TASCENSO (fingolimod)

TASCENSO (fingolimod)

Self-Administration – oral

Diagnosis considered for coverage:

• Relapsing forms of Multiple Sclerosis (MS): Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.

Coverage Criteria:

For diagnosis of MS: 

• Patient has a diagnosis of a relapsing form of MS (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions), AND
• Patient is 10 years of age or older, AND
• Not used in combination with another disease-modifying therapy for MS AND 
• Prescribed by or in consultation with a neurologist AND
• One of the following: 
  • Failure after a trial of at least 4 weeks, contraindication, or intolerance to at least two of the following disease-modifying therapies for MS:
    • Avonex (interferon beta-1a) 
    • Betaseron (interferon beta-1b) 
    • Copaxone/Glatopa (glatiramer acetate) 
    • Dimethyl fumarate
    • Plegridy
    • Rebif 
    • Vumerity (diroximel fumarate), OR 
  • Both of the following:
    • Patient is younger than 18 years of age, AND 
    • Failure after a trial of at least 4 weeks or intolerance to Gilenya (fingolimod) 
  • For continuation of therapy, defined as no more than a 45-day gap 

Reauthorization Criteria:

For diagnosis of MS:

• Patient demonstrates positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression) AND
• Not used in combination with another disease-modifying therapy for MS, AND
• Prescribed by or in consultation with a neurologist

Dosing:

For diagnosis of MS:

• Adults and pediatric patients 10 years of age and older weighing more than 40 kg:
  • 0.5 mg orally once-daily
• Pediatric patients 10 years of age and older weighing less than or equal to 40 kg:
  • 0.25 mg orally once daily
• Fingolimod doses higher than 0.5 mg are associated with a greater incidence of adverse reactions without additional benefit.

Coverage Duration: 

• Initial: 12 months
• Reauthorization: 12 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 (P&T) Committee.

Additional Information: 

• According to the National MS Society, of the four disease courses that have been identified in MS, relapsing-remitting MS (RRMS) is characterized primarily by relapses, and secondary-progressive MS (SPMS) has both relapsing and progressive characteristics. These two constitute “relapsing forms of MS” if they describe a disease course that is characterized by the occurrence of relapses. The effectiveness of interferon beta in SPMS patients without relapses is uncertain.  
• The advantage of using combination disease-modifying therapy (DMT) compared to monotherapy DMT use has not been demonstrated, but there are safety concerns, such as reduced efficacy or disease aggravation, with combination use. 

Policy Updates:

• 08/15/2023 – New policy approved by P&T.
• 6/1/2024 (policy effective date)- RRT MS update, removal of embedded DSE (P&T 5/20/2024) (P&T Meeting May) 

References:

1. Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline: Disease-modifying therapies for adults with multiple sclerosis. Neurology 2018;90:777-788. 
2. National Multiple Sclerosis Society. Types of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed March 29, 2019. 
3. Wingerchuk, D., & Carter, J. (2014). Multiple Sclerosis: Current and Emerging Disease-Modifying Therapies and Treatment Strategies. Mayo Clinic Proceedings, 89(2), 225-240. 
4. Sorensen, P., Lycke, J., Erälinna, J., Edland, A., Wu, X., & Frederiksen, J. et al. (2011). Simvastatin as add-on therapy to interferon beta-1a for relapsing-remitting multiple sclerosis (SIMCOMBIN study): a placebo-controlled randomized phase 4 trial. The Lancet Neurology, 10(8), 691-701. 
5. Tascenso ODT Prescribing Information. Cycle Pharmaceuticals Ltd. Cambridge, United Kingdom. December 2022.