SUPPORT & RESOURCES

Helping patients get access

to their prescribed medications with the information and support they need

TO BEGIN THE ENROLLMENT PROCESS, VISIT OUR WEBSITE:

https://www.ipsencares.com/somatuline-depot-patient-support

IPSEN CARES provides a single point of contact between patients/caregivers, healthcare providers, insurance companies, and Specialty Pharmacies

PHONE:

1-866-435-5677

FAX:

1-888-525-2416

HOURS: 8:00 am - 8:00 pm ET
MONDAY - FRIDAY

IPSEN CARES is staffed by dedicated Patient Access Specialists who can assist with:

Reimbursement assistance

Benefits Verification: Verifies patients’ coverage, restrictions (if applicable), and copayment/coinsurance amounts
Prior Authorization (PA)/Appeals:
- Provides information on documentation required by payers on PA specifics, and recommendations for next steps based on payer policy
- Provides information on the payer-specific processes required to submit a level I or a level II appeal, as well as provides guidance as needed through the process

Financial support

Copayment Assistance: Offers copayment assistance to eligible* patients. This includes referring to the Somatuline Depot Commercial Copay Program or referring to an independent nonprofit organization if available
Patient Assistance Program (PAP): Determines patients’ eligibility^† for PAP and dispenses free product to eligible patients

Product distribution

Institutions: Somatuline Depot can be acquired from wholesaler
Private Practices:
- Direct (buy-and-bill) acquisition from a group of approved specialty distributors
- Specialty Pharmacy delivery (IPSEN CARES can provide helpful information on selection of the appropriate Specialty Pharmacy for the patient by calling 1-866-435-5677)

Patient support

Communication: Conducts calls to both healthcare provider and patient with status updates about patient’s IPSEN CARES enrollment, benefits verification results, coverage status, dispense date, etc.

HCP online portal

The HCP Portal allows you to track the status of your patients enrolled in IPSEN CARES. We hope the HCP portal will be a convenient resource for you and your office. After you register and create a profile, your profile will be validated within 24 to 48 hours.

Through the online portal you can:

Send a message to the IPSEN CARES team
Upload relevant patient documents
Obtain Specialty Pharmacy dispensing information (if applicable)
Review case status notes for enrolled patients

Visit www.ipsencares.com/hcp-resources to learn more.

* See Copay Assistance Program Patient Eligibility & Terms and Conditions.

^† Patients may be eligible to receive free drug if they are experiencing financial hardship, are uninsured or functionally uninsured, are U.S. residents, received a prescription for an on-label use of Somatuline Depot as supported by information provided in the program application, and meet income criteria based on an Experian soft credit check. Eligibility does not guarantee approval for participation in the program. The PAP provides Somatuline Depot product only, and does not cover the cost of previously purchased product or medical services.

HCP Resource Guide

The Somatuline^® Depot Resource Guide contains important information to help you with purchasing, billing, coding and reimbursement, plus more details and FAQs for IPSEN CARES.

Download

Community organizations that provide patients with acromegaly information and support

National Endocrine and Metabolic Diseases Information Service

A service of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH).

https://www.niddk.nih.gov/health-information/endocrine-diseases/acromegaly

Hormone Health Network

http://www.hormone.org/diseases-and-conditions/pituitary

Pituitary Network Association

Learn more about pituitary disorders, get contact information about hormonal health hospitals near you, and get answers to frequently asked questions.

http://www.pituitary.org

IMPORTANT SAFETY INFORMATION & INDICATIONS

Contraindications

SOMATULINE DEPOT is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.

Warnings and Precautions

Cholelithiasis and Gallbladder Sludge

SOMATULINE DEPOT may reduce gallbladder motility and lead to gallstone formation.
Periodic monitoring may be needed.
If complications of cholelithiasis are suspected, discontinue SOMATULINE DEPOT and treat appropriately.

Hypoglycemia or Hyperglycemia

Patients treated with SOMATULINE DEPOT may experience hypoglycemia or hyperglycemia.
Blood glucose levels should be monitored when SOMATULINE DEPOT treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly.

Cardiovascular Abnormalities

SOMATULINE DEPOT may decrease heart rate.
In cardiac studies with acromegalic patients, the most common cardiac adverse reactions were sinus bradycardia, bradycardia, and hypertension.
In patients without underlying cardiac disease, SOMATULINE DEPOT may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia.
In patients suffering from cardiac disorders prior to treatment, sinus bradycardia may occur. Care should be taken when initiating treatment in patients with bradycardia.

Thyroid Function Abnormalities

Slight decreases in thyroid function have been seen during treatment with lanreotide in acromegalic patients.
Thyroid function tests are recommended where clinically appropriate.

Monitoring/Laboratory Tests: In acromegaly, serum GH and IGF-1 levels are useful markers of the disease and effectiveness of treatment.

Most Common Adverse Reactions

Acromegaly: Adverse reactions in >5% of patients who received SOMATULINE DEPOT were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%) injection-site reactions (9%) constipation (8%) flatulence (7%) vomiting (7%) arthralgia (7%) headache (7%) and loose stools (6%).

GEP-NETs: Adverse reactions in >10% of patients who received SOMATULINE DEPOT were abdominal pain (34%), musculoskeletal pain (19%), vomiting (19%), headache (16%), injection site reaction (15%), hyperglycemia (14%), hypertension (14%), and cholelithiasis (14%).

Carcinoid Syndrome: Adverse reactions occurring in the carcinoid syndrome trial were generally similar to those in the GEP-NET trial. Adverse reactions in ≥5% of patients who received SOMATULINE DEPOT and at least 5% greater than placebo were headache (12%), dizziness (7%) and muscle spasm (5%).

Drug Interactions

SOMATULINE DEPOT may decrease the absorption of cyclosporine (dosage adjustment may be needed); increase the absorption of bromocriptine; and require dosage adjustment for bradycardia-inducing drugs (e.g., beta-blockers).

Special Populations

Lactation: Advise women not to breastfeed during treatment and for 6 months after the last dose.

Moderate to Severe Renal and Hepatic Impairment: See full prescribing information for dosage adjustment in patients with acromegaly.

INDICATIONS

SOMATULINE^® DEPOT (lanreotide) is a somatostatin analog indicated for:

the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.

the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

the long-term treatment of patients with acromegaly who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal.