Alnylam Announces Alignment on Value-Based Agreements with Leading Health Insurers and Launches Comprehensive Patient Support Services for ONPATTRO™ (patisiran)
− Structure of Value-Based Arrangements Agreed in Principle with
− Alnylam Assist™ Program Designed to Facilitate Access to ONPATTRO and Provide Dedicated Patient Support –
“While preparing for approval and launch, we knew that our more than
15-year effort to advance RNAi therapeutics would only be successful if
ONPATTRO gets to the patients who need it,” said
Alnylam is actively discussing VBAs with leading commercial insurers, and has reached agreement in principle on the structure of value-based agreements with Harvard Pilgrim Health Care and other major health insurers, with many ongoing discussions. Based on MMIT, a leading medical policy reporting agency, these engaged payers cover approximately 76 percent of commercial medical lives in the U.S. The goal of these agreements is to ensure that Alnylam is paid based on the ability of ONPATTRO to deliver outcomes in the real world setting comparable to those demonstrated in clinical trials. Partnering with payers on these agreements is intended to provide more certainty to them for their investment, and help accelerate coverage decisions for patients. The agreements are structured to link ONPATTRO’s performance in real-world use to financial terms.
“Alnylam’s proactive approach to working closely with Harvard Pilgrim
far ahead of the drug approval date to develop a value-based agreement
highlights its commitment to patients, patient access, and delivering
meaningful outcomes to the healthcare system,” said
The VBAs build upon Alnylam’s Patient Access Philosophy announced last year, which focuses the Company’s commercial objectives on being proactive about patient access while delivering value to patients, physicians, and insurers. This Philosophy commits Alnylam to act with urgency for patients, pursue value-based agreements and to not increase the annualized price of its medicines above the consumer price index (CPI-U) unless valuable new innovation has been achieved.
Other insurers have also recognized Alnylam’s approach to delivering good value through reimbursement design:
“Alnylam’s approach is to start with a clinical package that provides
real benefit to patients and then ensure value is delivered in the real
world over time. It's about reducing uncertainty and knowing that you're
paying for the outcomes you expect,” said
Today, Alnylam also launched Alnylam Assist, a comprehensive support services program to help patients. Alnylam Assist will offer a wide range of personalized services that include access to in-house Case Managers who will assist with verification of insurance benefits and financial support for eligible patients, and field-based Patient Education Liaisons who will offer patients education on hATTR amyloidosis.
Physicians and patients can learn more about Alnylam’s comprehensive patient services by visiting AlnylamAssist.com or calling 1-833-256-2748.
Speeding Availability & Accurate Diagnosis
Given the rapid and debilitating progression of hATTR amyloidosis, Alnylam is working to expedite the availability of ONPATTRO to patients whose physicians have prescribed it so that they can initiate treatment as quickly as possible. Alnylam is partnering closely with a network of specialty pharmacies and distributors to make ONPATTRO commercially available within 48 hours of
Visit ONPATTRO.com for more information, including full prescribing information.
IMPORTANT SAFETY INFORMATION
Infusion-related reactions (IRRs) have been observed in patients treated with ONPATTRO. 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%).
For additional information about ONPATTRO, please see the full Prescribing Information.
About ONPATTRO™ (patisiran) lipid complex injection
ONPATTRO was approved by the
About hATTR Amyloidosis
Hereditary transthyretin (TTR)-mediated amyloidosis (hATTR) is an inherited, progressively debilitating, and often fatal disease caused by mutations in the TTR gene. TTR protein is primarily produced in the liver and is normally a carrier of vitamin A. Mutations in the TTR gene cause abnormal amyloid proteins to accumulate and damage body organs and tissue, such as the peripheral nerves and heart, resulting in intractable peripheral sensory neuropathy, autonomic neuropathy, and/or cardiomyopathy, as well as other disease manifestations. hATTR amyloidosis represents a major unmet medical need with significant morbidity and mortality. The median survival is 4.7 years following diagnosis. Until now, people living with hATTR amyloidosis in the U.S. had no
As part of Alnylam’s commitment to making therapies available to those who may benefit from them, Alnylam Assist will offer a wide range of services to guide patients through treatment with ONPATTRO, including financial assistance options for eligible patients, benefit verification and claims support, and ordering assistance and facilitation of delivery via specialty distributor or specialty pharmacy. Patients will have access to dedicated Case Managers who can provide personalized support throughout the treatment process and Patient Education Liaisons to help patients gain a better understanding of the disease. Visit AlnylamAssist.com for more information.
RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. RNAi therapeutics are a new class of medicines that harness the natural biological process of RNAi. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam's RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing proteins, thus preventing them from being made. This is a revolutionary approach in developing medicines to improve the care of patients with genetic and other diseases.
Alnylam Forward Looking Statements
Various statements in this release concerning Alnylam's future expectations, plans and prospects, including, without limitation, Alnylam's views with respect to the approval of ONPATTRO™ (patisiran) lipid complex injection, including the approved indication, and the implications of such approval for patients, the results from its APOLLO Phase 3 clinical trial for patisiran, its expectations concerning when ONPATTRO will be available for shipment to healthcare providers in the U.S., its plan to offer comprehensive support services for people prescribed ONPATTRO through Alnylam Assist™, the expected timing for additional regulatory filings for approval in global markets, its expectations regarding the potential for patisiran to improve the lives of hATTR amyloidosis patients with polyneuropathy and their families, its plans to work with the
Alnylam Pharmaceuticals, Inc.
Christine Regan Lindenboom, 617-682-4340
(Investors and Media)
Josh Brodsky, 617-551-8276