Statement of Medical Necessity - SKYTROFA® (lonapegsomatropin-tcgd) HCP Website
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Statement of Medical Necessity

Enroll a patient in the Ascendis Signature Access Program® (A·S·A·P)

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The Statement of Medical Necessity form has successfully submitted.

In order to complete your patient's enrollment, please submit an e-prescription to our program's pharmacy (NPI: 1699202838), or fax a written prescription to our program at 1-888-436-0193.

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Patient Information Authorization Insurance Diagnosis Medical Assessment Preferred Specialty Pharmacy Prescriber Information SKYTROFA® Prescription/Dosage and Prescriber Authorization Training Authorization Review Your Submission
Patient Information Authorization
Insurance
Diagnosis
Medical Assessment
Preferred Specialty Pharmacy
Prescriber Information
SKYTROFA® Prescription/Dosage and Prescriber Authorization
Training Authorization
Review Your Submission

Patient Information Authorization

*Required field.
Please select your patient's growth hormone (GH) treatment experience:*
Additional enrollment instructions:
†For Auto-Injector only, must include evidence of an approved claim by insurance.

Insurance

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Please select the appropriate statement:*

Patient Insurance Card (Front)

Patient Insurance Card (Back)

Prior Authorization (PA) Submitted:
PA Approval:

Diagnosis

*Required field.
Please check the applicable ICD-10 diagnosis code. Pediatric GH deficiency (GHD):*

Medical Assessment

*Required field.

Completing the Medical Assessment section is crucial for verification

Missing information can slow the verification process, insurance authorization, and treatment fulfillment. In the event of key information being missing from the SMN form, your office may be contacted as patient-specific plan details are entered into our system.

kg
%
cm
%
cm/yr
MRI (pituitary gland) completed:
ng/mL
ng/mL

Preferred Specialty Pharmacy:

Prescriber Information

*Required field.

SKYTROFA® Prescription/Dosage and Prescriber Authorization:

*Required field.

Recommended weight-based dosing ranges are based on 0.24 mg/kg/week.

kg
mg

The SKYTROFA Auto-Injector is packaged in a separate carton.

By signing below, I certify that: (a) I am a licensed practitioner, in good standing under applicable state law; (b) the information I have provided on this enrollment form is, to the best of my knowledge, true, complete, and accurate; and (c) I have obtained the necessary authorization from the patient, patient's caregiver, and/or legal representative to use, disclose, share, or otherwise release the above information, including the patient's protected health information (“PHI”) for the purpose of providing patient assistance, including verifying insurance coverage, arranging training services, and evaluating patient's eligibility for alternate sources of funding. Further, I appoint the Ascendis Signature Access Program® (“A·S·A·P”), on my behalf, to convey this prescription to the dispensing pharmacy. I will immediately notify Ascendis Pharma if the above-named patient, individually or through their caregiver, and/or legal representative, revokes their consent. I give you permission to contact me, or the above-named patient, patient's caregiver, and/or legal representative.

Please note that the authorization you are providing is not a valid prescription. In order to complete your patient's enrollment, please submit an e-prescription to our program's pharmacy (NPI: 1699202838), or fax a written prescription to our program at 1-888-436-0193.

Nurse Injection Training Authorization

A·S·A·P will provide my patient and/or his/her caregiver with training from a company-funded clinical nurse educator on the proper self-administration of SKYTROFA. I am requesting A·S·A·P to coordinate a nurse to provide SKYTROFA self-administration training for my patient. I will receive information on my patient's injection training via the fax number I provided above. This order is valid for 1 year.

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Please click the Review button below if you wish to check the accuracy of the information provided. When ready, click the Submit button. A confirmation message will appear when the form has successfully submitted.

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.

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