Alnylam in Value-Based Agreements with Insurers, Patient Support for New Med

− Structure of Value-Based Arrangements Agreed in Principle with Harvard Pilgrim Health Care and Other Major Health Insurers –

− Alnylam Assist™ Program Designed to Facilitate Access to ONPATTRO and Provide Dedicated Patient Support –

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced it has agreed on the structure and key terms of value-based agreements (VBA) with leading health insurers for ONPATTRO™ (patisiran) lipid complex injection, a first-of-its-kind RNA interference (RNAi) therapeutic for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. ONPATTRO, approved today by the U.S. Food and Drug Administration (FDA), is the first FDA-approved treatment available in the United States for this indication. ONPATTRO was shown to improve polyneuropathy, with reversal of neuropathy impairment in a majority of patients, as measured by change from baseline in the modified Neuropathy Impairment Score +7 (mNIS+7) primary endpoint in the APOLLO pivotal study. In the largest controlled study of hATTR amyloidosis patients with polyneuropathy, ONPATTRO was also shown to improve quality of life, as measured by the Norfolk Quality of Life-Diabetic Neuropathy (QoL-DN) patient-reported assessment, reduce autonomic symptoms, and improve activities of daily living.

“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 Barry Greene, President of Alnylam. “Our pursuit of value-based agreements with insurance providers and our Alnylam Assist™ program demonstrate how we intend to operate as a commercial company, consistent with our Patient Access Philosophy. We believe these initiatives are the right things to do for patients and will deliver value to the healthcare system.”

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 Michael Sherman, M.D., M.B.A., Chief Medical Officer of Harvard Pilgrim Health Care. “By virtue of linking level of reimbursement to meaningful patient outcomes, this agreement will help us meet the needs of hATTR amyloidosis patients by supporting our efforts to balance access and affordability.”

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.

“Express Scripts is enthusiastic about this approval as it represents a new therapeutic technology that should improve the lives of patients. We applaud Alnylam for taking a responsible approach to pricing and patient access in the rare disease space, an increasingly complicated challenge,” said Steve Miller, M.D., Chief Medical Officer, Express Scripts. “We want to work together toward a common goal of ensuring broad, affordable access to important medicines for rare conditions.”

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 Jim Clement, Executive Director, Value Based Care and Supply Chain Management, Aetna Pharmacy Management. “I congratulate Alnylam for establishing the Company as a proactive, innovative and influential leader in the industry, and am looking forward to being a part of this Alnylam initiative.”

Alnylam Assist™
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.

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