Forms and Documents

We've made enrollment simpler, faster and more intuitive with some key changes to our forms. The Prescriber Service Form and the Patient Consent Form are required for enrollment in Genentech Access SolutionsThese forms replace the Statement of Medical Necessity (SMN) and the Patient Authorization and Notice of Request for Transmission of Health Information to Genentech Access Solutions and Genentech® Access to Care Foundation (PAN).

 

POLIVY Access Solutions Enrollment Forms

 

Other Important Documents

Considerations for Composing a Letter of Medical Necessity

This guide provides tips to help you draft a letter of medical necessity. A sample letter is also included for your reference. Use the links below to find additional information to enclose in your letter.

FDA approval letter (Follow this link and search by the drug name)

Prescribing Information

Sample coding for POLIVY

 

Considerations for Composing a Sample Appeal Letter

This guide provides tips to help you draft an appeal letter. A sample letter is also included for your reference. Use the links below to find additional information to enclose in your letter.

FDA approval letter (Follow this link and search by the drug name)

Prescribing Information

Sample coding for POLIVY

 

Enrolling in the Genentech Patient Foundation

The Genentech Patient Foundation gives free medicine to people who don't have insurance coverage or who have financial concerns and to people who meet certain income criteria.

 

Temporary POLIVY Vial Supplement Program Form

Complete this form to enroll in the Temporary POLIVY Vial Supplement Program. Depending on an individual patient’s weight, a patient may require more than 1 single-use 140-mg vial of POLIVY per treatment cycle. This program provides a credit for the second infused vial per treatment cycle. To receive a credit, you must agree not to bill for the second vial.

Please note: Your patients must also be enrolled in POLIVY Access Solutions.

 

Fax Cover Letter

Use this cover sheet when faxing documents to POLIVY Access Solutions.

Important Safety Information & Indication

Indication Statement

POLIVY in combination with bendamustine and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least 2 prior therapies.

Accelerated approval was granted for this indication based on complete response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Warnings and Precautions
Peripheral Neuropathy: Monitor patients for peripheral neuropathy and modify or discontinue dose accordingly.
Infusion-Related Reactions: Premedicate with an antihistamine and an antipyretic. Monitor patients closely during infusions. Interrupt or discontinue infusion if reactions occur.
Myelosuppression: Monitor complete blood counts. Manage using dose delays or reductions and growth factor support. Monitor for signs of infection.
Serious and Opportunistic Infections: Closely monitor patients for signs of bacterial, fungal, or viral infections.
Progressive Multifocal Leukoencephalopathy (PML): Monitor patients for new or worsening neurological, cognitive, or behavioral changes suggestive of PML.
Tumor Lysis Syndrome: Closely monitor patients with high tumor burden or rapidly proliferating tumors.
Hepatotoxicity: Monitor liver enzymes and bilirubin.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 3 months after the last dose.

The Most Common Adverse Reactions
The most common adverse reactions (≥20%) included neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, nausea, pyrexia, decreased appetite, abdominal pain, and pneumonia.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the full Prescribing Information for additional Important Safety Information.