Transcript Horizon scanning by UKMi

Horizon scanning
for managing
medicines
Produced by UKMi to support the
Prescribing Outlook series
November 2007
Horizon scanning
What is horizon scanning?
Why is it necessary?
How is it done?
What will be the key pressures on
medicines budgets in the NHS in
2007-2008?
What is horizon scanning?
Horizon Scanning is defined by the
Office of Science and Technology
(OST) as:
'the systematic examination of
potential threats, opportunities and
likely future developments, including
(but not restricted to) those at the
margins of current thinking and
planning.'
Why horizon scan for medicines?
• Manage budgets
• Plan services - new and redesign
• Anticipate pressures (financial and service
delivery)
• Identify areas for disinvestment
• Manage entry into hospital/ formulary
/practice etc
• Be prepared! It’s better than fire fighting!
Drivers of growth in prescribing (1)
• New drugs for diseases where previous
therapeutic/ management options were limited e.g.
rare genetic diseases, HPV vaccine
• Ageing population
• Expanded indications (increase in eligible
population) e.g. chemotherapy drugs moving from
last-line use to first-line use
• Displacement of old drugs with new drugs at higher
cost (accounts >60% of rise ) e.g. “biologicals”
• New drugs added to standard therapy e.g.
chemotherapy
• Medicalisation e.g. anti-obesity drugs
Drivers of growth in prescribing (2)
• National Service Frameworks
• National Institute for Health and Clinical
Excellence (NICE)
• Quality and Outcomes Framework in
primary care
• SIGN, Scottish Medicines Consortium
(SMC), All Wales Medicines Strategy
Group (AWMSG)
Benefits of advance information
• Enables assessment of safety &
efficacy
• Enables assessment of value or cost
effectiveness (rarely)
• Informs and primes NHS
organisations to implement
management strategies
New drugs and the NHS
Horizon
scanning
New
product
reviews
Clinical
opinion
Patients & the
public view
NICE
Directive
Market
authorisation
‘licence’
Health
Technology
assessments
Prescribed
for patients
Local
formularies
Local
budgetary
control
Clinical
judgement
The horizon scanning process
Stage 1
systematic early
identification
‘horizon scanning’
Stage
4
Stage
5
Stage 2
filtration and
selection
prioritisation
information
retrieval
assessment
dissemination
Stage
3
Stage
6
Stage 1
systematic early
identification
‘horizon scanning’
• Journals – specialist and
general
• Industry
• General media
• Clinical specialists
• Specialist media for press
releases highlighting
– conference presentations
– dates for submission to
licensing authorities
– plans for development
• Licensing agencies
• Other horizon
scanners
Stage 2
filtration and selection
Stage 3
information retrieval
• Specialist databases
• Company contacts, websites, annual
reports
• In-house files
Stage 4
prioritisation
Group work 1
Factors that influence impact
• List factors that influence the impact a
new drug/ licence extension/ new
formulation might have.
• Hint: Think about what drugs have
had a large impact on your
organisation over recent years and
why this was so
Impact Factors (1)
Financial factors
• Cost of drug and administration
• PbR
• Will it change where patients are
treated e.g. hospital vs healthcare at
home vs primary care.
• Funding of services?
Impact Factors (2)
Drug properties/therapeutics
• Anticipated licensed indication – is it wide or
narrow?
• Formulation and administration?
• First in class?
• Place in therapy?
• Significant improvement in disease management?
• What could be its USP (unique selling point)?
• Other trials ongoing? (Licence extensions are
easier to obtain and there may be off label use.)
Impact Factors (3)
External factors
• Size of target
• NHS priorities?
population i.e. large
population or significant • Where in NICE
agenda?
subset of large
population? What is
• Which company? GSK
large?
vs Valent
• Local services e.g.
• Local rep activity?
tertiary centre
• Patient groups
• Local use (in ongoing
clinical trials or
• Media interest
unlicensed use)
Factors used by UKMi for
prioritorisation
The drug will be considered for inclusion in Prescribing Outlook if:
• the drug is expected to provide a significant improvement in
disease management
• the drug is first in class or has a major new indication
• there are limited other drug/non-drug alternatives
• the drug cost will be high
• the target population is large
• there is likely to be a significant effect on service implications e.g.
route/ formulation/ method of delivery
• the drug or disease area is considered an NHS priority
• the drug has significant additional indications in the advanced
pipeline stage
• the drug is in the EU licensing process
• there is likely to be significant media interest.
Group work 2
Prioritisation weighting
• You have 6 drugs. Decide which 3 you
need to highlight to your Trust.
• You are given some information to
help you decide.
• Feedback with choice and reasons
Finally …..
Stage 5
Stage 6
assessment
dissemination
UKMi Horizon scanning products
Stage 6
Key new drugs or licence extensions
in 2007-08
• Dabigatran
• Rivaroxaban
• Human papilloma virus vaccine
• Vildagliptin
• Bevacizumab for non small cell lung cancer
• Lapatinib
• p53 protein
• Sorafenib for hepatocellular carcinoma
• Thalidomide
Oral anticoagulants (1) –
Dabigatran and Rivaroxaban
Anticipated launch 2008
Indication: for use in the prevention of deep vein thrombosis
and pulmonary embolism after hip and knee prosthetic
surgery.
Impact? Primary and secondary care.
– In 2005-06 in England about 218 per 100,000 people underwent
prosthetic joint replacements; 60 - 90% of pts receive
anticoagulant prophylaxis.
– Oral anticoagulants will compete with low molecular weight
heparins.
– The impact will be in primary care where district nursing services
will be freed from continued administration post discharge for
course completion.
– Licence for treatment of venous thromboembolism
anticipated 2009.
Oral anticoagulants (2) –
Dabigatran and Rivaroxaban
Notes
– Recent NICE guidance (Apr 07) states that:
• Patients having elective orthopaedic surgery should be
offered mechanical prophylaxis and either LMWH or
fondaparinux
• Patients having hip replacement surgery with one or more
risk factors for VTE should have their LMWH or fondaparinux
therapy continued for 4 weeks after surgery
– Ximelagatran, an oral anticoagulant was launched some
years ago in other EU countries. However, it was
withdrawn worldwide last year due to concerns about
hepatic adverse effects. Mild increases in LFTs have
been associated with dabigatran and rivaroxaban.
Oral anticoagulants (3) –
Dabigatran and Rivaroxaban
Cost
– Unknown.
– Savings in district nursing services.
– Savings in reduced monitoring will only be realised when
these new agents are licensed for the same indications as
warfarin e.g. stroke prevention in patients with atrial
fibrillation. PIII trials are underway for this indication.
Human papilloma virus vaccine (1)
Anticipated launch 2007
Indication: Prevention of cervical cancer.
Impact? Primary care.
• There are about 1,250 12-13yr old girls per
100,000 people in the UK.
• A Department of Health programme will involve
PCT Immunisation co-ordinators to facilitate
implementation
• Implementation will be complex as three doses are
required involving liaison with schools and sexual
and public health agencies.
Human papilloma virus vaccine (2)
Notes
• Will be routine HPV vaccination of girls aged 12 13 years starting from September 2008.
• There will be a two-year catch up campaign starting
in Autumn 2009, for girls up to 18 years.
Cost
• Cost will be funded centrally but is about £250 for a
three dose course.
• PCTs will plan how to deliver the programme locally
but it will probably be through schools.
Vildagliptin (1)
Anticipated launch 2007
Indication: Type 2 diabetes for use as dual therapy
in combination with metformin, a sulphonylurea or a
glitazone.
Impact? Primary and secondary care.
• The prevalence of Type 2 diabetes in England &
Wales is about 2,500 per 100,000 people.
Vildagliptin (2)
Notes
• Dipeptidyl peptidase IV inhibitor, belonging to a
new class of oral antidiabetic agents, the only other
one currently available being sitagliptin.
• Licence for vildagliptin will be broader than that for
sitagliptin which is only licensed for dual therapy
with metformin or a glitazone.
• Recently reported adverse effects associated with
glitazones may influence uptake of new agents.
Cost
• It will compete with other generically available
second-line therapies. Likely to be similarly
priced to sitagliptin (£433 per annum).
Bevacizumab
Anticipated launch 2007
Indication: Metastatic non-squamous non-small cell lung
cancer - first-line use.
Impact? Secondary care.
• The UK incidence of non-squamous non-small cell lung
cancer (NSCLC) is about 32 per 100,000 people; 25-50%
receive first-line chemotherapy (8 to 16 per 100,000 people).
Notes
• Bevacizumab will be add-on therapy for first-line use in this
indication and would be used in advance of erlotinib or
pemetrexed indicated for second-line treatment of all
NSCLCs.
Cost
• Assuming an average 70kg pt receives a 15mg/kg every 3
weeks for 10 doses, additional drug cost will be
£30,300 per patient.
Lapatinib
Anticipated launch 2007
Indication: Metastatic breast cancer in HER2 positive patients
– last-line treatment.
Impact? Secondary care.
• About 20% of pts with breast cancer overexpress HER2
indicating about 10 per 100,000 people may be eligible.
• It may delay progression to palliative care.
• Oral administration will limit service impact.
Notes
• In PIII trials for first-line use; a competitor to trastuzumab.
Cost
• Likely to be similar to other drugs in this field
• Cost of overall treatment will increase as it will be
used when other treatments have failed.
p53 protein
Anticipated launch 2008
Indication: Head & neck cancer.
Impact? Secondary care.
•
The incidence of head and neck cancer as a group ranges from 8 to
15 per 100,000 people.
•
Rates of the most common forms (mouth and larynx) are rising.
Surgery is the main treatment.
Notes
•
It is likely p53 protein will initially be available in 2007 for treatment of
Li-Fraumeni syndrome, a rare genetic disorder. The licence for head
and neck cancer will follow.
•
It will be the first gene therapy available in the EU.
Cost
•
Unknown at this stage but as a gene therapy it is likely to be
expensive.
Sorafenib
Anticipated launch 2008
Indication: Advanced hepato-cellular carcinoma.
Impact? Secondary care.
• UK liver cancer incidence is 4-5 per 100,000 people with
hepatocellular carcinoma being the most common form.
Notes
• Current options include surgery and transplantation but few
patients are eligible; non-surgical options are less satisfactory.
• Sorafenib could become first-line treatment.
Cost
• Cost of 400mg orally twice daily is over £2,500 per month.
Thalidomide
Anticipated launch 2008
Indication: Multiple myeloma, first-line use.
Impact? Secondary care.
• UK incidence of multiple myeloma is 3 to 4 per 100,000
people.
Notes
• Thalidomide for first-line use would be additional to standard
therapy. Currently, lenalidomide and bortezomib are licensed
for second-line use.
Cost
• Current unlicensed cost assuming an average dose of 100mg
daily is at least £5,000 pa. However, unlicensed cost may not
reflect licensed cost. Lenalidomide costs about £52,000 pa.