| 8.2.3 Other Anti-lymphpcyte monoclonal antibodies |
| RED Alemtuzumab solution for infusion [Lemtrada 12mg/1.2ml concentrate] |
NICE TAG312 Approved as an option for the treatment of relapsing-remitting multiple sclerosis.
|
| |
Appendix 6 Unlicensed use in Multiple sclerosis
|
|
RED Avelumab, Concentrate for solution for infusion (Bavencio® 200mg/10ml)
|
| NICE TA517 Recommended as an option for treating metastatic Merkel Cell carcinoma [partially updated by NICE TA691] |
| NHS England Commissioned |
| NICE TA645 Avelumab with axitnib is recommended for use within the Cancer Drugs Fund as an option for untreated |
| advanced renal cell carcinoma in adults. It is recommended only if the conditions in the managed access |
| agreement for avelumab with axitinib are followed. |
| Cancer Drugs Fund |
| NICE TA691 Recommended as an option for treating metastatic Merkel cell carcinoma in adults who have not had |
| chemotherapy for metastatic disease. [updates and replaces recommendation 1.2 in NICE TA517] |
| NHS England Commissioned |
| NICE TA788 Recommended as an option for maintenance treatment of locally advanced or metastatic urothelial cancer |
| that has not progressed after platinum-based chemotherapy in adults, only if: |
| > avelumab is stopped at 5 years of uninterrupted treatment or earlier if the disease progresses and, |
| > the company provides avelumab according to the commercial arrangement |
| NHS England Commissioned |
| |
RED Blinatumomab Powder for solution for infusion NHS England Commissioned
|
| NICE TA450 Recommended within its marketing authorisation as an option for treating Philadelphia-chromosome- |
| negative relapsed or refractory precursor B-cell acute lymphoblastic leukaemia in adults, only if the |
company provides it with the discount agreed in the patient access scheme.
|
| NICE TA589 Recommended as an option for treating Philadelphia-chromosome-negative CD19‑positive B‑precursor acute |
| lymphoblastic leukaemia in adults with minimal residual disease (MRD) of at least 0.1%, only if: |
| > the disease is in first complete remission and |
| > the company provides blinatumomab according to the commercial arrangement. |
RED Crizanlizumab 10 mg/ml concentrate for solution for infusion NHS England Commissioned
|
| NICE TA743 Recommended as an option for preventing recurrent sickle cell crises (vaso-occlusive crises) in people aged |
| 16 years or over with sickle cell disease only if the conditions in the managed access agreement are followed. |
|
| RED Durvalumab solution for infusion |
| NICE TA578 This guidance has been updated and replaced with NICE TA798 |
| NICE TA798 Recommended as an option for treating advanced unresectable non-small-cell lung cancer in adults whose |
| tumours express programmed cell death ligand 1 [PD-L1] on 1% or more of cells and whose disease has not |
| progressed after platinum-based chemoradiation, only if: |
| > they have had concurrent platinum-based chemoradiation |
| > the company provides durvalumab according to the commercial arrangement |
| This guidance updates and replaces NICE TA578 NHS England Commissioned |
RED Idelalisib (Zydelig)
|
| NICE TA359 Recommended, in combination with Rituximab, for untreated chronic lymphocytic leukaemia in adults with a |
17p deletion or TP53 mutation or for chronic lymphocytic leukaemia in adults when the disease has been
|
treated but has relapsed within 24 months. Idelalisib is recommended only if the company provides the drug
|
with the discount agreed in the simple discount agreement.
|
|
RED Inotuzumab ozogamicin NHS England Commissioned
|
NICE TA541 An option for treating relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia in
|
tyrosine kinase inhibitor.
|
| |
| RED Mogamulizumab [Poteligeo] NHS England Commissioned |
| NICE TA754 Recommended, within its marketing authorisation, as an option for treating Sézary syndrome in adults who |
| have had at least 1 systemic treatment. It is recommended only if the company provides mogamulizumab |
| according to the commercial arrangement. |
| Mogamulizumab is recommended as an option for treating mycosis fungoides in adults, only if: |
| > their condition is stage 2Bor above and |
| > they have had at least 2 systemic treatments and |
| > the company provides mogamulizumab according to the commercial arrangement |
| |
| |
RED Obinutuzumab Concentrate for intravenous infusion
|
NICE TA343 [Gazyvaro]Recommended, in combination with chlorambucil, as an option for adults with untreated chronic
|
lymphocytic leukaemia who have comorbidities that make full-dose fludarabine-based therapy unsuitable for
|
them only if:bendamustin-based therapy is not suitable and the company provides obinutuzumab with the
|
discount agreed in the patient access scheme
|
NICE TA629 [Gazyvaro] Recommended, within its marketing authorisation, with bendamustine followed by obinutuzumab,
|
as an option for treating follicular lymphoma that did not respond or progressed up to 6 months after
|
treatment with rituximab or a rituximab-containing regimen. (replaces NICE TA472) Cancer Drugs Fund
|
| NICE TA699 [Kesimpta] Recommended as an option for treating relapsing-remitting multiple sclerosis in adults with active |
disease defined by clinical or imaging features. This is only if the company provides ofatumumab according to
|
the commercial arrangement.
|
| |
RED Ocrelizumab Concentrate for solution for infusion (Ocrevus 300mg/10mL) NHS England Commissioned
|
NICE TA533 Recommended as an option for treating relapsing-remitting multiple sclerosis in adults with active disease
|
defined by clinical or imaging features, only if:
|
| > alemtuzumab is contraindicated or otherwise unsuitable and |
| > the company provides orcelizumab according to the commercial arrangement |
| NICE TA585 Recommended as an option, within its marketing authorisation, for treating early primary progressive multiple |
| sclerosis with imaging features charecteristic of inflammatory activity in adults. |
| |
|
RED Ofatumumab, Concentrate for intravenous infusion
|
| NICE TA344 *Approved as an option for use for for untreated chronic lymphocytic leukaemia in combination with chlorambucil or bendamustine. |
| *[Guidance withdrawn because Novartis has discontinued ofatumumab (Arzerra) |
| |
NICE TA699 [Kesimpta] Recommended as an option for treating relapsing-remitting multiple sclerosis in adults with active
|
disease defined by clinical or imaging features. This only if the company provides ofatumumab according to the
|
commercial agreement
|
|
RED Pembrolizumab (Keytruda®) for intravenous infusion
|
| NICE TA357 Recommended as an option for treating advanced (unresectable or metastatic) melanoma in adults only: |
| > after the disease has progressed with ipilimumab and, for BRAF V600 mutation-positive disease, a BRAF or |
MEK inhibitor and
|
| > when the company provides pembrolizumab in line with the commercial access agreement with NHS England |
| |
NICE TA366 Recommended as an option for treating advanced (unresectable or metastatic) melanoma that has not been
|
| previously treated with ipilimumab, in adults, only when the company provides pembrolizumab in line with the |
commercial access agreement with NHS England.
|
| RED Ravulizumab (Ultomiris®) concentration for solution for infusion |
| NICE TA710 Recommended, within its marketing suthorisation, as an option for treating atypical haemolytic uraemic |
| syndrome in people weighing 10kg or more: |
| > who have not had a complement inhibitor before or |
| > whose disease has responded to at least 3 months of eculizumab treatment |
| It is recommended only if the company provides ravulizumab according to the commercial arrangement. |
NHS England Commissioned
RED Tisagenlecleucel (Kymriah) |
| NICE TA554 Recommended for use within the Cancer Drugs Fund as an option for treating relapsed or refractory B-cell acute |
| lymphoblastic leukaemia in people aged up to 25 years, only if the conditions in the managed access agreement |
are followed. Cancer Drugs Fund
|
| NICE TA567 Recommended for use within the Cancer Drugs Fund, as an option for treating relapsed or refractory diffuse |
largeB-cell lymphoma in adults after 2 or more systemic therapies, only if the conditions in the managed access
|
| agreement are followed. Cancer Drugs Fund |
|
