| 20048 |
Amikacin Sulfate |
Arikayce® liposomal nebuliser dispersion |
For the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis. |
NCPE Assessment Process Complete |
20th October 2023 |
 |
| 22053 |
Asciminib |
Scemblix® |
For the treatment of Adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in the chronic phase, who have previously been treated with two or more tyrosine kinase inhibitors. |
Rapid Review Complete |
20th October 2023 |
|
| 21007 |
Cemiplimab |
Libtayo® |
Is indicated as monotherapy for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation. |
NCPE Assessment Process Complete |
24th October 2023 |
|
| - |
Delta-9-tetrahydrocannabinol/Cannabidiol, THC/CBD |
Sativex® |
Indicated as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. |
NCPE Assessment Process Complete |
20th October 2023 |
|
| 22068 |
Empagliflozin |
Jardiance® |
For the treatment of symptomatic chronic heart failure with left ventricular ejection fraction >40% |
Rapid review complete |
20th October 2023 |
|
| 22052 |
Eptinezumab |
Vyepti® |
For the prophylaxis of migraine in adults who have at least four migraine days per month |
Rapid review complete |
20th October 2023 |
|
| 23055 |
Glofitamab |
Columvi® |
Glofitamab is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. |
Rapid Review Complete |
3rd October 2023 |
|
| 22062 |
Macimorelin acetate |
Ghryvelin® |
For the diagnosis of growth hormone deficiency (GHD) in adults. |
Rapid Review Complete |
20th October 2023 |
|
| 23032 |
Niraparib in combination with abiraterone acetate |
Akeega® |
Niraparib in combination with abiraterone acetate and prednisone/prednisolone is indicated for the treatment of adults with metastatic castration resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. |
Rapid Review Complete |
20th October 2023 |
|
| 21043 |
Nivolumab |
Opdivo® |
Nivolumab as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. |
NCPE Assessment Process Complete |
20th October 2023 |
|
| 22045 |
Nivolumab |
Opdivo® |
Nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell PD-L1 (programmed death ligand 1) expression ≥1%. |
Rapid Review Complete |
20th October 2023 |
|
| 21011 |
Olaparib |
Lynparza® |
Olaparib in combination with bevacizumab is indicated for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability. |
NCPE Assessment Process Complete |
20th October 2023 |
|
| 23020 |
Pegunigalsidase alfa |
Elfabrio® |
Pegunigalsidase alfa (Elfabrio®) is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase). |
Rapid Review Complete |
20th October 2023 |
|
| 23054 |
Pitolisant hydrochloride |
Wakix® |
Pitolisant hydrochloride (Wakix®) is indicated in adults, adolescents, and children aged 6 years and older for the treatment of narcolepsy with or without cataplexy |
Rapid Review Complete |
4th October 2023 |
|
| 21006 |
Risdiplam |
Evrysdi™ |
For the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. |
NCPE Assessment Process Complete |
20th October 2023 |
|
| 19041 |
Voretigene neparvovec |
Luxturna® |
For the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. |
NCPE Assessment Process Complete |
20th October 2023 |
|
| 22028 |
Vosoritide |
Voxzogo® |
For the treatment of genetically confirmed achondroplasia in patients aged two years and older whose epiphyses are not closed. |
NCPE Assessment Process Complete |
5th October 2023 |
|
| 23010 |
Zanubrutinib |
Brukinsa® |
Zanubrutinib as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL). The place in therapy for zanubrutinib, proposed by the Applicant, is narrower than the licensed population i.e. as monotherapy for patients with CLL, who are treatment naïve and have del(17p) and/or TP53 mutations or for patients that have relapsed and/or refractory disease |
Rapid Review Complete |
20th October 2023 |
|
