ALECENSA Access Solutions offers a range of access and reimbursement resources for your patients and practice after ALECENSA is prescribed, including help with benefits investigations (BIs), resources for prior authorizations (PAs), sample billing and coding information, resources for denials and appeals, information about distribution and referrals to potential financial assistance options.
Get help understanding insurance benefits and coverage, such as with benefits investigations and prior authorization resources.
ALECENSA Access Solutions can conduct a benefits investigation (BI) which can determine:
*If your patient’s request for a prior authorization is not granted, your ALECENSA Access Solutions Specialist can work with you to determine your next steps.
Get started with enrollment by following the steps below.
If your practice has a registered account for My Patient Solutions, you can get started by logging into your account.
Don't have an account?
Your patient is required to complete the Patient Consent Form. You can either upload their Patient Consent Form as part of your application or have your patient submit the form via fax, text or e-submit.
An online tool to help you enroll patients in ALECENSA Access Solutions and manage your service requests at your convenience.
Step 1: Print one of the Patient Consent Forms below for your patient to complete.
Step 2: Print and complete the Prescriber Service Form below.
Step 3: Submit the completed forms via fax or text.
Both forms are required. We must have both the Patient Consent Form and the Prescriber Service Form before we can help you.
What to expect next:
Genentech reserves the right to modify or discontinue the program at any time and to verify the accuracy of information submitted.
The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and healthcare provider. Genentech makes no representation or guarantee concerning coverage or reimbursement for any service or item.
When a medical treatment is authorized by the patient’s insurance plan for a limited period of time, it will generally require reverification of coverage for continued treatment. ALECENSA Access Solutions can help you obtain reverification for your patients.
If the patient’s health insurance plan denies the request for reverification, your practice may file an appeal on behalf of your patient.
Sample coding information and resources for denials and appeals
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.
Download sample coding and the important safety information for ALECENSA below.
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.
If your patient’s health insurance plan has issued a denial, your ALECENSA Access Solutions Specialist can provide resources as you prepare an appeal submission, as per your patient’s plan requirements.
If a plan issues a denial:
A sample appeal letter and additional considerations are available on the Practice Forms and Documents page.
Appeals cannot be completed or submitted by Genentech on your behalf.
My Patient Solutions is an online tool to help you enroll patients in ALECENSA Access Solutions and manage your service requests, all through one portal. It allows you the flexibility to work with ALECENSA Access Solutions when it’s convenient for you.
With My Patient Solutions, you can:
How to register
Account registration can be completed by one person for the entire practice and for multiple practice locations. For help with registration or if you have questions, call us at 877-GENENTECH (877-436-3683) (6AM-5PM PST, Monday through Friday).
Genentech has contracted with a network of authorized specialty distributors and specialty pharmacies (SPs) to service practices choosing to prescribe ALECENSA.
These partners have made a commitment to product integrity and have agreed to distribute only products purchased directly from Genentech and not to distribute ALECENSA through secondary channels.
For a full list of authorized distributors and in-network specialty pharmacies, please visit the Genentech Access Solutions website or contact ALECENSA Access Solutions at 888-249-4918.
With Buy and Bill, the practice purchases the medication in advance, then bills the patient's health insurance plan for reimbursement. The practice is responsible for storing and handling the drug as well as collecting the patient's co-pay for both the drug and its administration. With Buy and Bill, practices can maintain a stock of the drug, giving them the flexibility to treat patients when clinically appropriate.
ALECENSA Access Solutions works with specialty pharmacies (SPs) to help patients receive their prescribed Genentech medicines.
In addition to distributing medicines, an SP may provide the following services:
You can work with your preferred SP or contact ALECENSA Access Solutions to learn which SP the patient’s health insurance plan mandates or prefers.
Genentech does not influence or advocate the use of any one specialty distributor or specialty pharmacy. We make no representation or guarantee of service or coverage of any item. For any product-specific distribution questions, call ALECENSA Access Solutions at 888-249-4918 (6AM-5PM PST, Monday through Friday).
We are serious about patient safety. If your Genentech product is spoiled, expired or damaged, we may be able to help you replace it.
Please contact Genentech Customer Service at (800) 551-2231 for any order or return-related questions.
ALECENSA [prescribing information]. South San Francisco, CA: Genentech USA, Inc; 2024.
ALECENSA [prescribing information]. South San Francisco, CA: Genentech USA, Inc; 2024.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.10.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed September 24, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way. See the NCCN Guidelines® for detailed recommendations.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.10.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed September 24, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way. See the NCCN Guidelines® for detailed recommendations.
Arbour KC, Riely GJ. Diagnosis and treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer. Hematol Oncol Clin North Am. 2017;31(1):101-111.
Arbour KC, Riely GJ. Diagnosis and treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer. Hematol Oncol Clin North Am. 2017;31(1):101-111.
Gainor JF, Shaw AT. Novel targets in non-small cell lung cancer: ROS1 and RET fusions. Oncologist. 2013;18(7):865-875.
Gainor JF, Shaw AT. Novel targets in non-small cell lung cancer: ROS1 and RET fusions. Oncologist. 2013;18(7):865-875.
Chevallier M, Borgeaud M, Addeo A, Friedlaender A. Oncogenic driver mutations in non-small cell lung cancer: past, present and future. World J Clin Oncol. 2021;12(4):217-237.
Chevallier M, Borgeaud M, Addeo A, Friedlaender A. Oncogenic driver mutations in non-small cell lung cancer: past, present and future. World J Clin Oncol. 2021;12(4):217-237.
Chen MF, Chaft JE. Early-stage anaplastic lymphoma kinase (ALK)-positive lung cancer: a narrative review. Transl Lung Cancer Res. 2023;12(2):337-345. doi: 10.21037/tlcr-22-631
Chen MF, Chaft JE. Early-stage anaplastic lymphoma kinase (ALK)-positive lung cancer: a narrative review. Transl Lung Cancer Res. 2023;12(2):337-345. doi: 10.21037/tlcr-22-631
Johung KL, Yeh N, Desai NB, et al. Extended survival and prognostic factors for patients with ALK-rearranged non-small-cell lung cancer and brain metastasis. J Clin Oncol. 2016;34(2):123-129.
Johung KL, Yeh N, Desai NB, et al. Extended survival and prognostic factors for patients with ALK-rearranged non-small-cell lung cancer and brain metastasis. J Clin Oncol. 2016;34(2):123-129.
Rangachari D, Yamaguchi N, VanderLaan PA. Brain metastases in patients with EGFR-mutated or ALK-rearranged non-small-cell lung cancers. Lung Cancer. 2015;88(1):108-111. doi: 10.1016/j.lungcan.2015.01.020.
Rangachari D, Yamaguchi N, VanderLaan PA. Brain metastases in patients with EGFR-mutated or ALK-rearranged non-small-cell lung cancers. Lung Cancer. 2015;88(1):108-111. doi: 10.1016/j.lungcan.2015.01.020.
Chouaid C, Danson S, Andreas S, et al. Adjuvant treatment patterns and outcomes in patients with stage IB-IIIA non-small cell lung cancer in France, Germany, and the United Kingdom based on the LuCaBIS burden of illness study. Lung Cancer. 2018;124:310-316.
Chouaid C, Danson S, Andreas S, et al. Adjuvant treatment patterns and outcomes in patients with stage IB-IIIA non-small cell lung cancer in France, Germany, and the United Kingdom based on the LuCaBIS burden of illness study. Lung Cancer. 2018;124:310-316.
Postmus PE, Kerr KM, Oudkerk M, et al. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(suppl 4): iv1-iv21.
Postmus PE, Kerr KM, Oudkerk M, et al. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(suppl 4): iv1-iv21.
Wan JCM, Massie C, Garcia-Corbacho J, et al. Liquid biopsies come of age: towards implementation of circulating tumour DNA. Nat Rev Cancer. 2017;17(4):223-238.
Wan JCM, Massie C, Garcia-Corbacho J, et al. Liquid biopsies come of age: towards implementation of circulating tumour DNA. Nat Rev Cancer. 2017;17(4):223-238.
Kris MG, Mitsudomi T, Peters S. Adjuvant therapies in stages I–III epidermal growth factor receptor-mutated lung cancer: current and future perspectives. Transl Lung Cancer Res. 2023;12(4):824-836.
Kris MG, Mitsudomi T, Peters S. Adjuvant therapies in stages I–III epidermal growth factor receptor-mutated lung cancer: current and future perspectives. Transl Lung Cancer Res. 2023;12(4):824-836.
West H, Hu X, Zhang S, et al. Treatment patterns and outcomes in resected early-stage non-small cell lung cancer: an analysis of the SEER-Medicare data. Clin Lung Cancer. 2023;24(3):260-268.
West H, Hu X, Zhang S, et al. Treatment patterns and outcomes in resected early-stage non-small cell lung cancer: an analysis of the SEER-Medicare data. Clin Lung Cancer. 2023;24(3):260-268.
Yang P, Kulig K, Boland JM, et al. Worse disease-free survival in never smokers with ALK+ lung adenocarcinoma. J Thorac Oncol. 2012;7:90-97.
Yang P, Kulig K, Boland JM, et al. Worse disease-free survival in never smokers with ALK+ lung adenocarcinoma. J Thorac Oncol. 2012;7:90-97.
Shin SH, Lee H, Jeong B-H, et al. Anaplastic lymphoma kinase rearrangement in surgically resected stage IA lung adenocarcinoma. J Thorac Dis. 2018;10:3460-3467.
Shin SH, Lee H, Jeong B-H, et al. Anaplastic lymphoma kinase rearrangement in surgically resected stage IA lung adenocarcinoma. J Thorac Dis. 2018;10:3460-3467.
Dalurzo ML, Avilés-Salas A, Soares FA, et al. Testing for EGFR mutations and ALK rearrangements in advanced non-small-cell lung cancer: considerations for countries in emerging markets. Onco Targets Ther. 2021;14:4671-4692.
Dalurzo ML, Avilés-Salas A, Soares FA, et al. Testing for EGFR mutations and ALK rearrangements in advanced non-small-cell lung cancer: considerations for countries in emerging markets. Onco Targets Ther. 2021;14:4671-4692.
Lindeman NI, Cagle PT, Aisner DL, et al. Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: Guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med. 2018;142(3):321-346.
Lindeman NI, Cagle PT, Aisner DL, et al. Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: Guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med. 2018;142(3):321-346.
LUNGevity Foundation. What you need to know about biomarker testing. Available at: https://www.lungevity.org/sites/default/files/request-materials/LUNGevity-biomarker-testing-booklet-112817.pdf. Accessed February 26, 2024.
LUNGevity Foundation. What you need to know about biomarker testing. Available at: https://www.lungevity.org/sites/default/files/request-materials/LUNGevity-biomarker-testing-booklet-112817.pdf. Accessed February 26, 2024.
Gregg JP, Li T, Yoneda KY. Molecular testing strategies in non-small cell lung cancer: optimizing the diagnostic journey. Transl Lung Cancer Res. 2019;8(3):286-301.
Gregg JP, Li T, Yoneda KY. Molecular testing strategies in non-small cell lung cancer: optimizing the diagnostic journey. Transl Lung Cancer Res. 2019;8(3):286-301.
Compton CC, Robb JA, Anderson MW, et al. Preanalytics and precision pathology: pathology practices to ensure molecular integrity of cancer patient biospecimans for precision medicine. Arch Pathol Lab Med. 2019;143(11):1346-1363.
Compton CC, Robb JA, Anderson MW, et al. Preanalytics and precision pathology: pathology practices to ensure molecular integrity of cancer patient biospecimans for precision medicine. Arch Pathol Lab Med. 2019;143(11):1346-1363.
Levy BP, Chioda MD, Herndon D, et al. Molecular testing for treatment of metastatic non-small cell lung cancer: how to implement evidence-based recommendations. Oncologist. 2015;20(10):1175-1181.
Levy BP, Chioda MD, Herndon D, et al. Molecular testing for treatment of metastatic non-small cell lung cancer: how to implement evidence-based recommendations. Oncologist. 2015;20(10):1175-1181.
Sakamoto H, Tsukaguchi T, Hiroshima S, et al. CH5424802, a selective ALK inhibitor capable of blocking the resistant gatekeeper mutant. Cancer Cell. 2011;19(5):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(5):679-690.
Avrillon V, Pérol M. Alectinib for treatment of ALK-positive non-small-cell lung cancer. Future Oncol. 2017;13(4):321-335.
Avrillon V, Pérol M. Alectinib for treatment of ALK-positive non-small-cell lung cancer. Future Oncol. 2017;13(4):321-335.
Della Corte CM, Viscardi G, Di Liello R, et al. Role and targeting of anaplastic lymphoma kinase in cancer. Mol Cancer. 2018;17(1):30.
Della Corte CM, Viscardi G, Di Liello R, et al. Role and targeting of anaplastic lymphoma kinase in cancer. Mol Cancer. 2018;17(1):30.
Mahato AK, Sidorova YA. RET receptor tyrosine kinase: role in neurodegeneration, obesity, and cancer. Int J Mol Sci. 2020;21(19):7108.
Mahato AK, Sidorova YA. RET receptor tyrosine kinase: role in neurodegeneration, obesity, and cancer. Int J Mol Sci. 2020;21(19):7108.
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(5):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(5):1023-1028.
Löscher W, Potschka H. Blood-brain barrier active efflux transporters: ATP-binding cassette gene family. NeuroRx. 2005;2(1):86-98.
Löscher W, Potschka H. Blood-brain barrier active efflux transporters: ATP-binding cassette gene family. NeuroRx. 2005;2(1):86-98.
Deeken JF, Löscher W. The blood-brain barrier and cancer: transporters, treatment, and Trojan horses. Clin Cancer Res. 2007;13(6):1663-1674.
Deeken JF, Löscher W. The blood-brain barrier and cancer: transporters, treatment, and Trojan horses. Clin Cancer Res. 2007;13(6):1663-1674.
Wu YL, Dziadziuszko R, Ahn JS, et al. Alectinib in resected ALK-positive non-small-cell lung cancer. N Engl J Med. 2024;390(14):1265-1276. doi:10.1056/NEJMoa2310532.
Wu YL, Dziadziuszko R, Ahn JS, et al. Alectinib in resected ALK-positive non-small-cell lung cancer. N Engl J Med. 2024;390(14):1265-1276. doi:10.1056/NEJMoa2310532.
A study comparing adjuvant alectinib versus adjuvant platinum-based chemotherapy in patients with ALK positive non-small cell lung cancer. ClinicalTrials.gov identifier: NCT03456076. https://clinicaltrials.gov/study/NCT03456076. Updated December 13, 2023. Accessed December 15, 2023.
A study comparing adjuvant alectinib versus adjuvant platinum-based chemotherapy in patients with ALK positive non-small cell lung cancer. ClinicalTrials.gov identifier: NCT03456076. https://clinicaltrials.gov/study/NCT03456076. Updated December 13, 2023. Accessed December 15, 2023.
Data on File. Genentech, Inc.
Data on File. Genentech, Inc.
Wu YL, Dziadziuszko R, Ahn JS, et al. Alectinib in resected ALK-positive non–small-cell lung cancer. N Engl J Med. 2024;390(14)(suppl):1265-1276. doi:10.1056/NEJMoa2310532.
Wu YL, Dziadziuszko R, Ahn JS, et al. Alectinib in resected ALK-positive non–small-cell lung cancer. N Engl J Med. 2024;390(14)(suppl):1265-1276. doi:10.1056/NEJMoa2310532.
IQVIA US Claims, December 2022-March 2024.
IQVIA US Claims, December 2022-March 2024.
Criteria | ALECENSA dose modification |
---|---|
ALT or AST elevation of >5X ULN with total bilirubin ≤2X ULN | Temporarily withhold until recovery to baseline or to ≤3X ULN, then resume at reduced dose. See dose reduction schedule. |
ALT or AST elevation >3X ULN with total bilirubin elevation >2X ULN in the absence of cholestasis or hemolysis | Permanently discontinue ALECENSA. |
Total bilirubin elevation >3X ULN | Temporarily withhold until recovery to baseline or to ≤1.5X ULN, then resume at reduced dose. See dose reduction schedule. |
Any grade treatment-related ILD/pneumonitis | Permanently discontinue ALECENSA. |
Grade 3 renal impairment | Temporarily withhold until serum creatinine recovers to ≤1.5X ULN, then resume at reduced dose. See dose reduction schedule. |
Grade 4 renal impairment | Permanently discontinue ALECENSA. |
Symptomatic bradycardia | Withhold ALECENSA until recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume ALECENSA at previous dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. If no contributing concomitant medication is identified, or if contributing concomitant medications are not discontinued or dose modified, resume ALECENSA at reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. See dose reduction schedule. |
Bradycardiaa (life-threatening consequences, urgent intervention indicated) | Permanently discontinue ALECENSA if no contributing concomitant medication is identified. If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume ALECENSA at 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. See dose reduction schedule. |
CPK elevation of >5X ULN | Temporarily withhold until recovery to baseline or to ≤2.5X ULN, then resume at same dose. |
CPK elevation >10X ULN or second occurrence of CPK elevation of >5X ULN | Temporarily withhold until recovery to baseline or to ≤2.5X ULN, then resume at reduced dose. See dose reduction schedule. |
Hemolytic anemia | Withhold ALECENSA if hemolytic anemia is suspected. Upon resolution, resume at reduced dose or permanently discontinue. See dose reduction schedule. |
aHeart rate <60 bpm.
ALT=alanine transaminase; AST=aspartate transaminase; bpm=beats per minute; CPK=creatine phosphokinase; ILD=interstitial lung disease; ULN=upper limit of normal.
The information contained in this section of the site is intended for U.S. healthcare professionals only. Click "OK" if you are a healthcare professional.
The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. Genentech, Inc. makes no representation as to the accuracy of the information contained on sites we do not own or control. Genentech does not recommend and does not endorse the content on any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.