This technology appraisal focuses on DESs only. The preceding appraisal of DESs (NICE's technology appraisal on the use of coronary artery stents) considered only three devices (Taxus, Cypher and Dexamet) because at the time of publication, these were the only DESs that had been granted Conformité Européene (CE) marking for use within EU countries. Eight additional DESs have been included in this appraisal.
Each DES has an instruction for use (IFU) document that includes the indications for which the specific device can be used. The indications for use for each DES vary, although the majority specify the sizes of vessels (diameter and length) to be treated and are in accordance with their CE marking. Also included in the IFU documents are details of side effects and specific contraindications for DESs.
Different drugs elute from the stents that are included in this appraisal: paclitaxel is a broad-spectrum antimitotic agent that inhibits cell division; sirolimus (previously known as rapamycin) is an immunosuppressive agent that reduces inflammation; ABT-578 is a synthetic analogue of sirolimus; everolimus is an immunosuppressive agent that is closely related to sirolimus; tacrolimus is an immunosuppressive agent; and dexamethasone is a synthetic adrenocortical steroid that reduces inflammation. These drugs may elute at different rates, depending on the presence or absence of additional polymer coatings on the stent.
The following list prices for DESs exclude VAT.
The DES Axxion (Biosensors Limited) is a non-polymeric paclitaxel-eluting stent (PES) with a list price of £995 (BMS equivalent: Nexus).
The DES CoStar (Biotronik Limited) is a non-polymeric PES (BMS equivalent: DepoStent). CoStar was originally included in this appraisal but is no longer available.
The DES Taxus (Boston Scientific) is a polymeric PES with a list price of £1,300 (BMS equivalent: Express).
The second-generation DES Taxus Liberté (Boston Scientific) is a polymeric PES with a list price of £1,300 (BMS equivalent: Liberté).
The DES Cypher (Cordis Corporation) is a polymeric sirolimus-eluting stent (SES) with a list price of £1,340 (BMS equivalent: Bx Velocity).
The second-generation DES Cypher Select (Cordis Corporation) is a polymeric SES with a list price of £1,340 (BMS equivalent: Sonic).
The DES Endeavor (Medtronic AVE) is a polymeric sirolimus analogue ABT‑578 (zotarolimus)-eluting stent (ZES) with a list price of £1,450 (BMS equivalent: Driver).
The DES Janus (Sorin) is a polymeric tacrolimus-eluting stent (TES) with a list price of £1,500 (BMS equivalent: Janis).
The DES Xience V (Guidant Ltd) is a polymeric everolimus-eluting stent (EES) with a list price of £1,500 (BMS equivalent: Multi-Link Vision).
The DES Dexamet (Abbott Vascular Devices Ltd) is a polymeric dexamethasone-eluting stent (BMS equivalent: BiodivYsio). Dexamet was originally included in this appraisal but is no longer available in the EU.
The DES Yukon (Kiwimed Ltd) is a non-polymeric stent that can be coated with any drug to be eluted and has a list price of £650.
As list prices are not commonly used for procuring devices in the NHS, updated prices of DESs and BMSs were sought from the NHS Purchasing and Supply Agency. Procurement of devices is complex and it should be noted that the prices for DES and BMS are driven by a number of factors including the: market conditions at the time of contracting; contract period; renewal date for the procurement arrangements (contracts are usually updated annually and the most recent contracts show significant decreases in the prices of DESs); volume commitment; period commitment; combination of period and volume commitment; product rationalisation or standardisation; retrospective threshold discounts (for example, free set quantities of stents when agreed volumes have been exceeded); consignment stock (for instance, when a supplier provides an inventory to trust); and other added value inclusive arrangements (for example, the provision of additional training and related equipment).
From the sample 2007/08 data received from the NHS Purchasing and Supply Agency for NHS organisations in England for the stents included in this appraisal, the mean price of DES was £529 and the mean price of BMS was £131. The price difference between DESs compared with BMSs ranged from £203 to £615 across a number of Health Authorities in England, although it should be noted that the higher price differences tended to be seen in the older contracts which will be re-tendered in due course, in accordance with relevant contract renewal schedules.