Business Case for COPD Local Enhanced Service. Distribution Seen prior to overall Gateway Sign-Off Date

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1 Programme Title Author Primary Care Business Case for COPD Local Enhanced Service Jessica Adcock Dr Mark Lim Distribution Seen prior to overall Gateway Sign-Off Date SRO Sadie Parker Project Manager Jessica Adcock Finance Lead TBC [FRG 11 th January 2018] TBC PMO Lead Tessa Litherland BI Lead Sara Morris Primary Care Lead Sadie Parker Clinical Lead Michael Dennis, Jessica Adcock and Dr Mark Lim Document Location This will updated following the Shared Drive Redesign. Version Control Version number Date Created Reason for Update /12/2017 Circulation prior to simultaneous submission to FRG 8 th January and Clinical Executive 11 th January (simultaneous required due to no FRG on 1 st January) /01/2018 Addition of ICS/LABA, trial of LAMA, step down ICS to LABA/LAMA device /01/2018 Revised Financial Summary with LABA costs Changes marked in document by Dr Mark Lim Jessica Adcock Dr Mark Lim Document Status Draft Draft Submitted to CEC and FRG

2 Executive Summary Context: The last NICE Clinical Guideline for COPD was published in Since then there have been effective primary-care based initiatives for COPD, including two focused on admission reduction in the region (Ipswich & East Suffolk and Southend) and others focused on reviewing patients on inhaled steroids (Going for GOLD) which draws heavily on guidelines from the Global Initiative for Chronic Obstructive Lung Disease. Most patients on inhaled steroids use this drug as one of three aimed at controlling their disease ( triple therapy ). Commissioning guidance from the National Clinical Director for Respiratory Disease has shown that triple therapy has a widely variable cost-effectiveness in practice, between 7,000 and 187,000 per Quality Adjusted Life Year. Despite declining smoking prevalence, the absolute number of COPD cases will increase in the Western World by more than 150% from 2010 to In particular, the greatest growth will be in the older age group, 75yrs and older, where the absolute number will increase by 220%. This makes it especially important that commissioners reduce the reliance on specialists at the hospital and take into account the potential risks that older, frailer patients face if admitted because of their COPD. In Great Yarmouth and Waveney, known COPD prevalence in high 2.7% compared to an England average of 1.9%; this is the ninety-first centile. The proposal is for a Local Enhanced Service to improve COPD care. The reasons for commissioners preferring this route, and why this constitutes an enhanced service, are set out in section 2 of this document. The six key components are: Six Key Components: 1. Review of COPD Patients currently prescribed an inhaled corticosteroid (ICS). Each patient will be recommended one of the following actions: a) Step down and stop patients inappropriately prescribed ICS b) Patients who require ICS to be switched to appropriate cost-effective inhaler device c) Continue on current regimen 2. Reducing their risk of admission through: a) Issuing a steroid rescue pack if appropriate b) Giving the patient a red card which would gain immediate access to a General Practitioner or nurse practitioner and c) Referring to smoking cessation if appropriate

3 Benefits There will be clinical benefits to the patients in terms of receiving treatment of a suitable intensity for their disease. It would provide value for money through: a) Switching of patients on triple therapy to a cost-effective single triple device or b) Step down to LABA / LAMA for 12-month period or c) Trial patients on ICS/LABA with LAMA and step down to LABA/LAMA d) Reduction of non-elective admissions through the above early intervention measures e) Patients taken off steroids are at lower risk of non-elective admissions triggered by infection Clinical Executive is asked to: a) Approve the clinical aspects of this Business Case such as patient selection, use of the more cost-effective inhaler, stepping down, and review with a view to reducing admission; this will be used in particular to populate a GP review section which will be added to this template. b) Advise whether the assumptions are clinically realistic. Primary Care Committee is asked to: Approve the Business Case overall including the preferred placement suggested by the Clinical Commissioning Team. Financial Summary Year One The Spend ( ) 55,068 Savings 295,733 Net Spend or Savings 234,789 Project Definition 1. Introduction and Overview The epidemiological context was stated on the first page of this template. The business case seeks to: a) To summarise the clinical evidence for a primary care scheme aimed at keeping patients at high risk of non-elective admission at home and appropriate use of inhaled corticosteroids b) To obtain clinical approval and secure GP support for the Project c) To obtain financial approval and secure formal investment in the Project

4 If approved, the CCG will undertake the actions set out in Section 9, namely offer a Local Enhanced Service to General Practices, establish a reporting mechanism for both the inhaled corticosteroid and admission prevention elements, and monitor impact through the CCG s regular QIPP programme reporting requirements. Aside from the clinical and financial direct to the CCG and its patients, it is hoped that there will be indirect benefits in terms of reduced pressure on A&E, ambulance services, community services, out of hours general practice, and over the course of the year, general practice itself. 2. Service Proposals and Expected Benefits At the time of writing, the current number of patients on corticosteroids who would be reviewed is 2344 out of a population of 6511 registered COPD patients i.e 36%. As the cohort of 2344 patients will mostly be those on triple therapy (i.e. more or less maximal treatment in primary care though there may be some on LABA and ICS without trial of LAMA) for pragmatic reasons we suggest this is also the cohort reviewed for nonelective admission prevention actions (assessment for need of red card, rescue pack and smoking cessation referral). Review of Patients with Inhaled Corticosteroids Below is the protocol provided by South Devon and Torbay CCG team in its resource pack to fellow CCGs considering the implementation of the scheme.

5 The full-year predicted savings would be 250,000 based on 50% of each group switch to single triple device or step down to LABA/LAMA for 12 month period. This is however phased if the business case is implemented in Q1 in practices savings made in Q2, Q3 and Q4 = 177,820. This however has to be offset by the fact that some patients with LABA+ICS may be prescribed LAMA, which leads to a part year effect of 173,688. Workings shown on table on following page. Admission Prevention 1. Mainly as a winter recovery action, Southend CCG approved a similar business case and LES in December out of 19 practices took up the task to review 25% of their COPD population by April 1 st 2017 and if appropriate, issue steroid rescue packs, provide red cards for fast access and refer to smoking cessation: In the business case, the scheme was intended to reduce the number of admissions by 26. The 25% fixed figure was used so that the CCG could identify exactly how much money the LES would cost. The number of non-elective admissions using codes J22X, J440, J441, J448, J449 between April 1 st 2017 and September 30 th 2017 was 353, compared to 383 in 2016 (a nine percent decrease). An interesting comparator is Castle Point and Rochford CCG which shares the same medicines management team, acute trust, same community provider and same out of hours general practice provider. This CCG did not implement the scheme and experienced a slight increase, 311 compared to 308 (one percent increase). 2. Ipswich and East Suffolk CCG ran a similar scheme, where there was also an element

6 of case-finding and use of GRASP-COPD to select patients. In the end 2253 out of 6522 registered COPD patients (35% of patients) were seen. The Lay Chair of the Commissioning Governance Committee (equivalent of the Primary Care Committee) has shared that the number of COPD admissions in Jan- March 2014 was twenty-four percent less than in Jan-March 2013, and that the scheme was therefore renewed for 2014/5. There was however no comparator as good as Castle Point and Rochford was for Southend. From 2015/6 onward the CCG was in a block contract with Ipswich Hospital. 3. For Great Yarmouth and Waveney CCG, in 2016/17 there were 598 COPD admissions costing 1,241,707 if Primary Diagnosis is used. The figures are similar if the data is filtered using the financial coding system called the Healthcare Resource Group 635 admissions, 1,297,336 so we can be reasonably confident of the amount of admissions we are trying to affect. In terms of estimating what our local impact might be, an estimate between nine and twenty four percent would be obviously arbitrary, but commissioners would tend towards the Southend effect size due the control CCG, but take into account the relatively low uptake in Southend. For the purposes of this business case, a percentage of thirteen percent has been taken; as a proportion of 1,241,701 this would be 161,421; if the practices are asked to complete the review by the end of June and nine-month part year effect of 121,065. There may be some additional benefit from the steroid reductions in terms of infective exacerbations.

7 Savings from Inhaler Switches and Step-downs COPD 1 FEV1 <50% Spiriva Triple COPD 2 FEV1 >50% Spiriva Triple No asthma COPD 3 FEV1 <50% Seebri Triple COPD 4 FEV1 >50% Seebri Triple No asthma COPD 5 FEV1 >50% ICS/LABA No LAMA No asthma No of patients LAMA + LABA/ICS /28 days TT Single device /28 days LABA/LABA /28 days Clenil 100 Step down 1 x 200 Savings /28 days Savings /12 months (13 disp minus Clenil cost) CCG savings based on 50% switch /12 months CCG savings based on phasing /Q2,Q3,Q ,793 25, ,036 67, ,979 13, ,045 72, (3.18) (48.76) ( ) ( )

8 3. Market Analysis The current Quality and Outcomes Framework for General Practices covers the following aspects of care for COPD: Establish and maintain a register of patients with COPD Confirm diagnoses of COPD using handheld equipment (spirometry) and the use of bronchodilator (airway opening) drugs Review the extent to which the patient is breathless using a scale developed by the Medical Research Council Quantify how effective the lungs are at expelling air (FEV1) Measure oxygen levels in the more severely affected patients Give the flu jab The six additional actions which form this proposal are not on the above list. Commissioners nevertheless recommend the General Practice as best setting for the service proposals for the following reasons. General practices will have access to the fullest information e.g. their latest FEV1, how many times they visited their GP with an exacerbation. One of the actions is GPs issuing red cards to fast track COPD patients within their own surgeries. We want most prescribing decisions for each COPD patient to be under the auspices of primary care; having an outside entity do this runs counter to this. This is different to some other clinical scenarios (such as Direct Oral Anticoagulants) where patients do not require shifts between different classes of drugs as often as COPD patients. A prescriber is required. GP resources are scarce, but the CCG would not want respiratory specialist nurses or consultants undertaking mass reviews, and would prefer them focused on cases where the standard treatments have not worked. Referral from a patient s regular GP is one of the most effective prompts to smoking cessation. The two successful case studies for the admission prevention element in the region were both commissioned from General Practice. Clinical Executive and Primary Care Committee are asked to note that the CCG has already taken significant actions to improve the acute, community services and ambulance services elements through the STP Respiratory RightCare Project further information on these projects is available on request. 4. Funding Source / Timing / Certainty The cost of the Suffolk scheme was 26 per patient. Based on this, the Southend scheme was 26 per patient as well. This is also consistent with research on unit costs at the University of Kent in 2011 which estimated that nurse appointments cost 23 and GP appointments cost 36, excluding the cost of training.

9 It is possible that some practices may lack the capacity to do the reviews and we would not wish them to opt out entirely if they did not have capacity to do all the actions. The proposed approach is to therefore offer a per patient reviewed reimbursement mechanism of 26 per patient. If there the LES was taken up and every single patient on inhaled steroids at the time of writing was reviewed, the total cost would be: 60, Cost / Benefits Assessment Cost of Local Enhanced Services at 100% Uptake: ( 60,994) Part Year Effect of Medicines Management: 173,868 Part Year Effect of Admission Prevention: 121,865 Estimated net Financial Benefit in 2018/19: 234,789 There are likely to be ongoing financial benefits from patients being on few corticosteroid inhalers or cheaper triple inhalers in 2019/ Delivery Timeline, with Key Project Milestones Main Milestones and Dates Proposed Start Proposed End Proposal to Financial Recovery Group 5 th January th January 2018 Proposal to Clinical Executive 5 th January th January 2018 Approval at Primary Care Committee 1 st February st February 2018 Write Local Enhanced Service Specification 12 th January st February 2018 Development of Practice Guidance 12 th January st March 2018 Development of Clinical System Templates 12 th January st March 2018 Patient Reviews in Primary Care 1 st April th June Risk Register Risks Impact Response Inadequate incentivisation Fewer step-downs and 3-month implementation period or capacity within primary switches, lesser effect on Financial Incentivisation care may hamper uptake non-elective admissions Once reviewed there may be fewer than expected switches and step-downs, Fewer than anticipated step-downs and switches and lesser effect on nonelective Development of a Clinical Systems Template and a signature Read code to track uptake. or smoking referrals, use of red cards and steroid admissions Development of STP steroid rescue pack guidance rescue packs Return required for reimbursement will ask for numbers of each of the six actions

10 8. Options Risks Advantages Disadvantages Do nothing Avoid the initial financial resource to fund the Local Enhanced Service Avoid the project management resource required to issue the Local Enhanced Service and monitor its effects Avoidance of additional workload on general practice This project has the potential to save money, improving quality of care. The CCG would have to find a replacement scheme which may not improve quality. Lost opportunity to drive down smoking prevalence Respiratory winter pressures may force commissioners to act in any case; a late implementation would be harder to achieve and less effective. Approve LES Switching of patients on triple therapy to a cost-effective single triple device Step down to LABA / LAMA for 12-month period. Patients taken off steroids are at lower risk of non-elective admissions triggered by infection Reduction of non-elective admissions through the above early intervention measures Element of risk, not guaranteed that the time spent by General Practice or money spent by the CCG will be recouped The CCG will have to trust the practices self-reporting to a certain extent in order to make this proposal workable 9. Recommendation Clinical Executive is asked to: a) Approve the clinical aspects of this Business Case such as patient selection, use of the more cost-effective inhaler, stepping down, and review with a view to reducing admission; this will be used in particular to populate a GP review section which will be added to this template. b) Advise whether the assumptions are clinically realistic. Primary Care Committee is asked to: Approve the Business Case overall including the preferred placement suggested by the Clinical Commissioning Team.

11 10. Sign-Off Business case Project title, with PMO reference and Version No Approved subject to minor amendments Requires resubmission to (Date) CFO Decision Comments FRG Decision Comments CEC Decision Comments Date Date Date Appendices Please list all appendices and ensure you have cross-referenced them in the main text so that sign-off is made with full view of the additional information (number/letter) (number/letter) (number/letter) (number/letter) (number/letter) GP Sign Off CQRA/EIA/PIA/DPIA as applicable Stakeholder Plan (provided by Communications and Engagement team) Finance and Activity Profile Summary Other References. Please return completed form to

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