Referrals to the Genentech® Access to Care Foundation (GATCF)
GATCF provides free medicine to eligible patients who are uninsured,
rendered uninsured by payer denial or underinsured. To qualify,
patients must meet financial criteria.
Is My Patient Eligible?
Does your patient have health insurance?
Is your patient’s annual household adjusted gross income (AGI) less than $100,000?
Is your patient’s annual household adjusted gross income (AGI) less than $150,000?
Does your patient spend 5% or more of his or her annual household AGI on the out-of-pocket costs for his or her Genentech medicine?
Your Patient Appears to Be Eligible for GATCF
To get started with GATCF, complete and submit the SMN and PAN to Pulmozyme Access Solutions. Patients must complete Sections 5 and 6 of the PAN to apply for GATCF.
Your Patient Does Not Appear to Be Eligible for GATCF, but Other Options May Be Available
Several options are available to help eligible patients with the out-of-pocket costs of their Genentech medicines.
Call Pulmozyme Access Solutions at (800) 690‑3023 or use our Patient Assistance Tool to find out which option may be right for your patient.
To be eligible for free Genentech medicine from GATCF, insured
patients must have exhausted all other forms of patient assistance
(including the Pulmozyme Co-pay Card Program and support from
independent co-pay assistance foundations) and meet financial
criteria. Uninsured patients must meet different financial criteria.
Download this flash card to view a summary of GATCF eligibility and enrollment information.
Only the information requested on these forms is required. Providing additional documents or information will delay processing.
Once we receive your patient’s information, Pulmozyme Access Solutions will contact the patient with further instructions. This may include verifying financial eligibility.
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
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.
Important Safety Information
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.
The safety and effectiveness of Pulmozyme have been established in pediatric patients 5 years of age and older. The safety of Pulmozyme, 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 65 patients with cystic fibrosis aged 3 months to < 5 years. While clinical trial data are limited in pediatric patients younger than 5 years of age, the use of Pulmozyme should be considered for pediatric CF patients who may experience potential benefit in pulmonary function or who may be at risk of respiratory tract infection.
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 BABY™ 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.
For further information, please see the Pulmozyme full Prescribing Information.