Local Coverage Article Response to Comments

Response to Comments: Off-label Use of Rituximab and Rituximab Biosimilars


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Response to Comments: Off-label Use of Rituximab and Rituximab Biosimilars
Article Type
Response to Comments
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This policy addresses the off-labeled use of rituximab for non-anti-neoplastic conditions.

The following are comments received during open comment period February 11, 2021 thru March 28, 2021 for DL38920 Off-label Use of Rituximab abd Rituximab Biosimiliars. The policy iswill be in notice effective June 24, 2021, 2021 and become effective August 8, 2021.

Response To Comments


The American College of Rheumatology (ACR), representing over 7,700 rheumatologists and rheumatology interprofessional team members, appreciates the opportunity to provide comments on CGS proposed Local Coverage Determination (LCD) DL38920, “Off label use of Rituximab and Rituximab biosimilars.”

Rheumatologists treat patients with a variety of inflammatory and autoimmune conditions. Many of these patients with rare and debilitating diseases are not able to access treatment because the appropriate medication is not approved by the FDA for the intended indication, despite being standard of care. For treatments covered under Medicare Part D, patient access relies upon inclusion in one of the Medicare-approved compendia. However, for treatments covered under Medicare Part B, patients often have no option to access critical off-label treatments.

The ACR appreciates CGS recognizing the role of Rituximab in the treatment of off-label indications, and specifically, the inclusion of lupus nephritis in the proposed LCD. We would appeal for your consideration of two additional clinical states where Rituximab is both a) clinically accepted as standard of care for refractory patients and b) often available through appeal pathways from commercial insurance carriers. These are immune mediated myopathies and IgG4 related systemic disease. While the proposed LCD mentions immune mediated myopathies, it does not appear to propose coverage. Due to the rarity of these diseases, it is impractical to expect large scale randomized trials to be completed. For each indication, we would agree Rituximab treatment should only be considered when a patient is refractory to conventional (yet also non-FDA approved) treatments.

CGS has reviewed the additional literature submitted to support the use of Rituximab in refractory cases of immune mediated myopathies and IgG4 related systemic disease. The evidence review and limited coverage criteria has been incorporated into the final LCD. With additional supporting literature provided the immune mediated myopathy anti-synthetase syndrome was removed from non-covered and added to limited coverage. Thank you for your support of the policy.

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