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Implantable ventricular assist devices

An overview of market access challenges for implantable VADs in European countries

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Procedure coding

Typically, procedure coding is well-established for ventricular assist devices in European countries. 

For example, in England, a specific OPCS code K54.1 “Open implantation of ventricular assist device” exists to cover implantable VADs. Percutaneous VADs are coded separately. 

In some countries, only a limited number of procedure codes exist, while in others, a very detailed classification of VADs is available. 

For example, in Germany, OPS procedure coding distinguishes between different types of VAD systems, including mono- and bi-ventricular, intra- or para-corporeal devices, etc. 

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Payment mechanism

The payment model varies by country.

In England, Netherlands, Norway, and most of other EU countries, the implantation of VAD is reimbursed solely via the diagnosis-related group (DRG) mechanism. 

In some countries (e.g. France and Germany), ventricular assist devices attract additional (top-up) reimbursement, which is paid in addition to the DRG tariff. 

For example, in Germany, many add-on ZE categories exist depending on the type of VAD (mono-, bi-ventricular; intra- or para-corporeal) with pricing mostly determined at the local level.

Add-on reimbursement can be either generic (at the class level, as in Germany) or brand-specific (with specific LPPR codes for individual brands in France). 

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Policy considerations

Due to high cost, VADs can be subject to specific policies from payers or national decision-makers in the countries where such frameworks exist. 

For example, in England, the national payer, NHS England, developed so-called Service Specifications for the use of ventricular assist devices, in which NHS England outlined patient pathways, eligible hospitals, responsibilities of different stakeholders, etc. 

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Health technology assessment

Due to the high cost and high clinical risks for patients, and the existence of different clinical indications (bridge-to-transplant vs destination therapy), VADs are often a subject of HTA in different European countries. 

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Future challenges 

Classic VADs have established reimbursement and funding in most of the European countries. New health technology assessments are unlikely to be relevant. 

Classic VADs are unlikely to benefit from the innovative payment schemes. 

Novel ventricular assist devices with unique designs or properties, or different cost profiles might need to develop specific procedure codes and adjust payment mechanisms to fully leverage their unique technology or cost profile. 

An important topic for VAD is the expansion of indications towards destination therapy (in the countries, where it is not yet established). 

MTRC has experience with more than 26 projects, related to implantable ventricular assist devices in Europe

News and insights

Specialized clinical commissioning policies work plan updated in England

On September 11, 2024, NHS England published an updated work plan for specialized clinical commissioning policies development. One MedTech-related policy was added to the program on long-term left ventricular assist devices (LVAD) for destination therapy in adults with heart failure. No new policies were published.

Med Tech-related health technology assessments from NIHR in August 2024

In August 2024, the National Institute for Health and Care Research (NIHR) in England released eight MedTech-related assessments in its Health Technology Assessment (HTA) Journal, which concerned automated devices for identifying peripheral arterial disease, left ventricular assist devices as destination therapy, cerclage suture type to prevent pregnancy loss, gynecological cancer surveillance in Lynch syndrome, multiparametric MRI in bladder cancer pathway, in-home monitoring for people with glaucoma, real-time ultrasound elastography of thyroid nodules, and AI-based software for analyzing chest X-ray images. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and informs National Institute for Health and Care Excellence (NICE) guidance.

Rapid HTAs of seven medical devices released in Tuscany

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 16951 of July 22, 2024, Tuscany Regional Healthcare published five new assessments and two reassessments of medical devices in the cardiovascular, peripheral vascular, surgical procedures, and obstetrics and gynecology areas.

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