Is continuation of infliximab (Remicade) 5 mg/kg IV every 8 weeks medically necessary for a patient with Crohn's disease who has achieved and maintained long-term clinical and endoscopic remission on this therapy, despite Aetna's brand selection criteria?

Continuation of Remicade (Infliximab) is Medically Necessary Despite Brand Selection Criteria

For this patient with Crohn's disease who has achieved and maintained long-term clinical and endoscopic remission on Remicade (infliximab) 5 mg/kg IV every 8 weeks, continuation of the current therapy is medically necessary and should not be subject to mandatory biosimilar switching based solely on cost considerations. 1, 2

Clinical Justification for Continuing Current Therapy

Evidence Supporting Maintenance of Stable Therapy

• Patients who have achieved sustained clinical and endoscopic remission on infliximab should continue their current regimen, as interruption of effective therapy can lead to disease relapse, antibody formation to infliximab, and potential loss of response to the medication 2

• The British Society of Gastroenterology guidelines explicitly support maintaining consistent, effective treatment to prevent flare-ups and complications in Crohn's disease 1, 2

• The ACCENT I trial demonstrated that patients maintaining infliximab every 8 weeks had significantly longer time to loss of response (>40 weeks) compared to those who discontinued (14 weeks, P<0.001) 3

Standard Dosing Confirmation

• The FDA-approved and guideline-recommended maintenance dose for Crohn's disease is 5 mg/kg IV every 8 weeks, which is exactly what this patient is receiving 4

• The European Crohn's and Colitis Organisation (ECCO) and British Society of Gastroenterology both strongly recommend infliximab at this dose as maintenance therapy for moderate-to-severe Crohn's disease 1, 2

Addressing the Brand Selection Requirement

Clinical Guidelines on Biosimilar Switching

• While biosimilar switching is supported in stable patients according to the British Society of Gastroenterology, this is presented as an option, not a mandate 5

• The Canadian Association of Gastroenterology guidelines specifically state that switching biologics is NOT recommended in patients who are doing well on anti-TNF therapy 2

• When switching is considered appropriate, guidelines recommend measuring drug levels before switching and close monitoring afterward, particularly at the first infusion 5

Risk-Benefit Analysis of Mandatory Switching

• The patient has documented long-term clinical AND endoscopic remission, which represents optimal disease control 2

• Switching a stable patient introduces unnecessary risks including:

  • Potential immunogenicity with the new product 5
  • Risk of loss of response requiring dose escalation or therapy change 5
  • Disruption of established therapeutic drug levels 5

• The patient's history of severe disease complications (fistulas requiring switch from Humira to Remicade) demonstrates the importance of maintaining effective therapy 2

Medical Necessity Determination

Meeting Aetna's Own Criteria

• The "at least as likely to produce equivalent therapeutic results" standard in Aetna's policy is NOT met for mandatory biosimilar switching in this stable patient because:
  • The patient has already achieved optimal outcomes (clinical and endoscopic remission) on current therapy 2
  • Switching introduces measurable risks of loss of response that do not exist with continuation 5
  • Guidelines do not support mandatory switching in well-controlled patients 2

Documentation Supporting Medical Necessity

• Patient has documented long-term remission on current therapy 2
• Patient failed previous biologic therapy (Humira) and required switch to infliximab 2
• Current dose (5 mg/kg every 8 weeks) is FDA-approved standard dosing 4
• No evidence of treatment failure, inadequate response, or need for dose escalation 2

Recommendation

Approve continuation of Remicade (infliximab) 5 mg/kg IV every 8 weeks as medically necessary. The brand selection criteria should not override clinical judgment when a patient has achieved optimal disease control on their current regimen, particularly given the patient's history of biologic failure and the established risks of switching stable patients. 1, 2, 5

Important Caveats

• If the patient were starting anti-TNF therapy de novo, biosimilar alternatives (Avsola, Inflectra, Renflexis) would be appropriate first-line options 5

• If the patient develops loss of response or requires dose escalation in the future, biosimilar alternatives could be reconsidered at that time 2, 5

• The lack of documentation of preferred alternative trials is irrelevant for continuation of established, effective therapy—this requirement applies to new therapy initiation, not maintenance of successful treatment 2