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HealthPartners

Coverage criteria policies

Alemtuzumab (Lemtrada™)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Lemtrada™ (alemtuzumab) requires prior authorization for use from Pharmacy Administration.

Coverage

Lemtrada™ (alemtuzumab) will generally be covered when used in the following manner:

  1. First treatment course
    1. Patient with diagnosis of relapsing-remitting multiple sclerosis (RRMS); and;
    2. Patient has documented treatment failure on any two of the following preferred agents: Tecfidera, Gilenya, Aubagio, Avonex, Plegridy, Rebif, Extavia, Copaxone 40 mg, Glatopa; and,
    3. Patient has not been previously treated with Lemtrada™; and,
    4. Patient is not receiving alemtuzumab in combination with another disease modifying agent (e.g., interferon beta preparations, glatiramer acetate, dimethyl fumarate); and,
    5. The prescribed regimen is consistent with the FDA approved labeling of 12 mg intravenously daily for 5 consecutive days.
      Authorization will be provided for one course of 5 daily doses.
  2. Second treatment course
    1. Patient with diagnosis of relapsing-remitting multiple sclerosis (RRMS); and,
    2. Patient has received one 5 day course of treatment with alemtuzumab 12 months ago; and,
    3. Patient is not receiving alemtuzumab in combination with another disease modifying agent (e.g., interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, or teriflunomide); and,
    4. The prescribed regimen is consistent with the FDA approved labeling of 12 mg intravenously daily for 3 consecutive days.

Authorization will be provided for one course of 3 daily doses.

Requests for additional doses/courses beyond two courses will not be approved.

Definitions

Lemtrada™ is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada™ should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

HCPCS

Codes

Description

J0202

Injection, alemtuzumab, 1 mg

NDC

Codes

Description

58468020001

12 mg/1.2 mL single dose vials

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Lemtrada™ prescribing information and medication guide. Cambridge, MA: Genzyme Corporation; November 2014.
  2. National Multiple Sclerosis Society. “Who Gets MS?”. Available at http://www.nationalmssociety.org/What-is-MS/Who-Gets-MS. Accessed November 19th, 2014.
  3. National Multiple Sclerosis Society. “FDA Approves Lemtrada (alemtuzumab) for Relapsing MS”. Available at http://www.nationalmssociety.org/About-the-Society/News/FDA-Approves-Lemtrada%E2%84%A2-(alemtuzumab)-for-Relapsing. Accessed November 20th, 2014.
  4. Genzyme Online Newsroom [November 14th, 2014]. “Genzyme’s Lemtrada Approved by the FDA”. Available at http://news.genzyme.com/press-release/genzymes-lemtrada-approved-fda. Accessed November 20th, 2014.
  5. Lemtrada REMS (Risk Evaluation and Mitigation Strategy) Program. Available at http://www.lemtradarems.com. Accessed November 20th, 2014.
  6. Biopharm Insight. Lemtrada Global Consensus Forecast Report. Available at https://www.biopharm-insight.com/biopharm/AccessPoint.aspx?action=InfinataFrame.DisplayFrame&random_x=606912649#. Accessed November 24th, 2014.

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Policy activity

  • 02/23/2015 - Date of origin
  • 07/01/2017 - Effective date
Review date
  • 05/2017
Revision date
  • 07/01/2017

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