Patients & Caregivers Site

Helpful Resources for Your Practice

Pulmozyme Access Solutions offers a range of access and reimbursement resources for your patients and practice after Pulmozyme 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.

Quick Links

Help with coverage (BIs and PAs)
Reimbursement (billing, coding and appeals)
Online patient enrollment
Pulmozyme Distribution

Coverage

Get help understanding insurance benefits and coverage, such as with benefits investigations and prior authorization resources

Benefits investigations
Pulmozyme Access Solutions can conduct a benefits investigation (BI) which can determine:

  • If treatment is covered
  • If treatment is denied
  • If a prior authorization or pre-determination is required*
  • If your patient's insurance plan has a mandated or preferred SP

*If your patient’s request for a prior authorization is not granted, your Pulmozyme Access Solutions Specialist can work with you to determine your next steps.

Option 1: Submit forms online

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?

  • An online tool to help you enroll patients in Pulmozyme Access Solutions and manage your service requests at your convenience.

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.

Option 2: Print forms and fax or text

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 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:

  • The request will be processed within five business days upon receipt of both required forms.
  • Your office will be contacted to discuss the application outcome and any next steps.

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.

Reimbursement

Sample coding information and resources for denials and appeals

Pulmozyme Sample Coding

This coding information may assist you as you complete the payer forms for Pulmozyme. 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 Pulmozyme below.

Download Pulmozyme Sample Coding

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.

Appeals

If your patient’s health insurance plan has issued a denial, your Pulmozyme 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: 

  1. The denial should be reviewed, along with the health insurance plan’s guidelines to determine what to include in your patient’s appeal submission.
  2. Your Pulmozyme Access Solutions Specialist has local payer coverage expertise and can help you determine specific requirements for your patient.

A sample appeal letter and additional considerations are available on the Practice Forms and Documents page.

Appeals cannot be completed or submitted by Pulmozyme Access Solutions on your behalf.

Online patient enrollment

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

My Patient Solutions is an online tool to help you enroll patients in Pulmozyme Access Solutions and manage your service requests, all through one portal. It allows you the flexibility to work with Pulmozyme Access Solutions when it’s convenient for you.

With My Patient Solutions, you can:

  • Enroll and re-enroll patients in financial assistance programs entirely online
  • Communicate with your Pulmozyme Access Solutions Specialist
  • Easily identify next steps for service requests
  • View Benefits Investigation reports for all your enrolled patients
  • Follow up on prior authorizations or appeals
  • View co-pay assistance outcomes and referral information

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 Pulmozyme Access Solutions at 866-422-2377 (6AM-5PM PST, Monday through Friday).

Register for My Patient Solutions

Pulmozyme Distribution

Pulmozyme 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:

  • Clinical services to help patients throughout their treatment
  • The ability to manage the specialty handling and shipping needs linked with many specialty therapies

 

You can work with your preferred SP or contact Pulmozyme 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 Pulmozyme Access Solutions at 866-422-2377 (6AM–5PM PST, Monday through Friday).

Contact a representative

Questions? Contact Pulmozyme Access Solutions

Call 866-422-2377 (Mon.-Fri., 6AM-5PM PST)

Financial support

Financial Support

Find the right financial resources option for your patients.

Explore Options
Next Page: Practice Forms & Documents

Important Safety Information

Indication and Usage

Pulmozyme (dornase alfa) is indicated for daily administration in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.

In CF patients with an FVC ≥ 40% of predicted, daily administration of Pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics.

Pulmozyme is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product.

The most common adverse reactions associated with the use of Pulmozyme include: voice alteration, pharyngitis, rash, laryngitis, chest pain, conjunctivitis, rhinitis, decrease in FVC of ≥ 10%, fever, dyspepsia, and dyspnea. There have been no reports of anaphylaxis attributed to the administration of Pulmozyme. Mild to moderate urticaria and mild skin rash have been observed and have been transient.

Pediatric Use

The safety and effectiveness of Pulmozyme in conjunction with standard therapies for cystic fibrosis have been established in pediatric patients. Use of Pulmozyme in pediatric patients is supported by evidence in the following age groups:

  • Patients 5 to 17 years of age: A randomized, placebo-controlled trial of 303 of clinically stable cystic fibrosis patients 5 to 17 years of age who received Pulmozyme.
  • Patients less than 5 years: Extrapolation of efficacy data in patients 5 years of age and older with additional safety data in 65 pediatric patients aged 3 months to less than 5 years who received Pulmozyme 2.5 mg daily by inhalation for 2 weeks.

The safety of Pulmozyme, 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 98 pediatric patients with cystic fibrosis 3 months to 10 years of age (65 aged 3 months to < 5 years, 33 aged 5 to ≤ 10 years). The PARI BABYTM reusable nebulizer (which uses a facemask instead of a mouthpiece) was utilized in patients unable to demonstrate the ability to inhale or exhale orally throughout the entire treatment period (54/65, 83% of the younger; and 2/33, 6% of the older patients). Overall, the nature of adverse reactions was similar to that seen in the placebo-controlled trials in older patients. The number of patients reporting cough was higher in the younger age group as compared to the older age group (29/65, 45%; compared to 10/33, 30%) as was the number reporting moderate to severe cough (24/65, 37%; compared to 6/33, 18%). The number of patients reporting rhinitis was higher in the younger age group as compared to the older age group (23/65, 35%; compared to 9/33, 27%) as was the number reporting rash (4/65, 6% as compared to 0/33, 0%).

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 Pulmozyme full Prescribing Information for additional Important Safety Information.

    • Pulmozyme (dornase alfa) [package insert]. South San Francisco, CA: Genentech, Inc; 2024.

      Pulmozyme (dornase alfa) [package insert]. South San Francisco, CA: Genentech, Inc; 2024.

    • Harms HK, Matouk E, Tournier G, et al; DNase International Study Group. Multicenter, open-label study of recombinant human DNase in cystic fibrosis patients with moderate lung disease. Pediatr Pulmonol. 1998;26(3):155-161.

      Harms HK, Matouk E, Tournier G, et al; DNase International Study Group. Multicenter, open-label study of recombinant human DNase in cystic fibrosis patients with moderate lung disease. Pediatr Pulmonol. 1998;26(3):155-161.

    • Chmiel JF, Konstan MW. Anti-inflammatory medications for cystic fibrosis lung disease: selecting the most appropriate agent. Treat Respir Med. 2005;4(4):255-273.

      Chmiel JF, Konstan MW. Anti-inflammatory medications for cystic fibrosis lung disease: selecting the most appropriate agent. Treat Respir Med. 2005;4(4):255-273.

    • Puchelle E, de Bentzmann S, Zahm JM. Physical and functional properties of airway secretions in cystic fibrosis—therapeutic approaches. Respiration. 1995;62(suppl 1):2-12.

      Puchelle E, de Bentzmann S, Zahm JM. Physical and functional properties of airway secretions in cystic fibrosis—therapeutic approaches. Respiration. 1995;62(suppl 1):2-12.

    • King M. Mucolytics and mucus clearance. In: Rubin BK, van der Schans CP, eds. Therapy for Mucus-Clearance Disorders. New York, NY: Marcel Dekker Inc; 2004:201-224.

      King M. Mucolytics and mucus clearance. In: Rubin BK, van der Schans CP, eds. Therapy for Mucus-Clearance Disorders. New York, NY: Marcel Dekker Inc; 2004:201-224.

    • Flume PA, Van Devanter DR. State of progress in treating cystic fibrosis respiratory disease. BMC Med. 2012;10:88.

      Flume PA, Van Devanter DR. State of progress in treating cystic fibrosis respiratory disease. BMC Med. 2012;10:88.

    • Drug development pipeline. Cystic Fibrosis Foundation website. https://www.cff.org/trials/pipeline. Accessed August 17, 2020.

      Drug development pipeline. Cystic Fibrosis Foundation website. https://www.cff.org/trials/pipeline. Accessed August 17, 2020.

    • Research milestones. Cystic Fibrosis Foundation website. https://www.cff.org/about-us/our-history. August 17, 2020.

      Research milestones. Cystic Fibrosis Foundation website. https://www.cff.org/about-us/our-history. August 17, 2020.

    • Fuchs HJ, Borowitz DS, Christiansen DH, et al. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. N Engl J Med. 1994;331(10):637-642.

      Fuchs HJ, Borowitz DS, Christiansen DH, et al. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. N Engl J Med. 1994;331(10):637-642.

    • Data on file. Genentech, a member of the Roche Group.

      Data on file. Genentech, a member of the Roche Group.

    • Cystic Fibrosis Foundation Patient Registry 2016 Annual Data Report. Bethesda, MD. ©2017 Cystic Fibrosis Foundation.

      Cystic Fibrosis Foundation Patient Registry 2016 Annual Data Report. Bethesda, MD. ©2017 Cystic Fibrosis Foundation.

    • Sly PD, Brennan S, Gangell C, et al. Lung disease at diagnosis in infants with cystic fibrosis detected by newborn screening. Am J Respir Crit Care Med. 2009;180(2):146-152. 

      Sly PD, Brennan S, Gangell C, et al. Lung disease at diagnosis in infants with cystic fibrosis detected by newborn screening. Am J Respir Crit Care Med. 2009;180(2):146-152. 

    • Sly PD, Gangell CL, Chen L, et al. Risk factors for bronchiectasis in children with cystic fibrosis. N Engl J Med. 2013;368(21):1963-1970.

      Sly PD, Gangell CL, Chen L, et al. Risk factors for bronchiectasis in children with cystic fibrosis. N Engl J Med. 2013;368(21):1963-1970.

    • Bakker EM, Volpi S, Salonini E, et al. Small airway deposition of dornase alfa during exacerbations in cystic fibrosis; a randomized controlled clinical trial. Pediatr Pulmonol. 2020;49(2):154-161.

      Bakker EM, Volpi S, Salonini E, et al. Small airway deposition of dornase alfa during exacerbations in cystic fibrosis; a randomized controlled clinical trial. Pediatr Pulmonol. 2020;49(2):154-161.

    • Trikafta [Package insert]. Boston, MA: Vertex Pharmaceuticals Incorporated; 2021. 

      Trikafta [Package insert]. Boston, MA: Vertex Pharmaceuticals Incorporated; 2021. 

    • Heijerman HGM, McKone EF, Downey DG, et al. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial. Lancet. 2019;394(10212)1940-1948. 

      Heijerman HGM, McKone EF, Downey DG, et al. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial. Lancet. 2019;394(10212)1940-1948. 

    • Middleton PG, Mall MA, Dřevínek P, et al. Elexacaftor–tezacaftor–ivacaftor for cystic fibrosis with a single Phe508del allele. N Engl J Med. 2019;381(19):1809-1819. 

      Middleton PG, Mall MA, Dřevínek P, et al. Elexacaftor–tezacaftor–ivacaftor for cystic fibrosis with a single Phe508del allele. N Engl J Med. 2019;381(19):1809-1819. 

    • Pulmozyme Instructions for Use. South San Francisco, CA: Genentech, Inc; 2024.

      Pulmozyme Instructions for Use. South San Francisco, CA: Genentech, Inc; 2024.

    • Mogayzel PJ, Naureckas ET, Robinson KA, et al. Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2013;187:680-689.

      Mogayzel PJ, Naureckas ET, Robinson KA, et al. Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2013;187:680-689.

    • Clancy JP. Ongoing research into CFTR modulation. Adv Stud Med. 2010;10(1):14-18.

      Clancy JP. Ongoing research into CFTR modulation. Adv Stud Med. 2010;10(1):14-18.

    • Treatments and therapies. Cystic Fibrosis Foundation website. https://www.cff.org/Life-With-CF/Treatments-and-Therapies/. Accessed July 22, 2021. 

      Treatments and therapies. Cystic Fibrosis Foundation website. https://www.cff.org/Life-With-CF/Treatments-and-Therapies/. Accessed July 22, 2021. 

    • Medications. Cystic Fibrosis Foundation website. https://www.cff.org/Life-With-CF/Treatments-and-Therapies/Medications/. Accessed July 22, 2021.

      Medications. Cystic Fibrosis Foundation website. https://www.cff.org/Life-With-CF/Treatments-and-Therapies/Medications/. Accessed July 22, 2021.

    Non-US Residents visit: Pulmozyme.global