Download Guidance - Scottish Medicines Consortium

Scottish Medicines Consortium
Guidance
on
Horizon Scanning Process
October 2013
Contents
Page
1. Background
1
2. Outputs
2.1 Forward Look reports
2
2.2 Forward Look addendum
4
2.3 Forward Look interim updates
4
2.4 Ad hoc advice
4
3. Horizon scanning processes
3.1 Overview and timelines
5
3.2 Company contacts
8
3.3 Collation of intelligence
8
3.4 Forward Look report content
10
3.5 Product monographs
10
3.6 Clinical expert advice
10
3.7 Pharmaceutical industry input
11
3.8 Financial spreadsheets
11
4. Confidentiality
12
5. Using the Forward Look report in
practice
13
Appendices
Appendix A
Example of a completed horizon scanning
update form
14
Appendix B
Sample monograph and monograph
template
17
Appendix C
Example of financial spreadsheet
25
1. Background
In 2003 the (then) Scottish Executive requested that the Scottish Medicines Consortium (SMC)
establish a horizon scanning initiative to provide Scottish Health Boards with advance intelligence
on new medicines to support financial and service planning for their managed introduction into
practice.
The main focus of the horizon scanning initiative is to provide financial planners with reliable
information to support resource planning for the managed introduction of new medicines. In
accordance with SMC’s remit, the horizon scanning initiative encompasses new medicines as well
as new indications, licence extensions and new formulations of existing medicines. The budget
implications of new medicines are subject to a high degree of uncertainty. However, if financial
planning processes are supported by robust intelligence about medicines in the pipeline and their
potential cost impact, this should facilitate patient access to cost-effective new medicines at the
earliest opportunity after SMC approval. Horizon scanning intelligence also assists SMC in
workload planning in relation to new product assessments.
As part of the current new product assessment process, pharmaceutical companies provide SMC
with an estimate of the potential budget impact of the new medicine for NHS Scotland within the
new product assessment form (‘submission’). Companies estimate the net resource implications
over the five years following a medicine’s introduction, taking into account the acquisition cost as
well as any direct effect on the use of other resources. These budget impact estimates are
intended to give Health Boards an indication of the financial implications if the medicine is
accepted for use in NHS Scotland. However, they are not a component of SMC decision making
on cost-effectiveness.
Since 2005 SMC has produced an annual horizon scanning report, entitled Forward Look, to
provide NHS Boards with information on potentially ‘high impact’ medicines that may come to the
UK market within the next calendar year. A new medicine is regarded as ‘high impact’ if it: (i) has a
predicted net drug budget impact (relative to comparators) for NHS Scotland of >£500K per annum
within the first five years of its introduction in the UK; or (ii) may be associated with major service
implications. The Forward Look report provides an insight into the potential costs associated with
the adoption of a new medicine and hence provides a tool for illustrating the pressures on the
budget allocation process.
The purpose of this guidance document is to give stakeholders a detailed overview of SMC horizon
scanning processes and outputs, including standard documentation. The Association of the British
Pharmaceutical Industry (ABPI) has contributed to the development and maintenance of these
processes through the SMC User Group Forum. It is hoped that the document will foster a better
understanding of the horizon scanning processes and lead to more efficient and effective
interactions between SMC and the pharmaceutical industry to produce higher quality horizon
scanning information for NHS Scotland.
The aims, processes, timelines and outputs of the horizon scanning initiative are described, with an
emphasis on how pharmaceutical companies can optimise their contribution. The document also
outlines the type and sources of information that are of value to SMC in providing Health Boards
with a realistic forecast of the potential budget impact of new medicines.
1
2. Outputs
2.1 Forward Look Reports
Horizon scanning information is detailed in an annual report (Forward Look) issued in confidence
each October to key Health Board personnel, including Chief Executive Officers and Directors of
Medicine, Finance, Pharmacy and Public Health. The Directors of Finance and Pharmacy also
receive a set of financial spreadsheets that summarise the net budget impact of ‘high impact’ new
medicines.
The report lists all new medicines expected to reach the UK market within the next calendar year
but focuses on those with the potential for ‘high impact’. These include medicines with a predicted
moderate to high net drug budget impact for NHS Scotland (i.e. >£500,000 per annum at year five)
and those potentially associated with major service implications. Detailed information on these new
medicines is provided within the report in a product monograph. In the past, Forward Look also
provided detailed information on all medicines being developed for orphan indications. However
from 2010 onwards medicines with orphan status have been treated like all other medicines in the
report, with detailed information only being included in the form of a monograph if the medicine is
predicted to have a moderate to high net drug budget impact for NHS Scotland (i.e. >£500,000 per
annum at year five) and / or the potential for major service implications.
The report consists of two main sections. The first is arranged by British National Formulary (BNF)
chapter and contains tabulated information on all new medicines likely to be launched in the UK in
the next calendar year, with a brief description of the key developments. An example is shown in
figure 1.
Figure 1: Forward Look Section 1 - Example of Format
BNF Section 1: Gastro-intestinal system
Product
Drug A
Drug B
Drug C
Therapeutic Area
Peptic ulcers
Crohn’s disease
Constipation
Comments
Compete with existing therapy
Monograph
Compete with existing therapy
Summary:
A key development is the potential launch of drug B, the first drug in a new pharmacological class
for the treatment of Crohn’s disease.
The second main section contains detailed product monographs for medicines that are expected to
be associated with moderate to high net drug budget impact and / or major service implications.
These are arranged alphabetically within BNF chapters, with cancer drugs further sub-divided by
tumour type. An example of a product monograph is shown in figure 2.
There is also a summary table that includes all new medicines in the report that are expected to be
associated with moderate to high net drug budget impact or major service implications. This
includes details of their estimated UK launch date, estimated uptake and predicted net drug budget
impact at years one and five.
2
Figure 2: Forward Look - Example of Product Monograph Format
Product
Indication
Status
Mode of
action
Estimated
eligible
population
in Scotland
Estimated
uptake
Drug C (Brand C) Intravenous Injection (Company)
Treat adults with moderate to severe psoriasis unresponsive to standard therapies.
Plan to file with EMA Q3 2013. Estimated UK launch Q3 2014.
Biologic. Likely to be first in this new class of biologic drugs.
Estimated prevalent population of adults with psoriasis unresponsive to standard
therapies of approximately 625 patients.
Assumptions
 Estimated prevalent adult population with psoriasis of approximately 100,000 patients. 1
 An estimated 2.5% of patients with psoriasis have moderate to severe disease,2
equivalent to approximately 2,500 patients.
 An estimated 25% of these patients fail on standard therapies, 2 equivalent to
approximately 625 patients.
Uncertainties
 The proportion of patients failing on standard therapies may alter over time with the
introduction and greater use of biologic drugs as standard therapies.
Estimated uptake in years 1 and 5 by approximately 30 and 95 eligible patients,
respectively.
Assumptions
 Drug C would be given to approximately 5% and 15% of eligible patients in years 1 and
5, respectively.
Estimated
incremental
drug
acquisition
cost
Estimated
net drug
budget
impact
Service
Implications
Key
references
Uncertainties
 Uptake may be influenced by cost-effectiveness relative to alternatives and this is
unknown.
 Uptake may be influenced by the publication of new guidelines for psoriasis and the
availability of other new therapies.
Estimated incremental drug acquisition cost of up to approximately £10,000 per annum.
Assumptions
In the absence of advice from the pharmaceutical company, the estimated drug
acquisition cost of Drug C is approximately £10,000 to £12,000 per annum (30mg
intravenously once a month).
 Drug C would be used in place of Drug X (25mg orally per day) and Drug Y (100mg
subcutaneously per week).
 The alternative treatments (Drug X and Drug Y) cost approximately £1,000 and £3,000
per annum, respectively. The average of these has been assumed as the cost of
alternative treatments.
Uncertainties
 Drug X is likely to be out of patent protection in the next few years and generic versions
are expected to cost less. Thus the incremental cost of Drug C could increase.
Year 1: 30 x £10,000 = £300,000
Year 5: 95 x £10,000 = £950,000
Additional healthcare resources will be required to administer Drug C by intravenous
injection once a month. However, this is not expected to be associated with significant
service implications.
1. Bloggs J et al. Ann Intern Med 2013
2. Smith J et al. N Engl J Med 2013
3
2.2. Forward Look Addendum
It is common for SMC to receive late notification of medicines that are predicted to reach the UK
market within the next calendar year. Depending on when notification is received, it might be
feasible to list the medicine in the main report but there may be insufficient time to develop a
detailed monograph if the medicine is predicted to have significant budget or service impact. In
such circumstances, it is possible to develop an addendum to the main report that includes the
monographs. Such an addendum must be received by the January prior to the beginning of the
new financial year to allow Health Boards to consider the predicted impact of the medicine for
financial planning purposes. If it is not possible to produce a monograph within this timeframe, it
will be necessary to list the medicine in the next interim update (see section 2.3) without the
detailed information being presented in a monograph. This will therefore limit the information
available to Health Boards for financial planning purposes, which could be problematic for high
impact medicines.
Late notification from pharmaceutical companies is not desirable as it means that financial planning
information provided to Health Boards is fragmented. It also means that SMC’s resource is diverted
onto monograph production for medicines in the late notification category, rather than focusing on
the pipeline updates and early intelligence on medicines that will feature in the next year’s report.
2.3 Forward Look Interim Updates
In addition to the annual Forward Look report that is made available in October each year, SMC
produces an interim update to the main report in the April of the following year. The interim update
includes.




Details of new medicines that may reach the UK market in the timelines for the previous
Forward Look report but that have not been included in any earlier Forward Look reports.
Updates on medicines featured in previous Forward Look reports where the regulatory
timeframe has changed and UK launch is now expected in the timeframe for the previously
published Forward Look report or some other aspect of the information in the previous Forward
Look report relating to the product has changed.
Information on medicines featured in previous Forward Look reports where clinical
development has since been delayed or discontinued.
Information on scheduled or ongoing re-submissions for medicines in the SMC work
programme.
Work is ongoing to refine the content of the main Forward Look reports and the interim updates.
Consideration is being given to whether information on delayed and withdrawn products and resubmissions for medicines in the SMC work plan could be extracted from the reports and made
available to Forward Look recipients via the secure SMC website. This would allow this information
to be updated more frequently than is currently possible.
2.4 Ad Hoc Advice
Horizon scanning intelligence may be used to answer ad hoc enquires from staff within NHS
Scotland. Such enquiries can range from simple enquires by clinicians about an expected UK
launch date of a new medicine to requests for more complex information, for example provision of
input to ten-year plans for service development within a clinical speciality. In answering enquires
SMC maintains the confidentiality of any information provided in confidence by the Pharmaceutical
Industry and would not disclose sensitive UK launch or cost data provided in confidence.
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3. Horizon Scanning Processes
3.1 Overview and Timelines
Horizon scanning work is carried out by a team including principal and senior pharmacists, finance
experts and an administrator. The figure below provides an overview of horizon scanning
processes and timelines.
The timelines for the production of the annual Forward Look report are driven by financial timelines
in Health Boards. In October each year financial planners require estimates of the potential budget
and service impact of new medicines likely to be launched in the UK in the next financial year to
inform decisions in annual budget setting processes. The Forward Look report covers a calendar
year but the availability of products to prescribe in the UK will align with the financial year as it is
considered that SMC advice on a product will be available three months after UK launch (i.e. Q4
2014 UK launch equates to Q1 2015 SMC advice).
Figure 3: Overview of Processes and Timelines for Production of the Forward Look Report
Interactions with the pharmaceutical industry are shown in italics.
January
 Extract pipeline updates for medicines expected to be launched in the UK in the
designated Forward Look timeframe from UK PharmaScan for companies registered to
use the system.
 Receive annual horizon scanning update from companies via SMC proformas for
companies not registered to use UK PharmaScan.
 Review all pipeline updates and request further information from companies where
necessary.
February
 Draft a list of all new medicines, new indications of existing medicines and new
formulations expected in the following calendar year (i.e. provisional content of next
Forward Look report).
March to
April
 Start the filtration process to identify medicines with the potential for high budget and /
or service impact.
 Seek views on potential impact of new medicines from the Horizon Scanning Steering
Group and Clinical Review Group and NHS clinical experts as required.
 Inform companies by email of all new medicines for inclusion in the next Forward Look
report and detail which products are anticipated to have high impact. If company views
are required on likely impact, seek feedback at this time.
 Review company feedback on provisional content of the Forward Look report.
March to
June
June to
August
 Prepare draft product monographs and forward to NHS clinical experts for comment.
August to
September
 Review company feedback on monographs and prepare final versions.
 Collate report in the appropriate format and draft the narrative for section 1 of the
report that includes all medicines expected in the designated time horizon.
 Quality assure final content of report.
 Prepare the financial spreadsheets that accompany the Forward Look report for high
impact medicines.
October
 Make Forward Look report and financial spreadsheets available to NHS Health
Boards.
 Review clinical expert comments and incorporate into monographs as appropriate.
 Prepare a revised draft of monographs for company review.
 Forward revised version of monographs to companies for comment.
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November
to
December
 Inform companies by email of the content of the Forward Look report relating to their
new medicines.
 Request annual horizon scanning update from companies not registered to use UK
PharmaScan and contact companies registered to use UK PharmaScan to request that
they confirm that their UK PharmaScan records are up to date.
6
Figure 4: SMC Forward Look Production Process
KEY INTELLIGENCE AND EXPERTISE
PROCESS AND TIMELINES
January
Gather intelligence on pipeline medicines
and populate SMC’s horizon scanning
database
Annual updates from Pharmaceutical
companies on pipeline drugs
Updates from UK PharmaScan for
registered companies on pipeline drugs
Continuous routine scanning of information
sources by Horizon Scanning Team
February
March to
April
Draft list of all new medicines expected in
the next financial year
Analysis and interpretation of intelligence,
and filtration / selection of medicines for
report based on predicted UK launch and
budget impact
Horizon Scanning Team
Horizon Scanning Steering Group and
Clinical Review Group
Horizon Scanning Team
NHS Clinical Experts
Verification of Forward Look content
Pharmaceutical Industry
Development of monographs for high
impact medicines in Forward Look report
Horizon Scanning Team
Verification of monograph content
NHS Clinical Experts
Verification of monograph content
Pharmaceutical Industry
Production of Forward Look report and
financial spreadsheets
Horizon Scanning Team
March to June
June to August
August to
September
October
Make Forward Look report and financial
spreadsheet available on the SMC secure
website
NHS Chief Executive Officers, Directors of
Medicine, Pharmacy, Finance and Public
Health and other key personnel
Local Health Boards use for financial
planning purposes
Inform Pharmaceutical Industry of Forward
Look report content
Pharmaceutical Industry
November to
December
Commence annual horizon scanning
update
7
Direct contact with Pharmaceutical Industry
UK PharmaScan
3.2 Company Contacts
When a medicine in clinical development is identified and added to SMC’s tracking lists, the
pharmaceutical company developing the medicine is identified. If SMC has not had any previous
contact with the company, the Horizon Scanning Team will attempt to identify the most appropriate
contact person within the company with responsibility for horizon scanning intelligence.
Companies planning to launch medicines in the UK that have not had previous contact with SMC
are requested to make contact to ensure that SMC is aware of their developments and is planning
to include their medicines in future Forward Look publications.
SMC maintains a database of named company contacts. It will include details of the primary
company contact(s) in relation to the new product assessment process and also contacts for the
horizon scanning function. It is possible that in some companies the same person may be
responsible for both aspects of communication with SMC. Contact is routinely made by email. It is
extremely helpful if companies can advise SMC of any personnel changes or any updated
information to their contact details.
3.3 Collation of Intelligence
The Horizon Scanning Team reviews a wide range of sources of information on new medicines in
clinical development on an ongoing basis and maintains details of these within a customised
database. These include:
 UK PharmaScan
 Confidential NHS publications
 Public domain information from regulatory authorities, pharmaceutical and commercial
analyst companies
 Other NHS organisations involved in horizon scanning work e.g. the National Institute for
Health Research Horizon Scanning Centre (NIHR NHSC) and the UK Medicines
Information (UKMI) network.
UK PharmaScan is a confidential national horizon scanning database populated by the
pharmaceutical industry that provides intelligence to horizon scanning organisations of company
pipeline medicines. Information in UK PharmaScan can be invaluable if it is kept up to date and it is
comprehensive. However, if information is missing or out of date, SMC will either need to source
the information from other sources or contact the pharmaceutical company directly. This can be
time consuming and if the information is not confirmed, it could result in information relating to a
company’s pipeline being missed from SMC Forward Look publications and therefore missed from
NHS Scotland’s financial and service planning cycles.
Pipeline updates are received by SMC either from UK PharmaScan or directly from the company if
the company is not registered to use UK PharmaScan. If no UK PharmaScan record is available
the company will be asked to complete a standard proforma issued by SMC in November or
December each year (see Appendix A for an example of a completed proforma). Note that
information is requested on all new indications, licence extensions and new formulations of existing
products as well as new medicines (chemical or biological entities) and biosimilars. If SMC
considers that a product listed in the proforma may have a significant financial or service impact for
NHS Scotland, a subsequent proforma is sent to the company that includes a monograph template
(see Appendix B for an example of a blank proforma and a proforma with guidance notes for
completion). The company will be asked to complete as much of the proforma as is possible at the
time of the communication. Companies that are registered to use UK PharmaScan and whose
records are complete and comprehensive will not be asked to complete a monograph proforma
and UK PharmaScan will be used to source the additional information required.
SMC acknowledges that companies may have difficulty providing all the information, particularly in
relation to the provision of uptake and costing data up to a year or more prior to UK launch when
studies may be incomplete. For some companies these difficulties may be compounded by the
8
need to have information sourced from or authorised by company divisions based outside the UK.
As this advice is a critical component of the information used by NHS financial planners to facilitate
the managed introduction of cost effective new medicines, SMC is committed to collaborative
working with the pharmaceutical industry to achieve effective input in these challenging situations.
When companies cannot provide a detailed cost analysis and point data for estimates of uptake
and costs then best ‘ball-park’ range estimates can be useful. These can be provided with caveats
indicating that they are early estimates. This will be taken into account when these are used
together with other information (e.g. clinical expert advice) to produce the final draft budget impact
estimates that are then shared with the company for further comment. General advice about
proposed costing strategies or estimated uptake can also be very useful. The table below contains
examples of information that SMC would find useful in the absence of more precise estimates.
Information useful to SMC
Horizon Scanning Team
Acquisition cost
An indication of potential cost
range or upper or lower levels of
range
Cost relative to comparators
An indication of potential cost
relative to existing treatments
Examples
Estimated uptake
An indication of uptake range or
upper or lower levels of range
Estimated uptake
An indication of estimated uptake
relative to existing treatments
 Likely to be given to at least 90% of eligible population
 Likely to be given to less than 5% of eligible population
 Likely to be given to between 40% to 60% of eligible population
 Likely to replace existing drugs within the same class, but not increase
numbers of patients prescribed this class
 Likely to be given to up to 10% of patients already receiving this class
of drug
 Likely to increase the proportion of the eligible population receiving
drug therapy for this condition by up to 90%
 Expected to cost between £5,000 to £10,000 per patient per annum
 Expected to cost more than £80,000 per patient per annum
 Expected to cost less than £500 per patient per annum
 Will be priced in the same range as other drugs in class
 Likely to cost less than alternative treatments
 Likely to cost 10% to 20% more than alternative treatments
UK PharmaScan contains fields to document anticipated uptake of medicines, costing data and
indicative budget impact information. Given the difficulties that companies often experience in
providing costing information, broader cost ranges are being added to UK PharmaScan.
When reviewing information from UK PharmaScan and the completed proformas at the beginning
of each calendar year (from companies not registered to use UK PharmaScan) SMC staff aim to
compile a comprehensive list of all new medicines expected to be launched in the UK in the next
calendar year and to gain an understanding of those likely to have significant budget and / or
service implications.
Companies may also be contacted on an ad hoc basis to clarify or provide additional information
on particular products. Companies are encouraged to contact SMC via email or telephone at any
time to update the information held about particular products, for example a change in the
estimated UK launch date. Companies registered to use UK PharmaScan should ensure that their
product pipeline information is kept up-to-date on an ongoing basis and that changes to regulatory
information are updated immediately the information becomes available to the company,
During production of a Forward Look report additional information and advice supporting the
interpretation and application of horizon scanning data is obtained from a variety of sources, for
example, epidemiological and prescription data from NHS National Services Scotland (NHS NSS)
or Health Protection Scotland (HPS), plus advice from clinical experts and pharmaceutical
companies.
SMC takes appropriate steps to safeguard the security of horizon scanning information provided by
pharmaceutical companies. Information provided is not copied. All horizon scanning intelligence is
9
maintained in strict confidence and stored securely. The in-house horizon scanning database is
accessible by SMC staff only.
3.4 Forward Look Report Content
At the beginning of each year a systematic review and assessment of horizon scanning intelligence
is performed to identify new medicines with a potential UK launch date within the timeframe
covered in the next annual Forward Look report and to determine those likely to require a product
monograph. Clinical expert advice is obtained to inform this process when necessary.
After the initial list of products has been collated for the next Forward Look report, SMC notifies
individual pharmaceutical companies by email in March or April each year about their products to
be included in the report. The communication specifies those products that are expected to have a
significant incremental net drug budget impact (relative to comparators) or a significant service
impact for NHS Scotland. It is these products that will require a product monograph. Companies
are asked to give careful consideration to the proposed content at this stage, particularly in relation
to the estimated timelines for product availability in the UK, judgements that have been made
about a product’s potential for financial impact and any important omissions (i.e. products that
SMC has not identified for inclusion in the report may be highlighted). Company feedback at this
stage is extremely helpful in ensuring that Forward Look features the relevant products and that
the Horizon Scanning Team’s preliminary estimates of a product’s anticipated incremental net drug
budget impact appear reasonable.
3.5 Product Monographs
A systematic search is performed for information on the following:






How does the new product differ from existing products (e.g. pharmacology, route of
administration)?
What is the likely indication for the new product?
How many people in Scotland would be eligible for treatment with the new product?
What proportion of the eligible population is likely to receive the new product?
What is the incremental drug acquisition cost of the new product relative to existing
products?
Would the new medicine be associated with any major service implications?
After identifying and assessing all relevant data, a summary statement for each point is included in
a draft product monograph together with any assumptions and uncertainties associated with the
statements. The research methodology and data supporting the draft monograph are peer
reviewed within the Horizon Scanning Team.
3.6 Clinical Expert Advice
The SMC Horizon Scanning Team works closely with expert clinicians practising within NHS
Scotland. These are identified from the SMC clinical expert panel. Advice is usually sought from
around five or six clinical experts from a variety of NHS Boards throughout Scotland whenever
possible for each product. However, for rare conditions the number of relevant clinicians in the
SMC expert panel may be less than this. In these circumstances, additional efforts are made to
identify further relevant clinical experts, for example via requests to Scottish Area Drug and
Therapeutics Committees (ADTCs) or identification of relevant clinicians practising within the NHS
in England, Wales or Northern Ireland.
Clinical experts may be contacted for advice on a new clinical development prior to monograph
production if the likely financial and / or service impact is uncertain. Help from clinical experts can
be invaluable at this stage as they can provide specific intelligence from a Scottish perspective on
current treatment options, current treatment protocols and guidelines, patients eligible for treatment
with the condition being considered and likely uptake.
10
After the first draft of the product monograph has been prepared by the SMC Horizon Scanning
Team, it is circulated for comment to clinical expert for review. Clinical experts are asked to
comment on each section of the draft monograph. Advice is specifically sought on: (1) the types of
patients or clinical circumstances in which the new product is likely to be used; and (2) the number
of patients in Scotland likely to receive the new product.
The clinical expert comments are collated and reviewed by a member of the SMC Horizon
Scanning Team then used to modify the draft monograph as appropriate. This revised monograph
undergoes further peer review within the Horizon Scanning Team.
3.7 Pharmaceutical Industry Input
After clinical expert advice has been incorporated into the draft product monograph it is sent to the
sponsor pharmaceutical company for review and comment.
Pharmaceutical companies are invited to comment on each section of the monograph and any
points on which input is specifically sought are highlighted. However, if preferred, companies can
make general comments on the monograph and / or on the main issues where their advice is
valuable. These usually relate to (1) the estimated uptake of the new product within the eligible
population and (2) the estimated acquisition cost of the new product.
Comments from the company are considered carefully by the SMC Horizon Scanning Team and
the draft monograph is modified further if required. If substantial changes to content are made then
the company is sent the revised draft for further review and comment.
In November each year, after the Forward Look report has been made available to Health Boards,
companies are sent an email with details of their products that have been included in the report
including any monographs that have been drafted for the companies’ products. Copies of the
context statement that forms the introduction of the report are also sent to companies.
3.8 Financial Spreadsheets
The purpose of the financial spreadsheets is to summarise the estimated incremental net drug
budget impact of each significant new medicine by geographical area (West of Scotland, East of
Scotland and North of Scotland) and by individual NHS Board. The spreadsheets summarise the
financial information identified in product monographs within the Forward Look reports and also
include new medicines identified in previous Forward Look reports that have not yet had a budget
impact (e.g. due to delayed UK launch). This ensures that the spreadsheets include the potential
budget impact of all medicines that may be initially used in the NHS in the following calendar year.
The spreadsheets categorise data into two main types:
(1) New cancer medicines, listed by tumour type and indication
(2) New non-cancer medicines listed by BNF category and indication.
The spreadsheets include data on the following:



Annual net cost of treatment per patient or net cost per patient per course (i.e. net of the
cost of substituted medicines). Non-recoverable VAT is added where believed appropriate.
Estimated patient numbers in the East, West and North of Scotland in years 1 and 5.
Patient numbers for each of the above geographical areas and Board are calculated based
on mid-year population estimates from the National Records of Scotland. National
Resource Allocation Committee (NRAC) shares are not used.
Estimated total cost of each new medicine in years 1 and 5 (assumed to be the maximum
financial cost) for East, West and North of Scotland and individual Board. In year 1 the
estimated cost takes into account the expected approval date of the new medicine by SMC.
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
Therefore for a medicine that is estimated to be reviewed by SMC in October the year one
cost will be reduced by half.
Whether there are any service implications. This warns the financial teams to be aware of
potential additional costs that may occur or savings that may be available (e.g. medicine
administration may be more or less complex requiring changes to resources).
The financial spreadsheets are prepared in Microsoft Excel format to allow NHS Boards to modify
factors (e.g. to adjust patient numbers for local epidemiology, or different rates of uptake based on
local clinical expert opinion [see section 5]).
The spreadsheets are emailed in confidence to Directors of Finance and Directors of Pharmacy.
The spreadsheets are distributed to those that require them for budget preparation, subject to the
requirement to maintain the confidentiality of the information provided.
An example of a spreadsheet on non-cancer medicines is set out at Appendix C.
4. Confidentiality
The provision by the pharmaceutical industry of intelligence, that is often commercially sensitive, is
central to the success of SMC’s horizon scanning initiative. The risks to a pharmaceutical company
associated with the release of this confidential information are comprehensively appreciated by
SMC. Thus SMC staff are particularly aware of the necessity to maintain its confidentiality and
various processes have been established to store the data securely, to restrict access to it and to
ensure NHS Board recipients understand the precautions associated with its use.
The report is issued in confidence to key named individuals within NHS Scotland, including Chief
Executive Officers and Directors of Finance, Pharmacy, Medicine and Public Health. These NHS
Board recipients are made aware that information included within the Forward Look report is
privileged, confidential and intended for those specifically authorised to receive it for planning of
resource and estimating budgets. In this regard NHS Scotland personnel who have access to the
Forward Look reports sign a confidentiality agreement each year that is accompanied by a code of
practice on the appropriate use of the intelligence in the reports.
If Health Boards receive requests under the Freedom of Information (FOI) Act relating to
information within the report it is strongly recommended that they consult with partners at SMC
prior to the release of any information. If information is extracted from the report and incorporated
into local documents, these must make reference to the commercially sensitive nature of the
information and the recommendation to refer any FOI requests relating to it to SMC.
When NHS clinicians are included in the SMC clinical expert panel they agree to maintain the
confidentiality of any information they receive in relation to their work for SMC. When these
clinicians are approached to comment on draft product monographs the confidential nature of the
information is highlighted and the need to maintain the confidentiality of this information is reiterated.
12
5. Using the Forward Look Report in Practice
Health Boards have established processes, mainly through ADTCs and prescribing advisory
structures, to utilise the intelligence in the Forward Look report for financial and service planning
purposes. The information in relation to specific new medicines is often shared in confidence with
local clinical specialists or groups to seek their opinion on the assumptions and estimates used in
the Forward Look report. This may provide reassurance, for example, with regard to the estimated
number of patients to be treated, or may prompt some reworking of the figures to reflect local
epidemiology, treatment of patients within clinical studies, or other aspects of how care is provided.
After consideration has been given to the application of the Forward Look report in the Health
Board (or region, particularly for new cancer medicines), further internal reports may be prepared
and provided to Health Boards or regional advisory groups. If any part of the report is shared with
individuals who are not named recipients of the report, they should be made aware of the
confidentiality issues and they will be asked to sign and return a confidentiality agreement to SMC.
SMC and Health Boards recognise that the figures in the Forward Look report may represent a
‘worst case scenario’ given that some of the new medicines listed may not reach the UK market
within the predicted timeframe or at all. Of those that do reach the UK market within the timeframe,
a proportion will not be accepted by SMC for use in NHS Scotland, and in these cases the
predicted cost impact will not be realised. To account for this, Health Boards may choose to apply
a ‘modifying factor’ to generate a more realistic figure for the costs that may be realised in practice.
There are inherent risks in this approach, due to uncertainty around what constitutes an
appropriate figure, and Health Boards understand the need to regularly review local projections to
reflect SMC advice and its forthcoming work programme.
The Forward Look financial spreadsheets have been developed to allow this ongoing, dynamic inyear adjustment by Health Boards. For example, if a new medicine is considered by SMC but not
recommended for use in Scotland, then it may be removed from the cost projections for the
remainder of the current year. If the UK launch of a new medicine is delayed by approximately six
months, then it is a straightforward step to adjust the projected costs accordingly. For medicines
predicted to have a moderate or high cost impact that are accepted by SMC, a detailed local
budget impact model may be prepared. This detailed model is based on epidemiology, literature
estimates and information from the SMC Detailed Advice Document. Assumptions in the model are
confirmed with local specialists and phased uptake of the product is taken into account (for
example the number of patients initiated per month or quarter). A detailed model of this type may
be used to inform a business case for the use of the medicine prepared by the relevant clinical
team, if appropriate.
For some high cost new medicines the actual expenditure in practice can then be tracked
alongside the local detailed budget impact model, although for various reasons this can be
problematic. When variance between predicted and actual budget impact is identified, clinical
expertise may be sought in an attempt to understand or justify the variance, although in practice
this is challenging.
October 2013
13
Appendix A: Example of a Completed Horizon Scanning Update Form (for companies not registered with UK PharmaScan)
Section 1: New Chemical / Biological Entities and Biosimilars
Please list new chemical / biological entities and biosimilar medicines that (1) have been filed for European or UK marketing approval (i.e. preregistration); (2) are in phase III clinical development; or (3) are in phase II clinical development and likely to be launched in the UK within two years.
We are particularly interested in those that are likely to be launched in the UK during 2014 (i.e. between calendar Q1 2014 and Q4 2014), as these
would be included in the next SMC report (Forward Look 9). To allow these products to be identified, please estimate the UK launch date by calendar
quarter, if possible.
Product generic (Brand)
names and formulation
Pharmacology or
therapeutic class
Indication or therapeutic
area
European
development
phase
Drug A (Brand A) tablet
NSAID
Pain
Phase III
Drug B (Brand B) inhaler
B-agonist
Asthma
Drug C (Brand C) sc injection
New biologic
Psoriasis
Preregistration
Phase III
Estimated
European
filing date
(and route
e.g. EMA/
MHRA)
Q3 or Q4 2013
Filed in UK Q2
2013
Q3 2013 via
EMA
Estimated
UK launch
date
Considered
to be a
‘significant’
development
Q3 or Q4
2014
Q2 2014
No
Q3 2014
Yes
No
* A new medicine is considered to be significant if (1) it is expected to have a moderate to high potential net drug budget impact for NHS
Scotland (i.e. >£500,000 per annum at year five); (2) it is expected to have a major service implication.
14
Section 2: New Indications for Existing Products
Please list new indications for existing products that (1) have been filed for European or UK marketing approval (i.e. pre-registration); (2) are in phase
III clinical development; or (3) are in phase II clinical development and likely to be launched in the UK within two years. We are particularly interested
in those that are likely to be launched in the UK during 2014 (i.e. between calendar Q1 2014 and Q4 2014), as these would be included in the next
SMC report (Forward Look 9). To allow these products to be identified, please estimate the UK launch date by calendar quarter, if possible.
Product generic (Brand)
names and formulation
Pharmacology or
therapeutic class
Indication or therapeutic
area
European
development
phase
Drug D (Brand D) tablet
NSAID
Arthritis
Phase III
Estimated
European
filing date
(and route
e.g. EMA/
MHRA)
Q4 2013 in
France
(reference
member state
for mutual
recognition
procedure)
Estimated
UK launch
date
Considered
to be a
‘significant’
developme
nt
Q4 2014
No
* A new indication is considered to be significant if (1) it is expected to have a moderate to high potential net drug budget impact for NHS
Scotland (i.e. >£500,000 per annum at year five); (2) it is expected to have a major service implication.
15
Section 3: New Formulations of Existing Medicines
Please list new formulations of existing medicines that (1) have been filed for European or UK marketing approval (i.e. pre-registration); (2) are in
phase III clinical development; or (3) are in phase II clinical development and likely to be launched in the UK within two years. We are particularly
interested in those that are likely to be launched in the UK during 2014 (i.e. between calendar Q1 2014 and Q4 2014), as these would be included in
the next SMC report (Forward Look 9). To allow these products to be identified, please estimate the UK launch date by calendar quarter, if possible.
Product generic (Brand)
names and formulation
Pharmacology or
therapeutic class
Indication or therapeutic
area
European
development
phase
Drug D (Brand D) sc injection
Biological therapy
Subcutaneous formulation for
the treatment of rheumatoid
arthritis (to replace existing
intravenous formulation)
Phase III
Estimated
European
filing date
(and route
e.g. EMA/
MHRA)
Q4 2013
Estimated
UK launch
date
Considered
to be a
‘significant’
developme
nt
Q3 2014
No
* A new formulation is considered to be significant if (1) it is expected to have a moderate to high potential net drug budget impact for NHS
Scotland (i.e. >£500,000 per annum at year five); (2) it is expected to have a major service implication.
16
Appendix B: Sample Monograph and Monograph Template
Monograph Production for Significant New Medicines and Indications
Please complete a product monograph template for each significant new medicine or indication likely to be marketed in the UK during 2014 (i.e.
between January 2014 and December 2014).
A new medicine or indication is considered to be significant if it has a moderate to high net drug budget impact (i.e. >£500,000 per annum at year
five) for NHS Scotland and / or major service implication for NHS Scotland.
A sample product monograph template with guidance notes in blue text is provided below. This details the information that should be included in the
monograph.
1. Sample Monograph with Guidance Notes
Product
Guidance notes: Enter details of the generic name; proprietary name and
formulation of the product. Please also enter the dosing schedule if known.
Indication
Guidance notes: Enter details of the likely indication of the new medicine. If this is
not known, then it may be possible to extrapolate this from details of the patient
population included in the registration clinical studies.
Status
Guidance notes: Note if the product has European orphan drug status for the
indication under consideration. Enter details of the licence status of the product,
including the estimated date of European filing for marketing authorisation that would
allow the product to be marketed in the UK and the route through which a marketing
authorisation will be sought. Also, enter details of the estimated launch date for the
product in the UK.
Mode of
action
Guidance notes: Enter brief details of pharmacology including pharmacological
class and if appropriate details of the clinical significance of the new product, for
example: likely to be the first drug in a new pharmacological class or likely to be first
oral formulation of a drug previously only available as parenteral formulations.
Estimated
eligible
population
Estimated prevalent / incident (delete as necessary) population with (insert likely
indication or patient group) of approximately (insert number) patients / episodes
(delete as necessary).
17
Assumptions
Guidance notes: Enter details of assumptions used to estimate the number of
patients who would be eligible for treatment with the new product or licence. These
are usually presented as bullet points, with one assumption per point. Where a
number of assumptions contribute to the estimate, these should flow in sequence
from the top.
Where possible Scottish data are used e.g. epidemiology data from NHS National
Services Scotland (NHS NSS) or Health Protection Scotland (HPS). If Scottish data
are not available, English or Welsh data from reliable sources (e.g. guidance from
the National Institute for Health and Care Excellence [NICE]) may be extrapolated to
produce estimates for Scotland. Information on the epidemiology of the condition
obtained through a systematic search of the published literature can be used to
check the estimates derived from these epidemiological data or may be used in
place of them, if these data are not available. Where the eligible population in
Scotland is estimated from an extrapolation of figures in published paper(s), Scottish
population data should be taken from the latest mid-year population estimates from
the General Register for Scotland. If possible, all assumptions should be clearly
referenced using superscript numbers in sequential order throughout the text.
Uncertainties
Guidance notes: Enter details of any factors or issues that create uncertainty
around the estimate of eligible population, for example limitations of data used to
estimate mean patient numbers for a rare condition or disease; or potential disparity
in the distribution of patients across Health Boards in Scotland for rare diseases with
a genetic component. These issues are usually presented as bullet points. If
possible, all uncertainties should be clearly referenced using superscript numbers in
sequential order throughout the text.
Estimated
uptake
Estimated uptake in years 1 and 5 by approximately (insert number) and (insert
number) eligible patients / episodes (delete as necessary), respectively.
Assumptions
 The new product would be given to / used in (delete as necessary) approximately
(insert percentage) and (insert percentage) of eligible patients / episodes (delete as
necessary) in years 1 and 5, respectively.
18
Guidance notes: Enter details of the proportion of the eligible population who would
be likely to receive the new product in the first and fifth full calendar years after it is
launched in the UK and any other assumptions used to estimate uptake, for
example, an assumption that the new product would only be given to those eligible
patients who had a certain severity of disease. Assumptions are usually presented
as bullet points, with one assumption per point. If possible, all assumptions should
be clearly referenced using superscript numbers in sequential order throughout the
text.
Uncertainties
Guidance notes: The first bullet point should read: ‘Uptake will be influenced by
cost-effectiveness relative to alternatives and this is unknown’.
Clinical data should be presented in this section. If phase III clinical studies are
underway these should be discussed here (ideally comparator studies but if only
placebo-controlled studies are available these should be discussed), with brief
details of methodology (clinicaltrial.gov reference number, planned or actual patient
numbers, treatment strategies, primary endpoints [and secondary endpoints if
relevant] and duration of the study or planned completion date if it is still ongoing). If
no phase III clinical study results are available but phase II data are available these
should be detailed briefly in this section. Ideally use one bullet point per study but if
there are multiple relevant studies a judgment should be made about whether the
data would best be presented in a different way. If results of clinical studies are
available provide details of statistical significance of the treatment under
consideration versus comparator(s) or placebo. Briefly describe safety results,
primarily focusing on grade III or IV adverse events for the drug under consideration
and the comparator(s) or placebo.
Finally, enter details of any factors or issues that create uncertainty around the
estimate of uptake of the new product, for example lack of data on the costeffectiveness of the new product relative to relevant comparators; the potential for
‘off-label’ use in patients not covered by the indication in the proposed product
licence; or proposed clinical guidance that may alter treatment pathways. These are
usually presented as bullet points.
If possible, all uncertainties should be clearly referenced using superscript numbers
19
in sequential order throughout the text.
Estimated
incremental
drug
acquisition
cost
Estimated incremental drug acquisition cost of approximately (insert cost) per annum
/ episode (delete as necessary).
Guidance notes: This is calculated by subtracting the drug acquisition cost of
alternative treatment(s) from the drug acquisition cost of the new product.
Assumptions
 The estimated drug acquisition cost of the new product is approximately (insert
cost) per annum / episode (delete as necessary).
Guidance notes: Enter details of the estimated drug acquisition cost (or cost range)
of the new product and the dosing regimen associated with this cost. This need not
be an accurate and definitive estimate; a range or ‘ball-park’ possible estimate is
acceptable.
If the product is used annually in some patients and per course in others (e.g.
seasonally), this should be accounted for in the cost calculations so that the cost per
annum and / or per course is clearly stated. If the product is to be used in the
hospital setting value added tax (VAT) should be added at the appropriate rate and
this should be clearly stated. If the product is to be used in the primary care setting
no VAT is added. If the product is initiated in the hospital setting but prescribing is
continued in the primary care setting or the product is made available via a
homecare arrangement no VAT is added. This also applies to the cost of
alternative(s) outlined below.
SMC acknowledges that providing a cost estimate up to one year in advance of UK
launch can be challenging. However, this is required as financial planners use the
monographs to set budgets (one year in advance) for the calendar year in which the
new product is likely to be introduced in the UK. Thus, financial planners have
advised SMC that they must have a figure for this budget setting process and, in the
absence of advice from the company, have requested that SMC provide an estimate
of acquisition cost. SMC acknowledges that their estimate of likely drug acquisition
cost (or cost range) will be less robust that an estimate made by the relevant
company and, therefore, seeks the advice of the company to help with this essential
estimate.
20
 The new product would be used in place of (insert details of alternative treatments
used in current practice).
Guidance notes: Enter details of the most common treatment(s) that the new
product is likely to replace within Scottish clinical practice. If the new product under
consideration will be used in addition to current practice or if there are no treatments
currently available for use in NHS Scotland, this should be stated. Consideration
should also be given to whether alternative products have been approved for use in
NHS Scotland by SMC at the time the monograph is being drafted.
 The alternative treatment costs approximately (insert cost) per annum / episode
(delete as necessary).
Guidance notes: Enter details of the drug acquisition cost of the treatment(s) that
the new product would replace and their associated dosing regimen(s). Cost should
be taken from Part 7 of the most recent version of the Scottish Drug Tariff where
possible and for other drugs from the most recent version of the BNF or MIMS. If
more than one alternative treatment is used routinely in NHS Scotland, they should
all be listed with associated costs and an average cost of alternatives should be
presented and subtracted from the cost of the new product being considered, unless
it is apparent that one alternative is used preferentially in NHS Scotland, in which
case a weighted estimate of proportion of usage should be considered and the
alternative costs calculated accordingly.
If possible, all assumptions should be clearly referenced using superscript numbers
in sequential order throughout the text.
Uncertainties
Enter details of any factors or issues that create uncertainty around the estimate of
incremental drug acquisition cost, for example the pending loss of patent protection
of an alternative treatment, or the pending UK launch of a similar new product. If the
duration of treatment is uncertain (generally applicable for cancer medicines) this
should be stated with reference to the reason the estimated duration of treatment
was chosen (e.g. median time to progression in the phase III clinical study used as a
guide).
All uncertainties should be clearly referenced using superscript numbers in
21
sequential order throughout the text.
Estimated
net drug
budget
impact
Year 1: (insert number of patients who will receive the new product) x £ (insert
incremental drug acquisition cost [i.e. cost of new product – cost of alternative]) = £
Year 5: (insert number of patients who will receive the new product) x £ (insert
incremental drug acquisition cost [i.e. cost of new product – cost of alternative]) = £
Guidance notes: Enter the appropriate figures from the above estimated uptake and
estimated incremental drug acquisition costs sections. If the product is used annually
in some patients and per course in others (e.g. seasonally), this should be
accounted for in the net drug budget impact calculation by using the appropriate cost
for each treatment duration and the appropriate proportion of the number of patients
who will receive each treatment strategy. The statement ‘(including VAT)’ should be
included after the budget impact figure for each year above if appropriate.
Guidance notes: Enter details of any potential impact (other than drug acquisition
Service
Implications cost) of the new product, for example cost of testing or new equipment associated
with its use; impact on staffing or service provision. Also, note whether the impact is
likely to be significant. If a diagnostic / therapeutic test is required to assess whether
patients are eligible for the new treatment, details (including estimated cost of the
test if available) should be included.
References
and
Additional
Information
Guidance notes: Enter references in the Vancouver style.
Enter any additional information that may be relevant to the medicine / indication
being considered.
22
2. Product Monograph Template
Product
Indication
Status
Mode of
action
Estimated
eligible
population
Estimated prevalent / incident (delete as necessary) population with (insert likely indication or patient group) of approximately (insert
number) patients / episodes (delete as necessary).
Assumptions

Uncertainties

Estimated
uptake
Estimated uptake in years 1 and 5 by approximately (insert number) and (insert number) eligible patients / episodes (delete as
necessary), respectively.
Assumptions
 The new product would be given to / used in (delete as necessary) approximately (insert percentage) and (insert percentage) of
eligible patients / episodes (delete as necessary) in years 1 and 5, respectively.
Uncertainties
 Uptake will be influenced by cost-effectiveness relative to alternatives and this is unknown.

Estimated
incremental
drug
acquisition
cost
Estimated incremental drug acquisition cost of approximately (insert cost) per annum / episode (delete as necessary).
Assumptions
 The estimated drug acquisition cost of the new product is approximately (insert cost) per annum / episode (delete as necessary).
 The new product would be used in place of (insert details of alternative treatments used in current practice).
 The alternative treatment costs approximately (insert cost) per annum / episode (delete as necessary).
Uncertainties

Estimated
Year 1: (insert number of patients who will receive the new product) x £ (insert incremental drug acquisition cost [i.e. cost of new
23
net drug
budget
impact
product – cost of alternative])) = £
Year 5: (insert number of patients who will receive the new product) x £ (insert incremental drug acquisition cost [i.e. cost of new
product – cost of alternative]) = £
Service
Implications
References
and
Additional
Information
24
Appendix C: Example of Financial Spreadsheet
Predicted Annual Expenditure
2014
Cost
per
patient
per
year or
course
Number
of
patients
or
Episodes
year 1
Number
of
patients
or
episodes
year 5
Health
Board 1
Health
Board 2
Health
Board
3
Projected Maximum Annual
Expenditure
Health
Board 1
Generic
Name
B
N
F
Drug 1
1
849
Drug 2
2
1,011
5
8
0
0
0
702
Drug 3
2
495
201
768
6,477
21,043
47,101
32,998
Drug 4
3
682
106
395
3,137
10,193
22,815
23,383
Drug 5
3
49
1,964
2,648
4,177
13,569
30,372
11,262
Drug 6
4
8,000
4
8
1,389
4,512
10,099
Drug 7
4
5,962
7
18
0
0
Drug 8
7
2,000
5
8
0
Drug 9
9
20,000
1
3
Drug 10
9
638
22
169
Drug 11
1
0
795
10
18
Total
£
Number
239
Number
401
Health
Board
2
Health
Board 3
Service
Implication
Predicted
Launch
Date
Predicted
SMC Date
214,891
No
Jan-14
Apr-14
1.00
2,281
5,105
No
Jan-14
Apr-14
1.00
107,205
239,957
No
Apr-14
Jul-14
0.75
75,968
170,039
No
Jul-14
Oct-14
0.50
36,590
81,899
No
Jul-14
Oct-14
0.50
5,555
18,048
40,397
No
Jul-14
Oct-14
0.50
0
9,315
30,263
67,738
Yes
Oct-14
Jan-15
0.25
0
0
1,389
4,512
10,099
No
Oct-14
Jan-15
0.25
2,155
7,001
15,671
5,208
16,920
37,872
No
Jan-14
Apr-14
1.00
0
0
0
9,359
30,406
68,057
No
Jul-14
Oct-14
0.50
518
1,681
3,764
1,242
4,035
9,032
No
Apr-14
Jul-14
0.75
35,465
115,221
257,900
129,965
422,235
945,088
£
£
17,613
£
57,221
£
128,077
£
29,551
25
96,007
£
Proportion
of 2014 / 15