Dedicated to Reimbursement Services and Patient Support

Nutropin GPS™ (Growing Patient Support) offers you and your patients assistance through every step of treatment from a dedicated case manager. Following the decision to prescribe growth hormone therapy, GPS services include device and injection training, insurance process management, a nurse hotline, and ongoing patient access and support programs. Call 1‐866‐NUTROPIN (1‐866‐688‐7674) to get started.

  • Nutropin GPS Provider Portal

    A password-protected portal that allows you to track patient status.

  • Priority Review

    Check if Nutropin AQ® [somatropin (rDNA origin) injection] is available on a patient’s formulary within one working day.

  • NuAccessSM

    A program providing medicine for eligible pediatric patients while their insurance coverage is being evaluated.

Nutropin GPS Provider Portal

Nutropin GPS offers the password-protected Nutropin GPS Provider Portal to allow you to:

  • Complete a Statement of Medical Necessity (SMN) form online
  • Monitor your patients’ progress from the first SMN submission through the end of therapy
  • Access reports on patient status that are updated daily
  • Manage prescriptions and reauthorizations
  • Securely communicate with your dedicated case manager

View the Portal

Priority Review

Use Priority Review to check if Nutropin AQ is available on formulary. This service provides benefit verification within one working day. Check off "Priority Review" and complete the bolded fields on the Statement of Medical Necessity (SMN) to request this service.

Pediatric SMN Adult SMN Pediatric Nephrology SMN

Patient Access and Assistance Programs

Genentech is committed to helping your patients receive the treatment and medications they need. To this end, we provide a broad range of patient access and assistance programs, including:

Patient: Can I receive assistance while I wait for insurance approval?

NuAccessSM Program

A program providing medicine for eligible pediatric patients while their insurance coverage is being evaluated.

  • New patients may receive Nutropin AQ NuSpin through the appeals process for up to 1 year
  • Existing patients may receive NuSpin or Nutropin AQ Pen for up to 30 days plus 2 refills
  • Patients must meet medical criteria for initial and subsequent requests
  • Product will be delivered to the patient’s home by a Genentech-designated pharmacy

Check off NuAccess on the SMN form and fax to your GPS case manager at (800) 545-0612 to start the process.

Pediatric SMN Adult SMN Pediatric Nephrology SMN

Patient: My insurance covers Nutropin, but can I receive help with my co-pay?

Nutropin GPSTM Co-pay Card Program

Genentech offers the Nutropin GPS Co-pay Card to help qualified patients with the out-of-pocket costs associated with their Nutropin AQ prescription.*

Download the Program Brochure

*By using the Nutropin Co-pay Card program, the patient
 acknowledges and confirms that at the time of usage, (s)he is currently eligible and
 meet the criteria set forth in the terms and conditions described.


This Co-pay Card is valid ONLY for patients with commercial (private or non governmental)
 insurance. It is not valid for patients who are Government
 beneficiaries or whose medications are covered, in whole or in part, under
 Medicaid, Medicare Part A, B, C and/or D, TRICARE, CHAMPUS, Puerto Rico
 Government Health Insurance Plan, or any other state or federal healthcare
 program. Patients who become Government beneficiaries during their enrollment
 period will no longer be eligible for the program as of the date they become a
 Government beneficiary.


This Co-pay Card program is not health insurance or a benefit plan. Distribution or
 use of the Co-pay Card does not obligate use or continuing use of any specific
 product or provider. Patient or guardian is responsible for reporting the receipt of all
 Co-pay Card program benefits or reimbursement received, to any insurer, health
plan, or other third party who pays for or reimburses any part of the prescription
 filled using the Co-pay Card program, as may be required.


The Co-pay Card is not valid for medications the patient receives for free or that are
 eligible to be reimbursed by private insurance plans or other healthcare or
 pharmaceutical assistance programs (such as: GATCF or any other charitable
 organization) that reimburse the patient in part or for the entire cost of his/her
 medication. Patient, guardian, pharmacist, prescriber and any other person using
 the
Co-pay Card agree not to seek reimbursement for all or any part of the benefit
 received by the recipient through the offer.


The Co-pay Card will be accepted by participating pharmacies, physician offices or 
hospitals. To qualify for the benefits of this Co-pay Card program, the patient may 
be required to pay out-of-pocket expenses for each treatment. Once enrolled, this
 Co-Pay Card program will not honor claims with date of service or medication
 dispensing that precede program enrollment by more than 120 days. This
Co-pay
 Card is only available with a valid prescription and cannot be combined with any 
other rebate/coupon, free trial, or similar offer for the specified prescription. Use of 
this Co-pay Card must be consistent with all relevant health insurance requirements
 and payer agreements. Participating patients, pharmacies, physician offices and
 hospitals are obligated to inform third-party payers about the use of the Co-pay
 Card as provided for under the applicable insurance or as otherwise required by 
contract or law. The Co-pay Card may not be sold, purchased, traded or offered for
 sale, purchase or trade. The Co-pay Card is limited to 1 per person during this
 offering period and is not transferable. This program expires within 12 months from
 enrollment. This program is not valid where prohibited by law. For Massachusetts’
 residents, the Co-pay Card is not valid for any prescription drug that has an AB
 rated generic equivalent as determined by the United States Food and Drug
 Administration. For Massachusetts’ residents, this program shall expire on or
 before July 1, 2017
.

The patient or their guardian must be 18 years or older to receive Co-pay Card
 program assistance. This Co-pay Card program is: (1) Void if the card is
 reproduced; (2) Void where prohibited by law; (3) only valid in the United States 
and Puerto Rico; and (4) only valid for Genentech products. Healthcare providers
 may not advertise or otherwise use the program as a means of promoting their
 services or Genentech’s products to patients. Genentech, Inc. reserves the right to 
rescind, revoke, or amend the program without notice at any time.

Patient: What other co-pay support options are available to me?

Referral to Co-Pay Assistance Foundations

If privately or publicly insured patients have difficulty paying for their Nutropin AQ co-pay, co-insurance, or other expenses, Nutropin GPS can refer them to a co-pay assistance foundation* that supports their disease state. For more information, contact Genentech at 1-866-688-7674.

*Genentech does not influence or control the operations of these co-pay assistance foundations, but Nutropin GPS can assist patients in navigating the process of seeking co-pay assistance by making an appropriate referral based on a patient’s diagnosis and by assisting with the application process. We cannot guarantee co-pay assistance once a patient has been referred by Nutropin GPS. The foundations to which we refer patients each have their own criteria for patient eligibility, including financial eligibility.

Patient: I have no insurance or Nutropin is not covered by my plan. Can you help?

Genentech Access to Care Foundation (GATCF)

GATCF helps eligible patients who meet specific medical and financial criteria receive Nutropin AQ® free of charge.

GATCF provides free medicine to eligible patients who are uninsured, rendered uninsured by payer denial or underinsured. To qualify, patients meet specific financial and medical criteria.

Eligibility Criteria

INSURANCE FINANCIAL MEDICAL
Patient is without coverage for Genentech medicine Patient household AGI is
≤$100,000
—OR—
Patient household AGI is
(uninsured or rendered uninsured by payer denial) >$100,000–≤$150,000
and the out-of-pocket (OOP) costs for his/her Genentech medicines account for ≥5% of his/her annual household AGI
Patient has coverage for Genentech medicines Patient household AGI is

≤$150,000
and the OOP costs for his/her Genentech medicines account for ≥5% of his/her annual household AGI

—AND—
All patient assistance options have been exhausted, including Genentech brand-specific co-pay cards and support from co-pay assistance foundations supporting the patient’s disease state
Patient must meet certain medical criteria as established by independent advisory board Patient has coverage for Genentech medicines

GATCF Eligibility Screening

If you think your patient might be rendered uninsured by payer denial, you may request GATCF Eligibility Screening when you initiate a benefits investigation (BI). GATCF Eligibility Screening assesses whether a patient might be eligible for free medicine from GATCF.

To initiate a GATCF Eligibility Screening request:

  1. Check the appropriate box under Services Requested on the Statement of Medical Necessity (SMN) form.
  2. Have your patients complete sections 5 and 6 on the Patient Authorization and Notice of Release of Information (PAN) form and submit it to Nutropin GPS.

Based on this documentation, GATCF reviews the patient’s financial and medical eligibility to determine whether or not the patient appears to meet GATCF eligibility criteria. A letter is then faxed to your office in as little as 24 hours of Nutropin GPS receiving completed SMN and PAN forms, notifying you of the outcome of the GATCF Eligibility Screening.

Disclaimer

A GATCF Eligibility Screening approval letter does not guarantee acceptance into GATCF; it only states the patient appears to meet GATCF’s medical and financial criteria based upon review of the SMN and PAN forms. GATCF will still need to confirm the patient’s insurance coverage for Nutropin and verify medical and financial qualifications based on documentation provided by the patient.

Indications

Nutropin therapy is indicated for the treatment of pediatric patients who have short stature or growth failure as a result of:

  • Growth hormone deficiency (GHD)
  • Idiopathic short stature (ISS), defined by height standard deviation score ≤-2.25, associated with growth rates unlikely to result in normal adult height, in whom other causes of short stature have been excluded
  • Turner syndrome (TS)
  • Chronic kidney disease (CKD) up to the time of renal transplantation

Nutropin therapy is indicated for the replacement of endogenous GH in adults with GH deficiency, either:

  • Adult-onset, as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
  • Childhood-onset. Patients treated for GH deficiency in childhood who have closed epiphyses should be reevaluated

Important Safety Information

CONTRAINDICATIONS

  • Acute Critical Illness: Somatropin should not be used to treat patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure. A significant increase in mortality has been reported in such cases
  • Prader-Willi Syndrome (PWS) in Children: Somatropin should not be used in pediatric patients with PWS who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death after initiation of somatropin treatment in such patients. Nutropin AQ is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed PWS.
  • Active malignancy: Somatropin is contraindicated in patients with any evidence of active malignancy. Growth hormone deficiency may be an early sign of a pituitary tumor or other intracranial tumor; the presence of such a tumor should be excluded before initiation of somatropin treatment
  • Diabetic retinopathy: Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy
  • Closed epiphyses: Somatropin should not be used for growth promotion in pediatric patients with closed epiphyses
  • Hypersensitivity: Nutropin therapy is contraindicated in patients with a known sensitivity to somatropin or excipients. Localized reactions are the most common hypersensitivity reactions

WARNINGS AND PRECAUTIONS

  • Patients with a history of GHD secondary to an intracranial neoplasm should be monitored routinely while on somatropin therapy for progression or recurrence of the tumor. Patients on somatropin therapy should be monitored carefully for increased growth, or potential malignant changes, of preexisting nevi. Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, these patients should be carefully monitored for development of neoplasms, if treatment with somatropin is initiated.
  • Glucose intolerance and diabetes mellitus
  • Intracranial hypertension
  • Fluid retention
  • Patients with hypopituitarism should have their other hormonal replacement treatments closely monitored during somatropin treatment
  • Hypothyroidism
  • Slipped capital femoral epiphysis in pediatric patients
  • Progression of pre-existing scoliosis in pediatric patients
  • Otitis media and cardiovascular disorders in patients with Turner syndrome
  • Pancreatitis
  • Children with growth failure secondary to CKD should be examined periodically for evidence of progression of renal osteodystrophy
  • Injection site should be rotated to avoid tissue atrophy. Patients should be informed that local or systemic allergic reactions may occur and that prompt medical attention should be sought in such cases
  • Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone and IGF-I may increase during somatropin therapy

DRUG INTERACTIONS

  • Somatropin inhibits 11ß-hydroxysteroid dehydrogenase type 1 (11ßHSD-1) in adipose/hepatic tissue and may significantly impact the metabolism of cortisol and cortisone. As a consequence, in patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked, requiring glucocorticoid replacement therapy
  • Careful monitoring is advisable when somatropin is administered in combination with insulin and/or other hypoglycemic agents, other drugs metabolized by CYP450 liver enzymes (eg, hydrocortisone or other corticosteroids, sex steroids, anticonvulsants, cyclosporine), or other hormone replacement therapy

USE IN SPECIFIC POPULATIONS

  • Somatropin should be used during pregnancy only if clearly needed and with caution in nursing mothers because it is not known whether somatropin is excreted in human milk
  • Clinical studies of somatropin did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger patients

ADVERSE REACTIONS

  • Common adverse reactions reported in adult and pediatric patients taking somatropin include injection site reactions. Additional common adverse reactions in adults include edema, arthralgia, and carpal tunnel syndrome.

You may report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see accompanying Nutropin full Prescribing Information for additional Important Safety Information.

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