PROCUREMENT & DISTRIBUTION INTEREST GROUP Autumn Symposium 2007
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Transcript of PROCUREMENT & DISTRIBUTION INTEREST GROUP Autumn Symposium 2007
PROCUREMENT & DISTRIBUTION INTEREST
GROUP
Autumn Symposium 2007
http://www.pdig.org.uk/
Pharma produce innovative products
Patients can’t access them!!
Is this true?
Professor Liz Kay, Clinical Director Medicines Management and Pharmacy Services
Leeds Teaching Hospitals NHS Trust
Overview
• Key stages in transition from trial to licence
• Compassionate use – what is this?
• Access to new medicines
• National systems delays
• Risk sharing
• What next?
Transition from trial to licence
• Key issue – separate ‘clinical trial’ and ‘unlicensed use’
• What is a clinical trial?
Research study, human volunteers, specific health question to answer
Phase I 20 to 80 people
Phase II 100 to 300 people
Phase III 100 to 1000s of people
Phase IV post licence
Clinical trials and LTH
• LTH Clinical trial policy
• REC – protect participants
• R+D check process
• Medicines Management and Pharmacy
• ‘Authorisation to proceed’ step = letter from Chief Pharmacist.
• All medicines managed by Pharmacy
LTH MMPS Authorisation stepWhat is this?
• Documentation in place
• Local risk assessment and procedures
• Operationally feasible
• Products manufactured in accordance GMP
• Written agreement about responsibilities with investigator
• Payment
New Product Review
Product Request Clinical Trial R&D Process
Outside Trial
Patient?
PbR
Unlicensed Risk Assessment
DTC
PbRRisk
AssessmentDTC
Patient?Licensed
Unlicensed
JANE 'LET DOWN OVER CANCER DRUG' 05/10/2007 14:17 (Daily Express +0) Mike Tomlinson, from Leeds, hit out after revealing that his wife had to travel to Nottingham to receive the cancer drug Lapatinib.
• Mr Tomlinson detailed how she battled to get access to Lapatinib. He said her medical team in Leeds decided the drug was her best option. However, Leeds Teaching Hospitals NHS Trust had taken the decision not to participate in a GlaxoSmithKline-sponsored access study of the treatment.
Medicines without marketing authorisation
• LTH Trust policy
• Management of policy via DTC
• Assessment of risk
• Patient consent
• Code of business conduct
• Involvement of commissioners
Unlicensed medicines policy
Element of assurance Required about the product
Licensed product (MA)
Used for licensed use
Licensed product Unlicensed use
Unlicensed product (imported or manufactured)
Responsibility for assessment
QUALITY Assured by licence
Assured by licence
No automatic assurance
Pharmacist/Purchaser
SAFETY Summary of Product
Characteristics (SPC)
No automatic assurance
No automatic assurance
Clinician/Pharmacist
EFFICACY Summary of Product
Characteristics (SPC)
No automatic assurance
No automatic assurance
Clinician/Pharmacist
Unlicensed medicines policy risk matrix
The Risk Matrix
Therapeutic Pharmaceutical
Evidence base “good” for efficacy, safety/toxicity, use, and patient status: Low Risk potential
Evidence base “moderate” for efficacy, safety/toxicity, use, and patient status: Moderate risk potential
Evidence base “poor” for efficacy, safety/toxicity, use, and patient status: High/Unknown Risk potential
Quality can be assured: Low Risk Potential
Green Yellow Red
Quality cannot be assured: High Risk Potential
Red Red Red
Relative Risk (green) LOW
Relative risk (yellow)
MODERATE
Relative risk (red) HIGH
Unlicensed medicines policy8.3 The table below summarises the minimum action required once an unlicensed medicines use has been assessed and categorised into one of the three
relative risk categories:-
Action Assessment Low relative risk potential Moderate relative risk potential High or Unknown relative risk potential
How is the new product reviewed prior to introduction to LTHT?
Requests for any new product are reviewed by LTHT D&T Committee.
Review of all unlicensed uses by LTH D&TC required. Unlicensed medicines submission required.
Review of all unlicensed uses by LTH D&TC.
What consent arrangements need to be established?
Obtain consent prior to treatment from patients or carers by discussing medicine choice as in normal practice. Additional arrangements should not normally be required.
Ensure as a minimum a record is made of a consent process in the individual patients medical notes with clear documentation of issues covered.
Formal written evidence of patient consent required.
Patient information: What written patient information is to be used?
Use generic unlicensed medicines information for outpatient or discharge medicines or specialist area patient information e.g. RCPCH and Pain/Palliative Care Patient Information Leaflets (PIL).
Use generic unlicensed medicines patient information or Patient group or unlicensed use specific information prepared for the purpose.
Product specific unlicensed medicines patient information will be required and will be reviewed by D&TC.
Will the product require specific labelling to highlight it unlicensed status?
Many products in this category will be licenced products being used for unlicensed use. In addition to standard requirements all products without a UK Marketing Authorisation will be labelled with the code “ULM”.
In addition to standard requirements all products without a UK Marketing Authorisation will be labelled with the code “ULM”.
In addition to standard requirements all products without a UK Marketing Authorisation will be labelled with the code “ULM”.
What product use records are legally required and how will these be managed?
Normal records of products issued will be retained by the Pharmacy Management System (PMS) at each dispensing episode.
Pharmacy will ensure a record is maintained of Prescribing Consultant, patients name and batch number details in addition to the PMS record of issues
Pharmacy will ensure record is maintained of, Prescribing Consultant, patients names and batch number details in addition to the PMS record of issues
See handout 1
EAPsDiscourage use of investigational agents outside clinical trials
ISSUESManagement of clinical risk‘Unlicensed medicine’Lose potentially valuable dataManagement of costs and financial risksSubstantial charges (‘admin and supply’!!)Equity of access for patientsPharma ‘bypass of process’ for managing entry of new drugs
National approval systems
• NICE and SMC
• Different terms of reference – timelines, Political issues??????????
• LTH approach
• Medicines Finance Committee and use of Health Economist
• Commissioning Group for Medicines, Yorkshire & The Humber (North)
What effect the PbR tariff?
• LTH £ 32+million spend (50%) non tariff
• Non tariff NICE approved – PCT pay to agreed volumes
• Non Tariff Non NICE (NTNN), individual patient PCT approval – postcode lottery, LTH 440+ in 2007
DoH view on Risk Sharing Schemes
• Not against such schemes in principle• Any schemes should be operationally workable for the
NHS (not lead to disproportionate costs or bureaucracy). • Velcade - content on this point and for NICE to appraise
the scheme.• Responder schemes - important that response can be
measured and in the case of Velcade, NICE agreed with the company's method for measuring response.
• Cash/credit or free stock – no strong view but vital that scheme is not too burdensome on the NHS.
NICE guidance on Bortezomib
Velcade Response Scheme
Janssen Cilag: Drug costs removed for ‘non responders’
NICE: Response based on serum M protein after 4 cycles
Rebate: ‘Patients responded less than partially’
ICER of £20,700 per QALY
Additional cost to NHS to administer – not funded.
Process for rebate: Form to Fax
Replace stock, credit note, cash
Myeloma matters – impact on NHS
• Bortezomib licence NICE approval planned use
• Lenalidomide (better than thalidomide)
Licensed June 2007
No NICE approval
Planned use
Cost £50K pa
NTNN – postcode lottery
Doesn’t reflect use
More responders thanplanned
Less rebates than DoH expected
Issues for industry
• Ready to use product – minimise waste (infliximab)
• Appropriate vial size – minimise waste (infliximab)
• Packed with risk management in consideration• Realistic costs – global pricing• Free stock or BOGOF – pharmacy computer
schemes• No more rebate schemes
Where next?
• Clarity about medicines used without or outside marketing authorisation and peer support for their use outside clinical trials
• Systems to ‘fast track’ to marketing authorisation for major advances
• Systems for ‘national approval’ faster than NICE• Commissioning on wide geographical scale to
ensure equity of access for patients