Lemtrada Health Insurance Denial
Lemtrada (alemtuzumab) first received FDA approval on November 14, 2014, for relapsing
forms of multiple sclerosis (MS), specifically for patients who have not adequately
responded to two or more other MS drugs. Initially, a Complete Response Letter was
issued in December 2013 due to potential issues with the study design.
The manufacturer, Genzyme, resubmitted the application in April 2014. (Genzyme sold
to Sanofi in 2011, but Genzyme remained the name on the FDA approval for Lemtrada)
Lemtrada gained approval in the European Union and other countries before it was
approved in the United States.
Patients who choose Lemtrada to treat their MS require close monitoring for potential
complications and side effects. If you have received a Lemtrada health insurance
denial, you may be frustrated and worried about your health. The best step you can
take is to contact the Law Offices of Scott Glovsky
to discuss your health insurance denial and your options.
What is Lemtrada?
Lemtrada is considered a disease-modifying drug (DMD), used to treat relapsing forms
of MS in adults when other MS medications have been ineffective. Lemtrada is an IV
infusion administered by a healthcare professional, typically over four hours, with
the initial treatment course consisting of 5 consecutive days, and the second course
12 months later, over three days.
Lemtrada is a humanized anti-CD52 monoclonal antibody
that works by targeting and depleting certain immune cells, such as monocytes, macrophages,
NK cells, and T and B lymphocytes. These immune cells are believed to contribute
to the progression of MS. Compared to other MS treatments, such as Rebif, clinical
studies have shown that Lemtrada results in a significant reduction in relapse rates.
Do Insurance Companies Cover Lemtrada as a Treatment for Multiple Sclerosis?
Insurance companies may cover Lemtrada for the treatment of relapsing forms of multiple sclerosis, but coverage is often subject to specific criteria. It may also be subject to prior
authorization, along with a diagnosis of relapsing-remitting MS or active secondary
progressive MS.
The disease must typically be documented by a neurologist. Step therapy
is also sometimes required by insurers; the patient must demonstrate an inadequate
response to other disease-modifying therapies. Lemtrada is usually approved as a
single-agent therapy, which means it is not used in conjunction with other MS medications.
Lemtrada is available only through a program known as the LEMTRADA REMS. While insurance
may cover Lemtrada, patients often have out-of-pocket costs that the LEMTRADA Co-Pay Program
can help offset. There are also other patient financial assistance programs available.
Government health insurance programs, such as Medicaid, can provide coverage for
Lemtrada as a treatment for MS; however, coverage may vary significantly from one
insurance company to another. Medicare, the federal health insurance program for
those 65 and older, may also provide coverage for Lemtrada, depending on the patient’s
individual circumstances. Medicare Advantage Plans
(Part C) and Medicare Part D (also known as Supplemental Plans) provide drug coverage.
Kaiser Permanente, Blue Shield, HCSC, Humana, UnitedHealthcare, Aetna,
Anthem Blue Cross, and other commercial private insurance companies will have differing coverage standards.
Whether or not your insurer will pay for Lemtrada will depend on whether it finds
the drug to be medically necessary, or has deemed it not medically necessary, experimental,
or investigational.
Is There a Biosimilar or Generic for Lemtrada?
Biosimilars are the generic counterparts of brand biologic
drugs. There is currently no generic version of Lemtrada, but biosimilar versions
are being developed. Lemtrada is a brand name for alemtuzumab, and its market is
facing competition from biosimilar drugs as Lemtrada’s patents expire.
The expiration of the patents protecting Sanofi’s alemtuzumab opens the door for
the development of biosimilars. Once available, a biosimilar can potentially lower
the cost of treatment. Companies Harvest Moon Pharmaceuticals and Biosavita, Inc.
are developing biosimilar versions and must demonstrate that their products are highly
similar to and have no clinically meaningful differences from Lemtrada.
How Much Does Lemtrada Cost?
As of July 2025, a single vial of Lemtrada lists for
$29,744.24. Estimates for the first year of treatment range from $87,000 to $180,000. The initial
higher cost is the result of the dosing schedule, which involves more infusions at
a higher dosage in the first year. The annual cost for the second year of Lemtrada
treatment is approximately $108,000.
Medically Necessary vs. Medically Beneficial
Prior authorization is often required by insurance companies, especially when a drug
or treatment is expensive. Prior authorization
means your health insurer determines whether a drug or treatment is medically necessary
for you. Unfortunately, the prior authorization process is often marred by glitches.
Even when a drug or treatment is deemed medically beneficial for you, your insurer
may still not find it medically necessary, since other (cheaper) drugs or treatments
could potentially treat your condition.
In other words, if a less expensive alternative exists, you are too often more likely
to receive a “not medically necessary” denial from your insurer. Your insurer may
require you to go through step therapy before they will approve Lemtrada. Step therapy
means you must try alternative, often less expensive, drugs for your symptoms.
If the cheaper or generic alternative proves to be ineffective, then the insurer
may re-evaluate your claim. Typically, patients are required to try at least two
other, less expensive treatments for at least 60 days and have their doctor confirm
that these treatments were ineffective before the insurer considers approval for
the more expensive drug or treatment.
In California,
exemptions
can be made for step therapy cases, but the process is complex. Unfortunately, step
therapy can prevent you from getting coverage for the drug you need, and the insurer’s
pursuit of pushing second-choice drug options can actually cause harm. Due to this,
obtaining prior authorization for Lemtrada may not be straightforward.
How Do Insurance Companies Evaluate Lemtrada Coverage Requests?
Your coverage for Lemtrada will be evaluated based on internal medical or pharmacy
policies of your insurer. When the FDA approves a new drug, insurers have their own
practitioners including pharmacists research the drug, developing an internal clinical
policy. These policies will determine whether your prescribed drug or treatment is
medically necessary or whether a drug can still be considered experimental or investigational.
Once a policy is developed by an insurance company, it is brought before an external
group of doctors. The doctors vote on whether the drug will be approved as medically
necessary in the policy, but these doctors are often “motivated” by financial gain
or the promise of a job from the insurance companies. This can result in a significant
difference between your physician’s and your insurer’s determination of what is medically
necessary for
you.
Medically Necessary vs. Experimental or Investigational
Often, when your insurer deems a drug to be not medically necessary, they may also
label it as investigational or experimental
– even when the drug has a significant history of positive results and FDA approval.
Your insurance policy should define what 'experimental' and 'investigational' mean.
If the FDA has not approved a drug specifically for how your doctor is prescribing
it – even though drugs are prescribed “off label” every day – your insurer may be
able to call the drug experimental. If there is at least some scientific evidence
that an alternative drug could be equally effective, your insurance company may deem
the prescribed drug experimental.
The guidelines used by insurers to determine whether a drug is medically necessary
or investigational are highly subjective, and different insurers will reach vastly
different conclusions. An insurance company could even potentially deem a drug like
Aspirin to be not medically necessary, so long as its contract language allows it.
What Duty Do Insurance Companies Have to Members Submitting Claims?
When you submit a claim, your insurer will review it and will either approve the
claim or deny it. Insurance companies have a duty to thoroughly investigate a request,
to fully inquire into all the reasons that could support the request, to have qualified
medical practitioners reviewing the claim, and to promptly respond to the claim.
If your insurer is negligent in any of these duties, you may have a bad faith insurance
claim against the company.
What Can You Do if You Receive a Lemtrada Coverage Denial?
If you have received a Lemtrada coverage denial, you do have rights. You can appeal
your insurer’s decision, but you must first determine whether you have ERISA (Employment
Retirement Income Security Act of 1974) or non-ERISA health insurance. Your plan
administrator can help you make this determination if you are unsure. Most private
employers provide ERISA plans, but there are exceptions. Government employee plans,
business plans that only cover the owner, religious organization plans, individual
and family plans purchased through private insurers like Blue Shield or Anthem Blue
Cross, and individual and family plans through Covered California
are all exceptions. If you do have an ERISA plan, you must exhaust all your administrative remedies, so you should definitely file
an appeal. For non-ERISA
policyholders, you may have different options and we recommend speaking with a qualified
health insurance denial lawyer before you proceed.
Contact the Law Offices of Scott Glovsky if You Receive a Lemtrada Health Insurance Denial
If you have received a Lemtrada health insurance denial, the Law Offices of Scott Glovsky
can help. We have been fighting for policyholders of health insurance coopanies for
nearly three decades.. Attorney Scott Glovsky and his legal team focus on health insurance bad faith, catastrophic personal injury, sexual abuse,
and consumer-related litigation as we strive to get justice for each client while
holding the wrongdoers accountable.
