WHA

KLISYRI (tirbanibulin)

SELF ADMINISTRATION - TOPICAL

Indication for Prior Authorization:
  • Indicated for the topical treatment of actinic keratosis on the face or scalp
Coverage Criteria:
  • Patient is 18 years of age or older, AND
  • Patient has a diagnosis of actinic keratosis on the face or scalp, AND
  • Patient is not a good candidate for liquid nitrogen cryotherapy and surgical curettage, AND
  • Patient has tried and failed imiquimod 5% or fluorouracil 5%
Dosing:
  • Apply sufficient amount to evenly cover up to 25 cm2 treatment field on the face or scalp once daily for 5 consecutive days using 1 single-dose packet per application
Coverage Duration:
  • 3 months
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 Committee.

Additional Information:
  • Warnings for ophthalmic adverse reactions and local skin reactions
  • The safety and effectiveness of Klisyri for actinic keratosis in subjects less than 18 years of age have not been established. Actinic keratosis is not a condition generally seen within the pediatric population
Review History:
  • 4/20/21- Original review
References:
  •  Aldara [package insert], Bridgewater, NJ: Bausch Health US LLC; April 2018.
  • American Academy of Dermatology. Clinical guidelines. https://www.aad.org/member/clinical-quality/guidelines. 2021. Accessed February 17, 2021.
  • Berman B. Treatment of actinic keratosis. UpToDate Web site. Updated February 18, 2021. www.uptodate.com. Accessed February 22, 2021.
  • Blauvelt A, Kempers S, Lain E, et al; Phase 3 Tirbanibulin for Actinic Keratosis Group. Phase 3 trials of tirbanibulin ointment for actinic keratosis. N Engl J Med. 2021;384:512-520.
  • Carac [package insert], Bridgewater, NJ: Bausch Health US LLC; May 2017.
  • Clinical Pharmacology Web site. http://www.clinicalpharmacology-ip.com/default.aspx. Accessed February 9, 2021.
  • ClinicalTrials.gov Web Site. www.clinicaltrials.gov. NCT01926496. Accessed February 22, 2021.
  • de Berker D, McGregor JM, Mohd Mustapa MF, Exton LS, Hughes BR. British Association of Dermatologists' guidelines for the care of patients with actinic keratosis 2017. Br J Dermatol. 2017;176(1):20-43.
  • Drugs@FDA: FDA-approved drug products. Food and Drug Administration Web site. https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed February 22, 2021.
  • Efudex [package insert], Bridgewater, NJ: Bausch Health US LLC; April 2020.
  • European Medicines Agency (EMA). Picato: Risks of Picato for actinic keratosis outweigh the benefits. Updated November 16, 2020. https://www.ema.europa.eu/en/medicines/human/referrals/picato. Accessed February 22, 2021.
  • Ezzedine K, Painchault C, Brignone M. Systematic literature review and network meta-analysis of the efficacy and acceptability of interventions in actinic keratosis. Acta Derm Venereol. 2021;101(1):adv00358.
  • Fluoroplex [package insert], Exton, PA: Almirall; October 2020.
  • Food and Drug Administration (FDA). Klisyri Multi-discipline review. December 9, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213189Orig1s000MultidisciplineR.pdf. Accessed February 7, 2021.
  • Gollnick H, Dirschka T, Ostendorf R, Kerl H, Kunstfeld R. Long-term clinical outcomes of imiquimod 5% cream vs. diclofenac 3% gel for actinic keratosis on the face or scalp: a pooled analysis of two randomized controlled trials. J Eur Acad Dermatol Venereol. 2020;34(1):82-89.
  • Gupta AK, Paquet M. Network meta-analysis of the outcome 'participant complete clearance' in nonimmunosuppressed participants of eight interventions for actinic keratosis: a follow-up on a Cochrane review. Br J Dermatol. 2013;169(2):250-259.
  • Gupta AK, Paquet M, Villanueva E, Brintnell W. Interventions for actinic keratoses. Cochrane Database Syst Rev. 2012;12(12):CD004415.
  • Health Canada; Government of Canada. Picato (ingenol mebutate gel, 0.015% and 0.05%) - product withdrawal in Canada due to potential increased risk of skin cancer. October 27, 2020. https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74193a-eng.php. Accessed February 22, 2021.
  • Jansen MHE, Kessels JPHM, Nelemans PJ, et al. Randomized trial of four treatment approaches for actinic keratosis. N Engl J Med. 2019;380(10):935-946.
  • Klisyri [package insert], Exton, PA: Almirall; December 2020.
  • LEO Pharma, Inc; Madison, NY. Personal communication with representative (Catherine). February 16, 2021.
  • Medi-Span Price Rx. https://pricerx.medispan.com. Accessed February 22, 2021.
  • National Comprehensive Cancer Network Web site. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Squamous Cell Skin Cancer. Version 1.2021. February 8, 2021. http://www.nccn.org. Accessed February 10, 2021.
  • Picato [package insert], Madison, NJ: LEO Pharma; December 2020.
  • Skin Cancer Foundation. Actinic keratosis overview: a common precancer. https://www.skincancer.org/skin-cancer-information/actinic-keratosis/. January 2021. Accessed February 9, 2021.
  • Solaraze [package insert], Princeton, NJ: PharmaDerm; May 2016.
  • Vegter S, Tolley K. A network meta-analysis of the relative efficacy of treatments for actinic keratosis of the face or scalp in Europe. PLoS One. 2014;9(6):e96829.
  • Wehner MR. Comparing the efficacy of field treatments for actinic keratosis: a critical appraisal of a randomized trial in the New England Journal of Medicine. Br J Dermatol. 2020;182(6):1343-1344.
  • Werner RN, Stockfleth E, Connolly SM, et al; International League of Dermatological Societies; European Dermatology Forum. Evidence- and consensus-based (S3) guidelines for the treatment of actinic keratosis - International League of Dermatological Societies in cooperation with the European Dermatology Forum - short version. J Eur Acad Dermatol Venereol. 2015;29(11):2069-2079.
  • Wu Y, Tang N, Cai L, Li Q. Relative efficacy of 5-fluorouracil compared with other treatments among patients with actinic keratosis: A network meta-analysis. Dermatol Ther. 2019;32(3):e12822.
  • Zyclara [package insert], Bridgewater, NJ: Bausch Health US LLC; February 2018.

 

Last review date: April 20, 2021