safety Screening Documentation

• Hepatitis B surface antigen testing was ordered on 5/6/2025 but results are not documented in the submitted materials 1
• QuantiFERON TB Gold testing was ordered on 5/6/2025 but results are not included 1
• The FDA label requires that patients be HBsAg negative or receiving concurrent antiviral therapy before initiating golimumab 1
• Untreated latent or active tuberculosis must be excluded prior to treatment 1

Missing Documentation for September 22,2025 Administration

• No infusion center note or administration documentation was provided for the 9/22/2025 date of service
• Cannot verify that the drug was actually administered or assess for any adverse events on that date

Criteria That Were Met

Continuation Therapy Requirements

• Patient demonstrates favorable response to prior golimumab administration, with documented improvement from pre-treatment PAIN 8/10 and RAPID3 6/10 to post-treatment PAIN 2/10 and RAPID3 2/10 2
• Patient is over 18 years of age 2
• Moderate to severe active rheumatoid arthritis documented with Disease Activity Score (RAPID3 5/10 at 5/6/2025 visit, which corresponds to moderate disease activity) 2
• No concurrent use of abatacept, anakinra, or other TNF inhibitors documented 2
• No active infection apparent at time of administration 2

Dosing and Administration

• Dosing of 2 mg/kg (175 mg for 87.5 kg patient) administered intravenously over 30 minutes is correct per FDA labeling 1
• The 8-week interval between infusions (initial dose, then week 4, then every 8 weeks) follows FDA-approved regimen 1
• CPT code 96413 for chemotherapy administration is appropriate as an ancillary code following the medication determination 3

Prior DMARD Failures Documented

• Failed hydroxychloroquine monotherapy 2
• Failed sulfasalazine 2
• Failed leflunomide after initial response 2
• Failed methotrexate due to widespread rash (though duration of trial not clearly documented) 2
• Multiple NSAID failures documented 2

Recommendations to Establish Full Medical Necessity

Immediate Documentation Needs

1. Obtain and document results of Hepatitis B surface antigen testing ordered 5/6/2025 - this is a mandatory safety requirement per FDA labeling 1
2. Obtain and document results of QuantiFERON TB Gold testing ordered 5/6/2025 - required to exclude latent/active tuberculosis 1
3. Obtain administration note for 9/22/2025 infusion to verify drug was given and document any adverse events

Methotrexate Requirement Resolution

The American College of Rheumatology guidelines indicate that if oral methotrexate cannot be tolerated, subcutaneous administration should be attempted before abandoning methotrexate therapy entirely 3, 4. The following options should be considered:

• Document a trial of subcutaneous methotrexate at doses of 15-25 mg weekly, as this route has superior bioavailability and may avoid the gastrointestinal and dermatologic side effects seen with oral administration 3, 4
• If subcutaneous methotrexate also causes rash, document this failure with specific details of the reaction
• If methotrexate is truly contraindicated, document the specific medical contraindication (e.g., severe hypersensitivity reaction, hepatotoxicity) to justify deviation from FDA labeling and ACR guidelines 3
• Consider alternative conventional DMARD combination: The patient is currently on hydroxychloroquine; adding sulfasalazine to create dual conventional DMARD therapy may partially address the combination therapy requirement, though this remains inferior to methotrexate combination per guidelines 2

Duration of Prior DMARD Trials

• Document the specific duration of each failed DMARD trial (hydroxychloroquine, sulfasalazine, leflunomide, methotrexate) 2
• The American College of Rheumatology recommends a minimum of 3 months for each DMARD trial based on efficacy and tolerability 2
• Current documentation states "failed" but does not specify if adequate trial duration was achieved

Clinical Rationale Supporting Continuation

Despite the documentation gaps, the clinical response to golimumab has been substantial and clinically meaningful 5, 6:

• Pain reduction from 8/10 to 2/10 represents a 75% improvement in patient-reported pain scores
• RAPID3 improvement from 6/10 to 2/10 indicates transition from moderate-high disease activity to low disease activity, which is the treatment target per ACR guidelines 2
• The patient has failed multiple conventional DMARDs and demonstrates seronegative rheumatoid arthritis (RF negative, though CCP antibody results from 6/2/2025 not provided in documentation)
• Real-world evidence supports that golimumab can be effective with or without methotrexate, though combination therapy remains preferred 6

Safety Considerations

Documented Safety Profile

• No serious adverse events documented in the 7/28/2025 infusion note 1
• Patient tolerated previous infusions well (treatment #16 on 7/28/2025) 1
• No documented infections, infusion reactions, or other complications 1

Ongoing Monitoring Requirements

• Continue tuberculosis screening periodically during therapy per FDA labeling 1
• Monitor for infections, as TNF inhibitors increase infection risk 1
• No concurrent live vaccines should be administered 1
• Monitor hepatic function if patient resumes any hepatotoxic medications 1

Common Pitfalls to Avoid

1. Assuming oral methotrexate failure justifies complete methotrexate avoidance - subcutaneous route must be attempted first per ACR guidelines 3, 4
2. Incomplete safety screening documentation - both TB and Hepatitis B testing are mandatory, not optional 1
3. Inadequate documentation of DMARD trial duration - stating "failed" without specifying if 3-month minimum trial was completed 2
4. Missing administration notes - each infusion must be documented to verify drug delivery and monitor for adverse events 1

Final Determination

For the July 28,2025 infusion: APPROVE with conditions - Patient meets continuation criteria based on documented favorable response to prior golimumab therapy, but requires completion of safety screening documentation (Hepatitis B and TB test results) 2, 1.

For the September 22,2025 infusion: PEND pending receipt of administration note - Cannot verify drug was administered without documentation 1.

For future infusions: Require documentation addressing methotrexate requirement - Either document trial of subcutaneous methotrexate or provide specific medical contraindication justifying deviation from FDA labeling requirement for combination therapy 3, 1.