PG电子

Table 1: unaudited sales reports 鈥� aggregate net sales subject to the affordability mechanism (measured sales)

Year	2019 voluntary scheme	Statutory scheme	Parallel imports	Total
2018	拢 8,847m	拢1,650尘	拢770尘	拢11,266尘
2019	拢 9,104m	拢1,673尘	拢698尘	拢11,475尘
2020	拢10,660尘	拢 379m	拢766尘	拢11,805尘
2021	拢11,769尘	拢 399m	拢806尘	拢12,974尘
2022 Q1	拢 3,046m	拢 12m	拢240尘	拢 3,299m
2022 Q2	拢 3,155m	拢 13m	拢249尘	拢 3,418m
2022 Q3	拢 3,280m	拢 13m	拢228尘	拢 3,521m
2022 Q4	拢 3,434m	拢 13m	拢195尘	拢 3,642m
2022	拢12,915尘	拢 52m	拢913尘	拢13,879尘

Table 1 notes

1. Table 1 sets out aggregate information about measured sales subject to the affordability mechanism. It includes information received on parallel imports from IQVIA adjusted to net prices, and information from audited annual sales reports and unaudited quarterly sales reports provided by members of the 2019 voluntary scheme and the statutory scheme.
2. The baseline for measured sales in respect of the statutory scheme and parallel imports has been calculated in accordance with Annex 4, paragraph 1 of the 2019 voluntary scheme.
3. 鈥楳easured sales鈥� is defined in the glossary of the 2019 voluntary scheme for branded medicines pricing and access as 鈥渟ales of scheme products by scheme members, statutory scheme sales and parallel import sales, but excluding exemptions from measured sales鈥�.
4. Figures for the 2019 voluntary scheme reflect any audited sales reports received. Annual totals from 2019 onwards for the statutory scheme reflect any audited sales reports received.
5. Measured sales in any particular period reflects all relevant scheme members in either the 2019 voluntary scheme or statutory scheme during that period. For example, several companies moved from the statutory scheme to the voluntary scheme at the start of 2020. Those companies鈥� measured sales will appear under the statutory scheme in 2019 but the voluntary scheme in 2020.

Table 2: 2019 voluntary scheme sales reports 鈥� eligible sales and resulting total scheme payments

Period	Aggregate eligible sales (column 1)	Resulting aggregate scheme payments (column 2)
2019	拢 8,804m	拢845尘
2020	拢10,075尘	拢594尘
2021	拢11,026尘	拢562尘
2022 Q1	拢 2,763m	拢414尘
2022 Q2	拢 2,967m	拢445尘
2022 Q3	拢 3,132m	拢470尘
2022 Q4	拢 3,279m	拢492尘

Table 2 notes

Table 2, which is derived from unaudited quarterly sales reports and any audited annual sales reports received from members of the 2019 voluntary scheme, sets out aggregate information showing eligible sales covered by the scheme payment and the resulting scheme payments.

There are 2 columns of information:

• column 1: aggregate eligible sales

• column 2: resulting aggregate scheme payments due for the respective periods

鈥楨ligible sales鈥� is defined in the glossary of the 2019 voluntary scheme as 鈥渟ales of scheme products but excluding exemptions from eligible sales鈥�. The percentage payment applies to these sales. Eligible sales excludes certain types of sales, including the first 拢5 million of sales by a medium-sized company and new active substance (NAS) sales. Both of these sales categories are, however, included in measured sales and, therefore, the calculation of the overall sum to be repaid across all scheme members.

Table 3: statutory scheme sales reports 鈥� net sales covered by the statutory scheme payment and resulting payments

2019 to 2021

Statutory scheme payment and resulting payments	2019	2020	2021
Aggregate net sales covered by the applicable annual statutory scheme payment (a)	拢636尘	拢34尘	拢197尘
Resulting aggregate statutory scheme payment (b)	拢63尘	拢2尘	拢22尘
Net sales of extant frameworks and public contracts subject to 7.8% payment (c)	拢311尘	拢17尘	拢17尘
Resulting statutory scheme 7.8% payment (d)	拢24尘	拢1尘	拢1尘
Total resulting statutory scheme payment (b + d)	拢87尘	拢4尘	拢23尘

2022

Statutory scheme payment and resulting payments		Jan to Mar 2022	Apr to Jun 2022	Jul to Sep 2022	Oct to Dec 2022
Aggregate net sales covered by the applicable annual statutory scheme payment (a)	听	拢12尘	拢13尘	拢13尘	拢13尘
Resulting aggregate statutory scheme payment (b)	听	拢1尘	拢1尘	拢2尘	拢2尘
Net sales of extant frameworks and public contracts subject to 7.8% payment (c)	听	拢0	拢0	拢0	拢0
Resulting statutory scheme 7.8% payment (d)	听	拢0	拢0	拢0	拢0
Total resulting statutory scheme payment (b + d)	听	拢1尘	拢1尘	拢2尘	拢2尘

Table 3 notes

Table 3 is derived from audited and unaudited statutory scheme sales reports. It sets out aggregate information showing net sales covered by the statutory scheme payment and the resulting payments.

Table 4: 2019 voluntary scheme updated calculations 鈥� observed modelled measured sales growth rates

Scheme element	2019 observed	2020 observed	2021 observed	2022 observed
2019 voluntary scheme	2.91%	16.01%	9.73%	8.70%
Statutory scheme	1.38%	-77.33%	5.39%	-89.41%
Parallel import	-9.37%	9.85%	5.12%	13.31%
Overall	1.85%	2.03%	9.29%	5.93%

Table 4 notes

1. Table 4 shows the observed full-year growth from 2019 to 2022.
2. In accordance with Annex 4, paragraph 34 of the scheme documentation, companies whose sales exceed (or fall below) 拢5 million between years, and so are included or excluded from measured sales of subsequent years, are excluded from the growth calculations.

General notes

1. The information in all tables is that held on the Department of Health and Social Care鈥檚 database at 17 February 2023.

2. Totals may not sum due to rounding.

3. All tables are subject to future correction such as where audited data replaces best available data and will be updated at each quarterly publication point to reflect the latest available information. The audit and reconciliation arrangements are set out in paragraphs 4.26 to 4.31 of the 2019 voluntary scheme. The statutory scheme audit requirements are set out at paragraph 23 of the regulations.

4. As set out in the scheme documentation, a 2-stage end-scheme reconciliation (ESR) process to address any outstanding under or over payments will reflect the fact the final audited and de-facto audited annual sales reports for 2022 and 2023 will not be received until 2024 and 2025, at the earliest, respectively. It will also account for any remaining rounding impact.

5. Following the close of the third quarter of 2024, the department should have received audited or de-facto audited returns for measured sales made in 2022, and updated data for measured sales made in 2023. This may be a mix of audited returns for scheme members with a financial year end of December, and unaudited returns for scheme members whose financial year end date differs from the calendar year end, or who have been delayed in providing their audited returns. This data will be used to calculate a revised payment percentage and corresponding payment for 2023. The revised payment percentage will be calculated to 2 decimal places. Any change arising in the payment due from scheme members following the revision of the 2023 payment percentage will be payable (or refundable) in the first quarter of 2025. This process will repeat following receipt of audited and de-facto audited returns for measured sales made in 2023 a year later.