Emgality Health Insurance Denial
FDA approval was granted to pharmaceutical company Lilly for Emgality (galcanezumab-gnlm)
on September 27, 2018. Emgality was initially approved for the preventative treatment
of migraines in adults, and was later approved to treat episodic cluster headaches
(June 4, 2019). The approval for the treatment of episodic cluster headaches made
Emgality the first and only medication approved for this specific purpose. Emgality
gives many patients more migraine-free days, cutting the number of monthly migraine
days by 50 percent or more for some patients.
Emgality is meant to prevent migraines before they start through a once-a-month injection
after an initial “loading” dose of 240 mg., or two injections. The vast majority
of Emgality users find the Emgality injector pen easy to use. This article will
address
Emgality health insurance coverage claims and how your insurer makes decisions
regarding
medical necessity. If you have received an Emgality health insurance denial,
your
first step should be to contact the Law Offices of Scott Glovsky.
How Does Emgality Work?
Emgality is a monoclonal antibody that is specifically designed to bind to calcitonin
gene-related peptides (CGRP) in the body. CGRP is a protein that widens blood vessels
in the brain, aiding in the development of migraine
and cluster headaches. Emgality prevents CGRP from binding to its receptor, blocking
its activity and effectively reducing the frequency and severity of migraines and
cluster headaches. Emgality is approved for use by adults. Additional information
regarding CGRP monoclonal antibody drugs for migraines and cluster headaches can
be found here.
Are There Other Drugs Similar to Emgality?
There are currently other CGRP drugs that are similar to Emgality, including:
- Erenumab (brand name Aimovig) is administered as monthly subcutaneous injections
for migraine prevention.
- Fremanezumab (brand name Ajovy) is administered either monthly or quarterly via subcutaneous
injection for migraine prevention.
- Eptinezumab (brand name Vyepti) is administered as a subcutaneous injection every
three months for migraine prevention.
Do Insurance Companies Cover Emgality as a Treatment for Migraines and Cluster Headaches?
Government health insurance programs like Medicare and Medicaid may provide coverage
for Emgality as a treatment for migraines and cluster headaches. Coverage may vary
by company, as well as state of residence. Medicare is the federal health insurance
program for those 65 years and older and may provide coverage through
Medicare Advantage Plans
(Part C) or Supplemental Plans (Part D). Patients are required to enroll separately
for Medicare prescription coverage.
Whether commercial private health insurance companies, such as Kaiser Permanente,
Blue Shield, HCSC, Humana, UnitedHealthcare, Aetna, and Anthem, will cover Emgality will depend on several factors. Many private insurers will
cover Emgality, but they may require prior authorization or step therapy. There is also a process within each company that determines whether a drug like
Emgality is medically necessary. If you have received an Emgality health insurance denial, it is essential to consult
with an experienced claims denial attorney.
Is There a Biosimilar or Generic for Emgality?
Biologic drugs
are complex medications derived from living cells. This makes biologics challenging
to copy precisely. Emgality is a biologic, derived from living organisms, rather
than traditional drugs that are synthesized through chemical processes. Biologics
have an intricate structure, making replication complex. There are currently no
FDA-approved
biosimilars (i.e., generic versions of biologic medications) for Emgality.
Since
Emgality’s patent extends through 2035 in some jurisdictions, it could be
years before
a biosimilar drug becomes available.
The cost of Emgality varies significantly; however, for those without insurance,
the list price as of July 2025 is $741.69
per month. There are several factors that affect your price of Emgality, including
whether your insurance plan covers the drug, the pharmacy you use, whether you have
an Eli Lilly savings card, or whether you have no insurance and take advantage of
patient assistance programs that offer free or reduced-price medications. Check
your
insurance plan, explore discount programs, consult with your doctor or pharmacist
to determine the best way to access Emgality, or consider patient assistance programs.
Medically Necessary vs. Medically Beneficial
Your health insurer likely requires prior authorization
before covering Emgality, or any other costly drug or treatment. Prior authorization
obtains a decision from your health insurance company that agrees a drug is medically
necessary to treat your condition. Unfortunately, there are many instances when
a
drug can be medically beneficial for a patient, yet a health insurer will label
it
as not medically necessary. In many cases, a variety of treatments are available
for any given condition, although some may be more effective than others for specific
individuals and conditions.
Unsurprisingly, insurance companies tend to favor less expensive treatment options.
Your insurer may also require step therapy before approving the drug or treatment
your doctor prescribes. This often means that if a cheaper or generic alternative
drug exists, you will be required to take it first, usually for at least 60 days.
You may be required to try two different alternative drugs before your insurer will
approve the more expensive or name-brand drug prescribed by your doctor.
The state of California has exemptions for step therapy cases, but the process is
often complex. Step therapy can prevent patients from getting approved for the drug
their doctor believes will help their medical condition in the best way possible,
as second-choice drug options are pushed. Insurance companies often require step
therapy for conditions that require expensive specialty drugs, such as cancer
and autoimmune disorders.
How Do Insurance Companies Evaluate Emgality Coverage Requests?
Your insurer will look at your diagnosis and determine whether the doctor-prescribed
drug is medically necessary for youbased on its own internal medical or pharmacy
policies. The policies are created by insurance company teams including pharmacists
that research the drugs and determine which drugs are medically necessary under
which
circumstances. These guidelines enable insurers to determine whether a drug
is medically
necessary, experimental, or investigational.
Once an insurer has fully developed policies, those policies are brought before a
group of external doctors who vote on them. While this might sound like a fair process,
insurers sometimes “motivate” these doctors with financial incentives, or the ability
to work for the insurer, which in turn leads the doctors to vote on overly restrictive
policies that may or may not consider what specific patients need.
To have your insurer approve Emgality, you will typically need a documented diagnosis
of chronic or episodic migraines or episodic cluster headaches that include your
detailed medical history and the frequency of your migraines or cluster headaches
(i.e., four migraine days per month for at least three months). You will often have
to undergo other therapies before Emgality will be covered, such as beta-blockers,
antidepressants, or even anti-epileptic drugs.
For episodic cluster headaches, you may need to demonstrate that you tried and failed
or were unable to tolerate a drug like verapamil. Some insurance plans require Emgality
to be prescribed by a neurologist or headache specialist. Dosages requested
must comply with the FDA-approved dosing regimen for Emgality, which typically includes
an initial loading dose and monthly maintenance doses. Renewal criteria usually
require
evidence of a reduction in migraine frequency, severity, or duration.
Off-label use will often be deemed experimental or investigational. If improved health outcomes are not clear, your insurer may also deem Emgality
experimental, investigational, or not medically necessary. Obviously, the guidelines
used by insurers are subjective; different insurers will make different decisions
regarding what is medically necessary and have significant leeway in labeling a
drug
as experimental or investigational.
What Duty Do Insurance Companies Have to Members Submitting Claims?
Insurance companies essentially have four basic duties to their members when a claim
is submitted. These include:
- The insurer must honestly and carefully review the claim, then make a decision to
approve or deny.
- The insurer must inquire into all the possible reasons that might support this request
for care.
- The insurer must promptly respond to claim requests.
- The insurer has a duty to appoint and employ qualified medical professionals to make
these decisions.
What Can You Do if You Receive an Emgality Coverage Denial?
How you respond to an Emgality insurance claim denial will depend on whether you
have an ERISA (Employment Retirement Income Security Act of 1974) plan or a non-ERISA
Plan. With a few exceptions, most private employers provide ERISA plans. The exceptions
are for government employees, religious organizations, business plans that only
cover
business owners, individual and family plans through Covered California, and
individual
and family plans through private insurers like Anthem Blue Cross or Blue
Shield of
California. If your plan is ERISA, you must file an appeal and exhaust all your administrative remedies. This process
benefits greatly from having a knowledgeable attorney. Non-ERISA plans have many
options, which you can learn about here.
Contact the Law Offices of Scott Glovsky if You Receive an Emgality Health Insurance Denial
If you have received an Emgality health insurance denial, it is important to know
that attorney Scott Glovsky worked for big insurance companies before he started
fighting against them over two decades ago. This gives him a unique perspective
that
benefits his clients. The Law Offices of Scott Glovsky
focuses on health insurance bad faith, catastrophic personal injury, sexual abuse, and consumer-related litigation, seeking justice for our clients and holding
insurers accountable.
