Transcript Horizon scanning by UKMi

Horizon scanning
for managing
medicines
Produced to support the Prescribing
Outlook series
November 2011
Outline
What is horizon scanning and why is it necessary?
How does the process of horizon scanning work?
What factors affect the prioritisation of new drugs?
How can medicines information support the process?
What will be the key pressures on medicines budgets
in the near future?
What is horizon scanning?
Horizon Scanning has been defined as:
‘the systematic examination of potential
threats, opportunities and likely future
developments…….
….may explore novel and unexpected
issues, as well as persistent problems
or trends.'
Why horizon scan for medicines?
‘the purpose of horizon scanning is not to predict the
future, but to explore ranges of possible futures in
order to challenge and inform strategy’
• Manage budgets
• Plan services - new and redesign
• Anticipate pressures (financial and service delivery)
• Identify areas for disinvestment
• Manage entry into hospital/ formulary /practice etc
• Identify drugs suitable for homecare
A woman with
advanced kidney
cancer and six
months left to live
says she is
missing out on a
potentially lifesaving drug…….
2010 Prescribing data (England)
• The overall NHS expenditure on medicines
in 2010 was £12.9 billion.
• Hospital use accounted for 31.7% of the
total cost (up from 30.9% in 2009)
• Cost of medicines rose by 4.8% overall but
by 7.7% in hospitals (compared to 5.6%
overall but by 13.2% in hospitals in 2009)
Hospital Prescribing 2010: England. NHS
Information Centre Oct 2011
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 e.g. “biologicals”, oral anticoagulants
• New drug regimens or maintenance treatments
added to standard therapy e.g. chemotherapy
• ‘Medicalisation’ e.g. social phobia
Drivers of growth in prescribing (2)
• National Institute for Health and Clinical
Excellence (NICE), Scottish Medicines
Consortium (SMC), All Wales Medicines
Strategy Group (AWMSG)
• Quality and Outcomes Framework in
primary care
• Cancer drugs fund
Benefits of advance information
• Enables assessment of safety and
efficacy
• Enables assessment of value or cost
effectiveness (rarely)
• Informs and primes NHS
organisations to implement
management strategies
The horizon scanning process
Systematic early
identification
(horizon
scanning)
Filtration and
selection
Information
retrieval
not
include
Prioritisation
include
Assessment
Dissemination
Information sources for the
horizon scanning process
• Specialist media for press • Industry (contacts,
websites, annual reports)
releases highlighting
– conference presentations
• UK PharmaScan
– dates for submission to
licensing authorities
• Licensing agencies
– plans for development
• Specialist databases
• Journals – specialist and
general
• General media
• Clinical specialists
• Other horizon scanners
Filtration and selection
PIII or filed in EU
(over 500 listed on
NDO)
Prioritisation………
…big hitters!
Group work 1
Factors that influence
prioritisation
List factors that influence the impact a new
drug/ licence extension/ new formulation
might have on an NHS organisation.
Hint: Think about which 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, administration and testing
• PbR
• Likely Commissioning for Quality and
Innovation (CQUIN) target
• 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?
large?
• Media/public interest
• Local services e.g.
tertiary centre
• Local use (in ongoing
clinical trials or
unlicensed use)
Factors used by UKMi for prioritisation
• 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.
UKMi Horizon scanning products
Prescribing outlook
www.nelm.nhs.uk
Password restricted
to NHS
UKMi Horizon scanning products
New Drugs Online (NDO)
• Contains over 1300 monographs
• Updated daily
• In August 2011
– 363 monographs updated
– 135 evidence based evaluations added
– 2,168 registered users
• Monthly newsletter
NDO via Evidence in Health and Social
care (NHS Evidence)
www.nelm.nhs.uk
Other UKMi products
(all via NeLM)
• London New Drugs Group reviews
• UKMi/NPC ‘On the horizon’
• New Medicines Profiles
• IFR summaries
• NICE bites
UK PharmaScan
• Common horizon scanning database for medicines
• Hosted by NICE
• Data input regularly by Pharma
• For horizon scanning bodies and organisations with
NHS planning remits
• Developed in collaboration with national horizon
scanning organisations (UKMi, SMC, AWMSG,
NHSC, NPC, NICE), ABPI and Department of
Health
• More info at ukpharmascan.org.uk
Key pressures on
medicines budgets in
2011-2012 due to new
medicines
Key new drugs or licence extensions
anticipated 2011-2012
• Rivaroxaban/ Apixaban for
stroke prevention
• Dabigatran/ Rivaroxaban/
Apixaban for VTE treatment
and long term prevention
• C1 esterase inhibitor for
hereditary angioedema
• Nalmefene for alcohol
dependence
• Telaprevir for hepatitis C
• Exenatide/ Liraglutide plus
basal insulin
• Pertuzumab for breast cancer
• Erlotinib for NSCLC
• Bevacizumab for ovarian
cancer
• Lenalidomide for multiple
myeloma
• Vemurafenib for malignant
melanoma
• Almetuzumab/ Laquinimod
for multiple sclerosis
• Strontium for osteoarthritis
Rivaroxaban/ Apixaban
Indication: Stroke prevention in atrial fibrillation
Impact? Primary care.
• Prevalence of AF is about 1,300 per 100,000 people. More than
20% of strokes are attributed to AF. NICE estimates about 47%
currently receive an anticoagulant with an additional 30% eligible,
but not receiving therapy. Availability of newer anticoagulants may
increase the number of patients treated.
• There is no requirement for monitoring of anticoagulation with the
newer agents but reversing the anticoagulant effect is difficult. This
may have implications for at risk patients. Increased cost of these
may be offset by reduced monitoring. There may be an impact on
commissioning of anticoagulant services.
• Dabigatran was recently launched for this indication.
Dabigatran/ rivaroxaban / apixaban
Indication: Venous thromboembolism treatment and long term prevention
Impact? Secondary and Primary care.
•
In England in 2009-10 there were over 37,000 finished consultant
episodes with a diagnosis of PE (~71 per 100,000 people). Following
an episode of VTE, risk of recurrence within 8 years is about 30%.
•
In primary care, newer drugs may free district nursing services from
administration of low molecular weight heparins and a licence for longterm secondary prevention may increase the number of people on
anticoagulants.
•
There is no requirement for monitoring but reversing the anticoagulant
effect is difficult which may have implications for at risk patients.
•
Increased cost of these may be offset by reduced monitoring. There
may be an impact on commissioning of anticoagulant services.
•
Differences in frequency of dosing may be important for compliance in
the long-term use.
C1 esterase inhibitor
Indication: Hereditary angioedema (HAE) – long term
prophylaxis.
Impact? Secondary care
• HAE is a genetic disorder with an estimated prevalence of 1
in 50,000.
• Current options for prophylaxis include oral danazol and
tranexamic acid; C1-esterase inhibitor may be an option
where these are contra-indicated.
• C1-esterase inhibitor is much more expensive and there are
significant service delivery implications as it is administered
i.v. twice weekly. Self-administration may be possible but
requires extensive training.
Nalmefene
Indication: Alcohol dependence.
Impact? Primary care
• In England, alcohol dependence affects around 4% of people
aged 16-65 years. 290 prescription items per 100,000 people
were dispensed for alcohol dependency in England in 2010.
• Unlike existing drug therapies, nalmefene is used ‘as-needed’
and does not require complete abstinence. This will make it
attractive and as a new treatment nalmefene could be
expensive.
Telaprevir
Indication: Hepatitis C (genotype 1) - treatment naïve and
resistant patients
Impact? Secondary care
• HCV infection is under diagnosed but testing is increasing. In
2009, estimates suggest 250,000 people in England and
Wales were infected; 146,000 chronically (262 per 100,000).
• Genotype 1 is the most resistant form and infects about 40%
of patients, of whom up to 60% do not have a sustained
virological response to the current standard (peginterferon
plus ribavirin).
• This, together with the recently launched boceprevir represent
a new treatment strategy especially for patients who have
failed on standard therapy where further treatment options are
limited. As add-on therapy, they will add considerably to the
cost of treatment. Boceprevir costs about £100/day.
Exenatide/ Liraglutide plus insulin
Indication: Type 2 diabetes mellitus (T2DM)
Impact? Primary care
• In 2009, the UK prevalence of diabetes mellitus in adults was
4% (about 90% with T2DM). It is thought up to 5% of people
in England have diabetes, including those undiagnosed. NHS
health checks will increase the number diagnosed.
• The combination of a GLP-1 and basal insulin will offer an
additional treatment step for patients with inadequate control
despite several therapies.
• The combination is currently used off-label to a limited extent,
but licensing may increase use.
Pertuzumab
Indication: Metastatic breast cancer – first line in HER2-positive.
Impact? Secondary care
• The incidence of breast cancer in the UK is about 78 per
100,000 people. Up to 40% of patients develop metastatic
disease within 10 years and one third of these are HER2positive (10 per 100,000).
• This is likely to be used as add on to standard therapy.
Erlotinib
Indication: Advanced NSCLC- first line in EGFR positive.
Impact? Secondary care
• The UK incidence of advanced NSCLC is 40 per 100,000. Of
the 25% of patients well enough to receive first-line therapy,
20-40% may be eligible for second-line therapy.
• Erlotinib will offer a less complicated and less toxic alternative
to first-line i.v. chemotherapy in selected patients.
• Current cost of erlotinib is about £1,630 per month.
Cost of testing should be taken into account.
Bevacizumab
Indication: Advanced ovarian cancer – first line.
Impact? Secondary care
• UK incidence of ovarian cancer is about 21 per 100,000
people. 40% of affected women are diagnosed with advanced
disease.
• NICE recommends paclitaxel and cisplatin or carboplatin as
first-line therapy after surgery. If licensed, bevacizumab will
be the first angiogenesis inhibitor for ovarian cancer and used
in combination with carboplatin and paclitaxel.
• Current cost of six 15mg/kg doses of bevacizumab given in 3weekly cycles to a 65kg woman is about £14,000.
Maintenance dose is 7.5mg/kg 3-weekly.
Lenalidomide
Indication: Multiple myeloma (MM) - maintenance.
Impact? Secondary care
• The UK incidence of MM is 6.6 per 100,000 people. Median
survival is 3-5 years, increasing to 7 years with intensive
therapy. Remission is followed by multiple relapses, and
ultimately treatment resistance.
• Lenalidomide offers the possibility of prolonged remission and
fewer relapses, compared to current therapy.
• Cost per 28-day cycle is between £3,570 and £4,368 (5mg
and 25mg doses).
Vemurafenib
Indication: Malignant melanoma.
Impact? Secondary care
• Incidence of malignant melanoma in the UK is about 15 per
100,000 people, and is doubling every 10-20 years. About
50% are BRAFV600 positive which is associated with
increased tumour aggressiveness.
• Dacarbazine is the current first-line choice but oral
vemurafenib has already attracted media attention.
• A test is needed to identify BRAFV600 positive patients.
• Vemurafenib is likely to be expensive but could offset current
outpatient i.v. administration costs. In the US, a 6-month
course will cost $56,400. Cost of the test should be
considered.
Alemetuzumab/ Laquinimod
Indication: Multiple sclerosis – relapsing remitting (RRMS).
Impact? Secondary care
• In England and Wales the annual incidence and prevalence of
MS is 3.5-6.6 and 100-120 per 100,000, respectively. Around
80% have RRMS at onset.
• Alemtuzumab is a new class of drug for MS and as a single
annual treatment it may be attractive.
• As an oral competitor to fingolimod laquinimod will have to be
competitive.
• Cost of MabCampath brand of alemtuzumab is about £1,300
for a 5 day course. However, as Lemtrada is a new brand for
MS the pricing structure may be different and could be in line
with the cost of other MS treatments.
Strontium ranelate
Indication: Osteoarthritis (OA).
Impact? Primary care
• By the age of 65, at least 50% of people have some degree of
joint OA. About 10% of people over 65 have a major disability
due to OA.
• Strontium will be an add-on therapy for patients who require
disease modifying therapy and will be an additional benefit for
those with osteoporosis and OA.
• Current cost of Protelos is about £30/month and will be an
additional treatment cost.