GuidelinesOther guideline
Anti-Infectives for Systemic Use
Fusidic acid Linezolid Ketoconazole Itraconazole Caspofungin/micafungin/anidulafungin Voriconazole (VCZ) Ribavirin Sofosbuvir-velpatasvir Intravenous Immunoglobulin (IVIG) Palivizumab ATC Code J01XC01 Medicine Fusidic acid Indication Treatment of staphylococcal infections, mainly involving bone and joints: - Methicillin-sensitive organisms, as alternative to cloxacillin or flucloxac
Caspofungin/micafungin/anidulafungin
Intravenous Immunoglobulin (IVIG)
| ATC Code | J01XC01 |
| Medicine | Fusidic acid |
| Indication |
Treatment of staphylococcal infections, mainly involving bone and joints: - Methicillin-sensitive organisms, as alternative to cloxacillin or flucloxacillin - Methicillin-sensitive organisms, in combination with cloxacillin or flucloxacillin - Methicillin-resistant organisms, as an alternative to e.g. glycopeptides or oxazolidinones (linezolid), especially in cases where prolonged treatment is required |
| NEMLC Recommendation | Not Approved |
| Review Indicators |
- New evidence of clinical comparative efficacy against alternatives, especially regarding long term treatment of MRSA where the oral preparation may be of benefit in comparison to parenteral glycopeptides and infections with glycopeptide resistant organisms where the potential toxicity of oxazolidinones (linezolid) when used for prolonged periods of time, may be problematic |
| Date Ratified | 13 March 2008 |
| ATC Code | J01XX08 |
| Medicine | Linezolid |
| Indication |
Resistant gram positive infections where vancomycin is contra-indicated |
| NEMLC Recommendation |
Approved - Special Access It may be available on special access basis as approved by PTC for: - Only with a microbiology report confirming vancomycin resistance in a relative organism or confirmation of severe adverse effect to vancomycin, (i.e. vancomycin induced neutropenia or anaphylaxis, but not the “red man syndrome”) - Confirmed contra-indication to the use of vancomycin |
| Review Indicators |
- Clinically significant increase in vancomycin resistance in the public sector - Significant decrease in cost of linezolid |
| Date Ratified | 27 November 2008 |
| ATC Code | J02AB02 |
| Medicine | Ketoconazole |
| Indication | Cushing’s syndrome |
| NEMLC Recommendation | Approved |
| Review Indicators | - Availability of alternate medication for this indication with superior efficacy or safety profile - New safety concerns |
| Date Ratified | 10 July 2008 |
| ATC Code | J02AC02 |
| Medicine | Itraconazole |
| Indication | Histoplasmosis |
| NEMLC Recommendation | Not Approved |
| Review Indicators | - New evidence of clinical comparative efficacy against alternatives, especially weekly Amphotericin B - Significant increase in incidence of the condition - Significant change in pricing |
| Date Ratified | 13 March 2008 |
| ATC Code | J02AX04/ J02AX05/ J02AX06 |
| Medicine | Echinocandins: (caspofungin/ micafungin/ anidulafungin) |
| Indication | Invasive candidiasis (resistant to fluconazole/ amphotericin B and/or where renal dysfunction is present and amphotericin B cannot be used) |
| NEMLC Recommendation | Approved - Special Access - Echinocandins approved as a class, with the most affordable agent to be procured - The use of echinocandins should be managed through motivation/ appropriate restrictions at facilities, as part of Antimicrobial Stewardship activities (See addendum – clinical criteria for use) |
| Review Indicators | - Availability of amphotericin B - Changing resistance patterns - New evidence |
| Date Ratified | 12 April 2018 |
| ATC Code | J02AC03 |
| Medicine | Voriconazole (VCZ) |
| Indication | Treatment of invasive Aspergillosis |
| NEMLC Recommendation | Not Approved |
| Review Indicators | - High quality randomised controlled trial with amphotericin B as the comparator |
| Date Ratified | 13 March 2008 |
| ATC Code | J05AB04 |
| Medicine | Ribavirin |
| Indication | Viral haemorrhagic fever (VHF) |
| NEMLC Recommendation | Approved To be supplied on motivation from a central supply point |
| Review Indicators | n/a |
| Date Ratified | 27 June 2013 |
| ATC Code | J05AP55 |
| Medicine | Sofosbuvir-velpatasvir |
| Indication | Viral Hepatitis C |
| NEMLC Recommendation | Approved |
| Review Indicators | New evidence of efficacy and safety (particularly local evidence), pricing changes |
| Date Ratified | 20 July 2023 |
| ATC Code | J06BA02 |
| Medicine | Intravenous Immunoglobulin (IVIG) |
| Indication | Acute Immune Thrombocytopenic Purpura (ITP) |
| NEMLC Recommendation | Approved - Life-threatening bleed with platelets <50 x 109/l - Urgent surgery (any surgery urgently required within 24 hours) where rapid rise in platelets is required - Pregnant patient prior to delivery as above - Rapid rise in platelets required when a patient has platelet count of <20 x 109/L, with additional risk factors for bleeding (such as severe hypertension, ongoing sepsis) |
| Review Indicators | Evidence of harm |
| Date Ratified | 5 July 2018 |
| ATC Code | J06BA02 |
| Medicine | Intravenous Immunoglobulin (IVIG) |
| Indication | Primary antibody immune deficiency with recurrent infections |
| NEMLC Recommendation | Approved |
| Review Indicators | - New data on dosing - Availability of more affordable subcutaneous formulations |
| Date Ratified | 11 April 2019 |
| ATC Code | J06BA02 |
| Medicine | Intravenous Immunoglobulin (IVIG) |
| Indication | Guillain-Barré syndrome (GBS) presenting within the first 2 weeks of onset of moderate to severe weakness |
| NEMLC Recommendation | Approved The recommended regimen is 0.4g/kg daily for 5 days |
| Review Indicators | New evidence |
| Date Ratified | 5 December 2019 |
| ATC Code | J06BB16 |
| Medicine | Palivizumab |
| Indication | Respiratory syncytial virus (RSV) infection in high-risk premature infants |
| NEMLC Recommendation | Not Approved |
| Review Indicators | Price reduction |
| Date Ratified | 25 April 2013 |