Reimbursement

Tarceva Sample Coding

This coding information may assist you as you complete the payer forms for Tarceva. 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
TYPE CODE DESCRIPTION
Diagnosis: ICD-10-CM C25.0—C25.3, C25.7—C25.9 Malignant neoplasm of pancreas
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.
10-digit 11-digit  
50242-062-01 50242-0062-01 25 mg (30 tablets)
50242-063-01 50242-0063-01 100 mg (30 tablets)
50242-064-01 50242-0064-01 150 mg (30 tablets)

ICD-10-CM=International Classification of Diseases, 10th Revision, Clinical Modification.
NDC=National Drug Code.

TYPE CODE DESCRIPTION
Diagnosis: ICD-10-CM C33 Malignant neoplasm of trachea
C34.00—C34.02 Malignant neoplasm of bronchus and lung; main bronchus
C34.10—C34.12 Malignant neoplasm of bronchus and lung; upper lobe
C34.2 Malignant neoplasm of bronchus and lung; middle lobe
C34.30—C34.32 Malignant neoplasm of bronchus and lung; lower lobe
C34.80—C34.82 Malignant neoplasm of bronchus and lung; overlapping sites
C34.90—C34.92 Malignant neoplasm of bronchus and lung; unspecified part
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.
10-digit 11-digit  
50242-062-01 50242-0062-01 25 mg (30 tablets)
50242-063-01 50242-0063-01 100 mg (30 tablets)
50242-064-01 50242-0064-01 150 mg (30 tablets)

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 and Astellas Pharma US do 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.

Appeals

If your patient’s health insurance plan has issued a denial, your BioOncology Field Reimbursement Manager (BFRM) or Tarceva 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:

  1. The denial should be reviewed, along with the health insurance plan’s guidelines to determine what to include in your patient’s appeal submission.
  2. Your BFRM or Tarceva Access Solutions Specialist has local payer coverage expertise and can help you determine specific requirements for your patient.

A sample appeal letter and additional considerations are available in Forms and Documents.

Appeals cannot be completed or submitted by Tarceva 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.

Important Safety Information & Indication

Indications

Metastatic Non-Small Cell Lung Cancer (NSCLC)

Tarceva is indicated for:

  • The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.

Limitations of use:

  • Safety and efficacy of Tarceva have not been established in patients with NSCLC whose tumors have other EGFR mutations.
  • Tarceva is not recommended for use in combination with platinum-based chemotherapy.

Pancreatic Cancer

Tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Important Safety Information

  • WARNINGS AND PRECAUTIONS:
    • Cases of serious interstitial lung disease (ILD), including fatal cases, have been reported.
    • Hepatic failure, hepatorenal syndrome, and severe acute renal failure (all including fatal cases) and renal insufficiency have been reported.
    • Gastrointestinal perforation (including fatal cases) has been reported.
    • Bullous, blistering and exfoliative skin conditions, including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal, have been reported.
    • In the pooled incidences in the 3 monotherapy lung studies and the pancreatic carcinoma trial, serious adverse reactions, including fatal cases, such as cerebrovascular accident and microangiopathic hemolytic anemia with thrombocytopenia were reported.
    • Decreased tear production, abnormal eyelash growth, keratoconjunctivitis sicca or keratitis can occur and can lead to corneal perforation or ulceration.
    • Severe and fatal hemorrhage associated with International Normalized Ratio (INR) elevations can occur when Tarceva and warfarin are used concurrently.
    • Embryo-fetal toxicity. Women should be advised to avoid pregnancy or breastfeeding.
  • MOST COMMON ADVERSE REACTIONS:
    • Metastatic NSCLC – First-Line Treatment of Patients With EGFR Mutations:
      • Diarrhea, asthenia, rash, cough, dyspnea, and decreased appetite.
    • Metastatic NSCLC – Maintenance Treatment:
      • Rash and diarrhea.
    • Metastatic NSCLC – Second/Third-line Treatment:
      • Rash and diarrhea.
    • Advanced Pancreatic Cancer – Tarceva Administered Concurrently with Gemcitabine:
      • Fatigue, rash, nausea, anorexia, and diarrhea.

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.

For additional Important Safety Information, please see full Prescribing Information.