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

‘Harmonised reimbursement approach key to reducing treatment inequalities’

Submitted by on 14 Jul 2017 – 10:07

Personalised breast cancer treatment for patients in Europe should be a priority, however a discordant reimbursement process means that many cannot access vital tests to prevent under or over treatment. Dr Marjolaine Baldo, EMEA Commercial Vice President, Agendia discusses the main issues within the process

Breast cancer is the most common cancer for women in Europe. With the help of national screening programmes that can detect and diagnose breast cancer early, survival is improving. However, current approaches for determining the chance of a patient’s cancer recurring post-surgery and how they should be further treated do not take into account the genes of the tumour itself, therefore a more individualised approach is urgently needed. Gene expression-based tests are available, but patients are routinely prevented from accessing them due to discordant reimbursement policies across Europe. Policy makers and payers must address this to help spare patients from unnecessary treatment, and reduce the financial burden of treatment of supportive care.

Accurate assessment of cancer recurrence risk can spare patients from unnecessary treatment

Typically, early-stage breast cancer patients have surgery to remove their tumour, followed by any subsequent treatment to reduce the risk of the cancer returning. Traditionally, this post-surgery decision is based on clinico-pathological risk factors such as the patient’s age, tumour size, number of lymph nodes affected and hormone receptor status. Whilst useful, this does not take into account the tumour biology.

Consequently, this can mean that a patient is classified at high risk of their cancer returning and advised to undergo chemotherapy, but when taking into account genomic data from their tumour, they are actually found to be low risk, needlessly suffering the arduous side effects of chemotherapy without any additional benefit.

The findings of the landmark MINDACT trial of almost 7,000 European breast cancer patients, which were published earlier this year, show that 46% of patients originally classified as high risk of their cancer returning according to clinico-pathological factors alone were reclassified by the MammaPrint® breast cancer recurrence assay to low risk. MammaPrint looks at the expression levels of the 70 genes most associated with cancer recurrence to provide a definite low or high risk result.

A disconnected approach to reimbursement across Europe

Tests like MammaPrint can benefit patients and their physicians by providing objective, quantitative data to clearly identify whether chemotherapy is needed or can be safely omitted from a treatment programme. However, many patients cannot access these tests unless through private health insurers due to a discordant approach to reimbursement in Europe.

Currently, each country can determine the price of tests and decide what to reimburse. These systems are usually complex and adapted to the country’s health and economic needs, therefore, the route to reimbursement varies dramatically. For example, MammaPrint is reimbursed in the Netherlands, Spain, Switzerland and Ireland. Patients in France can benefit from conditional reimbursement of the test for three years, but in Germany, reimbursement is still being assessed. Other European countries still have a long way to go.

Although many pan-European policies and treatment guidelines endorse these tests and encourage physicians to adopt them, I believe the lack of harmonisation or having a centralised procedure to obtain reimbursement is a substantial roadblock to universal introduction in standard practice.

Another issue is the lack of clear guidance on the essential requirements that test developers must meet to achieve reimbursement. There is also uncertainty amongst policy makers and payers of the level and extent of clinical evidence required for approval and reimbursement. Each country has its own reimbursement body, informed by national experts who evaluate the clinical utility of tests and make recommendations accordingly. However, what may be considered a satisfactory level of evidence in Spain, in the Netherlands, in Switzerland or in Ireland may not be acceptable in Germany.

A critical need to harmonise reimbursement to benefit patients

Fundamentally, there needs to be an aligned, Europe-wide and patient-oriented review and approval process. Transparency of the requirements for test developers to meet, and a roadmap for approval across Europe will also ensure that policy makers and payers from individual countries are empowered to make these decisions to the benefit of patients.

To achieve this, support is needed from the European Parliament, who could centrally define the essential requirements for reimbursement in Europe. The European Parliament has recently taken a first step by releasing new policies to recommend best practice breast cancer treatment, and is enhancing pan-European training programmes for gynaecologists and oncologists to ensure consistent knowledge and management of the disease, and optimised early diagnosis across the member states.

I believe that harmonisation of reimbursement is key to ensuring that breast cancer patients are not discriminated against in accessing a beneficial prognostic and predictive test simply due to their geographical location. With physicians and patients across Europe aligned in support for gene expression-based breast cancer recurrence tests, it’s time that the policy makers and payers recognise how beneficial these tests can be in improving and personalising how early-stage breast cancer is treated.