Technology assessment reports (TARs) for prostate cancer treatments under application; abiraterone acetate, apalutamide
Thank you for your request dated 11 April 2022, under the Official Information Act 1982 (OIA), for the technology assessment reports (TARs) for two prostate cancer treatments under application; abiraterone acetate and apalutamide. You requested:
- The TAR for Abiraterone Acetate for Prostate Cancer, metastatic, naïve / hormone sensitive(external link) (link to application on the tracker)
- The TAR for Apalutamide for Prostate cancer, non-metastatic, castration-resistant, high risk(external link) (link to application on the tracker)
Technology assessment report (TAR) for abiraterone acetate
I am pleased to provide you with the TAR for abiraterone acetate, attached with this response.
We have provided you with the TAR from August 2020 as this is the latest finalised TAR that Pharmac holds. I note that we previously advised that we expected the TAR for abiraterone acetate would be updated by August 2022 however, as the TAR is still in the process of being updated based on further new information, we have decided to provide you with the existing TAR to avoid any further delays. We would be happy to share the updated TAR for abiraterone acetate when it is finalised, but we are unable to confirm when that will be at this stage.
Additionally, we have provided you with two copies of the TAR for abiraterone acetate. One copy has no redactions made, as it relates to information provided to Pharmac by your organisation. The other copy of the TAR has been prepared for public release, as we intend to publish the TAR on our website. Please let us know if you have any concerns about this by 10 December 2022.
We have applied redactions to the TAR for public release, using the below applicable grounds of the OIA, where we consider this is necessary to:
- protect information which would be likely unreasonably to prejudice the commercial position of your organisation (section 9(2)(b)(ii)),
- protect information which is subject to an obligation of confidence and where releasing the information would be likely to prejudice the supply of similar information, or information from the same source, and it is in the public interest that such information should continue to be supplied (section 9(2)(ba)(i)); or
- enable Pharmac to carry on, without prejudice or disadvantage, negotiations (including commercial and industrial negotiations) (section 9(2)(j)).
Technology assessment report (TAR) for apalutamide
We are unable to provide the TAR for apalutamide at this stage as it does not exist (section 18(e) of the OIA). At this stage, the TAR for apalutamide is still in the process of being completed, and therefore we do not hold a TAR that can be released.
We previously declined your request for the TAR for apalutamide on 12 May 2022 as no TAR was held at that time. We noted that we expected the TAR for apalutamide to be available from August 2022, and intended to provide the TAR to you then, however this has been delayed to allow for further updates to be incorporated into the report. Given uncertainty in the time required to implement updates, there is currently no expected time for its completion. However, we would be happy to provide the updated TAR for apalutamide when it is finalised, if that would still be useful to you.
Our response to your request
On 12 May 2022, we extended the due date for our response to 3 June 2022. I acknowledge that a response to your request for information was due by 3 June 2022, and I apologise for the delay in sending this response to you. As you are aware, our team has experienced several interruptions to our work due to unplanned staff absences this year which has resulted in these delays. Finalising the TARs has also been delayed by updates to the economic analyses, based on external clinical advice received in April 2022 (CTAC) and internal advice on the bundle analysis.
You have the right to make a complaint to the Ombudsman about our response to your OIA, under section 28(3) of the OIA. Details of how to make a complaint(external link) are on the Ombudsman’s website.
We trust that this information answers your above queries. Please get in touch with us if you have any questions about this.