Real World Data Europe

Apr 28, 2014 - Apr 29, 2014, London, England

Demonstrate the true effectiveness of your drugs to satisfy payers, HTAs and improve patient outcomes

A New Era of Reimbursement in France

eyeforpharma interviews the President of HAS

Since the economic crisis, the French parliament has been applying consistent pressure to reduce the cost burden of healthcare to the economy. The necessity to cut costs has been hitting pharma hard; indeed, last year was the first time that reimbursement costs declined within France, by 2.2%. Further cuts look likely too, as France starts to implement a reform of its price determination processes. We spoke to Jean-Luc Harousseau, the President of HAS to find out more.

A need for reform

Given that France has successfully managed to reduce the costs of drug reimbursement over the last couple of years, we might question why there is even a need to change the current system. Why can’t costs be further controlled simply through discussion between the pricing committee and pharma?

Harousseau highlighted three reasons why there is a need for change.

The first is that although headway is being made on reducing costs, the fact remains that overall healthcare expenditures are growing faster than GDP. Frances’s capacity to meet its healthcare costs is therefore getting more difficult. Harousseau acknowledges this situation: “We are striving towards reducing the costs of our healthcare organizations, but we still need to continue efforts in managing price.”

A second reason why change is needed is that it is the view of HAS that France is reimbursing certain products that are far too expensive in the context of their clinical interest to the country. Harousseau pointed to recent products in statins and anti-diabetic agents as examples. HAS views recent innovations in these categories as being highly expensive, despite the fact that their benefit is not certain.

The third reason stems from the expectation both that R&D costs will increase, and that drugs will be increasingly targeted towards sub-groups of patients. It seems inevitable, therefore, that drug costs will be set on an upwards spiral, as pharma are required to recoup increased costs from smaller patient populations.

The need for reform:

  1.  Healthcare expenditure is increasing far faster than GDP growth 
  2.  HAS perceive a mismatch between prices and clinical value
  3.  Personalised medicine and increasing R&D costs will force an era of ever-increasing prices 


Due to these realities, Harousseau views the introduction of cost-effectiveness analysis as a necessary step for France. Harousseau says, “The objective of these new procedures will be to help decision makers through giving them scientific arguments to determine the price, supported by national health insurers. We want to help them make that choice.”   

As the national objective on healthcare costs is determined on an annual basis, it is difficult for Harousseau to state specific cost reduction targets. Moreover, as drug expenditure represents less than 20% of healthcare expenditure, it is difficult to state an objective on price reduction. Although the reimbursement climate in France will undoubtedly be harder for pharma, a formalised structure for reducing the cost of drugs will clarify the procedures for every party. Harousseau notes that, “Until now, price reduction has been decided by discussion, not based on scientific assessment of the cost-effectiveness of a product. In the future, it will be easier to have discussions with pharma, and this will benefit everyone.”

But although drugs represent a minor portion of the healthcare cost burden, they have received the brunt of cost reduction efforts. Harousseau says, “To be honest, until now, the maximum effort was directed towards drug price reduction and the de-reimbursement of less important drugs. Of course, other efforts were made, such as the reduction of doctors’ fees and patient transportation costs.”The reason behind this is the simple fact that it is easier to have a pricing conversation with pharma than it is to reform the structure of healthcare delivery. Looking to the future however, Harousseau states that less pressure will be placed on pharma to reduce overall costs; the longer-term national objectives focus on better organised primary care delivery. A lot of inspiration is being taken from recent reform in the USA and innovations such as patient-centred medical homes. Due to the nature of the projects however, it will take longer for the healthcare system to experience the benefits.

What will the new system look like?

The new cost-effectiveness system began operation this January in 2014.  Drugs will become assessed not just by clinical evaluation, but also by efficiency, a cost-effectiveness assessment of collective national interest in the product. The combination of both assessments will form the framework for price discussions with pharma. Although the parliamentary decision to create this system took place in October 2nd 2012, it took another year of discussion to categorize how drugs would be analyzed and assessed. Harousseau says, “This is a huge change in France for us to introduce cost-effectiveness in HTA.  As such the first dossier for assessment was only submitted in October 2013 and the first analysis only started in January 2014. Harousseau states, “We expect to have approximately 10 assessments in the first trimester of 2014.”

The assessment itself will be performed in parallel with medical assessment, and is expected totake 90 days. After this period, Harousseau says, “We will give either negative advice if the submitted dossier/model is not correct, and does not follow our guidelines, or positive advice if the model is ok. In the latter case, we will then suggest different prices to define different incremental cost-effectiveness ratios.” The pricing committee will take their decision not only based on the Improvement of Medical Benefit assessment (ASMR) but also on the cost-effectiveness analysis. Pharma will have the opportunity to discuss with the pricing committee after HAS make their recommendations, but they will also have the chance to get feedback before that stage as well. During the initial analysis, the company can come in and talk over the analysis directly with HAS as well.

The European level

Harousseau,recognizes that constantly changing requirements do not give them an easy task, saying, “I understand that it is not easy for pharma to comply with the rules of each country, as they can be very different. It is even more difficult when the rules are changing frequently in the country. ”Harousseau suggests that some hope might lie around the corner, however, with the work that is being done with EUnetHTA to unify assessment standards. Harousseau stated, “It is certainly good to try and unify procedures and the job that has been done so far is very useful.”

Despite the obvious benefits that would come with unification, Harousseau had some words of caution, “While effort is necessary, we cannot forget that each country has a different economic situation and a different healthcare system. It will always be different across the countries. For example, the Germans do not accept even the principle of cost-effectiveness analysis. It is enshrined in their constitution that everyone should have the best treatment. ”The situation is, that while we may be able to get a point whereby submission dossiers are common, the judgments that are then taken by authorities while be different, and may require different comparators.

For the foreseeable future at least, pharma’s juggling act will continue.

To speak directly with Jean-Luc Harousseau, President, HAS and other payer decision makers from across Europe, reserve your place at eyeforpharma’s Payers' Forum this September in Berlin. For further details, click here. 

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Real World Data Europe

Apr 28, 2014 - Apr 29, 2014, London, England

Demonstrate the true effectiveness of your drugs to satisfy payers, HTAs and improve patient outcomes