Drug Managed Entry Process for Joint
Formulary
(Abertawe Bro Morgannwg University Trust,
Bridgend LHB, Neath Port Talbot LHB, Swansea
LHB)
October 2008
This document may be made available in alternative formats and other
languages, on request, as is reasonably practicable to do so.
Policy Owner: Medical Director
Approved by: Executive Board
Issue Date:
January 2009
Review Date: January 2012
Policy ID:
ABM22
Drug Managed Entry Process for Joint
Formulary
Consultant completes request form
GP completes request formA (see
(appendix A)
clinical consideration point 1)
Interface/Fo
rmulary Pharmacist receives
formulary application form.
Drug costs>£2,000/patient/year to All Wales Medicines
Strategy Group for their consideration. If AWMSG do not
consider drug appropriate for review continue along algorithm.
Drugs covered by NICE guidance or on existing NICE work
programme (within 12 months) will not be considered. Cancer
drugs will be referred to All Wales Cancer drugs Group
WAG Minister for
Health and
NICE
Interface/Formulary
recommend
Social Services
Pharmacist completes new
prescribing of
endorse drug
product evaluation.
(from
AWMSG
drug through
guidance (TA,
advice). Add to
CG, IP). Add to
formulary.
formulary.
Formulary Subgroup – Clinical
discussion on potential use of drug
across local health care community.
Recommendation made to MMG.
Secondary care cost
Recommendation
>£10K, or Primary
and summary of
care cost >£80K
rationale. (Form
Business case template
Medicines Management Group (MMG).
Appendix B)
(
Appendix C)
Final decision on formulary status of
drug and how it should be used.
Final Formulary
Decision
ROLES & RESPONSIBILITIES of INDIVIDUALS
and GROUPS within the MANAGED ENTRY
PROCESS
The Medicines Management Group (MMG) will make final
formulary decision on all new formulary requests.
Clinical Considerations
1. The Joint formulary allows for requests for drug inclusion to the
formulary via Consultants in Secondary Care or General Practitioners in
Primary Care (in the latter case it is acknowledged that GPs are
independent practitioners and as such not bound to the terms of the
Joint formulary, however, it is anticipated GPs will recognise the value
of the Joint formulary and Medicines Management group as a source of
independent prescribing advice and on this basis utilise the managed
entry process). Specific “Request to assess a product for formulary
inclusion” forms (appendix A) are available from Formulary/Interface
Pharmacists (also available on Joint Formulary eBNF site) for this
purpose. Forms will only be processed if completely and correctly filled
out and returned to Formulary/Interface pharmacists.
The Formulary/Interface pharmacist will contact requestor where
specific additional details and rationale for request are required.
2. A “new product evaluation” will be completed by formulary/Interface
pharmacist where it is agreed with requestor to process application.
This evaluation will be based upon the “STEPS” methodology i.e.
Safety, Tolerability, Effectiveness, Price, and Simplicity. In addition a
summary page will be included, where necessary with a background
section, to assist non-clinicians in reaching a formulary decision.
3. If current guidance from NICE (Technology Appraisal (TA), Clinical
guideline (CG), Interventional procedure (IP), with specific guidance on
use of a drug) or AWMSG approval (with subsequent endorsement from
the Welsh Assembly Government Minister for Health and Social
Services) already exists, the drugs will automatically be added to the
formulary without production of “new product evaluation”. If drugs are
already on the AWMSG or NICE work programme (within 12 month
forward work programme), local formulary process shall be deferred.
4. The current remit of the All Wales Medicines Strategy Group
(AWMSG) requires that all new drugs with a cost in excess of
£2,000/patient/year will be considered by that group to make a
recommendation on its use in Wales. For this reason, the local managed
entry process will only be applied to drugs AWMSG does not consider
appropriate (or workload does not allow) for them to review.
5. Formulary requests for cancer drug treatments will be referred to All
Wales Cancer Drugs Group for prioritisation planning.
6. A formulary recommendation is made to Medicines Management
Group (MMG) from Formulary Sub-group including rationale for this
recommendation. MMG members will where relevant receive the full
new product evaluations.
In addition MMG members will receive a summary of the Formulary Sub-
group meeting debate for the requested drug (see appendix B). This will
include the pros and cons put forward in consideration of the evidence
and whether the group reached unanimous or split decision in terms of
the final recommendation made. The group will also specify how the
drug should be prescribed (in terms of whether it should be confined to
specific areas within the hospital or whether it may also be prescribed in
primary care, or subject to shared care- see additional information point
6) and rationale behind this decision.
Financial Considerations
1. Secondary Care- Requests with a net cost impact of above £10,000 pa
to the Trust will require the drug business case template (appendix C) to
be completed and submitted to MMG.
2. Primary Care- Requests with a net cost impact of above £80,000 pa to
Primary Care across the locality will require the business case template
(appendix C) to be completed and submitted to MMG.
3. Horizon Scanning- Wherever possible, potential cost impacts of new
drugs will be identified by an annual “horizon scanning” process
carried out by the Interface/Formulary pharmacists.
Note: Directors of Finance for Abertawe BroMorgannwg University NHS
Trust and Local Health Board will receive a completed drug business
case template (appendix C) for drugs that meet the above criteria within
48 hours of a positive Formulary Sub-group recommendation being
made. Logistically the Formulary Sub-group will meet at alternate
months to the Medicines Management Group (both will meet every two
months), allowing a minimum of 3 weeks notice to Directors of Finance
prior to discussion of that drug at MMG. A final formulary decision
(including acceptance or rejection of business case) will be made at that
Medicines Management Group meeting. MMG will not approve items
where Directors of Finance have rejected the business case.
Dissemination
1. All new drugs added to the Joint formulary will be marked as
formulary on the hospital pharmacy system and the eBNF Joint
Formulary system.
2. New product evaluations will be linked to the specific drug on the
eBNF for information.
3. A list of recent formulary decisions (over last 2 years) will be kept on
the Trust Intranet Pharmacy clinical site (accessible via HOWIS).
4. All new formulary decisions will be disseminated via an e-mail to
finance manager and clinical director and relevant pharmacist for each
Directorate/Division in Secondary Care.
5. Heads of Medicines Management for LHBs will be assisted by
Formulary/Interface pharmacist in disseminating information on new
formulary approvals in Primary Care.
Audit/Review
1. All new drugs added to Joint formulary will be audited every 6 months
after formulary inclusion for a period of 2 years in Primary and
Secondary care to ensure cost predictions are not exceeded.
For all requests with a cost impact of above £10,000 pa to Trust or LHB a
business case will need to be completed by directorate before
processing request further.
2. Each of the 12 main sections of the formulary (Gastro-intestinal,
Cardiovascular, Respiratory, Central Nervous System, Endocrine
system, Obstetrics/Gynaecology/Urinary Tract, Malignant disease and
Immuno-suppression, Nutrition and Blood, Musculoskeletal and Joint
disease, Eye, ENT, Skin; - infection will be reviewed through the
antimicrobial sub-group) will be reviewed in turn by MMG at each of its
meetings. This will ensure a thorough review of all drugs every 2 years
across the locality.
ADDITIONAL DETAILS
1. A list of pending formulary requests will be kept on the Trust Intranet
Pharmacy clinical site (accessible via HOWIS) until final formulary
decision is reached- it should be noted that the requesting Consultant in
Secondary Care may prescribe or recommend the requested product
which is pending final formulary decision up to a maximum cost impact
of £2,500pa.
2. The Joint formulary applies to prescribing and recommendations to
prescribe. For this reason it is requested that routine recommendations
for non-formulary drugs arising from secondary care should be referred
to the formulary/interface pharmacist to discuss potential formulary
request with relevant Consultant (“one off cases” will not give rise to a
formulary request unless it can be reasonably expected that another
such instance will arise. Formulary/Interface pharmacist will not
intervene in specific patient cases.)
3. Where an immediate decision is required for a non-formulary drug
costing >£500 i.e. fast track process for urgent clinical need,
agreement of the Medical Director/Deputy Medical Director of the Trust
(or LHB if prescribing is in Primary care) is required. This process may
be facilitated through the Formulary/Interface pharmacists).
4. For non-formulary drugs costing below £500 the drug may be
dispensed for one individual patient, for one specific Consultant- Such
usage will be audited every 6 months. Requesting consultants will be
invited to submit a formulary request at this point and informed that
prescriptions for further patients for this drug will need to be discussed
with the formulary/interface pharmacist.
5. In cases of non-urgent clinical need for an individual patient for a
non-formulary drug costing >£2000, the case should be referred to the
relevant LHB Individual patient commissioning panel.
6. Drugs on the formulary will be categorised according to the following
definitions to clarify how and where a drug should be prescribed-
Hospital only- All prescriptions are issued from hospitals or use only
applies to hospitals.
Specialist initiated- Follow up prescriptions may be issued by GPs but
initialisation/stabilisation should be performed by a specialist. This
group includes drugs for which shared-care protocols exist.
1st line- A suitable first choice for GPs and non-specialists.
2nd line- Also suitable for the above, but possibly reserved until after a
first line agent has been tried or rejected on grounds of side effects or
allergy. In many cases these will be the more expensive agents.
7. Products that are licensed as medical devices will only be considered
through the drug formulary managed entry process in cases where the
product is to all intents and purposes being used as a drug. In such
cases a presentation by the requesting Consultant directly to the
Medicines Management Group will be required (this presentation must
cover potential associated costs).
APPEALS PROCESS
An appeal may be lodged in writing, by the original applicant with the
Chairman of the Medicines Management Group within 15 working days
of being informed of a formulary rejection.
Where new relevant supporting data is submitted after formulary
decision has been taken the request will be dealt with as a
resubmission.
An appeal will be considered where:
•
There has been a failure to act fairly and in accordance with the
Joint formulary managed entry process.
The appeals panel will consist of 3 members nominated by the Chair of
Medicines Management Group, which will include a pharmacist, GP and
Hospital Consultant that have not been involved with the original
formulary consideration for that drug. The applicant will be informed
within 28 days of a legitimate appeal being lodged.
Document Outline
