Kesimpta Health Insurance Denial
Received a Kesimpta Health Insurance Denial? Contact Us
Kesimpta (ofatumumab) was initially approved in 2009 under the brand name Arzerra
as an intravenous infusion treatment for chronic lymphocytic leukemia. In 2015, Novartis acquired the rights to ofatumumab from GlaxoSmithKline, and in
2020, the FDA expanded Kesimpta’s approval to include the treatment of relapsing
multiple sclerosis
in adults, marking the first time a self-administered B-cell therapy became available
for relapsing multiple sclerosis (RMS).
Novartis continues to develop and market Kesimpta for MS with ongoing research and
clinical studies. Unfortunately, not all insurance companies will consider Kesimpta
a medically necessary drug and may issue insurance denials. There are steps you can
take after receiving a Kesimpta health insurance denial. Your first step should be to contact the Law Offices of Scott Glovsky.
What is Kesimpta?
Kesimpta is a prescription drug used to treat relapsing forms of multiple sclerosis
in adults, including:
- Clinically isolated syndrome, which can be the initial presentation of multiple sclerosis.
- Relapsing-remitting multiple sclerosis, which can present as periods of relapse (MS
symptoms flare up) followed by periods of remission when MS symptoms improve or disappear
entirely.
- Active secondary progressive multiple sclerosis, which is an MS stage where symptoms
get progressively worse with no periods of remission.
Kesimpta targets CD20, a protein found on B cells. The drug is a monoclonal antibody
that is believed to work by destroying B cells, which exacerbate inflammation and
nerve damage. Kesimpta reduces relapses and disease activity on MRI scans, and slows
the progression of MS disability. Potential side effects include injection site reactions,
upper respiratory tract infections, headaches, UTIs, and back pain.
How is Kesimpta Administered?
Kesimpta is a self-administered injection given under the skin once a month.
Do Insurance Companies Cover Kesimpta as a Treatment for Multiple Sclerosis?
While many insurance companies will cover Kesimpta as a treatment for relapsing and
secondary progressive forms of multiple sclerosis, coverage can vary significantly from one insurer to another. Some insurance providers
may require prior authorization
before covering Kesimpta, while others may require step therapy, which often involves prescribing other, less expensive medications to see if they
are effective before agreeing to pay for Kesimpta.
How Much Does Kesimpta Cost?
The July 2025 list price for Kesimpta is $9,347.07 per month. There are support programs
available for the drug, including the “Alongside KESIMPTA Patient Support Program”
by Novartis, which offers an access card to help commercially insured patients with
low or no co-pays. There is also a Bridge Program to help eligible commercially insured
patients who are initially denied coverage receive free Kesimpta for up to 12 months
while waiting for approval.
Medicaid may provide coverage for Kesimpta as a treatment for multiple sclerosis,
although coverage can depend on the state or residence. Medicare may also provide
coverage for Kesimpta through Supplemental Plans (Part D) or a Medicare Advantage Plan. Patients must enroll separately for drug coverage through Medicare.
Is There a Biosimilar or Generic for Kesimpta?
There is currently no generic or biosimilar drug for Kesimpta on the market. As a biologic drug, Kesimpta is made from living cells. Generic versions of drugs exist for nonbiologic
drugs, while biologic drugs can only have biosimilar versions. A biosimilar version
of a drug is highly similar to the original biologic, with no meaningful differences
in terms of potency, purity, and safety. News of a Kesimpta biosimilar in Europe
is expected by the end of 2025, according to
Multiple Sclerosis News Today, but it is unknown when these biosimilar drugs will reach the United States and
secure FDA approval.
Medically Necessary vs. Medically Beneficial
Medically necessary services, defined differently by each insurance company, are those that meet accepted standards
of medical practice and are required to manage, treat, or diagnose a medical condition.
Medically beneficial services are likely to improve a patient’s health but might
not be considered strictly necessary, especially by insurance companies, for basic
care. Emergency care, necessary surgeries, prescription medications, and diagnostic
tests are considered medically necessary services because they are not primarily
for the patient’s “convenience,” and are considered reasonable and necessary in the
treatment of an illness or disease.
Medically beneficial healthcare services will more than likely improve a patient’s
health, but may not be considered essential for basic treatment. Preventative screenings,
specialized therapies, and elective procedures that improve the quality of life but
may not be required for immediate medical needs are considered medically beneficial.
Insurance companies often deny treatments considered medically beneficial, while
they will typically – but not always - approve treatments they consider medically
necessary.
How Do Insurance Companies Evaluate Kesimpta Coverage Requests?
Insurance companies will evaluate Kesimpta coverage requests through a process that
may require prior authorization to confirm that certain criteria are met before Kesimpta
is covered. If this is the requirement, your doctor will submit a prior authorization
request to your insurance company that details your medical condition and explains
why Kesimpta is appropriate for your treatment.
Your insurer will consider this information and review its own coverage policies,
taking into account your diagnosis, any prior treatment history, your specific medical
needs, and the prescriber requirements (the prescription for Kesimpta may need to
be issued by a multiple sclerosis specialist or a neurologist). If your doctor’s
prior authorization request lines up with the insurer’s policies and medical necessity
has been demonstrated, Kesimpta may be approved by the insurer. If coverage for Kesimpta
is denied, you have the right to appeal the decision.
Medically Necessary vs. Experimental or Investigational
Experimental or investigational drugs or treatments
are those that may still be undergoing research to determine their safety or efficacy.
Medically necessary services or treatments are essential for diagnosing, treating,
or managing a medical condition. In some cases, drugs or treatments that have received
FDA approval may still be considered experimental or investigational by your insurer.
The insurer may claim that the drug or treatment is still being studied and researched
so is not yet considered an “established” treatment.
A drug that is still being tested in clinical trials, or a surgical procedure that
may not yet be widely adopted for a specific condition, could be considered experimental
or investigational. An appeal to your insurance company and evidence to support medically
necessity is typically necessary if you and your doctor believe the treatment is
medically necessary for your specific medical issue.
The guidelines for deeming a drug medically necessary as opposed to experimental
or investigational are extremely subjective. Different insurers will make different
decisions regarding whether a drug is medically necessary, and this decision is sometimes
based more on cost than on benefits to the patient.
What Duty Do Insurance Companies Have to Members Submitting Claims?
When you submit a claim, your insurer will review the claim and determine whether
it will be approved or denied. During this process, the insurer has certain duties,
including the duty to thoroughly investigate the claim, the duty to look into all
information that could support the request, and to respond to the claim promptly.
Your insurer also has a duty to appoint and employ qualified medical professionals
to make these claim review decisions.
What Can You Do if You Receive a Kesimpta Denial from Your Insurer?
If your insurer denies your doctor’s prescription for Kesimpta, you do have options.
You can appeal the claim denial, although the process will be different if you have
an ERISA (Employment Retirement Income Security Act of 1974) plan or a non-ERISA
plan. You can contact your plan administrator if you are unsure what type of plan
you have.
Most private employers provide employees with ERISA plans, with certain exceptions,
including government employee plans, religious organization plans, business plans
that cover only business owners, individual and family plans through Covered California,
and individual and family plans purchased through private insurance companies such as
Anthem Blue Cross
or
Blue Shield of California.
You must exhaust all your administrative remedies if you have an ERISA plan and it
is highly recommended that you consult an attorney before submitting the appeal.
You can learn more about what to do if you have an ERISA plan here. If you have a non-ERISA plan, you can learn more here. There are a number of avenues you can explore after receiving a Kesimpta denial
from your insurer. You can file an internal appeal, which essentially asks the insurer
to take a second look at your claim and approve it.
Many people will include a letter from their doctor with the appeal, explaining why
the treatment or prescription drug is necessary. If the claim is still denied, you
can file an external appeal. An external appeal asks a neutral third party to look
at the claim. If your claim is approved during your external appeal, your insurer
is bound by that decision. It can be extremely helpful to have an experienced insurance
denial attorney by your side who understands the system from both sides and will
fight for your rights, your health, and your future. That attorney is Scott Glovsky.
Contact the Law Offices of Scott Glovsky if You Receive a Kesimpta Health Insurance Denial
If you have received a Kesimpta Health Insurance Denial, contact the Law Offices of Scott Glovsky. We have represented injured consumers and victims of wrongful business practices
for over two decades. Our firm focuses on health insurance bad faith, catastrophic personal injury, sexual abuse, and consumer-related litigation. Attorney Glovsky gets justice for his clients,
holding the wrongdoers accountable.
