Tecfidera (dimethyl fumarate) — Blue Cross Blue Shield of Texas

Preferred products

• Avonex (interferon β-1a)
• Betaseron (interferon β-1b)
• dimethyl fumarate
• fingolimod
• glatiramer
• Glatopa (glatiramer)
• Kesimpta (ofatumumab)
• Mayzent (siponimod)
• Rebif (interferon β-1a)
• teriflunomide
• Zeposia (ozanimod)

Initial criteria

• 1. ONE of the following: A. The requested agent is eligible for continuation of therapy AND the following: Agents Eligible for Continuation of Therapy – All target agents except the following are eligible for continuation: Brand Aubagio, Brand Copaxone, Brand Gilenya 0.5 mg, Brand Tecfidera. 1. The prescriber states the patient has been treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR B. BOTH of the following: 1. ONE of the following: A. The patient has a diagnosis of a relapsing form of MS AND ALL of the following: 1. ONE of the following: A. The requested agent is a preferred agent OR B. The requested agent is a non-preferred agent AND ONE of the following: 1. The prescriber states the patient is currently being treated with the requested agent AND the patient is currently stable [chart notes required] OR 2. The patient is 17 years of age or younger AND ONE of the following: A. The requested agent is one of the following brand agents that does NOT have an equipotent generic strength (Gilenya 0.25 mg, Tascenso ODT 0.25 mg) OR B. The patient has tried and had an inadequate response to generic fingolimod (medical records required) OR C. Generic fingolimod was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes required] OR D. The patient has an intolerance or hypersensitivity to generic fingolimod (medical records required) OR E. The patient has an FDA labeled contraindication to generic fingolimod (medical records required) OR F. Generic fingolimod is expected to be ineffective or cause significant harm or adherence barriers [chart notes required] OR G. Generic fingolimod is not in the best interest of the patient based on medical necessity [chart notes required] OR H. The patient has tried another drug in same pharmacologic class or mechanism as generic fingolimod discontinued for lack of efficacy or AE [chart notes required] OR I. If requested agent is Tascenso ODT 0.5 mg, there is support for its use over generic fingolimod (e.g., swallowing difficulties) 3. The patient is age ≥ 18 years AND BOTH of the following: A. ONE of the following: 1. The patient has tried and had an inadequate response to TWO preferred agents FDA labeled for the indication [medical records required] OR 2. TWO preferred agents FDA labeled were discontinued due to lack of efficacy, diminished effect, or AE [chart notes required] OR 3. The patient has intolerance or hypersensitivity to TWO preferred agents [chart notes required] OR 4. The patient has FDA-labeled contraindications to ALL preferred agents [chart notes required] OR 5. TWO preferred agents are expected to be ineffective or cause harm/adherence barriers [chart notes required] OR 6. TWO preferred agents are not in best interest based on medical necessity [chart notes required] OR 7. The patient has tried another prescription drug in same class or mechanism as TWO preferred agents discontinued for lack of efficacy or AE [chart notes required] B. If requested agent is Tascenso ODT 0.5 mg, ONE of the following: inadequate response to generic fingolimod; generic fingolimod discontinued for lack of efficacy/AE; intolerance/hypersensitivity; contraindication; expected ineffectiveness or harm; not in best interest; prior similar-class discontinuation; or support for use over generic fingolimod (e.g., swallowing difficulties) 4. The patient has highly active MS disease activity AND ONE of the following: ≥ 2 relapses in previous year OR other physician-supported evidence [medical records required]

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND 2. The patient has had clinical benefit with the requested agent AND 3. A complete CBC with differential including lymphocyte count has been performed AND 4. The patient has a lymphocyte count ≥ 800 cells/microliter AND 5. The prescriber is a neurologist or has consulted with one AND 6. ONE of the following: A. The patient will NOT be using the requested agent in combination with an additional disease modifying agent (DMA) for the same indication OR B. There is support for use of additional DMA (e.g., relapse between cycles) AND 7. The patient has no FDA labeled contraindications to the requested agent AND 8. It has been at least 35 weeks but not more than 67 weeks since the last dose AND 9. BOTH of the following: A. The prescriber provided the number of completed courses (each course = 2 cycles of 4–5 days) AND B. The patient has NOT completed 2 courses AND 10. The requested dose does not exceed the maximum FDA-labeled dose for the patient’s weight.

Approval duration

12 months