| - |
Ustekinumab |
Stelara® |
For the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist or have medical contraindications to such therapies |
Rapid review complete |
11th January 2017 |
 |
| 19048 |
Ustekinumab |
Stelara® |
For the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies. |
Rapid review complete |
17th December 2019 |
|
| - |
Vandetanib |
Caprelsa® |
For the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. |
Rapid review complete |
4th July 2013 |
|
| - |
Vedolizumab |
Entyvio® |
For the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist. |
Assessment process complete |
13th November 2015 |
|
| - |
Vedolizumab |
Entyvio® |
For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist. |
Assessment process complete |
13th November 2015 |
|
| 20029 |
Vedolizumab |
Entyvio® |
For subcutaneous administration is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or an anti-TNFα. |
Rapid review complete |
12th August 2020 |
|
| 20030 |
Vedolizumab |
Entyvio® |
For subcutaneous administration is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or an anti-TNFα. |
Rapid review complete |
12th August 2020 |
|
| - |
Velaglucerase Alfa |
VPRIV® |
For long-term enzyme replacement therapy (ERT) in patients with type1 Gaucher disease. |
Rapid review complete |
20th June 2011 |
|
| - |
Vemurafenib |
Zelboraf® |
For the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. |
Assessment process complete |
3rd September 2012 |
|
| - |
Venetoclax |
Venclyxto® |
For the treatment of chronic lymphocytic leukaemia (CLL) |
Rapid review complete |
21st June 2018 |
|
| 22001 |
Venetoclax |
Venclyxto® |
In combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. |
NCPE Assessment Process Complete |
26th September 2023 |
|
| 20046 |
Venetoclax in combination with obinutuzumab |
Venclyxto® / Gazyvaro® |
For the treatment of adult patients with previously untreated chronic lymphocytic leukaemia. |
Assessment process complete |
17th August 2021 |
|
| - |
Venetoclax |
Venclyxto® |
For the treatment of adult patients with CLL who have received at least one prior therapy. |
Assessment process complete |
8th November 2019 |
|
| 21027 |
Vericiguat |
Verquvo® |
For the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring intravenous therapy. |
NCPE Assessment Process Complete |
15th July 2021 |
|
| - |
Vernakalant |
Brinavess® |
For haemodynamically stable, symptomatic patients with atrial fibrillation of less than 48 hours duration. |
Assessment process complete |
4th May 2011 |
|
| - |
Vestronidase alfa |
MEPSEVII® |
For the treatment of non-neurological manifestations of MPS VII. |
Rapid review complete |
22nd May 2019 |
|
| - |
Vismodegib |
Erivedge® |
For the treatment of adult patients with locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy or metastatic basal cell carcinoma. |
Assessment process complete |
22nd January 2014 |
|
| 23003 |
Voclosporin |
Lupkynis® |
Voclosporin is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN). |
Awaiting response from Applicant |
24th April 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 |
|
| - |
Vortioxetine |
Brintellix® |
For the treatment of major depressive episodes in adults. |
Assessment process complete |
18th November 2016 |
|
| 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 |
|
| 23035 |
Vutrisiran |
Amvuttra® |
Indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy |
Rapid Review complete |
3rd August 2023 |
|
| - |
Zanamivir |
Dectova® |
For the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥6 months) when the patient's influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient |
Rapid review complete |
18th October 2019 |
|
| 23072 |
Zanubrutinib |
Brukinsa® |
Zanubrutinib monotherapy is indicated for adult patients with relapsed/refractory marginal zone lymphoma with at least one prior anti-CD20-based therapy. |
Pre submission consultation scheduled |
7th March 2024 |
|
| 21044 |
Zanubrutinib |
Brukinsa® |
Monotherapy for the treatment of adult patients with Waldenström’s macroglobulinaemia who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy |
Rapid review complete |
16th November 2021 |
|
| 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 |
|
