OIA response: NPPA applications and exceptional circumstances applications for lamotrigine

NPPA Applications for the last 5 years and the lamotrigine exceptional circumstances applications

25 June 2020

[name and contact details redacted] 

Dear [name redacted] 

REQUEST FOR INFORMATION 

Thank you for your request dated 2 June 2020 under the Official Information Act 1982 (OIA), for information relating to Exceptional Circumstances funding requests.  You clarified your request on 10 June 2020, to ask: 

Could I please have the following figures for PHARMAC’s Named Patient Pharmaceutical Assessment funding request process, year on financial year, for the last 5 years.

  1. Broken down by drug type/category, how many funding requests where received by PHARMAC by therapeutic group?
  2. How many funding requests where declined?
  3. The reasons for declined requests
  4. The mean application assessment time?
  5. Regardless of year lodged, the number of requests still under consideration by PHARMAC, including denied requests appealed by the requestor.

Could I please have the following to date figures for PHARMAC’s Exceptional Circumstances applications process created for Lamotrigine users

  1. How many applications to stay on Lamictal or Arrow-Lamotrigine where received by PHARMAC
  2. How many funding requests where declined
  3. The reasons for declined requests
  4. The mean timeframe requests where received and accepted/declined
  5. The number of requests still under consideration by PHARMAC, including denied requests appealed by the requestor.

Named Patient Pharmaceutical Assessment (NPPA)

The tables below provide data that answer many of your questions. Please note:

  • The data in table one (applications received) includes all NPPA applications received, including those approved, declined or withdrawn for any reason (for example where the application did not meet the principles of the NPPA Policy), but with the exclusions noted below;
  • The data in all tables excludes renewal applications (of previous NPPA approvals);
  • The data in all tables excludes applications related to the lamotrigine brand change;
  • The data in table two (declined applications) excludes applications that did not meet the principles of the NPPA Policy or that were withdrawn for other reasons;
  • Data for the 2019/2020 financial year was correct as of 11 June 2020;
  • Financial years are defined as 1 July to 30 June.

Table One: NPPA applications received by PHARMAC, by financial year and therapeutic group

Therapeutic Group

2015/2016

2016/2017

2017/2018

2018/2019

2019/2020

Alimentary Tract and Metabolism

118

123

138

95

130

Blood and Blood Forming Organs

106

80

66

44

55

Cardiovascular

30

42

35

31

29

Dermatologicals

12

17

6

7

13

Genito-urinary System

11

13

13

14

17

Hormones

69

56

30

23

43

Infections

148

77

94

100

94

Musculoskeletal

19

17

11

16

28

Nervous System

101

106

125

123

109

Oncology agents and Immunosuppressants

249

270

266

322

276

Respiratory System and Allergies

26

26

8

11

11

Sensory Organs

60

45

56

46

38

Special Foods

23

24

13

12

19

Various

8

3

7

4

5

 Table Two: Number of declined NPPA applications

 

2015/2016

2016/2017

2017/2018

2018/2019

2019/2020

Number of declined NPPA applications

19

8

5

5

2

 Table Three: Mean assessment time (days) for NPPA applications

 

2015/2016

2016/2017

2017/2018

2018/2019

2019/2020

Mean assessment time (days)

12

11

10

13

11

We are declining your request for “the reasons for declined requests” under OIA section 9(2)(a), to protect the privacy of natural persons.

As at 11 June 2020, there were 47 active NPPA applications under assessment.   

Exceptional circumstances process for lamotrigine users

Information on Exceptional Circumstances applications relating to the lamotrigine brand change is already available on PHARMAC’s website here.

Lamotrigine information

This includes the total numbers of applications approved, withdrawn and declined, as well as the number of applications currently under assessment. The information on this web page is regularly updated. 

The mean assessment time for all lamotrigine Exceptional Circumstances applications is 6 working days. 

We are declining your request for “the reasons for declined requests” under OIA section 9(2)(a), to protect the privacy of natural persons. However, we note that the website page lists some of the main reasons that these applications have been declined. 

As required under the OIA, we 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. 

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. 

Please also 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 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