Aggregate net sales and payment information: February 2023
Published 16 March 2023
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Table 1: unaudited sales reports – aggregate net sales subject to the affordability mechanism (measured sales)
| Year | 2019 voluntary scheme | Statutory scheme | Parallel imports | Total |
|---|---|---|---|---|
| 2018 | £ 8,847m | £1,650m | £770m | £11,266m |
| 2019 | £ 9,104m | £1,673m | £698m | £11,475m |
| 2020 | £10,660m | £ 379m | £766m | £11,805m |
| 2021 | £11,769m | £ 399m | £806m | £12,974m |
| 2022 Q1 | £ 3,046m | £ 12m | £240m | £ 3,299m |
| 2022 Q2 | £ 3,155m | £ 13m | £249m | £ 3,418m |
| 2022 Q3 | £ 3,280m | £ 13m | £228m | £ 3,521m |
| 2022 Q4 | £ 3,434m | £ 13m | £195m | £ 3,642m |
| 2022 | £12,915m | £ 52m | £913m | £13,879m |
Table 1 notes
- 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.
- 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.
- ‘Measured sales’ is defined in the glossary of the 2019 voluntary scheme for branded medicines pricing and access as “sales of scheme products by scheme members, statutory scheme sales and parallel import sales, but excluding exemptions from measured sales”.
- 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.
- 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’ measured sales will appear under the statutory scheme in 2019 but the voluntary scheme in 2020.
Table 2: 2019 voluntary scheme sales reports – eligible sales and resulting total scheme payments
| Period | Aggregate eligible sales (column 1) | Resulting aggregate scheme payments (column 2) |
|---|---|---|
| 2019 | £ 8,804m | £845m |
| 2020 | £10,075m | £594m |
| 2021 | £11,026m | £562m |
| 2022 Q1 | £ 2,763m | £414m |
| 2022 Q2 | £ 2,967m | £445m |
| 2022 Q3 | £ 3,132m | £470m |
| 2022 Q4 | £ 3,279m | £492m |
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:
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column 1: aggregate eligible sales
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column 2: resulting aggregate scheme payments due for the respective periods
‘Eligible sales’ is defined in the glossary of the 2019 voluntary scheme as “sales of scheme products but excluding exemptions from eligible sales”. The percentage payment applies to these sales. Eligible sales excludes certain types of sales, including the first £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 – 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) | £636m | £34m | £197m |
| Resulting aggregate statutory scheme payment (b) | £63m | £2m | £22m |
| Net sales of extant frameworks and public contracts subject to 7.8% payment (c) | £311m | £17m | £17m |
| Resulting statutory scheme 7.8% payment (d) | £24m | £1m | £1m |
| Total resulting statutory scheme payment (b + d) | £87m | £4m | £23m |
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) | £12m | £13m | £13m | £13m | |
| Resulting aggregate statutory scheme payment (b) | £1m | £1m | £2m | £2m | |
| Net sales of extant frameworks and public contracts subject to 7.8% payment (c) | £0 | £0 | £0 | £0 | |
| Resulting statutory scheme 7.8% payment (d) | £0 | £0 | £0 | £0 | |
| Total resulting statutory scheme payment (b + d) | £1m | £1m | £2m | £2m |
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 – 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
- Table 4 shows the observed full-year growth from 2019 to 2022.
- In accordance with Annex 4, paragraph 34 of the scheme documentation, companies whose sales exceed (or fall below) £5 million between years, and so are included or excluded from measured sales of subsequent years, are excluded from the growth calculations.
General notes
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The information in all tables is that held on the Department of Health and Social Care’s database at 17 February 2023.
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Totals may not sum due to rounding.
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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.
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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.
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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.