Drug Tariff Part IX Statistics: Quarterly report - October to December 2020

Quarterly report Drug Tariff Part IX Statistics October to December 2020

11TH January 2021

Applications Received October to December 2020 Applications received October Applications received November Applications received December Total number of applications

73 40 20 133

KPIs Number of application meetings in this quarter 5 Number of Drug Tariff Forum meetings (rolling 12 0 months) Mean time to listing (working days) 33 Less than 30 days 20% 31-59 days 80% Over 60 days 0% * Time to listing is the number of working days from the acceptance letter being written to the product appearing in the Drug Tariff. Acceptance letters are usually issued 2 months prior to the suggested entry month. This allows 14 days for the manufacturer to confirm the suggested entry and that supplies will be available from the entry month. The remaining 6 weeks are to allow time for manufacturers to make supplies available and to coincide with Drug Tariff editing and print deadlines.

Average time taken to process applications for entry to Drug Tariff Part IX (Working Days) Period to accept/reject application

17

The average time taken to process applications relates to the time between receiving all of the information required to assess the application and the acceptance letter being sent.

Applications processed between October to December 2020 Approved 46 Rejected applications 0 PENDING 181 Minded to Reject 1 Not considered appropriate for GP/Nurse prescribing 0 Not considered cost effective 1 Not considered appropriate for prescribing and also not 0 considered cost effective Other Pending 180 Awaiting Assessment 56 Awaiting assessment of additional information 52 Price query 17 Awaiting more information from the applicant 52 On hold at applicant’s request 3 Applications withdrawn 2 11TH January 2021

Approved applications Number of me too products approved Number of line extensions approved Number of applications approved for new products % of me too / line extensions that could be approved first time*

43 3 0 38%

* This is the percentage of me too and line extension applications where the applicant provided all of the information required to make a listing decision on the first review, without us needing to request any information. This figure does not include any applications that were incorrect initially and that were therefore deleted and resubmitted. Please see Annex 1 for the breakdown of the incorrect applications, which could not be logged initially.

Average time taken to receive additional information for pending applications (Working days) Pending Applications 19 Pending applications are any out-standing applications received after 1st October 2020 but do not include applications on hold at manufacturer’s request.

Pending Applications Oldest application 31st August 2018 Awaiting assessment 108 * This includes applications that have not received a first assessment yet and any awaiting assessment of additional information.

Pending applications by the quarter they were received Quarter October, November, December 2019 January, February, March 2020 April, May, June 2020 July, August, September 2020

No. of Applications 9 6 0 23

11TH January 2021

Of the applications that could not be assessed first time the following information was missing: CE documents missing/ incorrect 8 30% Samples missing/ incorrect * 5 19% Incomplete application form 0 0% Insufficient information to support 14 51% cost effectiveness * This figure is derived from applications made after the request from the NHSBSA to supply digital copies of packaging and samples was made and it was subsequently either not supplied or was incorrect.

Break down of missing information in each category

CE documents missing/ incorrect Missing Declaration of Conformity

3

37%

Missing Confirmation of Member state 2 Missing Notified body certificate 3

26% 37%

Samples missing/ incorrect Incorrect or packaging missing * 5 100% No sample provided 0 0% No CE mark on packaging 0 0% Incomplete application form Category not stated 0 0% Application form not signed 0 0% * Applicants have been advised by the NHSBSA as to the digital images of packaging and sample requirements.

Number of items added to Part IX of the Drug Tariff Drug Tariff Edition October 2020 November 2020 December 2020

Number of Items 3 3 9

11TH January 2021

Part IX Applications Processed December 2019 to December 2020 80

70

60

No. of application

50

40

30

20

10

0 Dec-19

Jan-20

Feb-20

Mar-20

Apr-20

May-20

Jun-20

Jul-20

Aug-20

Sep-20

Oct-20

Nov-20

Dec-20

Months Number of applications received Number of application accepted and no further data required

Number of new appliances published in the Drug Tariff December 2019 to December 2020

25

Number of applications

20

15

10

5

0 Dec-19

Jan-20

Feb-20

Mar-20

Apr-20

May-20

Jun-20 Months

Jull-20

Aug-20

Sep-20

Oct-20

Nov-20

Dec-20

.

11TH January 2021

Annex 1 SUPPLEMENTARY INFORMATION There were 171 initial applications received of which 122 were incorrect and subsequently deleted. Of the applications that could not be processed first time the main reason was due to incorrect or missing certificates: Missing Certificates Declaration of Conformity Confirmation of Member State Notified Body

74 26 8

61% 22% 7%

11TH January 2021