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Home » EU Health, Health, Healthcare Policy, Prostate Cancer

Optimising prostate cancer care, providing patients with best outcomes

Submitted by on 14 Jul 2017 – 10:00

Innovative genomic-based diagnostic technologies can help patients and healthcare professionals to assess risk and personalise treatment. Claire Takizawa and Juliette Plun-Favreau from Genomic Health explain why barriers to equal access should be urgently addressed

Prostate cancer (PCa) is the most common cancer diagnosed in men, with 417,000 new cases every year in Europe (1), because of an ageing population and also the wide presence of screening programmes in developed countries.  Compared to the high incidence rate, PCa has a low mortality. Most men diagnosed with low and intermediate-risk prostate cancer will not die of PCa.

Nonetheless, in Europe, the majority of these patients are treated with radical therapy, despite the small chance of their disease progressing.  In addition to being costly, over-diagnosis of disease and overtreatment of non-clinically-meaningful tumours may result in lasting side effects such as urinal dysfunction, sexual dysfunction, bowel problems, pain, fatigue and disturbed sleep. (2)  Recent studies have demonstrated that more men with low risk disease can be managed safely with active surveillance (3), avoiding negative side effects and saving costs related to overtreatment.

Assessing risk and guiding treatment decisions – traditional tests

Traditionally, physicians have used PCa characteristics such as tumour stage, prostate specific antigen level, Gleason score and imaging to estimate the aggressiveness of PCa and to help guide treatment decisions.  These traditional characteristics and new imaging techniques (MRI) are helpful, but cannot fully determine whether a man has low-risk PCa that can be safely managed with active surveillance, or whether he has aggressive PCa that will benefit from more radical therapies.

The need for better tools – The Oncotype DX® Genomic Prostate Score™

There is a strong need for better tools to stratify newly diagnosed PCa patients and the aggressiveness of their tumour.  In this respect, genomic testing is increasingly being used by physicians to determine the risk of the patient’s PCa.  The Oncotype DX® test improves risk stratification by incorporating individual underlying tumour biology that can help patients and physicians decide on the best treatment option.

The Genomic Prostate Score™ is a biopsy-based genomic test that looks at 17 genes across four distinct biological pathways to predict prostate cancer aggressiveness.  The test is used in conjunction with the Gleason grading system, imaging (e.g. MRI) and conventional parameters to personalise prostate cancer treatment.  It adds independent predictive information beyond standard clinical and pathological measures, meaningfully impacting patient treatment decisions.  The development and validation of the Oncotype DX assay included over 1,500 patients. (1, 2, 3)  Additional information is available on: http://prostate-cancer.oncotypedx.com/en-US/Professional.

Prof. Roger Kirby, The Prostate Cancer Center, London, UK: “New genomic-based diagnostic technologies such as the Oncotype DX® Genomic Prostate Score™ are very valuable tools to personalise and optimise prostate cancer care, enabling physicians and patients to confidently decide on the best treatment option, leading to better outcomes. Unfortunately access for patients to the Oncotype DX assay and other genomic-based technologies is limited and unequal across Europe.  This needs to be addressed.”

Urgent action required to improve patients’ access

Despite the fact that genomic-based diagnostic tests offer important benefits to patients and healthcare professionals, access to these innovative technologies remains unequal across Europe, with reimbursement and value assessment constituting the main barriers. (1)  Current European healthcare systems are not designed to support innovative genomic-based technologies which can optimise PCa care, leading to better outcomes for patients. (2)  Unclear or non-existent reimbursement pathways, together with the lack of clear evidence requirements, have led to significant delays in the assessment of these new technologies in different countries or regions. (6)  Clarification and reform of such pathways, is urgently needed.  Clear value-based funding and reimbursement systems and rewarding outcomes should be developed and implemented at relevant levels (national or regional), together with adapted Health Technology Assessment (HTA) processes including clear evidence requirements and value recognition.  In addition, EU research and innovation programmes, should support research advancing the use of precision medicine in prostate cancer care, including genomic-based diagnostic tools and their impact on clinical practice.

EU initiatives in the areas of research, cancer and HTA (strengthening EU cooperation to clarify and harmonise evidence requirements) are an important opportunity to support PCa patients across Europe in accessing new tools, like the Oncotype DX test, that provide them with the best possible health and quality of life outcomes.

References:

1. Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11. Lyon, France: International Agency for Research on Cancer; 2013.

2. Cooperberg MR, Broering JM, Carroll PR. Time trends and local variation in primary treatment of localized prostate cancer. J Clin Oncol. 2010;28(7):1117-23.

3. Glass AS, Cooperberg MR, Meng MV, Carroll PR. Role of active surveillance in the 
management of localized prostate cancer. J Natl Cancer Inst Monogr. 2012;2012(45):202-6

4. Cooperberg et al. Development and validation of the biopsy‐based genomic prostate score (GPS) as a predictor of high grade or extracapsular prostate cancer to improve patient selection for active surveillance. AUA 2013

5. Cullen J et al. A biopsy-based 17 gene genomic prostate score predicts recurrence after radical prostatectomy and adverse surgical pathology in men with Prostate Cancer. Eur Urol 2014

6. Klein et al.  A 17-gene Assay to Predict Prostate Cancer Aggressiveness in the context of Gleason Score heterogeneity, tumor focality and biopsy undersampling. Eur Urol. 2014.

7. Plun-Favreau J, et al. Enabling Equal Access to Molecular Diagnostics: What Are the Implications for Policy and Health Technology Assessment? Public Health Genomics; 2016; 19:144–152

8. Miller I, et al. Market access challenges in the EU for high medical value diagnostic tests. Pers Med 2011;8:137–148.