Nutropin GPS Co-pay Card Program Form

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Nutropin GPS is a resource for access and reimbursement support.

We work to help you pay for your Genentech product. We can help in many different ways. We assist people who have a healthcare plan as well as those who don't.

For us to help, we need to look at, use and disclose your personally identifiable information (PII). Your healthcare provider and healthcare plan can disclose your PII to us only with your written authorization. By signing this authorization form, you are authorizing your healthcare provider and healthcare plan to release your PII to us, and authorizing us to disclose your PII as necessary to perform services for you. Once you sign this form and it is sent back to us, or submitted electronically by you or by your healthcare provider on your behalf, we can start to provide these services. You can choose not to agree to this authorization, however, please note that we cannot provide our services without it. This means you might need to pay for certain medications on your own.

Please read through this form carefully. If you have any questions, talk to your healthcare providers’ office or call us at: 1-866-688-7674.

1. Information to Be Disclosed or Used

This signed form lets my healthcare providers and healthcare plans send my PII and this form electronically, to Nutropin GPS. This includes:

  • All my health records relating to my treatment
  • Information about my healthcare plan benefits
  • The dollar balance left on the total of the lifetime payments covered by my healthcare plan policy (if this applies to my plan)
  • Any information having a bearing on my health or my adherence to my treatment

All of the above is considered part of my PII. I know this could include information about:

  • Sexually transmitted diseases
  • Mental health conditions
  • Genetic test results

2. Who May See And Use Personally Identifiable Information (PII)

My PII may be seen by Nutropin GPS. Nutropin GPS is sponsored by Genentech. Its address is 1 DNA Way, Mail Stop #858a, South San Francisco, CA 94080-4990.

It may also be seen by anyone helping Nutropin GPS perform services including Genentech employees and any of Genentech’s partners, for the purpose of facilitating access to Genentech products. Genentech may share your PII with partners, and/or their agents and affiliates, and your healthcare provider and health plan.

My PII May Be Used Only In These Ways:

  • Helping with my healthcare plan coverage for Genentech products
  • Determining eligibility for the Nutropin GPS Co-Pay Card Program
  • Determining eligibility for alternative forms of coverage and sources of funding
  • Coordination of prescription fulfillment through a pharmacy
  • Tracking my use of Genentech products
  • For Genentech, or our partners’ administrative purposes

3. Notices

This authorization and notice of release shall be in effect for five years from the date of my signature unless a shorter period is required by state law. I understand that if I am a resident of the state of Maryland, this authorization will be valid for no longer than 1 year from the date I signed it.

Once I sign this form, I know my PII might not be covered by any federal law that restricts the use and disclosure of my PII. There is no guarantee my PII might not be released to a third party. This third party might not need to follow the conditions of this authorization and notice of release.

I know I can refuse to sign this form. I may withdraw authorization at any time and for any reason. This won’t affect the start or continuing of my treatment, the quality of my treatment, and will have no impact on my treatment by my healthcare provider. To withdraw it, I must send a written notice to Genentech. It can be sent by fax to 1-800-545-0612 or by mail to the address on this page. This withdrawal goes into effect once it is received by Genentech. If I don’t sign this form or if I withdraw my authorization, Genentech will not be able to help me with access to my Genentech product(s).

I understand that I, as the patient or signer, have a right to obtain a copy of this signed authorization and notice of release during the time period this authorization is valid, or up to three years after it is signed.

4. Please review the Important Safety information for Nutropin

X

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.
  • Prader-Willi Syndrome (PWS) in Children: Somatropin is contraindicated in 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. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor.
  • Hypersensitivity: Nutropin AQ is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products.
  • Diabetic Retinopathy: Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
  • Closed Epiphysis: Somatropin should not be used for growth promotion in pediatric patients with closed epiphysis.

WARNINGS AND PRECAUTIONS

  • 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 after treatment with pharmacologic doses of somatropin. The safety of continuing somatropin treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established.
  • Prader-Willi Syndrome (PWS) in Children: There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with PWS 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. Patients with PWS should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin. If during treatment with somatropin, patients show signs of upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, treatment should be interrupted. All patients with PWS treated with somatropin should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively.
  • Neoplasms: 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. Monitor all patients with a history of GHD secondary to an intracranial neoplasm routinely while on somatropin therapy for progression or recurrence of the tumor. Monitor patients on somatropin therapy 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: Previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked during somatropin treatment. New-onset type 2 diabetes mellitus has been reported. As a result, blood glucose concentrations should be monitored periodically in all patients taking somatropin, especially in those with risk factors for diabetes mellitus. Patients with pre-existing type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely during somatropin treatment. The doses of antihyperglycemic drugs (i.e. insulin or oral/injectable agents) may require adjustment when somatropin therapy is instituted in these patients.
  • Intracranial Hypertension (IH): Funduscopic examination is recommended at the initiation of and periodically during therapy as intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting have been reported in a small number of patients treated with somatropin. If papilledema is observed by funduscopy during treatment with somatropin, treatment should be stopped. If somatropin-induced IH is diagnosed, treatment with somatropin can be restarted at a lower dose after IH-associated signs and symptoms have resolved. Patients with TS, CKD, and PWS may be at increased risk for the development of IH.
  • Severe Hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reaction and angioedema have been reported with postmarketing use of somatropin products. Patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs.
  • Fluid Retention: Transient and dose-dependent fluid retention during somatropin replacement in adults may occur.
  • 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 or stress doses following initiation of somatropin treatment.
  • Hypothyroidism: Patients treated with somatropin should have periodic thyroid function tests, and thyroid hormone replacement therapy should be initiated or appropriately adjusted in cases of unmasked or worsening hypothyroidism.
  • Slipped Capital Femoral Epiphysis in Pediatric Patients (SCFE): SCFE may occur more frequently in patients with endocrine disorders and in patients undergoing rapid growth. Any pediatric patient with the onset of a limp or complaints of hip or knee pain during somatropin therapy should be carefully evaluated.
  • Progression of Preexisting Scoliosis in Pediatric Patients: Progression of scoliosis can occur in patients who experience rapid growth. Somatropin has not been shown to increase the occurrence of scoliosis. Physicians should be alert to these abnormalities, which may manifest during somatropin therapy.
  • Otitis Media and Cardiovascular Disorders in Patients with Turner Syndrome: Patients with TS should be evaluated carefully for otitis media and other ear disorders as somatropin treatment may increase the occurrence of otitis media in these susceptible patients. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (eg, hypertension, aortic aneurysm or dissection, stroke) as they are at increased risk for these conditions.
  • Osteodystrophy in Pediatric Patients with Chronic Kidney Disease: Children with growth failure secondary to CKD should be examined periodically for evidence of progression of renal osteodystrophy. SCFE or avascular necrosis of the femoral head may be seen in children with advanced renal osteodystrophy. X-rays of the hip should be obtained prior to initiating somatropin therapy in CKD patients and physicians and parents should be alert to the development of a limp or complaints of hip or knee pain in these patients.
  • Lipoatrophy: When somatropin is administered subcutaneously at the same site over a long period of time, tissue atrophy may result. This can be avoided by rotating the injection site.
  • Laboratory Tests: Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone and IGF-I may increase during somatropin therapy.
  • Pancreatitis: Cases of pancreatitis have been reported rarely in children and adults receiving somatropin. Pancreatitis should be considered in any somatropin-treated patient, especially a child, who develops persistent, severe abdominal pain. Girls who have TS may be at greater risk than other somatropin-treated children.

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. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment.
  • Glucocorticoid replacement therapy should be carefully adjusted in children with concomitant GH and glucocorticoid deficiency to avoid both hypoadrenalism and an inhibitory effect on growth. Concomitant glucocorticoid therapy may inhibit the growth promoting effect of Nutropin AQ.
  • Careful monitoring is advisable when somatropin is administered in combination with other drugs metabolized by CYP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine), hormone replacement therapy, insulin and/or other hypoglycemic agents.

USE IN SPECIFIC POPULATIONS

  • Pregnancy/Nursing Mothers: 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.
  • Geriatric Use: 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. Elderly patients may be more sensitive to the action of somatropin and may be more prone to adverse reactions.

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 the 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.

Acceptance of Disclosure

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The patient information disclosed during this enrollment, including name, email address, mailing address, phone number, date of birth, and insurance information will be shared with Genentech, the sponsor of the card. In addition, information shared by the patient's pharmacy/physician, such as the date the patient filled the prescription, the date the medication was administered by patient's physician (if applicable), and the amount that patient will be reimbursed by Genentech, will be shared with Genentech, the sponsor of this card. The patient agrees to be contacted by phone, mail, or email with the information and/or materials about the patient's Genentech Nutropin GPS Co-pay Card. For more information, please see the Genentech Privacy Policy at gene.com.

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The patient information disclosed during this enrollment, including name, email address, mailing address, phone number, date of birth, and insurance information will be shared with Genentech, the sponsor of the card. In addition, information shared by the patient's pharmacy/physician, such as the date the patient filled the prescription, the date the medication was administered by patient's physician (if applicable), and the amount that patient will be reimbursed by Genentech, will be shared with Genentech, the sponsor of this card. The patient agrees to be contacted by phone, mail, or email with the information and/or materials about the patient's Genentech Nutropin GPS Co-pay Card. For more information, please see the Genentech Privacy Policy at gene.com.

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Eligibility

Please answer the questions below by clicking “yes” or “no”. This will determine if the patient qualifies for the Nutropin Co-pay Card Program.

1. I have read and agree to the Terms and Conditions of the program *
2. Are you 18 years of age or older OR are you a legal guardian of a patient who is under the age of 18? *
3. Is the patient obtaining free Nutropin AQ® NuSpin® (somatropin) injection, for subcutaneous use from the Genentech® Access to Care Foundation (GATCF) or any other charitable organization? *
4. Is the patient a government beneficiary and/or a participant in a federal or state-funded healthcare program including, but not limited to all Medicare including Parts A, B, C and/or D, Medicaid, Medigap, VA, DoD, or TRICARE? *
5. Will you be filing any claims for co-pay expenses you have paid out of pocket within 120 days prior to your enrollment in this program? *

Terms and Conditions

By using the Nutropin GPS™ Copay Card Program, the patient acknowledges and confirms that, at the time of usage, (s)he is currently eligible and meets the criteria set forth in the terms and conditions described.

This Copay Card is valid ONLY for patients with commercial (private or non-governmental) insurance who are taking the medication for a Food and Drug Administration (FDA)-approved indication. Patients using Medicare, Medicaid, Medicap, Veteran’s Affairs (VA), Department of Defense (DoD), TriCare or any other government-funded program to pay for their medications are not eligible. Patients who start utilizing their government coverage during their enrollment period will no longer be eligible for the program.

This Copay Card Program is not health insurance or a benefit plan. Distribution or use of the Copay 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 Copay 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 Copay Card Program, as may be required.

The Copay 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 Genentech® Patient Foundation or any other charitable organization) that reimburse the patient in part or for the entire cost of his/her Genentech medication. Patient, guardian, pharmacist, prescriber, and any other person using the Copay Card agree not to seek reimbursement for all or any part of the benefit received by the recipient through this Copay Card Program.

The Copay Card may be accepted by participating pharmacies, physician offices, or hospitals. To qualify for the benefits of this Copay Card Program, the patient may be required to pay out-of-pocket expenses for each treatment. Once enrolled, this Copay Card Program will not honor claims with date of service or medication dispensing that precede program enrollment by more than 120 days. This Copay Card is only available with a valid prescription and cannot be combined with any other rebate, free trial, or similar offer for the specified prescription. Use of this Copay 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 Copay Card as provided for under the applicable insurance or as otherwise required by contract or law. The Copay Card may not be sold, purchased, traded, or offered for sale, purchase, or trade. The Copay Card is limited to 1 per person during this offer period and is not transferable. Program eligibility period is contingent upon patient’s ability to meet and maintain all requirements as set forth by the program. Genentech will periodically verify eligibility and will terminate patients without obligation to pay claims if change to status is detected. This program is not valid where prohibited by law, and shall follow state restrictions in relation to AB-rated generic equivalents where applicable (e.g. MA, CA).

The patient or their guardian must be 18 years or older to receive Copay Card Program assistance. This Copay Card Program is (1) void if the card is reproduced; (2) void where prohibited by law; (3) only valid in the United States and U.S. Territories; 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 reserves the right to rescind, revoke, or amend the program without notice at any time.

By placing my electronic signature on this agreement, I expressly consent to use and rely on electronic agreements and signature, and I understand my signature will have the same binding effect as if I was providing a handwritten signature.

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I have read this document or have had it explained to me. By signing this form, I know I am authorizing the release and disclosure of my PII as discussed in this authorization form.

Today's date is Month DD, YYYY 12:00:00 PST

Thank you for submitting your information.

If you qualify, a Co-pay Card will be sent to you within 14 business days. If there are any questions about your eligibility, a Case Manager will contact you within 5 business days.

If you have any questions about the status of your application, please contact a GPS Case Manager at 1-866-NUTROPIN

1-866-688-7674.

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