GuidelinesOther guideline
Blood and Blood Forming Organs
Clopidogrel Recombinant Factor VIIa (rFVIIa) Haemophilia bypassing agents (rFVIIa/aPCC) Emicizumab ATC Code B01AC04 Medicine Clopidogrel Indication Percutaneous coronary intervention (stenting) NEMLC Recommendation Approved Clopidogrel plus aspirin recommended for a minimum of: - 30 days in situations where a bare metal stent is inserted - 90 days in situations where a sirolim
Recombinant Factor VIIa (rFVIIa)
Haemophilia bypassing agents (rFVIIa/aPCC)
| ATC Code | B01AC04 |
| Medicine | Clopidogrel |
| Indication | Percutaneous coronary intervention (stenting) |
| NEMLC Recommendation |
Approved Clopidogrel plus aspirin recommended for a minimum of: - 30 days in situations where a bare metal stent is inserted - 90 days in situations where a sirolimus drug- eluting stent is inserted - 180 days when a paclitaxel drug-eluting stent is inserted Thereafter allow aspirin indefinitely The evidence currently available to the Committee does not provide support for use beyond 6 months although there are recommendations endorsing longer term use in high risk patients |
| Review Indicators | n/a |
| Date Ratified | 20 September 2007 |
| ATC Code | B01AC04 |
| Medicine | Clopidogrel |
| Indication | Ischaemic heart disease (non-myocardial infarction) |
| NEMLC Recommendation | Approved for long-term use only in patients intolerant to aspirin, i.e. allergy or bleeding episodes. |
| Date Ratified | 20 September 2007 |
| ATC Code | B01AC04 |
| Medicine | Clopidogrel |
| Indication | Stroke |
| NEMLC Recommendation | Approved, only for long-term therapy where patient has confirmed aspirin intolerance |
| Review Indicators | - Decrease in clopidogrel price - New safety or efficacy data for either aspirin (at doses recommended by the DoH) or clopidogrel |
| Date Ratified | 24 July 2014 |
| ATC Code | B01AC04 |
| Medicine | Clopidogrel |
| Indication | Transient ischaemic attack with/without atrial fibrillation |
| NEMLC Recommendation | Not Approved |
| Review Indicators | - Decrease in clopidogrel price - New safety or efficacy data for either aspirin or clopidogrel |
| Date Ratified | 24 July 2014 |
| ATC Code | B02BD03 |
| Medicine | Recombinant Factor VIIa (rFVIIa) |
| Indication | Intractable bleeding |
| NEMLC Recommendation | Not Approved |
| Review indicators | Robust efficacy data |
| Date Ratified | 29 June 2017 |
| ATC Code | B02BD03 |
| Medicine | Haemophilia bypassing agents (rFVIIa/aPCC) |
| Indication | Haemophilia with inhibitors (on demand, when presenting with a significant bleed) |
| NEMLC Recommendation | Approved - Special Access One bypassing agent to be available on the EML (most affordable). An alternative bypassing agent can be made available as emergency stock on a special access basis as approved by the PTC for patients not responding to EML item |
| Date Ratified | 14 December 2017 |
| ATC Code | B02BX06 |
| Medicine | Emicizumab |
| Indication | Routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adults and children with severe haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors. |
| NEMLC Recommendation | Approved - Special Access Although EML, the use of emicizumab should be managed through motivation/ appropriate restrictions at facilities. Motivation should include data on the presence of factor VIII inhibitors, the patient's clinical state and prognosis, previous bleeding episodes, and the extent to which bypassing agents have been used. Utilisation and outcomes should be monitored by the responsible facility and provincial Pharmaceutical and Therapeutics Committees. (See Clinical criteria for use – Emicizumab document) |
| Review indicators | - New evidence of efficacy and safety, pricing changes, registration of alternative monoclonal antibodies with the same indications. |
| Date Ratified | Final ratification: 29 August 2024 (Initial recommendation: 14 March 2024) |