Darzalex

Drug - Darzalex™ (daratumumab) [Janssen Biotech, Inc.]

January 2018

Therapeutic area - Oncology

Approval criteria

Patient must be 18 years of age or older AND
Has a diagnosis of multiple myeloma AND
Has received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or are double-refactory to a proteasome inhibitor and an immunodulatory agent
Documentation of diagnosis from patient’s medical records must be provided at time of request

OR

Patient must be 18 years of age or older AND
Has a diagnosis of multiple myeloma AND
Has received at least one prior therapy AND
Darzalex must be used in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone
Documentation of diagnosis from patient’s medical records must be provided at time of request

OR

Patient must be 18 years of age or older AND
Has a diagnosis of multiple myeloma AND
Has received at least two prior therapies including lenalidomide and a proteasome inhibitor AND
Darzalex must be used in combination with pomalidomide and dexamethasone
Documentation of diagnosis from patient’s medical records must be provided at time of request

Quantity limit

Dosing is based on weight. Patient’s most current weight must be provided at time of request.

Maximum of 16mg/kg according to the following dosing schedule

Monotherapy and in combination with lenalidomide or pomalidomide and low-dose dexamethasone:
- Weekly: Weeks 1 to 8
- Every two weeks: Weeks 9 to 24
- Every four weeks: Week 25 onwards until disease progression
In combination with bortezomib and dexamethasone
- Weekly: Weeks 1 to 9
- Every three weeks: Weeks 10 to 24
- Every four weeks: Week 25 onwards until disease progression

Approvals

Initial approval will be limited to 6 months in duration
Renewal approval will be limited to 6 months in duration
- Documentation must be supplied at time of request showing patient is responsive to treatment

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411