After you've chosen to prescribe ONPATTRO® (patisiran) for your patient, follow the steps below to help enable patient access, proper claims submission, and reimbursement
- Together with your patient, complete the ONPATTRO Start Form to initiate verification of benefits and an eligibility assessment for patient financial assistance, if required.
- Schedule the patient’s ONPATTRO infusion.
- Before your patient’s first infusion, an Alnylam team member will reach out to schedule an on-site ONPATTRO preparation and administration educational in-service
- Work with Alnylam Assist® to determine the method for ordering ONPATTRO.
- The Alnylam Assist® team will provide you with information about how to order ONPATTRO. For some patients, home administration may also be an option
- Alnylam Assist® can explain the requirements and processes for prior authorizations, claims, and appeals
- An Alnylam Field Reimbursement Director can provide education about billing, coding, and the reimbursement process for ONPATTRO
- For patients on Medicare who are receiving ONPATTRO and are covered under Medicare Part B benefit, the Medicare Administrative Contractors (MACs) may require additional chart documentation to determine the medical necessity of the treatment, although prior authorization is not requireda
- For patients enrolled in Medicaid or a commercial health plan, ONPATTRO coverage will vary by payer or state Medicaid agency
- Some payers may also apply utilization restrictions for ONPATTRO
Alnylam's Field Reimbursement Directors are available to answer questions you or your staff have about ONPATTRO reimbursement, billing, and coding.
aIt is always the provider’s responsibility to determine the appropriate healthcare setting and to submit true and correct claims for those products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies.
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Important Safety Information and Indication
Important Safety Information
Infusion-related reactions (IRRs) have been observed in patients treated with ONPATTRO® (patisiran). In a controlled clinical study, 19% of ONPATTRO-treated patients experienced IRRs, compared to 9% of placebo-treated patients. The most common symptoms of IRRs with ONPATTRO were flushing, back pain, nausea, abdominal pain, dyspnea, and headache.
To reduce the risk of IRRs, patients should receive premedication with a corticosteroid, acetaminophen, and antihistamines (H1 and H2 blockers) at least 60 minutes prior to ONPATTRO infusion. Monitor patients during the infusion for signs and symptoms of IRRs. If an IRR occurs, consider slowing or interrupting the infusion and instituting medical management as clinically indicated. If the infusion is interrupted, consider resuming at a slower infusion rate only if symptoms have resolved. In the case of a serious or life-threatening IRR, the infusion should be discontinued and not resumed.
Reduced Serum Vitamin A Levels and Recommended Supplementation
ONPATTRO treatment leads to a decrease in serum vitamin A levels. Supplementation at the recommended daily allowance (RDA) of vitamin A is advised for patients taking ONPATTRO. Higher doses than the RDA should not be given to try to achieve normal serum vitamin A levels during treatment with ONPATTRO, as serum levels do not reflect the total vitamin A in the body.
Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (e.g. night blindness).
The most common adverse reactions that occurred in patients treated with ONPATTRO were upper respiratory tract infections (29%) and infusion-related reactions (19%).
ONPATTRO is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
For additional information about ONPATTRO, please see the full Prescribing Information.