Dyspepsia Impact On Primary Care

1. Dyspepsia Impact On Primary Care Dr Paul Pickering GP, Bridlington Prescribing Lead YW&C PCT

2. Overview The scale of the problem in primary care The cost of dyspepsia Practice-based dyspepsia clinics

3. The Scale of the Problem Dyspepsia prevalence 40% population National data shows 3-5% population present to their GP with symptoms Consultation rates of 355 per 10000 pt yrs at age 25-44 to 789 per 10000 pt yrs at age 75-84 Population surveys imply 10% seek assistance from their GP 1% population referred for endoscopy Discrepancy between national data and population surveys due to a combination of factors including pt recall and correct clinical coding of reasons for consultationDiscrepancy between national data and population surveys due to a combination of factors including pt recall and correct clinical coding of reasons for consultation

4. GI Drug Spend NHS GI drug spend is �1.26 billion(71% increase in 2 years) Source IMS BPI December 2002 GI represents 16% NHS drug budget NHS GI drug spend is �1.26 billion(71% increase in 2 years) Source IMS BPI December 2002 GI represents 16% NHS drug budget

5. Cost of Dyspepsia �1.2 billion/yr with a cost growth of 8-9% 19 million prescriptions for PPIs PPIs account for 34% of the volume but 83% of the NHS upper GI spend Alginates are 41% of the volume and 4% of the NHS upper GI spend 40% of PPIs are being prescribed to long term users Maintenance dose PPI represents the minority NHS GI prescribing spend: source IMS BPI Dec 02 Note numbers above relate to NHS budget add further�130M on endoscopies(2000)NHS GI prescribing spend: source IMS BPI Dec 02 Note numbers above relate to NHS budget add further�130M on endoscopies(2000)

6. Cost of Dyspepsia Source IMS Health-MAT to Feb 2003 PPIs are 34% volume and 83% spend Alginates are 41% volume and 4% of spend Cost PPIs up 9.3% alginates down 1.1% Volume PPIs up 12.6% alginates down 0.7% Source IMS Health-MAT to Feb 2003Source IMS Health-MAT to Feb 2003 PPIs are 34% volume and 83% spend Alginates are 41% volume and 4% of spend Cost PPIs up 9.3% alginates down 1.1% Volume PPIs up 12.6% alginates down 0.7% Source IMS Health-MAT to Feb 2003

7. Cost of Dyspepsia Recorded reasons for long term PPI use Oesophagitis(2) 17% Reflux 40% Non-specific dyspepsia 30% Peptic ulcer disease 3% Oesophageal ulcer/stricture 2% Non-GI problems 1% Ref: (1) BNF September 2003, (2) Hungin APS, Rubin GP et al, 1999: Martin RM, Lim AG, 1998: Bashford JH, Norwood J, 1998 Findings at endoscopy British Society of Gastroenterology revised April 2002: 30% normal/30% HH,gastritis,duodenitis/10-17% oesophagitis/10-15%DU/5-10%GU/2%oesophageal-gastric cancerRef: (1) BNF September 2003, (2) Hungin APS, Rubin GP et al, 1999: Martin RM, Lim AG, 1998: Bashford JH, Norwood J, 1998 Findings at endoscopy British Society of Gastroenterology revised April 2002: 30% normal/30% HH,gastritis,duodenitis/10-17% oesophagitis/10-15%DU/5-10%GU/2%oesophageal-gastric cancer

8. Cost of Dyspepsia Findings at endoscopy Normal 30% Mild inflammation/HH 30% Oesophagitis 10-17% Malignancy 2-3% DU 10-15% GU 5-10% Stats from BS of Gastroenterology revised Apr 2002. NICE new document in discussion presently states 60% endoscopies are normal.Stats from BS of Gastroenterology revised Apr 2002. NICE new document in discussion presently states 60% endoscopies are normal.

9. National GORD Data PPI increase �10.5 M/yrPPI increase �10.5 M/yr

10. National GORD Data PPI increase 951,738 Rx or 8.6%PPI increase 951,738 Rx or 8.6%

11. National PPI Treatment Versus Maintenance Value Split Cost 65%:35% treatment to maintenanceCost 65%:35% treatment to maintenance

12. National PPI Treatment Versus Maintenance Volume Split Scripts 53%:47% treatment dose to maintenance Since NICE 2000 the ratio of maintenance dose PPI has improved from 42-47%(cf cost of PPIs increased by �102M over same period)Scripts 53%:47% treatment dose to maintenance Since NICE 2000 the ratio of maintenance dose PPI has improved from 42-47%(cf cost of PPIs increased by �102M over same period)

13. Current NICE Guidance Patients with mild symptoms of dyspepsia may be treated on either a step-up or step-down basis These patients should not normally be treated with a PPI on a long-term basis without a confirmed clinical diagnosis Patients with mild GORD symptoms and/or no proven pathology, can be frequently managed by alternative therapies such as alginates All doctors prescribing PPIs will need to review the indications for their use and assess the dose, with the aim of reducing or stopping them where appropriate NICE 2000 Guidance on the use of PPIs in the treatment of dyspepsia. Technology appraisal No.7NICE 2000 Guidance on the use of PPIs in the treatment of dyspepsia. Technology appraisal No.7

14. Cost of Dyspepsia Estimated that if this guidance was implemented it could lead to a reduction in PPI prescribing by at least 15% and save the NHS �40-50M/yr Reality is that the prescribing of PPIs for GORD and related conditions has increased by �102M since the guidance was published NICE 2000 No 7 Technology Appraisal Since NICE guidance published June 2000 the overall prescribing of PPIs for GORD and related conditions has increased from �446M to �548M(�102M increase or 23%)NICE 2000 No 7 Technology Appraisal Since NICE guidance published June 2000 the overall prescribing of PPIs for GORD and related conditions has increased from �446M to �548M(�102M increase or 23%)

15. Cost of Dyspepsia Apart from the financial implications are there any other costs relating to the prescribing of PPIs long term in the treatment of dyspepsia syndromes?

16. Cost of Dyspepsia Acid breakthrough day and night � 28% night-time, 17% after a heavy meal, and 8% daytime Safety and licence Masking of alarm symptoms Super secretion??? Abandoning lifestyle modifications Surveys suggest up to 60% pts on PPIs experience acid breakthrough symptoms at sometime (norm rather than exception!) other figures from 33%. Nocturnal acid breakthrough (NAB) defined as intragastric pH <4 for 1 hr during the night. As above thought to be common with first generation PPIs less common esomeprazole and rabeprazole. PPIs have short half-lives and only block active proton pumps. Even dosing PPI evening time will not necessarily block proton pumps that have become activated during the night.(NAB is reported commonly in pts taking PPIs bd) BNF licence for PPIs GORD-Initial 4 weeks at treatment dose followed by 4-8weeks treatment dose if not fully healed-maintenance dose thereafter(time frame not indicated)-increasing back to treatment dose if symptoms return Acid related dyspepsia maintenance-treatment dose 2-4 weeks according to response!(where licence stated-not all have this licence)Surveys suggest up to 60% pts on PPIs experience acid breakthrough symptoms at sometime (norm rather than exception!) other figures from 33%. Nocturnal acid breakthrough (NAB) defined as intragastric pH <4 for 1 hr during the night. As above thought to be common with first generation PPIs less common esomeprazole and rabeprazole. PPIs have short half-lives and only block active proton pumps. Even dosing PPI evening time will not necessarily block proton pumps that have become activated during the night.(NAB is reported commonly in pts taking PPIs bd) BNF licence for PPIs GORD-Initial 4 weeks at treatment dose followed by 4-8weeks treatment dose if not fully healed-maintenance dose thereafter(time frame not indicated)-increasing back to treatment dose if symptoms return Acid related dyspepsia maintenance-treatment dose 2-4 weeks according to response!(where licence stated-not all have this licence)

17. Practice-based Dyspepsia Clinics Nurse-led Stepped protocol NICE guidelines Systematic review of all patients on PPIs Patient education, awareness & involvement Promotion of a healthy lifestyle GP time freed up

18. Practice-based Dyspepsia Clinics Stepping-down appropriate patients from treatment to maintenance dose PPI Stepping-off appropriate patients from maintenance dose PPI to an alginate e.g. Gaviscon Advance Can significant prescribing savings be achieved?

19. Practice-based Dyspepsia Clinics PCTS SHARING DATA Bexley Brighton and Hove City Hartlepool North Lincolnshire � Scunthorpe Study Yorkshire Wolds & Coast � Field House Surgery Project Many PCOs have PPI review clinic pilots/processes underway(23) or actively considering(14) Scunthorpe-10,000 pt practice-initial study-Jane Cawston and Nicola Wood- Prescriber Feb 2003 FHS-Bridlington Practice/East Humberside 5.5 ptners-10,000 pts 35%>65yrs and 503 pts prescribed PPIs Project ran from Nov 02-Aug 03 Many PCOs have PPI review clinic pilots/processes underway(23) or actively considering(14) Scunthorpe-10,000 pt practice-initial study-Jane Cawston and Nicola Wood- Prescriber Feb 2003 FHS-Bridlington Practice/East Humberside 5.5 ptners-10,000 pts 35%>65yrs and 503 pts prescribed PPIs Project ran from Nov 02-Aug 03

20. Field House Surgery Project GP agreement on process and protocol Database search on all PPI�s Establish a disease register Identify patients from inclusion criteria Send letters to all included patients explaining changes to medication and offering nurse-led dyspepsia clinics Dyspepsia clinics Audit results Dyspepsia clinics 15mins/appt More time for patient education and lifestyle modification. Use of stomach model and written information for patients e.g. education leaflets and NICE guidance leaflets. Dyspepsia clinics 15mins/appt More time for patient education and lifestyle modification. Use of stomach model and written information for patients e.g. education leaflets and NICE guidance leaflets.

21. Field House Surgery Project INCLUSION CRITERIA GORD Reflux oesophagitis up to grade 2 Hiatus hernia Patients who have completed ulcer healing treatment Non-ulcer dyspepsia Uninvestigated dyspepsia

22. Field House Surgery Project EXCLUSION CRITERIA Patients on treatment <3 months Patients awaiting referral or under the care of a consultant Barrett�s oesophagus and strictures Reflux oesophagitis >grade 2 Patients >90yrs Terminal illness Immunosuppression therapy Pts on NSAIDs were only eligible for step-downPts on NSAIDs were only eligible for step-down

23. Field House Surgery Project PATIENT SELECTION 503 patients on PPIs 246 patients satisfy inclusion criteria 81 patients to be stepped-down 165 patients to be stepped-off

24. Field House Surgery Project STEP-OFF 165 patients 129 patients (78%) remain stepped-off at 4 months 117 patients (71%) remain stepped-off at 6 months STEP-DOWN 81 patients 66 patients (81%) remain stepped-down at 4 months 59 patients (73%) remain stepped-down at 6 months

25. Field House Surgery Project PPI Cost Savings �2465.96 per month Potential per year is �29,591.52 Overall Cost Savings Total cost savings per month = �1790.96(PPI savings � cost of other treatments) Potential cost savings for the year are �21,491.52 70%:30% maintenance:treatment dose PPI

26. Scunthorpe Study Step-Off 58% successfully maintained on Gaviscon Advance at 10 months after transferring from rabeprazole 10 mg 51% successfully maintained on Gaviscon Advance at 8 months after transferring from lansoprazole 15 mg Step-down 90% of patients remained on maintenance dose PPI after 7 months Prescriber Feb 2003 Jane Cawston/Nicola WoodPrescriber Feb 2003 Jane Cawston/Nicola Wood

27. Scunthorpe Study Overall Cost Savings �14,744 projected over the year

28. Practice-based Dyspepsia Clinics Establishing a process of review supported by NICE guidance. Improving patient management Breaking the cycle of long term PPI use Cost effective and appropriate prescribing Savings released to meet anticipated growth in prescribing relating to NSF targets and the new GMS contract NSFs-increased prescribing costs within existing budgets. Savings on inappropriate PPI prescribing can be released for other priority areas of healthcareNSFs-increased prescribing costs within existing budgets. Savings on inappropriate PPI prescribing can be released for other priority areas of healthcare

29. Dyspepsia Clinics and the New GMS Contract Records & information about patients - recording smoking status Medicines management - medication reviews/meeting PCO prescribing advisor Patient experience - patient surveys New GMS contract Quality indicators/quality points which can be contributed to by PPI review programmes Also whatever form the revised NICE Dyspepsia Guidelines recommendations will be made to review patients on PPIs regularly. 11-records/information/smoking status 23-medicines management/medication reviews/meeting PCO PA 30-patient experience/pt surveys 64 points!!!New GMS contract Quality indicators/quality points which can be contributed to by PPI review programmes Also whatever form the revised NICE Dyspepsia Guidelines recommendations will be made to review patients on PPIs regularly. 11-records/information/smoking status 23-medicines management/medication reviews/meeting PCO PA 30-patient experience/pt surveys 64 points!!!

30. Summary and Conclusions The scale of the problem in primary care - high prevalence 40% population The cost of dyspepsia - �548M/yr PPIs/83% upper GI spend Practice-based dyspepsia clinics - Cost-effective and evidence-based review of patients with chronic or relapsing symptoms NB �548M/yr on PPIs in GORD and related conditions PPI represent 83% upper GI spend PPI volume growth 12.6% PPI cost growth 9.3%(difference ? Generic PPI)NB �548M/yr on PPIs in GORD and related conditions PPI represent 83% upper GI spend PPI volume growth 12.6% PPI cost growth 9.3%(difference ? Generic PPI)

31. DyspepsiaImpact on Primary Care Dr Paul Pickering GP Bridlington Prescribing Lead YW&C PCT