The Government Affairs committee remains active on several fronts.
Because of our widening mandate, we changed our name from “Exceptional Access Program” committee to “Government Affairs.”
We continue to meet with the MoH EAP every 3-4 months and maintain close communications with them around issues related to biologics, biosimilars and new limited use products.
We have created a new biosimilars form, which includes the name, LU code and indications for all the biosimilars we have available and this document will be kept up to date on the ORA website. We have also met with the three Rituximab biosimilar providers, to outline the rheumatology community’s needs and expectations around these new products and their availability to our patients.
The Ministry of Health’s electronic EAP portal, SADIE, has moved to a new phase where you can now create delegates who can fill in the electronic forms for you, thought he prescriber still needs to sign off on the final form prior to e-submission. The various patient support programs are training on this new platform at this time.
Finally, the Government Affairs Committee remains engaged with the Ministry of Health in regards to their biosimilar transition planning and any further details on this will be relayed to ORA members as they become available.