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Benefits Investigation

 

Why is a benefits investigation important?

 

Erivedge Access Solutions conducts Benefits Investigation (BI) to help you better understand your patient's health plan coverage for some or all of the costs associated with Erivedge® (vismodegib) treatment. The BI can also determine if a prior authorization or patient assistance might be needed.

 

To have Erivedge Access Solutions conduct a BI, all you need to do is request our assistance on the signed Statement of Medical Necessity (SMN) form.

 

 

 

There are 3 possible outcomes of a BI:

  • Treatment is covered
  • Prior Authorization is required
  • Treatment is denied

 

To begin with Erivedge Access Solutions, you must complete and submit the SMN and have your patient complete and submit a Patient Authorization and Notice of Release of Information (PAN) form.

 

The SMN can be submitted online via My Patient Solutions™ or downloaded from Forms and Documents.

Patients can access the PAN through Forms and Documents 

 

This description of a BI is for informational purposes only. The completion and submission of a BI are the responsibility of the patient and your office. Erivedge Access Solutions makes no representation or guarantee concerning reimbursement or coverage for any service or item.

 

Prior Authorization

 

Erivedge Access Solutions can help your practice identify whether a prior authorization (PA) is needed and help you in the process of securing it. All we need to begin are a completed and signed SMN form requesting our assistance with the PA as well as a signed and dated PAN form.

 

 

 

 

Erivedge Access Solutions can help you as you submit the required PA forms and documentation. If the PA is not granted, Erivedge Access Solutions can work with you to determine your next steps. Tips like this can be found in Forms and Documents.

 

FAQs

Q: How long does it take to establish coverage for Erivedge?
A: Several factors affect when and where patients may receive treatment. The time it takes to assess a PA varies among plans. In most cases, it takes 15 to 45 days to establish coverage. In some cases, a PA is not needed.

Q: If the prior authorization is approved, what is the approval duration?
A: Approval lengths can vary among health plans. Contact the plan to determine the duration of the authorization. Be aware of deadlines, since some can be as early as one month after the approval date.

Erivedge Sure Start

With the Erivedge Sure Start Program, the patient can begin receiving free treatment while awaiting a coverage determination.

 

Erivedge Sure Start Program Eligibility

A patient should be eligible for the Erivedge Sure Start Program if the following conditions are met:

 

  • Patient is taking Erivedge for a labeled indication
  • Your patient has not received the initial benefits investigation (BI) or prior authorization (PA) decision for Erivedge within 7 days
  • Your patient has not received a coverage decision within 7 days from Erivedge Access Solutions receipt of the SMN form

 

Patients who are not eligible for the Erivedge Sure Start Program include:

 

  • A patient who is not insured
  • A patient whose health plan does not require a Prior Authorization (PA)

 

If your patient qualifies for the Erivedge Sure Start Program, submit completed SMN and PAN forms to Erivedge Access Solutions.

 

 

Eligible patients can receive a 14-day supply of Erivedge for up to 6 refills. Once coverage has been determined, the patient no longer qualifies for the Erivedge Sure Start Program.

Did you know...


 

  • Learn more about prior authorizations by downloading our Prior Authorization Tips in Forms and Documents.
  • For a checklist to help you conduct a prior authorization, visit Forms and Documents.

 

Learn More About
Erivedge
  • LEARN about treatment with Erivedge
  • FIND the right patient assistance program with our Compass for Patient Access tool
  • LEARN HOW the Genentech BioOncology Co-pay Card can help with the out-of-pocket costs for Erivedge
  • Download: new forms for enrollment in GATCF

 

 

 

 

 

 

 

  • Form Statement of Medical Necessity
  • Form Statement of Medical Necessity for Dermatologists, Mohs Surgeons and Other Specialties
  • Form Patient Authorization and Notice of Release of Information

Erivedge Indication and Important Safety Information

INDICATION

ERIVEDGE® (vismodegib) capsule is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.

Boxed Warning and Additional Important Safety Information

Embryo-Fetal Death and Severe Birth Defects

  • Erivedge capsule can cause fetal harm when administered to a pregnant woman based on its mechanism of action
  • Verify pregnancy status prior to the initiation of Erivedge. Advise male and female patients of these risks. Advise female patients of the need for contraception during and after treatment and advise male patients of the potential risk of Erivedge exposure through semen
  • Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant
  • Immediately report exposure to Erivedge during pregnancy and encourage women who may have been exposed to Erivedge during pregnancy, either directly or through seminal fluid, to participate in the Erivedge pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at (888) 835-2555

Blood Donation

  • Advise patients not to donate blood or blood products while receiving Erivedge and for at least 7 months after the last dose of Erivedge

Nursing Mothers

  • Inform female patients of the potential for serious adverse reactions in nursing infants from Erivedge, taking into account the importance of the drug to the mother

Adverse Reactions

  • The most common adverse reactions (≥10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia
  • In clinical trials, a total of 3 of 10 premenopausal women developed amenorrhea while receiving Erivedge
  • Treatment-emergent grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%)

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 accompanying full Prescribing Information for a complete discussion of the risks associated with Erivedge, including the BOXED WARNING and the Medication Guide.