Forms and Documents

Erivedge Access Solutions Enrollment Forms

The Prescriber Service Form and PAN are required for enrollment in Erivedge Access Solutions. The Prescriber Service Form replaces the Statement of Medical Necessity (SMN).

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 Erivedge

 

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 Erivedge

 

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.

 

Fax Cover Letter

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

PAN=Patient Authorization and Notice of Request for Transmission of Health Information to Genentech Access Solutions and Genentech® Access to Care Foundation.

Important Safety Information & Indication

Indication

ERIVEDGE® (vismodegib) capsule is 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.

Important Safety Information and BOXED WARNINGS

Embryo-Fetal Toxicity

  • Erivedge can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Erivedge is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations
  • Verify pregnancy status of females of reproductive potential within 7 days prior to initiating Erivedge therapy. Advise females of reproductive potential to use effective contraception during and after Erivedge therapy. Advise males of the potential risk of Erivedge exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential. Advise pregnant women of the potential risks to a fetus
  • Advise female patients and female partners of male patients to contact their healthcare provider with a known or suspected pregnancy. Report pregnancies to Genentech at (888) 835‑2555

Female Patients

  • Advise females of reproductive potential to use effective contraception during therapy with Erivedge and for 24 months after the final dose

Male Patients

  • Advise males of the potential risk to an embryo or fetus if a female partner of reproductive potential is exposed to Erivedge. Advise male patients to use condoms with a pregnant partner or a female partner of reproductive potential, even after a vasectomy, during therapy and for 3 months after the final dose of Erivedge

Blood Donation

  • Advise patients not to donate blood or blood products while receiving Erivedge and for 24 months after the final dose of Erivedge

Semen Donation

  • Vismodegib is present in semen. It is not known if the amount of vismodegib in semen can cause embryo-fetal harm. Advise male patients not to donate semen during and for 3 months after the final dose of Erivedge

Premature Fusion of the Epiphyses

Premature fusion of the epiphyses has been reported in pediatric patients exposed to ERIVEDGE. In some cases, fusion progressed after drug discontinuation

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
  • Amenorrhea can occur in females of reproductive Reversibility of amenorrhea is unknown. In clinical trials, a total of 3 of 10 pre-menopausal 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%)
  • Additionally, in a post-approval clinical trial conducted in 1232 patients with locally advanced or metastatic BCC treated with ERIVEDGE, a subset of 29 patients had baseline values for CPK reported. Within the subset of patients, 38% had a shift from baseline, and one of the patients had a Grade 3 value. The prevalence of Grade 3/4 CPK elevation across the entire study population with any CPK measurement was 2.4% (11 out of 453 patients)

Use In Specific Populations

Lactation

  • No data are available regarding the presence of vismodegib in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Because of the potential for serious adverse reactions in breastfed infants from Erivedge, advise a nursing woman that breastfeeding is not recommended during therapy with Erivedge and for 24 months after the final dose

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 a complete discussion of the risks associated with Erivedge, including the BOXED WARNING and the Medication Guide.