Commissioning policy for exceptional treatment requests - National ...

Commissioning Policy
for
Exceptional Treatment Requests
A policy for unlicensed and/or unapproved drugs and
therapeutic interventions to support clinical care outside
current Service Level Agreements
February 2008
Document Reference Number
Version 1.20 – February 2008 – db
Previous Document Number
Version 1.19 – February 2007 – nb
Author‟s Name
Alan Marsh/Nickie Burgess/Denise Bell
Author‟s Job Title
Head of Contracting/Contracts Manager/IFR Manager
Department/Service/Directorate
Contracts Department
Document Status
Re-draft
Issue Date/Publication Date April 2008
Initial Review Date September 2007
Full Review Date April 2009
Distribution
All GP Practices
All PBC Cluster Chairs
Professional Executive Team
Local Acute Providers
Patient Advice & Liaison Service (PALS)
Committee Ratifying Policy
Date of Approval
Professional Executive Committee (PEC)
20 February 2008
Committee Ratifying Policy
Date of Approval
Dudley PCT Trust Board
20 February 2008
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Contents
Commissioning Policy for Exceptional Treatment Requests
1 Executive Summary ................................................................................................................... 3
2 Introduction ................................................................................................................................ 3
3 The Scope of this Policy ............................................................................................................ 5
4 The Referral Process to make an Exceptional Treatment Request (ETR)................................. 5
5 Ethical Framework ................................................................................................................... 12
6 The Legal Framework .............................................................................................................. 13
7 The National Context ............................................................................................................... 14
8 Research ................................................................................................................................. 16
9 Decision Process for unlicensed or unproven Drug and Therapeutic Interventions ................. 17
10 Managing the entry of new drugs ............................................................................................ 17
11 Co-Funding ............................................................................................................................ 18
12 Policy review .......................................................................................................................... 18
13 Distribution ............................................................................................................................. 18
14 Reference Documents ........................................................................................................... 18
Appendix 1- Membership of ETAP ............................................................................................. 19
Appendix 2 – ETR Pro-forma ....................................................................................................... 20
Appendix 3- Appeals Procedure ................................................................................................. 24
Appendix 4- Digital Recording of Appeals Procedure ................................................................. 28
Appendix 5 – Business Case Guidance ....................................................................................... 29
Appendix 6 – Process of Managing Exceptional Treatment Requests ........................................ 33
Appendix 7 – ETR Decision Report ............................................................................................ 34
Appendix 8 – Abbreviations ......................................................................................................... 35
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Commissioning Policy for Exceptional Treatment Requests
1. Executive Summary
This policy covers the Primary Care Trust‟s (PCTs) decision making process for the commissioning
of interventions/treatments that fall outside of current commissioning contracts. The policy includes
the legal and national framework for such decisions.
All applications for Exceptional Treatment Request (ETR) funding are required to make a formal
case outlining the rationale for the intervention/treatment, appropriate monitoring and the potential
benefits to the individual and the health economy and include details of the overall costs involved.
When considering an ETR the following points are taken into account:
* Available evidence on the effectiveness and safety of the intervention for the patient.
* The potential for a precedent to be set with regard to the future funding of the
intervention/treatment.
* Agreeing funding in isolation may distort clinical and commissioning priorities.
* Funding may subject the PCT to unplanned financial risk.
* The existence of any research programmes, that may lead to benefits for other patients
This policy does not cover new developments which clinicians wish to provide on a regular basis.
Funding for these must be requested through the Local Development Plan (LDP) process.
2. Introduction
2.1 The role and responsibilities of Dudley PCT in commissioning healthcare services
This is a policy regarding the PCTs decision-making process for responding to Exceptional
Treatment Requests and the commissioning of drugs, treatments, procedures, investigations, that
fall outside of current commissioning contracts.
It is the statutory duty of the NHS and Primary Care Trusts (PCTs) to provide services to such
extent as it considers necessary to meet all reasonable requirements within the resources
available. “A national health service will always need to operate within the resources
available. It is in no one‟s interest locally to „break the bank”. (Source: The NHS in England:
the operating framework for 2006/07- Annex C Demand Management in 2006/07) This includes
the responsibility to make decisions on the commissioning of healthcare services that do not fall
under existing contracts or are unlicensed or not approved by the National Institute for Health and
Clinical Excellence (NICE) and ensuring that all decisions are made in the interest of the whole
population of Dudley within the resources available. The PCT owes this duty to patients registered
with a Dudley PCT GP or to unregistered patients resident within its geographical boundary.
Each year the PCT receives a number of requests for treatments not covered by a Service Level
Agreement or other Contract. This policy sets out the PCT processes for managing those
requests. Throughout this document these requests will be known as Exceptional Treatment
Requests or ETRs.
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Commissioning Policy for Exceptional Treatment Requests
Inevitably there will be occasions when it is both reasonable and legitimate for the PCT to restrict or
not commission a particular healthcare intervention. In such circumstances, it is important that the
process by which the PCT came to that decision is open and explicit. This policy document sets
out that process and defines the framework within which such commissioning decisions are made.
2.2 Policy Statement
This policy covers the decision making process for ETRs including requests to fund the use of
unlicensed and/or unapproved drugs and therapies. The policy does not cover requests for GPs to
prescribe an FP10 (primary care prescription) – such requests must be passed to the PCT
Prescribing Committee. There is a register associated with this policy which documents associated
policies used for decision making regarding drugs, treatments or interventions where a
policy/procedure is in place for decision making with regard to a particular drug, treatment or
intervention. This Register is available from the ETR Manager.
The implications for the commissioner are:
There is pressure on the Primary Care Trust (PCT) to fund a drug or intervention prior to the
availability of significant evidence on the effectiveness and safety of the drug/intervention.
PCTs require time to consider other aspects of the drug or intervention including cost
effectiveness and priority rating.
There is potential for a precedent to be set with regard to the future funding of the
intervention, regardless of its cost-effectiveness and the priority it has in relation to other
services.
Agreeing the funding of a drug or therapy in isolation has the danger of distorting clinical and
commissioning priorities.
It may subject the PCT to unplanned financial risk.
The PCT will not support the prescribing of unlicensed or unapproved drug/interventions or
treatment unless there are fully assessed clinical and psychological circumstances that indicate
significant benefit to the patient by the use of the treatment/intervention and there is sufficient
resources within the PCT available to fund the treatment without jeopardizing funding to support
currently commissioned or Local Delivery Plan (LDP) funded technologies, all of which need to be
agreed in advance.
The PCT will not be responsible for funding unlicensed or unapproved drugs that have been
prescribed without prior approval.
The PCT reserve the right to review the evidence of the safety, efficacy and cost efficiency of a
drug or therapy prior to funding within a reasonable time period.
New therapies, technologies, drugs or new indications for established drugs should be seen in the
same light as any service development and Trusts or others making applications for funding are
required to produce a formal case for funding.
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Commissioning Policy for Exceptional Treatment Requests
Patient care that will be advised/used for treatment across multiple patients must not be processed
through the ETR route and a formal business case must be made to the Director of Patient
Experience & Service Improvement. Submitted business cases should be endorsed by the Provider
Organisation at a corporate level prior to their submission. This will ensure appropriate treatments
are fully evaluated and financed within contract, if necessary as an in-year decision through the
Contract Variation process or annually through the LDP process. (See Appendix 5).
3. The Scope of this Policy
The PCT must ensure that it provides the community of Dudley with the best health care from the
funds available. This includes the responsibility to make decisions for funding requests that do not
fall under existing contracts which includes unlicensed or unproven therapeutic interventions and
unusual or novel treatments and ensuring that decisions made are in the interest of the whole
Dudley population. An Exceptional Treatment Approval Panel (ETAP) has been established to
consider these requests in the PCT. A list of the members of this group is available at Appendix 1.
The purpose of this policy is to:
Clarify the decision making process for dealing with ETRs and the responsibility for
taking those decisions.
Provide a framework appropriate for the handling of exceptional cases.
Ensure consistency between decisions on exceptional cases.
Ensure limited resources are used to best effect.
Provide clear criteria against which requests and any appeal can be judged.
Set out the appeals process in the event that an initial request is refused.
4. The Referral Process to make an Exceptional Treatment Request
(ETR)
The first stage of the process is for an ETR Pro-forma (Appendix 2) to be completed by a GP,
Consultant or a person involved in the clinical care of the patient to be sent to the Contracts
Department at the PCT for a decision.
Information required on the form includes the following:
Name of clinician making application.
Patients name, address and date of birth.
Patient‟s GP and Practice Address.
Level of urgency.
Brief health history including previous treatment for relevant indication.
Treatment/intervention requested.
Cost effectiveness, where possible include data from economic evaluations with a list of
references.
Information on alternative treatment available.
Proposed provider of treatment.
Costings and length of treatment.
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Commissioning Policy for Exceptional Treatment Requests
Evidence for improvement on health, including data from clinical trials or relevant guidance
and patient monitoring arrangements.
Implications for patient if not funded.
Any patient exceptional applicable circumstances and a summary of what information has
been provided to the patient about the proposed treatment.
Summary of NICE recommendations if this is an application to fund an interventional
procedure.
Rationale for bringing this case to the ETAP.
Monitor and evaluate effectiveness/duration of reporting back to the PCT.
Patient has been informed of request.
Benefits to the patient as a result of receiving treatment.
Patient informed of risks associated with treatment.
Treatment/process fully explained to the patient.
Additional information submitted by the patient.
The referring clinician is expected to advise the patient that they can submit comments to the panel
for consideration in the decision making process. The patients comments should be forwarded with
the pro-forma. The pro-forma will ensure that the PCT receives the correct information needed to
make a decision as quickly as possible.
This form is to be used for equipment, drugs and treatments outside of existing contracts including
un-licensed or unapproved therapeutic interventions. Completed forms should be sent to:
Exceptional Treatment Requests Manager
Contracts Department
Dudley PCT
St John‟s House
Union Street
Dudley
DY2 8PP
Fax: 01384 366497 (Safe haven fax rules apply)
Email: ETR@dudley.nhs.uk
When the ETR Pro-forma is received by the Contracts Department at the PCT it will be logged to
keep track of its progress and acknowledged by email within 3 working days confirming receipt to
the referring clinician/contracts manager.
Each request will be reviewed by 1 member of the Contracts and/or Commissioning Departments,
with input from the Public Health Department when necessary to ensure its completion in line with
this policy and to ensure that any related policy and relevant criteria are met and that the request is
not funded by any national or local specialised commissioning arrangements. In instances where
not all referral criteria are met and no exceptional circumstances have been identified, the request
for funding will not be presented to ETAP for a decision and the patient, the GP and the referrer will
be sent a formal refusal of funding letter. There is no right of appeal against a PCT Commissioning
Policy within this process. Should the patient/referring clinician wish to challenge a PCT
Commissioning policy, this should be addressed in writing to the Director of Patient Experience &
Service Improvement in the first instance. Comments received from patients and referring
clinicians will be considered when the policy is formally reviewed.
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Commissioning Policy for Exceptional Treatment Requests
Where it is the case that the ETR provided by the referrer meets referral criteria, funding will
automatically be approved without sending for additional information from the patient or
presentation to the ETAP. Requests that do not fall into either category will be forwarded to the
ETAP for consideration.
A flow diagram showing the process of managing ETRs is available at Appendix 6. A register of
associated policies is available by contacting the ETR Manager.
4.1 The Decision Making Process
4.2 The Exceptional Treatment Approval Panel (ETAP)
The ETAP routinely meet once per month in order to make decisions on requests received. At each
meeting the ETAP will receive anonymised referral information and any copies of additional
correspondence which may be relevant to the decision making process. A member of the Public
Health Department and a member of the Contracts Department will ensure the ETAP receive and
consider a briefing of the evidence concerning the requested treatment. When considering whether
to support the request the ETAP will take the following into consideration:
Details of evidence and decisions already considered by the PCT/ other PCTs and any
relevant associated PCT policy.
The nature of the proposed treatment.
The individual needs of the patient, the case advanced by the clinician and the view of the
GP (where the GPs view is provided and the referring clinician is not the GP).
The seriousness of the illness/condition and availability of alternative treatment and relative
evidence of the cost and clinical effectiveness and associated risks of such treatment. All
treatments/Interventions need to provide clear evidence of effectiveness * and value for
money. There must be evidence of the efficacy and safety of the treatment/intervention
requested within the ETR, including relevant clinical trials and their outcomes, NICE
Guidance, DoH Guidance or any other relevant guidance, if available and noted if the
treatment has Medicines and Healthcare products Regulatory Agency (MHRA) approval.
Information from specialist clinical network will be sought if required.
The ETAP considers any evidence pertaining to the level of cost – effectiveness of the
treatment and risk, it also considers cost benefit analysis to the population of Dudley for
whom the PCT serves, taking into account the PCT‟s financial position on agreed local
priorities as outlined in the Local Delivery Plans (LDP) and other applications for exceptional
treatment.
Regard will also be had to the available budget within the PCT and whether the case is likely
to create a precedent which may commit the PCT to funding similar cases. In these
circumstances the likely financial exposure for the PCT together with any opportunity costs
in terms of competing priorities for funding will be considered.
The willingness of the patient in the future to co-operate in having their condition regularly
assessed to determine whether the treatment is effective and thus whether it should be
continued.
* This is defined as good quality observational control or case control studies or better i.e. controlled trials. This is
based on the levels recommended by NICE.
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Commissioning Policy for Exceptional Treatment Requests
In Summary, the following factors will be considered:
• Does the patient meet PCT referral criteria
• Nature of proposed treatment/intervention and its clinical effectiveness
• Analysis of alternative treatment and its cost effectiveness/value for money
• Long term benefits/cost analysis
• Patient exceptional circumstances
• Number of people in Dudley that may be affected by the decision.
• Precedent setting.
The decision of the ETAP will be documented as identified at Appendix 7. Thereafter the decision
will be communicated directly to the patient, the patients own GP and the referrer.
In fulfilling the primary purpose of the ETAP meeting, the ETAP will ensure it has adequate
supporting information upon which to base its decision. In the absence of such information,
decisions will be deferred until supplementary information is available to the ETAP.
There will be a written response to the referrer within 10 working days or as soon as practicable
after the ETAP taking place giving the outcome or feedback on the progress of the request.
4.2.1 Exceptionality
There can be no exhaustive definition of the conditions which may potentially come within the
definition of an exceptional case. The word “exception” means “a person, thing or case to which
the general rule is not applicable”. The following criteria, however, are indicative of the presence or
absence of exceptionality in the present context:
To be an exception, there must be unusual or unique clinical factors about the patient that
suggest that he or she is:
I. Significantly different from the wider group of patients with the same condition; or
II. Likely to gain significantly more benefit from the intervention than might be expected
from the average patient with the same condition.
The fact that a treatment is likely to be effective for a patient is not, in itself, a sufficient basis for
establishing an exception.
If a patient‟s clinical condition matches the „accepted indications‟ for a treatment, but the
treatment is not funded, then the patient‟s circumstances are not, by definition, exceptional.
It is for the requesting clinician (or patient) to make the case for exceptional circumstances.
Social value judgments are rarely relevant to the consideration of exceptional status.
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4.3 Scheme of Delegation
Commissioning Policy for Exceptional Treatment Requests
The ETAP acts as a formal sub-committee of the PCT Professional Executive Team (PEC) and has
the authority to commit financial resources within the frameworks agreed. The ETAP will report a
summary of the outcomes of its decisions to the PCT PEC meetings on an annual basis. On
occasion ETAP may request PEC to input into the decision making process, in this case the
request will be referred directly to the next PEC for their input. PEC may be asked for their input
when there are significant financial or political implications or where a wider issue than the
Exceptional Treatment Request is identified.
The ETAP will be quorate when there is a minimum of 5 in attendance or involved in the decision
making. These 5 persons should include the Chairperson (who will be the Director of Patient
Experience and Service Improvement or their nominated deputy, a representative from Public
Health from the PCT, 2 Clinical representatives, one of which must be a Dudley GP and a lay
representative or Non-Executive Director. However, in the event of an even number in attendance
at ETAP the Chair will abstain from the vote.
4.4 Informing Referrers of Decisions – Correspondence Standards
Referrers will be sent an acknowledgement letter within 3 working days after receipt of an
Exceptional request for funding. After the referral has been considered by the ETAP the final
decision will be sent in writing to the referrer within 10 working days after the ETAP meeting at
which the case has been presented. The decision of the ETAP will be communicated directly to
the referrer, the patient and the patient‟s own GP. The right to appeal the process within 25 days of
receipt of the decision letter will be communicated where a decision has been made not to fund a
request. The ETAP will not enter into direct patient correspondence other than to communicate on
matters of process, information clarification and policy matters.
4.5 What decision will be made
There are 5 different decisions possible for an Exceptional case when presented to the ETAP.
1. Agree to fund/support the request
2. Defer decision pending further information/investigation
3. Refuse to support/fund the request
4. Identify a Service Development which will be referred on to the appropriate PCT
Commissioning/LDP group or HENIG if appropriate and inform referrer. (See Section 9)
5. Refer to PEC for input.
4.6 Requirement for Urgent Decisions
It is recognised that on occasions emergency and urgent decisions will be required. In such
circumstances referring parties are encouraged to liaise with their patients and with their agreement
include details of exceptional circumstances with the referral or encourage patients to send this
information to the PCT without delay. Given the need for expediency the ETAP will make the
decision based on the information put before it in such circumstances.
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Commissioning Policy for Exceptional Treatment Requests
In exceptionally clinically urgent situations the ETAP will operate virtually e.g. using
email/telephone to reach speedy decisions if it is necessary. It is important that no member of the
group make decisions on their own. It is recommended that the decision is taken by the
Chairperson of the ETAP (or nominated Deputy Chairperson), 1 GP and a representative from
Public Health (3 members as a minimum). The decision will be recorded by the ETR Manager (or
nominated representative) following discussion with panel members. The final decision will be
reported to the panel members of the next scheduled ETAP.
4.7 Appeals
In the event that the patient wishes to appeal against the process the appeals procedure set out in
Appendix 3 needs to be followed.
The Appeals Panel (the Panel) is established as the Panel for the PCT Board to consider appeals
by a referring Medical Practitioner and/or their patient against the process followed by the PCT with
regard to an ETR. Where a decision to refuse an ETR is made the patient will be advised of their
right to appeal the process in writing and the process for doing so. Where a Medical Practitioner is
appealing on behalf of the patient this needs to be confirmed by patient‟s written consent to the
PCT.
4.8 Initiating the Appeal
The right of appeal is valid for a period of 25 days following the date of letter advising that the ETR
has been refused. It is the responsibility of the referring clinician to discuss the appeal process and
implications fully with the patient concerned. A letter from the patient/advocate requesting an
appeal against the decision must be provided to:
Exceptional Treatment Requests Manager
The Contracts Department
Dudley PCT
St Johns House
Dudley
DY2 8PP
Fax No: 01384 366497 (safe haven fax rules apply)
Email: ETR@dudley.nhs.uk
Please note: Should this deadline 25 day deadline be missed a new ETR will be required.
4.9 Role of the Appeals Panel
The Panel‟s role is to consider whether the correct process has been followed to reach a decision.
The appeals panel should ensure that the ETAP have considered the following factors:
• Does the patient meet PCT referral criteria
• Analysis of proposed treatment
• Analysis of alternative treatment and its cost effectiveness/value for money
• Precedent setting
• Long term benefits/cost analysis
• Nature of proposed treatment/intervention and its clinical effectiveness
• Patient exceptional circumstances
• Number of people in Dudley that may be affected by the decision.
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Commissioning Policy for Exceptional Treatment Requests
The Appeals panel does not have the jurisdiction to change/amend PCT Commissioning Policies
that have been approved by the PCT Board and will make decisions based on current
Commissioning Policies at the time of the Appeals hearing.
Should the referring clinician/patient wish to challenge a PCT Commissioning Policy, this will need
to be in writing addressed to the Director of Patient Experience & Service Improvement in the first
instance.
Should the Appeals Panel uphold an appeal, the case must be referred back to the ETAP to be
reconsidered.
4.10 Membership of the Appeal Panel
The Panel shall comprise of a minimum of 5 persons none of whom should have sat on the ETAP
for the case under consideration. There shall be at least one Non-Executive Director, one Director
who is not the Chief Executive and who is from the Commissioning arm of the PCT (not Provider
Services), this includes Directors of Governance, Human Resources, Public Health and Patient
Experience & Service Improvement), together with at least one GP representative (who must be a
member of the PEC, a Clinical Lead or PBC Cluster Chair), a Public Health representative, a
commissioning representative or a finance representative (this representative must have expertise
in Local Development Plan (LDP) knowledge. The panel will decide prior to the meeting
commencing who will Chair the appeals panel, this would normally be either the Non-Executive
Director or PCT Director. The panel Chairperson may co-opt onto the Panel a Medical Practitioner,
nurse or other healthcare professional with relevant healthcare expertise. The patient will be
entitled to attend the hearing and to make oral representations either personally or by a parent,
guardian, carer or other appropriate advocate.
4.11 Complaints
If a complaint is made about the handling of an appeal, the PCT‟s complaints procedure can be
invoked within 6 months of the date of notification of the decision to the patient by the Appeal Panel
Chairperson. If the complaint relates to the impact of a commissioning policy on an individual then
the complaints procedure will only be implemented once the Appeal Panel has reached a final
decision. Please note: A complaints investigation will review the process only and not the decision
made by the Appeals Panel.
4.12 Health Care Commission
Following a complaint, if we have been unable to resolve all concerns, the patient has the right to
ask the Healthcare Commission to review the process. This should be done within 6 months of
receiving the response to the complaint. The Healthcare Commission is an independent body
established to promote improvements in health care through the assessment of the performance of
those who provide services. Their website address is: www.healthcarecommission.org.uk. You
can contact the Healthcare Commission on 0845 601 3012 or write to them at:
Healthcare Commission
Complaints Team
Peter House
Oxford Street
Manchester M1 5AN
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Commissioning Policy for Exceptional Treatment Requests
4.13 Patient Advice and Liaison Service
The role of PALS is to provide information, advice and support to patients, service users, carers
and relatives with concerns or issues about their health service.
PALS liaises with service providers and other outside agencies to resolve patient queries, concerns
and issues and assists services with learning lessons.
5 Ethical Framework
In reaching its decisions, the PCT aims to;
take into account and weigh all the relevant evidence
take into account the opinion of relevant clinicians
give proper consideration to the views of the patient or group of patients involved and accord
proper weight to their needs against other groups competing for scarce resources
take into account only material factors
act in the utmost good faith
make a decision that is in every sense reasonable and affordable to the PCT achieving
financial balance
This ethical framework should enable the PCT to make fair and consistent decisions that treat
patients equitably and take full account of the needs of minority ethnic people recognising the
varied requirements of patients and carers whether they are based on gender, culture, age,
disability, race or religion.
A patient‟s health needs will be assessed in relation to their capacity to benefit from a healthcare
intervention, its efficacy, safety and risk cost benefit analysis. In the absence of evidence of health
need, treatment will not generally be recommended solely because a patient requests it. Similarly,
a treatment of potentially very little benefit and not good value for money will not be provided
because it is the only treatment available. This is necessary to ensure that resources are used to
provide the greatest health benefit for all the PCT population and that healthcare provided by the
PCT is reasonable and affordable.
The Ethical Framework is especially concerned with the following:
evidence of clinical and cost effectiveness and the resources available within the health
community
the needs of the patient(s)
needs of the community
5.1 Evidence of clinical and cost effectiveness
In order to assess the potential healthcare benefits of drug therapies, interventions or procedures
the PCT strives to obtain the best evidence of clinical effectiveness and Value For Money (VFM).
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Commissioning Policy for Exceptional Treatment Requests
„Clinical effectiveness‟ can be defined as, „the application of the best knowledge, derived from
research, clinical experience and patient preferences to achieve optimum processes and
outcomes of care for patients. The process involves a framework of informing, changing
and monitoring practice‟ (Source: Promoting Clinical Effectiveness DOH 1996).
Evidence for clinical effectiveness will be sought from large-scale randomised clinical trials, but if
these have not been conducted or published, evidence from less authoritative sources will be
considered, including controlled trials, cohort studies and case studies. Patients‟ evidence of
clinical effectiveness will also be considered. When assessing evidence of clinical effectiveness the
outcome measures which will be given greatest importance are those considered important by
patients and clinicians.
The PCT has a statutory obligation not to exceed its budget, the cost of healthcare interventions
will be considered and also the impact of investing in one area of healthcare that will inevitably
divert resources from other uses. The ETAP will compare the cost of treatment to its overall
benefit, both to the individual and the community. It will consider technical cost-benefit
calculations.
6 The Legal Framework
It is the statutory duty of the NHS and its PCTs „to provide comprehensive healthcare within the
resources available‟. The Health Act 1999 identifies new section 97D of the NHS Act 1977 which
places a financial duty on the PCT not to spend more than the sum of the amount allotted to them
by their Health Authority (the cash limit). “Regulations 3(7)-(10) of the National Health Service
(Functions of Strategic Health Authorities and Primary Care Trusts and Administrations
Arrangements) (England) Regulations 2002 place upon the PCT the statutory duty to provide
services to such extent as it considers necessary and to meet all reasonable requirements.
Further, in making commissioning decisions, the ETAP and the PCT needs to consider the Human
Rights Act (1998), in particular:
Article 2
Article 8
Article 12
Article 14
the right to life
respect for private and family life
the right to marry and found a family
prohibition of discrimination
Under the Human Rights Act, a legal challenge regarding the inability of the PCT to
fund/commission a particular treatment would focus on whether the decision was linked to (a)
unaffordability, (b) the PCT‟s priorities and (c) how those priorities were decided.
The Rogers v. Swindon PCT appeal decision in April 2006 decided that it was “permissible for a
PCT to carry out a cost/benefit analysis when deciding what treatment to fund and what to decline
to fund. Given that all PCT‟s have a legal duty to break even, it is arguable that PCTs are obliged
to consider the cost of all treatments before agreeing to fund them.” Also the case recognised that
PCTs cannot afford to fund all patients who might benefit from all the treatments that could be
prescribed and “this case affirmed that it is permissible to select those patients who could benefit
from a treatment using a combination of clinical effectiveness and social grounds. Provided the
PCT accepts up front that cost grounds are relevant, it is lawful to have a policy which says that
one patient will get funding because she has disabled dependants or other relevant social
circumstances but another will not” (Source: Mills and Reeve Herceptin Briefing: 18 th April 2006).
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Commissioning Policy for Exceptional Treatment Requests
The PCT will not commit funds to the treatment for individuals which put other funding decisions
already made through the LDP process at risk without due consideration. Patients with unusual or
rare medical conditions have as much right to medical care as anyone else. Patients, through their
doctor, have the opportunity to have their ETR considered on their own merits and against this PCT
policy in each case.
7 The National Context
A further responsibility of the PCT is to implement changes in the local NHS in line with the
requirements of the Department of Health. The PCT will do this through strategy formulation,
Service Level Agreement (SLA) review along with performance management and clinical
governance.
The Government‟s strategic plan for the modernisation of the NHS (The NHS Plan, Department of
Health, 2000) states, as a core principle, that, "The NHS will work continuously to improve quality
services and to minimise errors."
“An important means of achieving this is for healthcare agencies and professionals to
establish ways to identify procedures that should be modified or abandoned and new
practices that will lead to improved patient care”.
The Government and Department of Health have established „standard-setting‟ organisations as
key drivers for their plans for service improvement and evidence-based healthcare.
The work of two of these organisations is particularly relevant to this policy: the National Institute
for Health and Clinical Excellence (NICE) and the Healthcare Commission. As identified by the
Department of Health, by waiting to fund new drugs and interventions following NICE approval this
process would “balance the need for speed with the need to ensure that all the evidence is looked
at thoroughly and the guidance produced is authoritative” so that “patients can get access to
clinically and cost-effective treatments”. This national guidance was the government‟s action
toward ending postcode prescribing and promoted as “providing national standards for a national
health service. It makes sense for a national body to tackle these difficult decisions to avoid each
health authority duplicating the process of what they can fund for patients and thereby reducing the
incidence of post-code prescribing.” Source (Department of Health (DoH) published press release
notice Ref 2000/0252)
In addition, the release of National Service Frameworks that address, for example, the prevention,
management and treatment of chronic diseases, are of importance.
7.1 The National Institute for Health and Clinical Excellence (NICE)
National Institute for Health and Clinical Excellence (NICE) is an independent organisation
responsible for providing national guidance on treatments and care. NICE guidance is available to
healthcare professionals, patients and carers to help them make healthcare decisions.
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Commissioning Policy for Exceptional Treatment Requests
Once NICE guidance is published, health professionals are expected to take it fully into account
when exercising their clinical judgment. However, NICE guidance does not override the individual
responsibility of health professionals to make decisions appropriate to the circumstances of the
individual patient, in consultation with the patient and/or their guardian or carer.
The Chief Executive of each NHS organisation is ultimately accountable for the implementation of
NICE guidance.
7.2 Guidance from the National Institute for Health and Clinical Excellence (NICE)
Currently NICE produces guidance in three areas:
the use of new and existing medicines and treatments within the NHS in England and Wales –
Technology Appraisals
the appropriate treatment and care of people with specific diseases and conditions with the
NHS in England and Wales – Clinical Guidelines
the use of surgical or other invasive interventions for diagnosis of treatment as to their safety
and effectiveness – Interventional Procedures
The NICE website also publishes Public Health Guidance.
Since January 2002, Primary Care Trusts have been required to provide funding and resources for
drug therapies and other interventions recommended by NICE through its Technology
Appraisals.
The NHS normally has three months from the date of publication for each Technology Appraisal to
provide funding and resources. NICE may extend this period if there are good reasons, such as
lack of trained, specialist staff to implement the service.
There is currently no standard time scale for the implementation of either NICE Clinical
Guidelines or guidance on Interventional Procedures, although specific advice is sometimes
given by the Department of Health. Where a referring clinician is of the opinion that the treatment
he advises to a patient falls within NICE Clinical Guidelines or Interventional Procedures that will be
advised/used for treatment across multiple patients then this must not be processed through the
ETR route and a formal business case must be made to the Director of Patient Experience &
Service Improvement. Submitted business cases should be endorsed by the Provider Organisation
at a corporate level prior to their submission. This will ensure appropriate treatments are fully
evaluated and financed within contract, if necessary as an in-year decision through the Contract
Variation process or annually through the LDP process. (See Appendix 5).
7.3 The Healthcare Commission
The Healthcare Commission (previously known as the Commission for Healthcare Audit and
Inspection - CHAI) is responsible for monitoring progress on the implementation of NICE guidance
nationally.
7.4 National Service Frameworks
As part of its commitment to improving health and reducing inequalities the Department of Health
has produced National Service Frameworks (NSFs). NSFs do this by setting national standards,
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Commissioning Policy for Exceptional Treatment Requests
defining service models, putting in place strategies to support implementation and establishing
performance measures against which progress is measured. NSFs have been published in a
number of disease areas, for example, coronary heart disease; cancer; paediatric intensive care;
mental health; older people; diabetes; long-term conditions; renal services; children, young people
and maternity services.
Where a referring clinician is of the opinion that the treatment he advises to a patient falls within
NSF recommendations that will be advised/used for treatment across multiple patients then this
must not be processed through the ETR route and a formal business case must be made to the
Director of Patient Experience & Service Improvement. Submitted business cases should be
endorsed by the Provider Organisation at a corporate level prior to their submission. This will
ensure appropriate treatments are fully evaluated and financed within contract, if necessary as an
in-year decision through the Contract Variation process or annually through the LDP process.
8 Research
As regards clinical research, this must be funded by appropriate research designated monies and
not through budgets that the PCT has allocated for the commissioning of health services, or
funding Exceptional Treatment Requests (ETRs).
However, in line with Health Service Guideline (HSG (97) (32) – 1997) The PCT will meet the
additional costs of patients entered into NHS supported research trials (only where local
agreements have been negotiated.) The PCT will not support clinical trials that have not been
supported by the NHS research and Development Agency.
With regard to new healthcare interventions, the treatment of rare conditions, or interventions for
which there is currently little evidence of effectiveness, the PCT may request that NHS
organisations provide data to national or regional databases in order to facilitate the accumulation
of knowledge and experience.
As indicated previously, the PCT will not support the prescribing of unlicensed or unapproved drugs
outside the context of a well designed trial unless there are fully assessed clinical, social and
psychological circumstances that prove undoubted benefit to the patient by the use of the
treatment/intervention, with consideration of current resources, agreed in advance with the
responsible PCT.
The PCT will not automatically pick up the funding of a patient‟s drug once they come off a trial.
Patients should be made aware of this if entered into a trial and the trial co-ordinator, not the PCT,
must identify clear exit strategy to the PCT and the patient as part of the trial protocol, with this
information fully informed to the patient.
The PCT will not automatically pick up the funding of a patient who has been sponsored by a drug
company for a limited period of time. Approval must be sought prior to discussing this with the
patient and certainly before commencing treatment.
The PCT reserve the right to review the evidence of the safety, efficacy and cost-efficiency of the
drug trial prior to funding any drug and to take account of the PCT‟s financial situation.
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Commissioning Policy for Exceptional Treatment Requests
9 Decision Process for unlicensed or unproven Drug and
Therapeutic Interventions
In order to provide a broad view on the implications of a request for funding approval for an
unlicensed drug or unproven therapeutic therapy, the Health Economy Nice Implementation Group,
hereafter known as HENIG, supports the ETAP by providing a Guidance Note when requested for
a Technology Appraisal on the approval schedule whilst they are in progress prior to their
approval/unapproval. A Public Health Specialist attends the ETAP to ensure specialist knowledge
is available during the decision making for ETRs with regard to Clinical Guidelines and
Interventional Procedures.
HENIG will manage and correspond regarding funding requests for:
* All technologies for which NICE has issued a draft consultation or subsequent document as part
of the Technology Appraisal process.
* All PbR exclusions which have been prospectively identified with the acute trust as subject to
agreed guidelines (such as the Specific Product Characteristics (SPC) or appropriate clinical
criteria).
If a Clinician wishes to enable patient access to a specific healthcare intervention which is subject
to NICE Clinical Guidelines and/or Interventional Procedures, or vary criteria within NICE Clinical
Guidance for a Technology Appraisal, for all patients or a selected group of patients, then a
Business Case proposal must be submitted to the PCT (See Appendix 5) and will be evaluated at
HENIG in order that an appropriate analysis can be made and thereafter appropriate
commissioning undertaken through the LDP, Commissioning and Contracting processes.
If a clinician wishes to provide a treatment for an individual patient who does not meet the eligibility
criteria specified in NICE Guidance as a Technology Appraisal, or the treatment is outside of the
PCT Service Level Agreement/Contract, then an application should be made to the PCT‟s ETAP
through the Exceptional Treatment (ETR) process. Details of the ETR procedure are listed in
the ETR section at Section 4 of this policy. Public Health will provide specialist advice to ETAP
on the evidence base for the intervention in addition to the information provided by the clinician
requesting funding.
As required the PCT will also obtain a broad view on the implications of funding the intervention
from appropriate teams including the Specialist Services Commissioning Team at the Strategic
Health Authority (SHA).
10 Managing the entry of new drugs
New drug therapies are constantly being developed and this leads to pressure from both patients
and the pharmaceutical industry to prescribe them.
NHS Trusts employ their own mechanisms for managing the entry of new drugs into the health
economy and should fund them from within their existing resources or planned for as a service
development within the Local Delivery Plan.
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Commissioning Policy for Exceptional Treatment Requests
The PCT works with NHS Trusts and relevant clinical networks to develop joint prescribing
arrangements to achieve the introduction of effective and cost-effective new drug therapies. Where
a new drug or procedure is deemed to have significant
health benefit and is not the subject of a Technology Appraisal a business case should be made
and forwarded as per Appendix 5 for evaluation at HENIG and funding will need to be prioritised
against other clinical areas. Formulary approval from the Area Medicines Management Committee
will also need to be sought.
The PCT will not generally commission drugs that are unlicensed for use in the UK.
10.1 Prescribing Responsibility
Prescribing responsibility lies with the person who signs the prescription.
11 Co-funding
The PCT will not co-fund treatments/drugs/therapeutic interventions as outlined in Section 13 of the
National Health Services Act 2006. The PCT is currently developing a policy on Co-funding.
12 Policy Review
This policy will be reviewed as required or no later than 2 years after agreement or following the
introduction of new and relevant legislation will be reviewed within 3 months. PEC will review this
policy and will receive an annual report from the Contracts Department.
13 Distribution
This policy will be made available to all Dudley GP Practices, Professional Executive Team, Dudley
Group of Hospitals NHS Trust, Local Acute Providers and PALS.
14 Reference Documents
1. Health Act 1999
2. Department of Health HSG97(32)
3. Department of Health press release notice 2000/0252
4. Department of Health press release notice 2005/0379
5. NICE 2006/017
6. Redditch and Bromsgrove PCT Commissioning Policy, the funding of drugs for patients
coming off drug trials or drug company sponsored patients
7. Swindon PCT – Clinical Priorities Policy for commissioning Selected Services
8. Mills and Reeve Solicitors: Herceptin: Briefing following Rogers v. Swindon PCT (April 2006)
9. Mills and Reeve Solicitors: Vital Signs (Winter 2005)
10. Department of Health - Improvement, Expansion and Reform: The next 3 years: Priorities
and Planning Framework 2003-2006
11. Department of Health – The NHS Cancer Plan, A plan for investment, A plan for reform
(September 2000)
12. Mills and Reeve Solicitors: Primary Care Trusts Commissioning novel or uncertain
treatments (Health Client Briefing – undated)
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Commissioning Policy for Exceptional Treatment Requests
Appendix 1 - Membership of ETAP
Membership of Exceptional Treatment Approval Panel (ETAP) - February 2008
Director of Patient Experience & Service Improvement (Chairperson) or nominated
Deputy)
2 Clinical Representatives of which 1 must be GP representatives (ensuring where
possible representation from North and South Dudley Clusters)
Public Health Advisor
Lay representative and/or Non-Executive Director
The PCT Manager with responsibility for Exceptional Treatment Requests will also attend
the meetings.
Notes:
Other parties may be co-opted onto the group as the need arises, for example Health
Economist.
The ETAP will be quorate when there is a minimum of 5 in attendance or involved in the meeting.
These 5 persons should include the Chairperson or nominated Deputy Chairperson, a
representative from Public Health from the PCT, 2 Clinical representatives of which one must be a
Dudley GP representative and a lay representative or Non-Executive Director. However, in the
event of an even number in attendance at ETAP, the Chair will abstain from the vote.
Expertise of the clinical panel members – Principal expertise is in interpreting clinical evidence and
other clinical information including cost effectiveness to enable decision making and allocating
scarce resources across competing priorities. The panel will seek evidence when necessary from
Specialists within
individual clinical fields.
Expertise of lay or Non-Executive Director members – Principal input is to provide patient
independent perspective for input in decision making and allocating scarce resources across
competing priorities.
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Commissioning Policy for Exceptional Treatment Requests
Appendix 2 – ETR Pro-forma
Application Form
Exceptional Treatment Request (ETR) – Dudley PCT
Name of clinician making application
Patients Name
Patients Address
Date of Birth
GP Name
Practice Address
Brief and relevant health history,
current patient condition including any
patient individual applicable
circumstances
Treatment/intervention requested
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Clinical Urgency Rate:
Emergency / Urgent / Routine
(please delete as appropriate)
Clinical Emergency
Within 2 working days
Clinically Urgent
Within 14 working days
Clinically Routine
for decision at routine ETAP
meetings
Commissioning Policy for Exceptional Treatment Requests
Information on alternative treatment(s)
available and information regarding
previous treatments provided.
Proposed provider of treatment – to
include alternative providers.
Cost implications (including any
maintenance costs) and length of any
monitoring arrangements.
Evidence that the treatment proposed
has the potential to result in health
improvement for the patient, including
recent evidence of effectiveness. (A
decision not to commission a
service/therapy often reflects a lack of
evidence of effectiveness, or evidence
of limited benefit balanced against
adverse effects. Please provide details
of research/clinical evidence that
supports this particular application.
Reference to articles and copies of
reports may be attached, including any
NICE recommendations.
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Commissioning Policy for Exceptional Treatment Requests
Please document what information
regarding the proposed treatment you
have provided to the patient and
document what you have told the
patient about the proposed treatment.
Implications for the patient if proposed
treatment is not funded.
Rationale for bringing this case to the
Exceptional Funding Approval (ETAP)
How do you propose to monitor and
evaluate effectiveness of this
treatment/intervention and how and
when will you report back to the PCT.
Please confirm that you informed the
patient that you have applied for
funding.
What benefits would you expect for this
patient as a result of receiving this
treatment
Has the patient been informed of any
associated risks associated with this
treatment
I confirm that all of the information
provided within this form is accurate
and has been fully discussed with the
patient.
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Commissioning Policy for Exceptional Treatment Requests
Additional information may be
submitted to the ETAP if they or their
representatives wish.
Please confirm you have discussed
this with the patient.
Any information from the patient MUST
be submitted with this pro-forma.
I confirm that I have read and
understood the appropriate
Commissioning Policy (if applicable).
Signed
Date
Please Return form to:
Exceptional Treatment Request Manager
Contracts Department
Dudley PCT
St Johns House
Union Street
Dudley
DY2 8PP
Fax No: 01384 366497
Email: ETR@dudley.nhs uk
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Commissioning Policy for Exceptional Treatment Requests
APPENDIX 3 - Appeals Procedure
Introduction
Appeals Procedure for Exceptional Treatment Requests
The Appeals Panel (the Panel) is established as the Panel for the PCT Board to consider appeals
by a referring Medical Practitioner and/or their patient against a decision of the PCT Exceptional
Treatment Approval Panel (ETAP). Where a decision to refuse an ETR is made the patient will be
advised of their right to appeal the decision in writing and the process for doing so. Where a
Medical Practitioner is appealing on behalf of the patient this needs to be confirmed by patient
written consent to the PCT.
Initiating the Appeal
The right of appeal is valid for a period of 25 days following the date of letter advising that the ETR
has been refused. A letter from the patient/advocate requesting an appeal against the process
must be provided to:
Exceptional Treatment Request Manager
The Contracts Department
Dudley PCT
St Johns House
Dudley
DY2 8PP
Fax No: 01384 366497(safe haven fax rules apply)
Email: ETR@dudley.nhs.uk
Role of the Appeals Panel
The Panel‟s role is to consider whether the correct process has been followed to reach a decision.
The appeals panel should ensure that the ETAP have considered the following factors:
• Does the patient meet PCT referral criteria
• Analysis of proposed treatment
• Analysis of alternative treatment and its cost effectiveness/value for money
• Precedent setting
• Long term benefits/cost analysis
• Nature of proposed treatment/intervention and its clinical effectiveness
• Patient exceptional circumstances
• Number of people in Dudley that may be affected by the decision.
The Appeals panel does not have the jurisdiction to change/amend PCT Commissioning Policies
that have been approved by the PCT Board and will make decisions based on current
Commissioning Policies at the time of the Appeals hearing.
Should the referring clinician/patient wish to challenge a PCT Commissioning Policy, this will need
to be in writing addressed to the Director of Patient Experience & Service Improvement in the first
instance.
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Commissioning Policy for Exceptional Treatment Requests
Should the Appeals Panel uphold an appeal, the case must be referred back to the ETAP to be
reconsidered.
Membership
The Panel shall comprise of a minimum of 5 persons none of whom should have sat on the ETAP
for the case under consideration. There shall be at least one Non-Executive Director, one Director
who is not the Chief Executive and who is from the Commissioning arm of the PCT (not Provider
Services), this includes Directors of Governance, Public Health and Patient Experience & Service
Improvement), together with at least one GP representative (who must be a member of the PEC, a
Clinical Lead or PBC Cluster Chair), a Public Health representative, a commissioning
representative or a finance representative (this representative must have expertise in Local
Development Plan (LDP) knowledge). The panel will decide prior to the meeting commencing who
will chair the appeals panel, this would normally be either the Non-Executive Director or PCT
Director. The panel Chairperson may co-opt onto the Panel a Medical Practitioner, nurse or other
healthcare professional with relevant healthcare expertise. The patient will be entitled to attend the
hearing and to make oral representations either personally or by a parent, guardian, carer or other
appropriate advocate.
Appeals Secretary
The servicing and administrative support to the Panel will be undertaken by a member of the PCT
staff from the Contracts or Commissioning Departments who will be responsible for managing the
administration of the appeal from receipt of the letter of appeal through to the notification of the
decision. The Appeals Secretary will ensure the patient is provided with a copy of the papers which
have been presented to the Panel.
Evidence available to the Appeals Panel
a) Documents
i) All documents that were available to the ETAP together with the decision and
reasons.
ii)
Any further information that has come to light since the ETAP decision.
b) Representations
i) Upon prior written application by the patient to the Chairperson of the Panel at an
interval of not less than 5 working days prior to the Appeals Panel Meeting date, the
patient will be entitled to attend the hearing and to make oral representations either
personally or by a parent, guardian, carer or other appropriate advocate. The patient
must advise the Chairperson within the above timescale of any persons attending the
hearing with them and in what capacity they will be attending. The maximum number
of persons attending the Appeal Panel is 3 persons in total. Where this right is
enacted upon by the patient, the patient/patient‟s representatives will have the
opportunity during the meeting to present their case, however, the panel members will
deliberate the decision in private thereafter.
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Holding the Panel Hearing
Commissioning Policy for Exceptional Treatment Requests
The Chairperson of the Panel will state the remit of the panel and the criteria against which their
decision is to be taken at the opening address to all in session at the hearing. The Chairperson of
the panel will identify at the outset of the session which members are the decision makers and
clearly identify in what capacity other members of the PCT are in session on behalf of the PCT.
The Appeals Panel discussions will be recorded on digital recording equipment for the purpose of
accurate minute taking only. The digital recording of each Appeal hearing will be kept no longer
than is required to transcribe the recording into minutes for the Panel and in any event no longer
than 10 working days. Once the minutes have been agreed by the Chair of the Appeals Panel, the
digital recording will be destroyed. Consent to record this meeting will be sought from the patient
prior to the Appeals Panel commencing (See Appendix 4) – Digital Recording of Appeals
Procedure.
The designated officer will formally present and explain to the Panel the basis of the exceptional
request.
The Panel will have the opportunity to question the designated officer and to clarify any points
within the briefing papers.
The patient and/or representative should then be invited to present any information that s/he feels
to be relevant to the Panel. The Panel may also wish to ask questions in order to clarify points with
the patient/representative.
The patient/representative and the designated officer will then be requested to withdraw from the
meeting enabling the panel to deliberate in private.
The Panel will then consider whether there is sufficient information available to enable it to arrive at
a decision. If this is not the case then the Chairperson should adjourn the hearing and request the
designated officer to obtain the information or arrange for the appropriate person to attend at the
next meeting, along with the patient/representative if they request to do so.
If no further information is deemed necessary, the Panel should make its decision in accordance
with the remit which is set out below.
Decision making remit of the Panel:
The Appeal Panel will at the end of their deliberation either
1. Uphold the appeal and refer the case back to ETAP or
2. Reject the appeal and confirm the decision of the ETR panel.
The decision of the panel will be notified to the patient in writing by the Chief Executive of the PCT
within 10 working days of the decision being taken.
Any further clarification of the appeal decision by the patient must be made in writing and directed
to the Chief Executive of the PCT. The PCT will respond accordingly in writing.
When an appeal panel deems it necessary that a debriefing session for panel members following
the appeal is necessary this will be organized by the Appeal Secretary.
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Commissioning Policy for Exceptional Treatment Requests
Confidentiality
Panel members are bound by the Code of Confidentiality in respect of all written material and
verbal discussions concerning the appeal. All papers are to be collected at the end of the Panel‟s
sitting except those required by an executive member for subsequent action. Any member who
does not attend the sitting is responsible for returning all papers to the Appeals Secretary for
shredding.
Complaints
If a complaint is made about the handling of an appeal, the PCT‟s complaints procedure can be
invoked within 6 months of the date of notification of the decision to the patient by the Appeal Panel
Chairperson. If the complaint relates to the impact of a commissioning policy on an individual then
the complaints procedure will only be implemented once the Appeal Panel has reached a final
decision. Please note: A complaints investigation will review the process only and not the decision
made by the Appeals Panel.
Health Care Commission
Following a complaint, if we have been unable to resolve all concerns, the patient has the right to
ask the Healthcare Commission to review the process. This should be done within 6 months of
receiving the response to the complaint. The Healthcare Commission is an independent body
established to promote improvements in health care through the assessment of the performance of
those who provide services. Their website address is: www.healthcarecommission.org.uk.
You can contact the Healthcare Commission on 0845 601 3012 or write to them at:
Healthcare Commission
Complaints Team
Peter House
Oxford Street
Manchester
M1 5AN
Patient Advice and Liaison Service
The role of PALS is to provide information, advice and support to patients, service users, carers
and relatives with concerns or issues about their health service.
PALS liaises with service providers and other outside agencies to resolve patient queries, concerns
and issues and assists services with learning lessons.
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Commissioning Policy for Exceptional Treatment Requests
Appendix 4 – Digital Recording of Appeals Procedure
Background
The Commissioning Policy Group has agreed that due to the increasing complexities and length of
Appeal hearings, that the accurate recording of minutes using manual shorthand alone is becoming
unattainable. The group recognises the importance of accurate record keeping in this area and its
impact on the Trust‟s requirements under the Data Protection Act 1998 and Freedom of Information
Act 2000. The Group has purchased a number of dictaphones to enable the digital recording of
Appeals as an administration aid only.
Agreed Procedure
At the commencement of each appeal hearing all attendee‟s will be informed of the presence and
purpose of the digital recording equipment. The digital recording of each Appeal hearing will be
kept no longer than is required to transcribe the recording into minutes for the Panel and in any
event no longer than 10 working days. This is solely for the purpose of minute taking.
Management and Retention
The digital recording will be stored in a secure area whilst not in use; all recording will be clearly
labeled until such time as the digital recording is erased. The retention period for the digital
recording is no longer than 10 working days. Should a request for a copy of the recording be
received after this timescale has elapsed then a final check should be made to ensure that the
Trust no longer holds the information in digital recording form, if this is the case a refusal for the
information can be appropriately provided under the requirements of both the Data Protection and
Freedom of Information Act.
Requests for Information
Should a request for information held on digital recording equipment be received prior to the
expiration of the retention period the digital recording should immediately be removed from the
process of erasure and re-use. All such requests and digital recordings should be provided to the
Information Governance Department which will administer the process of duplication and release of
appropriate information with legislative boundaries.
Dudley Primary Care Trust holds and processes personal information in accordance with the
requirements of the Data Protection Act 1998. Any person upon request is entitled to any
information held about them by the Trust. Any request for information should be made in writing
and addressed to:
The Information Governance Department
St Johns House
Union Street
Dudley
DY2 8PP
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Commissioning Policy for Exceptional Treatment Requests
Appendix 5 - Business Case Guidance
Advice and guidance for persons providing a Business Case for consideration
by Dudley PCT.
Presentation of new drugs, technologies or procedures
The Dudley PCT identify at a local level, whether new drugs and treatments, or treatments that are
not routinely available should be funded, as well as discussing the impact of service developments.
All new Business Cases for consideration by the PCT must be sent to:
Director of Patient Experience & Service Improvement
Dudley PCT
St Johns House
Union Street
Dudley
West Midlands, DY2 8PP
Presenters of a Business Case should note funding is allocated on an annual basis through the
commissioning process and LDP planning process. In-year funding may be agreed where
appropriate.
What should the case include
Background
‣ An introduction to the new drug/technology
‣ Is this a new innovation or a new indication for an existing drug/technology
NICE guidance (if appropriate)
‣ A summary of NICE recommendations
‣ What are the differences between guidance and current
practice
‣ What are the clinical and service implications of the guidance
‣ What are the financial implications of the guidance
Guidance from other bodies (if appropriate)
‣ Clinical Networks
‣ National Professional Groups
‣ Royal Colleges
Current practice
‣ What other/alternative drug/technology is currently being used in Dudley
‣ How many patients are treated
‣ What are the current criteria for treatment
‣ What is the cost of current methods per patient, full year effect
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Commissioning Policy for Exceptional Treatment Requests
Proposal for consideration
‣ Outline of proposed usage of drug/technology
‣ Any staffing or service implications
‣ Briefing on drug/technology/indication not being carried out (if applicable)
National Priorities
‣ Is the drug/technology a National Priority
‣ Has National guidance been issued in this area
‣ Is National guidance in the pipeline
Local Priorities
‣ How can this treatment be funded within the current allocation of resource (i.e. How can
this new treatment substitute another treatment that is of less value within current
resources)
‣ Where does the treatment rank in terms of other priorities within your specialty
‣ Does this treatment support the PCTs LDP How
Evidence of effectiveness
‣ Data from research studies should be presented and a list of references provided
‣ What are the benefits
‣ What is the size of the benefit
‣ Do any sub-groups of patients benefit more than others
‣ How many patients will benefit
Cost-effectiveness
‣ Data from economic evaluations should be presented and a
list of references provided
‣ Cost per QALY should be shown where available
Equity
‣ How does the treatment compare with those (of the same general type) from other clinical
areas (e.g. life extending treatments from two different clinical areas)
Patients Views
What are the views of individual patients and patient groups with regards to:
‣ Quality of Life
‣ Convenience
‣ Impact on their life
Implications of not using this treatment
‣ What are the alternatives for treatment
‣ Are patients at risk if this treatment is not used If yes, how
Audit process for NICE guidance
‣ How will you audit the implementation of the NICE guidance in terms of adherence to the
recommendations and its cost
Financial Impact
A financial impact statement (attached) should be completed and presented by the finance
department of the organisation presenting the business case.
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Financial Impact Statement
Commissioning Policy for Exceptional Treatment Requests
Name of Guideline, Innovation, Drug or Health Technology Assessment:
Trust: Division/Directorate: Specialty:
Change in practice, if any.
Please include any procedure or drug this innovation will replace – where possible
providing PbR HRG Code/s price or local price).
Proposed Timetable for implementation – e.g. introduction with effect from a certain
date or over a number of years.
Major commissioners affected (so that we can work with them to find a consistent
approach). If the data can be split over the main commissioners please do this, if
not, then please list the commissioners here.
„Work group‟ Involved – if applicable. If this has been discussed at a „work group‟
meeting please give date of meeting and/or reference in minutes. (For example –
Cancer Network, local LIT group)
Has this been requested as an ETR previously If so please give date, reference
number and result of decision.
Form completed by /
contact for queries:
Name
Position
Tel E-mail Date
Notes:
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Commissioning Policy for Exceptional Treatment Requests
Number of patients expected to be
treated - this may build up over a period of
years.
Current Year
Next Year
Full Year
Total (Gross) Cost – this may include
staff, drugs, equipment etc. Again it would
be useful to show the total costs for the
Trust and the amount that would be
required from each Commissioner. This
may simply be in the same proportion as
the number of patients.
This section must also include any
associated impacts on long and or short
term PbR activity, for example: the
inclusion of any associated day case costs
to provide the treatment.
Cost Savings from ceasing previous
treatment – if applicable.
Current Year
Next Year
Full Year
Current Year
Next Year
Full Year
Net (Additional) Cost – i.e. Total or Gross
Cost less Savings. If the new procedure
replace a more expensive one this will be
Net Savings.
Any funding already agreed – please
say if some of this has already been
recognised by the PCT or other
Commissioners. Please say which
Commissioners have agreed funding.
Current Year
Next Year
Full Year
Current Year
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Commissioning Policy for Exceptional Treatment Requests
Appendix 6 – Process of Managing Exceptional Treatment Requests
ETR pro-forma completed by
Clinician and sent to the
Contracts Department at the
Dudley PCT
Contracts Department log receipt of pro-forma and acknowledge receipt to referrer via email within 3
working days. Contracts/Commissioning staff check the pro-forma for completeness against any related
policy/relevant criteria. Incomplete or inappropriate referrals will be returned to the referrer.
Completed forms including any additional information received are
copied to the PCT Specialist in Pharmaceutical Public Health for review
and a possible a funding decision where criteria are applicable where
necessary (more details available in the full policy at Section 4)
Refer to ETAP with any additional
material received from Public Health
or additional professional advice
gathered for decision
Decision taken at ETAP.
The outcome from the ETAP or outcome of the criteria based
decision is communicated in writing to the patient, the referrer
and the patient‟s GP within 10 working days following the
decision.
Has there been an appeal
against the process within
25 days
No
Decision logged and any
actions undertaken.
Yes
Refer on to Appeals Panel
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Commissioning Policy for Exceptional Treatment Requests
Appendix 7 – ETR Decision Report
ETR
Number
Case No
ETAP
Decision
Date
Decision
Outcome
Decision
Reasons
1. Agree to fund
2. Defer decision pending further information/investigation
3. Refuse to fund
4. Service Development referred to :………………………..
5. Refer to PEC
TREATMENT REQUEST -
Factors involved in considering the ETR decision:
Does the patient meet PCT
available referral criteria
(Criteria score attached if applicable)
Analysis of proposed
treatment – documenting
discussion around
guidance available (eg
NICE), effectiveness,
efficacy and safety, MHRA
approval recognition and
VFM
Analysis of alternative
treatment and its cost and
effectiveness and VFM
discussion record
Yes/No/Not applicable
Likelihood and discussion
record related to precedent
setting and long term
benefits/costs analysis
Nature of the proposed
treatment/intervention –
discussion record regarding
clinical case/s put forward.
Patient exceptional
circumstances taken into
account – discussion
record. Please note
whether information
provided on an ETR Patient
Additional Information Form
was considered.
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Appendix 8 – Abbreviations
Commissioning Policy for Exceptional Treatment Requests
DoH
GP
HC (CHAI)
HENIG
HRG
HSG
ETAP
ETR
LDP
LIG
MHRA
NICE
NHS
NSF
PALS
PbR
PEC
PCT
QALY
SHA
SPC
VFM
Department of Health
General Practitioner
Healthcare Commission (Commission for Healthcare Audit
and Inspection)
Health Economy Nice Implementation Group
Healthcare Resource Group
Health Service Guidance
Exceptional Treatment Approval Panel
Exceptional Treatment Request
Local Delivery Plan
Local Implementation Group
Medicines and Healthcare Products Regulatory Agency
National Institute for Health and Clinical Excellence
National Health Service
National Service Framework
Patient Advice and Liaison Service
Payment by Results
Professional Executive Committee
Primary Care Trust
Quality Adjusted Life Year
Strategic Health Authority
Specific Product Characteristics
Value For Money
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