Chronic lymphocytic leukaemia
Rationale 1,6
Rationale: 1,6
Metachromatic leukodystrophy
Rationale 1,6
Lung cancer non-small cell
Rationale: 1,6
Acute lymphoblastic leukaemia
Rationale 1,6
For untreated advanced or recurrent non-small-cell lung cancer when platinum-doublet chemotherapy is unsuitable (terminated appraisal)
Rationale 1,6
Multiple myeloma
Belantamab mafodotin with pomalidomide and dexamethasone for previously treated multiple myeloma
Rationale 1,6
Cytotoxic drug
Rationale 1,6
Cutaneous T-cell lymphoma (CTCL) - skin manifestations of advanced stage
Rationale 1,6
Rationale 1,6
Mantle cell lymphoma
Rationale: 1
Multiple Myleloma
Rationale: 1
NICE NG35 Myeloma: diagnosis and management
NICE TA228 Bortezomib and thalidomide for the first‑line treatment of multiple myeloma
Chronic myeloid leukaemia
Rationale: 1,6
NICE TA401 Bosutinib for previously treated chronic myeloid leukaemia August 2016
Refractory B-cell acute lymphoblastic leukaemia
Rationale: 1,6
Anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Rationale 1,6
Rationale- 1,6
Rationale 1,6
Rationale 1,6
Lymphoblastic leukaemia (Acute)
Rationale: 1,2,3
Rationale 1,6
Melanoma - advanced (unresectable or metastatic) melanoma in adults expressing a BRAF V600 gene mutation
Non-small cell lung cancer (NSCLC) in combination with trametinib with a BRAF V600 mutation
Stage III Melanoma with a BRAF V600 mutation, following complete resection."
Rationale: 1
Paediatric cancers
Rationale: 1,6
Multiple Myeloma
In combination for treating newly diagnosed systemic amyloid light-chain amyloidosis
Rationale 1,6
NICE TA897 Daratumumab with bortezomib and dexamethasone for previously treated multiple myeloma
NICE TA763 Daratumumab in combination for untreated multiple myeloma when a stem cell transplant is suitable
NICE TA783 Daratumumab monotherapy for treating relapsed and refractory multiple myeloma
Drug Safety Update Aug 19; Daratumumab (Darzalex▼): risk of reactivation of hepatitis B virus
Establish hepatitis B virus status before initiating daratumumab and in patients with unknown hepatitis B virus serology who are already being treated with daratumumab
Durvalumab with chemotherapy before surgery (neoadjuvant) then alone after surgery (adjuvant) for treating resectable non-small-cell lung cancer
With etoposide and either carboplatin or cisplatin for untreated extensive-stage small-cell lung cancer
With Tremelimumab for untreated advanced or unresectable hepatocellular carcinoma
Rationale 1,6
Monotherapy for the treatment of adults with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy
Rationale 6
Melanoma (unresectable or metastatic) - in adults
Mutation-positive metastatic colorectal cancer in adults
Rationale 1,6
ROS1-positive advanced non-small-cell lung cancer in adults
NTRK fusion positive solid tumours in adults and children 12 years and older
Rationale 1,6
Relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic treatments
Rationale 1,6
Use as monotherapy for the treatment of adults with unresectable or metastatic urothelial carcinoma, harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting
Rationale 1,6
Cancer - breast (locally advanced or metastatic after 2 previous chemotherapy) treatments
Liposarcoma (unresectable)
Rationale: 1,6
Advanced renal cell carcinoma
Cancer -breast (hormone receptor-positive, HER2/neu negative advanced)
Neuroendocrine tumours - unresectable or metastatic, well- or moderately differentiated of pancreatic origin in adults with progressive disease.
Renal angiomyolipoma associated with tuberous sclerosis complex
Transplantation - Kidney, Heart
Transplantation - Liver
Rationale 1,6
Treatment of adults with metastatic colorectal cancer who have been previously treated with available therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, with or without an anti-VEGF therapy, and, if RAS wildtype and medically appropriate, an anti-EGFR therapy
Rationale 1,6
Treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy
Rationale 1,6
Treating relapsed or refractory diffuse large B-cell lymphoma
Rationale 1,6
NICE TA927 Glofitamab for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic treatments
To reduce toxic plasma methotrexate concentration in adults and children (aged ≥28 days) with delayed methotrexate elimination
Rationale 1,6
Acute Lymphoblastic Leukaemia - paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy
Chronic myeloid leukaemia
Relapse following resection of Kit (CD117) positive gastrointestinal stromal tumours (GIST)
Rationale 1,6
Drug Safety Update
Patients should be tested for hepatitis B virus before starting treatment with BCR-ABL tyrosine kinase inhibitors. May2016
Leukaemia (acute lymphoblastic)
Rationale: 1,2
Advanced and metastatic colorectal cancer
Rationale: 1,2,3
For untreated acute myeloid leukaemia with an IDH1 R132 mutation in combination with azacidine
Rationale 1,6
Advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2) in combination with Capecitabine
Rationale 1,2,3
Solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion
Rationale: 1, 6
NICE TA630 Larotrectinib for treating NTRK fusion-positive solid tumours May 2020
Hepatocellular carcinoma
Differentiated thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). Progressive, locally advanced or metastatic/
Renal cell carcinoma (advanced)
Rationale 1
Rationale 1,6
Acute myeloid leukaemia
Aggressive systemic masto cytosis
Systemic Masto cytosis with associated haematological neoplasm (SM-AHN)
Mast cell leukaemia (MCL)."
Rationale 1,6
Advanced adrenal cortical carcinoma
Rationale 1
Doctors, nurses, pharmacists and their staff must be made aware that the prescribing, dispensing and administering of oral
anti-cancer medicines should be carried out and monitored to the same standard as injected therapy. This requires that:
* Healthcare organisations should prepare local policies and procedures that describe the safe use of these oral
medicines.
* Treatment should be initiated by a cancer specialist.
* All oral anti-cancer medicines should be prescribed only in the context of a written protocol and treatment plan.
* Non-specialists who prescribe or administer on-going oral anti-cancer medication should have ready access to
appropriate written protocols and treatment plans including guidance on monitoring and treatment of toxicity.
* Staff dispensing oral anti-cancer medicines should be able to confirm that the prescribed dose is appropriate for the
patient, and that the patient is aware of the required monitoring arrangements, by having access to information in the
written protocol and treatment plan from the hospital where treatment is initiated and advice from a pharmacist with
experience in cancer treatment in that hospital.
* Patients should be fully informed and receive verbal and up-to-date written information about their oral anticancer
therapy from the initiating hospital. This information should include contact details for specialist advice, which can be
shared with non-specialist practitioners. Written information, including details of the intended oral anti-cancer regimen,
treatment plan and arrangements for monitoring, taken from the original protocol should be given to the patient. When
shared with pharmacists and dispensing staff, this would enable the above dispensing requirements to be satisfied.
* Full use should also be made of NHS cancer centre web sites to provide information for healthcare staff, patients and carers to ensure the safe use of oral anti-cancer medicines.
Risks of incorrect dosing of oral anti-cancer medicines - NPSA January 2008
Myelofibrosis-related splenomegaly or symptoms
Rationale 1,6
Chronic myelogenous leukaemia (CML), Resistant Philadelphia chromosome-positive CML
Rationale 1,6
Cancer- maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal
Rationale 1,6
Cancer- adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy
For maintenance treatment of BRCA mutation-positive advanced ovarian, fallopian tube or peritoneal cancer after response to first-line platinum-based chemotherapy
For treating BRCA mutation-positive HER2-negative advanced breast cancer after chemotherapy
Rationale 1,6
Red listed for Positive NICE TA recommendations - Grey listed for any non recommended conditions
Rationale:1,6
Pancreatic cancer (metastatic)
Ovarian Cancer
Non small-cell lung cancer
Rationale 1,6
Renal cell carcinoma (advanced) and selective subtypes of soft tissue sarcomas
Rationale 1,6
Chemotherapy for untreated advanced HER2-negative gastric or gastro-oesophageal junction adenocarcinoma
Adjuvant treatment of resected non-small-cell lung cancer
In combination with carboplatin and paclitaxel
Rationale 1,6
Chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia
Rationale 1,6
Hodgkin's disease, other advanced lymphomata and solid tumors
Rationale 1
Doctors, nurses, pharmacists and their staff must be made aware that the prescribing, dispensing and administering of oral
anti-cancer medicines should be carried out and monitored to the same standard as injected therapy. This requires that:
* Healthcare organisations should prepare local policies and procedures that describe the safe use of these oral
medicines.
* Treatment should be initiated by a cancer specialist.
* All oral anti-cancer medicines should be prescribed only in the context of a written protocol and treatment plan.
* Non-specialists who prescribe or administer on-going oral anti-cancer medication should have ready access to
appropriate written protocols and treatment plans including guidance on monitoring and treatment of toxicity.
* Staff dispensing oral anti-cancer medicines should be able to confirm that the prescribed dose is appropriate for the
patient, and that the patient is aware of the required monitoring arrangements, by having access to information in the
written protocol and treatment plan from the hospital where treatment is initiated and advice from a pharmacist with
experience in cancer treatment in that hospital.
* Patients should be fully informed and receive verbal and up-to-date written information about their oral anticancer
therapy from the initiating hospital. This information should include contact details for specialist advice, which can be
shared with non-specialist practitioners. Written information, including details of the intended oral anti-cancer regimen,
treatment plan and arrangements for monitoring, taken from the original protocol should be given to the patient. When
shared with pharmacists and dispensing staff, this would enable the above dispensing requirements to be satisfied.
* Full use should also be made of NHS cancer centre web sites to provide information for healthcare staff, patients and carers to ensure the safe use of oral anti-cancer medicines.
Risks of incorrect dosing of oral anti-cancer medicines - NPSA January 2008
Cancer - Colorectal (metastatic) in adults who have been previously treated with, or are not considered candidates for, available therapies.
Cancer -Hepatocellular carcinoma (HCC)
Rationale 1,6
Cancer - breast HR+tive, HER2-tive post menopausal, locally advanced or metastatic
Hormone +ve, HER2-ve, locally advanced or metastatic breast cancer in adults who have had previous endocrine therapy
Rationale: 1,6
Maintenance treatment of epithelial ovarian, fallopian tube, or primary peritoneal (monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade)
Maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer
Rationale :1,6
Myelofibrosis - Chronic idiopathic myelofibrosis and treatment of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia
Polycythaemia vera
Rationale 1,6
NICE TA386 Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis
NICE TA921 Ruxolitinib for treating polycythaemia vera
Rationale 1,6
| Pack | Price |
|---|---|
| 12 tablet (4 x 3 tablets) | £5,520.00 |
| 16 tablet (4 x 4 tablets) | £7,360.00 |
| 20 tablet (4 x 5 tablets) | £9,200.00 |
| 8 tablet (4 x 2 tablets) | £3,680.00 |
Rationale 1,6
Pancreatic neuroendocrine tumours
Advanced/Metastatic renal cell carcinoma.
Rationale 1,6
Acute leukaemia and chronic myeloid leukaemia
Rationale 1
Rationale 1,6
Metastatic melanoma with a BRAF V600 mutation
Non-small cell lung cancer with a BRAF V600 mutation.
Stage III Melanoma with a BRAF V600 mutation, following complete resection
Rationale 1
Treatment of adults with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features
Rationale 1,6
For treating symptomatic anaemia in adults having dialysis for chronic kidney disease
Rationale 1,6
Melanoma - adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma
Rationale 1,2
Treating marginal zone lymphoma after anti-CD20-based treatment
Relapsed or refractory mantle cell lymphoma and in combination with Obinutuzumab
Rationale 1,6
Pancreatic cancer
Rationale 2
No NICE or SPC available
Use in combination with amivantamab for the first-line treatment of adults with advanced non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations
Rationale 6
NICE guidance in development
Treatment of disease-related splenomegaly or symptoms in adults with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Kinase inhibitor naïve or have been treated with ruxolitinib
Rationale 6
Idiopathic Pulmonary Fibrosis (IPF) and Progressive fibrosing interstitial lung diseases
Rationale 6
Use as monotherapy for the treatment of adults with relapsed or refractory mantle cell lymphoma who have been previously treated with a Bruton´s tyrosine kinase (BTK) inhibitor, and use as monotherapy for the treatment of adults with relapsed or refractory chronic lymphocytic leukaemia who have been previously treated with a BTK inhibitor
Rationale 6
Treatment of adults with advanced gastrointestinal stromal tumour who have received prior treatment with ≥3 kinase inhibitors, including imatinib
Use in combination with carboplatin and etoposide for the first-line treatment of adults with extensive-stage small cell lung cancer
Rationale 6
Monotherapy for the treatment of adults with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy
Multiple myeloma
Rationale 2
All licensed indications
Rationale: 2
Use in combination with durvalumab for the first-line treatment of adults with advanced or unresectable hepatocellular carcinoma
Rationale 6
Aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease
Rationale 1
Use in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2‑negative gastric or gastro-oesophageal junction adenocarcinoma whose tumours are Claudin 18.2 positive
Rationale 2