How to Help Your Patients Find Givlaari in Stock: A Provider's Guide

For patients with acute hepatic porphyria (AHP), Givlaari (givosiran) can dramatically reduce attack frequency and improve quality of life. But the path from prescription to injection is far more complex than for most medications. As a provider, you play a central role in ensuring your patient actually receives their monthly dose — not just in writing the prescription, but in navigating the specialty distribution system, coordinating with pharmacies, and troubleshooting access problems before they become crises.

This guide is designed to be a practical reference for your office and care team.

Step 1: Submit the Alnylam Assist® Start Form

The first step after deciding to prescribe Givlaari is to complete and submit the Givlaari Start Form. This form is submitted to Alnylam Assist® and initiates the access process. It includes:

• Prescriber information and signature
• Patient demographic and insurance information (attach copies of both sides of medical and prescription insurance cards)
• Patient signature (required — form cannot be processed without it)

Fax completed pages 1 and 2 to 1-833-256-2747. An Alnylam Assist® Case Manager will then be assigned to your patient and will reach out within 1-2 business days.

Step 2: Prepare Your Prior Authorization Documentation

While Alnylam Assist® can provide prior authorization education, the documentation must come from your office. A complete prior authorization package typically includes:

• AHP diagnosis confirmation: recent urine ALA and PBG results (ideally within the past 12 months) with reference ranges, and/or genetic confirmation
• Attack history: detailed log of ≥2 porphyria attacks in the prior 6 months (or ≥4/year for some payers), with dates, symptoms, treatment received (hemin, ER visit, hospitalization)
• Hemin history: dates, doses, frequency, and reasons hemin is insufficient for long-term management
• Baseline monitoring labs: LFTs (ALT/AST), creatinine/eGFR, homocysteine
• Medical necessity letter from specialist: specific, point-by-point addressing the payer's criteria with clinical detail

Step 3: Identify the Site of Care

Givlaari must be administered by a healthcare professional. Your patient will need a site of care that can receive the medication and administer it monthly. Options include:

• Your office — If you have infusion or injection administration capability and are enrolled to receive specialty medications
• Hospital or independent infusion center — Many infusion centers can accommodate specialty injectables; they need to coordinate with CVS Specialty or Accredo to receive shipments
• Home nursing visit — Available in some areas; Alnylam Assist® can facilitate this arrangement for eligible patients

If you're unsure of available sites near your patient, call Alnylam Assist® at 1-833-256-2748 and request a site search by the patient's zip code.

Step 4: Proactive Monitoring and Renewal

Once a patient is started on Givlaari, your office must manage ongoing monitoring and annual prior authorization renewal. Build these into your system:

• Order LFTs monthly for the first 6 months, then every 3-6 months
• Order urine ALA and PBG every 3-6 months to document ongoing disease control (required by most payers for renewal)
• Monitor kidney function (creatinine, eGFR) periodically
• Document attack frequency (or confirmed absence of attacks) at each visit
• Initiate renewal PA 30-90 days before the current authorization expires

What to Do When an Authorization Is Denied

Denials are common on initial submission, especially if documentation is incomplete. When a denial arrives:

1. Read the denial letter carefully and identify the specific reason codes.
2. File an internal appeal within the stated window (typically 60-180 days). Address each denial reason point-by-point with clinical evidence.
3. Request expedited review if your patient is at high risk for a porphyria attack due to the treatment delay.
4. Contact Alnylam Assist® Bridge Program immediately so your patient does not miss doses while the appeal is pending.

medfinder: A Tool to Support Your Patients

Direct your patients to medfinder. medfinder calls specialty pharmacies and clinical administration sites to identify which ones can fill and administer Givlaari near your patient. This reduces the logistical burden on your staff and helps ensure patients don't miss injections due to site-of-care issues — especially for patients who have relocated or whose preferred site has capacity issues.

Summary: Provider Checklist for Givlaari Access

• Complete and fax Givlaari Start Form to 1-833-256-2747
• Prepare comprehensive PA documentation (labs, attack log, hemin history, medical necessity letter)
• Identify site of care with Alnylam Assist®
• Conduct comprehensive medication reconciliation for CYP1A2/CYP2D6 interactions
• Set up monthly LFT monitoring for first 6 months
• Track PA expiration and initiate renewal 30-90 days early
• See also: Givlaari access: what providers need to know in 2026