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Euro'vision blog

A look at the key issues for pharma across Europe

Europe's market access outlook

An ever-closer union?
Europe's market access outlook

Surveying Europe's market access landscape, the trend for cross-border collaboration looks set to continue, but there are significant changes ahead as some of the region's largest markets pursue their own agendas for market access reform.

Driving this is the issue of pharmaceutical prices, criticism of which has reached unprecedented levels in the last couple of years, and one product in particular - Gilead's Sovaldi (sofosbuvir) - has been the main subject of scrutiny. The drug's price has prompted headlines such as: 'Sovaldi: why a pill can cost €700'; 'A pharma company wants to charge… 280 times the cost price of a drug'; and 'The price of this drug is deadly'. This adverse publicity is a major challenge, not just for Gilead but for the entire research-based industry, given that the controversy has become a catalyst for pricing reform initiatives across Europe and beyond.

Increasing collaboration between EU member states
In June 2014 Marisol Touraine, the French Minister of Health, proposed a collaboration on new hepatitis C therapies to the Council of the European Union. The French government favours the establishment of a network of information exchanges to share knowledge on matters such as pricing, therapeutic protocols and guidelines, registry design and details of negotiations with drug manufacturers. Fourteen countries expressed support for this initiative. Furthermore, the French government ensured pharmaceutical prices were on the agenda at May's G7 Summit in Japan plans to use this month's G20 Summit in China to continue its campaign for wider international collaboration to control drug prices.

One of the most vocal critics of the price of innovative medicines is Edith Schippers, the Dutch Minister of Health. In April 2015, she announced plans for the Netherlands and Belgium to work together on matters such as horizon scanning, refinement of evaluation methods, establishment of patient registries, data sharing, possible joint evaluations and price negotiations. The programme will focus initially on high-priced orphan drugs. Luxembourg was quick to join this alliance and in June 2016 Austria also signed up to the partnership. Other countries with similar healthcare systems are invited to join the alliance.

Schippers also used the Dutch Presidency of the Council of the European Union in the first half of 2016 to pursue her agenda for faster access to innovative drugs and increased collaboration on pharmaceutical pricing. In June, the Council published its conclusions on how to redress the balance in pharmaceutical systems in the EU and its member states. Ministers expressed particular concern about three trends in the European pharmaceutical sector: market failures, increasing segmentation of patient populations and poor access to innovative medicines in some smaller European markets. The Council identified several possible responses to market access pressures, including voluntary cooperation between individual member states on horizon scanning, early dialogue, knowledge sharing, exchange of pricing data and joint pricing negotiations, as well as shared health technology assessment (HTA) procedures or mutual recognition of HTA reports.

The pharmaceutical price controversy has become a catalyst for pricing reform initiatives across Europe

Pan-European initiatives to improve access to medicines
The Council also emphasised the importance of pan-European initiatives such as the HTA Network and the European Network for Health Technology Assessment (EUnetHTA). In particular, ministers would like to explore the potential of registries and digital methods of assessing the effectiveness of medicines, as well as possible synergies between the work of regulatory authorities, HTA agencies and payers.

For its part, the HTA Network has called for more routine international collaboration in HTA, including greater cooperation on horizon scanning and establishing clusters of expertise by disease and technology in specified national or regional HTA agencies. The HTA Network's Strategy for EU Cooperation on HTA, published in October 2014, recommends the following changes:

  • The creation of a collaborative model to assist national HTA authorities to base their reports on other HTA agencies' work
  • Closer cooperation on defining evidence requirements at all stages of the product life cycle 
  • Extending EU collaboration beyond its current focus on clinical domains of HTA (notably, relative effectiveness assessment) to encompass economic, organisational and societal perspectives
  • Addressing the needs of a broader range of stakeholder groups, including health policymakers, regulators, payers, manufacturers of innovative health technologies, healthcare providers and patients.

The pharmaceutical industry's experience to date of pan-European HTA initiatives has been mixed. Early dialogue with HTA agencies and regulators has enabled manufacturers to address important issues such as patient population, comparator choice, clinical trial design, endpoints, patient stratification and health economic data. However, joint guidance from the European Medicines Agency and HTA bodies is complicated by their very different perspectives: regulators focus on a drug in isolation (ie, its safety, efficacy and quality), whereas HTA agencies need to take account of the impact a medicine is likely to have on their healthcare systems.

If a product does not deliver on its clinical promise, society should not continue to pay for it

Germany prepares for significant change
Notwithstanding growing interest in international collaboration, market access remains ultimately a national prerogative. Larger markets, in particular, will likely continue to follow a largely independent course with regard to pricing and reimbursement decision-making. Germany, the largest of all Europe's markets, is poised for significant change to its market access environment. The Ministry of Health has recently published an outline for pricing reform legislation: the initial proposals are based largely on the recommendations of the Pharmadialog, an extended discussion involving three government ministries, the leading pharmaceutical industry associations and several academic bodies:

  • The current price freeze on reimbursable medicines, scheduled to end in 2017, will be extended until the end of 2022, although increases in line with inflation will be permitted from 2018 onwards. Extending the price freeze will save €1.5-2bn.
  • Manufacturers will remain free to set the prices of new medicines for the first year after launch. However, if sales in that period exceed a certain threshold (€250m has been proposed), companies will be liable to pay rebates. 
  • Price-volume agreements could be introduced in the future.
  • Failure to submit an early benefit assessment dossier, or the submission of incomplete documentation, will be penalised by a price cap below the annual treatment costs of the comparator therapy.
  • At present, the price of a drug that is deemed to offer no additional benefit is set in relation to the price of the least-expensive appropriate comparator therapy. This rule could be relaxed in exceptional circumstances - for example, where a new medicine might offer some patients a useful therapeutic alternative.
  • Prescribing restrictions could be imposed on drugs that are judged to offer no additional benefit, but might be of value to particular patient subpopulations.
  • Details of drug rebates will, in future, be available only to institutions of the German healthcare system that require this information to fulfil their legal obligations. 
  • The option of creating reference pricing groups that consist exclusively of patent-protected drugs will be abolished. 
  • The early benefit assessment process could be applied to drugs launched prior to January 2011 that are approved for significantly different new indications.
  • In an effort to promote greater use of drugs that have undergone early benefit assessment, the Ministry of Health will work with manufacturers and the GBA (Federal Joint Committee) to develop prescribing software to inform physicians of the outcomes of this process.

The German government has indicated that it aims to pass this legislation by the end of the year.

Industry responses to a fast-changing environment
Faced with a crescendo of criticism, the life science industry appears willing to explore radical new approaches to pricing. In June, Reuters published brief excerpts from a leaked copy of an EFPIA internal report on pricing. The Roadmap for Change Towards Outcomes-Based Reward Systems reportedly acknowledges that 'affordability is a major issue for healthcare systems across Europe', and the advent of novel oncology combination therapies, antibiotics and stem cell therapies will only intensify financial pressures. The report proposes: 'If a product does not deliver on its clinical promise, society should not continue to pay for it. Equally, if the product delivers more value than was ever expected, this extra value must be rewarded.' In return for much wider adoption of outcomes-based agreements, EFPIA would apparently look to European governments to abolish external reference pricing and tenders for patent-protected medicines, and to curb parallel trade.

The EU undoubtedly appears committed to promoting greater pan-European collaboration in HTA. In addition, greater cross-border collaboration on pricing is particularly attractive to smaller markets because it boosts their bargaining power with manufacturers. However, given the profound differences in the organisation and funding of Europe's healthcare system, market access decisions are likely to remain a national prerogative for the foreseeable future. The challenge now facing the life science industry is how to influence the evolution of market access environments to ensure fairness for all stakeholders - payers, patients and producers.

Article by
Neil Grubert

is an independent global market access consultant

15th September 2016

From: Regulatory



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