Today the PBAC and Vertex both released statements following the MARCH PBAC meeting.
I have just been called by the media to give my opinion on the two statements released by both PBAC and Vertex this is what I said. (I hope that I have said the right thing- please note I am also still processing the whole situation!)
From my understanding both PBAC and Vertex are still at a point of negotiation which basically means our situation has merely stayed the same. We are very glad that PBAC and Vertex are actively negotiating however we as a community are still very anxious about the amount of time these negations take!
I understand to a certain extent why the PBAC have placed restrictions on the access to Kalydeco. These restrictions and access criteria sound very similar to the processes and steps taken to gain access to Pulmozyme. I understand that the govt. need to be able to monitor and make sure that the extensive amount of money they are spending on patients is being used properly. You must remember there is a compliance issue that both Govt. and Vertex need to consider. While the majority of Cystic Fibrosis patients are very diligent and compliant patients who ALWAYS look after them selves properly and always take medication regularly, some patients do not do this all the time and therefore would not be 100% benefitting from the medication. This is unfortunate however a reality.
I also said that I was a little confused as to why Vertex released a statement stating that they are very concerned that the most sickest CF patients would not get access to Kalydeco under the restrictions the PBAC have listed. I said I was confused because nowhere in PBAC statement does it mention restrictions based on FEV1 lung function below 40%? It merely states that there must be an increase in lung function after a 3 month period of time. It is very concerning when the two statements are conflicting and don't support the same information? It makes me feel like we perhaps are not being told everything?
I went on to say that if the restrictions the PBAC have listed do NOT exclude 'the sickest patients' (FEV below 40%- these people NEED it the most!!!) from accessing Kalydeco than I understand why the eligibility criteria is in place. I have 100% faith that each and every G551D patient that takes Kalydeco WILL see at least a 10% increase in lung function over 3 months and therefore it is not a RESTRICTION it is simply a HOOP WE JUMP through to get it. If thats the only hoop they are going to make us jump through than I think thats reasonable. However if Vertex's statement about 'sickest patients' unable to access it under these restrictions is true then NO i do not think that is reasonable. I think that is outrageous and unacceptable. Hmmm but I am not sure what statement is true???
So I concluded by saying HURRY UP!! I understand there needs to be negotiations but bloody HURRRRRY UP!!!!! Its already May and we have hardly moved since NOVEMBER…. Both the Govt. and Vertex both equally need to come to the party! Vertex needs to be more reasonable as well!