Download Sample Letter of Medical Necessity – Breast Cancer

[Date]
[Payer name]
[Payer contact name]
[Payer address]
Patient: [Patient’s first and last name]
Subscriber ID#: [Insurance ID #]
Subscriber Group #: [Insurance group #]
Re: Authorization for PERJETA™ (pertuzumab) Intravenous Infusion
Dear [Payer Contact]:
I am writing to request an authorization of PERJETA for my patient, [patient name]. Please see
information below demonstrating the medical necessity of PERJETA for my patient. I would
appreciate prompt review of the enclosed information for authorization of PERJETA in combination
with trastuzumab and docetaxel 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 not received prior anti-HER2 therapy or chemotherapy for
metastatic disease.
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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 PERJETA]
[Social & family information]
[REMINDER: If a payer has a published policy, include here]
[REMINDER: If state statute exists, include here]
Treatment Rationale
PERJETA was FDA approved on June 8, 2012 in combination with trastuzumab and docetaxel for
patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy
or chemotherapy for metastatic disease. The effectiveness of PERJETA in combination with
trastuzumab and docetaxel in HER2-positive metastatic breast cancer patients who have not received
prior anti-HER2 therapy or chemotherapy for metastatic disease is based on progression free survival.
PERJETA is a recombinant humanized monoclonal antibody that is designed specifically to prevent the
HER2 receptor from pairing with other HER receptors (EGFR/ HER1, HER3 and HER4), a process that
is believed to play an important role in the growth and formation of several different cancer types. By
preventing receptor pairing, PERJETA is thought to block cell signaling, which may inhibit cancer cell
growth or lead to the death of the cancer cell. Binding of PERJETA to the HER2 receptor may also
signal the body’s immune system to destroy the cancer cells.
[Include plan of treatment (dosage, length of treatment), FDA Approval Letter, relevant journal articles,
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clinical studies, and clinical practice guidelines (i.e. National Comprehensive Care Network) that
support the use of PERJETA. Consider mentioning experts in the field who also support the treatment]
Summary
In summary, I am requesting authorization to treat my patient, [patient name] with PERJETA in
combination with trastuzumab and docetaxel. 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. Please review this information promptly for authorization of PERJETA.
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 PERJETA
Package Insert for PERJETA
Safety information for PERJETA (safety information can be found at www.PERJETA.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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