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Personalized Support

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To speak with a member of our support team, please call 1‑844‑442‑7236 or start a chat now
(available from 8 AM to 8 PM ET, Monday through Friday)

Get Started

Meet the dedicated support team

To contact us, please call 1‑844‑442‑7236

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Nurse Advocate

  • Provides overall case management
  • Completes insurance verification
  • Assists with prior authorization and appeal support
  • Can initiate FastStart fulfillment
  • Ships Auto-Injector directly to patients
  • Offers co-pay assistance
  • Provides ongoing patient support
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Field Reimbursement Manager

  • Provides case assistance and support through the insurance submission process (prior authorization/appeal)
  • Offers a local and regional market access reimbursement overview to you and your office
  • Reviews the Ascendis Signature Access Program® (A·S·A·P) process, including collaboration with a Nurse Advocate partner
  • Provides ongoing reimbursement support
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Clinical Educator

  • Schedules virtual or in-person injection training
  • Trains your patients on how to use their device
  • Provides ongoing injection support

A·S·A·P is with your patients every step of the way

START HERE
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Enrollment confirmed

  • SMN form is submitted to A·S·A·P
    • Patient’s case is created in our system

Complete the SMN form here

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Benefits verification completed

  • Summary of Benefits is received and reviewed by your office
  • Patient receives Welcome Call from the assigned Nurse Advocate

Patient Consent form is confirmed during the Welcome Call

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Insurance authorization approved

  • Prior authorization, plan formulary exception, or appeal submission complete

Your FRM is a valuable resource to use when navigating submissions and appeals

AFTER APPROVAL
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Auto-Injector shipped directly to patients

  • The Auto-Injector is available only through A·S·A·P enrollment
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Injection training completed by Clinical Educator

  • Training scheduled after Auto-Injector shipment
  • HCP notified upon training completion

The office may be trained by the Clinical Educator team if the HCP prefers to train their patients

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Triage Specialty Pharmacy for prescription fulfillment

  • Review Co-Pay Program with eligible patients
IN CASE OF DENIAL

Coverage denial and appeal submission

  • In the event of a denial, submit an appeal
  • You may receive more than one denial before approval

Reach out to A·S·A·P or your FRM to see what additional resources are available

FastStart enrollment and approval

  • SKYTROFA Auto-Injector shipment occurs within 7 business day of FastStart approval
  • Injection training scheduled and completed by Clinical Educator
  • HCP notified of training completion

Insurance authorization approved

  • Prior authorization, plan formulary exception, or appeal submission complete
The A·S·A·P program provides patient support services to eligible patients who were prescribed SKYTROFA for its approved indication.

Guide to Starting Patients on SKYTROFA

Download an overview of the A·S·A·P patient initiation process

Download

Authorization Submission Checklist

Review important submission criteria that insurance companies may request

Download
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FastStart Program

The FastStart Program is available for commercially insured patients experiencing a delay in treatment due to denied coverage determination or appeals, who have an open active-insurance authorization*

*Patients are not eligible if they participate in any federal or state healthcare program.
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Co-Pay Program for SKYTROFA®

Eligible patients pay as little as $5 per monthly prescription with no monthly cap and an annual maximum cap of $6000 per calendar year*

A·S·A·P offers eligible patients help accessing treatment. For full terms and conditions and eligibility criteria, click here

*Terms & Conditions apply. See Eligibility and Restrictions.

To learn more about starting your patients, call 1-844-442-7236 to speak with a member of our support team or chat live (available from 8 AM to 8 PM ET, Monday through Friday)

A·S·A·P Chat
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Questions about coverage for your patients?

Get an individualized coverage summary for SKYTROFA

Explore Coverage

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

SKYTROFA® (lonapegsomatropin-tcgd) injection is a human growth hormone (GH) indicated for the:

  • Treatment of pediatric patients aged 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous GH
  • Replacement of endogenous GH in adults with growth hormone deficiency (GHD)

CONTRAINDICATIONS

SKYTROFA 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 risk of increased mortality with use of somatropin
  • Hypersensitivity to somatropin or any of the excipients in SKYTROFA

Click here to contact Ascendis Pharma Medical Information or call 1-844-442-7236.

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

SKYTROFA® (lonapegsomatropin-tcgd) injection is a human growth hormone (GH) indicated for the:

  • Treatment of pediatric patients aged 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous GH
  • Replacement of endogenous GH in adults with growth hormone deficiency (GHD)

CONTRAINDICATIONS

SKYTROFA 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 risk of increased mortality with use of somatropin
  • Hypersensitivity to somatropin or any of the excipients in SKYTROFA
  • Pediatric patients with closed epiphyses
  • Active malignancy
  • Active proliferative or severe non-proliferative diabetic retinopathy
  • Pediatric 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: Increased mortality has been reported after treatment with somatropin in patients with acute critical illness due to complications following open-heart surgery, abdominal surgery, multiple accidental trauma, and in patients with acute respiratory failure
  • Severe Hypersensitivity: Serious systemic hypersensitivity reactions including anaphylaxis and angioedema have been reported with post-marketing use of somatropin products, including SKYTROFA. Inform patients and/or caregivers that such reactions are possible and that prompt medical attention should be sought if an 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 complete prior to instituting SKYTROFA. In childhood cancer survivors treated with radiation to the brain/head for their first neoplasm who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Children with certain rare genetic causes of short stature have an increased risk of developing malignancies and should be carefully monitored for development of neoplasms. Monitor patients with a history of GHD secondary to an intracranial neoplasm for progression/recurrence of the tumor. Monitor patients carefully for development of neoplasms and/or increased growth/potential malignant changes of preexisting nevi. Advise patients/caregivers to report changes in the appearance of preexisting nevi
  • Glucose Intolerance and Diabetes Mellitus: Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. Previously undiagnosed impaired glucose tolerance and overt type 2 diabetes mellitus may be unmasked. Monitor glucose levels in all patients, especially those with risk factors for type 2 diabetes mellitus, such as obesity or a family history of type 2 diabetes mellitus. When initiating SKYTROFA, monitor patients with preexisting type 1 or type 2 diabetes mellitus or impaired glucose tolerance closely, and adjust the doses of antihyperglycemic drugs as needed
  • Intracranial Hypertension: Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with somatropin. Symptoms usually occurred within 8 weeks of the initiation of somatropin and resolved rapidly after cessation of therapy/reduction of the dose. Perform fundoscopic examination prior to initiation of treatment and periodically thereafter. If papilledema is observed, stop the treatment. If somatropin-induced IH is confirmed, restart SKYTROFA treatment at a lower dose after IH-associated signs and symptoms have resolved
  • Fluid Retention: May occur during somatropin therapy. Clinical manifestations of fluid retention (eg, edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent
  • Hypoadrenalism: Patients receiving somatropin therapy who have or are at risk for pituitary hormone deficiency(s) 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/stress doses following initiation of SKYTROFA therapy. 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 SKYTROFA. Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of SKYTROFA
  • Slipped Capital Femoral Epiphysis in Pediatric Patients: Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth and may lead to osteonecrosis. Evaluate pediatric patients receiving SKYTROFA 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 in Pediatric Patients: Monitor patients with a history of scoliosis for disease progression
  • Pancreatitis: Cases of pancreatitis have been reported in pediatric patients receiving somatropin. The risk may be greater in pediatric patients than in adults. Consider pancreatitis in patients with persistent severe abdominal pain
  • Lipoatrophy: Lipoatrophy may result when somatropin 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 fatalities 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 female patients. SKYTROFA 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 alkaline phosphatase and phosphate may increase after SKYTROFA therapy. Serum levels of parathyroid hormone may increase after somatropin treatment. If a patient is found to have abnormal laboratory tests, monitor as appropriate

ADVERSE REACTIONS

  • Pediatric patients with GHD: the most common adverse reactions (≥ 5%) in patients treated with SKYTROFA and more frequently than in those treated with daily somatropin were viral infection, pyrexia, cough, nausea and vomiting, hemorrhage, diarrhea, abdominal pain, and arthralgia and arthritis
  • Adult patients with GHD: the most common adverse reaction (≥ 5%) in patients treated with SKYTROFA and more frequently than in those treated with placebo were edema and central (secondary) hypothyroidism

DRUG INTERACTIONS

  • Glucocorticoids: Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of SKYTROFA
  • Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment: Adjust glucocorticoid dosing in pediatric patients to avoid both hypoadrenalism and an inhibitory effect on growth
  • Cytochrome P450-Metabolized Drugs: SKYTROFA may alter the clearance. Monitor carefully if used with SKYTROFA
  • Oral Estrogen: Patients receiving oral estrogen replacement may require higher SKYTROFA dosages
  • Insulin and/or Other Antihyperglycemic Agents: Dose adjustment of insulin and/or antihyperglycemic agent may be required for patients with diabetes mellitus

You are encouraged to report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Ascendis Pharma at 1-844-442-7236.

Please click here for SKYTROFA full Prescribing Information.

FRM = field reimbursement manager; SMN = statement of medical necessity.