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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
  • AWMSG
  • LNCDG
  • NECDAG
  • 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

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
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
slide11

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
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
  • 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
challenges for the future
Challenges for the Future
  • 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
  • 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
  • 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
  • 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
  • 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?
conclusions
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!)
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