Cancer remains a devastating public health challenge with more than 1.9 million deaths due to cancer in Europe alone last year.¹ The emergence of cutting-edge treatment approaches such as precision medicines and advanced therapy medicinal products offer the potential to change what a cancer diagnosis means for patients. This has long been Janssen’s goal. However, the benefit of these therapies can only be fully realised when patients can access them in a timely manner, which is not always the case. On average, the time from marketing authorisation to reimbursement of cancer therapies in Europe is more than 18 months.² This is just not good enough.

To improve patients’ access to the new wave of cancer therapies, Health Technology Assessment (HTA) frameworks and methods across Europe need to evolve, as indicated in a newly published report by The Economist Intelligence Unit (EIU).³

The report, ‘Assessing Innovation: How HTA can adapt to improve the evaluation of novel cancer therapies in Europe’ examined the assessment processes for new generation oncology therapies across Europe, to explore how we might start doing things differently.¹

Insights were garnered from:

• Eight European countries: Belgium, England, France, Germany, Italy, The Netherlands, Spain and Sweden
• The approval process and timelines for twelve new innovative cancer therapies
• Comprehensive desk research and literature review
• Thirteen in-depth interviews with a range of academics, HTA experts, patient experts and other stakeholders

The EIU’s analysis shines a light on the inter-country variation  in time to HTA decision – and ultimately access – across Europe. This can be anywhere from around 50 days to almost 1000 days, yet there is no clear pattern to the wide variation seen between assessments and between countries.¹ 1000 days is more than two-and-a-half years. When we think about cancer, time is life and patients simply cannot wait this long.

In Germany, for example, all therapies are available without restriction at time of marketing authorisation, whereas the EIU showed access in countries such as England and Sweden were more frequently conditional, based on managed access or restriction.³

Janssen welcomes the EIU’s recommendations and believes that action to address them will help tackle barriers to timely access for patients. The EIU signposted their priority takeaways as:

1. HTA structures and methodologies across Europe are coming under increasing pressure to adapt, to allow greater, quicker patient access to innovative therapies, highlighting the clear need for change.
2. A greater range of conditional agreements are needed to improve patient access.
3. Improved data collection infrastructure is required.
4. Greater transparency in the decision-making process should become the norm.
5. Patient views need to play a greater role in decision-making and deliberation.
6. Greater harmonisation between countries can be helpful but remains challenging.

One of the key challenges recognised in the report is the continued requirement for mature overall survival (OS) data as the primary measure for determining the value of a treatment to secure reimbursement at an acceptable price.¹ As cancer outcomes continue to improve, and patients live longer than ever before, the ability to show significant differences in OS data within the timeframe of a clinical trial becomes increasingly unrealistic. While positive for patients from one perspective, incomplete OS data at the time of assessment can lead to accusations of uncertainty in the evidence base, and that can significantly impact reimbursement discussions.

The consequences for patients are very real. Those in need of life-prolonging medicines must wait while lengthy negotiations take place, and this is time some patients just don’t have. Although regulatory bodies have evolved their methods for evaluating the most promising new treatments, HTA frameworks have largely remained static.¹

A more holistic approach to medicine evaluation is needed; one which enables access to innovation and allows patients to benefit from the latest treatments. We must work together with HTA agencies to improve decision-making amid perceived uncertainty, and to consider a broader assessment of value that includes the wider benefits to patients, carers and society as a whole. It is crucial to consider more than just the immediate costs of treatment.

We also support the EIU’s recommendation that patient views need to play a greater and more meaningful role in HTA decision-making. Patient engagement is vital to understanding the value of new health technologies, yet there is considerable variation in how the patient perspective is accounted for, if at all, across agencies. Incorporating patient-relevant endpoints and improving the quality of real-world data from patient registries are routes towards enhancing the patient voice in HTA processes.

The EIU mention harmonisation across Europe and we welcome the recommendations put forward in the European Commission's Europe's Beating Cancer Plan, which highlights the importance of sharing resources, expertise, and capacity between member states.⁴ Indeed, work on the future EU HTA legislation is already underway with EU Member States.

Ensuring every patient can access the right treatment at the right time is at the heart of what we do at Janssen. We advocate for urgent dialogue between patients, payers, policymakers, HTA agencies, regulators, and industry, so we can achieve a more suitable value assessment framework for innovative cancer therapies. A move towards more flexible, outcomes-based approaches will be pivotal in driving value-based healthcare.

In a world where everyone is touched by cancer in some way during their lifetime, I see these proposed HTA reforms as not just an opportunity, but an obligation. An obligation to do what is best for patients, and to make cancer a challenge we can collectively overcome.

A full copy of the EIU report is available at: https://eiuperspectives.economist.com/healthcare/assessing-innovation-health-technology-assessment-europe

References:

1. WHO. Globocan 2020. Europe. Available at: https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf. Last accessed: May 2021.

2. IQVIA. EFPIA Patients W.A.I.T. Indicator 2019 Survey. Available at: https://www.efpia.eu/media/554526/patients-wait-indicator-2019.pdf. Last accessed May 2021.

3. Economist Intelligence Unit. Assessing innovation: How HTA can adapt to improve the evaluation of novel cancer therapies in Europe. 2021. Available at: https://eiuperspectives.economist.com/healthcare/assessing-innovation-health-technology-assessment-europe. Last accessed: May 2021

4. European Commission. Europe’s Beating Cancer Plan. 2021. Available at: https://ec.europa.eu/health/sites/health/files/non_communicable_diseases/docs/eu_cancer-plan_en.pdf. Last accessed: May 2021.