1. EGFR tests included for NSCLC in WHO’s third Essential Diagnostics List
Lung cancer is the most commonly diagnosed cancer worldwide and is a major cause of cancer-related morbidity, disability and mortality.
Within this, EGFR-addicted non-small cell lung cancer (NSCLC) presents especially high mortality and morbidity burdens. However, today, targeted treatments such tyrosine kinase inhibitors (TKIs) can more than double median survival time in this subtype of lung cancer. In particular, the median survival time is nearly 3 years if the patient receives both targeted medicines and chemotherapy, compared with a median survival time of around 10 months for patients receiving chemotherapy alone.
The EGFR test underscores the importance of making effective diagnostics accessible for targeted treatment, thus leading to improved patient outcomes. Given such compelling evidence, WHO’s EDL 3 now includes the tissue-based EGFR test as an essential diagnostic for low- and middle-income countries.
2. Germany has a liquid biopsy tariff for locally advanced or metastatic NSCLC
Advanced countries have gone a step further to reimburse liquid-based biopsies for certain subgroups of patients. Since 2019, German NSCLC patients who could not undergo biopsy or lack tumour tissue for testing could benefit from liquid biopsies, which are reimbursed by local public tariffs.
In particular, the German public tariff list (Einheitlicher Bewertungsmaßstab or EBM in short) states that liquid biopsies are reimbursed for the “detection or exclusion of all known EGFR-activating mutations in exons 18 to 21, using circulating DNA to indicate targeted treatment of adult patients with locally advanced or metastatic non-small cell lung cancer”. This is covered at a price of 437.63 EUR.
However, it is only billable if a NSCLC has been proven histologically and not enough tumour tissue is available or cannot be obtained as test material. It is not applicable for monitoring.
3. Breast cancer recurrence risk scores: Oncotype DX first to be nationally reimbursed in Germany but others may soon join the game
Switching gears from lung to breast cancer, we detected a case study where the high value breast cancer diagnostic OncoType DX gained first mover’s advantage in the German market but may soon face more competition as similar tests catch up.
The OncoType DX test is an impactful one as it generates a risk score for breast cancer recurrence and helps doctors judge to what extent patients would benefit from chemotherapy.
In 2019, OncoType DX was reimbursed in Germany to guide decisions for adjuvant chemotherapy in primary node-negative, hormone receptor-positive, HER2-negative early-stage breast cancer. The decision followed a positive IQWiG assessment based strongly on Oncotype DX’s landmark TAILORx trial, which followed 10,000 women with early breast cancer for an average of 9 years. Given strong evidence and the ability to address a substantial unmet need, OncoType DX was reimbursed in the EBM public tariff list at a notable price tag of 3296.50 EUR in Germany.
In contrast, its competitors e.g. Prosigna already had selective contracts with particular insurers but fared less successfully in the IQWiG assessment due to a lack of evidence back then.
However, changes are afoot as EndoPredict, Prosigna and MammaPrint may soon be enrolled in the EBM national tariff list. The Federal Joint Committee (GBA) consisting of physicians, hospitals and self-insurance funds recently made the recommendation for these 3 tests to be included in the EBM.
However, this recommendation was not without controversy as another health body the National Association of Health Statutory Health Insurance Funds (GKV) noted that there was a lack of randomised controlled trials to demonstrate reliable predictive power of EndoPredict, Prosigna and MammaPrint.
Nonetheless, the Federal Joint Committee argued that the three new test procedures were already part of selective contracts and recommended by guidelines of the specialist societies.
As of October 2020, the decision to include the 3 additional tests was still awaiting approval from the Federal Ministry of Health. For the process to be complete, the National Association of Statutory Health Insurance Physicians (KBV) and National Association of Health Statutory Health Insurance Funds (GKV) must also agree to include these tests in the EBM reimbursement list.
Oncotype DX is also seeing similar competition in the UK. In a 2013 assessment, it was recommended by NICE for use in ER+, LN- and HER2- early breast cancer patients, whereas its competitors MammaPrint, IHC4 and Mammostrat were recommended for research use only due to uncertainty about their overall clinical benefit and consequently their cost effectiveness.
However, today, NICE recommends similar tests EndoPredict and ProSigna for use in the same subgroup, following an assessment update in 2018.
In the UK, list prices of the tests are as follows: Oncotype DX (2580 GBP, test carried out in US Genomic Health Lab, including sample handling and customer service), ProSigna (1,970 GBP, test carried out in NHS lab), EndoPredict (1,500 GBP, test carried out in Myriad Genetics lab in Munich). However, these tests are available to the NHS at a commercial-in-confidence agreement, likely with further discounts.
As this use case for breast cancer recurrence risk scores shows, strong evidence (e.g. TAILORx trial for Oncotype DX) plays a key role in reimbursement but competitors may also catch up later. In Germany especially, selective contracts and specialist guidelines may be powerful tools to get the medical community onboard and pave the way forward.
Want to know more about diagnostics reimbursement? Read our short book Diagnostics Reimbursement Compass: A 90 Minute Guide to Define, Demonstrate and Capture Diagnostics Value Confidently
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