Drug - Vumerity® (diroximel fumarate) [Biogen]
Therapeutic area - Multiple Sclerosis Agents
Initial approval criteria
- Patient is at least 18 years old AND
- Must be used as single agent therapy AND
- Patient has a diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., relapsing-remitting disease (RRMS)*, active secondary progressive MS (SPMS)†, or clinically isolated syndrome (CIS)‡ AND
- Confirmed diagnosis of MS as documented by laboratory report (e.g., MRI) AND
- Patient must not have moderate to severe renal impairment (i.e., patient’s CrCl must be at least 50 mL/min) AND
- Patient has had inadequate response§ after a 6-month adherent trial of glatiramer, unless contraindicated AND
- Patient has had inadequate response§ after a 6-month adherent trial of dimethyl fumurate or Tecfidera with unacceptable GI side effects, unless contraindicated
- Initial approval is for 12 months
- Patient continues to meet initial approval criteria AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: anaphylaxis and angioedema; prolonged (more than 6 months) lymphopenia (<0.5 x 109/L); serious flushing reactions; progressive multifocal leukoencephalopathy (PML); liver injury; etc. AND
- Continuous monitoring of response to therapy [manifestations of MS disease activity include, but are not limited to, an increase in annualized relapse rate (ARR), development of new/worsening T2 hyperintensities or enhancing lesions on brain/spinal MRI, and progression of sustained impairment as evidenced by expanded disability status scale (EDSS), timed 25-foot walk (T25-FW), 9-hole peg test (9-HPT)]
- Renewal approval is for 12 months
* Definitive diagnosis of RRMS is based on BOTH dissemination in time and space:
- Dissemination in time (development/appearance of new central nervous system [CNS] lesions over time) is defined as ≥ 2 clinical attacks or 1 clinical attack plus either select MRI indicators (e.g., simultaneous presence of gadolinium-enhancing and non-enhancing lesions at any time or by a new T2-hyperintense or gadolinium-enhancing lesion on follow-up MRI compared to baseline scan) or CSF-specific oligoclonal bands.
- Dissemination in space (development lesions in distinct anatomical locations within the CNS/multifocal) is defined by 2 lesions or 1 lesion plus either clear-cut historical evidence of a previous attack involving a lesion in a distinct anatomical location or MRI indicating ≥ 1 T2-hyperintense lesions characteristic of MS in ≥ 2 of 4 areas of the CNS (periventricular, cortical or juxtacortical, infratentorial, or spinal cord).
† Definitive diagnosis of SPMS is based on all of the following: EDSS score ≥ 3; disease is progressive ≥ 3 months following an initial relapsing-remitting course (e.g., EDSS score increase by 1 in patients with EDSS ≤ 5.5 or increase by 0.5 in patients with EDSS ≥ 6); and either ≥ 1 relapse within the previous 2 years or gadolinium-enhancing activity or new and unequivocally enlarging T2 contrast-enhancing lesions as evidenced by MRI.
‡ Definitive diagnosis of CIS is based on all of the following: a monophasic clinical episode with patient-reported symptoms and objective findings reflecting a focal or multifocal inflammatory demyelinating event in the CNS; neurologic symptom duration of at least 24 hours, with or without recovery; absence of fever or infection; and resembles a typical MS relapse (attack and exacerbation) but occurs in a patient not known to have MS.
§ Inadequate response, in those who have been adherent and receiving therapy for sufficient time to realize the full treatment effect, is defined as ≥ 1 relapse, ≥ 2 unequivocally new MRI-detected lesions, or increased disability on examination over a 6 to 12-month period.
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