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

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Cancer medicine approval in nhs north east

Cancer Medicine Approval In NHS North East

Steve Williamson

Consultant Pharmacist

Northern Cancer Network


Northumbria Healthcare NHS Trust

North of england cancer drug approvals group
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?

Introducing new cancer drugs how to get it right
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

Cancer drug approvals in the uk
Cancer Drug Approvals in the UK

  • NICE

  • SMC




  • Other Network Groups

Neccdag who are we
NECCDAG - Who Are We?

  • Serves 3.2 Million (Bigger than Wales! 3/5 of Scotland)

  • SHA Promoting NHS North East – Strong Vision and Leadership

North of england cancer drug approval group ne cdag
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

North of england cancer drug approval group ne cdag1
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


  • 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

North of england cancer drug approval group ne cdag2
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

North of england cancer drug approval group ne cdag3
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

North of england cancer drug approval group ne cdag4
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

Cancer medicine approval in nhs north east

North of England Cancer Drug Approval Group (NE CDAG)

Summary of Application Process

Local Chemotherapy Group


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)





Scanning (Potential Applications & Applicant identified)

Gateway Group

Prioritises Applications.

Adds Financial & Service

Impact information.

Advises on Implementation.

Cancer Drug Approval Group

Clinical & FinancialApproval



for 12 months


new evidence

Decision Communicated to Stakeholders: PCTs, TSG Chairs, Trusts, Network Boards, Network Chemo Groups

Press Release Prepared


14 days




  • Implementation according to plan in application form undertaken

  • Treatment protocol added to NCN/CCA Chemotherapy Approved Lists

Decision making simple approach to quality adjusted life years
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!!

Working with qalys
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

Working with qalys1
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.

Lessons learnt
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

Lessons learnt1
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

Still learning
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!

Necdag decisions
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…..

Consequences of cost effectiveness rationing of chemotherapy the saga of alimta
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


  • 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

Challenges for the future
Challenges for the Future – The saga of Alimta

  • Saying No – Dealing with appeals

  • Marginal Benefit

  • Right to NHS treatments

  • Patient and public pressure

  • Exceptional circumstance pathway

  • Co-Payment

Challenge of saying no
Challenge of Saying No – The saga of Alimta

  • 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

Challenge of marginal benefit
Challenge of Marginal Benefit – The saga of Alimta

  • 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

Exceptional circumstance
Exceptional Circumstance – The saga of Alimta

  • 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

Co payment
Co- Payment – The saga of Alimta

  • 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


  • Access to treatment regardless of ability to pay

  • Will Chemotherapy PBR open this up further?

Conclusions – The saga of Alimta

  • 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!)