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Cover Sheet Template for Committee Meetings Final Version 1.2 July 2018 of 3

Clinical Commissioning Group Collaborative Decision-Making Committee

Date Tuesday, 09 October 2018

Document Title Access to and Implementation of Freestyle Libre® Guidance in South West London

Lead Director (Name and Role)

Louise Fleming, Director of Quality and Governance

Clinical Sponsor (Name and Role)

N/A

Author(s) (Name and Role)

Sarah Taylor, Head of Medicines Optimisation (Chief Pharmacist), Sutton CCG

Agenda Item No. 6 Attachment No. 4

Purpose (Tick as Required) Approve Discuss Note

Executive Summary Background: The FreeStyle Libre® flash glucose monitoring system is a device for the self-monitoring of glucose levels. Unlike traditional finger-prick devices (that measure the glucose level in the blood), FreeStyle Libre® measures the glucose level in the interstitial fluid, via a sensor that sits just under the skin. It can provide a near-continuous record, which is produced by the patient scanning the sensor with their reader-device, as and when required. FreeStyle Libre® was added to the drug tariff, and therefore available to prescribe on FP10, in November 2017. In November 2017, a national position statement was issued by the NHSE Regional Medicines Optimisation Committee (RMOC) for FreeStyle Libre®, for local adaption/adoption and implementation. This paper describes the background to Freestyle Libre, the anticipated benefits and financial costs, and the implementation plan is included for information. Purpose: The purpose of this paper is to highlight that all CCGs in SWL have approved FreeStyle Libre® to be made available to specific cohorts of patients. This paper will enable the Committee in Common to understand:

A South West London view of the impact of implementation of this technology

Risks associated with resourcing implementation, and how it is proposed that these are minimised.

Reason for Committee Review: To ensure that all CCGs have full understanding of the process for implementation of the Freestyle Libre® technology, including the criteria for stopping use of the

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technology, the financial risks associated with implementation of the technology, and the steps in place to mitigate this.

Key Issues: 1. Freestyle Libre® has been approved for implementation in all 6 CCGs in South West London. 2. Implementation will be in line with the London-wide implementation plan, which includes definition of eligible patient groups, initiation by hospital specialists only, assessment of outcomes at 6 months, and stopping use of technology if agreed outcomes are not achieved. 3. Implementation presents financial pressure to CCGs via the primary care prescribing budgets. If improved outcomes for patients are achieved, this will result in improved outcomes and quality of care for patients and savings elsewhere within the NHS. The implementation plan includes steps to ensure use of the technology where improved outcomes are demonstrated, and to mitigate the financial pressure.

Conflicts of Interest: None

Mitigations: N/A

Recommendation: The Committee is asked to NOTE the decision made by CCGs and the implementation plan.

Corporate Objectives This document will impact on the following CCG Objectives:

Management of financial resources

Improving outcomes for patients.

Risks This document links to the following CCG risks:

Potential for increased financial risk if implementation of the technology is not undertaken in a planned and equitable way.

Mitigations Actions taken to reduce any risks identified:

Implementation plan includes steps to ensure that use continues only where improved outcomes are demonstrated.

Financial/Resource/ QIPP Implications

Whilst the technology represents an initial cost pressure to CCGs, it is anticipated that future savings would come from improved glucose control, translating into fewer complications, reduced emergency admission, and less use of glucose test strips. This assumes that patients achieve the intended outcomes in blood sugar control. Strict monitoring is intended to ensure that patients only

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continue using the device if intended outcomes are achieved (at 6 months and annually thereafter).

Has an Equality Impact Assessment (EIA) been completed?

N/A

Are there any known implications for equalities? If so, what are the mitigations?

N/A

Patient and Public Engagement and Communication

N/A

Previous Committees/ Groups Enter any Committees/ Groups at which this document has been previously considered:

Committee/Group Name: Date Discussed:

Outcome:

NHS South West London Senior Management Team.

Thursday, 02 August 2018

Decision for paper to be sent to Committee in Common for note.

Croydon, Kingston, Merton, Richmond, Sutton, and Wandsworth CCG’s (individual) Medicines Governance Committees.

Various Criteria for patient selection and implementation plan agreed between April and August 2018 (depending on CCG).

Click here to enter a date.

Supporting Documents Attached paper: Access to and Implementation of Freestyle Libre® Guidance in South West London

Sarah Taylor, Head of Medicines Optimisation. NHS Sutton CCG (on behalf of SWL CCG Chief Pharmacists) 07/09/2018

Access to and Implementation of Freestyle Libre ® guidance in South West London

The purpose of this paper is primarily to highlight that all CCGs in SWL have approved FreeStyle Libre® to be made available to specific cohorts of patients.

The paper will enable the Committee in Common to

have a South West London view of the impact of implementation of this technology

understand risks associated with resourcing implementation and how it is proposed that these are minimised

BACKGROUND

The FreeStyle Libre® flash glucose monitoring system is a device for the self-monitoring of glucose levels. Unlike traditional finger-prick devices (that measure the glucose level in the blood), FreeStyle Libre® measures the glucose level in the interstitial fluid, via a sensor that sits just under the skin. It can provide a near-continuous record, which is produced by the patient scanning the sensor with their reader-device, as and when required. FreeStyle Libre® was added to the drug tariff, and therefore able to prescribe on FP10, in November 2017. In November 2017, a national position statement was issued by the NHSE Regional Medicines Optimisation Committee (RMOC) for FreeStyle Libre®, for local adaption/adoption and implementation. London RMOC identified that more detailed implementation guidance was essential in the context of clinical priorities and configuration of services within the London region. This guidance was developed by the London clinical networks working in collaboration with the NHS London Procurement Partnership (LPP) This consensus is based on the RMOC position statement and recommends that the device is currently indicated for use in people with type 1 diabetes only, who are under specialist care, using multiple daily injections (MDI - 4 or more doses of insulin a day) or insulin pump therapy, as per the RMOC statement released in November 2017. The specific cohorts of patients within this group are detailed in the recommendations below. Future savings will come from improved glucose control translating into fewer complications, reduced emergency admission and less use of glucose test strips. However, at this stage, the scale of the savings cannot be quantified. The monitoring requirements will ensure that only patients achieving the required outcome to lead to clinical benefit will continue to receive the intervention, and therefore provide the assurance that the spend is an appropriate use of NHS resources. Criteria – Patient Groups

Recommended implementation of FreeStyle Libre® prescribing for patients with type 1 diabetes on MDI or insulin pump therapy who test frequently

Recommended implementation of FreeStyle Libre® prescribing for patients with type 1 diabetes with HbA1c >8.5% (69.4mmol/mol) or disabling hypoglycaemia who would be eligible for insulin pump therapy (per TA151) – pathway for specialist initiation

Recommended implementation of FreeStyle Libre® prescribing for patients with type 1 diabetes on MDI or insulin pump therapy where conventional monitoring is not possible with SMBG testing

Benefits

For patients with type 1 diabetes on MDI (4 or more insulin doses per day) or insulin pump therapy who test frequently (use of 8 or more test strips per day).

Savings arise from reduction in SMBG. Aim to reduce test strips by at least 8 strips/day (7 in children aged 0-19) to achieve cost-neutrality. Discontinue if not achieved by 6 months


For patients with type 1 diabetes with HbA1c > 69.4 mmol/mol (8.5%) or disabling hypoglycaemia who would be eligible for insulin pump therapy (NICE TA 151)

Improvement in clinical outcomes – continuation only if HbA1c reduced by 0.6% (6.6mmol/mol) and /or severe hypoglycaemia reduced by 75%

For patients with type 1 diabetes on MDI or insulin pump therapy where conventional monitoring is not possible with SMBG testing

Ensures appropriate monitoring of glucose levels for patients e.g. those with needle phobia (diagnosed), dementia, learning disability

These clinical criteria have been discussed and APPROVED by all SWL CCGs, via their medicines governance routes (e.g. Medicines Management Committees, Clinical Reference Groups etc.).

FINANCIAL IMPLICATIONS

Total no. patients registered with type 1 diabetes 1

1. for patients with type 1 diabetes on MDI or insulin pump therapy who test frequently2. Cost Neutral

2 for patients with type 1 diabetes with HbA1c >8.5% (69.4mmol/mol) or disabling hypoglycaemia who would be eligible for insulin pump therapy as per TA151

3. for patients with type 1 diabetes on MDI or insulin pump therapy where conventional monitoring is not possible with SMBG testing.

Total Budget impact

Budget impact

No. of patients

Budget impact 3

No. of patients

Budget impact

Total

Croydon CCG 1145 £0 172 £107,684 115 £100,188 £207,872

Kingston CCG 640 £0 96 £60,190 64 £56,000 £116,190

Merton CCG 490 £0 74 £46,083 49 £42,875 £88,958

Richmond CCG 640 £0 96 £60,190 64 £56,000 £116,190

Sutton CCG 740 £0 111 £69,595 74 £64,750 £134,345

Wandsworth CCG

1035 £0 155 £97,339 104 £90,563 £187,902

Total 4690 £0 704 £441,082 469 £410,375 £851,457 Note 1: data based on 2016/2017 National Diabetes Audit submissions Note 2: Intention should be to reduce test strips by at least 8 strips/day (7 in children aged 0-19) Note 3 Represents cost of freestyle libre® minus reduction in use of blood glucose test strips

Free style Libre® costs £840 per patient per year. There are potential offset costs from reduced use of blood glucose testing strips. There are other potential cost savings from e.g. reduction in carer/nursing time for those patients where conventional monitoring is not possible/difficult and future cost benefits if improved outcomes for patients are achieved resulting in reduced costs arising from managing the complications of diabetes. There is a cohort of patients across South West London who are currently self-funding the device. The numbers of these patients are not known and it is also not known how many of these patients meet the agreed criteria described on page 1 and would therefore be eligible for NHS funded devices It is worth noting that the costing model above represents the full year financial effect, assuming 100%

implementation and the patient number assumptions made in the modelling tool. Given that it is now


October and that implementation will be affected by hospital clinic capacity, the 18/19 financial impact will

be less than shown below, and therefore 50% of this figure may be considered more appropriate for 18/19.

It is acknowledged that investment monies are not available to support the funding of this device and the

expenditure will manifest as a cost pressure in the CCG primary care prescribing budgets.

A consistent approach to funding across SWL (and London) is desirable in terms of equity for patients, but additionally, patient choice will lead to patients choosing to be referred to providers, and being initiated on FreeStyle libre®, who are commissioned to provide the device, and therefore because of the reciprocal commissioning arrangements, CCGs will be required to continue treatment in line with host commissioner arrangements, and therefore bear the costs anyway, in addition to new attendance costs at that provider. IMPLEMENTATION

The detailed implementation plan is described in Appendix 1

The implementation plan and associated documentation is designed to ensure that the intended benefits of Freestyle Libre® are achieved, treatment stopped when agreed outcomes are not achieved and therefore minimise the financial risk to the NHS.

The implementation plan and documentation has been discussed and APPROVED by all SWL CCGs, via their medicines governance routes, as above.

For patients that meet (or may meet) the criteria, FreeStyle Libre® is recommended for specialist initiation and therefore initial prescriptions will be issued by specialist centres, not by primary care. Patients should not be referred into the specialist service for the specific purpose of obtaining an assessment to see if they meet the eligibility criteria for FreeStyle Libre®. The implementation plan requires that patients would be considered for NHS funded treatment at their next specialist appointment i.e. no new specialist capacity should be required. Rate of uptake will therefore be limited by hospital/appointment capacity:

Assessment will take place at their next routine appointment at the specialist centre.

Specialist Centre are to provide an annual update in usual appointment clinic that patient is benefitting from FreeStyle Libre® and therefore should continue.

Additional education and training, provided by the manufacturer, is necessary for any healthcare professionals or patients who wish to use this system

Patients currently self-funding this device will only be eligible for NHS treatment if evidence that the London Clinical Network criteria were met before starting treatment. These patients must be enrolled onto the NHS pathway via the local specialist service.

For patients who are currently self-funding this device and who do not meet the eligibility criteria for NHS funding, requests will be managed via the Individual Funding Request process, in line with all other interventions which are not routinely commissioned by the NHS.

Appendix 1 : Implementation Plan


Supplies and Review

Sp

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ialis

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up

ply

Initial supply Starter pack (one reader and one sensor) provided direct from clinic - no prescription required (note that this is provided to the specialist centre free of charge by the manufacturer) plus one sensor on a hospital prescription from the specialist centre. To be provided on the day of the training session. A copy of the patient-prescriber agreement* is sent to the GP practice

Further supply at 1 month follow up

Patients are expected to attend an initial follow-up session regarding use of the device at 1 month to confirm appropriate usage, ensure that the patient remains engaged and us using the device correctly and without problems etc. If use is to continue, one further prescription from the specialist centre for two sensors to be supplied (one month). Request for short-term prescribing* (recommendation 2) or request for primary care review *(recommendation 1&3) provided to the GP practice via transfer of care documents (see attached)

Pri

mary

care

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ly v

ia F

P1

0

fro

m M

on

th 3

Prior to confirmation of outcomes (clinic outcome review appointment at 3-4 months)

Primary care practitioners are asked to issue acute prescriptions for months 3, 4 and 5 (maximum of three months) prior to confirmation of transfer of prescribing to repeats. Primary care practitioners may wish to confirm details for recommendations 1 and 3 in their practices and feedback information to the clinic at 6 weeks. The specialist’s details should be included on the form.

At 6 months Specialist centre to review patient and complete outcome forms, ‘request for long term prescribing of FreeStyle Libre ® for people with type1 diabetes*’/ ‘request for primary care follow-up* for FreeStyle Libre®’.

After confirmation of outcomes

After the final clinic outcome review appointment, transfer of prescribing responsibility form*s should be completed to confirm if prescribing can continue in the community on repeat prescription. It is important that the supply of sensors is not interrupted.

Ongoing review is expected via the specialist clinics at subsequent follow-up appointments

Summary table of responsibilities and paperwork

Month Activity Paperwork required Month -1 Initial discussion regarding FreeStyle Libre®

and agreement between prescriber and specialist clinician.

Patient-prescriber agreement to be read through and discussed. Referral to in-house training session.

Month 0 (Group) Training session at specialist site. If patient wishes to continue, completion of training will result in supply of FreeStyle Libre® handset and sensor starter pack, plus one additional sensor. Complete and sign patient- prescriber agreement.

Notify GP of initiation of FreeStyle Libre®, by sending completed patient-prescriber agreement. Clinic to complete initiation data collection form (see later section on data and monitoring).

Month 1 Patient to attend specialist centre for initial usage review (recommended in original training group) to discuss any potential issues with the technology. If continuation agreed, one further month of sensors (2 sensors) to be supplied from specialist care. Request short-term prescribing from

Prescription for 2 sensors from specialist centre. Send short-term prescribing request (indication 2) or request for prescribing review (1/3). Patient to book primary care appointment for 6 weeks’ post initiation, if applicable.


primary care using appropriate form.

Month 2 If locally agreed - GP to inform clinic of progress of outcomes for recommendations 1 and 3 following primary care appointment at 6 weeks. Primary care is asked to supply acute prescriptions for up to a further 3 months. The clinic will confirm continuation and need for repeat prescribing after next scheduled clinic appointment (at 3-4 months).

Primary care prescriptions – acute – for up to 3 months if GP practice has agreed.

Month 3-4 Specialist review of outcome achievement (may be facilitated by information from GP for 1 and 3) and formal request for long-term prescribing.

If continuation confirmed send long- term prescribing agreement to primary care. Continuation data collection form by specialist care. Set up of repeat prescription in primary care, if applicable.

1 year Review and annually thereafter Continuation data collection form by specialist care.

Note: The actions below are intended to additionally support appropriate prescribing of freestyle libre®

If patients do not attend agreed appointments (as detailed in patient-prescriber agreement) then prescribing will not be continued.

There is a short expiry on sensors (3 months) so large quantities should not be prescribed.

If a sensor fails, the manufacturer will replace them. It is important that patients are aware and do not request replacement sensors for faulty ones on prescription.

If the patient is not benefitting from FreeStyle Libre® and needs to move onto treatment with an insulin pump, FreeStyle libre® should be withdrawn.

Where appropriate and necessary, it is proposed that Medicines Optimisation teams could audit freestyle libre® use to ensure appropriate use and therefore provide assurance of spend. This may include

o patient selection is in line with recommendations o appropriate information has been provided to primary care o prescribing is only continued where anticipated outcomes are achieved o quantities of sensors prescribed are appropriate

Next steps Local clinicians need to be engaged in discussions to facilitate local implementation and ensure a controlled and supported rollout. This will include diabetologists, DSNs, GPs, & Practice Nurses. It is proposed that this will be undertaken across SWL and will establish

Process for initiation locally

Process for prescribing by acute specialist followed by GP practices including transfer of care documents.

Ordering information

Responsibility for reviewing treatment and stopping treatment if expected benefits are not met.

Potential for GP practices to conduct an initial primary care review of outcomes at 6-8 weeks for recommendation 1 and recommendation 3. This to be agreed locally.

Provision of training for clinicians