Erivedge Sample Coding
This coding information may assist you as you complete the payer forms for Erivedge. These tables are provided for informational purposes only. Please visit CMS.gov or other payers’ websites to obtain additional guidance on their processes related to billing and coding for single-use vials and wastage.
You can generate a PDF of these coding tables by selecting either the "Download All" or the "Download Section" button:
- "Download All" lets you download or print a coding table for all indications
- "Download Section" lets you download or print a coding table for a specific indication
Advanced Basal Cell Carcinoma
|Diagnosis: ICD-10-CM||C44.01||Basal cell carcinoma of various sites, overlapping sites and unspecified|
|Drug: NDC |
Note: Payer requirements regarding use of a 10-digit or 11-digit NDC may vary. Both formats are listed here for your reference.
|50242-140-01||50242-0140-01||150 mg (28 capsules)|
ICD-10-CM=International Classification of
Diseases, 10th Revision, Clinical Modification.
NDC=National Drug Code.
These codes are not all-inclusive; appropriate codes can vary by patient, setting of care and payer. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements. Genentech does not make any representation or guarantee concerning reimbursement or coverage for any service or item.
Many payers will not accept unspecified codes. If you use an
unspecified code, please check with your payer.
If your patient’s health insurance plan has issued a denial, your BioOncology Field Reimbursement Manager (BFRM) or Erivedge Access Solutions Specialist can provide resources as you prepare an appeal submission, as per your patient’s plan requirements.
If a plan issues a denial:
- The denial should be reviewed, along with the health insurance
plan’s guidelines to determine what to include in your patient’s
- Your BFRM or Erivedge Access Solutions Specialist has local payer coverage expertise and can help you determine specific requirements for your patient.
A sample appeal letter, checklist and additional tips are available in Forms and Documents.
Appeals cannot be completed or submitted by Erivedge Access Solutions on your behalf.
PAN=Patient Authorization and Notice of Request
for Transmission of Health Information to Genentech Access Solutions
and Genentech® Access to Care Foundation.
SMN=Statement of Medical Necessity.
Important Safety Information & 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
- 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
- Advise females of reproductive potential to use effective contraception during therapy with Erivedge and for 24 months after the final dose
- 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
- Advise patients not to donate blood or blood products while receiving Erivedge and for 24 months after the final dose of Erivedge
- 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
- 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
- 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.