Transcript CDF-SOP-Stakeholder-Engagement-Slides-FINAL-John

Appraisal and Funding of Cancer Drugs from July 2016
(including the new Cancer Drugs Fund)
A new deal for patients, taxpayers and industry
Tuesday 5 July 2016
www.england.nhs.uk
Overview
1. What do the changes mean?
2. How we got here
3. Overview of the new arrangements:
a)
b)
c)
d)
Start of the process- NICE appraisal
Early access- provision of interim funding
Resolving uncertainty- the new ‘CDF’
Financial control
4. Off-label Cancer Drug Indication Management
5. Transition Arrangements
6. Evaluation
www.england.nhs.uk
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1.
What do the changes mean?
Three key objectives:
•
Firstly, patients have faster access to the most promising new cancer treatments.
•
Secondly, taxpayers get better value for money in drug expenditure.
•
Thirdly, pharmaceutical companies that are willing to price their products
responsibly can access a new, fast-track route to NHS funding for the best and
most promising drugs.
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2.
How we got here….
•
NHS England and NICE ran a joint, 12-week public consultation on our proposals
between November 2015 and February 2016.
•
We received more than 300 responses to consultation.
•
NHS England and NICE Boards approved the proposals in Feb / March.
•
Extensive engagement subsequently with patient groups and industry on the
development of the operational detail.
•
New Standard Operating Procedure will be published on 8 July.
•
New process goes ‘live’ on 18 July.
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Overview of new process
All new cancer drugs / indications
expected to receive a
marketing authorisation referred to
NICE by DH Ministers
a) Start of the process-NICE Appraisal
NICE First Appraisal Committee Meeting
(In Private)
Committee for Medicinal Products for
Human Use Opinion Published
Appraisal
Consultation
Document
Yes
Appraisal
Consultation
Document
No
Appraisal
Consultation
Document
CDF
Usually ~3 months (can be less)
Marketing Authorisation
Interim Funding
Interim Funding
90 day target
Final Appraisal
Determination
YES
b) Early Access – Provision of interim funding
Final Appraisal
Determination
NO
Final Appraisal
Determination
CDF
Final
Guidance
No
Final
Guidance
CDF
Interim Funding
Final
Guidance
Yes
c) Resolving Uncertainty – the new ‘CDF’
Usually (but not exclusively) no
more than 2 years
CDF- Managed Access Scheme – CDF
IFR
Funding
Only
90 day legal funding
directive (30 days for
EAMS drugs)
Baseline
Funding
End of Agreed Managed
Access Period
90 day legal funding
directive (30 days for
EAMS drugs)
Appraisal
Consultation
Document
Yes
Appraisal
Consultation
Document
No
Final Appraisal
Determination
Yes
Final Appraisal
Determination
No
Final
Guidance
Yes
Final
Guidance
No
Interim Funding
3.
IFR
Funding
Only
Baseline
Funding
d) Financial Control
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a) Start of the process – NICE appraisal
•
•
From now on, all new cancer drugs/indications expected to
receive a marketing authorisation will be appraised by NICE.
A modified appraisal process, introduced on 1st April 2016,
allows NICE to make one of three recommendations:
All new cancer drugs / indications
expected to receive a
marketing authorisation referred to
NICE by DH Ministers
NICE First Appraisal Committee Meeting
(In Private)
Committee for Medicinal Products for
Human Use Opinion Published
Appraisal
Consultation
Document
Yes
-
Recommended for routine commissioning – ‘yes’
Not recommended– ‘no’
Recommended for use within the CDF – this is new
Appraisal
Consultation
Document
No
Appraisal
Consultation
Document
CDF
Usually ~3 months (can be less)
Marketing Authorisation
•
The new recommendation can be used when NICE considers there to be plausible potential
for a drug to satisfy the criteria for routine commissioning, but where there is significant
remaining clinical uncertainty.
•
The new appraisal process starts much earlier, with the aim of publishing draft guidance
prior to marketing authorisation and Final Guidance within 90 days of marketing
authorisation.
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b) Early Access- interim funding (1)
We want patients to benefit from new cancer drugs as quickly as possible.
Appraisal
Consultation
Document
Yes
Therefore, pharmaceutical companies will now have the option of
accessing interim funding from the point of marketing authorisation for
those drugs that have received either:
Marketing Authorisation
90 day target
 a draft recommendation for use within the CDF
Provision of interim funding will be met out of the fixed CDF budget
(£340m) and will be conditional on the pharmaceutical company agreeing
to the expenditure control mechanism described later.
Final Appraisal
Determination
YES
Final Appraisal
Determination
NO
Final Appraisal
Determination
CDF
Interim Funding
 a draft recommendation for routine commissioning; or
•
Appraisal
Consultation
Document
CDF
Interim Funding
•
Appraisal
Consultation
Document
No
Interim Funding
•
Final
Guidance
Yes
Final
Guidance
No
90 day legal funding
directive (30 days for
EAMS drugs)
Baseline
Funding
•
Where a company signs up to receive interim funding, that drug can be made immediately
available to all eligible patients.
•
Where a company does not wish to access interim funding, the drug in question cannot be
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made available to patients at that point in time.
b) Early Access- interim funding (2)
•
•
•
.
For drugs/indications receiving a positive draft recommendation –
reimbursement will be set at 100% of the price that generated that
recommendation.
Appraisal
Consultation
Document
Yes
Appraisal
Consultation
Document
CDF
Interim Funding
Interim Funding
Marketing Authorisation
90 day target
Funding will then switch permanently to baseline commissioning
budgets 90 days after NICE Final Guidance (30 days if an EAMS
drug).
For drugs/indications recommended for use within in the CDF –
reimbursement will be at the price that is subsequently agreed as part
of the CDF Managed Access Agreement (MAA).
Appraisal
Consultation
Document
No
Final Appraisal
Determination
YES
Final Appraisal
Determination
NO
Final Appraisal
Determination
CDF
Interim Funding
•
Final
Guidance
Yes
Final
Guidance
No
90 day legal funding
directive (30 days for
EAMS drugs)
Baseline
Funding
However, because this price will not be known at the point of marketing authorisation,
the price submitted to NICE for the appraisal will be temporarily used with the
pharmaceutical company then rebating the CDF budget the difference once the MAA
price has been set.
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c) Resolving uncertainty – the CDF (1)
•
For those drugs/indications that receive a recommendation for use within the
CDF – a Managed Access Agreement (MAA) will need to be agreed between
the pharmaceutical company and NHS England.
Final
Guidance
CDF
The purpose of the ‘managed access’ period will be to resolve the significant
remaining clinical uncertainty highlighted by NICE, and will comprise of
End of Agreed Managed
Access Period
 A CDF Commercial Agreement; and,
Appraisal
Consultation
Document
Yes
Appraisal
Consultation
Document
No
Final Appraisal
Determination
Yes
Final Appraisal
Determination
No
Final
Guidance
Yes
Final
Guidance
No
IFR
Funding
Only
90 day legal funding
directive (30 days for
EAMS drugs)
 A Data Collection Arrangement
Usually (but not exclusively) no
more than 2 years
CDF- Managed Access Scheme – CDF
•
Final Appraisal
Determination
CDF
Baseline
Funding
•
The aim will be to have the MAA in place as close to publication of the NICE Final Appraisal
Determination as possible.
•
At the end of the managed access period, NICE will re-appraise the drug with a view to
deciding whether or not it can be recommended for routine commissioning.
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c) Resolving uncertainty – the CDF (2)
CDF Commercial Agreement (1)
•
The CDF commercial agreement will determine the level of reimbursement
during the managed access period.
Final
Guidance
CDF
This will be a confidential agreement between NHS England and the
pharmaceutical company, with input from NICE, and will be considered on
a case by case basis.
End of Agreed Managed
Access Period
Appraisal
Consultation
Document
Yes
Appraisal
Consultation
Document
No
Final Appraisal
Determination
Yes
Final Appraisal
Determination
No
Final
Guidance
Yes
Final
Guidance
No
IFR
Funding
Only
90 day legal funding
directive (30 days for
EAMS drugs)
•
However, the level of reimbursement should reflect the decision
uncertainty, and the pharmaceutical company will need to present an offer
that brings the range of potentially plausible cost effectiveness estimates
as determined by NICE to below the relevant cost effectiveness threshold
i.e. £30k per QALY or £50k per QALY for end of life care.
•
The entire eligible patient population, as determined by NICE, will be covered.
Usually (but not exclusively) no
more than 2 years
CDF- Managed Access Scheme – CDF
•
Final Appraisal
Determination
CDF
Baseline
Funding
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c) Resolving uncertainty – the CDF (3)
Data Collection Arrangement
•
Final Appraisal
Determination
CDF
When considering if a drug is suitable for the CDF, the NICE appraisal
committee will define and describe the specific area(s) of clinical uncertainty to
be covered in the data collection arrangement. Possible data sources include:
Final
Guidance
CDF
CDF- Managed Access Scheme – CDF
Systemic Anti-cancer Therapy (SACT) dataset collection
–May be linked to other Public Health England sources
–Theoretically, other established tumour registries could be used
Clinical studies
–Ongoing studies
–Setting up a new study/ data collection
Usually (but not exclusively) no
more than 2 years
End of Agreed Managed
Access Period
Appraisal
Consultation
Document
Yes
Appraisal
Consultation
Document
No
Final Appraisal
Determination
Yes
Final Appraisal
Determination
No
Final
Guidance
Yes
Final
Guidance
No
IFR
Funding
Only
90 day legal funding
directive (30 days for
EAMS drugs)
Baseline
Funding
•
To support SACT data collection, all providers wishing to access CDF drugs will have to
have e-prescribing systems in place by April 2017.
•
The exact length of time that is required for appropriate data collection for each
drug/indication will vary. The timeframe should be as short as possible, normally up to two
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years, but will be considered on a case by case basis.
d) Financial control (1)
•
The CDF budget is fixed at £340m and will have to cover the costs of:
Appraisal
Consultation
Document
Yes
Appraisal
Consultation
Document
No
Appraisal
Consultation
Document
CDF
Interim Funding
 Interim Funding Agreements
Final Appraisal
Determination
YES
Final Appraisal
Determination
NO
Final Appraisal
Determination
CDF
Final
Guidance
No
Final
Guidance
CDF
Interim Funding
90 day target
Final
Guidance
Yes
IFR
Funding
Only
90 day legal funding
directive (30 days for
EAMS drugs)
Usually (but not exclusively) no
more than 2 years
CDF- Managed Access Scheme – CDF
 CDF Managed Access Agreements
 Existing CDF drug indications pending NICE appraisal / reconsideration
Interim Funding
Marketing Authorisation
Baseline
Funding
End of Agreed Managed
Access Period
 Existing Individual Funding Request commitments
Appraisal
Consultation
Document
Yes
Appraisal
Consultation
Document
No
Final Appraisal
Determination
Yes
Final Appraisal
Determination
No
Final
Guidance
Yes
Final
Guidance
No
 Any off label indication commitments agreed as part of the clinical
policy development process
 CDF administration
•
An expenditure control mechanism is needed to ensure the CDF budget does not
overspend. The ABPI has previously agreed with the Department of Health that only CDF
expenditure up to £320m will count towards the agreed voluntary PPRS rebate scheme.
d) Financial control (2)
Appraisal
Consultation
Document
Yes
Interim Funding
Marketing Authorisation
Interim Funding
90 day target
Final Appraisal
Determination
YES
Final Appraisal
Determination
NO
Final Appraisal
Determination
CDF
Final
Guidance
Yes
Final
Guidance
No
Final
Guidance
CDF
IFR
Funding
Only
90 day legal funding
directive (30 days for
EAMS drugs)
Baseline
Funding
•
•
Agreement to this mechanism will be a condition for all pharmaceutical
companies receiving funding from the CDF budget.
Usually (but not exclusively) no
more than 2 years
CDF- Managed Access Scheme – CDF
In order to ensure that the CDF does not overspend and, therefore, that it
never has to close to potential new entrants, a proportional rebate will be
applied to all pharmaceutical companies receiving any CDF funding in the
event of an overspend.
Appraisal
Consultation
Document
CDF
Interim Funding
•
Appraisal
Consultation
Document
No
End of Agreed Managed
Access Period
Appraisal
Consultation
Document
Yes
Appraisal
Consultation
Document
No
Final Appraisal
Determination
Yes
Final Appraisal
Determination
No
Final
Guidance
Yes
Final
Guidance
No
A joint NHS England/NICE CDF Investment Group will be responsible for
overall budget management. It will have two principal roles:
 determining if, and when, the rebate needs to be applied; and,
 approving CDF Managed Access Agreements
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4. Off label cancer drugs
•
Off label drugs will have similar opportunities for gaining access to CDF funding as licensed
drugs, if deemed to be clinically promising. The process for considering off label indications
will be integrated with NHS England’s specialised commissioning policy development
process with NICE, in time, providing all the necessary underpinning evidence reviews.
•
Applications will be made by clinicians, with endorsement from NHSE’s Chemotherapy
Clinical Reference Group. Once endorsed, NHS England will include them in its policy
development work programme and, ultimately, make one of three recommendations:
 Progress as a routine commissioning proposal for consideration in the annual
prioritisation round
 Progress as a not routinely commissioned proposal for consideration as an in year
decision
 Progress within the CDF for further data evaluation to inform a commissioning position
•
The CDF budget will provide a funding bridge for any off-label indications that are
recommended for routine commissioning until annual prioritisation decisions are made
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5. Transition Arrangements
•
All drugs on the previous CDF as of 31st March 2016 will be reconsidered or
appraised by NICE over the next 18 months.
•
These drugs will continue to receive funding from the CDF budget at current
commercial terms until such point that NICE is able to provide a commissioning
recommendation.
•
All funding will, however, be subject to the new expenditure control mechanism
as required.
•
If NICE does not recommend an existing CDF drug for routine commissioning or
the new CDF, the drug/indication will cease to be available to new patients but
will continue to be available for existing patients.
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6. Evaluation
•
NHS England will keep the operational arrangements for the new CDF under
continuous review.
•
The single, national list of approved drugs will be updated regularly and published on
the NHS England website, along with activity data, at www.england.nhs.uk/ourwork/cdf/
•
We will conduct a formal evaluation of the overall operation of the new scheme, for
completion no later than autumn 2017 and plan to involve all of our stakeholders in that
process.
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