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 prescribe GIVLAARI and 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:

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

  • Patient Assistance ProgramProvides GIVLAARI at no cost to eligible patients

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

Patients with Medicare, Medicaid, or other government-sponsored insurance are not eligible for Alnylam’s Commercial Copay Program.

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 the personalized support that Alnylam Assist® offers—with benefit verification notification within 2 business days.

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Step 2:

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

Want to learn more about Alnylam Assist® and the Start Form?

Contact a local rep

Contact a local rep

What happens next:

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

Alnylam Assist® personalized support services for patients on treatment icon

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 Case Manager who can provide personalized patient support throughout the GIVLAARI® 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® 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. PELs are employees of Alnylam Pharmaceuticals and do not provide medical advice.

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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 machine 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 Access and Reimbursement Kit
 

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.

Blood Homocysteine Increased

Increases in blood homocysteine levels have occurred in patients receiving GIVLAARI. In the ENVISION study, during the open label extension, adverse reactions of blood homocysteine increased were reported in 15 of 93 (16%) patients treated with GIVLAARI. Measure blood homocysteine levels prior to initiating treatment and monitor for changes during treatment with GIVLAARI. In patients with elevated blood homocysteine levels, assess folate, vitamins B12 and B6. Consider treatment with a supplement containing vitamin B6 (as monotherapy or a multivitamin preparation).

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.