| - |
Evolocumab |
Repatha® |
For both primary hypercholesterolaemia and mixed dyslipidaemia and heterozygous familial hypercholesterolaemia. |
Assessment process complete |
16th May 2018 |
 |
| 25055 |
Evolocumab |
Repatha® |
Evolocumab is indicated for both primary hypercholesterolaemia and mixed dyslipidaemia and heterozygous familial hypercholesterolaemia. In this submission the Applicant is proposing to reduce the LDL-C thresholds specified in the current managed access protocol. The revised patient population includes: • adults with established atherosclerotic cardiovascular disease (i.e. confirmed diagnosis of myocardial infarction +/- revascularisation procedures, non-haemorrhagic stroke or peripheral arterial disease [i.e. secondary prevention] or in those who have undergone coronary artery bypass graft), with a LDL-C persistently ≥ 3.0 mmol/L and • adults with a confirmed diagnosis of heterozygous familial hypercholesterolaemia with a LDL-C persistently ≥ 2.5 mmol/L. |
Rapid Review Complete |
30th September 2025 |
|
| - |
Exenatide |
Bydureon® |
For the treatment of type II diabetes mellitus combined with Metformin, Sulphonylurea, Thiazolidinedione, Metform and SU and Metformn and TZD in adults who have not acheived glycaemic control on maximally tolerated doses of these oral therapies. |
Rapid review complete |
9th June 2011 |
|
