Special Authority approvals for bortezomib for the treatment of systemic AL amyloidosis
22 April 2021
Dear [name and contact details withheld]
REQUEST FOR INFORMATION
Thank you for your request dated 25 March 2021 under the Official Information Act 1982 (OIA) for information relating to Special Authority approvals for bortezomib. You requested:
Data for approved Special Authority applications for bortezomib (SA1889) for use in symptomatic systemic AL amyloidosis initiated and/or renewed in the past five years until the most recently available data.
Please find the information requested in the table below.
Table 1: Approved Special Authority applications for bortezomib for use in symptomatic systemic AL amyloidosis, from calendar year 2016 to calendar year 2020
|
Calendar year |
Application type |
Approved applications |
|---|---|---|
|
2016 |
Initial application |
23 |
|
2017 |
Initial application |
19 |
|
2018 |
Initial application |
25 |
|
2019 |
Initial application |
38 |
|
2020 |
Initial application |
33 |
Please note:
- These figures represent the number of Special Authority approvals in each year for this indication. They do not necessarily represent the number of patients being dispensed the relevant medicine in the given period.
- SA1889 is the latest version of Special Authority application form. This data includes applications using old versions such as SA1127 and SA1576.
- In all versions of the Special Authority form, the indication "symptomatic systemic AL amyloidosis" is only identified in initial applications.
- SA1889 states "Approvals valid without further renewal unless notified".
We trust that this information answers your queries. We are making our information more freely available, so we will now publish selected OIA responses (excluding personal details) on our website. Please get in touch with us if you have any questions about this.
Yours sincerely
Rachel Read
Manager, Policy and Government Services