Transcript Oral Chemotherapy - British Oncology Pharmacy Association

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?
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

NICE

SMC

AWMSG

LNCDG

NECDAG

Other Network Groups
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)

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 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 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 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 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
Local
Chemotherapy
Group
North of England Cancer Drug
Approval Group (NE CDAG)
TSG
CANCER DRUG
APPLICATION
FORM
Horizon
Scanning
(Potential
Applications &
Applicant
identified)
Summary of Application Process
Imminent NICE
Appraisal
(Financial & Service
Impact Assessed)
Cancer Drug
Approval Group
Gateway Group
Prioritises Applications.
Adds Financial & Service
Impact information.
Advises on Implementation.
Decision Communicated to
Stakeholders: PCTs, TSG Chairs,
Trusts, Network Boards, Network
Chemo Groups
Press Release Prepared
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
Clinical & Financial
Approval
Within
14 days
No
APPROVED
Yes
1.
2.
Implementation according to plan in application form undertaken
Treatment protocol added to NCN/CCA Chemotherapy Approved Lists
NO
re-submission
for 12 months
Unless
new evidence
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

Difference between QALYS and associated costs used to assess
cost effectiveness = Incremental Cost Utility Ratio ICR
Cost
Utility =
Ratio (£)
(ICR)
Cost of
Intervention A
No. QALYS with
Intervention A
-
-
Cost of
Intervention B
No. QALYS with
Intervention B

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 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 (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

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 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!

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

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…..
Pressures facing cancer drug decision
makers The case of Alimta in North East
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

Saying No – Dealing with appeals

Marginal Benefit

Right to NHS treatments

Patient and public pressure

Exceptional circumstance pathway

Co-Payment
Challenge of Saying No

Benchmarking



Variation in Cost effective Analysis




Same evidence why different decisions?
Health economist advice
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

Key is benefit


What is marginal ?



Clinical, Economic, or Both
? 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

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



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







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!)