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Gilenya (fingolimod) — Blue Cross Blue Shield of Illinois

relapsing form of multiple sclerosis

Preferred products

  • Avonex (interferon β-1a)
  • Betaseron (interferon β-1b)
  • dimethyl fumarate
  • glatiramer
  • Glatopa (glatiramer)
  • Kesimpta (ofatumumab)
  • Mayzent (siponimod)
  • Rebif (interferon β-1a)
  • 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 Brand Aubagio, Brand Copaxone, Brand Gilenya 0.5 mg, Brand Tecfidera. 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 on the requested agent [chart notes required] OR
  • 2. The patient is age ≤ 17 years 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, cause a significant barrier to adherence, worsen a comorbid condition, decrease functional ability, or cause an adverse reaction or harm [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 prescription drug in the same pharmacologic class or with the same mechanism of action as generic fingolimod and it was discontinued due to lack of efficacy, diminished effect, or an adverse event [chart notes required] OR
  • I. If the requested agent is Tascenso ODT 0.5 mg, there is support for use over generic fingolimod (e.g., swallowing difficulties).
  • OR
  • 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 requested indication [medical records required] OR
  • 2. TWO preferred agents were discontinued due to lack of efficacy, diminished effect, or an adverse event [chart notes required] OR
  • 3. The patient has intolerance or hypersensitivity to TWO preferred agents [chart notes required] OR
  • 4. The patient has an FDA labeled contraindication to ALL preferred agents [chart notes required] OR
  • 5. TWO preferred agents are expected to be ineffective, cause barriers to care, worsen comorbid condition, reduce function, or cause harm [chart notes required] OR
  • 6. TWO preferred agents are not in the patient’s best interest based on medical necessity [chart notes required] OR
  • 7. The patient has tried another drug in the same class or mechanism as TWO preferred agents and it was discontinued due to lack of efficacy, diminished effect, or an adverse event [chart notes required].
  • AND
  • B. If the requested agent is Tascenso ODT 0.5 mg, ONE of the following:
  • 1. The patient has tried and had an inadequate response to generic fingolimod [medical records required] OR
  • 2. Generic fingolimod was discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
  • 3. The patient has intolerance or hypersensitivity to generic fingolimod not expected to occur with requested agent OR
  • 4. The patient has an FDA labeled contraindication to generic fingolimod not expected to occur with requested agent OR
  • 5. Generic fingolimod expected to be ineffective, cause adherence barrier, worsen comorbid condition, reduce function, or cause harm [chart notes required] OR
  • 6. Generic fingolimod not in the best interest of the patient [chart notes required] OR
  • 7. The patient has tried another drug in the same class or mechanism as generic fingolimod discontinued due to efficacy or adverse event issues [chart notes required] OR
  • 8. There is support for use over generic fingolimod (e.g., swallowing difficulty).
  • OR
  • 4. The patient has highly active MS disease activity AND ONE of the following (medical records required): ≥2 relapses in the prior year OR other documentation of high disease activity.

Reauthorization criteria

  • 1. Patient previously approved for requested agent through plan’s PA process AND
  • 2. Patient has had clinical benefit with requested agent AND
  • 3. Complete CBC with differential including lymphocyte count performed AND
  • 4. Lymphocyte count ≥ 800 cells/microliter AND
  • 5. Prescriber is or consulted with a neurologist AND
  • 6. ONE of the following: A. Patient will NOT use requested agent in combination with a disease modifying agent OR B. There is support for combination use (e.g., relapse between cycles) AND
  • 7. Patient does NOT have any FDA labeled contraindications to requested agent AND
  • 8. It has been ≥35 weeks but ≤67 weeks since last dose AND
  • 9. BOTH: A. Prescriber provided number of courses completed (2 cycles of 4–5 days each) AND B. Patient has NOT completed 2 courses AND
  • 10. Requested dose does NOT exceed maximum FDA labeled dose for patient's weight.

Approval duration

12 months (BCBSIL, BCBSMT, BCBSTX); 3 months (others)