Download Preparing a Business Case for a New Medicine

How to get new medicines for your patients?
The Formulary is a prescribing list that includes the names of medicines approved by
the Drugs and Therapeutics Committee (DTC) and, if required, the Medicines
Resource Group (MRG). Medicines on the Formulary are reviewed regularly by
the DTC and MRG at bi-monthly meetings.
All St George's Hospital doctors may prescribe any medicine that is on the
Formulary, unless the medicine is restricted in some additional way.
Drugs and Therapeutics Committee (DTC)
The remit of the Drugs and Therapeutics Committee (DTC) is to ensure that the best
medicines are available for use at St George’s. New drugs should only be made
available if they offer a significant advantage over existing products. An advantage
may be conferred by improved efficacy, safety and/or patient acceptability.
The Drug & Therapeutics Committee exists to review and control all aspects of
medicine usage relating to safety, efficacy and patient acceptability. It will maintain a
list of medicines and guidance which will be known as the Trust Formulary.
Committee Constitution
The membership of the Drugs and Therapeutics Committee will comprise of:
Chair.
Vice Chair.
Professor in Clinical Pharmacology
Chief Pharmacist / Clinical Director
for Medicines Management
Formulary & Protocols Co-ordinator
Formulary Pharmacist
Representatives from Divisions & Directorates
Medicine and Cardiothoracic Division
Acute Medicine
Specialist Medicine
Cardiothoracics
Surgery, Theatres, Neurosciences and Cancer Division
Surgery
Anaesthetics & Critical Care
Cancer services
Neurosciences
Childrens and Women Division
Child Health & Endocrinology
Radiology
Microbiology & Infectious Diseases
Pharmacy
Clinical Pharmacology
Junior Doctors
Non Medical Prescribers
Nursing
Joanne Harding
Assistant Chief Pharmacist
St Georges Healthcare NHS Trust
Representatives from Primary Care
General Practitioner x 2
Chief Pharmacist
In Attendance
Divisional Director of Operations
Education & Training
Invited representative
As appropriate
Other Trust officers or clinicians may be asked to attend when the Committee is
discussing drugs relevant to specialties that are not represented on the Committee
The Committee chair will be elected from the Committee membership and will usually
be a clinician with expertise in Clinical Pharmacology
Attendance at meetings will be monitored; members are required to appoint
appropriate deputies to attend on their behalf if they cannot attend.
Administrative support for the Committee will be provided by the Corporate Office
Quorum
The quorum for meetings of the Committee shall be 3 clinician (medical, nursing,
allied health professional) members and 2 members from pharmacy
The quorum for the DTC subcommittee will be:
 One of chair/vice chair/ other senior committee member
 One other clinician (medical/nursing/allied health professional)
 One other pharmacist
Frequency of meetings
Full DTC meetings currently occur every 2 months
Subcommittee meetings occur every 2 months in between full Meetings to review
conditions to approval or applicant replies so that action can be taken in a timely
manner.
The MRG would meet on the same day (before the subcommittee) and will consider
drugs with full or conditional approval from the previous DTC.
Additional meetings may be held on agreement with the Chair of the Committee.
Appeals for rejected drugs are submitted to the next Full DTC meeting
Applicants would be given a time slot at full DTC meetings (using the example of the
ethics committee) when they will be invited to be on standby to answer any queries of
the committee. This should reduce considerably the number of conditions on DTC
letters
Duties and Responsibilities
Joanne Harding
Assistant Chief Pharmacist
St Georges Healthcare NHS Trust
Purpose
The purpose of the Committee is to maintain the St George’s formulary. The
formulary is a list of drugs that can be prescribed by clinicians working for the Trust
and that are stocked in pharmacy. The formulary also includes protocols and
guidelines advising on the use of these medicines in the Trust.
Duties
To consider applications for the use of new medicines by clinicians working for St
George’s NHS Trust
 To determine whether these new medicines are safe, effective and acceptable to
patients
 To determine whether new medicines improve safety, effectiveness, outcomes or
acceptability of treatment compared to existing medicines on the formulary
 To make recommendations to the Medicines Resources Group to support
decisions around funding of new medicines
To review existing medicines on the St George’s formulary and consider removal of
medicines
 Where new safety concerns are raised
 Where more effective or acceptable alternatives are available
 Where equally safe/effective/acceptable medicines are available that are more
cost effective
To consider individual medicines in the context of complex disease management by
developing pathways and guidelines. This purpose may be achieved by
commissioning and supporting specialty user groups and reviewing guidelines
produced by these groups
To take information from other national and local groups into account during decision
making including:
 NICE
 Scottish Medicines Consortium
 London New Drugs Group
 London HIV Drugs & Treatment Group
 London Cancer Network
 Formulary Committees from associated hospitals
 South West London and St George’s Mental Health Trust
To take account of the impact across the health economy, including primary and
intermediate care when making decisions
To make the formulary available to clinicians via the Trust through the intranet and
other means and to promote good quality and cost effective use of drugs within the
Trust
The subcommittee will consider matters arising from the preceding full committee
meeting, but only where these have been delegated to the subcommittee by the full
committee. Examples of actions to be undertaken by the subcommittee include
approving applicant responses to committee letters and reviewing amended
protocols
What Does a Formulary Committee Need to Know?
1. Medicine Details
2. Place in Therapy and Restrictions for Use
Joanne Harding
Assistant Chief Pharmacist
St Georges Healthcare NHS Trust
a. Proposed areas / restrictions for use
b. Current formulary medicines
c. How will patients be selected?
d. Exisiting guidelines documents
3. Evidence
a. Clinical efficacy
b. Safety
c. Patient acceptability
d. References
4. Continuing Care arrangements
a. Shared care with GPs
5. Financial Implications
Preparing a Business Case for a New Medicine
The remit of the Medicines Resource Group (MRG) is to assess that funding has
been identified and secured, and support the applicant with facilitation of process
with relevant partners e.g. Southwest London Prescribing Committee.
1. Background
a. Brief Summary of formulary approval details (drug, indication, patient
group, restrictions, and place in therapy)
b. Does this medicine replace any existing treatment or is it a service
development?
c. Outline benefits to patient and organisation
2. Confirm Drug Prices
a. Confirm drug prices for new/proposed drug and for current or
alternative drug
b. Always confirm price with Pharmacy Procurement and ensure that
there are no other contracting issues to be aware of
c. Check if there are any other agencies e.g. LPP doing pertinent work
around this medicine (liaise with pharmacy)
3. Confirm Usage Calculation
a. Need to ascertain how much of the new drug will be used
b. Okay to give a range but need to cost out both min and max costs of
this
c. Consider duration of supply – be careful about assuming the Trust will
only provide one month of medicines (via outpatients) and that the
prescribing will then transfer to primary care. Primary care will often
refuse to pick up the prescribing costs because
i. The medicine is unlicensed or used off-label
ii. The medicine is black triangle
iii. The medicine requires dose titration or monitoring
d. For advice regarding PCT prescribing we work with our host PCT who
can make sector decisions, consult with SL PCTs or take to SWL
Prescribing Committee as appropriate
4. Calculate Costs
a. Break it down into a meaningful denominator – cost per pack is not
usually very useful. Cost per patient or per treatment cycle is better.
Need to take pack size into account for both current and new drugs
b. Adjust according to recommendations of the DTC committee
Joanne Harding
Assistant Chief Pharmacist
St Georges Healthcare NHS Trust
i. E.g. levobupivacaine (application for use in theatres –
approved for Trust wide switch over meant that different
preparations needed to be sourced and considered and usage
figures needed total recalculation
ii. If the DTC committee states that primary care prescribing will
not be supported (see above)
5. Consider Income or Savings
a. What tariff is associated with these patient attendances? Consider
current pattern of care
i. Inpatient tariffs
ii. Outpatient – new appointment
iii. Outpatient – follow up appointment
iv. Procedure tariffs (outpatient)
b. Will the patient’s attendances be the same with the new medicine?
Remember that if a medicine results in less patient attendances to the
hospital that the Trust will be losing income. This needs to be factored
into your calculation
c. Meet with the General Manager to go through how episodes of care
are currently coded, how this will change with the new medicine and
work through the income and expenditure together
d. Details of any potential cost saving or additional income identified
6. Consider Funding / Resource Implications
a. For PbR medicines the committee will need to see evidence that there
is a tick box form in place and that this is approved in SW London.
The committee will also need reassurance that there is a robust and
resourced process for SLAM reporting
b. New tick box forms may need to be drawn up for new NICE drugs. In
this case we work with our host PCT who conducts the consultation
with other PCTs in SW London
c. For Homecare the committee will need reassurance that there are
governance arrangements in place for homecare, that the pharmacy is
resourced to provide the service and that there is a process for
reclaiming cost of medicine via SLAM
d. For patient access schemes committee will need reassurance of
process, who will do what, and how this will be resourced and
monitored. Also, ethical consideration around the end of the scheme is
vital
e. Consider resource implications for pharmacy and divisions e.g.
i. Outpatient dispensing
ii. Pharmacist screening
iii. Financial / operation reporting or monitoring
iv. Clinical monitoring and service impact
v. Other consumables / nurse time (GM / Consultant to advise)
7. Think Globally
a. If the medicine will be used Trust wide the business case needs to
reflect all areas of usage. A case pertaining just to one care group will
be rejected by the MRG
b. For example – new oral anticoagulants that will be used in Acute
medicine and cardiology
c. Vitamin D that will be used in adults and paediatrics
d. Need to contact all relevant GMs and present a cohesive case to the
MRG
Joanne Harding
Assistant Chief Pharmacist
St Georges Healthcare NHS Trust
e. For medicines that have an unusually wide usage (and a significant
cost pressure) may need to take a more corporate approach. Seek
advice of MRG committee members for guidance e.g. fidaxomicin
antibiotic for C.Difficile
f. Where a medicine is low cost, a “must do” e.g. as per NICE and trust
wide the committee can take decisions on behalf of the Trust. If
unsure whether a full consultation is required please contact a
committee member prior to the meeting
8. Conduct Business Prior to Meeting
a. Realistically a General Manager, if presented with a new business
case in a meeting, is unlikely to be able to assess this and give
approval on the day. They will want to check the figures, consider
service impacts and come back to us.
b. Therefore, it is vital that contact is made with the General Manager
prior to any meeting
9. Cases can be taken to Commissioners if necessary
a. Seek advice from MRG committee if your calculations show that a
medicine will result in a loss of tariff or is unaffordable then the
commissioners can be approached to agree a new or amended tariff
b. A simple paper can be prepared (see attached) proposing either
i. That drug costs are funded in addition to tariff (i.e. addition to
excluded drugs list)
ii. That a new tariff is agreed to cover drug costs
Joanne Harding
Assistant Chief Pharmacist
St Georges Healthcare NHS Trust