On June 7th, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval for the biologic infusion ADUHELM. (Read the press release). ADUHELM is indicated for the treatment of Alzheimer’s disease and is the first and only treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain.
For patients interested in receiving ADUHLEM at an IVX Health center or for providers seeking to refer patients to IVX Health, please review the information provided on this page to learn more about the prerequisites for therapy.
The following labs, tests, and scans will be required for all Aduhelm patients seeking treatment at an IVX Health center. These diagnostics are not completed by IVX Health. Patients should consult their referring physician on next steps.
Brain MRI within one year before starting treatment
The patient will be required to complete three MRIs at different stages of the ADUHELM therapy regimen. The first must be completed before therapy starts, and the next MRIs must be completed after the sixth and eleventh infusion. IVX Health does not order or administer these MRIs. Patients must work with their referring physician to complete these diagnostic tests.
Cognitive test showing patient has reached the clinical stages for Alzheimer’s disease defined as mild cognitive impairment or mild dementia
Patients must receive a cognitive test showing mild cognitive impairment or mild dementia prior to receiving ADUHELM at IVX Health Patients should work with their referring physician to complete this diagnostic test.
Confirmation of Amyloid Beta Pathology – either in the form of an Amyloid Beta Pet Scan or through Cerebral Spinal Fluid (CSF) biomarker testing
Biogen is providing CSF biomarker test at no charge to patients through LabCorp and Mayo Clinic. The Amyloid βeta Confirmed™ program is being offered to help improve patient access to CSF biomarker testing to help support timely and accurate diagnosis of AD.
If you meet all three of the above criteria, please fill out the New Patient Form below, and IVX will contact you within 2 business days.
If you do not meet all of the above criteria, please talk to your neurologist or primary care provider about getting the tests you need.
New Patient Form
Before completing the form, please consult your referring physician to confirm that each of the listed diagnostic procedures have been completed.
Because Medicare has not published any reimbursement guidelines, IVX will be requiring all ADUHELM patients to sign a standard Medicare Advance Beneficiary Notice (ABN), also known as a waiver of liability, at the time of treatment. By signing this document, the patient (or patient’s representative) is acknowledging that they understand that Medicare may deny payment for this specific treatment. IVX will submit the patient’s claim to Medicare, but the patient will be personally responsible for full payment if Medicare denies payment.
Because commercial insurance companies have not released guidelines about whether they will pay for ADUHELM treatment IVX will not be accepting patients with commercial insurance or Medicare Advantage coverage at this time. We encourage patients with this type of insurance to contact Biogen’s Patient Support Services to find a site of care.
IVX Health is currently accepting referrals of ADUHELM. In addition to the diagnostic procedures listed above, IVX Health requires that all referrals are submitted with an IVX Health order form. To complete all phases of the ADUHELM therapy regimen, IVX Health will require three order forms, each submitted at different phases. Each order form, along with guidance on the timing and requirements for referral submission, is available for download on our Referrals page.
To move forward with a new ADUHELM patient referral, please visit our Referrals page and follow the set of instructions that outline our patient referral process.