ALECENSA Sample Coding
This coding information may assist you as you complete the payer forms for ALECENSA. 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
Non-small Cell Lung Cancer (NSCLC)
|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.
|50242-130-01 ||50242-0130-01 ||150 mg (240 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 Genentech BioOncology® Access Solutions for ALECENSA 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 Genentech BioOncology 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 Genentech BioOncology 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
ALECENSA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (mNSCLC) as detected by an FDA- approved test.
Important Safety Information
Hepatotoxicity: Monitor liver function tests every 2 weeks during the first 3 months of treatment, then once a month and as clinically indicated, with more frequent testing in patients who develop transaminase and bilirubin elevations. Based on the severity of the adverse reaction, withhold then dose reduce, or permanently discontinue ALECENSA.
Interstitial Lung Disease (ILD)/Pneumonitis: ILD/pneumonitis occurred in 0.7% of patients. Immediately withhold ALECENSA in patients diagnosed with ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis have been identified.
Renal Impairment: Renal impairment occurred in 8% of patients. Incidence of Grade ≥3 was 1.7%, of which 0.5% were fatal events. Based on the severity of the adverse reaction, withhold then dose reduce, or permanently discontinue ALECENSA.
Bradycardia: Monitor heart rate and blood pressure regularly. If symptomatic, withhold ALECENSA then dose reduce or permanently discontinue.
Severe Myalgia and Creatine Phosphokinase (CPK) Elevation: Advise patients to report any unexplained muscle pain, tenderness, or weakness. Assess CPK levels every 2 weeks for the first month of treatment and as clinically indicated in patients reporting symptoms. Based on the severity of the CPK elevation, withhold, then resume or dose reduce ALECENSA.
Embryo-Fetal Toxicity: ALECENSA can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ALECENSA and for 1 week following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with ALECENSA and for 3 months following the final dose.
Most Common Adverse Reactions: The most common adverse reactions (incidence ≥20%) were constipation (34%), fatigue (26%), myalgia (23%), edema (22%), and anemia (20%).
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
Please see additional Important Safety Information in full Prescribing Information.