Cancer Medicine Approval In NHS North East

1. Cancer Medicine Approval In NHS North East Steve Williamson Consultant Pharmacist Northern Cancer Network & Northumbria Healthcare NHS Trust

2. North Of England Cancer Drug Approvals Group • Who are we? • What are we doing? • What Lessons have we learnt? • What Challenges do we all face?

3. Introducing new cancer drugs -How to get it right • Resources limited, money, staff to make & give chemo • Cancer drugs have readily identifiable costs and benefits • Can’t have everything, Decisions have to be made • Is the drug clinically effective? • Is the drug cost effective? • Can the local healthcare economy afford the budget impact? • Balance tensions between efficiency and equity • Must ensure consistency of approach • Must assess each drugs case on its own merits

4. Cancer Drug Approvals in the UK • NICE • SMC • AWMSG • LNCDG • NECDAG • Other Network Groups

5. NECCDAG - Who Are We? • Serves 3.2 Million (Bigger than Wales! 3/5 of Scotland) • SHA Promoting NHS North East – Strong Vision and Leadership

6. North of England Cancer Drug Approval Group (NE CDAG) • Formed May 2005 • Two Cancer Networks in North East • Two sets of decisions = PCT’s making different funding decisions • Two High profile media drug campaigns highlighted issues to North East Chief Execs (Herceptin & Alimta) • SHA wanted equity • PCT wanted help with difficult decisions • NECDAG born

7. North of England Cancer Drug Approval Group (NE CDAG) • Chair – Ian Dalton, Chief Executive of North East NHS (SHA) Formerly CE of North Tees & Hartlepool Trust Purpose • To ensure that all patients with cancer in the North East Cancer Networks receive equitable access to a clinically defined appropriate range of cancer medicines. • Acts as an expert body within the North East • Make decisions about availability of new and existing cancer drugs

8. North of England Cancer Drug Approval Group (NE CDAG) • Accept all NICE recommended Drugs • Advise PCTs of financial and service impact • NICE due within 3 to 6 months = not considered • Prioritise:- non NICE recommended potentially curative drug- non NICE Palliative (non curative) • ‘Horizon Scan’ • Audit, Evaluate, Support Implementation • Make dis-investment decisions where appropriate • Encourage the use of new drug therapies in clinical Trials

9. North of England Cancer Drug Approval Group (NE CDAG) • NECDAG Considers • New drugs for cancer • New indications for old drugs • New combinations of drugs • Hormonal, supportive and other licensed new / novel treatments • Unlicensed medicines only in exceptional circumstances • Reviewing policy on off-label medicines, e.g. FEC-T

10. North of England Cancer Drug Approval Group (NE CDAG) • Meets 4 to 5 times per year. • Quorm = 3 out of the 5 PCT cluster representatives • 75% majority for agreement • In event of lack of unity Final Voting rests with PCT commissioners • Submissions sent electronically on the ‘New Product Request’ form by set deadlines • Network Pharmacists provide cost analysis & support • Requests presented by a nominated member of the Tumour Specific Group • PCTs / Trusts informed of decisions within 7 days

11. North of England Cancer Drug Approval Group (NE CDAG) Summary of Application Process Local Chemotherapy Group TSG Approval Group Membership: 2 Network Chairs (rotating) 2 Network Directors 2 Clinical Reps NCN 2 Clinical Reps CCA 2 Network Medical Directors 2 Network Pharmacists 1 SHA Executive Director 1 SHA Communications Lead 2 Network Patient Reps 5 PCT Executive Directors (1 Cumbria, 4 from joint SHA area) 2 Public Health Reps Imminent NICE Appraisal (Financial & Service Impact Assessed) CANCER DRUG APPLICATION FORM Horizon Scanning (Potential Applications & Applicant identified) Gateway Group Prioritises Applications. Adds Financial & Service Impact information. Advises on Implementation. Cancer Drug Approval Group Clinical & FinancialApproval NO re-submission for 12 months Unless new evidence Decision Communicated to Stakeholders: PCTs, TSG Chairs, Trusts, Network Boards, Network Chemo Groups Press Release Prepared Within 14 days No APPROVED Yes • Implementation according to plan in application form undertaken • Treatment protocol added to NCN/CCA Chemotherapy Approved Lists

12. Decision making - Simple Approach to Quality Adjusted Life Years QALY’s combine the Quantity and Quality of Life (QoL). Utility Values • One year of perfect health = 1 • One year of less than perfect Health > 1 (RIP = 0) Calculating QALYs • Intervention A = patient lives extra 2 years in heath state 0.75 • 2 years extra life @ 0.75 QoL = 2 x 0.75 = 1.5 QALYs gained Applying QALYS to cost effectiveness decisions • Intervention A, costs £10,000 and generates 1.5 QALYs • Therefore cost per QALY = £10,000/1.5 = £6,667 • Intervention A appears NICE friendly!!

13. Working with QALYs • Difference between QALYS and associated costs used to assess cost effectiveness = Incremental Cost Utility Ratio ICR • ICR can show differences between chemotherapy regimens • E.g. CHOP vs. R-CHOP for aggressive Non-Hodgkin's Lymphoma ICR = £7,500 for patients < 60 years & £10,500 for > 60 years* *Ref ‘Rituximab for aggressive Non-Hodgkin's Lymphoma’ NICE Technology Appraisal 65 Sep 2003

14. Working with QALYs • Not all interventions easily assessed by ICR model • Health Economic studies use robust cost utility models (computer simulations) e.g. Markov models • Sensitivity analyses crucial to check accuracy of model • Sensitivity analysis test affect of changes in clinical outcomes andresource costs on QALY outcomes (CI’s) • Changes in Median overall survival benefits • Changes in Median progression-free survival benefits • Quality of life (utility) for stable vs. progressive disease • Drug costs; discounts, No of cycles of drug given etc.

15. Lessons Learnt • Look to NICE to set the standards • Be brave don’t just make easy clinical decisions • Don’t be scared of QALYS • Health economist expertise very rare • Use as a guide only, not the be all and end all • Not perfect, best tool we’ve got • More complex is not necessarily better

16. Lessons Learnt • Why have we been a success? • Action at Chief Executive level • PCT and Commissioner ‘buy in’ from start • Funds follow decisions • Use NICE standards for assessing evidence • Make Tough decisions, i.e. We do say No • Strong Leadership & respected experts • Patient Presence

17. Still Learning! • Want to offer North East patients best medicines • Have to keep commissioners happy • Learn to deal with Phase II evidence & Lack of survival data • Need good intelligence e.g. ASCO etc • Need credibility with clinicians • Learn to work with industry on prices • Need to manage the media – Press officer vital • We need to encourage NICE to go faster!

18. NECDAG Decisions • Adjuvant Temozolomide Approved for PS 0 & PS1 <50 years (Nov 06) • Revised NICE FAD (March 07) very later similar • Erlotinib initially rejected but to be reviewed in Nov 07 • Dasatinib – not approved • Sunitinib for Renal Cell cancer - Approved • Pemetrexed – approved pre NICE…..

19. Pressures facing cancer drug decision makers The case of Alimta in North East

20. Consequences of cost effectiveness rationing of chemotherapy – The saga of Alimta • 2005 application for to use (Alimta) pemetrexed for mesothelioma in North East England was rejected as not shown to be cost effective. • (QALY = £36,000 to £47,000) • Industrial heritage = local population greatly affected • Patients and their oncologists very unhappy with decision • Northeast Newspaper Campaign Petition from MP’s, footballers! etc • Public pressure forces executive action from health bosses • ALIMTA APPROVED • But…NICE then reject Alimta • Appeal Hearing Nov 2006 • March 2007 Draft appraisal still negative • July 2007 – FAD Alimta approved – QALY’s drop from £60K to £34.5

21. Challenges for the Future • Saying No – Dealing with appeals • Marginal Benefit • Right to NHS treatments • Patient and public pressure • Exceptional circumstance pathway • Co-Payment

22. Challenge of Saying No • Benchmarking • Same evidence why different decisions? • Health economist advice • Variation in Cost effective Analysis • NECDAG uses simple in house QALY models • Do we trust QALYS? • BMJ article showed great variance in NICE QALYS vs Industry1 • Threat of litigation • PCTs statutory body – NECDAG advisory • ? Can we be sued? • Publication of our decisions - NHS or Public 1. Comparing estimates of cost effectiveness submitted to the National Institute for Clinical Excellence (NICE) by different organisations: retrospective study A H Miners et al BMJ 2005;330;65

23. Challenge of Marginal Benefit • Key is benefit • Clinical, Economic, or Both • What is marginal ? • ? 3 months extra erlotinib / pemetrexed in lung • < 6 weeks Gem/Cap for pancreas • Supply and Demand • Cancer medicines Big business • Patients want hope • International Market can take premium prices • Need to Work Industry on UK pricing

24. Exceptional Circumstance • PCTs have to consider EC requests • Difficult to refuse on grounds of cost • How to ensure equity if each PCT make own decision? • NECDAG has vested interest • Can you have guidance on what is an exception? • If it can be anticipated then is it an exception? • Approvals process needs to anticipate potential EC requests, e.g. look at subgroups etc. • More pressure on upfront decisions

25. Co- Payment • PCTs need NECDAG advice • Can NHS Patients buying their own medicines? • Difficult exceptional Cases • Drug rejected on evidence of marginal response and high cost – i.e. low average response rate… but • NHS patient buys drug privately is a responder • Runs out of money- can we morally refuse to treat? • Patients Right to NHS treatment vs • Access to treatment regardless of ability to pay • Will Chemotherapy PBR open this up further?

26. Conclusions • North East Group Effective and Credible • Can be done elsewhere • Needs Regional Approach = Unity • Equity within North East but differences elsewhere – regional postcode prescribing. • Higher Profile = More scrutiny • Continues to face fresh challenges • Would be happy to not exist (Fast NICE!)