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Frequently Asked Questions (FAQs)
What is Alnylam Assist®?
Alnylam Assist® is a team of dedicated Case Managers, Patient Education Liaisons, and Field Reimbursement Directors who provide support to patients prescribed Alnylam therapies. These services include verification of insurance benefits, reimbursement education, financial assistance support for eligible patients, and disease education. Each member of our team is assigned to specific geographic regions to work with patients, their caregivers, family members, healthcare providers, and insurance companies to support patients throughout treatment on GIVLAARI® (givosiran).
How do I enroll my patient in the Alnylam Assist® program?
There are 3 ways to enroll your patient:
- Complete the electronic Start Form
•You will receive an auto-generated confirmation after submission to let you know we have received the Start Form and are initiating services
•You and your patient will each receive a phone call from his or her case manager within 1-2 business days of receipt
- Download the writable PDF version and fax the completed Start Form to Alnylam Assist® at 833-256-2747
•You and your patient will receive a phone call from his or her Case Manager within 1-2 business days of receipt
- Begin filling out the DocuSign form and email it to your patient to complete
•Once you have finished your portion of the Start Form and provided an eSignature, it will be emailed to your patient so he or she can verify the information and fill out any remaining fields
•Both you and your patient will receive notification via email when the completed Start Form has been submitted to Alnylam Assist®
•A Case Manager dedicated to your patient’s needs will reach out to you and your patient within 1-2 business days of receiving the completed Start Form
•For help submitting the DocuSign form, download our DocuSign Instructions.
See how to enroll your patients ›
Where can I find more materials about GIVLAARI® (givosiran) and Alnylam Assist®?
Support and educational materials about GIVLAARI and Alnylam Assist® can be found on this site. See additional materials ›
What services does Alnylam Assist® provide?
Alnylam Assist® provides patients with product support services, including:
•Benefit verification for GIVLAARI
•Education on the prior authorizations, claims, and appeals processes
•Financial assistance program enrollment for eligible patients*
•Disease and GIVLAARI education
•Facilitation of product orders
Get more information about patient services ›
*Patients must meet specified eligibility criteria to qualify for assistance. Alnylam reserves the right to make eligibility determinations and to modify or discontinue the program at any time.
Who makes up the Alnylam Assist® team?
Case Managers are experienced in helping individuals get started on treatment and providing ongoing support. They will tailor their level of contact based on each individual's personal needs. Here’s how Case Managers provide additional patient support ›
Field Reimbursement Directors (FRDs) are dedicated to providing education about the GIVLAARI reimbursement process. FRDs are knowledgeable in chart documentation best practices and GIVLAARI billing and coding requirements. Here’s more information about the FRD role ›
Patient Education Liaisons (PELs) have backgrounds in nursing or genetic counseling, and are experienced in educating individuals and their families about matters related to acute hepatic porphyria. PELs can help patients in a variety of ways, including providing disease and product education, connecting patients to additional resources, and answering questions about treatment with GIVLAARI. Get acquainted with members of the PEL team ›
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IMPORTANT SAFETY INFORMATION
Contraindications
GIVLAARI® (givosiran) is contraindicated in patients with known severe hypersensitivity to givosiran. Reactions have included anaphylaxis.
Anaphylactic Reaction
Anaphylaxis has occurred with GIVLAARI treatment (<1% of patients in clinical trials). Ensure that medical support is available to appropriately manage anaphylactic reactions when administering GIVLAARI. Monitor for signs and symptoms of anaphylaxis. If anaphylaxis occurs, immediately discontinue administration of GIVLAARI and institute appropriate medical treatment.
Hepatic Toxicity
Transaminase elevations (ALT) of at least 3 times the upper limit of normal (ULN) were observed in 15% of patients receiving GIVLAARI in the placebo-controlled trial. Transaminase elevations primarily occurred between 3 to 5 months following initiation of treatment.
Measure liver function tests prior to initiating treatment with GIVLAARI, repeat every month during the first 6 months of treatment, and as clinically indicated thereafter. Interrupt or discontinue treatment with GIVLAARI for severe or clinically significant transaminase elevations. In patients who have dose interruption and subsequent improvement, reduce the dose to 1.25 mg/kg once monthly. The dose may be increased to the recommended dose of 2.5 mg/kg once monthly if there is no recurrence of severe or clinically significant transaminase elevations at the 1.25 mg/kg dose.
Renal Toxicity
Increases in serum creatinine levels and decreases in estimated glomerular filtration rate (eGFR) have been reported during treatment with GIVLAARI. In the placebo-controlled study, 15% of patients receiving GIVLAARI experienced a renally-related adverse reaction. The median increase in creatinine at Month 3 was 0.07 mg/dL. Monitor renal function during treatment with GIVLAARI as clinically indicated.
Injection Site Reactions
Injection site reactions were reported in 25% of patients receiving GIVLAARI in the placebo-controlled trial. Symptoms included erythema, pain, pruritus, rash, discoloration, or swelling around the injection site. One (2%) patient experienced a single, transient, recall reaction of erythema at a prior injection site with a subsequent dose administration.
Drug Interactions
Concomitant use of GIVLAARI increases the concentration of CYP1A2 or CYP2D6 substrates, which may increase adverse reactions of these substrates. Avoid concomitant use of GIVLAARI with CYP1A2 or CYP2D6 substrates for which minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP1A2 or CYP2D6 substrate dosage in accordance with approved product labeling.
Adverse Reactions
The most common adverse reactions that occurred in patients receiving GIVLAARI were nausea (27%) and injection site reactions (25%).
INDICATION
GIVLAARI is indicated for the treatment of adults with acute hepatic porphyria (AHP).
For additional information about GIVLAARI, please see full Prescribing Information.