Australian Government ‘Department of Health LETTER TO PHARMACISTS Listing of biosimilar infliximab (Inflectra®) on the Pharmaceutical Benefits Scheme (PES) Lam writing to provide you with inforchation on the listing of biosimilar infliximab (Inflectra®} on the PBS from 1 December 2015. As you will be already aware, infliximab is a biological medicine that is used to treat inflammatory and autoimmune diseases. Infliximab is currently subsidised on the PBS for the treatment of rheumatoid arthritis, ankylosing spondylitis, ulcerative cots, psoriatic arthritis, plaque psoriasis, and Crohn's disease. Inflectra®, a new brand of infliximab, has been assessed by the Therapeutic Goods Administration to be as safe and effective as the reference biological medicine Remicade?. ‘The Pharmaceutical Benefits Advisory Gommittee (PBAC) has now considered this new brand for subsidy through the PBS. When the PBAC recommended the listing of Inflectra® on the PBS in July 2015, tkey also recommended that Inflectra? and Remicade® should be substitutable at the pharmacy level ‘This means that, as with the current process for generic medicines, you are able to offer patients a choice between brands of infliximab at the time of dispensing, as long as the prescriber has not specified “brand substitution, hot permitted” on the prescription, In making this decision the PBAC considered a range of factors including, data from clinical trials, which showed that the two biologicals hed ‘comparable safety and efficacy. In addition, where changing from Remicade? to Inflectra® occurred, the daa indicated no difference in ellicacy, safety, or immunogenicity between the biosimilar and reference biological ‘The use of biosimilars introduces competition to biological medicnes, which ccan reduce the cost of the medicines to the health system. The listing of Inflectra® has already triggered a reduction in the price Government pays for this medicine, 7; lemon: (0) ao 1588Reduced costs can male « medicine more cost-effective, which means it ‘could be made available to a broader patient population. It also contributes to keeping the cost of the PBS sustainable. Without competition in the Australian marketplace, prices for all medicines would stay high, We need to ensure that policies to drive competition are in place, such as substitution, which also provides choice for prescribers and patients ‘There will be no difference in the price Australian patients pay for these medicines, which will be no more than the relevant co-payrent (currently $86.10 for concessional or $37.70 for general patients} ‘A fact sheet explaining biosimilars, substitution, and the listing of Inflectra has been enclosed with this leter to assist you in conversations with patients about the availabilty of biosimilar infliximab and whether they may Wish to choose brand substitution, More information on biosimilars provided as part of the Biosimilax ‘Aqvareness Initiative is available at www pbs, gov,au/biosimilars, and the public summary document for Inflecra® is available at industry/listing elements /pbac-meetings/psd/2015- O7Jinfiximab- psd Yours sincerely Gf Hints : ‘Andrew Stuart Deputy Secretary Deparment of Health