Patient Financial and Practice Resources
Patient Financial and Practice Resources
Genentech can help identify the most appropriate assistance program to help your patient get the medicines he or she needs.
Is your patient insured?
Does your patient have commercial insurance?What does this mean?
Has your patient already been referred to the Genentech BioOncology Co-pay Card and is either ineligible or no longer receiving assistance?
Has your patient already been referred to an independent co-pay assistance foundation and is either ineligible or no longer receiving assistance?
Is the patient 18 years of age or older?
Your Patient Might Qualify for a Referral to the Genentech BioOncology Co-pay Card
If eligible commercially insured patients need assistance with their out-of-pocket costs, Genentech BioOncology® Access Solutions for ALECENSA can refer them to the Genentech BioOncology Co-pay Card.*
*In order to be eligible for the Genentech BioOncology Co-pay Card, the patient must have commercial insurance, must not have Medicare, Medicaid or other government insurance, and must meet other eligibility criteria. They also must agree to the rules set forth in the terms and conditions for the program. Please visit CopayAssistanceNow.com for the full list of terms and conditions.
Your Patient Might Qualify for a Referral to an Independent Co-pay Assistance Foundation
For eligible patients with commercial or public health insurance, Genentech BioOncology® Access Solutions for ALECENSA offers referrals to independent co-pay assistance foundations.*
*Genentech does not influence or control the operations or eligibility criteria of any independent co-pay assistance foundation and cannot guarantee co-pay assistance after a referral from Genentech BioOncology Access Solutions. The foundations to which we refer patients are not exhaustive or indicative of Genentech’s endorsement or financial support. There may be other foundations to support the patient's disease state.
Your Patient Might Qualify for a Referral to the Genentech® Access to Care Foundation (GATCF)
GATCF helps eligible patients who meet specific criteria receive their Genentech medicine free of charge.*
*To be eligible for free Genentech medicine from GATCF, insured patients must have exhausted all other forms of patient assistance (including the Genentech BioOncology Co-pay Card and support from independent co-pay assistance foundations) and meet financial criteria. Uninsured patients must meet different financial criteria.
Genentech BioOncology® Access Solutions for ALECENSA® (alectinib)
Genentech BioOncology Access Solutions offers a full range of access and reimbursement support for your patients and practice to minimize a delay in therapy and understand patient coverage and out-of-pocket (OOP) costs.
Patient Assistance Options
Genentech BioOncology Access Solutions can help identify the most appropriate patient assistance option to help eligible patients get the ALECENSA they have been prescribed. Our patient assistance options help patients with commercial insurance, public insurance (eg, Medicare Part D, Medicaid, TRICARE), or no insurance.a
Coverage and Reimbursement Support Services
Genentech BioOncology Access Solutions can conduct a benefits investigation (BI) to help you determine your patient’s coverage for ALECENSA. BIs can help your practice understand what’s covered, if prior authorizations (PAs) are required, and determine the patient’s cost sharing responsibilities.
Your patient will receive a letter with information about his or her specialty pharmacy and patient assistance for which he or she might qualify. Your practice will also receive a copy of the letter.
The Genentech BioOncology Co-pay Card
If your commercially insured patients have concerns about the OOP costs for ALECENSA, they may be eligible for the Genentech BioOncology Co-pay Card. Patients who qualify for the Genentech BioOncology Co-pay Card pay $25 per ALECENSA prescription. The annual benefit limit of the Co-pay Card is $25,000. There is no patient income requirement.
The SureStart® Program
If your eligible patient has not received an initial BI or PA decision for ALECENSA within 7 days, they can receive a free 30-day supply of ALECENSA. Shipments can continue for up to 3 months if a coverage decision is still pending.
For more information on ALECENSA patient and practice support programs and services
The ALECENSA Patient Support Line offers live phone service from registered oncology nurses to patients and their care partners, as well as translation services for a number of languages
|a||Patients must meet eligibility criteria.|
The Access Solutions logo is a registered trademark of Genentech, Inc. Genentech BioOncology® and its logo are registered trademarks of Genentech, Inc. SureStart® is a registered trademark of, and the SureStart logo is a trademark of Genentech, Inc.
Important Safety Information & Indication
ALECENSA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Warnings and Precautions
- Elevations of AST >5X the upper limit of normal (ULN) occurred in 3.6% of patients, and elevations of ALT >5X the ULN occurred in 4.8% of patients. Elevations of bilirubin >3X the ULN occurred in 2.8% of patients in Studies 1 and 2. The majority (76% of the patients with hepatic transaminase elevations and 68% of the patients with bilirubin elevations) of these events occurred during the first 3 months of treatment. Four patients discontinued ALECENSA for Grade 3-4 AST and/or ALT elevations, and three patients discontinued ALECENSA for Grade 3 bilirubin elevations. In Studies 1 and 2, two patients with Grade 3-4 AST/ALT elevations had documented drug-induced liver injury by liver biopsy. Concurrent elevations in ALT or AST ≥3X the ULN and total bilirubin ≥2X the ULN, with normal alkaline phosphatase, occurred in <1% of patients treated with ALECENSA across clinical trials
- Monitor liver function tests including ALT, AST, and total bilirubin 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 drug reaction, withhold ALECENSA and resume at a reduced dose, or permanently discontinue ALECENSA
Interstitial Lung Disease (ILD)/Pneumonitis
- Severe ILD (Grade 3) occurred in one (0.4%) of 253 patients exposed to ALECENSA in Studies 1 and 2
- Promptly investigate for ILD/pneumonitis in any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, and fever)
- Immediately withhold ALECENSA treatment in patients diagnosed with ILD/pneumonitis and permanently discontinue ALECENSA if no other potential causes of ILD/pneumonitis have been identified
- Symptomatic bradycardia can occur with ALECENSA. Cases of bradycardia (7.5%) have been reported in patients treated with ALECENSA. Twenty percent of 221 patients treated with ALECENSA for whom serial ECGs were available had heart rates of <50 beats per minute (bpm)
- Monitor heart rate and blood pressure regularly. Dose modification is not required in cases of asymptomatic bradycardia. In cases of symptomatic bradycardia that is not life-threatening, withhold ALECENSA until recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm and evaluate concomitant medications known to cause bradycardia, as well as anti-hypertensive medications. If attributable to a concomitant medication, resume ALECENSA at a reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm, with frequent monitoring as clinically indicated. Permanently discontinue ALECENSA in case of recurrence. Permanently discontinue ALECENSA in cases of life-threatening bradycardia if no contributing concomitant medication is identified
Severe Myalgia and Creatine Phosphokinase (CPK) Elevation
- Myalgia or musculoskeletal pain occurred in 29% of patients in Studies 1 and 2. The incidence of Grade 3 myalgia/musculoskeletal pain was 1.2%. Dose modifications for myalgia/musculoskeletal pain were required in 0.8% of patients
- Elevations of CPK occurred in 43% of 218 patients with CPK laboratory data available in Study 1 and Study 2. The incidence of Grade 3 elevations of CPK was 4.6%. Median time to Grade 3 CPK elevation was 14 days (interquartile range 13-14 days). Dose modifications for elevation of CPK occurred in 5.0% of patients
- 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 ALECENSA, then resume or reduce dose
- Based on findings from animal studies and its mechanism of action, ALECENSA can cause fetal harm when administered to pregnant women. Administration of ALECENSA to pregnant rats and rabbits during the period of organogenesis resulted in embryo-fetal toxicity and abortion at maternally toxic doses with exposures approximately 2.7X those observed in humans with ALECENSA 600 mg twice daily. 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
Most Common Adverse Reactions
- The most common adverse reactions (incidence ≥20%) were fatigue (41%), constipation (34%), edema (30%), and myalgia (29%). Management of adverse reactions may require temporary interruption, dose reduction, or discontinuation of treatment with ALECENSA
Use in Specific Populations
- Based on animal studies and its mechanism of action, ALECENSA can cause fetal harm when administered to a pregnant woman. There are no available data on ALECENSA use in pregnant women
- In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically-recognized pregnancies is 2% to 4% and 15% to 20%, respectively
- Because of the potential for serious adverse reactions in breast-fed infants from ALECENSA, advise a lactating woman not to breastfeed during treatment with ALECENSA and for 1 week after final dose
Females and Males of Reproductive Potential
- ALECENSA can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ALECENSA and for 1 week after the final dose
- Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with ALECENSA and for 3 months following the final dose
Patient Counseling Information
- Inform patients of the signs and symptoms of photosensitivity. Advise patients to avoid prolonged sun exposure while taking ALECENSA and for at least 7 days after discontinuation and to use proper protection from the sun. Advise patients to use a broad spectrum ultraviolet A (UVA)/ultraviolet B (UVB) sunscreen and lip balm (SPF ≥50) to help protect against potential sunburn