RUBRACA (rucaparib)

RUBRACA (rucaparib)

SELF ADMINISTRATION - ORAL

Indications for Prior Authorization:

• for use as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies

Patients must meet the following criteria for the indication(s) above:

• Diagnosis of deleterious germline BRCA mutations confirmed by genetic testing

• Patient has prior history of treatment with at least 2 chemotherapy regimens
• Females of reproductive potential: pregnancy testing prior to treatment initiation and use of contraception during therapy and for 6 months after the last dose
• Continuation allowed until disease progression or unacceptable toxicity

The following conditions do not meet the criteria for use as established by WHA P&T committee:

• All non-FDA approved uses not listed in the approved indications

Dosing:

• 600mg (two 300mg tablets) orally twice daily

Approval:

• Initial approval: 2 months

• Renewal: 6 months