Valeant Pharmaceuticals International has announced that, following the approval of its Patient Access and Pricing Committee (PAPC), it has decided to list brodalumab injection (Siliq) at $3,500 per month, which the company says is the lowest price for an injectable biologic psoriasis treatment currently on the market.
In May 2016, Valeant established the PAPC to be responsible for the pricing of the company’s drugs. The PAPC ensures that Valeant’s pricing, contracting, compliance, and reimbursement strategies are consistent and compliant with all relevant laws, regulations, and guidance, as well as the company’s position on patient-affordable access to medications, the company said.
Brodalumab is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and have failed to respond or have lost their response to other systemic therapies. Marketing of the product in the United States is expected to begin during the second half of 2017.
In February 2017, the FDA approved the biologics license application for brodalumab, a human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by preventing the binding of several types of IL-17 to the receptor. By blocking IL-17 from activating the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.
The labelling for brodalumab includes a boxed warning regarding the risk of suicidal ideation and behaviors, including completed suicides. The most common adverse events associated with the drug include headache, arthralgia, fatigue, oropharyngeal pain, and diarrhea. Brodalumab is contraindicated in patients with Crohn’s disease.
In recent years, Valeant has been mired in a series of drug-pricing scandals, including hiking the cost of a human immunodeficiency virus (HIV) treatment by 5,500%.