Frequently Asked Questions

Will insurance cover the patient's Increlex^® prescription?

What if the patient's insurance carrier changes?

What should I do if my patient's insurance does not approve Increlex therapy?

Is Medicaid covering Increlex?

Do you know what the copay would be if a patient started Increlex?

Do you have an uninsured program?

Do you have a Starter program for Increlex?

How can the PACE^SM program help my patients?

How long does it take to obtain insurance coverage for Increlex?

Why is the package of Increlex so large?

Will insurance cover the patient's Increlex prescription?

Once you complete the Increlex SMN and submit it to PACE, a Patient Care Liaison (PCL) will be assigned to the patient case. The PCL can determine and communicate the patient’s insurance benefits, payer requirements and out-of-pocket costs for Increlex. Contact PACE at 1-866-435-5677 for more information.

What if the patient's insurance carrier changes?

If your patient's insurance carrier changes, be sure to have your patient contact his or her PACE PCL right away so that records are updated and changes in coverage can be identified. Contact PACE at 1-866-435-5677 for more information.

What should I do if my patient's insurance does not approve Increlex therapy?

PACE may be able to assist you if your patient's insurance does not approve Increlex and you would like to file an appeal. Contact PACE at 1-866-435-5677 for more information.

Is Medicaid covering Increlex?

Coverage may vary depending upon the particular carrier, but a PACE PCL can help you get answers to questions you may have. For more information, please call PACE at 1-866-435-5677.

Do you know what the copay would be if a patient started Increlex?

When you submit the SMN to PACE, the PCL will call your patient's insurance company to investigate his/her benefits. Please be aware that we can help determine potential out-of-pocket costs, but this is not a guarantee of payment. Contact PACE at 1-866-435-5677 for more information.

Do you have an uninsured program?

Yes, we do have a program to help eligible, uninsured patients gain access to Increlex. Please call PACE at 1-866-435-5677 for eligibility information.

Do you have a starter program for Increlex?

Yes, we do offer a starter program for eligible patients. Eligible patients may receive up to 8 months of Increlex therapy at no cost if the following criteria are met: Patient has been diagnosed with severe Primary IGFD. Patient’s prescriptions are not paid in part or full by any state-funded or federally-funded programs, including but not limited to Medicare, Medicaid, Medigap, VA, DOD or TriCare. Patient is not a resident of Massachusetts. Insurance coverage for Increlex is actively being pursued by the prescriber. The patient's insurance company has not yet communicated a final coverage decision. Ipsen reserves the right to deny free starter drug therapy to anyone deemed ineligible with the stated program criteria. Call PACE at 1-866-435-5677 for more details.

How can the PACE program help my patients?

PACE is a comprehensive service and support program designed to help patients and caregivers with questions they may have about starting and staying on Increlex therapy. PCL is at the center of PACE and can assist by determining and communicating the patient's insurance benefits, payer requirements and out-of-pocket costs for Increlex, coordinating delivery of Increlex starter therapy at no cost for eligible patients*, arranging for injection training and education through the Ipsen Nurse Network at your request, explaining Increlex financial assistance programs, coordinating delivery of Increlex through our specialty pharmacy network and providing educational materials on Increlex and severe Primary IGFD for the patient and his or her family. Contact PACE at 1-866-435-5677 for more information.

*Eligible patients may receive up to 8 months of Increlex therapy at no cost if the following criteria are met: Patient has been diagnosed with severe Primary IGFD. Patient's prescriptions are not paid in part or full by any state-funded or federally-funded programs, including but not limited to Medicare, Medicaid, Medigap, VA, DOD or TriCare. Patient is not a resident of Massachusetts. Insurance coverage for Increlex is actively being pursued by the prescriber. The patient's insurance company has not yet communicated a final coverage decision. Ipsen reserves the right to deny free starter drug therapy to anyone deemed ineligible with the with the stated program criteria.

How long does it take to obtain insurance coverage for Increlex?

This varies by insurance plan and will depend on whether a decision needs to be appealed. Approval of coverage may take up to 90 days or more. Contact PACE at 1-866-435-5677 for more information.

Why is the package of Increlex so large?

Because Increlex must be stored in the refrigerator at all times, it is delivered along with refrigerated ice packs to maintain temperature. Contact PACE at 1-866-435-5677 for more information.

Indication and Important Safety Information

INCRELEX^® (mecasermin [rDNA origin] injection) is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency, or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Severe primary IGF-1 deficiency (IGFD) is defined by height standard deviation score ≤ -3.0 and basal IGF-1 standard deviation score ≤ -3.0 and normal or elevated growth hormone (GH). Severe Primary IGFD includes classical and other forms of growth hormone insensitivity. Patients with Primary IGFD may have mutations in the GH receptor (GHR), post-GHR signaling pathway including the IGF-1 gene. They are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.

INCRELEX is not intended for use in subjects with secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Thyroid and nutritional deficiencies should be corrected before initiating INCRELEX treatment.

Limitations of use: INCRELEX is not a substitute to GH for approved GH indications.

INCRELEX is contraindicated in the presence of active or suspected malignancy, and therapy should be discontinued if evidence of malignancy develops. INCRELEX should not be used by patients who are allergic to mecasermin (rhIGF-1) or any of the inactive ingredients in INCRELEX, or who have experienced a severe hypersensitivity to INCRELEX [see Warnings and Precautions and Adverse Reactions]. Intravenous administration of INCRELEX is contraindicated. INCRELEX should not be used for growth promotion in patients with closed epiphyses.

INCRELEX has insulin-like hypoglycemic effects and should be administered 20 minutes before or after a meal or snack. Hypersensitivity and allergic reactions have been reported, including a low number of cases indicative of anaphylaxis requiring hospitalization. Intracranial hypertension has occurred in patients treated with INCRELEX. Funduscopic examination is recommended at the initiation of and periodically during the course of therapy. Patients should have periodic examinations to rule out potential complications from tonsillar/adenoidal hypertrophy and receive appropriate treatment if necessary. Children with onset of limp or hip/knee pain should be evaluated for possible slipped capital femoral epiphysis. Monitor any child with scoliosis for progression of the spine curve.

In clinical studies of 71 pediatric subjects with severe Primary IGFD representing 274 patient-years of treatment, no subjects discontinued due to adverse events. Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy with INCRELEX. Most cases of hypoglycemia were mild or moderate in severity. Five subjects had severe hypoglycemia (requiring assistance and treatment) on one or more occasion and four subjects experienced hypoglycemic seizures/loss of consciousness on one or more occasion. Symptomatic hypoglycemia was generally avoided when a meal or snack was consumed either shortly (i.e., 20 minutes) before or after the administration of INCRELEX. Tonsillar hypertrophy was noted in 11 (15%) subjects in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years. Intracranial hypertension occurred in three subjects. In two subjects the events resolved without interruption of INCRELEX treatment. INCRELEX treatment was discontinued in the third subject and resumed later at a lower dose without recurrence.

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