Cancer Medicine Approval In NHS North East

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Cancer Medicine Approval In NHS North East

• Steve Williamson
• Consultant Pharmacist
• Northern Cancer Network
• Northumbria Healthcare NHS Trust

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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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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
• Cant 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

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Cancer Drug Approvals in the UK

• NICE
• SMC
• AWMSG
• LNCDG
• NECDAG
• Other Network Groups

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NECCDAG - Who Are We?

• Serves 3.2 Million (Bigger than Wales! 3/5 of
  Scotland)
• SHA Promoting NHS North East Strong Vision and
  Leadership

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North of England Cancer Drug Approval Group (NE
CDAG)

• Formed May 2005
• Two Cancer Networks in North East
• Two sets of decisions PCTs 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

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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

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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

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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

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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

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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)
Cancer Drug Approval Group
Gateway Group Prioritises Applications. Adds
Financial Service Impact information. Advises
on Implementation.
Clinical Financial Approval
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
No
Within 14 days
APPROVED
Yes

1. Implementation according to plan in application
   form undertaken
2. Treatment protocol added to NCN/CCA Chemotherapy
   Approved Lists

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Decision making - Simple Approach to Quality
Adjusted Life Years

• QALYs combine the Quantity and Quality of Life
  (QoL).
• Utility Values
• One year of perfect health 1
• One year of less than perfect Health gt 1 (RIP
  0)
• Calculating QALYs
• Intervention A patient lives extra 2 years in
  heath state 0.75
• 2 years extra life _at_ 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!!

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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
  lt 60 years 10,500 for gt 60 years
• Ref Rituximab for aggressive Non-Hodgkin's
  Lymphoma NICE Technology Appraisal 65 Sep 2003

Cost Utility Ratio () (ICR) Cost of Intervention A - Cost of Intervention B
Cost Utility Ratio () (ICR) No. QALYS with Intervention A - No. QALYS with Intervention B
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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 and resource costs on QALY
  outcomes (CIs)
• 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.

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Lessons Learnt

• Look to NICE to set the standards
• Be brave dont just make easy clinical decisions
• Dont 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 weve got
• More complex is not necessarily better

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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

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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!

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NECDAG Decisions

• Adjuvant Temozolomide Approved for PS 0 PS1 lt50
  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..

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Pressures facing cancer drug decision makers The
case of Alimta in North East
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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 MPs,
  footballers! etc
• Public pressure forces executive action from
  health bosses
• ALIMTA APPROVED
• ButNICE then reject Alimta
• Appeal Hearing Nov 2006
• March 2007 Draft appraisal still negative
• July 2007 FAD Alimta approved QALYs drop
  from 60K to 34.5

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Challenges for the Future

• Saying No Dealing with appeals
• Marginal Benefit
• Right to NHS treatments
• Patient and public pressure
• Exceptional circumstance pathway
• Co-Payment

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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
  200533065

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Challenge of Marginal Benefit

• Key is benefit
• Clinical, Economic, or Both
• What is marginal ?
• ? 3 months extra erlotinib / pemetrexed in lung
• lt 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

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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

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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?

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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!)