Learn About Our Services

Genentech BioOncology® Access Solutions for ALECENSA is your resource for access and reimbursement support after ALECENSA is prescribed.

Coverage

Help understanding benefits and coverage, such as benefits investigations and prior authorization resources

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Reimbursement

Sample coding information and resources for denials and appeals

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Product Distribution

A list of authorized distributors and specialty pharmacies

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Online Patient Enrollment

Submit Genentech BioOncology Access Solutions forms and check the status of your service requests online using My Patient Solutions

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Our Commitment to Patients

Over the past 20+ years,
Genentech has helped more than

1.7 million

patients access the Genentech medicines they need.

In 2017, we helped more than

227,000

patients access the Genentech medicines they need.

Communication assistance services

Genentech BioOncology Access Solutions employs a multilingual call center staff and offers teletypewriter (TTY) services for callers. 

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.