Xpovio - NC Standard

Restricted Product(s)

• Xpovio™ (selinexor)

FDA Approved Use

• Indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) 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. 
• 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. 
• In combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior therapy.

Criteria for Approval of Restricted Product(s)

1. The patient is currently taking the requested medication for a cancer diagnosis; AND 
   1. The patient will utilize the generic formulation of this product (if available); OR 
2. The patient is 18 years of age or older; AND 
3. The patient is being managed by or in consultation with an oncologist; AND 
4. The patient has been diagnosed with relapsed or refractory multiple myeloma (RRMM) (medical record documentation required); AND 
   1. The patient has received at least four prior therapies (medical record documentation required); AND 
   2. The patient’s disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody (medical record documentation required); AND 
   3. The patient will be taking the requested medication in combination with dexamethasone; OR 
5. The patient has been diagnosed with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma (medical record documentation required); AND 
   1. The patient has received at least two lines of systemic therapy (medical record documentation required); OR 
6. The patient has been diagnosed with multiple myeloma (medical record documentation required); AND 
   1. The patient has received at least one prior therapy (medical record documentation required); AND 
   2. The patient will be taking the requested medication in combination with bortezomib and dexamethasone; AND 
7. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. [Medical records and references / evidence must be provided]; AND
8. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
   
   Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

March 2025: Criteria update:  Added new therapy pack strength 10 mg (40 mg once weekly) to the policy. Added P&T statement.
October 2022: Criteria change: Added medical record documentation required for diagnosis. Formatting changes.
May 2021: Criteria update: Added new therapy pack strengths to the policy.
December 2020: Criteria update: Added new indication for multiple myeloma in combination with bortezomib and dexamethasone.
July 2020: Criteria update: Added new strengths, 40mg once weekly, 40mg twice weekly, & 60mg twice weekly.
July 2020: Criteria update: Added new indication for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
February 2020: Original utilization management criteria issued.