UKONIQ (umbralisib)

UKONIQ (umbralisib)

Self Administration – Oral

Indications for Prior Authorization:

• Indicated for the treatment of adult patient with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen
• Indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.

Coverage Criteria:

For diagnosis of marginal zone lymphoma:

• Dose does not exceed 800 mg once daily, AND
• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with a hematologist/oncologist, AND
• Disease is either relapsed or refractory, AND
• Patient has received at least one prior anti-CD20 based regimen (e.g., bendamustine + rituximab, bendamustine + obinutuzumab, etc.)

For diagnosis of relapsed or refractory follicular lymphoma (FL):

• Dose does not exceed 800 mg once daily, AND
• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with a hematologist/oncologist, AND
• Disease is either relapsed or refractory, AND
• Patient has received at least three prior lines of systemic therapy (e.g., bendamustine + rituximab, bendamustine + obinutuzumab, etc.)

Reauthorization Criteria:

For diagnosis of marginal zone lymphoma/ follicular lymphoma (FL):

• Dose does not exceed 800 mg once daily, AND
• Patient does not show evidence of progressive disease while on therapy

Coverage Duration:

• Initial: 1 year
• Reauthorization: 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:

• Uknoiq is the first and only targeted kinase inhibitor of PI3K-delta and CK1-epsilon
• Warnings and Precautions
  • Infections: monitor for fever and any new or worsening signs and symptoms of infection
  • Neutropenia: monitor blood counts during treatment
  • Diarrhea or non-infectious colitis: monitor for development of diarrhea or colitis and provide supportive care as appropriate
  • Hepatotoxicity: monitor hepatic function
  • Severe cutaneous reactions: withhold treatment, reduce dose, or discontinue treatment depending on severity and persistence of severe cutaneous reaction
  • Allergic reactions due to inactive ingredient FD&C Yellow No. 5: Ukoniq contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions
  • Embryo-fetal toxicity: can cause fetal harm

Policy Updates:

• 06/15/2021 – New policy approved by P&T

References:

• Aliqopa [package insert], Whippany, NJ: Bayer Healthcare Pharmaceuticals, Inc.; December 2020.
• Copiktra [package insert], Needham, MA: Verastem Inc.; July 2019.
• Food and Drug Administration/Center for Drug Evaluation and Research. FDA approved drug products. Food and Drug Administration Web site. https://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed February 15, 2021.
• Freedman AS, Aster JC. Clinical manifestations, pathologic features, and diagnosis of extranodal marginal zone lymphoma of mucosa associated lymphoid tissue (MALT). UpToDate Web site. Updated February 10, 2021. www.uptodate.com. Accessed February 15, 2021[a].
• Freedman AS, Aster JC. Clinical manifestations, pathologic features, diagnosis, and prognosis of follicular lymphoma. UpToDate Web site. Updated October 28, 2020. www.uptodate.com. Accessed February 15, 2021[b].
• Freedman AS, Aster JC, Ng AK. Treatment of extranodal marginal zone lymphoma of mucosa associated lymphoid tissue (MALT lymphoma). UpToDate Web site. Updated January 4, 2021. www.uptodate.com. Accessed February 15, 2021[a].
• Freedman AS, Aster JC, Ng AK. Initial treatment of stage I follicular lymphoma. UpToDate Web site. Updated October 26, 2020. www.uptodate.com. Accessed February 15, 2021[b].
• Freedman AS, Friedberg JW. Initial treatment of stage II to IV follicular lymphoma. UpToDate Web site. Updated December 19, 2020. www.uptodate.com. Accessed February 15, 2021(a).
• Freedman AS, Friedberg JW. Treatment of relapsed or refractory follicular lymphoma. UpToDate Web site. Updated January 28, 2020. www.uptodate.com. Accessed February 15, 2021(b).
• National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology – B-Cell Lymphomas. V3.2021. NCCN Web site. URL. Accessed March 18, 2021.
• Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.
• Piqray [package insert], East Hanover, NJ: Novartis Pharmaceuticals; September 2020.
• Ukoniq [package insert], Edison, NJ: TG Therapeutics.; February 2021.
• Ukoniq [dossier], Edison, NJ: TG Therapeutics.; March 2021.
• Zydelig [package insert], Foster City, CA: Gilead Sciences; October 2020.