XPOVIO (selinexor)

XPOVIO (selinexor)

SELF ADMINISTRATION - ORAL 

Indications for Prior Authorization:

• Diffuse Large B-Cell Lymphoma: Xpovio® is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.
• Multiple Myeloma:
  • Xpovio® in combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
  • Xpovio® in combination with dexamethasone is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

Coverage Criteria:

For diagnosis of diffuse large B-cell lymphoma:

• Dose does not exceed 60 mg orally on days 1 and 3 of each week, AND
• 18 years of age or older, AND
• Prescribed by or in consultation with an oncologist/hematologist, AND
• Chart note documentation is provided and supports the diagnosis of diffuse large B-cell lymphoma and therapies tried and failed, AND
• Patient has received at least two lines of systemic therapy (e.g., RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone), DHAP (dexamethasone, cisplatin, cytarabine) +/- rituximab, DHAX (dexamethasone, cytarabine, oxaliplatin) +/0 rituximab, GDP (gemcitabine, dexamethasone, cisplatin or carboplatin) +/- rituximab, ICE (ifosfamide, carboplatin, etoposide) +/- rituximab, Gem Ox (gemcitabine, oxaliplatin) +/- rituximab (non-transplant candidates), polatuzumab vedotin +/- bendamustine +/- rituximab after >/= 2 prior therapies (non-transplant candidates))

For diagnosis of multiple myeloma:

• Dose does not exceed 100 mg orally on days 1 of each week, AND
• 18 years of age or older, AND
• Prescribed by or in consultation with an oncologist/hematologist, AND
• Chart note documentation is provided and supports the diagnosis of multiple myeloma and therapies tried and failed, AND
• Patient has received at least one prior therapy (e.g., bortezomib/lenalidomide/dexamethasone, daratumumab/lenalidomide/dexamethasone), AND
• Used in combination with bortezomib and dexamethasone

For diagnosis of relapsed/refractory multiple myeloma:

• Dose does not exceed 80 mg orally on days 1 and 3 of each week, AND
• 18 years of age or older, AND
• Prescribed by or in consultation with an oncologist/hematologist, AND
• Chart note documentation is provided and supports the diagnosis of relaspsed/refractory multiple myeloma and therapies tried and failed, AND
• Tried and failed at least 4 prior therapies and disease is refractory to ALL of the following:
  • at least two proteasome inhibitors (i.e., Velcade® (bortezomib), Kyprolis® (carfilzomib),Ninlaro® (ixazomib)), AND
  • at least two immunomodulatory agents (i.e., Revlimid® (lenalidomide), Pomalyst® (pomalidomide), Thalomid® (thalidomide)), AND
  • one anti-CD38 monoclonal antibody (i.e., Darzalex™ (daratumumab)), AND
• Used in combination with dexamethasone

Reauthorization Criteria: 

For diagnosis of diffuse large B-cell lymphoma:

• Dose does not exceed 60 mg orally on days 1 and 3 of each week, AND
• Patient does not show evidence of progressive disease while on therapy

For diagnosis of multiple myeloma:

• Dose does not exceed 100 mg orally on days 1 of each week, AND
• Patient does not show evidence of progressive disease while on therapy, AND
• Used in combination with bortezomib and dexamethasone

For diagnosis of relapsed/refractory multiple myeloma:

• Dose does not exceed 80 mg orally on days 1 and 3 of each week, AND
• Patient does not show evidence of progressive disease while on therapy, AND
• Used in combination with dexamethasone

Coverage Duration:

• Initial: 1 year
• Renewal: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Warnings and precautions include: thrombocytopenia, neutropenia, gastrointestinal toxicity, hyponatremia, serious infection, neurologic toxicity, embryo-fetal toxicity, and new onset/exacerbation of cataract.

Policy Updates:

• 10/15/2019 – New policy approved by P&T
• 3/7/2022 – Criteria updated for new indications

References:

• NCCN guidelines Version 3.2022 Multiple Myeloma.  https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1445. Last Accessed November 29, 2021 
• NCCN guidelines Version 5.2021 Diffuse Large B-Cell Lymphoma. https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1480. Last Accessed November 29, 2021
• Xpovio Prescribing Information. Karyopharm Therapeutics Inc. Newton, MA. December 2020.