| - |
Darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide |
Symtuza® |
For the treatment of HIV-1 in adults and adolescents. |
Rapid review complete |
26th October 2017 |
 |
| - |
Lacosamide |
Vimpat® |
As monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. The Applicant is seeking reimbursement for an extension to the product license to cover children (≥4 years of age) and adolescents (≤ 15 years of age). |
Rapid Review Complete |
31st October 2017 |
|
| - |
Obeticholic acid |
Ocaliva® |
For the treatment of primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. |
Assessment process complete |
31st October 2017 |
|
| - |
Pembrolizumab |
Keytruda® |
For the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 (tumour proportion score [TPS] ≥ 50%) with no EGFR or ALK positive tumour mutations and no prior systemic therapy for advanced disease. |
Assessment Process Complete |
10th October 2017 |
|
| - |
Sarilumab |
Kevzara® |
In combination with methotrexate (MTX) for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARD). Sarilumab can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. |
Rapid Review Complete |
4th October 2017 |
|
| - |
Sofosbuvir/velpatasvir |
Epclusa® |
For the treatment of chronic hepatitis C virus (HCV) infection in adults. This indication covers all genotypes (GT1, 2, 3, 4, 5 and 6) i.e. pangenotypic. |
Rapid review complete |
19th October 2017 |
|
