In August 2022, we have identified the following access and policy-relevant news that caught our attention from the (digital) diagnostics perspective. Check them out:
1. NICE Updates Guidance on Pre-eclampsia Testing (UK)
In the guidance, NICE recommends four placental growth factor (PLGF)-based tests, used with standard clinical assessment. Two of the recommended tests are made by PerkinElmer: Delfia Xpress PLGF 1-2-3; and Delfia Xpress sFlt-1/PLGF 1-2-3 ratio. One of the recommended tests is made by Roche Diagnostics: Elecsys immunoassay sFlt‑1/PLGF ratio. The fourth recommended test is the Triage PLGF test, manufactured by Quidel.
The global leader in real-time continuous glucose monitoring for people with diabetes, and NHS England today announced the availability of the easy to use Dexcom ONE rt-CGM System on prescription via the NHS England, Wales, Scotland and Northern Ireland drug tariff to everyone with type 1 or type 2 diabetes using insulin.
3. Guidelines update: use of FIT in colorectal cancer referrals (UK)
In July, the British Society of Gastroenterology issued new guidance on the use of faecal immunochemical testing (FIT) to optimise referral pathways for patients with signs and symptoms of colorectal cancer (CRC).
4. NICE updates evidence standards framework to include AI and data-driven tech (UK)
NICE updated their evidence standards framework (ESF), working with stakeholders, system partners and thought leaders to ensure that digital health technologies (DHTs) are “clinically effective and offer value to the health and care system”.
5. NICE recommends smartphone-linked ECG device (UK)
NICE has published first draft guidance which recommends a smartphone-linked electrocardiogram (ECG) device for people taking antipsychotic medication.
6. IQWiG also recommends mammography screening for younger and older people (Germany)
According to the Institute for Quality and Efficiency in Health Care ( IQWiG ), both younger and older women could benefit from the program. As the institute announced, the breast cancer-specific survival advantage outweighs possible damage caused by false-positive findings or overdiagnosis. However, the advantage documented in studies in both age groups for the individual woman is only very small
7. Lung disease COPD: G-BA updates its requirements for the DMP (Germany)
The diagnostics and therapy provided for in the DMP have now been adapted to the latest medical knowledge by the G-BA in the course of regular reviews. The scientific basis for this was an evaluation of the medical guidelines by the Institute for Quality and Efficiency in Health Care.
8. Tepmetko: Pathologists can bill for mutation diagnostics (Germany)
The assessment committee has regulated the billing of mutation diagnostics in patients with non-small cell lung cancer before the start of systemic therapy with the drug Tepmetko (active ingredient tepotinib).
9. E-health — Remote monitoring takes a step towards reimbursement with a published benchmark (France)
Entry into ordinary telemonitoring law has been delayed but is progressing with the publication of the reference system for the interoperability of digital medical devices for telemonitoring. The ANS therefore opens a window in advance of the phase.
10. Economy — HAS modifies the criteria triggering a medico-economic assessment (France)
From 2023, new rules come into force within the High Authority for Health. They concern the triggering of the medico-economic evaluation of drugs or medical devices claiming a significant improvement in service.
The digital transformation is coordinated by the Ministry of Health in combination with the autonomous communities and cities through seven working groups. The projects are articulated in plans that make it possible to take advantage of technology to bring artificial intelligence to health centers and allow both personalized attention and the digital transformation of health services.
12. South Korea to streamline rules on medical AI, digital technology devices (South-Korea)
The Ministry of Health and Welfare and the Ministry of Food and Drug Safety have recently disclosed their plan to revise some related regulations on medical devices.