Estimate of Net Budget Impact
Generic Name: Enter generic name
Brand Name: Enter brand name
Indication:
Enter indication
Insert the generic, brand name and the indication of medicine in the cells above.
Estimate of Net Budget Impact
General Guidance
1 Introduction
The main reasons for the change in process for presenting net budget impact figures are
as follows:
(a) Consistency
The introduction of a template ensures consistency in presentation and allows the reader to
follow and understand the calculations of net budget impact more easily.
(b) Flexibility
The use of an excel based template allows rapid re-calculation of net budget impact when
changes are necessary (e.g. when SMC imposes a restriction in use).
The spreadsheet is expandable to allow inclusion of reference sources and explanatory notes.
(c) NHS Service Use
The template will be passed to NHS Boards and relevant departments on issue of SMC advice.
The template numbers can be easily amended for local patient numbers and costs to give an
estimate of local net budget impact.
Of great importance to the NHS are the potential service implications arising from the
introduction of the new medicine. These may not lead to a budget impact, but present
challenges and opportunities that the NHS needs to be aware of as early as possible to
facilitate planning.
2 Guidance points
There are a number of general guidance points:
(a) Costs and other information inserted in the template must be consistent with the health
economic model in the SMC submission.
(b) Unless clearly indicated data are required to be on a per annum basis, e.g. medicine costs per
annum.
(c) All costs should be net of VAT.
(d) Point estimates of costs, patient numbers and other data are required.
(e) Minor costs and savings may be ignored if their impact is not material.
Costs/savings are not material if they are less than the lower of:
10% of the net medicine cost per annum, or £50,000 per annum.
(f) NHS opportunity costs (e.g. increase or decrease in inpatient days due to the new medicine)
are not accounted for. However these should be identified for potential service re-design
purposes.
(g) Estimates are required covering a 5 year period from introduction of the new medicine.
(h) Full year costs must be calculated, even if the new medicine is introduced part way through a
year. The NHS service will adjust for mid year introduction locally.
(i) Only cells shaded yellow should be completed where appropriate.
(j) Review the final numbers as a sense check.
(k) Where there is a Patient Access Scheme (PAS) planned for the new medicine, two versions of
the net budget impact are required, one with and one without the PAS.
This is required as individual Health Boards may not implement the PAS.
(l) Where the new medicine is a bio similar with several indications, a separate template is
required for each indication.
3 Detailed guidance
Explanatory notes and guidance on completion are provided within each worksheet which
explain in detail how to complete each part of the template.
Hyperlinks to notes are provided and indicated by underscored numbers on the left-hand side
of the text.
Landing on grey cells (this colour) provides guidance on completion.
This budget impact template is made up of the following
worksheets:
Click on any of the worksheet names below to go directly to that worksheet.
Annual treated patient numbers
This spreadsheet calculates the estimated numbers of patient that will be treated with the new
medicine in Scotland.
It is important to show sources of information and bases of calculations to allow clinical experts,
economic assessors and other reviewers to check assumptions. In order to facilitate this, a
free-form spreadsheet is also provided ('derivation of patient numbers') that can be completed
with tables, calculations, graphs and reference sources.
Derivation of patient numbers
This worksheet should be used to provide detailed workings to explain how the numbers of
eligible patients and the numbers of patients to be treated have been estimated.
Use the details from this spreadsheet to populate the tables in the 'annual treated patient
numbers' worksheet.
Medicine acquisition cost
This worksheet estimates the acquisition cost of the new medicine for NHS Scotland based on
the list price.
The acquisition cost must be consistent with the economic model in the SMC submission and
should be the list price only.
Additional cost-savings-medicines
New medicines often displace other medicines currently used to treat the target
disease/condition, or may require the additional use of other supportive medicines. These
costs and savings need to be taken into account in estimating the net budget impact.
This worksheet identifies the additional costs and savings associated with other medicines,
resulting from the use of the new medicine.
Other cost savings
This worksheet identifies the potential costs and savings that may arise from introduction of the
new medicine, other than from other medicines displaced. These are the marginal or variable
costs/savings associated with the new medicine that lead to cash releasing savings or
additional cash costs for the NHS.
The economic assessment may identify additional costs/savings arising from, for example,
reduced numbers of outpatient appointments, inpatient stays, theatre sessions. However the
costs associated with such items are largely fixed and rarely lead to cash releasing savings or
increased costs; the departments affected might be a little less, or more, busy, but it is likely
that the same number of staff will be employed and the facilities will still require to be heated,
cleaned and maintained. These types of potential changes should be identified under the
'service implications' section.
Service implications
This worksheet is a checklist of possible service implications arising from the introduction of
new medicines.
The information is very important because although it may not reveal cash releasing efficiency
savings it may allow creation of additional capacity at nil or marginal cost. In addition the
information may facilitate the introduction of the new medicine.
Summary
Net budget impact
The net budget impact section of the summary sheet is populated automatically from the
detailed spreadsheets.
After completing the detailed spreadsheet you are advised to review the summary sheet to
sense check the results in order to identify any errors.
Service implications
The service implications section of the summary sheet is populated automatically from the
detailed spreadsheet.
After completing the detailed spreadsheets you are advised to review the summary sheet to
sense check the results in order to identify any errors.
Scotland ISD contacts
This worksheet provides details of several websites that can be used to access epidemiological
data specific to the Scottish population.
Page 2 Blank_Budget_Impact_template_v6
Number Reference Sources
1 Scotland population
5,168,500 Per census estimate June 2008
2 Prevalence and incidence Year 1 Year 2 Year 3 Year 4 Year 5
Prevalence
3
Incidence
Estimated number of patients with the
0 0 0 0 0
condition
Mortality Year 1 Year 2 Year 3 Year 4 Year 5
4 Mortality rate of patient cohort with the
condition.
5 Licence - eligible patient population
Proportion of patient cohort with the
condition treatable under the licence
(eligible patients)
6 Sub-population
Sub-population of eligible patient cohort
(%)
Proportion of eligible patients treated Year 1 Year 2 Year 3 Year 4 Year 5
7 with new medicine
8 Treatment discontinuation
Discontinuation rate
Summary
Year 1 Year 2 Year 3 Year 4 Year 5
Estimated number of patients with the
0 0 0 0 0
condition
Mortality rate of patient cohort with the
0.00% 0.00% 0.00% 0.00% 0.00%
condition
Net number of patients with the condition 0 0 0 0 0
Proportion of patient cohort with the
condition treatable under the licence 0.00% 0.00% 0.00% 0.00% 0.00%
(eligible patients)
Potential number of eligible patients
0 0 0 0 0
treated each year in licence
Sub-population of eligible patient cohort
0.00% 0.00% 0.00% 0.00% 0.00%
(%)
Potential number of eligible patients
0 0 0 0 0
treated each year in sub-set
Proportion of eligible patients treated with
0.00% 0.00% 0.00% 0.00% 0.00%
new medicine
Potential number of eligible patients
0 0 0 0 0
treated each year
Discontinuation rate 0.00% 0.00% 0.00% 0.00% 0.00%
Number of patients treated in each year 0 0 0 0 0
APPLICABLE ONLY AFTER SMC
ADVICE
9 Restriction in use following SMC decision 0.00% 0.00% 0.00% 0.00% 0.00%
Number of patients treated in each year 0 0 0 0 0
10
Estimate of Net Budget Impact
Derivation of patient numbers
Generic Name: Enter generic name
Brand Name: Enter brand name
Indication:
Enter indication
Use this sheet to provide your detailed workings to explain how you have estimated the numbers of
eligible patients and the number of patients to be treated.
Use the details from this spreadsheet to populate the tables in the "annual treated patient numbers" worksheet
This is a free-form spreadsheet and you should expand and change the sheet as necessary to set
out your calculations and any other relevant information such as tables, graphs and reference
sources, etc.
A series of prompts is set out below to assist you in providing the information required by the SMC
assessors:
a) Current Prevalence
Estimate the total number of patients in Scotland who have the condition relating to the indication under
consideration (current prevalence) and an indication of the course of estimated numbers.
(insert additional rows below was required)
b) Yearly Incidence
Estimate the number of newly diagnosed patients each year over the first five years after introduction
(yearly incidence) and an indication of the source of estimated numbers.
(insert additional rows below as required)
c) Net Number of Patients
Estimate the net number of patients in each of the first five years after introduction
(net number = prevalent cases plus incident cases less those who recover or die)
(insert additional rows below as required)
d) Number of patients likely to be prescribed the new medicine
Estimate the number of patients likely to be prescribed the treatment, with the basis for the calculation.
(insert additional rows below as required)
Estimate of Net Budget Impact
Medicine acquisition cost
Generic Name: Enter generic name
Brand Name: Enter brand name
Indication:
Enter indication
1 Patient Access Scheme (PAS)
Is there a PAS planned? Yes Select using arrow
Does this version of the template adjust for the PAS? No Select using arrow
Acquisition cost per annum per patient
2 Year 1 Year 2 Year 3 Year 4 Year 5
Total estimated medicine cost per annum per patient
Assumptions and detail of calculations of acquisition cost
List below assumptions used to calculate cost per patient per annum:
Use average cost where there may be different dosages.
If acquisition cost is reduced by a PAS, show how this is calculated.
Explain basis of calculation of cost and state any assumptions below:
(insert more rows and columns as necessary)
3 VAT
Y/N %
Primary Care Yes
Homecare No
Secondary Care Yes
Notes Description
1 Patient access scheme (PAS)
If a PAS is planned you are required to submit two versions of the budget impact calculations to correspond to
the SMC submission; one without and one with the PAS.
Ensure that you identify clearly which version is with the PAS and which is not.
2 Estimated acquisition cost of the new medicine per annum per patient
Acquisition cost should be calculated on the basis of annual cost of the new medicine per patient.
The new medicine may be administered in a variety of ways; as a single dose, as a regular dose, increasing
doses, in a number of cycles, etc. It is important that the acquisition cost is calculated as the annual cost per
patient.
If dosages of the new medicine vary, estimate the average dose to calculate the annual acquisition cost.
3 VAT
The NHS cannot recover VAT in the Secondary Care sector and it is therefore a factor in calculating a total
budget impact. While you should exclude VAT from calculation of acquisition cost, the NHS needs to know in
which sector the new medicine is likely to be administered.
If known, indicate whether patients will be treated with the new medicine in the Primary Care Sector, the
Secondary Care Sector or through a Homecare scheme.
Where there is a potential mix of sectors, if known, indicate the estimated proportion of where the new medicine
will be used.
If you do not know or are unsure in which sectors the new medicine will be delivered, leave blank.
Yes
No
Estimate of Net Budget Impact
Additional costs/savings - medicines
Generic Name: Enter generic name
Brand Name: Enter brand name
Indication:
Enter indication
Costs
1 Additional supportive medicine required
Insert name Assumptions
Name of medicine
Year 1 Year 2 Year 3 Year 4 Year 5
Estimated supportive medicine cost
per patient per annum
If additional supportive medicines are required, provide an analysis below.
Enter text
Savings
2 Displaced medicines
I Name of medicine displaced by Insert name Assumptions
new drug Year 1 Year 2 Year 3 Year 4 Year 5
Estimated displaced medicine (I) cost
per patient per annum
Estimated % reduction of displaced
medicine (I)
Estimated displaced medicine (I) cost
£0.00 £0.00 £0.00 £0.00 £0.00
per patient per annum
II Name of medicine displaced by Insert name Assumptions
new drug Year 1 Year 2 Year 3 Year 4 Year 5
Estimated displaced medicine (II) cost
per patient per annum
Estimated % reduction of displaced
medicine (II)
Displaced cost per patient per annum £0.00 £0.00 £0.00 £0.00 £0.00
III Name of medicine displaced by Insert name Assumptions
new drug Year 1 Year 2 Year 3 Year 4 Year 5
Estimated displaced medicine (III)
cost per patient per annum
Estimated % reduction of displaced
medicine (III)
Displaced cost per patient per annum £0.00 £0.00 £0.00 £0.00 £0.00
Summary
Year 1 Year 2 Year 3 Year 4 Year 5
Supportive medicine A
£0.00 £0.00 £0.00 £0.00 £0.00
Total £0.00 £0.00 £0.00 £0.00 £0.00
Displaced medicine (I) 0.00 0.00 0.00 0.00 0.00
Displaced medicine (II) 0.00 0.00 0.00 0.00 0.00
Displaced medicine (III) 0.00 0.00 0.00 0.00 0.00
Total 0.00 0.00 0.00 0.00 0.00
Notes Description
1 Additional supportive medicine(s) required
Identify any additional supportive medicine(s) required resulting from the introduction of the new medicine.
Insert the trade name and generic name of the medicine in the yellow shaded cell shown.
Calculate the estimated cost of the supportive medicine on the basis of cost per patient per annum for each year of the five
year period.
Insert the cost in the yellow shaded cells.
List price of the supportive medicine must be used, excluding VAT.
Set out the assumptions used in your calculations and describe how you calculated the costs.
Add additional rows or columns if necessary.
If there is more than one additional supportive medicine required, include the appropriate share of costs in your calculations
and give details.
2 Displaced medicines
Identify any medicines that are displaced resulting from the introduction of the new medicine.
Insert the trade and generic name of the medicines in the yellow shaded cells shown.
Calculate the estimated cost of the displaced medicines on the basis of cost per patient per annum for each year of the 5
year period.
Insert the cost in the yellow shaded cells.
List price of the displaced medicine must be used, excluding VAT.
The medicines in current use may be displaced in different shares by the new medicine.
Insert in each table the estimated percentage reduction of each current medicine that will be displaced. For example the
new medicine may displace 50% of the use of the drug (I), 25% of drug (II) and 63% of drug (III). The total patient numbers
resulting from application of these percentages will equate to the patients treated with the new medicine, as shown below:
Current After new %
usage medicine reduction
New medicine 0 35
Current medicine (I) 10 5 50%
Current medicine (II) 20 15 25%
Current medicine (III) 40 15 63%
Total eligible patients 70 70
The table will automatically calculate the reduction in cost for each medicine.
Set out the assumptions used in your calculations and describe how you calculated the costs and percentage reductions for
each medicine.
Add additional rows or columns if necessary.
Estimate of Net Budget Impact
Other costs/savings
Generic Name: Enter generic name
Brand Name: Enter brand name
Indication:
Enter indication
The introduction of new medicines sometimes creates savings and/or additional costs.
Other significant savings or additional costs are the exception rather than the rule and should be
relatively obvious.
Should you have difficulty in calculating the saving/cost, describe the item in the 'service
implications' worksheet.
Other savings
1 Additional savings
Year 1 Year 2 Year 3 Year 4 Year 5
Describe the additional savings per annum and assumptions used to calculate savings below:
Use of the new medicine obviates the need for special genetic testing that can only be performed
at a specialist lab in the USA. The NHS would realise a saving of £2,500 per patient and a total
saving of £25,000 for the 10 patients treated per annum.
Other costs
2 Additional costs
Year 1 Year 2 Year 3 Year 4 Year 5
Describe the additional costs per annum and assumptions used to calculate costs below:
For example: Patients require to be monitored using CT scanner 10 times per annum using an
expensive contrast agent at an additional cost of £1,000 per scan. Total cost per patient is
£10,000, leading to total additional costs of £100,000 for the 10 patients treated per annum.
NotesDescription
1 Additional savings
Estimate the total additional savings per annum resulting from the introduction of the new medicine
from the perspective of the whole of NHS Scotland.
Insert the savings per annum in the relevant cells in the spreadsheet in respect of each year.
Set out the assumptions used in your calculations and describe how you calculated the savings.
2 Additional costs
Estimate the total additional costs per annum resulting from the introduction of the new medicine
from the perspective of the whole of NHS Scotland.
Insert the additional costs per annum in the relevant cells in the spreadsheet in respect of each
year.
Set out the assumptions used in your calculations and describe how you calculated the costs.
Estimate of Net Budget Impact
Service implications
Generic Name: Enter generic name
Brand Name: Enter brand name
Indication:
Enter indication
Overview
New medicines may create or reduce demand in different sectors of the NHS. For example a new medicine may be
given in tablet form, replacing a medicine that was administered intravenously in a hospital ward setting. While this
change may reduce the workload in the hospital setting, costs are not reduced, as the hospital still needs to be
maintained and heated and the impact might be that ward would be a little less busy, i.e. the cost savings would be
marginal at best. However it is vital that the NHS is aware of the service implications arising from the introduction of new
drugs, as services are constantly being re-designed to improve efficiency and to absorb new demands.
There may be a number of service implications for the NHS e.g. the new medicine might require extra or fewer inpatient
stays compared to current treatments. Such implications may only create marginal additional costs/savings, but may
create (or reduce) capacity in NHS Scotland facilities. It is important to identify these implications for service planning.
A checklist is set out below.
Element of service Impact Estimate of addition/(reduction) per annum
Describe units
Y/N? year 1 year 2 year 3 year 4 year 5
Operating theatre sessions
1 Inpatient bed days/length of stay
Day cases
Outpatient attendances
GP appointments
Community nurse visits
2 Laboratory tests (describe)
Pathology
Pharmacy
Radiology
3 Other - describe below
A.
B
C
D
E
Notes Description
1 New medicine has fewer side effects reducing inpatient bed days.
2 New medicine requires monitoring of liver function.
3 New medicine requires monitoring with additional MRI scans.
Estimate of Net Budget Impact
Summary
Generic Name: Enter generic name
Brand Name: Enter brand name
Indication:
Enter indication
Year 1 Year 2 Year 3 Year 4 Year 5
Medicine acquisition cost per patient per annum £0 £0 £0 £0 £0
ADD: Supportive medicines cost per patient per
£0 £0 £0 £0 £0
annum
GROSS ADDITIONAL MEDICINES COSTS PER
£0 £0 £0 £0 £0
PATIENT PER ANNUM
LESS: Displaced medicines cost per patient per
0 0 0 0 0
annum
NET ADDITIONAL MEDICINES
£0.00 £0.00 £0.00 £0.00 £0.00
(SAVINGS)/COSTS
Number of patients treated in each year 0 0 0 0 0
BUDGET IMPACT (new medicine and
£0 £0 £0 £0 £0
supportive medicine costs only)
BUDGET IMPACT - NET MEDICINE COSTS £0 £0 £0 £0 £0
OTHER (SAVINGS)/COSTS
(Savings) 0 0 0 0 0
Costs £0 £0 £0 £0 £0
Total other (savings)/costs £0 £0 £0 £0 £0
NET TOTAL BUDGET IMPACT £0 £0 £0 £0 £0
Service Implications
List below the estimated significant service implications consequent on the introduction of the new medicine.
A checklist is provided per the "service implications" tab
SERVICE ELEMENT UNITS Impact Year 1 Year 2 Year 3 Year 4 Year 5
Operating theatre sessions 0 0 0 0 0 0 0
Inpatient bed days/length of stay 0 0 0 0 0 0 0
Day cases 0 0 0 0 0 0 0
Outpatient attendances 0 0 0 0 0 0 0
GP appointments 0 0 0 0 0 0 0
Community nurse visits 0 0 0 0 0 0 0
Laboratory tests (describe) 0 0 0 0 0 0 0
Pathology 0 0 0 0 0 0 0
Pharmacy 0 0 0 0 0 0 0
Radiology 0 0 0 0 0 0 0
Other - describe below 0 0 0 0 0 0 0
A. 0 0 0 0 0 0 0
B 0 0 0 0 0 0 0
C 0 0 0 0 0 0 0
D 0 0 0 0 0 0 0
E 0 0 0 0 0 0 0
You are asked to provide an estimate of the total number of patients in Scotland who have the condition relating to the indication under
consideration together with details of the source of this information. Where possible, the data on eligible patients should be specific to Scotland. If
this is not possible, UK data may be adapted based on Scottish population statistics. Population estimates based on the 2001 census are now
available from the General Register Office for Scotland:
http://www.gro-scotland.gov.uk
Several websites can be used to access epidemiological data specific to the Scottish population:
Information Services Division Scotland website – Information and Statistics:
http://www.isdscotland.org/isd/3348.html
ISD routinely publishes Scotland's official health statistics on the ISD website. For the main topics see: Main Programmes
http://www.isdscotland.org/isd/3348.html
For latest and previous releases see News and Releases:
http://www.isdscotland.org/isd/810.html
For a full list of topics see A-Z Subject Index:
http://www.isdscotland.org/isd/782.html
Incidence and prevalence data
There are several sources of information on the ISD website that may be helpful in identifying the incidence and prevalence of specific conditions.
(a) Secondary care
The section on Acute Hospital Care (www.isdscotland.org/isd/3409.html) brings together information on different
aspects of acute hospital care, sourced from hospital administrative systems across Scotland. There is information on patients treated on an outpatient or inpatient/day case basis
including information on the main diagnosis of patient discharges from hospitals
(www.isdscotland.org/isd/4334.html):
http://www.isdscotland.org/isd/3409.html
http://www.isdscotland.org/isd/4150.html
http://www.isdscotland.org/isd/4334.html
For further information, enquirers can contact the Secondary Care Team:
mailto:nss.isdSCT@nhs.net
(b) Primary care
1) General Practice - Practice Team Information (PTI):
PTI collects data from a small sample of Scottish general practices, relating to consultations between patients and a GP or practice-employed practice nurse. From the sample PT
http://www.isdscotland.org/pti
There is a lot of supplementary information about PTI on the web pages, for example explaining what data are collected and what their uses and
limitations are. An example of the limitations is that PTI data tell us what signs, symptoms or diagnoses are recorded against the consultation, but
they do not tell us about any underlying conditions that the patient may have, unless those conditions are specifically mentioned as the reason for
the consultation. Note that the data sources cannot reliably differentiate between incident and prevalent cases.
All of the published PTI information is available free of charge and with instant access from the website. If a pharmaceutical company is
interested in other information that can be derived from PTI but which is not already published, it may be possible to provide this (depending on
exact requirements) but there would be a charge to provide it.
2) QOF (Quality and Outcomes Framework):
ISD also publishes all of the QOF data on behalf of NHS Scotland – at www.isdscotland.org/qof . The figures include numbers of patients on individual QOF registers and numbe
http://www.isdscotland.org/qof
If further information is required, enquirers can contact the GP practice team:
mailto:nss.isdGereralPractice@nhs.net
(c) Other sources of incidence/prevalence data
Depending on the condition of interest, there are various publications, web pages etc. that may provide useful reference information. For example:
Scottish Public Health Observatory (ScotPHO) – includes data on a number of conditions:
http://www.scotpho.org.uk/home/home.asp
ISD’s Long Term Conditions Programme web pages:
http://www.isdscotland.org/isd/5658.html
Scottish Diabetes Survey reports (linked to from ScotPHO).
If further information is needed from ScotPHO or ISD’s Long Term Conditions programme, please contact those teams direct. Contact details are
given on the web pages.
(d) Making an information request
If you can’t find the information you’re looking for on the ISD website there is also a section on information requests:
http://www.isdscotland.org/isd/755.html
Contact the Customer Support Desk by call on 0131 275 7777 or by email
mailto:nss.csd@nhs.net
NB There is a charge for Information Requests. For more details, ISD's Information Request Protocol is available.
