Tivdak™

Drug - Tivdak™ (tisotumab vedotin) [Seagen Inc.]

April 2022

Therapeutic Area - Oncology, Injectable – Cervical Cancer

Initial approval criteria

Patient at least 18 years of age AND

Universal Criteria

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

Cervical Cancer

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

Renewal criteria

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

Quantity limits

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.

Background

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.

Questions?

MHCP Provider Resource Center 651-431-2700 or 1-800-366-5411