Funding Cancer Treatments and Pathways in a Financially Challenged and Changing NHSAngela McFarlane

Senior Principal

Local Market Access

June 2015

Implementing an Early Access System in the UK2

Session Objectives

• Clarity over who in the NHS funds the different components of cancer pathways, from diagnosis to treatment to palliative care

• Knowledge and skills about how to make a business case for investment to commissioners

• Clarity over how to make a successful application for a treatment via the revised scorecard of the Cancer Drugs fund

June 2015

3

Global Leaders in Real World Evidence

World’s leading source of Real World healthcare intelligence

Reference Data

Treatments

Outcomes

Electronic Health Records

Prescriptions

Medical Claims

Genomics

100,000+ suppliers

10+ Petabytesof unique data

Encrypted & secure

Social Media

85%+ global sales 500M+

de-identified patient lives

2mm+ professionals & organizations

300,000+ sources of social media

1.4mm+ Products

780,000+ Data feeds

Note: Anonymous patient data.

June 2015Implementing an Early Access System in the UK

4

• A patient profile from HES data of currently diagnosed patients

• Analysis of variance in different diagnosis environments and different patient cohorts

• A predictive algorithm allowing classification of currently undiagnosed patients

• National patient flow with identified barriers to treatment

Outputs

Objective: Identify the barriers to rare disease diagnosis & treatment and support further patient identification

•A global pharma company has an established treatment for a rare disease

•Clinical leaders felt that patients were being missed from diagnosis and access to appropriate therapy

•The client agreed to fund a predictive analytics initiative to support earlier diagnosis through IMS

Client NeedCombining HES with Predictive Analytics

IMS utilized HES, a secondary care patient level database to build a patient profile of diagnosed patients

This also allowed us to understand patients’ route to diagnosis, their treatments and outcomes

Predictive AnalyticsIMS then applied the data fingerprint to the wider universe to identify potentially undiagnosed patient records by location, demographic characteristics and key clinical factors

Our Solution

Initial project of 24 weeks

Implementing an Early Access System in the UK

Centre with diagnosis and treatment

Centre with only diagnosis

Referrals to centres from initial presentation

Hunter Syndrome care pathway analysis

Using patient data in rare diseases2

Family Screening GP Referral

Local Consultant LSD Centre

Diagnosis

Local follow-up Shared Care

Initial Assessment

Permanent Hospital Infusion

Referred to local hospital

First 2-12 infusions at LSD centre

Referred to homecare

Home training

Permanent Nurse Home Infusion

Independent with on call support

ERT

Contracts and Commissioners

Informed

MPS IH ERT / HSCT

No Treatment

Palliative Care

Review 3 months – 1 year

TreatmentTreatment Changes

Change Dosage

New Drug Stop

June 2015

Implementing an Early Access System in the UK5 June 2015

Implementing an Early Access System in the UK6

• Delivered over 300 UK Market Access programmes and numerous in-market access initiatives

Market Access track record:

NHS-centric Market Access:

Commercialisation of opportunities:

• Unique Market Access solutions developed collaboratively with the NHS

• Unique network of 1000 NHS Associates across the UK

• Accelerate© database: NHS England, Area Team Commissioners, CCG/CSU clinical, commissioning lead, HoMMs

• Ahead of the curve in respect of NHS market change

• Practical solutions aligned to NHS need that enable funding despite the barriers faced

IMS Market Access (previously HGS)

June 2015

Implementing an Early Access System in the UK7

Market Access Excellence-The End Game!

June 2015

The NHS Environment in which Business Cases are being made

June 2015Implementing an Early Access System in the UK

England NHS Environment: The Perfect Storm

• Financially challenged NHS: QIPP

• The £8bn promised will just keep the NHS lights on

• Financial risk is being shifted to the provider

• The NHS has a statutory responsibility to balance the books

Implementing an Early Access System in the UK

Implementing an Early Access System in the UK10

The Big Issues in Health-2015-16

10

Collaborative Commissioning Mobilised

Simon Stevens: NHS Five Year Forward View Implementation (5YFV)Small Majority-Strong Bureaucrats

Integrated Health and Social Care Accelerated across NHS in England

NHS England Reform Accelerates: Speciality drugs Decision Making Framework, IFR SoP consultation

Commissioning through EvaluationCollaborative commissioning

Accelerated Access Review Final Rec’ns

More Providers in Deficit (ETO, VTO & Tougher Procurement)

Changes to Cancer Drugs Fund

NICE/CDF/PPRS??

2015 2016

IMMTreV Work programme commences: Renamed

Accelerated Access Review(AAR)

June 2015

Implementing an Early Access System in the UK11

The revised NHS England Framework is unchartered water-can it keep pace with itself and innovation?

June 2015

Implementing an Early Access System in the UK12

Highly Specialised Services

Specialised Commissioning

Non-Specialised Commissioning

Pati

en

t N

um

bers

Current

Centralised – full national control of budgets/contracting• Budget and accountability rest with NHS England• Will include all highly specialised services and other services

requiring national planning (eg v rare genetic disorders)

NHSE + CCG Collaborative Commissioning • Budgets and accountability rest with NHS

England but CCGs collaborate as networks-eg specialised asthma, spec dermatology, specialised immunology?

CCGs individually or in networks• Budgets and accountability rest with

individual CCGs

Level 1

Level 2

Level 3

Current/Future

Collaborative Commissioning: Shifting the Deckchairs on the Titanic?

June 2015

Implementing an Early Access System in the UK13

NHS Finance: The Four Horsemen of the Apocalypse

June 2015

Enhanced Tariff Option

- 0.5% lower tariff prices as compared to 2014/15- This is lower than the tariff deflator previously

consulted - Includes 2.5% CQUIN schemes- Any activity below base rate: NHSE to retain 50% of the

difference- If exceed the base rate: Providers to be paid SBV plus

70% of the excess- Includes NICE and non-NICE HCDs & Devices- Majority of providers now signed- Notable exception – all Shelford Trusts- Over activity-providers will only be re-imbursed by 70% of

tariff

June 2015

Implementing an Early Access System in the UK15

‘Voluntary Tariff’

CQUINs (2.5% income £10m to UCLH) forgone

2014/15 list of excluded drugs will not be updated-HyQvia is in this list

Members

• University Hospitals Birmingham NHS Foundation Trust

• University College London Hospitals NHS Foundation Trust (UCLH)

• Sheffield Teaching Hospitals NHS Foundation Trust

• Oxford University Hospitals NHS Trust (OUH)

• Newcastle-Upon-Tyne Hospitals NHS Foundation Trust

• King’s College Hospital NHS Foundation Trust

• Imperial College Healthcare NHS Trust

• Guy’s and St Thomas’ NHS Foundation Trust

• Central Manchester University Hospitals NHS Foundation Trust (CMFT)

• Cambridge University Hospitals NHS Foundation Trust (CUH)

Shelford Group signed

June 2015

Implementing an Early Access System in the UK16

NHS Finance to 2020: Providers in Meltdown; access to high cost drugs will be impactedMarginal Tariff will impact access in 2015/16• £30bn funding gap by 2020/21; £8bn additional funding per year required in

the next CSR

• Financial performance of NHS providers gone from a net surplus of £582m in 2012/13 to a net deficit of £789m at the end of Q3 of 2014/15; Provider efficiency gains only 0.4% over this parliament (Nuffield)

• Despite an expected under-spend from commissioners of £197m, the NHS is projected to overspend by £626m by the end of 2014/15. 

Deficit Drivers

• Tariff cuts

• Francis report and new demands on staffing

• Marginal Tariff

• No room for more pay restraint

Why rush to drive NICE TA’s when budget

uplift not taken into account by Tariff?

NICE implementation given unknown risk?

2014/15 PbR excluded drug lists will not be updated impacting access to

drug launches in 2015/16

NICE Innovation Score-card will be trumped by Marginal Tariff every time:• Specialist hospitals that are drivers of high cost drug spend likely to become very risk averse and apply inward pressure on clinicians to use what is affordable

Marginal Tariff Impact on Providers?

June 2015

Implementing an Early Access System in the UK17

Procurement of therapy classes to become more mainstream following ‘Carter Review’

• Interim report published wc next week finds NHS could save £1bn by 2020 by cutting number of product lines from 500,000 to less than 10,000.

• All hospital trusts will be given individual savings targets, to begin delivering from January 2016.

A new “adjusted treatment index” to rate each hospital in England on efficiency.

Trust submits existing

procurement data

Efficiency baseline

comparisons begin

Efficiency baseline score provided for

year-year comparisons

Staffing, Medicines, Devices,

Consumables, Premises

Future Procurement Efficiency

Likely Impact on IndustryCarter Review on top of Aggregate Contract Monitoring (ACM)

• Every high cost drug scrutinisable by patient, monthly• Procurement tenders more robustly implemented – impact for next

PID tender??• Shared and new therapy classes targeted for commoditisation via

procurement

June 2015

Implementing an Early Access System in the UK18 June 2015

Implementing an Early Access System in the UK19

Key Strategic Questions for starting a business case

1. Is it on the NICE work programme?− Do not accept we are waiting for NICE as a reason not to reach a position on whether to fund or not

in the interim.

2. Who is the commissioner of this service?− The funding route strategy will be different depending on if its a case to NHS England (specialised

services and chemotherapy) or to a Clinical Commissioning Group (CCG)

3. What will our funding route strategy be?

4. What is the current standard of care in UK? Are our trials against that SoC? Are there any commissioner outcomes in our trials

5. What difference will this make to the current service pathway?

6. Do we have UK clinical experience(trials), are our clinicians passionate and willing and knowledgeable about how to make the case?

7. Do we have a price, or a price range.

8. What is the patient cohort who will really benefit from this treatment/service/device and how do we know

9. Is there clinical demand and consensus about where our treatment fits in the pathway?

June 2015

Is it on the NICE Work Programme?

June 2015

21

Is it on the NICE work programme?

•“It is not acceptable (for commissioners) to cite a lack of NICE guidance as a reason for not providing a treatment. A key role of the NHS is to make decisions about the use of new interventions and this has always been the case, long before NICE was established.(1)

• The NHS Constitution enshrined in Statute a number of rights in respect of access to medicines:

− “You have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if your doctor says they are clinically appropriate for you.

− You have the right to expect local decisions on funding of other drugs and treatments to be made rationally following a proper consideration of the evidence.” (2)

• Decisions by the courts have made it clear that, although a Commissioner can have a policy not to fund a particular treatment, it cannot have a blanket policy:-

− i.e. it must consider exceptional individual cases where funding might be provided.(2)

1.Department of Health Good practice guidance on managing the introduction of new healthcare interventions and links to NICE technology appraisal guidance, at: http://www.dh.gov.uk/enbestpracticeguidance/DH 7521/.

2. Handbook to the NHS Constitution for England, January 2009, http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_093421

12

June 2015Implementing an Early Access System in the UK

You need to know that...

Implementing an Early Access System in the UK22

Pays for complex low volume/high cost drugs eg: CF, Hep C, HIV, orphan drugs, chemotherapy£14.8bn budget

English NHS Market Access LandscapeWho is the Accountable Commissioner for the Service/Drug?

Responsible for large population services incl most cancer services, £66bn budget

Commissioning Support Units

NHSEngland

Clinical Commissionin

g GroupsCCGs (209)

NHS E Clinical Reference Groups (75)

Expert Counsel to NHS E on fund/don’t

fund. ]

June 2015

Implementing an Early Access System in the UK23

High cost PbR Ex Drugs/procedures are funded by different commissioners

June 2015

24

What is our Funding Route Strategy?

Implementing an Early Access System in the UK

NICE Multiple Technology Appraisal

(MTA)Commissioning

Through Evaluation?

NICE Highly Specialised

Technologies (HST)

Programme

National Institute for Health and Care Excellence

(NICE)?

NICE Single Technology Appraisal

(STA)

NHS England Clinical

Commissioning Policy?

CCGs ?

NationalCancer Drugs

Fund?

Commercial Medicines

Unit?

June 2015

Implementing an Early Access System in the UK25

The NHS Funding Route Map

June 2015

Service Development

• Pre- or post-NICE or NHSE

• Not “In-Year” • Ongoing

Policy

Takes 0-6 months

Prior Approval

• Pre NICE• Clear cohort• Underpinned

by business case and audit

Policy

IFREntry ticket in some areas

(NHS E)

Optimal funding route

Cancer Drug Fund

• Pre-NICE or if not recommended by NICE

• Regional variation• IFRs first in some

areas

Policy

Bypass Route(Eng only)

Pragmatic route

Cul-de sac of doom?

A 1

CCG Business Cases-the key Principles

June 2015Implementing an Early Access System in the UK

Implementing an Early Access System in the UK27

The business case basics

• Justified (feasibility study)

• Evidence based – clinically effective

• Meets local and national priorities

• Cost-effective and affordable

• A new way of working

• Clear benefits - hits right buttons e.g. inequalities

• Clear governance

June 2015

Implementing an Early Access System in the UK28

A winning CCG Business case?

• The Provider must be conversant with the CCGs priorities/commissioning objectives • They can find them on the CCG web-site in the Strategic and Operational

Plan

• Align the CCG Priorities to the business case • e.g. improved access to services, shared care, moving services closer to

home, commission care which offers value for money

• Starts with explaining the current treatment options of patients for your service bid • link to wider population and why it could be better

(morbidity/mortality/quality of life, family relationships unplanned emergency admissions etc).

June 2015

Implementing an Early Access System in the UK29

A winning business case?

• Consultants shouldn’t presume that people around the table are conversant with the detail of the existing treatment arrangements or indeed its impact on the patient population

• The timescales for implementation need to be clear- It will be necessary for the organisation to be clear about when budgets should

be changed

• Pay due attention to the impact on other organisations – whether funders or service providers-for example homecare delivery services

• Know the numbers inside out and think how they might be attacked!

June 2015

Implementing an Early Access System in the UK30

What makes for a robust business case?

• What is the health need?− Severity of the condition

− Number of people affected

− Importance of the JSNA as a key commissioning document

• Will the proposal improve health?− Tackle inequalities, improve access, address prevention and early

detection

• What proportion of people will benefit?− Number benefiting compared with the number treated

• •What is the magnitude of benefit?− Curative, significant improvement in quality of life

− Objective assessments are needed

• Is there corporate support?–Evidence of management backing–Capacity, capability, governance, implementation plan

June 2015

Implementing an Early Access System in the UK31

Analysis

• What is the evidence of effectiveness? − Type & strength of evidence

− Strength of evidence

− Primary outcomes, NNT & NNH

• What is the evidence of cost-effectiveness?− Value for money, QALYs etc.

• Has there been a needs assessment?

• What gaps have been identified?− Specific strategy produced–Network support

• Is it clear where the service/intervention fits in the patient pathway?

• How does it link with other services?− Patient pathway described–Interface issues addressed (referral pathways etc.)–

Implications for other services

June 2015

Implementing an Early Access System in the UK32

Common Problems with Business cases

• Identifying good quality, reliable data – need for competence in critically appraising available data and studies.

• Trials – abbreviated, surrogate markers, wrong comparators, insufficient data re adverse events, only one published study, pooled populations and outcomes

• Unpublished data – posters, abstracts• Patient population not representative of clinical practice• Intervention not representative of clinical practice• Limited or no outcomes data e.g. ADL, QoL

• No cost impact data over time

• Translation of economic terminology e.g. explanation of what is meant by QALYs or Markov model

• Translation of published studies to a local level – modelling to a local setting/real life clinical practice

• Timescale – timely information-in line with business planning round

June 2015

Implementing an Early Access System in the UK33

Workload

Demographics

Who?

Therapeutic area

Current provision

Proposal

Outcomes

Financials

Risk – clinical & financial

Evaluation

Review

Equipment/Staffing

Local commitment

Exec. Summary

Nat.& Local Priorities

When?

B U S CI AN SE ES S

June 2015

Implementing an Early Access System in the UK34

The bid has been rejected!

•Ask for an explanation – where, when, why, by who?

•Can it be re-submitted?

•Review the strengths & weaknesses etc.

•Re-write

•Re-submit

June 2015

Making a Business Case to NHS England

You will need to have absolute insight to the new NHS England Prioritisation Framework and Rules

June 2015Implementing an Early Access System in the UK

Implementing an Early Access System in the UK36

NHS England New Prioritisation Framework

June 2015

Implementing an Early Access System in the UK37

Criteria to Address in the Business Case

CPAG criteria Aims

Does the product, service or technology work?

• Clinical effectiveness and potential for improving health• Clinical safety and risk• Severity and capacity to benefit

Does the product, service or technology add value to society?

• Needs of patients and society• Stimulating research and innovation

Is the product service or technology at a reasonable cost to the public?

• Average cost per patient• Overall cost impact and affordability• Value for money compared to alternatives

Best clinical practice in delivering the service

• Best clinical practice• Economic efficiency of provision• Continuity of provision• Accessibility

June 2015

Implementing an Early Access System in the UK38

Timing is everything, when making a business case

June 2015

Implementing an Early Access System in the UK39

JulyAugustSept

Providers: business cases for 2015-16 CPs2016-17 Prescribing Outlook issued to NHS

JanuaryFebruary

Sept-December

Review of bidsPrioritisation by NHSECommissioning Intentions agreedMonitor Finalises tariffPSSAG agrees what’s in The Manual

CRG Work Programmes for 2016-17 finalisedAgreement on funding-no new monies in year

March

CDF ends?Final contracts signedCRGs horizon scanning for2017-18

Final sign off April 1st

Money for development decided. Allocation less forecast spend less unavoidable development

NHS Commissioning Round 2016-17

June 2015

Implementing an Early Access System in the UK40

Decision Maker

Where canIndustryEngage?

Influencer GatekeeperNHS England Phasing &

Rationale

Does Product X fit the NHSE criteria?

Is it likely to be a priority?

Making the case (Clinical/Economic

Evaluation)

Drafting the policy

Ranking Priority

Final funding decision

Industry engagement at each step?

CtECRG

NPOC

Clinical Appraisal

Panel

NPOC

CPAG

SCC

CET

CRG

CRGCET

CRGCET

CETNPOC

NPOC

CRG

June 2015

Implementing an Early Access System in the UK41

What support might you need?

NHS England Phasing & Rationale

Does Product X fit the NHS E criteria?

Is it likely to be a priority?

Making the case (Clinical/Economic

Evaluation)

Drafting the policy

What can Industry do?

Get your product on the NHS E Payer and Clinician Radar

Engage with NHS England (specifically CRGs)

Make sure the clinical and economic evidence is backed

by clinicians and ‘Payer Proof’ by testing it with payers/clinicians early

Ensure you have enough supporting evidence if gaps

are identified during consultation

How can IMS Market Access Help?

Ensure specialised service and correct CRG

Reach and Access to right clinicians in EnglandAbility to CHALLENGE

Business Case & IFR Training• Clinical consensus• Train Drs to make the case

for funding• Test the case via NHS E

payer ad boards• Reach within the NHS E to

test clinical and economic evidence with NHS Payers

The ability to combine payer feedback with real

world evidence

June 2015

Making a Case for Cancer Services, device or via CDF

June 2015Implementing an Early Access System in the UK

Implementing an Early Access System in the UK

It begins by knowing who pays?

GP DiagnosisCCG

Process Commissioner

PSA via Blood Test

Secondary CareBiopsy, MRI,

CT Scan, Bone Scan

Localised Prostrate

Cancer

Locally Advanced Prostrate

Cancer

Metastatic Prostrate

Cancer

Radical prostatectomy (open/robotica

lly assisted)NICE CG 175

External beam radiotherapy (EBRT)

Brachytherapy

Neoadjuvant and adjuvant

hormone therapy

1st Line:docetaxel and prednisolone

NICE TA101 Published date:

June 2006

2nd Line:abiraterone NICE +ve

Bone targeted therapies like bisphosphonate, strontium-89 and radium dicloride-223NICE decision due Jan 2016.

Palliative Care2nd Line:cabazitaxel

NICE -ve* NICE decision due 2016

* commissioners to make decision see notes

High intensity focused ultrasound (HIFU),

CryotherapyNICE TA101 Published

date: June 2006

Provider Baseline

CDF

Implementing an Early Access System in the UK44

Payments for chemotherapy matters (to clinicians and to business managers)… especially when preparing a business case

Income for baseline drugs• Paid at local price; usually the cost of

the drug to the hospital (including VAT) BUT NHS England may define maximum price they will reimburse if hospital cost is higher than known contract prices

• Additional income usually available to cover cost to prepare injections ready for supply to clinical areas (including ready-prepared dose-banded) – local negotiation with NHS England

• May be an extra flat-rate payment to cover a limited number of associated therapies e.g. anti-emetics

Income for activity• Income for administering a drug,

including supply of oral chemotherapy, is from a ‘mandatory tariff’ i.e. fixed NHS price across England

• Fixed price then has an upward adjustment for Market Forces Factor; MFF is set nationally but is different for different hospitals.

• National Tariff and MFF will be paid to your hospitals by NHS England for chemotherapy activity (CCGs for non-specialist activity)

• Monitor/NHS England together now provide details of these aspects of National Tariff (previously known as Payment by Results – PbR)

http://www.england.nhs.ukJune 2015

Implementing an Early Access System in the UK45

Cancer Drugs Fund

• The CDF increased to £340 million for 2015/16.

• In January 2015: 25 different cancer treatments no longer funded by the CDF− creating approximately £80 million of savings for re-investment.

The revised CDF Scorecard Criteria1. Clinical benefit

2. Survival & quality of life

3. Toxicity

4. Safety of the treatment

5. The level of unmet need

6. Median cost per patient

June 2015

Implementing an Early Access System in the UK46

Changes to CDF-May 21st 2015

• May 21st 2015: NHS England published the updated Cancer Drugs Fund (CDF) list

− The review looked at whether the Standard Operating Procedures, on which NHS E consulted, were fully followed.

• It did not look at the medical decisions made by doctors on the national CDF Panel.

− The Board referred five of these back to the CDF panel to review;

− One of the five drug indications that were looked at again will remain on the CDF (Regorafenib).

• NHS England has made some factual changes and clarifications to the Standard Operating Procedures for the Cancer Drugs Fund − It plans to make some further changes and

launched a four-week consultation on these.

June 2015

Implementing an Early Access System in the UK47

Consultation on the Cancer Drugs Fund – some suggested changes to the scoring tool

June 2015

1. Quality of Life data: Only Published and peer-reviewed data will be scored− Greater flexibility around use of quality of life data− The criteria for scoring quality of life require a “significant improvement” (scores of 2 or 1); not measured or

analysed (score 0) or significant deterioration (minus 1 or 2); however “significant” is not fully defined and it is unclear how modest changes in QoL should be scored

2. Rarity defined as 100 patients

3. More granular consideration of unmet need− Refining the scoring system which allocates either 0 or 3 ‘points’ –seen as too blunt an instrument

4. The allocation of toxicity scores based only on the comparator in published trials is narrow and fails to provide a realistic

assessment for real world practice 

5. Comparators and use of unlicensed and off-label comparators− The definition of ‘alternative active standard treatment’ is too broad and does not therefore fully take into account

the specific sub-diagnosis of the disease, and specific indications of the medicine

− With advances in personalised medicines and genomics the CDF scoring tool might be adapted to differentiate between the genetic subtypes of cancer types

− Unlicensed or off label medicines should not be included as alternative treatments when re-evaluating or assessing new medicines, where there is an alternative licensed treatment available. This should be set out in the SOP for the avoidance of doubt.

Implementing an Early Access System in the UK48

CDF Working Party

• A number of proposals are being looked at to reach an integrated process between NHS England and NICE which results in clear and final decisions on baseline commissioning of chemotherapy drugs.

• One option being discussed in more detail is further extending NHS England’s ‘commissioning through evaluation’ (CtE) programme which enables patients to access innovative new drugs and treatments not routinely commissioned by the NHS. Discussions on linking CtE outcomes to the NICE appraisal scheme is one proposal being looked at .

The Cancer Drug Fund: Working Party set up to create a better way forward for appraising and commissioning new cancer drugs

June 2015

Implementing an Early Access System in the UK49

CDF-Do’s and don’ts....

• Use only published evidence

• Do not use evidence from Paper A for one score-eg PFS and then use paper b for side effects data

• Be objective, don’t stretch the argument− Unmet need and no treatment available for that cancer doesnt count even if

its the only option

• Cross-over or virtual working on OS through some mathematical algorithm wont be accepted

• Phase 2 data will have the PFS score haved and the overall survival score marked = 0

• Present the price for the cost score

• Know what the UK Standard of Care is, and ideally the trials would be against UK SoC.

June 2015

Implementing an Early Access System in the UK50

CDF-our approach

• Ensure global colleagues understand what needs to be done

• Conduct a review of recent (last 3m CDF panel decsions) and review analogues

• Complete the scoring tool with the team, supported by an NHs associate

• Once completed invite 3 clinicians 2 payors and patient group to rehearse the presenting clinician

− This needs to be a combination of Critical Friends meet Dragons Den

• Amend and rehears again

• Submit in a timley manner ensuring easy access to all relevant clinical evidence

• Ensure clinicians are absolutely united on standard of care and do not expose any ‘creep’ behaviour

• Sort the price negotiation out from the outset-CDF hasn’t got inclination to keep going back

• Be conscious of other drugs undergoing review

June 2015

Implementing an Early Access System in the UK51

CDF: A Managed Exit Strategy? The test of bureaucrats over Politicians

May 21st

June 18th July Sept Dec

Mar 2016

April2016

Consultationannounced CDF

Consultationcloses

Revised CDFSoP

Issued

CDF Working GroupAlignment with

NICE/AARCDF due to terminate

CDF-a Managed Exit?

• QoL Scoring• Rarity Definition• Appeals Process

CDF Alignment with NICE

Consultation On

Life after CDF

CDF-The Sequel?

1 2 3 4

FinalConsultations on

future of CDF

Timing with CSR? Son of

CDF?

?

June 2015

Implementing an Early Access System in the UK52

IMPLEMENTATION

STRATEGY

A winning business case

I think you need to be more explicit here in step 2

June 2015

Funding Cancer Treatments and Pathways in a Financially Challenged and Changing NHSAngela McFarlane

Senior Principal

Local Market Access

June 2015