MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including cardiovascular technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for cardiovascular devices in Europe.

In Sweden, the Centre for Assessment of Medical Technology (CAMTÖ) leads the development of HTA cooperation in the healthcare region Uppsala-Örebro. In August 2019, CAMTÖ started its work on the assessment of sclerotherapy in Achilles tendinopathy. After the completion of the evaluation process, the report would be published at the web-site of Örebro County Council.

At the beginning of August 2019, North Rhine-Westphalia presented the plans for “Virtual Hospital,” a digital platform that will bundle specialist expertise nationwide and make it more accessible.

In August 2019, the Norwegian Institute of Public Health (NIPH) has released a single technology assessment report for molecular profiling panel – Prosigna aimed to investigate its prognostic accuracy, clinical and cost-effectiveness in patients with breast cancer. It was outlined that it is uncertain to what extent Prosigna contributes prognostic information that turns into better clinical results; conclusions about the cost-effectiveness of Prosigna cannot be made due to the lack of existing information.

A positive conclusion regarding the model project “Rhineland-Palatinate breathes through - telemedicine for healthy lungs” (“Rheinland-Pfalz atmet durch – Telemedizin für eine gesunde Lunge”) was drawn by the Mainz Ministry of Health.

Within the framework of the Federal HTA program, the benefits currently paid under the compulsory health insurance are being reevaluated. On the 4th of September, 2019, the health technology assessment of arthroscopy of the knee, developed by the Swiss Medical Board on behalf of the Federal Ofice for Public Health, has been published.

In August 2019, the National Institute for Health and Care Excellence published one new MedTech innovation briefings for vacuum therapy for colorectal anastomotic leakage and two new interventional procedure guidance for endovascular insertion of an intrasaccular wire-mesh blood-flow disruption device for intracranial aneurysms and the Papillon technique for locally advanced rectal cancer.

Responding to requests from our clients, we are starting to provide the services of development of value dossiers. We can support our clients with both early and core value dossiers. Dossiers can be developed from the global or European perspectives.

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in July and August 2019 concern various types of devices, including orthopedic, cardiovascular, and blood glucose meters. A total of 29 decisions were made.

In response to multiple requests from our clients, we have started the provision of service of health economic modeling for medical technologies and IVD tests in Europe. Both early and comprehensive models eligible for publication are supported.

We have released the second part of the interview on the Market Access Insider channel on Youtube. The interview covered key stakeholders, procedure coding, principles of functioning of DRG system and add-on reimbursement for medical devices via LPPR List. Reimbursement pathways for devices, evidence requirements, pricing considerations, innovation funding (PHRC, PRME, forfeit innovation, Article 51, ETAPES program) were also discussed.

The report presents a summary of the reimbursement situation for use of biologic and synthetic skin substitutes in Europe. The following clinical indications are considered: burns; chronic wounds (hypertrophic scar). The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland. It is also possible to add analysis in the Czech Republic, Finland, Hungary, Romania, Russia and Turkey.