Access & Support

US Formulary Coverage

Access

Patient Support

Device Training Education

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Summary of Coverage for NGENLA

NGENLA has the broadest preferred commercial coverage in the US of any pediatric LAGH and is:

Exclusive

Exclusive on the Express Scripts National Preferred and Flex Formularies, and Preferred on the Basic Formulary

Tier 3*

Preferred on Optum Rx and United Healthcare National Formularies

Covered

Covered on various other national and regional formularies

For all plans listed below, a step through a SAGH or LAGH is not required to get approval for NGENLA.

Payer	NGENLA Status	Step through SAGH Required (Y/N)	PA Required (Y/N)
Express Scripts National Preferred and Flex Formularies	Exclusive	N	Y
Express Scripts Basic Formulary	Preferred	N	Y
OptumRx National Formulary	Tier 3*	N	Y
United Healthcare Traditional and Advantage Preferred Drug Lists	Tier 3*	N	Y
Cigna Healthcare^SM Standard, Value and Legacy Formularies	Preferred	N	Y

Payer	NGENLA Status	Step through SAGH Required (Y/N)	PA Required (Y/N)
Express Scripts National Preferred and Flex Formularies	Exclusive	N	Y
Express Scripts Basic Formulary	Preferred	N	Y
OptumRx National Formulary	Tier 3*	N	Y
United Healthcare Traditional and Advantage Preferred Drug Lists	Tier 3*	N	Y
Cigna Healthcare^SM Standard, Value and Legacy Formularies	Preferred	N	Y

SAGH, short-acting growth hormone.

Tier 3 means NGENLA is a covered product on the plan’s formulary with no required step edit through another growth hormone competitor.

The information in this communication is valid until 10/20/2025 and is subject to change without notice. The information provided in this communication is not a guarantee of coverage or payment (partial or full). Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures. Nothing herein may be construed as an endorsement, approval, recommendation, representation or warranty of any kind by any plan or insurer referred herein. This communication is solely the responsibility of Pfizer.

Reference:

Data on file. Pfizer Inc., New York, NY.

CoverMyMeds

The CoverMyMeds* platform can help streamline the prior authorization (PA) process

Through 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 hours

On 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.

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 applicable

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:

Educate

Educate about the insurance approval process, including prior authorizations (PA), appealing PA denials, and reauthorizations

Coordinate

Coordinate with the Pfizer Bridge Program^® to understand financial assistance options for enrolled patients

Communicate

Communicate 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.

Interim Care Program*

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 180 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 180 days depending on the type of coverage delay. Commercially insured patients only and may not reside in Massachusetts, Michigan, Minnesota, or Rhode Island.

Specialty Pharmacy

Every specialty pharmacy can dispense NGENLA. Once you have prescribed NGENLA, patients can receive their medication through:

Specialty pharmacy

A specialty pharmacy, which is approved by the patient’s health plan

Self-dispensing pharmacy

A self-dispensing pharmacy, which is selected by the patient

Note: 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 Program

Dedicated 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

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 copay card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:

Patients are not eligible to use this card if they are enrolled in a state or federally-funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, or a state prescription drug assistance program. Patient must have private insurance. Offer is not valid for cash-paying patients. Patients are responsible for as little as a $0 monthly copayment based upon program utilization. The value of this copay card is limited to a maximum of $6,000 per calendar year. This copay card 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 copay card 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 copay card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the copay card, as may be required. You should not use the copay card if your insurer or health plan prohibits use of manufacturer copay cards. This copay card is not valid where prohibited by law. Copay card cannot be combined with any other savings, free trial or similar offer for the specified prescription. 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. This copay card is not health insurance. Offer good only in the U.S. (including 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 30 days per patient. No other purchase is necessary. No membership fee. 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 12/31/2025. For more information, visit our website www.NGENLA.com, call 1-800-645-1280 or visit pfizer.com. NGENLA Copay Program, PO Box 220746, Charlotte, NC 28222-0746.

References:

Data on file. Pfizer Inc., New York, NY.

Data on file. CoverMyMeds. NGENLA Executive Summary. December 2024. Pfizer Inc., New York, NY.

The Pfizer Bridge Program® can support your patients through their NGENLA journey in many ways

Insurance

Assist with understanding the insurance process

Copay

Copay assistance for eligible patients*

Shipping

Arrange for the first shipment from the pharmacy and address issues that may lead to pharmacy delays or treatment interruptions

Device training

Device training education by an experienced nurse

Submit a complete Patient Enrollment Form to the Pfizer Bridge Program to get started

Enrollment in the Pfizer Bridge Program is not required to access NGENLA

Submit an enrollment form via fax at 1 ‑800-479-2562 or efax at WWW.PATIENTSUPPORTNOW.ORG and enter patient support code 8004792562

Download a Patient
Enrollment Form

Complete the Patient Enrollment Form digitally via the Pfizer Bridge Program HCP Portal

Pfizer Bridge Program HCP Portal

If the patient and/or caregiver is unavailable to sign the enrollment form, you can still submit and direct them to the below website to complete their consents: https://pfizerbridgeprogram.com/BridgeProvider/s/esign-ondemand. The Pfizer Bridge Program will also make an outreach to the patient to obtain any missing required consents.

If the patient and/or caregiver is unavailable to sign the enrollment form, you can still submit and direct them to the below website to complete their consents: https://pfizerbridge
program.com/BridgeProvider/s/esign-ondemand. The Pfizer Bridge Program will also make an outreach to the patient to obtain any missing required consents.

Pfizer FAS will communicate with you when action is needed for your patients enrolled in the Pfizer Bridge Program.

FAS, field access specialist.

TERMS AND CONDITIONS
By using this copay card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:

Patients are not eligible to use this card if they are enrolled in a state or federally-funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, or a state prescription drug assistance program. Patient must have private insurance. Offer is not valid for cash-paying patients. Patients are responsible for as little as a $0 monthly copayment based upon program utilization. The value of this copay card is limited to a maximum of $6,000 per calendar year. This copay card 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 copay card 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 copay card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the copay card, as may be required. You should not use the copay card if your insurer or health plan prohibits use of manufacturer copay cards. This copay card is not valid where prohibited by law. Copay card cannot be combined with any other savings, free trial or similar offer for the specified prescription. 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. This copay card is not health insurance. Offer good only in the U.S. (including 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 30 days per patient. No other purchase is necessary. No membership fee. 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 [12/31/2025]. For more information, visit our website www.NGENLA.com, call 1-800-645-1280 or visit pfizer.com. NGENLA Copay Program, PO Box 220746, Charlotte, NC 28222-0746 or visit pfizerbridgecopay.com.

Reference:

Data on file. Pfizer Inc., New York, NY.

Instructional video

Step-by-step video tutorial on how to prepare and give an injection with the NGENLA prefilled pen. You can also download the complete Instructions for Use here.

Go to Video

Device training education is always available through the Pfizer Bridge Program by an experienced nurse.

Learn More

Dosing overview²

NGENLA is available in 2 different dosing strengths:

24 mg/1.2 mL (dose can be adjusted in 0.2-mg intervals)
60 mg/1.2 mL (dose can be adjusted in 0.5-mg intervals)

Dosing is based on weight: 0.66 mg/kg of body weight administered once weekly by subcutaneous injection.

If a dose is missed, NGENLA should be administered as soon as possible within 3 days after the missed dose, then the usual once-weekly dosing schedule should be resumed. If more than 3 days have passed, the missed dose should be skipped and the next dose should be administered on the regularly scheduled day.

Learn More

References:

Data on file. Pfizer Inc., New York, NY.

NGENLA. Prescribing information. Pfizer Inc.; 2023.

Request to be contacted by a Pfizer representative

Pfizer representatives are here to help answer questions you might have about treatment with NGENLA. To speak with a representative, simply submit the required information below. Please do not disclose any data, including health data, that could potentially identify a specific individual.

Thank you for submitting your request. A Pfizer representative will respond to your request as soon as possible.

LAGH, long-acting growth hormone

Reference:

Data on file. Pfizer Inc., New York, NY.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Somatrogon is contraindicated in patients with acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with growth hormones.

NGENLA is contraindicated in patients with hypersensitivity to somatrogon or any of its excipients.

Somatrogon is contraindicated in patients with closed epiphyses.

Somatrogon is contraindicated in patients with active malignancy due to the risk of malignancy progression.

Somatrogon is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.

Somatrogon is contraindicated in patients with 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 risk of sudden death.

WARNINGS AND PRECAUTIONS
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. The safety of continuing NGENLA treatment for the approved indication who concurrently develop these illnesses has not been established.

Severe systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with somatropin. Inform patients and caregivers that such reactions are possible and that prompt medical attention should be sought if allergic reaction occurs.

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 with NGENLA. Discontinue NGENLA if there is evidence of recurrent malignancy.

In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. Monitor all patients with a history of GHD secondary to an intracranial neoplasm while on NGENLA therapy for progression or recurrence of the tumor.

Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, thoroughly consider the risks and benefits of starting NGENLA in these patients. If treatment with NGENLA is initiated, carefully monitor these patients for development of neoplasms.

Monitor patients on NGENLA therapy carefully 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.

Treatment with growth hormone may decrease insulin sensitivity, particularly at higher doses. New-onset type 2 diabetes mellitus has been reported in patients receiving growth hormone. 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, such as obesity, Turner syndrome, or a family history of diabetes mellitus. Patients with preexisting type 1 or type 2 diabetes mellitus or pre-diabetes should be monitored closely. The doses of antidiabetic agents may require adjustment when NGENLA is initiated.

Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in patients treated with somatropin. Symptoms usually occurred within the first 8 weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of somatropin dose. NGENLA should be temporarily discontinued in patients with clinical or fundoscopic evidence of IH. If IH is confirmed, restart treatment with NGENLA at a lower dose after IH-associated signs and symptoms have resolved.

Fluid retention during NGENLA therapy may occur. Clinical manifestations of fluid retention (eg, edema and nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent.

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. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NGENLA treatment. Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism.

Undiagnosed/untreated hypothyroidism may prevent an optimal response to NGENLA therapy. In patients with GH deficiency, central (secondary) hypothyroidism may first become evident or worsen during treatment with growth hormone therapy. Therefore, patients should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated.

Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Evaluate pediatric patients with the onset of a limp or complaints of persistent hip or knee pain.

NGENLA increases growth rate, and progression of preexisting scoliosis can occur in patients who experience rapid growth. Growth hormone treatment has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for disease progression.

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.

When growth hormone is administered subcutaneously at the same site over a long period of time, lipoatrophy may result. Rotate injection sites when administering NGENLA to reduce this risk.

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 than females. NGENLA is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

Serum levels of phosphorus, alkaline phosphatase, and parathyroid hormone may increase with NGENLA therapy. If a patient is found to have abnormal laboratory tests, monitor as appropriate.

ADVERSE EFFECTS
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.

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.