Patient Access & Support

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How to get your patients started on GIVLAARI® (givosiran)

Together with your patient, complete the Start Form to initiate verification of benefits and eligibility assessment for financial assistance if required.

Alnylam Assist® provides personalized support for patients prescribed GIVLAARI. Alnylam Assist® can explain the requirements and processes for prior authorizations, claims, and appeals.

Financial Assistance Programs

Alnylam Assist® offers various options to help patients who need additional assistance:

  • Copay Assistance: Covers out-of-pocket costs for eligible patients

  • Quick Start: Provides up to 3 doses of GIVLAARI at no cost to eligible patients if coverage is delayed due
    to prior authorization

  • Patient Assistance ProgramProvides GIVLAARI at no cost to eligible patients

*Coverage may vary for individual and plan. Data as of February 2021.

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.

Help your patients get started with GIVLAARI® (givosiran) with Alnylam Assist®

Fill out the start form available below—this will help your patient access personalized support and benefits that Alnylam Assist® offers—with benefit verification notification in 1-2 business days. Want to learn more about Alnylam Assist® and the Start Form? Contact your local rep here.

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Step 2:

Print, complete with your patient, then fax to 1-833-256-2747

What happens next:

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Your patient’s dedicated Alnylam Assist® Case Manager will reach out to you and your patient within 1-2 business days and provide a benefit verification summary and information about coverage and financial assistance options if needed

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The Alnylam Assist® team will send your patient’s GIVLAARI prescription to a specialty pharmacy and/or provide you information about specialty distributors.

Alnylam Assist® provides personalized support for your patients throughout the treatment process

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A dedicated Case Manager

Alnylam Assist® will connect patients with a dedicated Alnylam Assist® Case Manager who can provide personalized support throughout the GIVLAARI® (givosiran) treatment process.

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Benefit verification

Coverage for GIVLAARI will vary by plan and by patient. Alnylam Assist® can help determine patient-specific coverage requirements.

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Financial assistance

Eligible patients* may qualify for the Alnylam Assist® Quick Start Program, Patient Assistance Program, or Commercial Copay Program.

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Disease and product education

Patient Education Liaisons (PELs) are available to help educate patients and their families on acute hepatic porphyria and GIVLAARI.

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Field Reimbursement Directors (FRDs)

Alnylam Assist® support team members are located across the country—local FRDs can meet with HCPs and staff to educate on GIVLAARI access and reimbursement, including the prior authorization process and requirements, claims, and appeals in the case of a denial. They can also help explain billing and coding, chart documentation, and payer requirements for GIVLAARI.

*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.

Monday–Friday, 8AM–6PM ET

fax icon 1-833-256-2747

Coverage, coding, and reimbursement Download the following guides for more information:

Downloadable guide icon Billing and Coding Guide for Hospitals Downloadable guide icon Billing and Coding Guide for Physicians Downloadable guide icon Reimbursement Guide
 

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.