M
- F
, 8
am - 6
pm ET
How Alnylam Assist® Can Help Your Patients
Alnylam Assist® will be there for your patients throughout treatment with GIVLAARI™ (givosiran). Ready to enroll your patient?
Alnylam Assist® Services Overview
Upon receipt of the Start Form, an Alnylam Case Manager dedicated to your patient’s needs will reach out to you and your patient within 1-2 business days. Your patient’s Case Manager will help with the following:
Benefit Verification
Help determine patient-specific coverage requirements, which include the following:
•Initiate a benefit verification for your patient and provide you and your patient with a benefit verification summary
•Provide information about patient financial assistance programs for eligible patients,* if necessary
Treatment Coverage
Explain the requirements and processes for prior authorizations, claims, and appeals, which include the following:
•Research the payer requirements as part of the benefit verification process
•Discuss the standard process for submitting a prior authorization and reimbursement claims
•Investigate reasons for denied or rejected prior authorizations, claims, and/or appeals
Financial Assistance
Review financial assistance programs your patient may qualify for based on his or her eligibility. Select patients may qualify for the following financial assistance programs*†:
•Quick Start Program: Provides up to 3 doses of GIVLAARI at no cost to eligible patients if coverage is delayed
•Patient Assistance Program (PAP): Provides GIVLAARI at no cost to eligible patients
•Commercial Copay Program: Covers out-of-pocket medication costs for eligible patients
Disease and Product Education
Provide information to your patients for the following:
•A Patient Starter Kit, including educational materials designed to help patients understand GIVLAARI and Alnylam Assist®
•Education for your patients from a designated Alnylam Patient Education Liaison (PEL) to help them gain a better understanding of acute hepatic porphyria and treatment with GIVLAARI
Facilitation of Product Orders
Alnylam Field Reimbursement Directors (FRDs) are available to provide education about the GIVLAARI reimbursement process. FRDs will share their knowledge of:
•GIVLAARI billing and coding requirements
•Chart documentation requirements
•Payer requirements
* 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.
† Alnylam Assist® Financial Assistance Programs do not cover the costs associated with GIVLAARI administration.
Where can I find the necessary forms and documents to enroll patients in Alnylam Assist®?
Alnylam Assist® provides all the required forms and documents to enroll your patients, as well as downloadable educational resources. View the associated GIVLAARI forms and documents ›
Enroll Your Patients Now
Together with your patient
(in office)
Initiate then send to patient
(via email)
IMPORTANT SAFETY INFORMATION
Contraindications
GIVLAARITM (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.