Posted 30 April 2018
Celgene has said they would not be re-applying for reimbursement of psoriasis drug Otezla in the near future after the PBAC rejected the seventh submission for the therapy in last month's meeting.
The drug was submitted to the committee four times as a therapy for plaque psoriasis and three times for psoriatic arthritis. Its first appearance before the committee was in March 2015.
The company said it would "not be pursuing further PBS listings for Otezla in Australia in the short to medium term following the recent rejection by the PBAC".
Price was the main issue with a spokesperson saying the company "regrettably" could not offer Otezla "at the price that the PBAC is seeking".
It added it was "committed" to developing innovative medicines for patients, and "this commitment has been extended to Australian patients... through the provision of seven submissions for consideration by the PBAC."
According the recently released PBAC outcomes for the meeting, the regulator and Celgene were not able to agree on the risk sharing agreement (RSA) accompanying the application, which was made on a cost-minimisation basis with genericised immunosuppressant cyclosporin.
"The RSA proposed by the sponsor was unlikely to achieve an overall price per patient for [Otezla] within the range the PBAC advised at its November 2017 meeting would be considered cost-effective," the outcomes stated.
Meanwhile Celgene maintained it had demonstrated "favourable efficacy and better tolerability" compared to cyclosporin.
Currently Otezla is reimbursed in 28 jurisdictions excluding Australia, the company said.
Yajun Ma