Portugal: A Glimpse into Europe's Future in an Era of Austerity and HTA Reform?

By Xcenda |

Controlling the rapidly growing healthcare spend in Europe is a frequent topic of discussion for many healthcare stakeholders, Reining in cost is even more critical in European countries like Portugal that were hardest hit by the global financial crisis and were subject to tough austerity measures. In response to health- and policy-related financial pressures, in 2014, Portugal instituted an overhaul of their HTA and pricing/reimbursement system via the SiNATS (Sistema Nacional de Avaliação de Tecnologias de Saúde). We take a closer lookt at SiNATS, which may be the harbinger for market access reform in Europe and abroad.

HTA QUARTERLY | WINTER 2017

Portugal: A glimpse into Europe’s future in an era of austerity and HTA reform?

By Chelsey Campbell, PharmD, MBA, MS and Ryan Clark, PharmD, MBA, MS 

Controlling the rapidly growing healthcare spend in Europe is a frequent topic of discussion for many stakeholders, including politicians, insurers, national health technology assessment (HTA) agencies, and manufacturers. Reining in cost is even more critical in European countries like Portugal that were hardest hit by the global financial crisis and were subject to tough austerity measures. In response to health- and policy-related financial pressures, in 2014, Portugal instituted an overhaul of their HTA and pricing/reimbursement system via the SiNATS (Sistema Nacional de Avaliação de Tecnologias de Saúde). Emphasizing a broader HTA, risk-sharing and ongoing evidence generation, and reassessment of current technologies,1 SiNATS may be the harbinger for market access reform in Europe and abroad.
 

Structure of Portuguese healthcare system 

The SNS (Serviço Nacional de Saúde), or national health service, has offered universal healthcare coverage since 1979, though the care provided is not comprehensive.2 Private or voluntary insurance and special insurance schemes for certain professions cover approximately 30% to 50% of the Portuguese population. While the majority of health services are provided and controlled by the state, there is a significant private sector regulated by the government: approximately 30% of all medical consultations occur in private institutions.3 Portugal is just shy of Italy and Spain in terms of healthcare spending, with 9.0% of its GDP going to private and public health spend.4
 
When it comes to pharmaceuticals, INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; National Authority of Medicines and Health Products) is responsible for authorizing, regulating, distributing, and monitoring pharmaceuticals (and as of 2014, medical devices).2 INFARMED is also responsible for decision making around reimbursement of pharmaceuticals based on efficacy, safety, and cost-effectiveness and can set a maximum manufacturer price on outpatient medicines.2 The maximum price for an outpatient medication is calculated based on an average of the 3 reference countries (Spain, France, and Slovakia).5 In 2006, INFARMED was expanded to include hospital drugs, with an assessment including therapeutic value and cost-effectiveness. For hospital drugs only, the maximum price is set at the lowest (instead of the average) price in the 3 reference countries.2
 

Reform of HTA in wake of global pressures

While there have been a number of reforms in Portugal since the 2007/2008 global financial crisis, the most significant enhancement to the Portuguese healthcare system was the introduction of SiNATS in 2014. SiNATS was instituted to accomplish the following objectives6:

 

 

SiNATS reforms were focused on several key areas1:

 

Now responsible for medical devices in addition to pharmaceuticals, the independent Health Technology Assessment Committee (Comissão de Avaliação de Tecnologias de Saúde; CATS) performs a regulatory, relative effectiveness, and cost-effectiveness assessment of novel products.1 SiNATS also emphasizes more creative solutions to controlling cost via access management, such as conditional reimbursement via managed entry agreements, ongoing registries, and reassessments. To incorporate these aspects, a pricing evaluation also takes place, and the following aspects are negotiated by the national agency as part of the approval process:

 
Risk-sharing schemes are also more critical under SiNATS. Both performance-based (ie, based on clinical factors) and cost-based (ie, based on financial factors) risk-sharing schemes will be employed.1 SiNATS aims to combine both financial and performance schemes to address key areas of concern: 

After agreement has been reached with the Ministry of Health, technology reports will be published outlining general recommendations for use and instructions on how the product should be used. Work for the manufacturer is not done yet, however: ongoing technology reassessment based on real-world evidence generation causes market access in Portugal to be an ongoing process.

Products approved before the introduction of SiNATS are not exempt either, as the reform calls for a reassessment of existing technologies.2 Disease states like cancer and HIV will be targeted using information from manufacturers along with outcomes data from national registries. INFARMED utilizing as much of the data available, both clinical and economic, is another focus of SiNATS.1 Using international registries/data monitoring sources like EUnetHTA and national HTAs and the national system (including academic centers and an HTA-sponsored database linked to hospital data), INFARMED will be poised to make well-informed decisions on prices and reimbursement of novel products. The key targets for the patient registries include:

  • Oncology
  • HIV/AIDS
  • Orphan/rare disease products
  • Medical devices
  • Hepatitis C
Key Take-aways

Although Portugal may not be one of the top targets for European market access due to its smaller size, the recent reforms in the country appear to be a signal of the way Europe may be shifting to better control the cost of healthcare. SiNATS focuses on global integration, big data, risk sharing/managed entry agreements, cost-effectiveness research, comparative effectiveness, and real-world evidence generation—all of which are hot button topics across the globe. To secure access in Portugal, it is critical that manufacturers consider early- and late-phase health economic and outcomes research along with novel contractual agreements to enhance product value and associated reimbursement. While Portugal may not initially be a high priority at product launch, it may be a sign of things to come when seeking European market access.

 

 

 

The article should be referenced as follows: 

Campblell C, Clark R. Portugal: A glimpse into Europe’s future in an era of austerity and HTA reform? HTA Quarterly. Winter 2017. Jan. 19, 2017.


 References

  1. New HTA and prices & reimbursement system (SiNATS) in Portugal:
    impact on the reimbursement of oncologic medicines. IHF Chicago: 39th World Hospital Congress. 2015. http://www.apdh.pt/sites/apdh.pt/files/2015IHFChicago_JOAO MARTINS (2).pdf.
  2. The Economist. Value-based healthcare in Portugal. https://www.eiuperspectives.economist.com/sites/default/files/ValuebasedhealthcarePortugal_0.pdf.
  3. Tavares AI. Portuguese health system, an overview and a SWOT review. Open Public Health J. 2016;9:16-30. http://benthamopen.com/FULLTEXT/TOPHJ-9-16.
  4. OECD.org 2016. https://data.oecd.org/healthres/health-spending.htm#indicator-chart.
  5. Barra M. Portuguese government changes reference countries for 2015 drug prices – Slovenia, Spain and France as new reference countries. https://pharmupdates.wordpress.com/2014/11/19/portuguese-government-changes-reference-countries-for-2015-drug-prices-slovenia-spain-and-france-as-new-reference-countries/.
  6. SNS. SiNATS - Sistema Nacional de Avaliação de Tecnologias de Saúde. http://www.infarmed.pt/portal/page/portal/INFARMED/MEDICAMENTOS_USO_HUMANO/SINATS.