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Home » EU Health, Health, Prostate Cancer

Ensure patient access to next-generation cancer treatments

Submitted by on 14 Jul 2017 – 09:31

There have been several new promising therapies for prostate cancer, but many patients across Europe are not yet getting equal access to treatment. Dr Marisca Marian from Bayer calls on policy makers, researchers and key stakeholders to work together to ensure drug-appraisal ensures timely patient access to new medicines

Enormous progress has been made in cancer treatment during the last 20 years. As researchers have learned more about the mechanisms of cancer drug resistance, they’ve developed a number of next-generation therapies that markedly delay the progression of disease, allowing patients to live longer. Cancers that would have been fatal a decade ago are now being managed with treatment, while patients are able to conduct their daily lives.

Prostate cancer is a case in point. Most men will be diagnosed early and their cancer can be controlled for years; however, there are times when it becomes life threatening. Clinical practice guidelines issued by the European Society for Medical Oncology (ESMO) and the European Association of Urology (EAU) offer a comprehensive overview of recommended treatments, ranging from active surveillance in early-stage disease to more aggressive approaches as it advances. However, the pattern of progression is rarely linear, and patients often have different and highly individualised treatment goals that may not always align exactly with the guidelines. Especially for men with late-stage cancer and rapidly spreading bone metastases, treatment is challenging. (3)

Thankfully, the past decade has ushered in several promising treatments for advanced prostate cancer. From 2004 to 2013, four new therapies have been approved. (3, 4, 5, 6)   However, even with these and other, newer life-extending prostate cancer therapies, many patients across Europe are still not getting equal and timely access to treatment. The clinical burden of prostate cancer in Europe remains substantial.

What explains the gaps in patient access? According to a recent Value in Health study, fragmented and outdated practices among health technology assessment (HTA) bodies delayed or even prevented patient access to 10 cancer drugs approved by the European Medicines Agency (EMA) from 2010 to 2012. (7) In other instances, HTAs discounted the merits of attributes like delaying time to bone metastasis or maintaining quality of life when assessing drug value, or discounted the economic burden associated with bone metastases and the trademark symptomatic skeletal events that result in costly hospital stays. (8) As a result, only a fraction of patients are seeing the benefits of scientific progress.

Advanced patients don’t have time to wait. It is critical that independent value assessments keep pace with advances in clinical evidence, which accumulates over time and takes into consideration input from all key stakeholders. In recent years, steps have been taken to streamline HTAs across the EU’s 28 member states.  Collaborations like the European Network for Health Technology Assessment (EUnetHTA) have formed to improve the process for granting patient access through joint approaches on scientific advice, mutual input on clinical guidelines and debate surrounding evidence requirements, like relative efficacy.

We manufacturers can also do our part to assist HTAs. We can provide real-world evidence demonstrating the benefits of alternating treatments and employing multiple lines of therapy in resistant or hard-to-treat cancers. We can define new, patient-focused endpoints that measure the value of quality-of-life (QoL), as well as surrogate endpoints beyond Overall Survival (OS). And we can ensure a closer dialogue with HTAs from early in drug development and along the life-cycle of products to better identify regulatory requirements and reduce duplication.

Evidence accumulates every day of next-generation cancer drugs extending survival while maintaining QoL. A few cancers are even becoming chronic diseases that can be controlled for long periods by a succession of different treatments. Nevertheless, the development of new therapies is meaningless when the very mechanisms for evaluating them are stalling their delivery to those who need them most.

All healthcare stakeholders – industry, researchers, policy-makers, payers, and regulators – need to work together to ensure drug-appraisal ensures timely patient access to new medicines. HTAs differ from country to country, but all share the same commitment to ensuring patient access to safe, quality treatments.

We’re hopeful the information sharing and progress being made to fill knowledge gaps, improve standards in methodology and assessment, and factor real-world evidence and other sources of data into decision-making will soon result in a more streamlined healthcare system that expands cancer treatment options for patients and physicians.

References:

1. Parker C, Gillessen S, Heidenreich A, Horwich A, on behalf of the ESMO Guidelines Committee. Cancer of the prostate: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 26 (Supplement 5): v69–v77, 2015/ doi:10.1093/annonc/mdv222. Published online 22 July 2015.

2. Mottet M et al. EAU-ESTRO-SIOG guidelines on prostate cancer. Eur Urol. 2017;71:618-629.

3. de Bono JS, et al. Lancet. 2010;376:1147-1154.

4. de Bono JS, et al. N Engl J Med. 2011;364:1995-2005.

5. Scher HI, et al. N Engl J Med. 2012;367(13):1187-1197.

6. Parker C, et al. N Engl J Med. 2013;369(3):213-223.

7. Akehurst, Ronald L et al. Variation in Health Technology Assessment and Reimbursement Processes in Europe

8. Value in Health. 2017;20 (1): 67-76.

9. Jayasekera J, et al. PharmacoEconomics. 2014;32 (2): 173-191.