Download Darzalex (daratumumab)

Market
Applicable
FL
&
FHK
X
FL
MMA
FL
LTC
NA
NA
Market Applicability/Effective Date
GA
KS
KY
LA
MD
NJ
NV
NY
TN
TX
WA
X
NA
X
X
X
X
X
X
NA
NA
X
*FHK- Florida Healthy Kids
Darzalex (daratumumab)
DRUG.00082
Override
Prior Authorization
Approval Duration
1 year
Medication
Darzalex (daratumumab)
Quantity Limit
N/A
APPROVAL CRITERIA
Requests for Darzalex (daratumumab) may be approved for the treatment of individuals with
multiple myeloma, including plasma-cell leukemia, when criteria I. and II. below are met:
I.
Treatment meets one of the following criteria:
a. Used as a single agent for relapsed or refractory disease following therapy with at
least 2 prior lines of therapy including a proteasome inhibitor (PI) (for example,
bortezomib, carfilzomib, or ixazomib) and an immunomodulatory agent (for example,
thalidomide, lenalidomide, or pomalidomide); OR
b. Double-refractory to a PI and an immunomodulatory agent;
AND
II. Individual has not received treatment with daratumumab or another anti-CD38 agent.
Darzalex (daratumumab) may not be approved when the above criteria are not met, and for
all other conditions, including but not limited to any of the following:
I.
II.
III.
Treatment used as first-line therapy; OR
Presence of human immunodeficiency virus (HIV) infection or hepatitis B virus infection;
OR
The reason for treatment is other than for a diagnosis of multiple myeloma, including
plasma-cell leukemia.
N/A
WEB-PEC-0469-16-A
N/A
State Specific Mandates
N/A
PAGE 1 of 3 07/25/2016
This policy does not apply to health plans or member categories that do not have pharmacy benefits,
nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit
limitations may apply.
Market
Applicable
FL
&
FHK
X
FL
MMA
FL
LTC
NA
NA
Market Applicability/Effective Date
GA
KS
KY
LA
MD
NJ
NV
NY
TN
TX
WA
X
NA
X
X
X
X
X
X
NA
NA
X
*FHK- Florida Healthy Kids
Key References:
American Cancer Society. Available at: http://www.cancer.org/docroot/home/index.asp. Accessed on March 8,
2016.
American Cancer Society. Cancer facts & figures 2016. Atlanta: American Cancer Society; 2016.
®
®
®
Daratumumab Monograph. Lexicomp Online, American Hospital Formulary Services (AHFS ) Online,
Hudson, Ohio, Lexi-Comp., Inc. Last revised November 20, 2015. Accessed on March 8, 2016.
®
Daratumumab (systemic). In: DrugPoints System (electronic version). Truven Health Analytics, Greenwood
Village, CO. Updated January 15, 2016. Available at: http://www.micromedexsolutions.com. Accessed on
March 8, 2016.
DARZALEX [Product Information], Horsham, PA. Janssen Biotech, Inc; November 15, 2015. Available
at: https://www.darzalex.com/shared/product/darzalex/darzalex-prescribing-information.pdf. Accessed on
March 8, 2016.
de Weers M, Tai YT, van der Veer MS, et al. Daratumumab, a novel therapeutic human CD38 monoclonal
antibody, induces killing of multiple myeloma and other hematological tumors. J Immunol. 2011; 186(3):18401848.
Janssen Research & Development, LLC. An efficacy and safety study of daratumumab in patients with
multiple myeloma who have received at least 3 prior lines of therapy (including a proteasome inhibitor [PI] and
immunomodulatory drug [IMiD] or are double refractory to a PI and an IMiD. NLM Identifier: NCT01985126.
Last updated on December 21, 2015. Available at: https://clinicaltrials.gov/ct2/show/NCT01985126. Accessed
on March 9, 2016.
®
Janssen Research & Development, LLC. Daratumumab (HuMAX -CD38) safety study in multiple myeloma.
NLM Identifier: NCT00574288. Last updated on December 21, 2015. Available
at: https://clinicaltrials.gov/ct2/show/NCT00574288?term=NCT00574288&rank=1. Accessed on March 9,
2016.
Lonial S, Weiss BM, Usmani SZ, et al. Daratumumab monotherapy in patients with treatment-refractory
multiple myeloma (SIRIUS): an open-label, randomized, phase 2 trial. Lancet. 2016; pii: S01406736(15)01120-4. doi: 10.1016/S0140-6736(15)01120-4. [Epub ahead of print]
Lokhorst HM, Plesner T, Laubach JP, et al. Targeting CD38 with Daratumumab Monotherapy in Multiple
Myeloma. N Engl J Med. 2015; 373(13):1207-1219.
National Cancer Institute. Available at: http://www.cancer.gov/cancertopics/types/alphalist. Accessed on:
March 8, 2016.
®
• Multiple myeloma (PDQ ). Last modified December 9, 2015.
®
™
National Comprehensive Cancer Network . NCCN Drugs & Biologic Compendium (electronic version). For
additional information visit the NCCN website: http://www.nccn.org. Accessed on March 8, 2016.
WEB-PEC-0469-16-A
PAGE 2 of 3 07/25/2016
This policy does not apply to health plans or member categories that do not have pharmacy benefits,
nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit
limitations may apply.
Market
Applicable
FL
&
FHK
X
FL
MMA
FL
LTC
NA
NA
Market Applicability/Effective Date
GA
KS
KY
LA
MD
NJ
NV
NY
TN
TX
WA
X
NA
X
X
X
X
X
X
NA
NA
X
*FHK- Florida Healthy Kids
®
™
National Comprehensive Cancer Network NCCN Clinical Practice Guidelines in Oncology . Revised March
8, 2016. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on
March 8, 2016.
• Multiple myeloma (V.3.2016) Revised January 15, 2016.
WEB-PEC-0469-16-A
PAGE 3 of 3 07/25/2016
This policy does not apply to health plans or member categories that do not have pharmacy benefits,
nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit
limitations may apply.