Health technology assessment

With a regional decree of December 18, 2019, Tuscany Regional Healthcare has published assessments of thirteen medical devices belonging to various therapeutic areas.

In December 2019, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance (for balloon dilation for chronic eustachian tube dysfunction), one new medical technologies guidance (for gammaCore for cluster headache), and five new MedTech innovation briefings (for Optowire for measuring fractional flow reserve, eXroid for internal hemorrhoids, and others).

In mid-November 2019, the report of the project OTCA20, titled “Prophylactic or therapeutic use of endoanchoring systems in endovascular aortic aneurysm repair (EVAR/TEVAR)” was published on the website of the European Network for HTA (EUnetHTA).

In early November 2019, the report of the project OTCA18, titled “Regional hyperthermia for high-risk soft tissue sarcoma treatment” was published on the website of the European Network for HTA (EUnetHTA).

In late November 2019, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA23 “Biodegradable rectum spacers to reduce toxicity for prostate cancer.”

In November 2019, the National Institute for Health and Care Excellence (NICE) published two new diagnostics guidance (for point-of-care creatinine devices and rapid tests for group A streptococcal infections), one new interventional procedure guidance (for irreversible electroporation for primary liver cancer) and two new MedTech innovation briefings (for Leukomed Sorbact for preventing surgical site infection and AmnioSense for unexplained vaginal wetness in pregnancy).

On the 10th of December 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI-HTA) has released a report on the implementation of an HPV screening test for the early detection of cervical cancer in women as a measure of cervical cancer prevention. The recommendations are positive.

In late November 2019, new HTA activities were published on the website of regional HTA program of Lombardy Region, after a period of inactivity. Twenty-six (26) new technologies are currently in various stages of the HTA process, and they should all be completed in 2020.

At the end of November 2019, the report of the project OTCA17, titled “Lithium triborate (LBO) laser for photoselective vaporization of the prostate (PVP) in the treatment of benign prostatic hyperplasia (BPH)” was published on the website of the European Network for HTA (EUnetHTA).

In November 2019, the Skåne Region released an HTA report for arthroscopic subacromial decompression (ASD) in subacromial pain syndrome that aimed to evaluate the scientific evidence for the procedure. It was concluded that the degree of clinical evidence is limited due to lack of study quality; the certain safety conclusions cannot be drawn due to the data diversity.

In October 2019, the Agency for Health Quality and Assessment of Catalonia (AQuAS) has released an assessment report regarding the evaluation strategies to prevent urinary tract infections associated with urethral/urinary catheters in critical patients in Intensive Care Units. The evidence is not conclusive, but there is scientific evidence that aims for the introduction of review measures for the indication of indwelling urethral/urinary catheters, its use in decubitus, and without kinking.

In Sweden, the Centre for Assessment of Medical Technology (CAMTÖ) leads the development of HTA cooperation in the healthcare region Uppsala-Örebro. In September 2019, CAMTÖ released an HTA report on PD-L1 positivity tested by McAb SP263 to guide immune checkpoint therapy in non-small-cell lung cancer. No safe conclusions could be drawn, but the wide range of positivity rates implies the difficulties in the standardization of PD-L1 expression and the need for better predictive biomarkers.