Cambridgeshire and Peterborough Clinical Commissioning Group’s Commissioning Framework
THIS REVISED TEMPLATE MUST BE USED FOR ALL BUSINESS CASES FOR 2015-16 IMPLEMENTATION
PBR EXCLUDED DRUGS AND SERVICE DEVELOPMENT BUSINESS CASES - please read all criteria before completing this template.
For further information on the Cambridgeshire and Peterborough CCGs’ commissioning arrangements please contact your hospital Chief Pharmacist or the
Cambridgeshire and Peterborough CCG Chief Pharmacists.
Developments about new drugs or new uses for drugs will be considered by Commissioners through this process for 2015-16. Each business case will be
considered in relation to existing and/or alternative drugs or services to meet the same or similar needs and in the context of overall priorities
Business cases previously submitted, but not funded, will only be considered for 2015-16 if they are submitted on this revised form, as additional information on
costs of activity etc. is required; absence of activity costs will prevent consideration of business cases.
Abbreviated Business Cases: Where clinicians wish to register an interest in prescribing a currently unfunded drug but accept that the drug may not satisfy
the criteria to form part of Cambridgeshire and Peterborough Clinical Commissioning Group priorities for funding then please fill in only the green shaded
sections of this document and return it through the normal business case route.
NOTE if funding is subsequently sought a FULL business case will have to be completed and considered through due process. For abbreviated business
cases that are subsequently recommended for use through a NICE TAG the appropriate implementation process must be followed.
In 2015-16, as in previous years, business cases will normally only be funded if they implement a NICE Technology Appraisal Guideline
or if they can be shown to produce in-year realisable savings within the wider Cambridgeshire health system. They must be received,
completed, in time for the Cambridgeshire and Peterborough Joint Prescribing Group meeting in January 2015 to be eligible for
consideration. In-year business cases may be considered if cost-saving but otherwise new funding will not be available in-year.
Submission of a case is no guarantee of funding, and conversely, absence of a business case will not make requests for funding any more or less likely to be
accepted as exceptional cases or individual funding requests. The CCGs’ position is that we do not fund any drugs for routine use unless and until they have
been through the full process.
If the policy is that a particular drug is not funded, or is normally only funded in limited circumstances, exceptional cases will be judged against the published
Cambridgeshire and Peterborough Clinical Commissioning Group criteria – details available from the Commissioning Directorate of Cambridgeshire and
Peterborough CCG or through the contacts listed on this page.
Each business case must aim to target drugs to those who may be expected to benefit more/most if we introduce this drug. If providers feel it is absolutely not
possible to target drugs to where they may be most effective or cost-effective, then commissioners may have to make their own decisions on thresholds or
phasing the implementation of this drug development.
 For details of drug costs and associated costs, the pharmacy department should be contacted.
 ALL costs must be included – including diagnostics, PbR and other activity charges for hospital spells, OP visits, etc. A key principle of
this process is that full cost and also the NET increase in cost of the new development must be shown.
 All business cases MUST be submitted through the hospital commissioning department; all activity and cost data must be completed –
incomplete business cases CANNOT be considered and will be returned to the hospital concerned.
Please note: if you encounter difficulty accessing any of the documentation associated with this process, please contact Kathy Duff High
Cambridgeshire and Peterborough CCG Commissioning Framework
THIS REVISED TEMPLATE MUST BE USED FOR ALL BUSINESS CASES FOR 2015-16IMPLEMENTATION.
Page 1 of 9
Cost Drugs Support Officer: Tel 01480 387120
Completed business case template(s) should be returned to: [email protected] by January 2015 for
consideration for funding in 2015-16
Cambridgeshire and Peterborough CCG Commissioning Framework
THIS REVISED TEMPLATE MUST BE USED FOR ALL BUSINESS CASES FOR 2015-16 IMPLEMENTATION.
Note:
The template is a fielded document - access is only available to the fields that require information. Tab to each field to enter the required information.
Pbr Excluded Drug and Service Development Business Case Template – see supporting documentation for more guidance if required
The following sets out the questions that commissioners will review to help them to consider the relative priorities of developments in out of tariff,
high cost drugs and other developments competing for resources for Cambridgeshire and Peterborough CCG patients.
Cambridgeshire and Peterborough CCG Commissioning Framework
THIS REVISED TEMPLATE MUST BE USED FOR ALL BUSINESS CASES FOR 2015-16IMPLEMENTATION.
Page 2 of 9
SECTION 1: CLINICIAN TO COMPLETE; Please complete all of parts A, B and C
PART A: WHAT ARE COMMISSIONERS BEING ASKED TO CONSIDER FUNDING?
Title of business case:
Name of Trust submitting this business case:
Name:
Contact details of person(s) completing the case and
who may be contacted (if necessary) for further details.
Job Title:
Contact email:
The name of the drug is:
Click on box to select as appropriate:
Is this a drug Excluded from PbR Tariff :
…..A request to develop shared care guidelines:
Indication or condition that this treatment will address
- only one indication per business case proforma please.
Please indicate other high cost drug business cases being submitted
for this indication, where appropriate.
Please indicate the place in therapy for this intervention. (e.g. first-line
second-line and place in treatment pathway).
Does this business case meet a currently unmet need?
Who would initiate treatment, i.e. GP, hospital, other?
(where other please clarify)
Anticipated duration of treatment.
Who is being suggested as responsible for long term prescribing, i.e.
GP, hospital, other (where other please clarify)?
Describe the major patient oriented outcome achieved by the drug.
Have therapeutics committees considered this locally and rejected or
supported its use for this indication; note that hospitals may treat
patients within their own resources where considered clinically
necessary even if the drug is not funded specifically by CCGs?
Has this treatment been the subject of a Drug and Therapeutics
Committee Chairman’s action or exceptional case or individual funding
request.
If yes, please give details.
What additional facilities would have to be provided before this
treatment could be implemented?
Cambridgeshire and Peterborough CCG Commissioning Framework
THIS REVISED TEMPLATE MUST BE USED FOR ALL BUSINESS CASES FOR 2015-16IMPLEMENTATION.
Page 3 of 9
Other:
(please specify)……………………………………
Criteria proposed for initiating therapy.
Criteria proposed for stopping therapy.
If treatment is initiated by specialists and it is proposed that prescribing
is continued by GPs, specify:

Period hospital would expect to prescribe before GP takes over.

Whether shared care (SC) needed.
Yes
No
Click on box to select as appropriate
Yes
No
Click on box to select as appropriate
If no, why not?

If shared care required, SC guideline status including who has
been/is developing this.
[Where a SCG has been approved by the submitting Trust or C&PJPG
or is available as a draft SCG or hospital guideline – please attach a
copy to the business case].
Is a home care provider to be considered/used for delivery of this
treatment?
If yes, at what stage would the treatment be considered suitable for
transfer to a homecare provider.
Will the introduction of this drug change threshold for treatment? E.g.
increase the cohorts of patients with this disease who would be
suitable for treatment If yes in what way?
Will the introduction of this treatment increase total cost on treatments
for this condition? If yes state additional cost per patient
Are there any additional tests and associated treatments/drugs that
will be charged to commissioners, i.e. not in tariff price or locally
agreed prices
What is/are the historical treatment(s) the submitted drug or
intervention will replace?
What is/are the average length(s) of treatment for the historical
treatment(s) the submitted drug will replace?
Population burden of disease:
How common is the indication that this particular business case
addresses?
for your hospital
Cambridgeshire and Peterborough CCG Commissioning Framework
THIS REVISED TEMPLATE MUST BE USED FOR ALL BUSINESS CASES FOR 2015-16IMPLEMENTATION.
Page 4 of 9
and
per 100,000 population
How many patients are being treated with the historical treatment that
this business case will replace, where applicable?
for your hospital
and
per 100,000 population
How many patients are already in treatment with this intervention, e.g.
through clinical trials, funded by the hospital, research etc or
compassionate access programmes?
for your hospital
and
per 100,000 population
Total number of patients that you expect may fit criteria for treatment
with the intervention submitted in this business case.
for your hospital
and
per 100,000 population
If this drug, for this indication, were funded how many EXTRA patients
might be expected to fit the given criteria for treatment at this hospital
and per 100,000 population?
(Population covered may vary by specialty; higher for tertiary work)
In 2015-16
In 2015-16
In
subsequent
years
If there is/are (an)other business case(s) being submitted for this
indication previously, what is the total number of Cambridgeshire
patients and the distribution across ALL business cases for this
INDICATION?
How well does this development go towards identifying local and
national priorities and targets?
Please give details – NOTE: planned NICE TAGs are already noted
by commissioners, but specialists are asked to provide information on
NICE clinical guidelines and other best-practice guidance that they are
aware is being developed.
Will this new treatment lead to increased or changed activity over
current levels? If yes, could this be delivered in a community hospital
or other non-acute setting
Explain how any savings within your own organisation can be released
from other treatments related to this or other conditions within your
specialty. Describe opportunity cost or potential disinvestments.
Identify any potential saving or costs which may occur to other
organisations in the system, e.g. social care
Cambridgeshire and Peterborough CCG Commissioning Framework
THIS REVISED TEMPLATE MUST BE USED FOR ALL BUSINESS CASES FOR 2015-16IMPLEMENTATION.
Page 5 of 9
for your hospital
population
for your hospital
population
for your hospital
population
and
.
per 100,000
and
per 100,000
and
per 100,000
PART B – WHAT BENEFITS WOULD THIS DELIVER?
Effectiveness
Describe the impact on individual patients of the condition that
this particular business case addresses, e.g. symptoms,
impact on independent living, impact on life expectancy.
Would you describe the severity of the illness to be treated as
mild, moderate, serious or life threatening?
Strength of evidence (please supply references (attach pdf links (if not available, please attach copies) for any evidence provided).
Is this derived from?:
Case studies/expert opinion only, single phase II study only.
One lower quality RCT and/or several phase II studies and or high quality observational
studies.
One high quality RCT and supporting non-randomised
(phase II) data.
Data from meta-analysis or from at least 2 high quality RCT.
Please provide information, where available, regarding cost
per QALY or cost per life year gained.
If this information is not available please provide the costs of
any elements of care that may be avoided by this treatment
and which may be used in such calculations.
Please complete NNT and NNH compared to current standard treatments, wherever available, to expedite consideration of business cases.
What is the NNT in relation to each key patient oriented
outcome compared to the treatment that would be given if this
business case was not funded? Please ask Pharmacy for
advice if needed.
What is the primary harm caused by this drug? If more than
one frequently occurring serious adverse effect please state
these also. Please state NNH for each if known.
Is the trial population similar to the local population?
Were there any significant differences in treatment regimes
between comparator drugs and local therapy?
Were existing local or UK treatments for this indication used as
the comparator?
Were there any other potentially significant differences
between trial comparator and local facilities for treatment?
Cambridgeshire and Peterborough CCG Commissioning Framework
THIS REVISED TEMPLATE MUST BE USED FOR ALL BUSINESS CASES FOR 2015-16IMPLEMENTATION.
Page 6 of 9
How do the benefits offered by this drug differ from other
treatments offered for management of this condition at
present?
Which treatment that offers less benefit can be stopped to
release resources to provide this drug?
How acceptable is this proposal likely to be to the
public/patient?
PART C– WHAT WILL THE IMPACT BE ON THE HEALTH SYSTEM
How much time is required to set up the development?
How long will it take to see some results/health improvement
from the development? For example, are trained staff already
in post and physical space available or would additional
training or new construction be needed?
Describe potential impact (positive or negative) on other NHS
or non-NHS agencies or services.
What gains in other parts of the system that YOU influence
can change as a direct result of introducing this drug, e.g.
hospital visits reduced, oral vs. injectable treatment?
What impact does this development have on equity and
fairness?
Does this development encourage self-care?
Does this development facilitate a potential reduction in health
services costs, e.g. reducing risk of hospital admission or
increase use of self-care?

Yes
No
Click on box to select as appropriate:
If yes, when might this reduction expect to be realised and
how?
Cambridgeshire and Peterborough CCG Commissioning Framework
THIS REVISED TEMPLATE MUST BE USED FOR ALL BUSINESS CASES FOR 2015-16IMPLEMENTATION.
Page 7 of 9
SECTION 2: COSTS ASSOCIATED WITH THE BUSINESS CASE (TO BE COMPLETED BY PHARMACY)
Costs of drug: In setting priorities, Cambridgeshire and Peterborough CCG Commissioners wish to consider net cost per patient per year, to assist in
comparisons between drugs wherever appropriate.
If current treatment is charged to the CCG as non-mandatory tariff (excluded from tariff services only) then the cost of drug to be charged if the new treatment is
approved must be provided.
a) Costs Associated With The Treatment(s) Submitted In This Business Cases That Would Require Commissioner Agreement To Fund
What are the average drug costs to be charged to commissioners per
patient associated with the submitted business case?
What is the average dose? (where this is calculated by weight or
body surface area please state the multiplier used).
What is the average length of treatment for the submitted drug?
Where homecare is being considered for this intervention please give
details of the suggested provider and the full costs involved.
What are the other costs associated with the submitted business
case, e.g. cost of drugs to treat adverse events or used
prophylactically?
Cost for average length of treatment of the submitted drug (specify
length of treatment used for calculation).
Hospital
Full cost
GP
Full cost
b) Costs Associated With The Standard Historical Treatment(S) That Would Have Been/Will Be Given If This Business Case Is Not Funded:
What is/are the intervention(s) that the patient would receive if this
business case were not funded and the drug costs associated with
this/these?
Cost, per patient, for average length of treatment for the historical
treatment the submitted drug will replace (specify length of treatment
used for calculation).
Hospital
Marginal cost (i.e. difference in cost of submitted drug compared to
historical treatment) for hospital and for GP budgets) per patient.
Hospital
GP
Full cost
Full cost
GP
Cambridgeshire and Peterborough CCG Commissioning Framework
THIS REVISED TEMPLATE MUST BE USED FOR ALL BUSINESS CASES FOR 2015-16IMPLEMENTATION.
Page 8 of 9
SECTION 3: FINANCE AND CLINICAL CODING (May require Clarification with the Clinician/Pharmacy)
If the current treatment is charged to the CCG as locally agreed prices (excluded from tariff services only) then cost of activity to be charged if the new
treatment is approved must be provided.
Business cases will not be accepted by the CCG unless data on historical treatment is completed.
Other Costs Associated With The Business Case
Business cases will not be accepted by the CCG unless this data is completed
Activity Cost: Please specify the HRGs that will be applied for
procurement and delivery (as appropriate) of the proposed
intervention in this business case, and the relevant prices.
Other costs to commissioners, e.g. hospital visits (OP, IP or day case
costs), associated tariff or indicative tariff over and above drug costs
(in section 2. above) for the intervention submitted through this
business case.
Cost of tests and associated treatments related to use of the
submitted drug/treatment that will be charged to commissioners, i.e.
not in tariff price or locally agreed prices.
Please specify the HRGs that are applied for procurement and
delivery (as appropriate) of the intervention(s) that the patient would
receive if this business case were not funded (historical treatment),
and the relevant prices. [as per section 2b above]
Other costs to commissioners, e.g. all hospital visits (OP, IP or day
case), including HRG/ PbR tariff or indicative tariff over and above
drug costs for the historical treatment the submitted drug will
replace (if appropriate). [as per section 2b above]
Cost of tests, associated treatments related to use of the historical
treatment the submitted drug will replace that will be charged to
commissioners, i.e. not in tariff price or indicative tariff (if appropriate).
[as per section 2b above]
Completed business case to be sent to the hospital pharmacy and hospital commissioning departments for forwarding to :
[email protected]
Cambridgeshire and Peterborough CCG Commissioning Framework
THIS REVISED TEMPLATE MUST BE USED FOR ALL BUSINESS CASES FOR 2015-16IMPLEMENTATION.
Page 9 of 9