Drug - Tivdak™ (tisotumab vedotin) [Seagen Inc.]
Therapeutic Area - Oncology, Injectable – Cervical Cancer
Initial approval criteria
- Patient at least 18 years of age AND
- Patient does not have active ocular surface disease or a history of cicatricial conjunctivitis AND
- Patient has not had prior Steven-Johnson syndrome AND
- Patient does not have Grade ≥2 peripheral neuropathy AND
- Patient does not have known coagulation defects leading to an increased risk of bleeding AND
- Patient has had an ophthalmic exam (i.e., visual acuity and slit lamp exam) at baseline, prior to each dose and as clinically indicated AND
- Tivdak is used as single agent therapy AND
- Patient has recurrent or metastatic disease AND
- Tivdak is used as subsequent therapy AND
- Patient has not received more than two prior systemic regimens including at least one prior platinum-based chemotherapy regimen
- Initial approval is for 6 months
- Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in the initial approval criteria AND
- Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: peripheral neuropathy, hemorrhage, recurrent or persistent grade 2 or greater pneumonitis, keratitis, conjunctival ulceration, etc.
- Renewal approval is for 6 months
- 200 mg every 21 days
- Patient’s body weight (in kg) must be submitted at time of request
Billing for Tivdak
- Tivdak must be billed as a medical claim.
Tivdak is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
MHCP Provider Resource Center 651-431-2700 or 1-800-366-5411