Assistance Options for Your Eligible Patients

Several options are available to help eligible patients with the out-of-pocket (OOP) costs of ALECENSA® (alectinib).

Find out if your patients could be eligible using the Patient Assistance Tool.

  • Is your patient insured?

  • Does the patient's insurance cover his or her Genentech medicine?

  • Does your patient have commercial insurance?

  • Has your patient already been referred to the Genentech Oncology Co-pay Assistance Program 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 Oncology Co-pay Assistance Program

If eligible commercially insured patients need assistance with their out-of-pocket costs, ALECENSA Access Solutions can refer them to the Genentech Oncology Co-pay Assistance Program.*

 

Learn More

 

*Eligibility criteria apply. Not valid for patients using federal or state government programs to pay for their medications and or administration of their Genentech medication. Patient must be taking the Genentech medication for an FDA-approved indication. See full Terms and Conditions at CopayAssistanceNow.com.

Your Patient Might Qualify for a Referral to an Independent Co-pay Assistance Foundation

For eligible patients with commercial or public health insurance, ALECENSA Access Solutions offers referrals to independent co-pay assistance foundations.*

 

Learn More

 

*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 ALECENSA 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 Patient Foundation

The Genentech Patient Foundation provides free Genentech medicine to people who don't have insurance coverage or who have financial concerns and to people who meet certain income criteria.*

 

Learn More

 

*To be eligible for free Genentech medicine from the Genentech Patient Foundation, insured patients who have coverage for their medicine should try to pursue other forms of financial assistance, if available, and meet certain income requirements. Uninsured patients and insured patients without coverage for their medicine must meet a different set of income requirements.

Out of pocket icon

Does Your Patient Have Commercial Insurance?

ALECENSA Access Solutions can refer eligible patients to the Genentech Oncology Co-pay Assistance Program for help with the out-of-pocket costs associated with ALECENSA.*

Patient assistance options icon

Does Your Patient Have Insurance?

If eligible publicly or commercially insured patients have difficulty paying for their co-pay, co-insurance or other OOP costs, ALECENSA Access Solutions can refer them to an independent co-pay assistance foundation supporting their disease state.

Genentech Patient Foundation icon

Does Your Patient Have No Insurance or Insurance Coverage, or High Out-of-Pocket Costs?

The Genentech Patient Foundation gives free Genentech medicine to people who don’t have insurance coverage or who have financial concerns and meet eligibility criteria.

Coverage determination icon

Is Your Patient Awaiting Coverage Determination?

With the ALECENSA SureStart® Program, eligible patients taking ALECENSA may receive free medicine while awaiting an insurance coverage determination.

*Eligibility criteria apply. Not valid for patients using federal or state government programs to pay for their medications and/or administration of their Genentech medication. Patient must be taking the Genentech medication for an FDA-approved indication. See full Terms and Conditions at CopayAssistanceNow.com.
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 Oncology 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.
To be eligible for free Genentech medicine from the Genentech Patient Foundation, insured patients who have coverage for their medicine should try to pursue other forms of financial assistance, if available, and meet certain income requirements. Uninsured patients and insured patients without coverage for their medicine must meet a different set of income requirements.

ALECENSA Access Solutions provides reliable, effective access and reimbursement support to assist your patients and practice after ALECENSA is prescribed.

Learn how we help.

Determine which patient assistance option is right for your patient with the Patient Assistance Tool.

To enroll in Genentech patient support services, patients always complete the Patient Consent Form. Prescribers choose a form based on the specific patient needs: 

Each option has its own time period where your eligible patients will receive assistance. You can call us at (877) 436-3683 for more information.

To learn more about our programs and services:

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.

Warnings and Precautions

Hepatotoxicity

  • Of 405 patients, elevations of AST >5X the upper limit of normal (ULN) occurred in 4.6% of patients, and elevations of ALT >5X the ULN occurred in 5.3% of patients. Elevations of bilirubin >3X the ULN occurred in 3.7% of patients. The majority (69% 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. Six patients discontinued ALECENSA for Grades 3-4 AST and/or ALT elevations, and 4 patients discontinued ALECENSA for Grade 3 bilirubin elevations. 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. Three patients with Grades 3-4 AST/ALT elevations had drug-induced liver injury (2 documented by liver biopsy)
  • 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

  • ILD/pneumonitis occurred in 3 (0.7%) patients treated with ALECENSA. One (0.2%) of these events was severe (Grade 3)
  • 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

Renal Impairment

  • Renal impairment occurred in 8% of patients. The incidence of Grade ≥3 renal impairment was 1.7%, of which 0.5% were fatal events
  • Dose modifications for renal impairment were required in 3.2% of patients. Median time to Grade ≥3 renal impairment was 3.7 months (range 0.5 to 14.7 months)
  • Permanently discontinue ALECENSA for Grade 4 renal toxicity. Withhold ALECENSA for Grade 3 renal toxicity until recovery to ≤1.5X ULN, then resume at reduced dose

Bradycardia

  • Symptomatic bradycardia can occur with ALECENSA. Cases of bradycardia (8.6%) have been reported in patients treated with ALECENSA. Eighteen percent of 365 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 are 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 26% of patients. The incidence of Grade 3 myalgia/musculoskeletal pain was 0.7%. Dose modifications for myalgia/musculoskeletal pain were required in 0.5% of patients
  • Elevations of CPK occurred in 41% of 347 patients with CPK laboratory data. The incidence of Grade 3 elevations of CPK was 4.0%. Median time to Grade 3 CPK elevation was 14 days (interquartile range 13-28 days). Dose modifications for elevation of CPK occurred in 3.2% 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

Embryo-Fetal Toxicity

  • 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 constipation (34%), fatigue (26%), edema (22%), myalgia (23%), and anemia (20%)

Use in Specific Populations

Pregnancy

  • 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

Lactation

  • Because of the potential for serious adverse reactions in breastfed 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

Hepatic Impairment

  • Increased exposure of alectinib occurred in patients with severe hepatic impairment (Child-Pugh C). The recommended dose of ALECENSA in patients with severe hepatic impairment (Child-Pugh C) is 450 mg orally twice daily

Patient Counseling Information

Photosensitivity

  • 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

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.

    • SHS US Claims, January 2019-June 2020; IQVIA US Claims, July-December 2020.

      SHS US Claims, January 2019-June 2020; IQVIA US Claims, July-December 2020.

    • ALECENSA [prescribing information]. South San Francisco, CA: Genentech USA, Inc; 2021.

      ALECENSA [prescribing information]. South San Francisco, CA: Genentech USA, Inc; 2021.

    • Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non–small cell lung cancer. N Engl J Med. 2017;377:829-838.

      Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non–small cell lung cancer. N Engl J Med. 2017;377:829-838.

    • Data on file. Genentech, Inc.

      Data on file. Genentech, Inc.

    • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.1.2021. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed December 1, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. 

      Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.1.2021. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed December 1, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. 

    • Carnio S, Novello S, Mele T, Levra MG, Scagliotti GV. Extending survival of stage IV non-small cell lung cancer. Semin Oncol. 2014;41:69-92.

      Carnio S, Novello S, Mele T, Levra MG, Scagliotti GV. Extending survival of stage IV non-small cell lung cancer. Semin Oncol. 2014;41:69-92.

    • Deeken JF, Löscher W. The blood-brain barrier and cancer: transporters, treatment, and Trojan horses. Clin Cancer Res. 2007;13:1663-1674.

      Deeken JF, Löscher W. The blood-brain barrier and cancer: transporters, treatment, and Trojan horses. Clin Cancer Res. 2007;13:1663-1674.

    • Silvestri GA, Gould MK, Margolis ML, et al. Noninvasive staging of non-small cell lung cancer: ACCP evidenced-based clinical practice guidelines (2nd edition). Chest. 2007;132(suppl):178S-201S.

      Silvestri GA, Gould MK, Margolis ML, et al. Noninvasive staging of non-small cell lung cancer: ACCP evidenced-based clinical practice guidelines (2nd edition). Chest. 2007;132(suppl):178S-201S.

    • Jena A, Taneja S, Talwar V, Sharma JB. Magnetic resonance (MR) patterns of brain metastasis in lung cancer patients: correlation of imaging findings with symptom. J Thorac Oncol. 2008;3:140-144.

      Jena A, Taneja S, Talwar V, Sharma JB. Magnetic resonance (MR) patterns of brain metastasis in lung cancer patients: correlation of imaging findings with symptom. J Thorac Oncol. 2008;3:140-144.

    • Sakamoto H, Tsukaguchi T, Hiroshima S, et al. CH5424802, a selective ALK inhibitor capable of blocking the resistant gatekeeper mutant. Cancer Cell. 2011;19:679-690.

      Sakamoto H, Tsukaguchi T, Hiroshima S, et al. CH5424802, a selective ALK inhibitor capable of blocking the resistant gatekeeper mutant. Cancer Cell. 2011;19:679-690.

    • Kodama T, Hasegawa M, Takanashi K, Sakurai Y, Kondoh O, Sakamoto H. Antitumor activity of the selective ALK inhibitor alectinib in models of intracranial metastases. Cancer Chemother Pharmacol. 2014;74:1023-1028.

      Kodama T, Hasegawa M, Takanashi K, Sakurai Y, Kondoh O, Sakamoto H. Antitumor activity of the selective ALK inhibitor alectinib in models of intracranial metastases. Cancer Chemother Pharmacol. 2014;74:1023-1028.

    • Löscher W, Potschka H. Blood-brain barrier active efflux transporters: ATP-binding cassette gene family. NeuroRx. 2005;2:86-98.

      Löscher W, Potschka H. Blood-brain barrier active efflux transporters: ATP-binding cassette gene family. NeuroRx. 2005;2:86-98.

    • Schinkel AH, Jonker JW. Mammalian drug efflux transporters of the ATP binding cassette (ABC) family: an overview. Adv Drug Deliv Rev. 2003;55:3-29.

      Schinkel AH, Jonker JW. Mammalian drug efflux transporters of the ATP binding cassette (ABC) family: an overview. Adv Drug Deliv Rev. 2003;55:3-29.

    • Bartels AL. Blood-brain barrier p-glycoprotein function in neurodegenerative disease. Curr Pharm Des. 2011;17:2771-2777.

      Bartels AL. Blood-brain barrier p-glycoprotein function in neurodegenerative disease. Curr Pharm Des. 2011;17:2771-2777.

    • Camidge DR, Dziadziuszko R, Peters S, et al. Updated efficacy and safety data and impact of the EML4-ALK fusion variant on the efficacy of alectinib in untreated ALK-positive advanced non-small cell lung cancer in the global phase III ALEX study [published online March 19, 2019]. J Thorac Oncol. doi:10.1016/j.jtho.2019.03.007.

      Camidge DR, Dziadziuszko R, Peters S, et al. Updated efficacy and safety data and impact of the EML4-ALK fusion variant on the efficacy of alectinib in untreated ALK-positive advanced non-small cell lung cancer in the global phase III ALEX study [published online March 19, 2019]. J Thorac Oncol. doi:10.1016/j.jtho.2019.03.007.

    • Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non–small cell lung cancer. N Engl J Med. 2017;377(protocol):1-384.

      Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non–small cell lung cancer. N Engl J Med. 2017;377(protocol):1-384.

    • Gadgeel, S. Alectinib vs crizotinib in treatment-naïve ALK+ NSCLC: CNS efficacy results from the ALEX study. Oral presentation at: European Society for Medical Oncology Congress; September, 2017; Madrid, Spain.

      Gadgeel, S. Alectinib vs crizotinib in treatment-naïve ALK+ NSCLC: CNS efficacy results from the ALEX study. Oral presentation at: European Society for Medical Oncology Congress; September, 2017; Madrid, Spain.

    • Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer. N Engl J Med. 2017;377(suppl):1-14.

      Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer. N Engl J Med. 2017;377(suppl):1-14.

    • Camidge DR, Peters S, Mok T, et al. Updated efficacy and safety data from the global phase III ALEX study of alectinib (ALC) vs crizotinib (CZ) in untreated advanced ALK+ NSCLC. Abstract no. 9043. Presented at: 2018 American Society of Clinical Oncology Annual Meeting; June 1-5, 2018; Chicago, IL.

      Camidge DR, Peters S, Mok T, et al. Updated efficacy and safety data from the global phase III ALEX study of alectinib (ALC) vs crizotinib (CZ) in untreated advanced ALK+ NSCLC. Abstract no. 9043. Presented at: 2018 American Society of Clinical Oncology Annual Meeting; June 1-5, 2018; Chicago, IL.