Prasugrel was approved for marketing in Portugal in 2009 and was used to treat 16.8% of myocardial infarction patients in the US from 2009-2011. The study characterized access to and use of new cardiovascular technologies in the US and Portugal. It found that most medical devices were approved earlier in Portugal, while drugs were generally available sooner in the US, despite some being approved earlier in Portugal. Differences in regulatory and pricing systems between the countries impact the types of treatments available and strategies to access markets.

1. Prasugrel
Portugal – Approved for marke.ng in 2009 and marketed since 2014
US – 16.8% of pa.ents with a myocardial infarc.on undergoing PCI between July 2009 and
June 2011 were treated at discharge with prasugrel
The Atlan2c Divide
in Coronary Heart Disease
Health technologies use in the US and Portugal
Lobo MF Ÿ Azzone V Ÿ Melica B Ÿ Bacelar-Nicolau L Ÿ Nisa C Ÿ Freitas A Ÿ
Azevedo LF Ÿ Rocha-Gonçalves FN Ÿ Resnic FS Ÿ Teixeira-Pinto A Ÿ
Pereira-Miguel J Ÿ Norman S-LT Ÿ Costa-Pereira A
www.cuteheart.com
marianalobo@med.up.pt
Background
Coronary heart disease (CHD) treatment has seen significant improvements due to
new health technologies in interven.onal cardiology
The health system of the United States (US) is mainly driven through the private
sector, presen.ng a high level of health expenditure when compared to Portugal
The health system of Portugal (PT) provides universal coverage through a public
network of healthcare ins.tu.ons and providers, financed through general taxa.on
Centralized medical device approval system in the US (federal level, FDA) vs.
Decentralized approval system in PT (European Union level)
Centralized drug approval system in the US vs. Variable in PT depending on the type
of drug and the number of countries marke.ng is sough
PT has lower CHD risk profiles, less than half the CHD hospitaliza.ons per capita and
significantly lower CHD deaths
Findings
Discussion
Disclosures: Nothing to disclose. Funded by FCT (HMSP-ICT/0013/2011)
CUTEheart
Compara.ve Use of Technologies
for Coronary Heart Disease
Harvard Medical School – Portugal Program
Methods
Thirty health technologies (medical devices and ac.ve substances) introduced
between January 1980 and February 2015 were iden.fied by experts and reviewed
Health technologies access lag was defined by the difference of approval/
commercializa.on/first use dates (US-PT)
Informa.on on use trends in US versus PT was addi.onally retrieved through a
comprehensive literature review
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Objectives
To characterize and compare the ability of the health systems of US and PT to access
and use new health technologies to treat CHD
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ISPOR 18th Annual European
Congress, 2015, Milan, Italy
Differences in regulatory mechanisms and price regula.ons have a significant impact
on market access strategies and types of available treatment for CHD
Most medical devices were approved sooner in Portugal
Our findings add to the current evidence that the .me advantage remains when
considering the first model of a new technological innova.on family
Most drugs were available sooner in the US, despite oeen approved earlier in
Portugal
At least five devices considered were adopted first or diffused faster in the US despite
an ini.al advantage due to earlier approval in Portugal
Approval of the drug-elu.ng balloon is s.ll pending in the US but approved in
Portugal since 2007
Commercializa.on dates of drugs in Portugal may not reflect inpa.ent use, results for
drugs such as abciximab and .rofiban should be interpreted cau.ously
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Dashed line represents median .me lag (US-PT); N/A – Not available; TAVR – Transcatheter Aor.c Valve Repair; PTCA – Percutaneous
Transluminal Coronary Angioplasty.
Access lag of medical devices was determined based on approval dates for the US available at the FDA/scien.fic journal, and, for PT,
dates of CE marking retrieved from personal communica.on with MD industry representa.ves/online press release/EUCOMED/
scien.fic journal and first use dates in Santa Cruz Hospital
Diffusion and Use of Health TechnologiesAccess to Health Technologies (US-PT)
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Dashed line represents median .me lag (US-PT); N/A – Not available; N/C – Not commercialized; GP - Glycoprotein.
Access lag of ac.ve substances was determined based on approval dates available for the US at the FDA and commercializa.on dates
available for PT at the INFARMED
* Approved for marke.ng sooner in PT than US, regardless of when marke.ng started
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Portugal – First case treated in late 2012, four years aeer approval Ÿ In 2014, there were 2
centers providing this therapy Ÿ 0.19 centers per million popula.on
US – More than 500 cases treated by the end of August 2014, one year aeer approval Ÿ In
2014, there were 76 centers providing this therapy Ÿ 0.25 centers per million popula.on
Percutaneous
Mitral Repair
System TAVR
Portugal – Use rate rate plateaued in 2010 with 20 TAVR per center, three years aeer approval
Ÿ 6.1 implants per million popula.on
US – In 2012, one year aeer approval, approximately 20 TAVR per center were performed Ÿ
15.8 implants per million popula.on
Impella
2.5L
Portugal – 5 pa.ents per center per year implanted between 2004-2007
US – 8 pa.ents per center per year implanted between 2010-2011
Intravascular
Brachytherapy
Portugal – Diffused into Portugal in 2001, one year aeer approval, mo.vated by FDA’s
approval demonstra.ng its effec.veness in intra stent-restenosis Ÿ Used for 6 months
US – FDA approved in December 2000 Ÿ In 2010 most centers no longer possessed the
necessary set up
Drug-Elu2ng
Stent
Portugal – By 2003, one year aeer approval, PT had the highest rate of DES implanta.on in
Europe, 55% of PCI Ÿ 0.3 cardiac catheteriza.on centers per 100 000 popula.on Ÿ PCI became
more frequently used than thrombolysis aeer 2007
US – By the third quarter of 2005, two years aeer approval, the use of DES per PCI peaked at
nearly 90% in the US Ÿ 0.5 cardiac catheteriza.on centers per 100 000 popula.on
Clopidogrel
Portugal – Approved for marke.ng in 1998 and marketed in 2003 Ÿ Ambulatory prescrip.on
started in 2003, the same year this drug became eligible for government reimbursement
US – Commercialized as Plavix with increasing sale rates since its approval in 1997
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Approval dates of Medical Devices
Marke2ng dates of Drugs