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Percutaneous coronary interventions

An overview of market access challenges for percutaneous coronary balloon angioplasty with or without stent insertion (PCI) in European countries.

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Procedure coding

Typically, procedure coding for PCI is well-established in European countries.

In some countries, the coding might be complex, with existence of multiple codes depending on the number of treated coronary vessels or type and number of coronary stents. For example, in Germany, the combination of OPS codes for percutaneous coronary balloon angioplasty, insertion of a coronary stent, and multiple supplementary codes to specify the type (non-drug eluting stent, drug-eluting stent, bioresorbable stent, etc.) and number of inserted stents (from one to six) and treated coronary vessels (single or multiple coronary vessels), is used to describe the procedure. 

In other countries, the number of procedure codes for PCI is limited. For example, in France, the procedure is described via a single CCAM code for percutaneous coronary balloon angioplasty without stenting (code DDAF010) or with stenting depending on the number of treated vessels (code DDAF006 for stent insertion in one vessel, code DDAF004 – in two vessels, code DDAF003 – in three or more vessels) and do not specify the type of stents in their description. 

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Payment mechanism

The payment model varies by country.

In most EU countries, PCI with or without stent insertion is reimbursed solely via the diagnosis-related group (DRG) mechanism. The DRG tariffs typically are higher for procedures with stent insertion. In some countries (e.g., Germany, Italy, and countries of the Nordic region), the DRG allocation and reimbursement amount for PCI also depends on the indication for the procedure with higher tariffs for acute myocardial infarction.

In some countries (e.g., France and Germany), coronary stents and certain types of balloons (drug-coated balloons) attract additional reimbursement, paid on top of the DRG tariff. 

For example, in Germany, there are several add-on ZE categories for drug-eluting balloons and coronary stents depending on the type (drug-eluting, bioresorbable) and number of inserted stents.

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

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Policy considerations

Due to high medical and social importance, PCI in acute myocardial infarction 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 primary PCI in ST-elevation myocardial infarction (STEMI), in which NHS England outlined patient pathways, eligible hospitals, responsibilities of different stakeholders, etc. 

In some countries, national decision-makers can restrict reimbursement of certain types of PCI. For example, PCI with a drug-coated balloon in Belgium is reimbursed only in case of re-stenosis.

Clinical guidelines and recommendations remain influential factors affecting the utilization of PCI.

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Health technology assessment

Due to established reimbursement in European countries, coronary stents rarely become a subject of HTA. 

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Future challenges 

PCI with or without stent insertion has established reimbursement and funding in most European countries. New health technology assessments are unlikely to be relevant. 

Coronary stents, which can fit the established generic categories, are unlikely to benefit from the innovative payment schemes. 

Novel coronary stents and balloons with unique designs or properties or different cost profiles might need to develop specific procedure codes and adjust payment mechanisms to leverage their unique technology or cost profile fully. 

An important topic is the improvement of access and increasing number of simultaneous use of invasive and noninvasive coronary diagnostics (FFR, IVUS) and PCI, which impacts the treatment outcomes and changes the number of patients and eligibility criteria for different PCI options.

MTRC has experience with more than 10 projects related to percutaneous coronary interventions in Europe

News and insights

Recommendations about add-on reimbursement for medical devices in France in December 2023

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in December 2023. Nine recommendations were published in relation to the registration of medical devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, peripheral vascular, and ophthalmological devices, as well as medical aids.

Recommendations about add-on reimbursement for medical devices in France in October 2023

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in October 2023. Twelve recommendations were published in relation to the registration of medical devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, e-health, endocrine, gastrointestinal, neurology and neurosurgery, neuromodulation, and orthopedic devices, as well as medical aids.

The preliminary version of the 2024 OPS procedure coding classification released in Germany

On August 11, 2024, the BfArM (Federal Institute for Drugs and Medical Devices) published the preliminary version of the 2024 OPS procedure coding classification. The OPS, together with the ICD-10-GM (International Statistical Classification of Diseases and Related Health Problems, 10th revision, German Modification), forms the basis for the reimbursement systems in inpatient and outpatient care in Germany.

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