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HealthPartners

Coverage criteria policies

Ipilimumab (Yervoy®)

These services may or may not be covered by your HealthPartners plans. 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

Ipilimumab requires prior authorization from Pharmacy Administration.

Coverage

Ipilimumab (Yervoy) is considered medically necessary when used for treatment of unresectable stage III or IV melanoma; AND, when prescribed using the FDA-approved regimen of 3 mg/kg x 4 doses all given within a 16-week period. Doses greater than 3mg/kg will not be approved.

Requests for retreatment will be reviewed on a case by case basis.

Providers who need to prescribe Yervoy at the 10mg/kg dose for the adjuvant treatment of fully resected stage III melanoma (lymph node > 1mm) may enroll their eligible patients in Bristol-Myers Squibb’s (BMS) Adjuvant Patient Program for Melanoma by contacting BMS Access Support Center at 800-861-0048 (Monday-Friday 8:00 a.m. to 8:00 p.m. ET) or visiting www.bmsaccesssupport.com.

Definitions

Melanoma is a cancer of skin cells or melanocytes.

Yervoy (ipilimumab) is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibody indicated for treatment of unresectable or metastatic melanoma.

If available, codes for a procedure, device or diagnosis 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

Code

Description

J9228

Injection, ipilimumab, 1 mg

NDC Codes

Codes

Description

00003232711

Yervoy 50 mg/10mL single use solution

00003232822

Yervoy 200 mg/40mL single use solution

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. Yervoy Prescribing Information. Princeton, NJ: Bristol-Myers Squibb Company. October 2015.
  2. Yervoy FDA Review. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125377Orig1s000SumR.pdf (Accessed 6/6/2011).
  3. Yervoy REMS Information. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125377_REMS.pdf (Accessed 6/6/2011).
  4. Hodi FS, O’Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010;363:711-23.
  5. Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus darcarbazine for previously untreated metastatic melanoma. N Engl J Med 2011;364:2517-26.
  6. NCCN Guidelines for Melanoma (Verson 4.2011, 5/3/11) http://www.nccn.org/professionals/physician_gls/pdf/melanoma.pdf (Accessed 7/22/2011).

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Policy activity

  • 09/08/2011 - Date of origin
  • 04/28/2017 - Effective date
Review date
  • 02/2017
Revision date
  • 05/16/2016

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