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HomeAbout NGENLAEfficacy & SafetyEfficacy &
SafetyPhase 3 Main Study + SafetyPhase 3 OLE Study + SafetyPhase 2 Study + SafetyDosingDosingDosingAdministrationMyNgenla PlanIGF-1 MonitoringAccess & SupportAccess &
SupportUS Formulary CoverageAccessPatient SupportDevice Training EducationRequest a Pfizer RepDownloadable MaterialsVideos Access & SupportNGENLA has the broadest preferred commercial coverage in the US of any pediatric long-acting growth hormone (LAGH).1 Pfizer is here to assist you in supporting your patients as they get started on treatment.
US Formulary CoverageAccessPatient SupportDevice Training EducationRequest a Pfizer RepCoverMyMeds
The CoverMyMeds* platform can help streamline the prior authorization (PA) processThrough an online platform and robust network integrations with leading EHRs, providers can use CoverMyMeds to electronically submit PA requests to every health plan.
Less than 24 hoursOn average, approximately 68% of NGENLA PA requests submitted through CoverMyMeds receive a determination in less than 24 hours2†Insurers may require a PA before approving coverage for NGENLA.
Insurers may require a PA before approving coverage for NGENLA.
To get started: Create a no-cost account, or log in to your existing account at CoverMyMeds.health. Questions and Live chat available at CoverMyMeds.health or call 1‑866‑452‑5017.
With your CoverMyMeds account, you can:
Access PA request monitoring with alerts when action is needed
Initiate appeal forms for denied PA requests, where appropriate
Automatically renew previously submitted PA requests, where applicableFor more information, please call 1-866-452-5017. Visit CoverMyMeds.health to start the PA process.
For more information, please call 1-866-452-5017. Visit CoverMyMeds.health to start the PA process.
This program is run by CoverMyMeds, independently of Pfizer.Average in 2024; times may vary.Pfizer Field Access Specialists (FAS)The role of the Pfizer FAS is to educate healthcare providers (HCPs) and growth hormone coordinators on the access and reimbursement process. They can:
EducateEducate about the insurance approval process, including prior authorizations (PA), appealing PA denials, and reauthorizations
CoordinateCoordinate with the Pfizer Bridge Program® to understand financial assistance options for enrolled patients
CommunicateCommunicate with HCPs when action is needed for patients enrolled in the Pfizer Bridge Program (eg, reauthorization of coverage, questions about the patient support program)Questions about NGENLA access or PA requirements? We’re here to help! Pfizer FAS are available to provide additional education on how your patients can get access to NGENLA.
Questions about NGENLA access or PA requirements? We’re here to help! Pfizer FAS are available to provide additional education on how your patients can get access to NGENLA.
Interim Care can help support your patients prescribed NGENLA*
Interim Care can help support your patients prescribed NGENLA*
If your patient's insurance coverage is delayed or denied due to certain circumstances, the NGENLA Interim Care program may be able to help. Eligible, commercially insured patients enrolled in the NGENLA Interim Care program may receive NGENLA at no cost from 30 days up to a maximum of 90 days depending on the type of coverage delay. Contact the Pfizer Bridge Program at 1-800-645-1280 for more information.
Interim Care must be requested by the physician. Patients must meet program criteria to receive the support. Interim Care support can range from 30 days to a maximum of 90 days depending on the type of coverage delay. Commercially insured patients only and may not reside in Massachusetts or Michigan.Specialty PharmacyEvery specialty pharmacy can dispense NGENLA. Once you have prescribed NGENLA, patients can receive their medication through:Every specialty pharmacy can dispense NGENLA. Once you have prescribed NGENLA, patients can receive their medication through:
Specialty pharmacyA specialty pharmacy, which is approved by the patient’s health plan
Self-dispensing pharmacyA self-dispensing pharmacy, which is selected by the patientNote: In either scenario, a PA may be required.*
PA, prior authorization.Pfizer does not recommend the use of any specialty pharmacy. Certain insurance plans may mandate the use of a specific specialty pharmacy.NGENLA Copay ProgramDedicated to helping with out-of-pocket costs for patients with the NGENLA Copay Program.One simple plan covers copays and deductibles. Terms and conditions apply.†
Click here for NGENLA Copay Assistance LoadingThis easy-to-use portal is available for you, specialty pharmacies, or caregivers to enroll eligible, commercially insured NGENLA patients for copay assistance. Copay details are provided on screen and emailed to the patient/caregiver. To learn more about the NGENLA Copay Card, contact the Pfizer Bridge Program at 1-800-645-1280 or visit pfizerbridgecopay.com.
This easy-to-use portal is available for you, specialty pharmacies, or caregivers to enroll eligible, commercially insured NGENLA patients for copay assistance. Copay details are provided on screen and emailed to the patient/caregiver. To learn more about the NGENLA Copay Card, contact the Pfizer Bridge Program at 1-800-645-1280 or visit pfizerbridgecopay.com.
TERMS AND CONDITIONS
By using this offer for the NGENLA Copay Program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
- Eligible patients with commercial prescription drug insurance coverage for NGENLA may pay as little $0 per prescription fill. Patient out of pocket expense will vary. The value of this offer is limited to annual benefit of $1,000-$8,000. Once a patient reaches the annual maximum benefit, patient is responsible for paying the remaining monthly out of pocket costs.
- Patients are not eligible for this offer if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
- Patients must have private insurance. Offer is not valid for cash paying patients.
- This offer is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs.
- You must deduct the value of this offer from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
- You are responsible for reporting use of the NGENLA Copay Program to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the NGENLA Copay Card as may be required. You should not use the NGENLA Copay Card if your insurer or health plan prohibits use of manufacturer copay cards.
- This copay card is not valid where prohibited by law.
- The benefit under the NGENLA Copay Program is offered to, and intended for the sole benefit of, eligible patients and may not be transferred to or utilized for the benefit of third parties, including, without limitation, third party payers, pharmacy benefit managers, or the agents of either.
- Third party payers, pharmacy benefit managers, or the agents of either are prohibited from assisting patients with enrolling in the NGENLA Copay Program.
- Copay card cannot be combined with any other external savings, free trial or similar offer for the specified prescription (including any program offered by a third party payer or pharmacy benefit manager, or an agent of either, that adjusts patient cost-sharing obligations, through arrangements that may be referred to as “accumulator adjustment” or “copay maximizer” programs).
- Some health insurers or pharmacy benefit managers (or their agents) may have established accumulator adjustment or copay maximizer programs based on the availability of support under the NGENLA Copay Program and/or exclude the financial assistance provided under the offer NGENLA Copay Program from counting towards patient deductibles or out-of-pocket cost limitations.
- Patients subject to an accumulator adjustment or copay maximizer program are not eligible for this offer. Since you may be unaware whether you are subject to an accumulator adjustment or copay maximizer program when you enroll in this offer, Pfizer may monitor program utilization data and reserves the right to discontinue, reduce, or otherwise modify this offer at any time without notice.
- Copay Card will be accepted only at participating pharmacies.
- If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer at www.pfizerbridgecopay.com.
- This copay card is not health insurance.
- Offer good only in the U.S. (excluding Puerto Rico, the U.S. Virgin Islands, and Guam).
- Copay card is limited to 1 per person during this offering period and is not transferable.
- A copay card may not be redeemed more than once per 21 days per patient.
- No other purchase is necessary.
- Data related to your redemption of the copay card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other copay card redemptions and will not identify you.
- Pfizer reserves the right to rescind, revoke, or amend this offer without notice.
- Offer expires 12/31/2026.
- For questions regarding the offer, please call 1-800-645-1280, visit www.ngenla.com or write NGENLA Copay Program, 430 Mountain Avenue, Suite 105, New Providence, NJ 07974
References:Data on file. Pfizer Inc., New York, NY.Data on file. CoverMyMeds. NGENLA Executive Summary. December 2024. Pfizer Inc., New York, NY.Access and SupportDownloadable MaterialsConvenient resources to support your patients as they begin treatment with NGENLA.
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Pfizer for Professionals 1-800-505-4426
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INDICATIONNgenla is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.
IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS
Ngenla is contraindicated in patients with:
- Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or acute respiratory failure due to the risk of increased mortality with somatropin
- Hypersensitivity to somatrogon-ghla or any of the excipients in Ngenla
- Closed epiphyses
- Active malignancy due to the risk of malignancy progression
- Active proliferative or severe non-proliferative diabetic retinopathy
- Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to the sudden risk of death
WARNINGS AND PRECAUTIONS
Increased Mortality in Patients with Acute Critical Illness: Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure has been reported with somatropin.Severe Hypersensitivity: Severe systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with somatropin. Inform patients and/or caregivers that such reactions are possible, and to seek prompt medical attention if allergic reaction occurs.Increased Risk of Neoplasms: There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy. Any preexisting malignancy should be inactive, and its treatment should be completed, prior to instituting therapy. In childhood cancer survivors treated with radiation to the brain/head for their first neoplasm and developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Monitor patients with a history of GHD secondary to an intracranial neoplasm for progression or recurrence of the tumor. Children with certain rare genetic causes of short stature have an increased risk of developing malignancies. Monitor for development of neoplasms. Monitor patients for increased growth or potential malignant changes of preexisting nevi. Advise patients and/or caregivers to report marked changes in behavior, onset of headaches, vision disturbances, and/or changes in skin pigmentation or changes in the appearance of preexisting nevi. Glucose Intolerance and Diabetes Mellitus: Treatment with growth hormone may decrease insulin sensitivity, particularly at higher doses. New-onset type 2 diabetes mellitus has been reported. Patients with undiagnosed pre-diabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic. Monitor glucose levels periodically in all patients receiving Ngenla, especially in those with risk factors for diabetes mellitus. The doses of antidiabetic agents may require adjustment when Ngenla is initiated. Intracranial Hypertension (IH): Has been reported in patients treated with somatropin, usually within 8 weeks of treatment initiation. Perform fundoscopic examination prior to initiation of treatment and periodically thereafter. If papilledema is identified, evaluate the etiology, and treat the underlying cause before initiating Ngenla. Temporarily discontinue Ngenla in patients with evidence of IH. If IH is confirmed, restart Ngenla at a lower dose after IH signs and symptoms have resolved. Fluid Retention: May occur during Ngenla therapy. Clinical manifestations of fluid retention are usually transient and dose dependent. Hypoadrenalism: Patients receiving growth hormone therapy who have or are at risk for pituitary hormone deficiencies may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Ngenla. Monitor patients with known hypoadrenalism for reduced serum cortisol levels and/or need for glucocorticoid dose increases. Hypothyroidism: Undiagnosed/untreated hypothyroidism may prevent an optimal response to Ngenla. Central (secondary) hypothyroidism may first become evident or worsen during treatment with growth hormone therapy. Monitor thyroid function periodically and appropriately initiate or adjust thyroid hormone replacement therapy. Slipped Capital Femoral Epiphysis: Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin. Evaluate pediatric patients with the onset of a limp or complaints of persistent hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly. Progression of Preexisting Scoliosis: Monitor patients with a history of scoliosis for disease progression. Pancreatitis: Cases of pancreatitis have been reported in patients receiving somatropin. The risk may be greater in pediatric patients compared with adults. Consider pancreatitis in patients who develop persistent severe abdominal pain. Lipoatrophy: May occur if Ngenla is administered at the same site over a long period of time. Rotate injection sites to reduce this risk. Sudden Death in Pediatric Patients with Prader-Willi Syndrome: There have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader‑Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk. Ngenla is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader‑Willi syndrome. Laboratory Tests: Serum levels of phosphorus, alkaline phosphatase, and parathyroid hormone may increase with NGENLA therapy. Monitor as appropriate. ADVERSE REACTIONS
Adverse reactions reported in ≥5% of patients treated with Ngenla are injection site reactions, nasopharyngitis, headache, pyrexia, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash, and oropharyngeal pain. Health care providers should supervise the first injection and provide appropriate training and instruction for the proper use of all NGENLA devices.DRUG INTERACTIONS
Glucocorticoids: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses.Cytochrome P450-Metabolized Drugs: Ngenla may alter the clearance. Monitor carefully.Oral Estrogen: Patients receiving oral estrogen replacement may require higher Ngenla dosages.Insulin and/or Other Antihyperglycemic Agents: Dose adjustment of insulin and/or antihyperglycemic agent may be required.INDICATION
Ngenla is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.
