Pharmacy Prior Authorization Criteria

Gilenya (fingolimod) - PA, NF

Indications for Prior Authorization

Gilenya (fingolimod)

• For diagnosis of Multiple Sclerosis
  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.

Criteria

Generic fingolimod, Brand Gilenya 0.25mg

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [A-D]
AND
• Patient is 10 years of age or older
AND
• Not used in combination with another disease-modifying therapy for MS [E, 5, 6]
AND
• Prescribed by or in consultation with a neurologist

Brand Gilenya 0.5mg

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [A-D]
AND
• Patient is 10 years of age or older
AND
• Failure after a trial of at least 4 weeks, or intolerance to generic fingolimod
AND
• One of the following:
• Patient is less than 18 years of age
OR
• Both of the following:
• Patient is 18 years of age or older
AND
• One of the following:
• Failure after a trial of at least 4 weeks, contraindication or intolerance to two disease-modifying therapies from the following:
• Avonex (interferon beta-1a)
• Betaseron (interferon beta-1b)
• Bafiertam (monomethyl fumarate)
• Copaxone/Glatopa (glatiramer acetate)
• Dimethyl fumarate
• Fingolimod
• Kesimpta (ofatumumab)
• Mayzent (siponimod)
• Vumerity (diroximel fumarate)
• Zeposia (ozanimod)
OR
• Both of the following:
• For continuation of prior therapy, defined as no more than a 45-day gap in therapy
• Patient demonstrates positive clinical response to therapy
AND
• Not used in combination with another disease-modifying therapy for MS [E, 5, 6]
AND
• Prescribed by or in consultation with a neurologist

Brand Gilenya, generic fingolimod

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression)
AND
• Failure after a trial of at least 4 weeks, or intolerance to generic fingolimod (applies to Brand Gilenya 0.5mg only)
AND
• Not used in combination with another disease-modifying therapy for MS [E, 5, 6]
AND
• Prescribed by or in consultation with a neurologist

Brand Gilenya 0.5mg

Non Formulary

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) confirming a diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [A-D]
AND
• Patient is 10 years of age or older
AND
• Both of the following:
• Submission of medical records (e.g., chart notes) confirming lack of adequate clinical response (with related symptoms) with generic fingolimod
AND
• Submission of medical records confirming generic fingolimod has not been effective AND valid clinical justification provided explaining how Brand Gilenya 0.5mg is expected to provide benefit when generic fingolimod has not been shown to be effective despite having the same active ingredient
AND
• One of the following:
• Patient is less than 18 years of age
OR
• Both of the following:
• Patient is 18 years of age or older
AND
• One of the following:
• Submission of medical records (e.g., chart notes) or paid claims confirming failure after a trial of at least 4 weeks, contraindication or intolerance to two disease-modifying therapies from the following:
• Avonex (interferon beta-1a)
• Betaseron (interferon beta-1b)
• Bafiertam (monomethyl fumarate)
• Copaxone/Glatopa (glatiramer acetate)
• Dimethyl fumarate
• Fingolimod
• Kesimpta (ofatumumab)
• Mayzent (siponimod)
• Vumerity (diroximel fumarate)
• Zeposia (ozanimod)
OR
• Both of the following:
• Submission of medical records (e.g., chart notes) or paid claims confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy for continuation of therapy
AND
• Patient demonstrates positive clinical response to therapy
AND
• Not used in combination with another disease-modifying therapy for MS [E, 5, 6]
AND
• Prescribed by or in consultation with a neurologist

P & T Revisions

2024-11-20, 2024-09-24, 2024-09-05, 2023-11-01, 2023-04-28, 2022-12-12

References

1. Gilenya Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. August 2023.
2. Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline: Disease-modifying therapies for adults with multiple sclerosis. Neurology 2018;90:777-788.
3. National Multiple Sclerosis Society. Types of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed March 29, 2019.
4. Per clinical consultation with MS specialist, December 29, 2010.
5. Wingerchuk, D., & Carter, J. (2014). Multiple Sclerosis: Current and Emerging Disease-Modifying Therapies and Treatment Strategies. Mayo Clinic Proceedings, 89(2), 225-240.
6. 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 randomised phase 4 trial. The Lancet Neurology, 10(8), 691-701.

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End Notes

1. 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. [3] The effectiveness of interferon beta in SPMS patients without relapses is uncertain. [2]
2. Initiation of treatment with an interferon beta medication or glatiramer acetate should be considered as soon as possible following a definite diagnosis of MS with active, relapsing disease, and may also be considered for selected patients with a first attack who are at high risk of MS. [2]
3. Based on several years of experience with glatiramer acetate and interferon beta 1a and 1b, it is the consensus of researchers and clinicians with expertise in MS that these agents are likely to reduce future disease activity and improve quality of life for many individuals with relapsing forms of MS, including those with secondary progressive disease who continue to have relapses. For those who are appropriate candidates for one of these drugs, treatment must be sustained for years. Cessation of treatment may result in a resumption of pre-treatment disease activity. [2]
4. MS specialists will use Copaxone in relapsing forms of disease, including SPMS with relapses. While there have been no trials of Copaxone in SPMS (so we have no evidenced-based data upon which to make decisions or recommendations), it's clear that where there are relapses, the injectable therapies are partially effective – they reduce relapses and new lesions on MRI. In SPMS, the trials suggest that the interferons work better in earlier, more inflammatory (i.e. those with relapses prior to the trial and with gadolinium-enhancing lesions, which is the MRI equivalent of active inflammation). Since Copaxone and the interferons appear to have rather similar efficacy in the head-to-head trials, most assume that Copaxone has a similar efficacy in SPMS: where there are relapses or active inflammation on MRI, it will likely have some benefit. Thus, most MS specialists will use Copaxone in patients with SPMS who have persistent relapses. [4]
5. 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. [5, 6]

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Revision History

• 2024-11-20: Updated effective date to 12/1, as per p&t approval
• 2024-09-24: 2024 Annual Review. Background updates. Added step through 2 disease-modifying therapies for PA for Gilenya 0.5mg for patients over 18 years.
• 2024-09-05: Updated NF criteria.
• 2023-11-01: 2023 UM Annual Review. Updated initial auth to include age criteria. Updated standard reauth criteria to say "Patient demonstrates positive clinical response to therapy". Updated references.
• 2023-04-28: Addition of NF criteria for Brand Gilenya 0.5mg
• 2022-12-12: New drug-specific guideline

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