Download Michael Barry Michael Barry - Irish Pharmaceutical Healthcare

The Value of Innovation
Michael Barry
26th November 2013
For discussion
• Medicines
Management Programme
• Pharmacoeconomic Assessment
• Value of innovation
The Medicines Management Programme
Multi-disciplinary Medicines Management Programme (MMP) headed by the
National Medicines Information Centre (NMIC) and the National Centre for
Pharmacoeconomics (NCPE) in collaboration with the HSE-Primary Care
Reimbursement Service (PCRS)
Providing sustained national leadership relating to
 Safe
 Effective
 Cost –effective prescribing
The MMP ‘preferred drug’ initiative
Factors considered in making a recommendation for a
‘preferred drug’
• range of therapeutic indication(s)
• clinical evidence base
• clinical guidelines ( National & International )
• cost
• patient related factors
• current prescribing practice
The MMP ‘preferred drug’ initiative
So remember:
Statins : Think SIMVASTATIN
PPI: Think LANSOPRAZOLE
ACE inhibitor: Think RAMIPRIL
ARB: Think CANDESARTAN
Next steps for the ‘preferred drug’ initiative
Selective Serotonin Reuptake Inhibitors (SSRIs)
Serotonin & Noradrenaline Reuptake Inhibitors (SNRIs)
Respiratory medicines
Reference pricing and the MMP
Reference pricing begins with the IMB identifying ‘interchangable drugs’ .
Atorvastatin (Lipitor) was the first drug and will be followed by
esomeprazole (Nexium), rosuvastatin (Crestor) with omeprazole
(Losec Mups) and pravastatin (Lipostat) later. It is envisaged that 20 drugs
will be identified as interchangable by May 2014.
In setting the reference price the following criteria are considered:
1. The ability of suppliers to meet patient demand
2. Value for money afforded by the relevant listed items
3. Equivalent relevant prices in other Member States ( EU 28 ).
4. The relevant prices of therapeutically similar listed items e.g. simvastatin for atorvastatin
5. Resources available to the Executive
6. The terms of any agreements in place with stakeholders e.g. IPHA
The new oral anticoagulants
Reimbursement
approval for new
Anticoagulant
Over 70% of NOAC
prescribing is for
patients ≥ 70 years
70-74 years = 17.53%
75 + years = 52.51%
Atrial fibrillation accounts for 86.9% of all applications for NOACs
The new Reimbursement Approval
form for NOACs – enhancing safety
The new reimbursement approval form will
include information in relation to the following:
CHADS ² Score
CHA²DS ² - VASc Score
HAS - BLED Score
Cockcroft -Gault Eqn for GFR (ml/min)
Current prescribing of oral anticoagulants – expenditure
Growth in NOAC
utilisation and
expenditure is, in
part, related to the
issue of INR
monitoring in the
primary care setting.
Over 60% of NOAC
prescribing takes
place in the South
and West of the
Country.
Which NOAC for AF ?
Bayesian mixed treatment comparison (MTC) underway
The Medicines Management Programme
Under the Medicines Management Programme there is an
increased emphasis in obtaining utilisation and
expenditure data under the Community Drugs Schemes.
HTA is considered part of MMP and may be used where
there is concern in relation to value for money
Examples of HTAs carried out under the MMP include:
 Omacor
 Pregabalin (Lyrica)
The Medicines Management Programme
An important component of the MMP is
communication with our prescribing colleagues.
The NMIC has a 20 year record in such
communications including our publications
‘NMIC Bulletin’ and ‘Therapeutics Today’.
Under the MMP we are now conducting a series of GP meetings around the
country with the support of the ICGP and the RCPI. Meetings to date:
• Dublin x 2
• Dun Laoghaire
• Waterford
• Killarney
• Donegal
Next meetings will be held in Kildare, Dublin, Cork and Galway
In 2014 we aim to communicate with GPs through our Pharmacy Advisors
National & Regional Prescribing Rates of Preferred Drugs – example NWHB
North Western Health Board Region
RAMIPRIL as % of all ACE inhibitors = 60%
CANDESARTAN as % of all ARBs = 8%
LANSOPRAZOLE as % of all PPIs = 30%
SIMVASTATIN as % of all Statins = 10%
National Prescribing Rates
RAMIPRIL as % of all ACE inhibitors = 53%
CANDESARTAN as % of all ARBs = 10%
LANSOPRAZOLE as % of all PPIs = 23%
SIMVASTATIN as % of all Statins = 6%
Pharmacoeconomic evaluation
Pharmacoeconomic assessment process
Pharmaceutical Company
HSE - CPU
Health Service Executive
– Corporate
Pharmaceutical Unit
(HSE-CPU)
NCPE
RAPID REVIEW
(www.ncpe.ie)
National Centre for
Pharmacoeconomics
(NCPE)
Number of NCPE rapid reviews/year
50
45
40
35
30
25
20
15
10
5
0
Rapid Review
2009
2010
2011
2012
2013
In 2012 62% of rapid reviews recommended a full HTA
‘Value of Innovation’
Innovation ?
• H2 receptor antagonists and PPIs for the treatment of PUD
• Protease inhibitors for the treatment of HIV infection
• Statins for the prevention of cardiovascular disease
• Protease inhibitors for the management of hepatitis C infection
• Antibiotic therapy
• Antihypertensive & Heart failure therapy with ACE inhibitors
• Trastuzumab for the treatment of HER2 positive breast cancer
From the HTA perspective innovation is not • a pharmaceutical product with a new mechanism of action but little advantage
in terms of health outcomes
• a “personalised medicine” or “targeted therapy” that does not work very well
• where the primary health outcome is a change in some obscure,
meaningless surrogate marker.
• a product which demonstrates non inferiority to the current standard of care
• a product that is considered unaffordable
Innovation – definition ?
“a new or existing medicine applied in a way which significantly
improves healthcare at a price the HSE can afford”
- does not have to be a new product
- does have to significantly improve heath outcomes
- does have to be affordable
there must be added value
How do we measure value ?
Value may be measured in natural units e.g. life years gained (LYG)
or
Value may also be determined from a composite of LYG and a
measure of utility or well being as assessed using any of the
‘Multi-attribute health status classification systems’
Quality of Well-Being (QWB)
Health Utilities Index (HUI)
EQ-5D
Short Form 6D
Mobility
Self-care
Usual activity
Pain/discomfort
Anxiety/depression
Cost-effectiveness threshold – IPHA 2012
Cost (€)
Q4
Q1
Effect (QALY)
Q3
Q2
The QALY threshold to be used in the HTA process is € 45,000
Capturing value vs affordability ?
Do we value innovation ?
Estimating revealed weights for a multi criteria decision analysis
approach to Health Technology Assessments: A case study in Ireland
Efficiency/Affordability
Clinical Utility
Consumer demand
Criteria
assessed
Social perspective
Economic incentives
Modelling issues
Cost-effectiveness
Gross Budget Impact
Safety & Tolerability
Process Utility
Unmet need
Orphan status
Disadvantaged population
End of life
Severe disease
Innovation
Reversibility
Quality of evidence
Uncertainty
Schmitz S. et al. 2013
Estimating revealed weights for a multi criteria decision analysis
approach to Health Technology Assessments: A case study in Ireland
The analysis confirms that recommendations for or against
reimbursement of technologies are driven by the following:
Cost-effectiveness (ICER)
Quality of available evidence
Safety & Tolerability
Innovation
Schmitz S. et al. 2013
Are we getting value for money ?
Recent ICERs
€ 203,028/QALY Pertuzumab BC
Crizotinib NSCLC € 165,616/QALY
Cabazitaxel PC € 110,032/QALY
?
?
€ 116,000/QALY Ipilimumab MM
€ 112,905/QALY Vemurafenib MM
€ 105,420/QALY Abiraterone PC
Cost (€)
€ 16,023/QALY Telaprevir – Hep C
€ 11,411/QALY Boceprevir – Hep C
Effect
(QALY)
Opportunity Cost !
Crizotinib NSCLC € 165,616/QALY
Cabazitaxel PC € 110,032/QALY
?
€ 203,028/QALY Pertuzumab BC
?
€ 116,000/QALY Ipilimumab MM
€ 112,905/QALY Vemurafenib MM
€ 105,420/QALY Abiraterone PC
Cost (€)
€ 16,023/QALY Telaprevir – Hep C
€ 11,411/QALY Boceprevir – Hep C
Effect
(QALY)
Opportunity Cost !
Crizotinib NSCLC € 165,616/QALY
Cabazitaxel PC € 110,032/QALY
?
€ 203,028/QALY Pertuzumab BC
?
€ 116,000/QALY Ipilimumab MM
€ 112,905/QALY Vemurafenib MM
€ 105,420/QALY Abiraterone PC
Cost (€)
What is the € and
health outcome
value of this ?
€ 16,023/QALY Telaprevir – Hep C
€ 11,411/QALY Boceprevir – Hep C
Effect
(QALY)
£ 80 million = 4,367 QALYs, 1337 LYGs, 295 deaths
Claxton K. ISPOR 2013
“fair prices and real value”
Developments at NCPE
• Multi criteria decision analysis (MCDA) and Health Technology Assessment
(HTA)
• Incorporating Irish values into measurement of Quality of Life
• Increasing emphasis on methodological developments around uncertainty
and Bayesian approaches in HTA
• Enhancing the existing link between the NCPE and academia.
“to date assessments in Ireland have been
conducted in a pragmatic, timely, transparent and
flexible manner and it is important that these
features continue to characterise the conduct of
future assessments”
November 2010
‘Innovations of Value’
Thank you