berkshire healthcare nhs foundation trust berkshire west … · 2020. 8. 11. · buckinghamshire,...

Berkshire West Integrated Care Partnership Representing

Berkshire West general Practice Berkshire West Clinical Commisioning Group

Royal Berkshire NHS Foundation Trust Berkshire Healthcare NHS Foundation Trust

* Medicines; includes all healthcare treatments, including devices, that may be considered in local formularies (NICE: Developing and updating local formularies. Published: 17 December 2012)

Document v.1.0 Published February 2020

Berkshire West Integrated Care Partnership

Prescribing Oversight Committee

TERMS OF REFERENCE

1. MISSION STATEMENT The Berkshire West ICP Prescribing Oversight Committee (POC) will provide strategic leadership on

the safe, consistent and cost effective management of medicines*, providing a health community

approach, across the Berkshire West Integrated Care Partnership (ICP). This will be done using the

agreed ICP POC Ethical Framework (Appendix 1) and taking into account clinical views of local

clinicians, stakeholders and statutory requirements.

For the purpose of this document, when referring to the Berkshire West ICP, the following

organisations are considered: Berkshire West Clinical Commissioning Group (CCG), Berkshire

Healthcare Foundation Trust, Royal Berkshire Foundation Trust and Berkshire West General Practice.

2. PURPOSE To proactively engage with clinicians, patients, the public and other stakeholders in

developing prescribing practice across the ICP.

To manage the entry of new medicines* onto the formulary which impact on any area of

practice in both primary and secondary care within the ICP.

To rationalise the medicines* on the formulary which impact on any area of practice in both

primary and secondary care within the ICP and remove medicines* from the formulary

where appropriate.

Where appropriate, to develop treatment pathways for those medicines* within the

formulary.

To promote patient safety:

o through improving clinical competencies

o through encouraging the provision of accurate information on medicines* when

patients move across boundaries.

To have a consistent approach to value for money and opportunities for investment and

disinvestment.

To monitor the impact of POC decisions across its member organisations and recommend

audits and report on outcomes.

To help ensure that the requirements of healthcare monitoring organisations are met

particularly with respect to timeliness and equity of access to new medicines*.






To discuss NICE technology appraisals and ensure the ICP formulary is updated in a timely

manner.

To interface with Regional Medicines* Optimisation Committees (RMOCs) when these are

fully established.

To interface with the POC committees (or equivalent) from neighbouring ICPs across the

Buckinghamshire, Oxfordshire and Berkshire West (BOB) Integrated Care System (ICS).

3. OBJECTIVES

Comprehensively horizon scan to provide a consensus view based on available evidence of

the place in therapy of new drugs and existing drugs for new indications, likely to impact on

the Berkshire West ICP, and ensure this view is disseminated to stakeholders to promote

equity of access to medicines* .

To advise on the management of medicines* excluded from the national tariff, including

arrangements for funding medicines* in year if necessary.

To promote seamless medicines* optimisation across organisational boundaries.

To consider the cost-effectiveness of existing treatments and make decisions on de-

prescribing where appropriate.

To facilitate the development and delivery of plans for the introduction of new treatments

and national guidance.

To make decisions to assist in the resolution of problems relating to prescribing at the

primary/secondary care interface.

To establish sub-groups (when needed) to ensure specified actions are delivered and

implemented.

To have a targeted audit programme to monitor and audit the implementation of key

decisions and feedback progress.

To provide guidance on medicines management issues that has an effect on clinical practice

and the overall delivery of healthcare in the local health economy.

To advise on the development of care pathways including input to Planning and

Transformation Teams.

To devise and agree the framework for essential prescribing guidelines / shared care

agreements, including developing (via a sub-group) and approving essential prescribing

guidelines / shared care agreements across Berkshire West.

To adopt recommendations on medicines made by the Thames Valley Priorities Committee

(or successor organisation).

To work collaboratively as part of the Buckinghamshire, Oxfordshire and Berkshire West

(BOB) Integrated Care System (ICS)






4. MEMBERSHIP & RESPONSIBILITIES

Each voting member will agree to carry out their role for the POC in line with the ICP POC Terms of

Reference (ToR) and Ethical Framework (Appendix 2). Each member must acknowledge that they

have read and understood this entire document prior to joining the committee or following any

updates to the framework.

Chairman

The Chair will be proposed by the committee and will be elected from the membership

(consideration should be given to a senior representative who has strong leadership qualities and is

able to command the respect of their peers). Consideration should also be given to the merits of

appointing a non-medical chair to reduce conflicts of interest.

A deputy chair may be appointed by the committee.

The POC shall include the following voting members for each Represented Organisation from within

the ICP:

Represented Organisation Members

General Practice Representation 2 x GP from within the BW ICP with a least 1 GP representing the PCNs

Berkshire West CCG Associate Director of Medicines Optimisation Interface Lead Pharmacist Contracts Manager

Royal Berkshire NHS Foundation Trust

Medical Director Contracts manager

Chief Pharmacist Formulary/Medicines Information Pharmacist

Berkshire NHS Foundation Trust

Medical Director Contracts manager

Chief Pharmacist Lead Formulary Pharmacist

Local Medical Committee Nominated representative

Local Pharmaceutical Committee Nominated representative

Lay Member / Other Lay member The CCGs Conflicts of Interest Guardian

For the purpose of the remainder of this document, when referring to the Represented Organisation, it relates to any one of the first 6

organisations/groups of staff listed in the table above

Non-voting members, who will be invited to each meeting and will receive all papers, but who will

not be including in any voting include;

Neighbouring CCG Medicines Optimisation Leads

BW CCG Medicines Optimisation Team Pharmaceutical Advisors






Private Provider Lead Pharmacists (one per provider)

Patient representatives from relevant patient groups if available.

The membership will take account of professional and organisational representation as well as

involving other stake holders. The membership is outlined above. Each Represented Organisation

will nominate their own members and named deputies and notify this to the committee secretary.

Additional members may be co-opted to attend for particular items but shall not be entitled to vote.

All voting member members will have voting rights where a vote is required, although the

Committee will aim to reach decisions by consensus opinion wherever possible.; each POC member

will have a single vote save that the Chair shall have a casting vote only. In order for a decision to be

carried out, a decision will require a 75% majority to be agreed.

It is not unreasonable for the committee to co-opt and additional voting member where there are

material conflicts and a reduced quorum for decisions.

Responsibilities of POC members:

Accept ownership of POC decisions

Undertake work as necessary between meetings

Promote two-way communication between the POC and relevant NHS colleagues/

organisations

Take specific views, from the POC, back to your own organisation/representing group for

comment, and then to feed back the responses to the POC, as appropriate

Commit to regular attendance of POC meetings, sending an appropriate deputy when

necessary, to ensure continuity and balance of input into decision-making

Be a committed, motivated and active participant in the committee and represent the views

of their organisations.

Declare prior to each meeting any conflict of interests, which might have a bearing on your

actions, views and involvement in discussions within the committee.

Attend every meeting where possible and ensure deputy (nominated prior to the meeting) is

sent for each meeting you are unable to attend. The deputy is expected to be able to

represent the views of their organisation.

Ensure you have read the POC Terms of Reference (ToR) at annually or following any update

to the ToR.

Declaration of Interest

The Chair has ultimate responsibility for deciding whether there is a conflict of interest and for

taking the appropriate course of action in order to manage the conflict of interest. This is particularly

important in the context of joint decision-making processes whilst working collaboratively with other

CCGs and local partners..






At every meeting, the Chair will ask members to declare their interests and ensure that declarations

are formally recorded. For the purposes of this guidance, a “conflict of interest” is defined as “a set

of circumstances by which a reasonable person would consider that an individual’s ability to apply

judgement or act, in the context of delivering, commissioning, or assuring taxpayer funded health

and care services is, or could be, impaired or influenced by another interest they hold”.

Staff may hold interests for which they cannot see potential conflict. However, caution is always

advisable because others may see it differently. It will be important to exercise judgement and to

declare such interests where there is otherwise a risk of imputation of improper conduct. The

perception of an interest can be as damaging as an actual conflict of interest.

Please read Appendix 2 - Guidance around Conflict of Interest and also refer to NHS England

Guidance; Managing Conflict of Interest: Revised Statutory Guidance for CCGs

A declaration made at a meeting is applicable:

If it relates to an Agenda Item

If it is deemed to conflict with the business of BW ICP.

If there is a personal interest (inc: spouse/partner/friend).

If there is a prejudicial interest

If an individual’s ability to apply judgement or act, in the context of delivering or

commissioning health care services is, could be, impaired or influenced by another interest

they hold.

If a member works across two organisations and the perception is organisational bias.

If a member has outside employment (secondary) directly related to their day job

If a member sits on a committee (including Advisory or specialist body) which makes

decisions about a product, or service being discussed

If a member is involved in developing a formulary or putting together a procurement panel

on which products are included.

If a member has a pension that is funded by a provider (where the value of this might be

affected by the success or failure of the provider).

If a declaration is made at a meeting:

The Chair makes a decision as to how to manage each interest which has been declared,

including whether / to what extent the individual member should continue to participate in

the meeting, on a case-by-case basis, and this decision is recorded.

These could be ‘Actual’ or ‘Potential’ interests.

Minutes: As a minimum the following should be recorded in the minutes.

Individual declaring the interest;

At what point the interest was declared;

The nature of the interest;

https://www.england.nhs.uk/wp-content/uploads/2017/06/revised-ccg-conflict-of-interest-guidance-v7.pdf






The Chair’s decision and resulting action taken;

Following the meeting, all new interests declared at the meeting should be promptly updated onto

the declaration of interest form, and then transferred onto the register of interests.

5. MEETINGS Frequency of meetings and quorum arrangements

The POC will meet bi-monthly. The meeting will be considered quorate if all of the following are in

attendance;

At least one representative from each of the following organisations

General Practice

Royal Berkshire NHS Foundation Trust

Berkshire Healthcare NHS Foundation Trust

Berkshire West Clinical Commissioning Group

At least two medically qualified persons, one of whom must be a GP.

At least one pharmacist

At least one member of BW Medicines Optimisation Team Model agenda / annual reporting Minutes of meetings will be ratified by the POC in the subsequent meeting. Decisions will also be communicated to practitioners through the stakeholder organisations’ Medicines Optimisation Teams or Drug & Therapeutics Committees as appropriate. The following will be standing items on the POC Agenda;

- Welcome & Apologies (every meeting) - Declaration of conflicts (every meeting) - Draft minutes from the previous meeting for ratification (every meeting) - Matters arising not included in main agenda items (every meeting) - ICP POC Term of Reference review including the Ethical Framework (12 monthly) - ICP POC Membership attendance rolling 12 month attendance list (every meeting) - Rolling 12 month work-plan (every meeting)

Topics for consideration Topics for consideration will be welcomed from primary care, secondary and tertiary care as well as

in response to national and local developments. The medicines optimisation team will co-ordinate

topics and seek approval from the POC on prioritisation of topics which have been horizon scanned.

A rolling 12 month plan will be a standing item on the POC Agenda.

Consultation Papers for discussion at each POC meeting will be sent to each stakeholder organisation for comments, a minimum of six weeks prior to the POC meeting. The expectation is that each






stakeholder organisation will disseminate the papers to the relevant staff within their organisation. A lack of response from the stakeholder organisations will be considered as a ‘no comment’ response and will be taken as such in any discussions held in the meetings. Outcomes & Implementation The outcome of any decisions made at the POC will be communicated to stakeholder organisations following each meeting. It is the responsibility of each Represented Organisation to ensure that the outcome of all decisions made at each POC meetings are disseminated to the relevant stakeholders within their own organisation. The only exception is General Practice, where this information will be communicated via the Medicines Optimisation Team. It is expected that these decisions are implemented across each Represented Organisation within 4 weeks of the receipt of these outcomes, were reasonably practical. Process for appeals An appeal can be raised if it is felt that the POC has not followed due process or where it is felt that with the evidence presented, a reasonable committee could not have reached the same decision. An appeal can be initiated by a clinician on behalf of the patient population. An intention to appeal should be made in writing to the POC secretary within 4 weeks of the Committee recommendation. The appeal must state the following:

Name of drug/s

Date of committee decision

Reason for appeal stating the potential failing

An acknowledgement will be sent the appellant to confirm receipt. The appeal will be screened and reviewed by the POC Secretary and Chair to confirm that it is an appeal in relation to a process issue, or an appeal proposing that a reasonable decision has not been made Appeal papers relating to the process and decision making will be presented to Frimley Health Area Prescribing Committee to review the appeal. Following review of the appeal, recommendations will be made to the POC as follows:

Appeal upheld and actions to be taken

Appeal dismissed and reasons why

The appellant will be informed in writing of the outcome of the appeal within 2 weeks of the meeting.






Appendix 1 - ETHICAL FRAMEWORK Background A primary responsibility of the ICP Prescribing Oversight Committee (POC) is to make decisions about medicines* that may effects the local population. This includes making decisions about how CCG commissioned treatments and services are implemented, as well as the introduction of new treatments and approaches to the delivery of care. Commissioners are subject to a statutory duty not to exceed their annual financial allocation. Furthermore, the NHS needs to make savings to narrow the substantial financial gap in order to continue to meet the demands for care and treatment. As the demand for NHS health care exceeds the financial resources available, commissioners are faced with difficult choices about which services to provide for their local populations. The POC has representatives of the NHS organisations across the Berkshire West Integrated Care Partnership (ICP) and includes lay members as well as clinicians and managers. The purpose of the POC is to make decisions on the managed entry of new medicines* and ratify local policies, clinical guidelines and pathways. To help in this process, an Ethical Framework, to facilitate fairness and transparency in the priority-setting process has been developed. The Ethical Framework has been adapted from the Thames Valley Priorities Committee Ethical

Framework, originally developed in 2004 by the NHS public health organisation Priorities

Support Unit (now Solutions for Public Health) and the Berkshire PCTs. Since then, the

Framework has been revised to take account of policy developments in the NHS and changes in

the law.

The purpose of the Ethical Framework The purpose of the ethical framework is to support and underpin the decision making processes of constituent organisations to support consistency through:

Providing a coherent structure for the consideration of local policies, clinical guidelines and pathways to ensure that all important aspects are discussed.

Promoting fairness and consistency in decision making from meeting to meeting and with regard to different topics, reducing the potential for inequity.

Ensuring that the principles and legal requirements of the NHS Constitution the Public Sector Equality Duty and the requirement to involve the public when making significant changes to the provision of NHS healthcare5 are adhered to.

Providing a transparent means of expressing the reasons behind the decisions made to patients, families, carers, clinicians and the public.

Supporting and integrating with the development of CCG Commissioning Plans. Formulating policy recommendations regarding health care priorities involves the exercise of judgment and discretion and there will be room for disagreement both within and outside the






Committee. Although there is no objective measure by which such decisions can be based, the Ethical Framework enables decisions to be made within a consistent setting which respects the needs of individuals and the community. The following Ethical Framework consists of 8 principles or relevant considerations that will be taken into account in the development of each recommendation. It does not prejudge the weight that any one consideration is given nor does it require that all should be given equal weight.

1. EQUITY

The Committee believes that people should have access to health care on the basis of need. There may also be times when some categories of care are given priority in order to address health inequalities in the community. However, the Committee will not discriminate, or limit access to NHS care, on grounds of personal characteristics including: age, race, religion, gender or gender identity, sex or sexual orientation, lifestyle, social position, family or financial status, pregnancy, intelligence, disability, physical or cognitive functioning. However, in some circumstances, these factors may be relevant to the clinical effectiveness of an intervention and the capacity of an individual to benefit from the treatment. 2. HEALTH CARE NEED AND CAPACITY TO BENEFIT

Health care should be allocated justly and fairly according to need and capacity to benefit. The Committee will consider the health needs of people and populations according to their capacity to benefit from health care interventions. As far as possible, it will respect the wishes of patients to choose between different clinically and cost effective treatment options, subject to the support of the clinical evidence.

This approach leads to three important principles:

In the absence of evidence of health need, treatment will not generally be given solely because a patient requests it.

A treatment of little benefit will not be provided simply because it is the only treatment available.

Treatment which effectively treats “life time” or long term chronic conditions will be considered equally to urgent and life prolonging treatments.

3. EVIDENCE OF CLINICAL EFFECTIVENESS

The Committees will seek to obtain the best available evidence of clinical effectiveness using robust and reproducible methods. Methods to assess clinical and cost effectiveness are well established. The key success factors are the need to search effectively and systematically for relevant evidence, and then to extract, analyse, and present this in a consistent way to support the work of the Committee. Choice of appropriate clinically and patient-defined outcomes need






to be given careful consideration, and where possible quality of life measures should be considered.

The Committees will promote treatments and services for which there is good evidence of clinical effectiveness in improving the health status of patients and will not normally recommend treatment and services that cannot be shown to be effective. For example, is the product likely to save lives or significantly improve quality of life? How many patients are likely to benefit? How robust is the clinical evidence that the treatment or service is effective?

When assessing evidence of clinical effectiveness the outcome measures that will be given greatest importance are those considered important to patients’ health status. Patient satisfaction will not necessarily be taken as evidence of clinical effectiveness. Trials of longer duration and clinically relevant outcomes data may be considered more reliable than those of shorter duration with surrogate outcomes. Reliable evidence will often be available from good quality, rigorously appraised studies. Evidence may be available from other sources and this will also be considered. Patients’ evidence of significant clinical benefit is relevant.

The Committee will also take particular account of patient safety. It will consider the reported adverse impacts of treatments and the licence status of medicines and the authorisation of medical devices and diagnostic technologies for NHS use.

4. EVIDENCE OF COST EFFECTIVENESS

The Committees will seek information about cost effectiveness in order to assess whether interventions represent value for money for the NHS. The Committees will compare the cost of a new treatment to the existing care provided and will also compare the cost of the treatment to its overall benefit, both to the individual and the community. The Committee will consider studies that synthesise costs and effectiveness in the form of economic evaluations (e.g. quality adjusted life years, cost-utility, cost-benefit), as they enable the relationship between costs and outcomes of alternative healthcare interventions to be compared, however, these will not by themselves be decisive.

Evidence of cost effectiveness assists understanding whether the NHS can afford to pay for the treatment or service and includes evidence of the costs a new treatment or service may release.

5. COST OF TREATMENT AND OPPORTUNITY COSTS

Because the ICP is duty-bound not to exceed its budget, the cost of a treatment must be considered. A single episode of treatment may be very expensive, or the cost of treating a whole community may be high. This is important because of the overall proportion of the total budget: funds invested in these areas will not be available for other health care interventions.

The Committee will compare the cost of a new treatment to the existing care provided, and consider the cost of the treatment against its overall health benefit, both to the individual and the community.

6. NEEDS OF THE COMMUNITY

Public health is an important concern of the Committee and they will seek to make decisions which promote the health of the entire community. Some of these decisions are promoted by






the Department of Health (such as the guidance from NICE and Health and Social Care Outcomes Framework). Others are produced locally. The Committee also supports effective policies to promote preventive medicine which help stop people becoming ill in the first place.

Sometimes the needs of the community may conflict with the needs of individuals. Decisions are difficult when expensive treatment produces very little clinical benefit. For example, it may do little to improve the patient’s condition, or to stop, or slow the progression of disease. Where it has been decided that a treatment has a low priority and cannot generally be supported, a patient’s doctor may still apply to the CCG, via an individual funding request (IFR) that there are exceptional circumstances which mean that the patient should receive the treatment.

7. NATIONAL POLICY DIRECTIVES AND GUIDANCE

The Department of Health issues guidance and directions to NHS organisations which may give priority to some categories of patient, or require treatment to be made available within a given period. These may affect the way in which health service resources are allocated by the ICP. The Committee operates with these factors in mind and recognise that their discretion may be affected by Health and Social Care Outcomes Frameworks, NICE technology appraisal guidance, Secretary of State Directions to the NHS and performance and planning guidance.

Locally, choices about the funding of health care treatments will be informed by the needs of the ICP.

8. EXCEPTIONAL CLINICAL BENEFIT

There will be no blanket bans on treatments since there may be cases in which the clinician providing the care can demonstrate why an individual patient is likely to obtain significant clinical benefit at reasonable cost from an intervention which is not normally funded. The CCG will consider such cases in accordance with the Individual Funding Request (IFR) policy.






Appendix 2 - Guidance around Conflict of Interest

Item Recommendation Comments

1 Sign in Sheet: At each meeting a sign in sheet (including Declarations of Interest) is presented for signature.

Already in place

2 Front Sheets for Agenda Items: For each agenda item the front sheet should include a declaration of any Conflict of Interest. It is the responsibility of the Author/Presenter to ensure that when submitting an agenda item (i.e. a policy for approval) any conflict of interest is identified and indicated on the front sheet.

Example front sheet.

consultation-cover-sheet.docx

3 Meeting Chair: It is the responsibility of the Chair to review all papers in advance of a meeting to:

Establish whether there is a conflict of interest.

If appropriate, put mitigations in place ahead of the meeting.

(Example Mitigations)

Exclude a member from meeting

Exclude a member from voting

If excluded from Voting, consider co-opting a member from another organisation.

4 Declarations of Interest: This is on every Agenda as a matter of course. It is the responsibility of each member to verbally declare conflict of interest as well as documenting on the sign in sheet.

Already in place

5 Declaration made at a meeting: If a declaration is made at a meeting:

The Chair makes a decision as to how to manage each interest which has been declared, including whether / to what extent the individual member should continue to participate in the meeting, on a case-by-case basis, and this decision is recorded.

These could be ‘Actual’ or ‘Potential’ interests.

A declaration made at a meeting is applicable:

If it relates to an Agenda Item

If it is deemed to conflict with the business of BW CCG.

If there is a personal interest (inc: spouse/partner/friend).

If there is a prejudicial interest

If an individual’s ability to apply judgement or act, in the context of delivering or commissioning health care services is, could be, impaired or influenced by another interest they hold.

If a member works across two organisations and the perception is organisational bias.

If a member has outside employment (secondary) directly related to their day job

If a member sits on a committee (including Advisory or specialist body) which makes decisions






about a product, or service being discussed

If a member is involved in developing a formulary or putting together a procurement panel on which products are included.

If a member has a pension that is funded by a provider (where the value of this might be affected by the success or failure of the provider).

A GP with special interests e.g. in dermatology, acupuncture etc.

A member is suffering from a particular condition requiring individually funded treatment.

6 Previous Declarations: Only conflicts that occur or have occurred whist in the employ of BW CCG need to be declared and taken into consideration. If a member of a partner organisation has a conflict that impacts on the business of the CCG they should declare it. Rules should be clear and robust but not overly prescriptive or restrictive. They should ensure that decision-making is transparent and fair whilst not being overly constraining, complex or cumbersome

There may be other occasions where the conflict of interest is profound and acute. In such scenarios (such as where an individual has a direct financial interest which gives rise to a conflict (e.g. involvement with an organisation which benefits financially from contracts for the supply of goods and services to a CCG) the CCG may consider whether, practically, such an interest is manageable at all.

7 Minutes: As a minimum the following should be recorded in the minutes.

Individual declaring the interest;

At what point the interest was declared;

The nature of the interest;

The Chair’s decision and resulting action taken

8 Following the meeting: All new interests declared at the meeting should be promptly updated onto the declaration of interest form, and then transferred onto the register of interests.

9 Governance Lead: Please contact [email protected] for advice.

mailto:[email protected]

mailto:[email protected]

berkshire healthcare nhs foundation trust berkshire west … · 2020. 8. 11. · buckinghamshire,...

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