Zytiga is currently approved for use in the post chemotherapy setting and the label stipulation is that patients must have received at least one course of docetaxel based chemotherapy. Use of Zytiga pre chemotherapy is considered an off-label use of this drug and the drug is currently not approved in this setting. Insurance company reimbursement of drug costs will only be made for use of the drug according to the label, and that means post chemotherapy. Furthermore the approved prescription usage of Zytiga in some countries requires prior docetaxel treatment.
This raises the possibility that physicians will administer docetaxel so that the patient qualifies for Zytiga treatment. Low dose docetaxel has already been used in this context and perhaps the restrictive legislation on Zytiga usage is actually encouraging the use of docetaxel chemotherapy to qualify for the post chemotherapy criterion.
Approval of Zytiga by the FDA for use pre chemotherapy will resolve this ridiculous situation by allowing the drug to be used on label at an earlier stage without the need for chemotherapy. In the pre chemotherapy setting Zytiga has been shown to delay the need for chemotherapy by over 2 years. The current situation encourages the use of chemotherapy whereas Zytiga was designed to replace the need for chemotherapy.
This is the situation relating to Zitiga currently in Australia. Interesting article on Incurable prostate cancer patients denied new medication on the PBS in Australia.
ReplyDeleteChemotherapy-naïve (never had chemo) patients also deserve Zytiga “free” on the PBS Please read the article here:
http://prostate-cancer-medication.blogspot.com.au/
Please also help in getting behind this petition
to make this medication available -
PBS should pay for Abiraterone for all incurable prostate cancer patients
https://www.change.org/en-GB/petitions/pbs-should-pay-for-abiraterone-for-all-incurable-prostate-cancer-patients?utm_campaign=mailto_link&utm_medium=email&utm_source=share_petition.html
Here the link to the article above:
ReplyDeletehttp://prostate-cancer-medication.blogspot.com.au/
This is the situation for Zytiga globally and it has not yet received FDA approval for use pre chemotherapy. So you have a fat chance of getting Zytiga pre chemotherapy on the PBS. The PBS have not even approved Zytiga post chemotherapy yet despite this now being TGA approved. The order of approval is first the FDA, second the EMA, and finally the TGA. Only TGA approved treatments will be considered by the PBS. The nexy stage in the development of Zytiga is FDA approval pre chemotherapy which is expected in December this year.
ReplyDeleteThis petition targets the Minister for health in Australia -
ReplyDeletePBS should pay for Abiraterone for all incurable prostate cancer patients
here is the link to the petition:
https://www.change.org/en-GB/petitions/pbs-should-pay-for-abiraterone-for-all-incurable-prostate-cancer-patients?utm_campaign=mailto_link&utm_medium=email&utm_source=share_petition.html