Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
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Notes: |
Updated in accordance with CDF and NICE guidance May 2018. For latest CDF list click here. |
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Chapter Links... |
Cancer Drugs Fund list |
Details... |
08.01.05 |
Other antineoplastic drugs |
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08.01.05 |
CDK inhibitors |
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08.01.05 |
Dacarbazine and Temozolomide |
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08.01.05 |
Platinum compounds |
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08.01.05 |
Protein kinase inhibitors |
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Abemaciclib (Verzenios®)
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Formulary



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Commissioned by CDF in line with NICE TA563 and TA579 and CDF criteria.
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NICE TA563: Abemaciclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer
NICE TA579: Abemaciclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy
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Acalabrutinib (Calquence®)
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Formulary



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Commissioned within the CDF as an option for untreated chronic lymphocytic leukaemia (CLL) in adults, only if: • they have a 17p deletion or TP53 mutation
Commissioned within the CDF as a second-line option for treating CLL in adults where: • ibrutinib is their only suitable treatment option
Commissioning will transfer to NHSE 90 days following NICE publication
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Afatinib (Giotrif®)
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Formulary


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Commissioned by NHS England in line with NICE TA310.
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NICE TA310: Lung cancer (non small cell, EGFR mutation positive) - afatinib
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Alectinib (Alecensa®)
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Formulary



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Commissioned by NHSE in line with NICE TA536 recommendations.
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NICE TA536: Alectinib for untreated ALK-positive advanced non-small-cell lung cancer
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Axitinib (Inlyta®)
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Formulary


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Commissioned by NHS England in line with NICE TA333.
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NICE TA 333: Axitinib for treating advanced renal cell carcinoma after failure of prior systemic treatment
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Binimetinib (Mektovi®)
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Formulary



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Commissioned by CDF in line with NICE TA562 and CDF criteria (in combination encorafenib).
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NICE TA562: Encorafenib with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma
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Bosutinib (Bosulif®)
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Formulary



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Commissioned by NHS England in line with NICE TA401.
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NICE TA401 Bosutinib for previously treated chronic myeloid leukaemia
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Brigatinib (Alunbrig®)
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Formulary



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Commissioned by NHSE in line with NICE TA571 as monotherapy for the treatment of adult patients with ALK-positive advanced non-small cell lung cancer previously treated with crizotinib.
Commissioned by NHSE in line with NICE TA670 as an option for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) that has not been previously treated with an ALK inhibitor in adults. • This indication is funded by CDF until 27th April 2021
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NICE TA571: Brigatinib for treating ALK-positive advanced non-small-cell lung cancer after crizotinib
NICE TA670: Brigatinib for ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor
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Cabozantinib (Cometriq®, Cabometyx®)
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Formulary



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Cabometyx®:
- Commissioned by NHSE in accordance with NICE TA463 and TA542 for the treatment of previously treated advanced renal cell carcinoma and untreated locally advanced or metastatic renal cell carcinoma respectively.
- Patients initiated on the Named Patient Programme should remain on free of charge stock for the duration of their treatment.
Cometriq®:
- Commissioned in accordance with NICE TA516 for the first line treatment of medullary thyroid cancer.
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NICE TA463: Cabozantinib for previously treated advanced renal cell carcinoma
NICE TA516: Cabozantinib for treating medullary thyroid cancer
NICE TA542: Cabozantinib for untreated advanced renal cell carcinoma
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Ceritinib (Zykadia®)
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Formulary



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Commissioned by NHS England in line with NICE TA395 and TA500.
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NICE TA395: Ceritinib for previously treated anaplastic lymphoma kinase positive non-small-cell lung cancer
NICE TA500: Ceritinib for untreated ALK-positive non-small-cell lung cancer
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Crizotinib (Xalkori®)
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Formulary




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Commissioned by CDF in line with CDF criteria and NICE TA529 and NHS England in line with NICE TA406 and TA422.
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NICE TA406: Crizotinib for untreated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer
NICE TA422: Crizotinib for previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer
NICE TA529: Crizotinib for treating ROS1-positive advanced non-small-cell lung cancer
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Dabrafenib (Tafinlar®)
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Formulary


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Commissioned by NHS England in line with NICE TA321, TA396 and TA544.
TA396 and TA544 require BlueTeq prior approval.
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NICE TA:321: Dabrafenib for treating unresectable or metastatic BRAF V600 mutation‑positive melanoma
NICE TA396: Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma
NICE TA544: Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma
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Dacomitinib (Vizimpro®)
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Formulary



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In accordance with NICE TA595
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NICE TA595: Dacomitinib for untreated EGFR mutation-positive non-small-cell lung cancer
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Dasatinib (Sprycel®)
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Formulary


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Commissioned by NHS England in line with NICE TA425 and TA426.
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NICE TA425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
NICE TA426: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
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Encorafenib (Braftovi®)
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Formulary




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Commissioned by CDF in line with NICE TA562 and CDF criteria (in combination binimetinib).
Commissioned by NHSE in combination with Cetuximab as an option for treating BRAF V600E mutation-positive metastatic colorectal cancer in adults who have had previous systemic treatment in line with NICE TA668. • NOTE: Interim funding is via the CDF until April 6th 2021
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NICE TA562: Encorafenib with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma
NICE TA668: Encorafenib plus cetuximab for previously treated BRAF V600E mutation-positive metastatic colorectal cancer
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Entrectinib (Rozlytrek®)
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Formulary




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Commissioned by NHSE in line with NICE TA643 for treating ROS1-positive advanced non-small-cell lung cancer (NSCLC) in adults who have not had ROS1 inhibitors.
Commissioned via the Cancer Drugs Fund (CDF) in line with NICE TA644 for treating neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours in adults and children 12 years and older if: • the disease is locally advanced or metastatic or surgery could cause severe health problems and • they have not had an NTRK-inhibitor before and • they have no satisfactory treatment options.
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NICE TA643: Entrectinib for treating ROS1-positive advanced non-small-cell lung cancer
NICE TA644: Entrectinib for treating NTRK fusion-positive solid tumours
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Erlotinib (Tarceva®)
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Formulary

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Commissioned by NHS England for cancer, policy in progress. See NICE TA162 and TA374.
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NICE TA258: Erlotinib for the first-line treatment of locally advanced or metastatic EGFR-TK mutation-positive non-small-cell lung cancer
NICE374: Erlotinib and Gefitinib for the treatment of non-small-cell lung cancer that has progressed after prior chemotherapy (previously TA162)
NICE TA227: Erlotinib monotherapy for maintenance treatment of non-small-cell lung cancer (not recommended)
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Everolimus (Afinitor®)
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Formulary


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Commissioned by NHS England in line with NICE TA recommendations.
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NICE TA421: Everolimus with exemestane for treating advanced breast cancer after endocrine therapy
NICE TA432: Everolimus for advanced renal cell carcinoma after previous treatment
NICE TA449: Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
NICE TA498: Lenvatinib with everolimus for previously treated advanced renal cell carcinoma
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Gefitinib (Iressa®)
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Formulary

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Commissioned by NHS England in line with TA192.
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NICE TA192: gefitinib for the first-line treatment of locally advanced or metastatic non-small-cell-lung cancer
NICE TA374: Gefitinib and erlotinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy (previously TA175) (not recommended)
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Gilteritinib (Xospata®)
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Formulary



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Commissioned by NHSE in line with NICE TA642 as monotherapy for treating relapsed or refractory FLT3‑mutation-positive acute myeloid leukaemia (AML) in adults.
Gilteritinib should not be given as maintenance therapy after a haematopoietic stem cell transplant.
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NICE TA642: Gilteritinib for treating relapsed or refractory acute myeloid leukaemia
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Ibrutinib (Imbruvica® )
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Formulary




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In accordance with CDF policy and NICE TA429, TA491 and TA502.
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NICE TA429:Ibrutinib for previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation
NICE TA491: Ibrutinib for treating Waldenstrom’s macroglobulinaemia
NICE TA502: Ibrutinib for treating relapsed or refractory mantle cell lymphoma
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Idelalisib (Zydelig® )
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Formulary


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Commissioned in accordance with NICE TA359.
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NICE TA 359: Idelalisib for treating chronic lymphocytic leukaemia
NICE TA 469: Idelalisib with ofatumumab for treating chronic lymphocytic leukaemia (terminated appraisal)
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Imatinib (Generic, Glivec®)
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Formulary


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For haematology indications use generic drug, for gastrointestinal stromal tumours use Glivec® brand.
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NICE TA70: guidance on the use of imatinib for chronic myeloid leukaemia
NICE TA209: Imatinib for the treatment of unresectable and/or metastatic gastrointestinal stromal tumours
NICE TA326: Imatinib for the adjuvant treatment of gastrointestinal stromal tumours (Previously NICETA196)
NICE TA425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
NICE TA426: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
NICE TA86: Imatinib for the treatment of unresectable and/or metastatic gastro-intestinal stromal tumours
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Larotrectinib (Vitrakvi®)
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Restricted



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Commissioned in line with CDF criteria and conditions of the managed access agreement in accordance with the recommendations in NICE TA630 for treating NTRK fusion-positive solid tumours.
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NICE TA630: Larotrectinib for treating NTRK fusion-positive solid tumours
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Lenvatinib (Kisplyx®, Lenvima®)
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Formulary



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Kisplyx®:
- Commissioned by NHSE in accordance with NICE TA498 for the treatment of previously treated renal cell carcinoma in combination with everolimus.
Lenvima®:
- Commissioned by NHSE in accordance with NICE TA535 for the treatment of differentiated thyroid cancer after radioactive iodine.
- Commissioned by NHSE in accordance with NICE TA551 for first line treatment of Child Pugh A locally advanced or metastatic hepatocellular carcinoma.
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NICE TA498: Lenvatinib with everolimus for previously treated advanced renal cell carcinoma
NICE TA535: Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine
NICE TA551: Lenvatinib for untreated advanced hepatocellular carcinoma
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Midostaurin (Rydapt®)
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Formulary



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Commissioned by NHSE in line with NICE TA523 recommendations.
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NICE TA523: Midostaurin for untreated acute myeloid leukaemia
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Neratinib (Nerlynx®)
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Formulary



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Commissioned by NHSE in line with the recommendations in NICE TA612.
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NICE TA612: Neratinib for extended adjuvant treatment of hormone receptor-positive, HER2-positive early stage breast cancer after adjuvant trastuzumab
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Nilotinib (Tasigna®)
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Formulary


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Commissioned by NHS England in line with NICE TA241 and TA251.
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NICE TA241: Dasatinib, nilotinib and high dose imatinib for CML
NICE TA425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
NICE TA426: Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
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Nintedanib (Vargatef®, Ofev®)
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Formulary


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Vargatef®:
- Commissioned by NHS England in line with NICE TA347 for non-small-cell lung cancer.
Ofev®:
- Commissioned by NHS England in line with NICE TA379 for idiopathic pulmonary fibrosis via specialist centres only.
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NICE TA 347: Nintedanib for previously treated locally advanced, metastatic, or locally recurrent non‑small‑cell lung cancer
NICE TA379: Nintedanib for treating idiopathic pulmonary fibrosis
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Osimertinib (Tagrisso®)
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Formulary



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Commissioned by NHSE for treating EGFR T790M mutation-positive advanced or metastatic non-small-cell lung cancer (NSCLC) in adults in accordance with NICE TA653, only if their disease has progressed after first-line treatment with an EGFR tyrosine kinase inhibitor.
Commissioned by NHSE for untreated EGFR mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults in accordance with NICE TA654.
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NICE TA653: Osimertinib for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer
NICE TA654: Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer
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Palbociclib (IBRANCE®)
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Formulary




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Commissioned in accordance with NICE TA495 for the treatment of previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer.
Patients inititated on the free of charge patient access programme should continue on free of charge treatment so long as they derive benefit.
Commissioned by CDF in line with NICE TA619 for treating hormone receptor-positive, HER2-negative, advanced breast cancer in combination with Fulvestrant.
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NICE TA495: Palbociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer
NICE TA619: Palbociclib with fulvestrant for treating hormone receptor-positive, HER2-negative, advanced breast cancer
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Pazopanib (Votrient®)
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Formulary

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Commissioned by NHS England as per NICE TA215.
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NICE TA215: pazopanib for the first line treatment of advanced renal cell carcinoma
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Pemigatinib (Pemazyre®)
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Formulary



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Available under EAMS for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy
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Ponatinib (Iclusig®)
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Formulary



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Commissioned by NHS England in line with NICE TA451.
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DSU vol 8, iss 4, Nov 2014: S2. Ponatinib (Iclusig): risk of vascular occlusive events
NICE TA451: Ponatinib for treating chronic myeloid leukaemia and acute lymphoblastic leukaemia
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Regorafenib (Stivarga® )
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Formulary



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Commissioned by NHS England in line with NICE TA488 and TA555.
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NICE TA488: Regorafenib for previously treated unresectable or metastatic gastrointestinal stromal tumours
NICE TA555: Regorafenib for previously treated advanced hepatocellular carcinoma
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Ribociclib (Kisqali®)
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Formulary




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Commissioned in accordance with NICE TA496 for the treatment of previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer.
Commissioned by the CDF in accordance with NICE TA687 for treating hormone receptor-positive, (HER2)-negative, locally advanced or metastatic breast cancer in adults - This indication will transition to NHSE on 29th June 2021
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NICE TA496: Ribociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer
NICE TA687: Ribociclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy
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Ruxolitinib (Jakavi®)
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Formulary



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Commissioned by NHS England in line with NICE TA386. BlueTeq is required for this indication from 16/12/2020
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NICE TA386: Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis
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Sorafenib (Nexavar®)
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Formulary




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Commissioned by NHS England in line with NICE TA474 and by CDF as per NICE TA535 and CDF policy.
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NICE TA474: Sorafenib for treating advanced hepatocellular carcinoma
NICE TA535: Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine
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Sunitinib (Sutent®)
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Formulary

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For use in line with NICE TA169, TA179 and TA449.
Blueteq prior approval required for the treatment of unresectable or metastatic neuroendocrine tumours of pancreatic origin with disease progression (TA449).
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NICE TA169: Sunitinib for the first-line treatment of advanced and/or metastatic renal cell carcinoma
NICE TA179: Sunitinib for the treatment of gastrointestinal stromal tumours
NICE TA449: Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
NICE TA178: Renal cell carcinoma (2nd line - not recommended)
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Tivozanib (Fotivda®)
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Formulary



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Commissioned by NHSE in accordance with NICE TA512.
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NICE TA512: Tivozanib for treating advanced renal cell carcinoma
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Trametinib (Mekinist®)
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Formulary




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Commissioned by NHS England in line with NICE TA396.
Commissioned by |CDF in line with CDF criteria and NICE TA544.
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NICE TA396: Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma
NICE TA544: Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma
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Vemurafenib (Zelboraf®)
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Formulary

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Commissioned by NHS England in line with NICE TA269.
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NICE TA269: vemurafenib for treating locally advanced or metastatic BRAF V600 mutation-positive malignant melanoma
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08.01.05 |
Taxanes |
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08.01.05 |
Topoisomerase I inhibitors |
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08.01.05 |
Monoclonal antibodies |
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.... |
Non Formulary Items |
Afatinib (Giotrif®)

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Non Formulary

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Not recommended by NICE TA 444 for locally advanced or metastatic squamous non-small-cell lung cancer after platinum-based chemotherapy |
NICE TA 444 Afatinib for treating advanced squamous non-small-cell lung cancer after platinum-based chemotherapy (terminated appraisal)
NICE TA 452: Ibrutinib for untreated chronic lymphocytic leukaemia without a 17p deletion or TP53 mutation (terminated appraisal)
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Alectinib

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Non Formulary

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Not recommended for previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer in accordance with NICE TA438 |
NICE TA438: Alectinib for previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer (terminated appraisal)
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Bosutinib (Bosulif®)

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Non Formulary

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Not recommended by NICE TA576 for untreated chronic myeloid leukaemia. |
NICE TA576: Bosutinib for untreated chronic myeloid leukaemia (terminated appraisal)
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Cabozantinib (Cometriq®)

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Non Formulary

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Not recommended in accordance with NICE TA582 |
NICE TA463: Cabozantinib for previously treated advanced renal cell carcinoma
NICE TA516: Cabozantinib for treating medullary thyroid cancer
NICE TA542: Cabozantinib for untreated advanced renal cell carcinoma
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Cobimetinib hemifumarate (Cotellic®)

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Non Formulary

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Not recommended by NICE TA414 for treating unresectable or metastatic melanoma in adults with a BRAF V600 mutation. |
NICE TA582:Cabozantinib for previously treated advanced hepatocellular carcinoma (terminated appraisal)
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Dabrafenib (Tafinlar®)

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Non Formulary

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Not recommended with trametinib for treating advanced metastatic BRAF V600E mutation-positive non-small-cell lung cancer as per NICE TA564. |
NICE TA564: Dabrafenib with trametinib for treating advanced metastatic BRAF V600E mutation-positive non-small-cell lung cancer (terminated appraisal)
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Everolimus (Votubia®)

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Non Formulary

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Commissioned by NHS England via specialist centres only for:
renal angiomyolipoma associated with tubular sclerosis subependymal giantcell astrocytoma (SEGA) associated with tuberous sclerosis complex |
Clinical Commissioning Policy 16066/P: Everolimus for subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex
Clinical Commissioning Policy Statement B14X09: Everolimus for treatment of angiomyolipomas associated with tuberous sclerosis
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Ibrutinib (Imbruvica® )

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Non Formulary

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In accordance with NICE TA437, TA452 and T608. |
NICE TA437: Ibrutinib with bendamustine and rituximab for treating relapsed or refractory chronic lymphocytic leukaemia after systemic therapy
NICE TA452: Ibrutinib for untreated chronic lymphocytic leukaemia without a 17p deletion or TP53 mutation (terminated appraisal)
NICE TA608: Ibrutinib with rituximab for treating Waldenstrom’s macroglobulinaemia (terminated appraisal)
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Idelalisib (Zydelig® )

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Non Formulary

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Not commissioned in combination with ofatumumab in accordance with as per NICE TA469 or for treating refractory follicular lymphoma as per NICE 604 |
NICE TA604: Idelalisib for treating refractory follicular lymphoma
NICE TA 469: Idelalisib with ofatumumab for treating chronic lymphocytic leukaemia (terminated appraisal)
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Lapatinib (Tyverb®)

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Non Formulary

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Not recommomended by NICE |
NICE TA257: in combination with an aromatase inhibitor for HER2 positive metastatic breast cancer
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Sorafenib

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Non Formulary

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Not recommended as first or second line for advanced/metastatic renal cell cancer (as in NICE TA178).
Also not recommended in the treatment of advanced hepatocellular cancer with Child-Pugh gradeB liver impairment (NICE TA474). |
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Temsirolimus (Torisel®)

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Non Formulary

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NICE do not recommended temsirolimus as a first drug treatments for people with advanced and/or metastatic renal cell carcinoma. |
NICE TA178: temsirolimus for first-line treatment of advanced and/or metastatic renal cell carcinoma (not recommended)
NICE TA207: Mantle cell lymphoma (relapsed) - temsirolimus (terminated appraisal)
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Trametinib (Mekinist®)

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Non Formulary

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Not recommended with dabrafenib for treating advanced metastatic BRAF V600E mutation-positive non-small-cell lung cancer as per NICE TA564. |
NICE TA654: Dabrafenib with trametinib for treating advanced metastatic BRAF V600E mutation-positive non-small-cell lung cancer (terminated appraisal)
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Vandetanib (Caprelsa®)

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Non Formulary

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In line with NICE TA550 from 11 February 2019 no new patients will be able to receive the drug for treating aggressive and symptomatic medullary thyroid cancer. However, existing patients, registered prior to this date and receiving the drug via CDF funding will continue to receive the drug funded by the CDF until they and their NHS clinician consider it appropriate to stop. |
NICE TA550: Vandetanib for treating medullary thyroid cancer - not recommended
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Cytotoxic Drug
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Controlled Drug
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High Cost Medicine
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Cancer Drugs Fund
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NHS England |
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Homecare |
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CCG |
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Traffic Light Status Information
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