Please see Important Safety Information on page 4.
Please click here for Full Prescribing Information.
1
You may submit an appeal letter if the payer:
• Denied coverage
• Claimed treatment was not medically necessary
• Said the prescription is not covered by your patient’s benets
Depending on the reason for the denial, dierent materials and additional steps may be required.
QUESTIONS?
CALL 1-800-ORILISSA (1-800-674-5477)
SUBMITTING AN
APPEAL LETTER
An appeal letter outlines the reasons
why a treatment is necessary to meet
the medical needs of your patient
Please see Important Safety Information on page 4.
Please click here for Full Prescribing Information.
2
ONCE YOU HAVE SUBMITTED THE LETTER WITH ANY SUPPORTING
DOCUMENTATION, THE PAYER MUST REVIEW AND DECIDE ON COVERAGE
The decision timeframe generally begins when the request is received by the plan sponsor. Below are standard
timeframes but timing varies by plan and may dier from the information presented here.
WRITING AN APPEAL LETTER
This information is presented for informational purposes only and is not intended to provide reimbursement or legal advice. Providers are encouraged
to contact third-party payers for specic information about their coverage policies.
Digital version available at Orilissa.com/hcp/appeals-letter-sample-template
Please open le on PC only to ensure usability
TO HELP FACILITATE A QUICK APPEAL PROCESS, INCLUDE ALL INFORMATION
INDICATED IN THE SAMPLE LETTER
Supplemental documentation may include:
•
A copy of your patient’s relevant medical records
•
A summary of your recommendation at the end of the letter
•
A letter of medical necessity (LMN)
APPEALING A STEP EDIT/STEP THERAPY?
If this appeal letter is intended to appeal a plan’s step edit therapy requirement, consider including the
following information in your letter:
This is our
[add level of request]
coverage authorization appeal. A copy of the most recent denial letter is
attached for reference. My patient’s relevant medical records are also included in response to the denial.
[Statement indicating why these step edit therapy requirements are inappropriate for this patient.]
for non-urgent care for services
already provided
for urgent care
30
days
60
days
72
hours
Please see Important Safety Information on page 4.
Please click here for Full Prescribing Information.
3
SAMPLE APPEAL LETTER
©2019 AbbVie Inc. North Chicago, IL 60064 US-ABBV-190418 December 2019 Printed in U.S.A.
[Date]
[Prior authorization department]
[Name of health plan]
[Mailing address]
Re: [Patient’s name]
[Plan identification number]
[Date of birth]
To whom it may concern:
My name is [physician’s name], and I am a [board-certified medical specialty] [NPI] writing on behalf of
my patient, [patient name], to request coverage for [product] [generic]. [Patient name] has been under my
care for [X months/years] for the treatment of [disease or symptoms].
We understand that the reason for your denial is [copy reason verbatim from the plan’s denial letter].
However, we believe that [product, dosage, frequency] is the appropriate treatment for my patient. In
support of our recommendation for [product] treatment, we have provided an overview of my patient’s
relevant clinical history below.
[Provide a brief medical history, including diagnosis, allergies, existing comorbidities, and International
Classification of Diseases (ICD) code(s)].
[Discuss rationale for using product vs other treatments. Insert your recommendation summary here,
including your professional opinion of your patient’s likely prognosis or disease progression without
treatment with product.]
The patient’s [list of pertinent medical records] are enclosed, which offer additional support for the
formulary exception request for [product]. Please consider coverage of [product] for my patient.
Please feel free to contact me, [physician’s name], at [office phone number] or [patient’s name] at [phone
number] for any additional information you may require. We look forward to receiving your timely
response and approval of this claim.
Sincerely,
[Physician’s name and signature]
[Physician’s medical specialty]
[Physician’s NPI]
[Physician’s practice name]
[Phone #]
[Fax #]
SAMPLE
Make sure
you match the
language from
the denial letter.
Note here if you are
including a letter of
medical necessity
along with your
appeal letter.
If you want to try
to expedite the
appeal process,
include:
I am requesting an
expedited review
on behalf of my
patient.
4
© 2022 AbbVie. All rights reserved.
ORILISSA
®
and its design are registered trademarks of AbbVie Inc.
US-ORIL-220132 September 2022
INDICATION AND IMPORTANT SAFETY INFORMATION
FOR ORILISSA
®
(elagolix)
Reference: 1. ORILISSA [package insert]. North Chicago, IL: AbbVie Inc.
Please click here for Full Prescribing Information.
INDICATION
1
ORILISSA
®
(elagolix) is indicated for the management of
moderate to severe pain associated with endometriosis.
Limit the duration of use based on the dose and
coexisting condition.
IMPORTANT SAFETY INFORMATION
1
CONTRAINDICATIONS
• ORILISSA is contraindicated in women who are pregnant
(exposure to ORILISSA early in pregnancy may increase
the risk of early pregnancy loss), in women with
known osteoporosis or severe hepatic impairment, in
women taking organic anion transporting polypeptide
(OATP) 1B1 inhibitors that are known or expected to
signicantly increase elagolix plasma concentrations,
and in women with known hypersensitivity reaction to
ORILISSA or any of its inactive components. Reactions
have included anaphylaxis and angioedema.
WARNINGS AND PRECAUTIONS
Bone Loss
• ORILISSA causes a dose-dependent decrease in bone
mineral density (BMD), which is greater with increasing
duration of use and may not be completely reversible
after stopping treatment.
• The impact of ORILISSA-associated decreases in BMD
on long-term bone health and future fracture risk is
unknown. ORILISSA is contraindicated in women with
known osteoporosis. Consider assessment of BMD in
patients with a history of low-trauma fracture or other
risk factors for osteoporosis or bone loss.
• Limit the duration of use to reduce the extent of bone loss.
Change in Menstrual Bleeding Pattern and Reduced
Ability to Recognize Pregnancy
• Women who take ORILISSA may experience a reduction
in the amount, intensity, or duration of menstrual
bleeding, which may reduce the ability to recognize the
occurrence of pregnancy in a timely manner. Perform
pregnancy testing if pregnancy is suspected, and
discontinue ORILISSA if pregnancy is conrmed.
Suicidal Ideation, Suicidal Behavior, and
Exacerbation of Mood Disorders
• Suicidal ideation and behavior, including one
completed suicide, occurred in subjects treated with
ORILISSA in the endometriosis clinical trials.
• ORILISSA users had a higher incidence of depression
and mood changes compared to placebo and ORILISSA
users with a history of suicidality or depression had an
increased incidence of depression. Promptly evaluate
patients with depressive symptoms to determine
whether the risks of continued therapy outweigh the
benets. Patients with new or worsening depression,
anxiety, or other mood changes should be referred to
a mental health professional, as appropriate.
• Advise patients to seek immediate medical attention for
suicidal ideation and behavior. Reevaluate the benets
and risks of continuing ORILISSA if such events occur.
Hepatic Transaminase Elevations
• In clinical trials, dose-dependent elevations of serum
alanine aminotransferase (ALT) at least 3 times
the upper limit of the reference range occurred
with ORILISSA.
• Use the lowest eective dose and instruct patients to
promptly seek medical attention in case of symptoms
or signs that may reect liver injury, such as jaundice.
• Promptly evaluate patients with elevations in liver
tests to determine whether the benets of continued
therapy outweigh the risks.
Interactions with Hormonal Contraceptives
• Advise women to use eective non-hormonal
contraceptives during treatment and for 28 days after
discontinuing ORILISSA.
• Coadministration of ORILISSA 200 mg twice daily
with an estrogen-containing contraceptive is not
recommended because of the potential for increased
estrogen-associated risks including thromboembolic
disorders and vascular events. Coadministration of
ORILISSA with an estrogen-containing contraceptive is
expected to reduce the ecacy of ORILISSA.
• Coadministration with progestin-containing
oral contraceptives may reduce the ecacy of
the contraceptive. The eect of progestin-only
contraceptives on the ecacy of ORILISSA is
unknown. Coadministration of ORILISSA with
progestin-containing intrauterine contraceptive
systems has not been studied.
ADVERSE REACTIONS
• The most common adverse reactions (>5%) in
clinical trials included hot ushes and night sweats,
headache, nausea, insomnia, amenorrhea, anxiety,
arthralgia, depression-related adverse reactions,
and mood changes.
These are not all the possible side eects of ORILISSA.
Safety and eectiveness of ORILISSA in pediatric
patients have not been established.
