Briumvi Health Insurance Denial
TG Therapeutics submitted a biologics license application (BLA) for Briumvi (ublituximab-xiiy)
on September 28, 2021. In March and April of 2022, the FDA received major amendments
to the BLA, extending the goal date. Briumvi received FDA approval on December 28,
2022, for the treatment of relapsing forms of multiple sclerosis in adults, based
on the results of the Phase 3 trials ULTIMATE I and II.
This article addresses Briumvi health insurance coverage claims, how insurers make
decisions regarding medical necessity, and what actions you can take after receiving
a Briumvi health insurance claim denial. If you have received a Briumvi health insurance
claim denial, contact the Law Offices of Scott Glovsky. This is a situation that can really benefit from having a strong legal advocate
on your side, and Attorney Scott Glovsky has been fighting for justice for his clients
for over two decades.
How Does Briumvi Work?
Multiple sclerosis (MS) is a chronic, systemic autoimmune disorder
characterized by inflammation and the degradation of the myelin sheaths that protect
the nerve fibers in the central nervous system. This degradation is known as demyelination
and occurs when the body’s immune system mistakenly attacks the myelin, resulting
in inflammation and damage. The primary cells involved in MS are T cells, although
B cells have also recently been implicated in the disease, leading researchers to
explore B cell therapy as an alternative treatment for MS.
B-cell therapy is based on depleting CD20-positive B cells. Rituximab (brand name
Rituxan used to treat Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Rheumatoid arthritis, and more), ocrelizumab (brand name Ocrevus used to treat MS), and ofatumumab (brand
name Kesimpta used to treat MS) are all anti-CD20 antibodies that have already garnered
FDA approval.
Who Can Take Briumvi and How is Briumvi Administered?
Briumvi is not for use in children and is administered as an intravenous infusion
every six months, following an initial two doses taken two weeks apart. Patients
with active hepatitis B infection or a history of allergic reactions to Briumvi should
not take the drug. You can find more information about Briumvi here.
Is Briumvi Expensive?
Briumvi can be considered an expensive medication for the treatment of multiple sclerosis,
with a 2025 list price of approximately $88,000
per year. With insurance, the out-of-pocket costs will vary significantly, depending
on your specific health insurance plan. Typical co-pays per infusion can be from
$0 to $5,000. Medicare patients may pay between $500 and $2,000 per infusion, while
Medicaid patients will likely pay significantly less.
TG Therapeutics offers a co-pay assistance program
for commercially insured patients to help cover co-pays. There are also patient assistance
programs for those who are uninsured or underinsured and meet financial eligibility
criteria. While Briumvi is expensive, it is the lowest-priced branded disease-modifying
therapy available for MS patients.
Is There a Biosimilar or Generic for Briumvi?
Briumvi is a biologic
medication. Biologics are complex and produced in living cells, while biosimilar
drugs are biologic medications that are very similar to an already approved biologic
drug, known as the reference product. Biosimilars, like generics, are close copies;
however, they are considered to have no clinically meaningful differences in terms
of safety, potency, or purity. In certain cases, biosimilars can be substituted for
the reference product at the pharmacy without intervention of the prescribing healthcare
professional in the same way the pharmacy can give you a generic drug rather than
the brand name. Learn more about biosimilars here.
Biosimilar drugs undergo a rigorous approval process from the FDA to ensure they
meet the same safety and efficacy standards as the reference product. As of July
2025, Briumvi is only available as a name-brand biologic, with no biosimilar yet
developed or approved. TG Therapeutics holds the patent on Briumvi, which extends
through 2043, providing market exclusivity.
Do Insurance Companies Cover Briumvi as a Treatment for Multiple Sclerosis?
Government health insurance programs, such as Medicaid and Medicare, may provide
coverage for Briumvi to treat multiple sclerosis, although coverage can vary depending
on the state of residence. Medicare is the federal health insurance program for those
65 and older. The prescription drug benefits may be available through Medicare Advantage Plans
(Part C) or Supplemental Plans (Part D). Patients are required to enroll separately
from “regular” Medicare for a prescription drug plan.
Anthem, Kaiser Permanente, Blue Shield, HCSC, Humana, UnitedHealthcare, and Aetna
are commercial private insurance companies that have different coverage standards
from one another. Many private insurance companies will cover Briumvi as a treatment
for multiple sclerosis, provided the insurer considers the drug medically necessary.
If you have received a Briumvi health insurance denial, you have the right to appeal
the denial, although how you appeal will be determined based on whether you have
an ERISA (Employment Retirement Income Security Act of 1974) or non-ERISA Plan. Your
plan administrator can help you determine which type of plan you have. Most private
employers offer ERISA plans, with the following exceptions:
- Religious organization plans
- Many government employee plans
- Individual and family plans purchased through private insurance companies like Anthem
Blue Cross or Blue Shield of California
- Individual and family plans through Covered California
- Business plans that only cover business owners
Those with ERISA plans should file an appeal, as all administrative remedies must
be exhausted. If you have a non-ERISA plan, you have more options and should speak
with an attorney prior to submitting your appeal. You can learn more about ERISA
plans here
and non-ERISA plans here.
Understanding Denials Based on Being Experimental, Investigational, or Not Medically Necessary
The goal of insurance companies is to make money, so other than denials based on
lack of information, errors, and out-of-network providers, the terms “investigational,”
“experimental,” and “not medically necessary” too often means that the drug or treatment
is expensive and the insurance company does not want to pay. Many insurers also require prior authorization
before covering an expensive drug. Prior authorization requires you to obtain approval
from your insurer before it will pay for the drug. There can be some bumps along
the way when obtaining prior authorization. Since there is usually more than one
drug to treat any given condition, insurance companies – not surprisingly – oftentimes
favor less expensive treatment options.
Step therapy
is a form of prior authorization that requires the patient to try alternative drugs
(usually 2, for 60 days each) to determine whether the alternative (less expensive)
drug will work. If the alternative drugs do not achieve the desired results, the
insurer may revisit the original claim and approve the doctor-prescribed drug. Sometimes,
there are exemptions in California for step therapies; the process can be time-consuming
and complex. Your doctor fills out the Prescription Drug Prior Authorization or Step Therapy Exception Request Form.
“Investigational and experimental” are additional terms sometimes used by insurers to avoid paying for an expensive
drug. The policy definitions of experimental and investigational can be used when
a drug is used off-label, even though doctors prescribe drugs off-label every day,
and it can be both legal and appropriate. However, if the condition is not what the
FDA approved the drug for, the insurer is likely to label it experimental or investigational.
When the FDA approves a new drug, insurance company teams have their professionals
including pharmacists research the drug to develop internal clinical policies that
will help the insurance company decide which drugs are medically necessary under
specific circumstances. Once the policies are developed, they are presented to a
board of external physicians, who, unfortunately, could be motivated by financial
gain or the potential to work for the insurer. This can result in overly restrictive
policies regarding the approval of particular drugs.
What Duties Do Insurance Companies Have to Members Submitting Claims?
Insurers have specific duties when members submit claims. These include:
- The duty to thoroughly investigate a claim request.
- The duty to fully inquire into every possible reason that could support the request
for care.
- The duty to promptly respond to claim requests.
- The duty to appoint and employ qualified medical professionals to make claim review
decisions.
Contact the Law Offices of Scott Glovsky if You Receive a Briumvi Health Insurance Denial
If you have received a Briumvi health insurance denial, it is important that you
speak to a legal professional who will advocate strongly on your behalf. The Law Offices of Scott Glovsky has represented injured consumers and victims of wrongful business practices
for over 20 years. The firm focuses on health insurance bad faith, catastrophic personal injury, sexual abuse, and consumer-related litigation. Attorney Glovsky and his legal team fight
for justice for each client, holding the wrongdoers accountable.
