Download Sample Appeal Letter - Genentech Access Solutions

[Date]
[Payer name]
ATTN: APPEALS
[Payer contact name]
[Payer address]
Patient: [Patient’s first and last name]
Subscriber ID#: [Insurance ID #]
Subscriber Group #: [Insurance group #]
Re: KADCYLA™ (ado-trastuzumab emtansine) Intravenous Infusion
Dates of Service: [Include all denied dates of service]
Dear Appeals Reviewer:
I am writing to request [appeal/redetermination/reconsideration] of the above denial(s) of KADCYLA
for my patient [patient name]. I understand from your denial letter that the denials were based on [denial
reason]. I would like to address [that reason/those reasons] now. I would appreciate prompt review of
the enclosed information demonstrating medical necessity and coverage of KADCYLA for my patient.
Patient’s Clinical History
[Patient’s name] is a [age] year old [gender] who was diagnosed on [date] with HER2-positive,
metastatic breast cancer and has received prior treatment with trastuzumab (Herceptin) and a taxane.
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[Include diagnosis and dates]
[Any past treatments]
[Any test results that indicate failure of past treatment]
[Extenuating circumstances that would preclude alternatives to KADCYLA]
[Social & family information]
[REMINDER: If a payer has a published policy, include here]
[REMINDER: If state statute exists, include here]
Treatment Rationale
KADCYLA injection, for intravenous use, was FDA approved on [DATE] as a single agent for the
treatment of patients with HER2-positive, metastatic breast cancer who previously received
trastuzumab and a taxane, separately or in combination. Patients should have either:
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Received prior therapy for metastatic disease, or
Developed disease recurrence during or within six months of completing adjuvant therapy
The effectiveness of KADCYLA in HER2-positive, metastatic breast cancer patients who have
received prior taxane and trastuzumab-based therapy is based on progression-free survival.
KADCYLA is an antibody-drug conjugate (ADC) designed to selectively deliver a cytotoxic agent,
DM1, to HER2-overexpressing tumor cells. It consists of three components: trastuzumab, DM1, and an
MCC linker. Upon binding to HER2, KADCYLA undergoes receptor-mediated internalization resulting
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in intracellular release of DM1. DM1 binds to tubulin, which inhibits polymerization causing cell-cycle
arrest and ultimately leads to apoptotic cell death. The MCC linker is designed to limit systemic release
and increase targeted delivery of DM1 to malignant cells.
[Include plan of treatment (dosage, length of treatment), FDA Approval Letter, relevant journal articles,
clinical studies, and clinical practice guidelines (i.e. National Comprehensive Care Network) that
support the use of KADCYLA. Consider mentioning experts in the field who also support the
treatment]
Summary
In summary, I am requesting [appeal/redetermination/reconsideration] of the denial(s) of KADCYLA
therapy for my patient, [patient name]. My patient was diagnosed with HER2-positive, metastatic breast
cancer, a form of breast cancer which is potentially life threatening for patients with limited alternative
treatment options. I am requesting that you reconsider coverage based on the information above. I am
readily available at my office phone [MD phone number] to address any questions or concerns you
might have regarding this appeal.
Thank you for your time and consideration.
Sincerely,
(Physician’s name and credentials)
Enclosures (suggested enclosures below – delete what is not applicable):
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FDA Approval Letter for KADCYLA
Package Insert for KADCYLA
Safety information for KADCYLA (safety information can be found at www.KADCYLA.com)
Clinical notes/diagnostic pathology report
CT/PET scans showing progressive disease
Journal articles, clinical practice guidelines and other supporting documentation
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