The 1st Value Added Medicines conference organised by the Value Added Medicines Group, a sector group of Medicines for Europe, which took place today, 22nd November, gathered a wide range of experts in the healthcare community to raise awareness and foster debate on a common approach to present solutions for patient-centric innovation and better patient access to these medicines.
Health delivery models in Europe are being challenged by an ageing, rising patient population and current healthcare economic constraints, threatening the sustainability of Europe’s healthcare systems. There is a need for a new value proposition for patients, healthcare professionals and healthcare systems, especially to address clinical (adherence, quality of life) and economic inefficiencies. According to IQVIA, patient non-adherence is undoubtedly the biggest source of these, representing 57% of all inefficiency costs[1], and limiting the ability for patients to best manage their condition. Value added medicines can address these challenges by improving patient adherence and quality-of-life issues, while addressing medicine-related healthcare inefficiencies and improving healthcare provision and organisation thereby contributing to the sustainability of healthcare systems.
Marc-Alexander Mahl, Medicines for Europe President, highlighted that ‘We have a responsibility to look at European healthcare systems and see how we can contribute value to patients, healthcare professionals and society. Value added medicines deliver patient-centric gains. To continue the development of this sustainable innovation, there is a need for a favourable environment, where the development efforts can be reasonably recognised, and the access to value added medicines is well integrated in healthcare systems.’
Umberto Comberiati, Chair of the Value Added Medicines Group at Medicines for Europe, commented: “The wide range of stakeholders present at today’s conference has confirmed the wide interest surrounding value added medicines. We actively engage all the stakeholders from policymakers to patients, industry and payers to see how together we can address patients’ needs through the relevant outcomes that value added medicines can deliver. These benefits need to be more widely recognised and incentivised to promote the development of value added medicines in Europe. Pricing, HTA and market access pathways should be adapted to fully appreciate the benefits of this patient centric innovation”.
[1] IQVIA European Thought Leadership; IQVIA Institute 2012 “Responsible use of Medicine”
Medicines for Europe is very glad to see the Council of the European Union reach a decision today, to relocate the European Medicines Agency (EMA) to Amsterdam. This is an important milestone in the Brexit process, bringing us from a point of uncertainty to clarity concerning the future of the EMA and the important work it carries out for public health.
Of course, the real work starts now. Looking to the next steps in the process, we hope for a well elaborated relocation plan, which will provide certainty for both EMA staff and for the continuity of the work of the agency. In particular, we hope to see key EMA projects and coordination run smoothly, to avoid disruptions in pharmaceutical regulatory activities – ranging from the approval for marketing to the post-marketing surveillance of medicines. In this regard, we particularly look forward to the EMA continuing to implement important information technology projects like ISO-IDMP, and to lead the way on biosimilar medicines, both in the EU and globally. The pioneering work of the EMA on biosimilars in Europe has ensured that patient access to treatment has increased, and to let this, as well as other projects of the EMA, slip during relocation would have serious negative consequences.
Our primary concern is that now this decision has been taken, we as healthcare stakeholders now focus on continuing this work, which of course is paramount to ensuring supply and access to medicines for patients. We look forward to continuing this important work in Amsterdam, the new home of the EMA.
On Thursday 12 October, the Directorate-general for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) launched a public consultation on the Supplementary Protection Certificate (SPC) Manufacturing Waiver and the Bolar exemption. Medicines for Europe calls for a swift introduction of the SPC manufacturing waiver in EU legislation and for a wide definition of Bolar. These measures would create a more competitive industry as demonstrated in the CRA study sponsored by the European Commission “Assessing the economic impacts of changing exemption provisions during patent and SPC protection in Europe”. According to the report, the SPC manufacturing waiver would:
The SPC compensates originator drug manufacturers for regulatory approval delays by extending their monopoly for up to 5 years after patent expiry. Whilst our industry does not challenge the principle of compensation for delays, the application of the SPC forces generic and biosimilar manufacturers to manufacture outside of Europe for export to countries without SPCs or whose SPC expires earlier than in Europe. With the SPC manufacturing waiver European medicine manufacturers will be able to re-invest in high skill jobs in Europe. To improve access to life saving medicines for patients, the SPC manufacturing waiver complements the Bolar provision and enable European manufacturers to bring competition at the date of SPC expiry and without unnecessary delays.
As proposed by the European Commission and confirmed in several studies, the SPC manufacturing waiver will not affect originator drug manufacturers as they will continue to benefit from the longest period of monopoly protection globally for most drugs.
Adrian van den Hoven, Director General at Medicines for Europe commented that “the CRA study shows the huge benefits that the SPC Manufacturing Waiver and Bolar harmonisation offer Europe in terms of jobs, manufacturing and a lower overall medicines bill. The Commission must now legislate to make this a reality.”
Medicines for Europe Communications:
Andrea Bedorin abedorin@medicinesforeurope.com
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The newly elected President of Medicines for Europe – Marc-Alexander Mahl – launched the “Access to Medicines: Better Care for More Patients” campaign which calls on health ministers to fully embrace generic, biosimilar and value-added medicines to improve the sustainability of healthcare systems across Europe.
Dr. Mahl takes over the Presidency of Medicines for Europe for 2 years. As Executive Vice President Business Unit Generic Drugs at Fresenius Kabi, Marc-Alexander Mahl chaired the Hospital Sector at Medicines for Europe. A physician by training, he completed his specialization in transfusion medicine and blood banking in 2001, the year he also joined Fresenius Kabi. He also holds an Executive MBA from INSEAD.
Today, in Warsaw, Marc-Alexander Mahl explained: “European healthcare is under financial constraint with many patients struggling to get access to treatments. The increasing overall cost of healthcare will force policy-makers to make difficult and unpopular choices about how best to allocate resources. Yet there is a very simple and obvious way to ensure access while managing healthcare budgets: to promote generic, biosimilar and value added medicines use by patients, medical professionals and pharmacists.” The new campaign will provide compelling data and proposals to help policy-makers and stakeholders improve access to medicines. In particular, the campaign will help policy-makers encourage competition in complex, specialty medicine markets where there are tremendous opportunities to increase access, spend resources more efficiently and improve overall care for patients.
Value added medicines represent a major opportunity to improve patients’ quality of life, health outcomes or adherence, and to address a number of medicine-related healthcare inefficiencies, improving healthcare provision and organisation while contributing to the sustainability of healthcare systems.
To ensure access to value added medicines for patients, the Value Added Medicines Group, a sector group of Medicines for Europe, will participate in the ISPOR 20th Annual European Congress on an Issue Panel entitled “Value Added Medicines: Time To Adjust The Health Technology Assessment Decision Frameworks?”.
Moderated by Professor Michael Drummond (Professor of Health Economics at the Univerity of York), the panellists (Professor Mondher Toumi from the Public Health Department of Aix-Marseille University, Professor Ulf Persson from the Swedish Institute of Health Economics and Luigi Burgio – Head of Market Access Teva Italy and Chairman of the HTA Working Group at Medicines for Europe) will debate current challenges for capturing the benefits of value added medicines as well as key recommendations to integrate and recognise patient-centric innovation in HTA decision frameworks.
Umberto Comberiati, the Chairman of the Value Added Medicines Group,: “The time has come to explore new areas to deliver better health and access for patients, tapping into a sustainable source of patient-centric innovation. Value added medicines are an opportunity to deliver benefits to patients, payers and healthcare systems. However, there is a challenge to ensure that benefits can be appropriately assessed via HTA decision frameworks. The ISPOR Issue Panel will allow an informed debate among experts, industry and stakeholders.”
Medicines for Europe invites you to join the ISPOR European Congress in Glasgow and please follow us on Twitter and LinkedIn to know more about how European patients can better benefit from value added medicines. More information on the Issue Panel and the challenges and recommendations on adjusted HTA decision frameworks for value added medicines can be found here.
Generic medicines have proven to be pivotal in increasing patient access and preventing medicine shortages. However, generic medicines policies have recently focused exclusively on reducing prices thereby increasing the risk of shortages. Short-term cost-cutting measures, such as ad-hoc price cuts, external reference pricing, payback, tendering etc., have driven the prices of some off-patent medicines to unsustainably low levels. This causes manufacturers of generic medicines to withdraw from the market, resulting in the increased risk of medicine shortages[1],[2],[3](see our position paper and reading list).
To address this public health risk, Medicines for Europe has commissioned The Economist Intelligence Unit (EIU) to investigate the impact and causes of medicine shortages. In the recent report, ‘Address medicine shortages in Europe’, the EIU underlines the importance of tackling the economic root causes of medicine shortages with healthy, predictable and pro-competitive market policies as well as regulatory efficiency and transparency in the supply chain from manufacturer to patient.
Adrian van den Hoven, Director General Medicines for Europe, commented: ‘Our industry supplies well over 60% of Europe’s medicines for hundreds of millions of patients each and every day. To avoid medicine shortages, the Economist study shows that we need predictable market policies for companies to continue investing in manufacturing. Preventing and mitigating shortages is a shared responsibility between manufacturers, regulators and payers who need to cooperate better in this field.’
[1] SFK (Foundation for Pharmaceutical Statistics), Pharmaceutisch Weekblad. 2014.
[2] APM Health 2015. Available at: http://www.apmhealtheurope.com/home.php.
[3] QuintilesIMS Health. An International Comparison of Best Practice Approaches to Drug Shortages. 2015.
Biosimilar medicines are transforming treatment by enabling better access to biological medicines while improving the sustainability of European healthcare budgets. For the first time, Medicines for Europe has reviewed the policies supporting biosimilar medicines in Europe in the ‘2017 Market Review – Biosimilar Medicines Markets’.
The 2017 Market Review provides a comprehensive overview of biosimilar medicines policies in 31 European countries detailing the status of biosimilar medicines availability, pricing system, tendering, reimbursement, and benefit sharing for physicians, pharmacists and patients.
The review illustrates that governments have realized that biosimilar medicines need a tailor-made policy framework and have disentangled their pricing policies from those of generic medicines. Physician-led switching, information and education for patients remain the key drivers for increased use of biosimilar medicines. EU education efforts , led by the European Commission, will facilitate these national activities thanks to the availability of translations into all EU languages later this year.
Adrian van den Hoven, Director General Medicines for Europe, commented: “Biosimilar medicines bring competition to the market and greatly improve access to biological therapies that are out of reach for too many patients in Europe. This overview shows that policy-makers need dedicated policies to provide more sustainable access to biosimilar medicines. Benefit sharing with stakeholders has proven to be the most successful approach to improve access and we encourage governments to learn from the best practices around Europe”.
With more than 10 years of positive experience and 700 Million patient days[i] in different therapeutic areas, including in supportive cancer care, biosimilar medicines are now entering the therapeutic armamentarium for primary oncology care.
Disparities in access to cancer medicines vary widely among countries, including for the standard of care, and need to be addressed urgently[ii]. The approval of oncology biosimilar medicines now offers patients a major access opportunity in cancer therapies contributing to both greater equality in access to healthcare products and services in the patients’ care pathway while supporting the sustainability of national healthcare systems in the long run.
To add further value to the educational journey of the ESMO 2017 Congress delegates, taking place from 8-12 September in Madrid, the Biosimilar Medicines Group, sector group of Medicines for Europe, has therefore organised an Industry Satellite Symposium, entitled “Biosimilars for Oncologists: what you need to know” [iii]. The aim is to provide an opportunity for oncologists to familiarise themselves with these safe and cost-effective treatment options. A thorough understanding of the science of biosimilar medicines and their development, the vast EU experience with this type of medicines, as well as of the pharmaco-economic impact of oncology products, will support oncologists and their patients in making informed treatment choices whilst maximizing their potential to increase patient access to oncology biologics.
Adrian van den Hoven, Medicines for Europe Director General, commented “Biosimilar medicines are a real game changer for better health. They can transform oncology care, by prioritising greater and equal patient access to biologic medicines treatment, supportive care and other needed health services.”
[i] Biosimilar medicines clinical use: an experience based-EU perspective
[ii] IMS Institute for Healthcare Informatics Global Oncology Trend Report 2016
[iii]ESMO 2017 Industry Satellite Symposium: Biosimilars for Oncologists: what you need to know
A new study “Value Added Medicines: Time to Adjust the HTA Decision Frameworks” was launched today in Brussels with the support of the Value Added Medicines Group, a sector group of Medicines for Europe. The study, conducted by Mondher Toumi, Professor of Public Health at Aix-Marseille University, highlights the need for adjustments in HTA decision frameworks to ensure that European patients can benefit from value added medicines. Professor Mondher Toumi emphasised that “value added medicines represent an opportunity for increasing the cost-effectiveness of treatments or services that may bring substantial value to individual patients and society. However, the current European HTA decision frameworks represent various challenges for the full value recognition of these products, which need to be addressed.”
According to the study, which counted on the important feedback of key HTA experts across Europe, value added medicines make a major contribution to patients’ quality of life, health outcomes or adherence, and address a number of medicine-related healthcare inefficiencies, improving healthcare provision and organisation while contributing to the sustainability of healthcare systems. The study underlines the importance of the eligibility of value added medicines for HTA, whenever requested, in order to demonstrate these relevant improvements. There is a need to adjust HTA decision frameworks to ensure that all benefits of value added medicines are appropriately captured and to ensure a patient-centric assessment. The manufacturers of value added medicines should also have the opportunity to get early HTA advice in order to better shape their clinical development plan. Professor Toumi commented that “taking into consideration the specific benefits of value added medicines will need efforts both on the research and policy fronts, but also the involvement of a broad range of stakeholders in the decision-making process”. Ten key recommendations are put forward in the report to ensure that value added medicines can be rightfully assessed by HTA decision frameworks in the future.
Umberto Comberiati, Chair of the Value Added Medicines Group ad interim, commented: ‘Research on known molecules is a valuable untapped opportunity for European patients and healthcare professionals alike. There is an urge to support research and adjust the HTA policy frameworks to encourage industry to invest in medicines with high potential value to patients and society and capitalise on healthcare professionals’ expertise. We are ready to work together with patients, healthcare professionals, policy makers and payers on how to ensure patients can benefit from value added medicines in Europe.”
Biosimilar medicines are transforming treatment by enabling better access to biological medicines in Europe and around the world, as stated today during the second day of the joint Medicines for Europe-IGBA conference in Lisbon. The IGBA (International Generic and Biosimilar Association) has commissioned new user-friendly material to acquaint and empower stakeholders with relevant information on the science and benefits of biosimilar medicines.
A new study on value added medicines highlights the necessary reforms in health technology assessment (HTA) decision frameworks in Europe to ensure market entrance of value added medicines to improve the treatment of chronic diseases in areas such as respiratory or mental health treatment. This innovative methodology will also enable new business models for value added antibiotics to address the growing threat of antimicrobial resistance.
Jacek Glinka, Medicines for Europe President commented: “Biosimilar and value added medicines can significantly improve healthcare for patients – if better access is pro-actively supported by all stakeholders. It took 25 years to create access for generic medicines, European patients cannot afford to wait that long for biosimilar medicines to come”.
Adrian van den Hoven, IGBA Chair highlighted that “The IGBA is committed to improving the information about the opportunities that biosimilar medicines can bring for patients around the world. We look forward to close cooperation with the WHO, governments and stakeholders to deliver better access to biological medicines”.
During the two-day conference, pharmaceutical industry leaders and key stakeholders from the generic, biosimilar and value added medicines sectors met in Lisbon to foster international partnership, cooperation and dialogue to address public health challenges for the future. Several key studies presented at the conference highlight the need for a major overhaul of medicines policies to stimulate more access to generic, biosimilar and value added medicines.
The International Generic and Biosimilar Medicines Association (IGBA) was founded as IGPA (International Generic Pharmaceutical Alliance) in March 1997 to strengthen cooperation between associations representing manufacturers of generic medicines. Its membership includes Medicines for Europe (Europe), the CGPA (Canada), the AAM (USA), the JAPM (Jordan), the Generic & Biosimilar Southern Africa (South Africa), the TGPA (Taiwan) and the JGA (Japan) while the associations from Australia (GBMA), Brazil (ProGenericos), Malaysia (MOPI) and Mexico (AMEGI) are Associate Members. The IGBA is at the forefront of stimulating competitiveness and innovation in the pharmaceutical sector by providing high quality pro-competitive medicines to millions of patients around the world. Through its constituent member associations, the IGBA maintains constant dialogue with government authorities (including the European Commission for Europe) as well as with international institutions such as WTO, WIPO and WHO. More information: www.igbamedicines.org