Is Amgen's Outcomes-Based Contract in Response to Biosimilar Competition?

Amgen and Harvard Pilgrim Healthcare have entered an outcomes-based contract that is based on the efficacy of Amgen’s immunomodulatory agent etanercept (Enbrel), for patients with rheumatoid arthritis.

In a press release Harvard Pilgrim said that the 2-year contract will score patients taking etanercept based on 6 criteria, including:

• Patient compliance
• Switching or adding drugs
• Dose escalation and steroid interventions

Patients scores that do not meet a predetermined threshold—meaning the treatment does not present the desired “value” and real-world effectiveness—will result in lower reimbursement for Amgen.

Etanercept, a monoclonal antibody that blocks the tumor necrosis factor receptor, acts on the immune system and is indicated in the treatment of moderate to severe rheumatoid arthritis, moderate to severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and chronic moderate to severe plaque psoriasis.

“Real-world performance of new medicines frequently differs from the well-controlled clinical trial setting,” Harvard Pilgrim Chief Medical Officer Michael Sherman, MD, said in a statement. Sherman pointed out that only about 33% of patients on etanercept and other drugs in the same class meet all 6 criteria. “By linking the ultimate cost of this drug to its real-world clinical efficacy, this agreement truly puts patients at the center of focus,” he added.

Amgen’s strategy to sign this value-based contract might have been influenced by the approval of its biosimilar competition, etanercept-szzs (Erelzi), developed by Sandoz. While a patent-related litigation between Amgen and Sandoz has pushed the biosimilar launch to 2018, Erelzi could potentially divert a significant portion of the originator product’s market share. The 2 companies are also locked in another case, which will be heard by the Supreme Court, over when a 6-monthh waiting period begins for a biosimilar developer who has informed the developer of the reference product about its drug.

Amgen is not a new entrant to the world of outcomes-based contracts—the company negotiated a similar deal with Harvard Pilgrim in 2015 for its anticholesterol agent Repatha, a PCSK9 inhibitor.