Oscar Briumvi (ublituximab) (PG134) Form

Multiple Sclerosis (MS)

Multiple sclerosis (MS) is a chronic autoimmune disorder that affects the central nervous system (CNS), which includes the brain, spinal cord, and optic nerves. The immune system mistakenly attacks and damages the myelin sheath that surrounds and protects nerve fibers, causing communication problems between the brain and the rest of the body. This results in a wide range of symptoms, including vision problems, muscle weakness, fatigue, and difficulty with balance and coordination.

MS is a progressive disease, meaning that symptoms tend to worsen over time, and it can be classified into several types, including relapsing-remitting MS (RRMS), primary progressive MS (PPMS), and secondary progressive MS (SPMS).

Currently, there is no cure for MS, but various treatment options are available to manage symptoms, slow the progression of the disease, and improve quality of life.

• Disease-modifying therapies (DMTs) are a class of medications that target the immune system to reduce inflammation and slow down the progression of the disease. The type of DMT prescribed will depend on the type and severity of MS, as well as the individual's medical history and preferences. Some common DMTs include interferon beta, glatiramer acetate, dimethyl fumarate, and fingolimod.
• Corticosteroids, such as prednisone, can be prescribed to reduce inflammation during acute MS relapses or exacerbations. These medications can help shorten the duration of symptoms and improve recovery.
• Symptomatic treatments are also available to manage specific symptoms of MS, such as muscle spasms, bladder problems, and depression. Physical therapy, occupational therapy, and speech therapy can help individuals with MS maintain mobility, independence, and communication skills.

Briumvi (ublituximab)

Briumvi (ublituximab) is 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 adults.

Definitions

• CIS (Clinically Isolated Syndrome): The first symptomatic episode lasting at least 24 hours caused by inflammation and demyelination in the CNS. Early treatment of CIS has been shown to delay the onset of MS.
• Compendia: Summaries of drug information and medical evidence to support decision-making about the appropriate use of drugs and medical procedures. Examples include American Hospital Formulary Service Drug Information, Clinical pharmacology, National Comprehensive Cancer Network Drugs and Biologics Compendium, Thomson Micromedex DrugDex, and United States Pharmacopeia-National Formulary (USP-NF).
• Disease Modifying Therapy: Treatments that reduce the number of relapses, delay progression of disability, and limit new disease activity.
• Immunoglobulins: Antibodies produced by the immune system in response to pathogens. There are five main classes: IgA, IgD, IgE, IgG, and IgM.
• MRI (Magnetic Resonance Imaging): A medical imaging technique that creates 3D images of organs and tissues. A brain MRI can reveal areas of active MS disease called lesions within the CNS.
• Quantitative: A measurement providing numerical data or information, used to assess immune function and diagnose conditions like immunodeficiency disorders and autoimmune diseases.
• Relapse: An attack or exacerbation of MS resulting in new or worsening symptoms.
• RRMS (Relapsing-Remitting MS): The most common type of MS with clearly defined attacks or relapses of increasing neurologic symptoms followed by recovery periods.
• Serum: The clear, yellowish liquid remaining after blood clotting, containing proteins, electrolytes, hormones, and other substances.
• SPMS (Secondary Progressive MS): A progression from an initial relapsing-remitting course, with worsening neurologic function and increased disability over time.

Medical Necessity Criteria for Initial Authorization

The Plan considers Briumvi (ublituximab) medically necessary when ALL of the following criteria are met:

1. Prescribed by or in consultation with a neurologist; AND
2. The member is 18 years of age or older; AND
3. The member has ONE of the following forms of multiple sclerosis: a. relapsing-remitting (RRMS); or b. active secondary progressive (SPMS); or c. clinically isolated syndrome (CIS); AND
4. Documentation of BOTH of the following: a. Hepatitis B virus (HBV) screening; and b. testing for quantitative serum immunoglobulins; AND
5. The member does NOT have ANY of the following: a. active hepatitis B virus (HBV) infection, as evidenced by positive results for HBsAg and anti-HB tests; or b. an active infection; or c. documentation indicating that the member will use Briumvi (ublituximab) concomitantly with other immune-modulating or immunosuppressant drugs for the treatment of multiple sclerosis (e.g., ocrelizumab, natalizumab, ofatumumab); or d. primary progressive multiple sclerosis (PPMS); AND
6. Briumvi (ublituximab) will be dosed within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in a compendia of current literature; AND
7. Chart documentation and supporting laboratory test results are provided for review to substantiate the above listed requirements.

If the above prior authorization criteria are met, the requested medication will be approved for 6 months.

Medical Necessity Criteria for Reauthorization

Reauthorization for 6 months will be granted if BOTH of the following are met:

1. the member still meets the applicable initial criteria; AND
2. chart documentation shows ONE of the following: a. The member has shown a clinical improvement (e.g., reduction in neurologic disability and/or the frequency of clinical relapses) in symptoms since starting the requested medication; or b. The member has experienced disease stability since starting the requested medication.

Experimental or Investigational / Not Medically Necessary

Briumvi (ublituximab) for any other indication or use is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.