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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


Cancer medicine approval in nhs north east

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 – 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

    vs

  • Access to treatment regardless of ability to pay

  • Will Chemotherapy PBR open this up further?


Conclusions
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!)