OIA response: Special Authority data for somatropin and pegylated interferon alfa-2a and funding data for rare diseases

Request for information relating to Special Authority (SA) approvals for somatropin and interferon and funding data for rare disease.

20 October 2020

Dear [name and contact details redacted]

REQUEST FOR INFORMATION

Thank you for your request dated 4 September 2020 under the Official Information Act 1982 (OIA) for information relating to Special Authority (SA) approvals for somatropin and interferon and funding data for rare disease.

You requested:

1.  Somatropin

a.  Total SA approvals split by indication, type (initial or renewal) and financial year (FYR 2018/19 and FYR 2019/20 only)

i.  Growth hormone deficiency in children
ii.  Turners syndrome
iii.  Short stature without growth hormone deficiency
iv.  short stature due to chronic renal insufficiency

b.  Total number of unique patients with a SA for somatropin, split by indication and financial year (FYR 2018/19 and FYR 2019/20 only)

i.  Growth hormone deficiency in children
ii.  Turners syndrome
iii.  Short stature without growth hormone deficiency
iv.  short stature due to chronic renal insufficiency

2.  Pegylated interferon alfa-2a

a.  Total SA approvals split by indication, type (initial or renewal) and financial year (FYR 2018/19 and FYR 2019/20 only)

i.  Chronic hepatitis C - genotype 1, 4, 5 or 6 infection or co-infection with HIV or genotype 2 or 3 post liver transplant
ii.  Chronic Hepatitis C - genotype 1 infection treatment more than 4 years prior
iii.  Hepatitis B
iv.  Myeloproliferative disorder or cutaneous T cell lymphoma

b.  Total number of unique patients with a SA for pegylated interferon alfa-2a, split by indication and financial year (FYR 2018/19 and FYR 2019/20 only)

i.  Chronic hepatitis C - genotype 1, 4, 5 or 6 infection or co-infection with HIV or genotype 2 or 3 post liver transplant
ii.  Chronic Hepatitis C - genotype 1 infection treatment more than 4 years prior
iii.  Hepatitis B
iv.  Myeloproliferative disorder or cutaneous T cell lymphoma

c.  Total annual gross spend for pegylated interferon alfa-2a split by financial year (FYR 2018/19 and FYR 2019/20 only)
d.  Total subsidised units in the community split by financial year (FYR 2018/19 and FYR 2019/20 only)
e.  Total subsidised units in DHB hospitals split by financial year (FYR 2018/19 and FYR 2019/20 only)

3.  Medicines for rare diseases

a.  Total PHARMAC spend on rare diseases for each year:

i.  1 July 2017-30 June 2018
ii.  1 July 2018-30 June 2019
iii.  1 July 2019-30 June 2020

b.  What medicines are on the pharmaceutical schedule for rare diseases?

Please find the requested data (and associated caveats) attached with this response in the provided template, subject to the exceptions in this letter.

Somatropin interferon and rare disease medicines data for release [XLSX, 25 KB]

Please note that PHARMAC approaches its assessment of requests for information under the OIA on the basis that, once released, the information becomes publicly available - in other words once we release the information to you it becomes available to any other party in that exact form (whether by you distributing it to others or by virtue of us receiving the same request from a different third party).

We have made some adjustments to the data attached where total applications is equal to or less than 10 (displayed as <10) as we consider withholding this information is necessary to protect the privacy of natural persons (section 9(2)(a)).

As required under the OIA, we also considered whether, in the circumstances, the withholding of this information was outweighed by other considerations which render it desirable, in the public interest, to make this information available.  In this case we did not consider that the public interest outweighed the reasons for withholding the information.

Additionally, we have been unable to provide the information requested under question 3.a.iii. above as the data is not held by PHARMAC in the form requested and on this basis this part of your request is refused as PHARMAC does not hold the information and I have no grounds to believe it is held by another agency in the form requested (section 18(g)). Please note PHARMAC may be able to provide the information requested under question 3.a.iii. at a later date.

Please note you have the right, by way of complaint under section 28(3) of the OIA to an Ombudsman, to seek an investigation and review of our decision.

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