Mavenclad Health Insurance Denial
Mavenclad (cladribine) was first submitted to the FDA in October 2009 as a potential
oral short-course multiple sclerosis therapy. Merck then received a Refuse to File
letter from the FDA, resubmitted the application in 2010, and was granted priority
review for Mavenclad for the treatment of relapsing forms of multiple sclerosis.
The drug did not receive final FDA approval until March 29, 2019, when it was approved
for adults with relapsing-remitting multiple sclerosis and active secondary progressive
multiple sclerosis.
Mavenclad is generally used for patients who have failed to respond well to other
MS treatments or are unable to tolerate other MS treatments. The recommended dosage
is 3.5 mg per kg over two years, administered in two yearly treatment courses. Further
treatment beyond two years is generally not recommended due to an increased risk
of malignancy. Clinical studies appear to indicate that Mavenclad significantly reduces
MS relapse rates and the progression of disability due to the disease.
Below, you will find additional information regarding Mavenclad health insurance
coverage claims as well as how insurance companies make decisions regarding medical
necessity. If you are facing a Mavenclad health insurance denial, it can be extremely
beneficial to contact the Law Offices of Scott Glovsky
and discuss your situation.
What is Mavenclad and How Does It Work?
Mavenclad is a prescription medication used to treat relapsing forms of multiple sclerosis, including active secondary progressive disease and relapsing-remitting disease
in adults. Mavenclad is generally prescribed only for those who have tried other
MS medications that have not worked well.
The innate immune cells and adaptive immune cells in our immune system work together
to protect the body. The innate immune cells are the body’s first line of defense,
while the adaptive immune cells (B and T cells) are the second line of defense. If
the immune system is functioning properly, the body is adequately defended against
infection. In some cases, the immune system attacks normal, healthy cells. This is
considered an autoimmune disease, which is what multiple sclerosis is believed to be.
Among those with MS, the immune system mistakenly attacks the central nervous system,
which in turn affects the optic nerve, spinal cord, and brain. B and T cells recognize
normal, healthy tissues of the central nervous system as being foreign invaders,
and the myelin sheath (the insulating layer protecting nerve fibers in the central
nervous system) is attacked, leading to inflammation and interrupting nerve signals.
Mavenclad targets and reduces the B and T cells that contribute to attacks of MS
so there are fewer of these cells attacking the nerves. Mavenclad allows other immune
cells to remain, defending the body from infections and responding appropriately
to vaccinations. Mavenclad does lower white blood cell counts, potentially increasing
the likelihood of other infections during treatment, although the immune system is
only temporarily weakened. You can find more information about Mavenclad here.
Who Can Take Mavenclad?
Mavenclad is for adults, not for children under the age of 18.
What is the Dosage Form of Mavenclad?
Mavenclad is a tablet taken as one or two pills per day (depending on your weight)
for four or five days in a row. You do this twice a year, approximately one month
apart, for two years.
How Much Does Mavenclad Cost?
Mavenclad currently costs almost $80,000 per year for seven tablets.
Does Mavenclad Work in the Same Way as Other Drugs for Relapsing MS?
Mavenclad is currently competing in a crowded market that includes other MS treatments
like Ocrevus manufactured by Roche, Gilenya, manufactured by Novartis, and Tecfidera,
manufactured by Biogen. Due to competition, Mavenclad, despite experiencing strong
growth following FDA approval, still faces stiff competition and is not among Merck’s
top revenue generators. Mavenclad’s sales have, however, helped offset the decline
in sales of Merck’s older MS drug, Rebif.
While Mavenclad selectively targets and reduces B and T cells in the body, other
drugs used to treat relapsing MS deplete specific types of immune cells or block
the migration of immune cells, preventing them from crossing the blood-brain barrier
and entering the central nervous system to attack nerve tissues. Some other drugs
for relapsing MS influence the immune system to shift towards a less inflammatory
state. Mavenclad is unique for its short-course oral treatment; many other similar
drugs require continuous administration or regular infusions or injections.
Do Insurance Companies Cover Mavenclad as a Treatment for Relapsing Forms of MS?
Whether Mavenclad is covered by your health insurer will depend on a variety of factors.
Government health insurance programs like Medicaid, Medicare Advantage Plans, and Supplemental Plans (Part D) usually cover drugs like Mavenclad. Medicare covers
individuals who are 65 and older, while Medicaid typically covers those with a lower
income level.
Commercial private insurance companies, such as Anthem, Kaiser Permanente,
Aetna, Blue Shield,
UnitedHealthcare, HCSC, and Humana, have different coverage standards than Medicaid or Medicare.
Many private insurance companies may cover Mavenclad for relapsing-remitting forms
of MS, although it must be deemed medically necessary
and may require prior authorization
or step therapy. If you receive a Mavenclad health insurance claim denial, the best course of action
is to consult with a knowledgeable health insurance denial attorney.
Is There a Biosimilar or Generic for Mavenclad?
Biosimilars are the generic counterparts of brand biologic
drugs. There are currently no biosimilar or generic versions of Mavenclad available
in the United States, although biosimilar research is ongoing for other MS treatments.
Generic drugs are exact copies of the active ingredients in brand-name medications,
but they are less expensive. Biosimilars are similar in nature but have been specifically
developed as biologic drugs.
The development of biosimilar drugs is much more expensive and complex than the development
of generic drugs. Although no biosimilar for Mavenclad exists, patent expiration
often paves the way for biosimilar versions to be developed and approved.
Medically Necessary vs. Medically Beneficial vs. Experimental or Investigational
Health insurance companies too often go out of their way to avoid paying for expensive
drugs or treatments. One of the ways they accomplish this is by deeming a drug or
treatment “not medically necessary,” “experimental,” or “investigational.” The individual
policy definitions will determine what is considered experimental or investigational.
When the FDA does not approve a drug for a specific use, insurers can label it as
experimental. Yet doctors routinely prescribe drugs off-label, with between 21 percent and 32 percent
of all prescriptions being considered off-label.
Off-label use is highest among cardiovascular
medications, constituting at least 45 percent of prescriptions. Insurers may also
label a drug as experimental when scientific evidence suggests that alternative (i.e.,
less expensive) drugs could be just as effective. The guidelines used for determining
whether a drug is medically necessary, experimental, or investigational are extremely
subjective, with different insurers making different designations.
Insurers have even deemed a drug like Aspirin, often used to lower the risk of heart
attack, as not medically necessary, and have the authority to deny virtually any
drug if the plan’s contract language allows it. Many health insurers will also
require prior authorization
before covering a specific drug, which requires a decision from the insurer that
the drug is medically necessary. Even when a physician believes that a specific drug
will be medically beneficial for a specific patient, the insurer may deem the drug
not medically necessary simply because a (less expensive) alternative exists.
Step therapy
is another method for an insurer to avoid paying for an expensive medication, treatment
or surgery, as it requires patients to try less expensive or generic alternatives
first. If the alternative proves ineffective, the insurer may re-evaluate the claim.
Insurers typically require at least two alternatives, which often must be tried for
a minimum of 60 days. Exemptions
for step therapy can be made in California, but the process is complex.
How Do Insurance Companies Evaluate Mavenclad Coverage Requests?
Health insurers evaluate coverage based on internal pharmacy or medical policies
that their own pharmacists have researched with a goal of developing internal clinical
guidelines that help insurers make decisions regarding whether a drug is medically
necessary, investigational, or experimental. Once policies are developed, they are
brought before a group of external doctors for a vote. Unfortunately, these doctors
may be “motivated” with financial incentives or the potential to work directly for
the insurers, which can lead to overly restrictive policies.
What Duty Do Insurance Companies Have to Members Submitting Claims?
When a member submits a claim, the insurer reviews it and makes a decision to approve
or deny the claim. The insurance company has certain duties during this process.
First, the insurer must thoroughly investigate claim requests, then inquire into
all the reasons that support the request. The insurer must promptly respond to claim
requests and appoint and employ qualified medical professionals to make these decisions.
What Can You Do if You Receive a Mavenclad Coverage Denial?
If you receive a Mavenclad health insurance denial, you can appeal the denial. How
you appeal will depend on whether you have an ERISA (Employment Retirement Income
Security Act of 1974) or non-ERISA plan. Most private employers provide ERISA plans
with exceptions for government employees, religious organizations, individual and
family plans through Covered California, and individual and family plans through private insurance companies like Anthem
Blue Cross or Blue Shield of California.
Contact the Law Offices of Scott Glovsky if You Receive a Mavenclad Health Insurance Claim Denial
Attorney Scott Glovsky and the Law Offices of Scott Glovsky
have represented injured consumers and victims of wrongful business practices for
over 20 years. Our firm’s focus is on health insurance bad faith, catastrophic personal injury, sexual abuse, and consumer-related litigation. We hold wrongdoers accountable as we pursue
justice on behalf of our clients.
