Ongoing assessment of femtosecond laser-assisted cataract surgery (FLACS) authored by Emilia Romagna Region

06

Mar 2018

Within the Work Package 4 of EUnetHTA Joint Action 3, femtosecond laser-assisted cataract surgery (FLACS) is currently under assessment by a team led by Emilia Romagna Region and supported by the Austrian agency Gesundheit Österreich (GÖG), the Belgian Health Care Knowledge Centre (KCE), and the Spanish agencies Basque Office for Health Technology Assessment (Osteba), Health Service of Canary Islands (SESCS), and Agency for Health Quality and Assessment of Catalonia (AQuAS).  

The project plan has been released in February 2018 while the assessment report is expected within the end of October 2018.

The technology was proposed for assessment by Emilia Romagna Region following a request from local decision makers. FLACS is available in private centres but not yet widely introduced across public institutions and could have a heavy organisational and economic impact on services for patients needing cataract surgery.

The PICO structure has been defined as follows:

  • Population

Adult patients (>18 years) of any gender, affected by cataract and for which the surgical treatment for cataract removal and insertion of intraocular lens could provide a gain in visual acuity and health-related quality of life.

  • Intervention

Femtosecond laser-assisted cataract surgery (FLACS) to be used during the first phases of the intervention to create incisions, perform capsulorhexis, and fragment the lens. Conventional ultrasound phacoemulsification technique is used to complete the surgical procedure.

  • Comparison

Standard cataract surgery.

  • Outcomes
    Clinical effectiveness: Corrected Distance Visual Acuity (1 month; 6 months); Uncorrected Distance Visual Acuity (1 month; 6 months); Refractive outcomes; Vision-related quality of life as measured by any validated questionnaire; Patient Reported Outcomes.

Safety: Anterior capsular tear; Posterior capsular tear; Vitreous loss; Elevated intraocular pressure (1 day - 1 week); Endothelial cells loss; Central corneal thickness; Iridocyclitis; Cystoid macular oedema (within 90 days); Infections (within 90 days); Corneal endothelial decompensation (within 90 days); Surgically induced astigmatism; Retinal detachment; Posterior capsule opacification; Visual acuity loss post cataract surgery (1 month - 6months); Surgical re-intervention (within 6 months); Secondary cataract (24 months).

Other outcomes: Patient satisfaction; Procedural time; Resource use.

Selection of studies will be limited to randomised controlled trials (RCT) for clinical effectiveness outcomes while, for safety-related and other outcomes, non-randomised controlled studies will be considered as well if presenting follow-up over 6 months.

The following systems will be included in the assessment: LenSx Laser System (Alcon), Catalys Precision laser system (Abbott), Victus femtosecond laser platform (Bausch & Lomb), Lensar laser system (Lensar) and Femto LDV Z8 (Ziemer). The manufacturers have been involved during the preparation of the project plan and have been asked to provide a submission file for their systems. Before the publication, they will be asked to take part to the review of the assessment draft (expected for July 2018).

See the project plan in English here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

Related news

26

Feb 2020

The General Director of Lombardy Healthcare released a decree no. 916 of 29.1.2020. The decree contains several important notices, the most important one being that the “Rules of the regional HTA commission” was published. In the first half of February 2020, it was published on the website of the regional HTA program of the Lombardy region.

Read more

14

Feb 2020

The Italian association of medical technology manufacturers, CONFINDUSTRIA dispositivi medici, published the results of a study in which they studied the average time the supplier of medical devices has to wait to get an invoice paid by the Italian hospitals. The differences vary between 35 days and 504 days.

Read more

10

Feb 2020

On January 30, 2020, the Institute for the Hospital Remuneration System (InEK) has published the List of the requests for innovation funding (NUB), submitted by the hospitals until October 31, 2019. Out of 778 technologies, 201 (26%) received the positive status 1, which means that the evaluated procedure or medical device meets the NUB criteria and allows the hospitals to negotiate with the sickness funds for the innovation funding for these technologies.

Read more

07

Feb 2020

New material codes for a set of equipment for the quantification of collateral ventilation in isolated pulmonary compartments and unidirectional endobronchial valve with placement system were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in February 2020.

Read more

05

Feb 2020

In late January 2020, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA21 “Hypoglossal nerve stimulation systems for treatment of obstructive sleep apnoea.”

Read more

04

Feb 2020

In January 2020, the Reimbursement Commission made changes to the Healthcare Implementation Communique in Turkey. The main changes relate to the addition of new laboratory test codes, procedure codes, new devices related to the ophthalmology, and price changing of materials related to interventional radiology.

Read more

03

Feb 2020

The HTA unit of the Lombardy region opens the possibility for the public to comment on the health technologies which are in the assessment phase. The call is open until February 28, 2020.

Read more

29

Jan 2020

New material code for a set of nets for the repair of prolapse (for vaginal placement) was added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in January 2020.

Read more

24

Jan 2020

In early January 2020, the Danish Health Authority (Sundhedsstyrelsen) has updated the national clinical guideline on the diagnosis and treatment of patients with age-related cataracts.

Read more

23

Jan 2020

In early January 2020, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA24 “The 24-hour blood pressure measurement device Mobil-O-Graph® with the built-in pulse wave velocity algorithm ARCSolver® to measure arterial stiffness for the optimization of hypertension treatment and assessment of cardiovascular risk”.

Read more

22

Jan 2020

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

Read more

16

Jan 2020

New material codes for implantable non-rechargeable neurostimulator, electrodes, and extensions for stimulation of the dorsal root nodes were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in December 2019.

Read more

07

Jan 2020

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).

Read more

03

Jan 2020

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).

Read more

26

Dec 2019

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.”

Read more

19

Dec 2019

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.

Read more

18

Dec 2019

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).

Read more

01

Nov 2019

New material codes for an implantable sensor for continuous measurement of glucose in interstitial fluid and embolization equipment were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in October 2019.

Read more

21

Oct 2019

In mid-September 2019, the report of the project OTCA19, titled “Screening for osteoporosis in the general population” was published on the website of the European Network for HTA (EUnetHTA).

Read more

11

Oct 2019

New material codes for extraction catheters were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in September 2019.

Read more

20

Sep 2019

In mid-August 2019, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA22 “Clinical utility of Point-of-care Tests (POCT) D-Dimer and Troponin.”

Read more

30

Aug 2019

In late July 2019, the report of the project OTJA10, titled “Stool DNA testing for early detection of colorectal cancer” was published on the website of the European Network for HTA (EUnetHTA).

Read more

15

Aug 2019

Domestic use of motor-driven moving splints (continuous passive motion, CPM) after interventions at the knee or shoulder joint remains covered by statutory health insurance. This has been determined by the G-BA (the Federal Joint Committee).

Read more

08

Aug 2019

In early July 2019, the network of European HTA agencies, EUnetHTA, published the report titled “Irreversible electroporation for the treatment of liver and pancreatic cancer”.

Read more

25

Jul 2019

Glioblastoma is an aggressive brain tumor with a low survival rate, usually occurring in late adulthood. The standard treatment consists of surgery, followed by radiation and chemotherapy. The Institute for Quality and Efficiency in Health Care (IQWiG) has examined possible benefits of tumor-treating field (TTF) therapy - new treatment based on electrostimulation in patients with glioblastoma.

Read more

03

Jul 2019

Notification to the Belgian Federal Agency for Medicines and Health Products (AFMPS) is a condition for obtaining reimbursement of compulsory medical insurance for implants and invasive medical devices for long-term use. Only devices that meet the notification requirements will be eligible for health care insurance.

Read more

27

Jun 2019

In mid-May 2019, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA18 “Regional hyperthermia for high-risk soft tissue sarcoma treatment.”

Read more

21

Jun 2019

On the 7th of May 2019, the new evaluation for bone-anchored prosthesis has been commenced in a framework of New Method, which provides a way for a managed introduction of innovations into Norwegian health care system. The proposal for the assessment was submitted by Oslo University Hospital in order to receive an opportunity to offer this method to achieve overall money saving and medical benefits as nowadays, only conventional prostheses are offered, and patients are sent to Gothenburg to receive the treatment, that is financed by the Norwegian health service.

Read more

14

Jun 2019

In early May 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI), has published a health technology assessment on robot-assisted surgery in thoracic and visceral indications as part of the EUnetHTA work.

Read more

07

Jun 2019

In France, there is a fast-track pathway, which provides reimbursement within the framework of the prospective medico-economic study, aiming at demonstrating benefits to patients or reduction of expenditure of health care system. On the 19th of April, the French National Authority for Health published two opinions regarding the inclusion of two devices into innovation package - eCLIPS: for treatment of cerebral aneurysm, Nuvaira™ Lung Denervation System for chronic obstructive pulmonary disease and asthma.

Read more

30

May 2019

The Federal Joint Committee (G-BA) has signed a further contract for scientific monitoring and implementation of a trial study for NYHA III heart failure therapy optimization by means of continuous blood pressure measurement and monitoring using an implanted sensor in the pulmonary artery.

Read more

29

May 2019

In April 2019, the Ministry of Health, Consumption and Social Welfare announced the update of the common package of benefits of the Spanish national health system with the inclusion of cervical cancer screening, nipple and areola micropigmentation and update of orthoprosthesis catalog.

Read more

24

May 2019

At the end of April 2019, the network of European HTA agencies, EUnetHTA, published the “Custom-made or customizable 3D printed implants and cutting guides versus non-3D printed standard implants and cutting guides for improving outcome in patients undergoing knee, maxillofacial, or cranial surgery.”

Read more

20

May 2019

With the regional decree of April 23, 2019, Tuscany Regional Healthcare has published assessments of six medical devices belonging to various therapeutic areas, including a system for monitoring in heart failure, TAVI, glaucoma drainage system, intravascular lithotripsy system.

Read more

07

May 2019

NHS England is inviting nominations for additions to, and removals from, the high-cost drugs and devices lists for the next national tariff come into effect in April 2020. All submissions must be submitted by May 31, 2019.

Read more

06

May 2019

Italian Ministry of Health, together with the national HTA agency, AGENAS, has published two Horizon Scanning reports in December 2018. Public consultations are open until May 25, 2019.

Read more

02

May 2019

At the beginning of April 2019, the Federal Cabinet has adopted the draft of a "Law on the Establishment of an Implants Registry in Germany and other amendments to the Fifth Book of the Social Code” (Implants Registry Establishment Law, Implantateregister-Errichtungsgesetz, EIRD).

Read more

01

May 2019

In Sweden, the Centre for Assessment of Medical Technology (CAMTÖ) leads the development of HTA cooperation in healthcare region Uppsala-Örebro. Currently, CAMTÖ is working on several assessments related to the medical devices and technologies such as equipment for 3D Printing, robot Intuitive daVinci Xi etc. After the completion of assessment procedure, the reports will be published at the web-site of Örebro County Council.

Read more

25

Apr 2019

The Swiss innovation agency, InnoSuisse, reminds that the deadline for the application for financing of truly innovative projects is May 20, 2019. The Swiss Federal Council has ensured additional funding of CHF 24 million for 2019 and 2020 for the “Impulse digitalization programme.”

Read more

24

Apr 2019

In April 2019, the Catalan Agency for Quality and Healthcare Evaluation, AQuAS, published a quick report with indication criteria for cochlear implants in children.

Read more

15

Apr 2019

With a regional decree of March 7, 2019, Tuscany Regional Healthcare has published assessments of seventeen medical devices belonging to various therapeutic areas.

Read more

08

Apr 2019

In late March 2019, the Italian Minister of Health announced that the European Commission has decided to adopt the Italian national classification system for medical devices for the database at European level.

Read more

02

Apr 2019

In late March 2019, the Italian Ministry of Health has published a new document on medical device governance. The document presents the guidelines for a new governance of medical devices, which aims at the efficient allocation of the NHS resources, the sustainability of innovation, the strengthening of supervision and the transparency of actions and reports concerning the procurement and use of medical devices.

Read more

28

Mar 2019

In early February 2019, the network of European HTA agencies, EUnetHTA, announced the final report of the project OTCA16 “Bioresorbable Stents for the Treatment of Cardiovascular Indications (coronary artery disease).”
In early February 2019, the network of European HTA agencies, EUnetHTA, announced the final report of the project OTCA16 “Bioresorbable Stents for the Treatment of Cardiovascular Indications (coronary artery disease).”

Read more

20

Mar 2019

On February 19, 2019 the new “Catalog of Goods and Services” for the centralized purchasing platform was presented to the regional health authorities by the Minister of Health. This new catalog includes up to 25,000 items, including drugs and health products.

Read more

05

Mar 2019

In mid-February 2019, the French High Authority for Health (HAS) has published the new guideline to clinical evaluation of connected medical devices in France.

Read more

26

Feb 2019

In early February 2019, the entity that performs health technology assessment for medical devices in Italy, AGENAS, has called for the voluntary contribution of the clinical experts and/or reviewers, as well as for the participation of the manufacturers for announced that they’re working on several HTA projects on different medical devices and procedures, including bariatric surgery, continuous glucose monitoring, Elecsys®sFlt-1/PlGF test and others.

Read more

21

Feb 2019

In early February 2019, the network of European HTA agencies, EUnetHTA, announced the final report of the project OTCA12 “C-reactive protein point-of-care testing (CRP POCT) to guide antibiotic prescribing in primary care settings for acute respiratory tract infections (RTIs)”.

Read more

14

Feb 2019

In late January 2019, the network of European HTA agencies, EUnetHTA, announced the ultimate project plan of the project OTCA20 “Prophylactic or therapeutic use of endoanchoring systems in endovascular aortic aneurysm repair (EVAR/TEVAR).”

Read more

11

Feb 2019

In January 2019, the Institute for the Hospital Remuneration System (InEK) has published the of medical devices and procedures approved for innovation funding (NUB). Out of 709 applications for drugs and technologies, 180 (25%) received the positive status 1, and 69 of them were the requests for the medical technologies.

Read more

06

Feb 2019

The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in January 2019. The decisions were made for eighteen medical devices.

Read more

17

Jan 2019

In late December 2018, the European HTA agency, EUnetHTA, announced the final report of the project OTCA06 - “Transcatheter aortic valve implantation (TAVI) in patients at intermediate surgical risk.”

Read more

10

Jan 2019

In late December 2018, the European HTA agency, EUnetHTA, announced the ultimate project plan of the project OTCA19 - “Screening for osteoporosis in the general population.”

Read more

09

Jan 2019

At the beginning of December 2018, the HTA entity of the Region of Tuscany has released a list of the upcoming assessments of the medical devices. Assessments include among others Impella ventricular assist device from Abiomed, Endocuff Vision colonoscope from Olympus, VascuFlex® Multi-LOC multiple stent delivery system from B Braun.

Read more

07

Jan 2019

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in December 2018 concern various types of devices (orthopedic, neurostimulators, drug-coated balloon and others). The decisions were brought for ten (10) medical devices.

Read more

14

Dec 2018

In mid-November, 2018, the European HTA agency, EUnetHTA, published the ultimate project plan of the assessment on “Custom-made or customizable 3D printed implants and cutting guides versus non-3D printed standard implants and cutting guides for improving outcome in patients undergoing knee, maxillofacial, or cranial surgery”.

Read more

13

Dec 2018

In mid-November, 2018, the Catalan Agency for Quality and Healthcare Evaluation, AQuAS, published their evaluation of bilateral cochlear implants in children and adults. The authors provided a list of criteria a patient has to fulfil in order to have a cochlear implant prescribed.

Read more

12

Dec 2018

In late October 2018, Assobiomedica, the body that represents the companies that operate in the medical device sector, published the fourth edition of the document “Public policies for the purchase of medical devices.”

Read more

07

Dec 2018

On November 7, 2018, the Italian Ministry of Health announced the document which should serve as a tool for the acquisition of medical devices through tenders.

Read more

04

Dec 2018

On 7th of November, 2018, the Italian Ministry of Health announced that the technical standards for magnetic resonance and its use are updated.

Read more

21

Nov 2018

On November 1, 2018, the European network for Health Technology Assessment, EUnetHTA, has announced that the patient groups’ input is required for a new Collaborative Assessment on a medical device for high-risk soft tissue sarcoma. The consultation is opened until November 30, 2018.

Read more

08

Nov 2018

On October 26, 2018, the French High Authority for Health (HAS) has announced that the composition of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) has been renewed.

Read more

07

Nov 2018

On October 26, 2018, the European Network for Health Technology Assessment has published the final report of femtosecond laser-assisted cataract surgery (FLACS) for the treatment of age-related cataract. The authors of this report are a group of experts from the Italian region of Emilia Romagna, together with Health Austria (Gesundheit Österreich, GÖG).

Read more

17

Oct 2018

On 3rd of October, 2018, the Italian Agency for Regional Healthcare Services, AGENAS, announced on their website that the reviewer volunteers are needed for reviewing the reports that should be published soon.

Read more

11

Oct 2018

In the early July 2018, the authorities of the Italian region Veneto brought a decree that updates the regional guidelines for the management of patients with colostomy, ileostomy and urostomy that were published in January 2017.

Read more

10

Oct 2018

EUnetHTA is a network of HTA bodies within Europe that promote the development of health technology assessment in all European countries by working together. This article will present the plans for the projects that will be published in the near future.

Read more

20

Sep 2018

Emilia Romagna Region published a preliminary information report on the LumiHeal™ KLOX system, a topical photo-converter system for the treatment of acute and chronic wounds.

Read more

18

Sep 2018

On July 27th, 2018, the European network for HTA has published a rapid assessment of the continuous glucose monitoring (CGM real-time) and flash glucose monitoring (FGM) as personal, standalone systems in patients with diabetes mellitus treated with insulin.

Read more

13

Sep 2018

In July of 2018, the Dental and Pharmaceutical Benefits Agency (Tandvårds-Läkemedelförmånsverket, TLV) has updated the product group codes for consumables for better understanding the range of the products. Editorial changes to the codes' descriptions were implemented. Seven new groups for stomach products, plates and bags of different types, which are especially intended for children have been included in the classification.

Read more

06

Sep 2018

Emilia Romagna Region published a rapid assessment report on the Medtronic’s Heli-FX™ EndoAnchor™ system. The authors concluded that published literature is of poor quality (mainly non-comparative studies) and mostly includes patients with abdominal aortic aneurysm. Data on the use of the device for thoracic aorta aneurysm repair are extremely limited.

Read more

17

Jul 2018

On the 5th of June of 2018, Dental and Pharmaceutical Benefit Agency (Tandvårds- och läkemedelsförmånsverket, TLV) has published a decision regarding inclusion of number of Verifine blood lancets produced by Mediq Sverige AB for diabetic patients to monitor the blood glucose levels into the list of pharmaceutical benefits with the price of SEK 23 per package.

Read more

11

Jun 2018

On 11th May, the Italian Ministry of Health announced from its website that five new Med Tech-related HTA documents are available for public consultation. See the details in the MTRC post.

Read more

05

Jun 2018

On the 14th of May of 2018, Dental and Pharmaceutical Benefit Agency (Tandvårds- och läkemedelsförmånsverket, TLV) has published a decision regarding inclusion of number of consumable medical devices for the treatment of asthma and chronic obstructive pulmonary disease (COPD) into the list of pharmaceutical benefits with the price of SEK 236.35 per piece.

Read more

30

May 2018

In mid-May 2018, the Basque office for Health Technology Assessment, OSTEBA, has published a rapid assessment report on treating prostate cancer with high-intensity focused ultrasound. The article is published under EUnetHTA framework.

Read more

29

May 2018

In April of 2018, Dental and Pharmaceutical Benefit Agency (Tandvårds- och läkemedelsförmånsverket, TLV) has published a number of consumable medical devices, which were excluded from the list of pharmaceutical benefits per manufacturers’ request.

Read more

16

May 2018

National Institute for Sickness and Disability Insurance (RIZIV/INAMI) reimburses some or all of the non-implantable medical devices provided by the pharmacist or in some cases by a supplier. In May 2018 the list of non-implantable medical devices has been updated.

Read more

15

May 2018

On 26th April, the Italian national agency for regional healthcare, AGENAS, announced that five new HTA documents will be produced for medical technologies during the next months.

Read more

11

May 2018

On the 26th of April of 2018, Dental and Pharmaceutical Benefit Agency (Tandvårds- och läkemedelsförmånsverket, TLV) has published a positive decision for inclusion of Aurum Convex (one-piece range of colostomy, ileostomy and urostomy bags with Manuka honey) into the list of pharmaceutical benefits with the price of its comparators of 48.13 SEK per product.

Read more

30

Apr 2018

On the 5th of April of 2018, Dental and Pharmaceutical Benefit Agency (Tandvårds- och läkemedelsförmånsverket, TLV) has published a positive decision for inclusion of VORTEX nozzle (spare part for VORTEX inhalation container) into the list of pharmaceutical benefits due to lower price of 45.42 SEK per product versus comparators.

Read more

26

Apr 2018

In mid-April 2018, the Galician HTA body, Avalia-T, has published a rapid evaluation report on screening of fetal trisomies 21, 18 and 13 by non-invasive prenatal testing. The report was done within EUnetHTA framework.

Read more

23

Apr 2018

In February of 2018, Dental and Pharmaceutical Benefit Agency (Tandvårds- och läkemedelsförmånsverket, TLV) has published a number of consumable medical devices, which were excluded from the list of pharmaceutical benefits per manufacturers’ request.

Read more

19

Apr 2018

Emilia Romagna Region published a preliminary information report on the Equistasi® device, a wearable proprioceptive stabilizer for rehabilitation of postural instability in Parkinson's disease, multiple sclerosis and athletes.

Read more

01

Mar 2018

The Italian Ministry of Health published a report presenting the expenditure on medical devices for the national healthcare system at 2016. On a total healthcare expenditure for goods and services of 17.6 billion of Euros, 5.8 billion (33%) are related to medical devices.

Read more

06

Feb 2018

Regional guidelines on the use of leadless pacemakers within the region have been released by the technical committee for medical devices in Veneto.

Read more

31

Jan 2018

EUnetHTA analyzed HTA and reimbursement procedures in relation to pharmaceutical and non-pharmaceutical health technologies in EUnetHTA partner countries. About 59 HTA agencies and decision-makers provided country-specific information and outlined the process of HTA and reimbursement in 31 European countries.

Read more

28

Dec 2017

Assobiomedica published a report presenting the status of the ventilation and monitoring equipment installed across the public and private hospitals at 2016. The scenario pictured by the analysis appears to be critical considering the high number of units older than 10 years.

Read more

08

Dec 2017

Emilia Romagna Region announced the launch of two new series of documents, according to the new regional assessment framework for medical devices developed during 2017: rapid assessment reports and preliminary information reports.

Read more

05

Dec 2017

Emilia Romagna Region published a preliminary information report on the CytoSorb® device, an extracorporeal cytokine adsorber for the reduction of circulating cytokines in the blood stream.

Read more

01

Dec 2017

Emilia Romagna Region published a rapid assessment report on the cardiac cryoablation catheter (also known as cryoballoon) for atrial fibrillation (AF). The authors concluded that, compared to radiofrequency ablation, cryoablation is not linked to higher effectiveness but presents shorter procedural time.Emilia Romagna Region published a rapid assessment report on the cardiac cryoablation catheter (also known as cryoballoon) for atrial fibrillation (AF). The authors concluded that, compared to radiofrequency ablation, cryoablation is not linked to higher effectiveness but presents shorter procedural time.

Read more

27

Nov 2017

EUnetHTA has published project plan of rapid assessment of TAVI procedure in patients with intermediate risk. Current plan describes the design and methodology of the assessment, list of involved reviewers, stakeholders and timelines of the project. The final report will be prepared till the end of January 2018.

Read more

20

Nov 2017

Annual report from the Italian Society of Interventional Cardiology (GISE) shows increasing trends in procedural volume of percutaneous coronary interventions (PCI), transcatheter aortic valve implantations (TAVI), mitral clip implantations, closure of left atrial appendage (LAA) and patent foramen ovale (PFO).

Read more

20

Oct 2017

The analyses were performed on the 2015 data from 16 Regions, on the basis of 35 indicators. According to the score assigned, Regions were classified as “compliant” (i.e., score ≥ 160 or between 140 and 160 with no critical values in any of the indicators) or “non-compliant” (i.e., score < 140 or between 140 and 160 with at least one critical value in one of the indicators). Overall results showed that the Country is split into two sections: Regions in the north were all compliant while those in the south, with the only exception of Basilicata, showed suboptimal performances.

Read more

09

Oct 2017

Agreement on the national HTA programme for medical devices has been reached between the central and regional authorities during the last Assembly. The main player in this context will be the Cabina di Regia per l’HTA. The steering committee will produce policy recommendations about the use of the assessed technologies and monitor implementation by procurement organizations. Read about the scope of the framework in our blog post.

Read more

23

Aug 2017

A list of scientific societies and technical and scientific medical associations appointed to release national guidelines will be defined in the next months by the Ministry of Health, following its decree issued on 2nd August 2017.

Read more

31

Jul 2017

The previous regional guidelines on brain stimulation therapy for advanced Parkinson’s disease, drug-resistant chronic migraine, and drug-resistant epilepsy, published in 2014, have been updated by the Regional Technical Commission for Medical Devices considering the new evidence on the specific groups of patients and some modifications in the indications for use of some devices. Check out indications for different neurostimulator technologies. These recommendations will form the foundation for reimbursement of devices in the region.

Read more

27

Jul 2017

As of today, 11 Italian regions have specific regulations for health technology assessment. Medical devices are among the most commonly assessed types of technologies. Read English summary of the comprehensive report on HTA in Italy, developed by Agenas and SIHTA.

Read more

27

Jun 2017

Assessments were directed by national HTA body AGENAS. They cover renal denervation for hypertension, next generation sequencing in oncology, robotic surgery, sling operation for urinary incontinence and vertebral disc replacement.

Read more

15

Jun 2017

For 19 of the surgical procedures in which laparoscopic techniques are more common, such approach is used in less than 4 out of 10 cases. Differences in levels of use emerged between Northern, Central, and Southern Regions in which the laparoscopic procedures were used less often.

Read more

12

Jun 2017

New publication in Obesity Facts provides insights into cost-effectiveness of bariatric surgery in Italy ("Cost-Utility Analysis of Bariatric Surgery in Italy: Results of Decision-Analytic Modelling"). Bariatric surgery was found to be cost effective at 10-year and cost saving at lifetime time horizon.

Read more

29

May 2017

An updated form for notification of medical technology to Italian national health technology assessment program has been released in May. Any stakeholder, including industry, can make notification, which will be reviewed and prioritize every six months.

Read more

27

Apr 2017

Assessment using HTA Core Model framework revealed that technology is safe, but evidence of efficacy is limited.

Read more