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Brentuximab vedotin (Adcetris®)

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 will be used to determine your coverage.

Administrative process

Brentuximab (Adcetris) will not be covered without prior authorization from HealthPartners Pharmacy Services.

Please see related content at the right for link to prior authorization form.

Brentuximab vedotin (Adcetris) is generally covered when:

  1. Prescribed for FDA-approved indications
    1. Treatment of Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) OR after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, OR
    2. Treatment of systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen, and
  2. Patients have a functional status of at least ECOG 0-2, and
  3. A risk/benefit discussion is documented in the medical record. Use of shared decision-making or informed consent tool is recommended.

The FDA-approved regimen is 1.8 mg/kg administered only as an intravenous infusion over 30 minutes every 3 weeks.

Authorization will be given for 4 doses/cycles (approximately three months). Requests for additional doses will be approved when there is no progression of disease.

A maximum of 16 cycles will be approved per FDA-labeling.

Indications that are not covered

Other conditions not listed in this policy will be reviewed on a case by case basis for medical necessity.

Brentuximab vedotin (Adcetris) is a CD30-directed antibody-drug conjugate indicated for:

  1. Treatment of Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates.
  2. Treatment of systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.

Orphan status has been granted for both indications.

Brentuximab vedotin is a CD30-directed antibody-drug conjugate consisting of three components: 1) the chimeric IgG1 antibody cAC10, specific for human CD30, the microtubule disrupting agent monomethyl auristatin E (MMAE), and 3) a protease-cleavable linker that covalently attaches MMAE to cAC10. The anticancer activity is likely to the binding of the ADC to CD30-expressing cells, followed by internalization of the ADC-CD30 complex, and the release of MMAE via proteolytic cleavage. Binding of MMAE to tubulin disrupts the microtubule network within the cell, subsequently inducing cell cycle arrest and apoptotic death of the cells.

Studies of unconjugated anti-CD30 antibodies showed little clinical effect.

CD-30 is expressed on the surface of Hodgkin’s Reed-Sternberg (HRS) cells in HL and by ALCL cells. It is also seen in embryonal carcinomas and select subtypes of B-cell derived, NHL and mature T-cell lymphomas. Normal expression of CD30 is limited to a relatively small population of activated B cells, T cells and a small portion of eosinophils, therefore, the deletion of CD30-expressing cells was hypothesized to provide targeted therapeutic value in these tumor types.

Hodgkin lymphoma is a cancer of lymph tissue found in the lymph nodes, spleen, liver, and bone marrow. Anaplastic large cell lymphoma (ALCL) is a rare type of Non-Hodgkin Lymphoma. Lymphoma occurs when lymphocytes, a type of white blood cell, grow abnormally.

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 Code

J9042 – Injection, brentuximab vedotin, 1 mg

NDC Codes

51144005001 – 50 mg single-dose vial

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

References

  1. Adcetris prescribing information. Seattle Genetics, Inc. August 2011.
  2. FDA Summary Review. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist (Accessed 10/10/2011)
  3. Younes A, Bartlett NL, Leonard JP, et al. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Eng J Med 2010;363:1812-21.
  4. NCCN Guidelines for Non-Hodgkin’s Lymphoma (Verson 4.2011, 8/24/11) http://www.nccn.org/professionals/physician_gls/pdf/nhl.pdf (Accessed 10/10/2011).

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.