ALECENSA Coverage
Benefits Investigations
Genentech BioOncology® Access Solutions for ALECENSA can conduct a
benefits investigation (BI) to help you determine if a Genentech
medicine is covered, if prior authorizations (PAs) are required, which
specialty pharmacy (SP) the health insurance plan prefers and if
patient assistance might be needed.
Potential outcomes of a BI:
- Treatment is covered
- PA is required
- Treatment is denied
A BI may be initiated once the SMN and PAN are submitted to
Genentech BioOncology Access Solutions.
These can be downloaded from Forms and Documents or submitted online via My Patient Solutions.
The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and health care provider. Genentech makes no representation or guarantee concerning coverage or reimbursement for any service or item.
Prior Authorization
Genentech BioOncology® Access Solutions for ALECENSA can help you
identify if a prior authorization (PA) is necessary and offer
resources as you obtain it for your patient. PA support may be
provided once the SMN and PAN are submitted to Genentech BioOncology
Access Solutions.
If your patient’s request for a PA is not granted, your BioOncology Field Reimbursement Manager (BFRM) or Genentech BioOncology Access Solutions Specialist can work with you to determine your next steps. You can find more tips like this in Forms and Documents.
The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and health care provider. Genentech makes no representation or guarantee concerning coverage or reimbursement for any service or item.
SureStart® Program
With the SureStart Program, eligible patients taking ALECENSA may receive free medicine while awaiting an insurance coverage determination.
If you think your patient qualifies for the SureStart Program,
submit the completed SMN and PAN to Genentech BioOncology® Access
Solutions for ALECENSA.
Eligible patients can receive a 30-day supply of ALECENSA. Once coverage has been determined, the patient no longer qualifies for the SureStart Program.
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
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.