The announcement followed an evaluation of the company’s Patient Access and Pricing Committee (PAPC), and make Siliq the lowest-priced injectable biologic psoriasis treatment now on the market, the company said in a press release. The product should be available by mid-year.
The therapy, a monoclonal antibody that targets the IL-17 receptor, was approved by the U.S. Food and Drug Administration to treat people with moderate-to-severe plaque psoriasis who have stopped or failed to respond to other systemic therapies. It will also be included in Valeant’s patient access program to offer financial additional support and access to patients.
Valeant decided to institute PAPC last year to establish a price for its drugs, as well as to ensure that all contracting, compliance and reimbursement strategies comply with laws, regulations and guidance.
“The Patient Access and Pricing Committee was constructed to help our company ensure patients have the best possible access to our products. Our goal with SILIQ is to provide outstanding efficacy while being the most affordable injectable biologic for patients with moderate-to-severe plaque psoriasis,” said Joseph Papa, Valeant’s chairman and CEO.
Siliq is to be given by subcutaneous injection at 210 mg (140 mg/mL, 1.5 mL prefilled syringe) for three weeks, followed by subsequent doses every two weeks. Its approval followed positive findings, espeicially in efficacy, in three pivotal Phase 3 studies, the AMAGINE clinical program. The psoriasis area and severity index (PASI) 100 score, which represents total clearance or 100 percent reduction in symptoms from baseline, was included in the clinical trials’ primary endpoint.
According to Valeant, no other drug has approached this efficacy. However, the drug has a Black Box Warning and tightly regulated access, because Siliq’s use was seen in the clinical trial to possibly increase the risk of suicide, or of suicidal thoughts, among people with histories of depression, mood swings, or other mental health problems.
The drug is only be available through a restricted program, called the Siliq Risk Evaluation and Mitigation Strategy (REMS). Doctors who prescribe it and pharmacies that dispense must to be certified with the program.