GuidelinesOther guideline

Antineoplastic and Immunomodulating Agents

Platinum coordination compounds, Taxanes, Doxorubicin Cyclophosphamide Chlorambucil Melphalan Ifosfamide Busulfan Temozolomide Bacille Calmette-Guerin (BCG) Dacarbazine Methotrexate Pemetrexed Mercaptopurine Thioguanine Fludarabine Cytarabine Topical 5 Fluorouracil Capecitabine Capecitabine plus Gemcitabine Fluorouracil Vinblastine Vincristine Vinorelbine Vinorelbine (IV) Vinorelbine (oral) Docet

Platinum coordination compounds, Taxanes, Doxorubicin

Cyclophosphamide

Bacille Calmette-Guerin (BCG)

Topical 5 Fluorouracil

Capecitabine plus Gemcitabine

Vinorelbine (IV)

Vinorelbine (oral)

Docetaxel, Paclitaxel

Taxanes

Idarubicin

Epirubicin

Etoposide

All-trans retinoic acid (tretinoin)

Goserelin, Buserelin

Gonadotrophin-releasing hormone (GnRH) analogue

Flutamide, Bicalutamide

Anastrozole, Letrozole, Exemestane

Aromatase inhibitors

Antithymocyte immunoglobulin (ATG)

Mycophenolate mofetil (MMF)

Leflunomide

Antithymocyte immunoglobulin (ATG)

Tumour necrosis factor alpha inhibitors

Interferon beta

Basiliximab

Tacrolimus

Tacrolimus extended-release formulation

Azathioprine

ATC Code	L01
Medicine	Chemotherapy: Platinum coordination compounds, Taxanes, Doxorubicin, Cyclophosphamide
Indication	Uterine Cancer/ Endometrial Cancer (Advanced stage and recurrent)
NEMLC Recommendation	Not Approved
Review Indicators	Better quality data
Date Ratified	22 January 2015

ATC Code	L01AA01
Medicine	Cyclophosphamide
Indication	Adjuvant breast cancer
NEMLC Recommendation	Approved (Cyclophosphamide plus Doxorubicin (AC))
Review Indicators	n/a
Date Ratified	27 November 2008

ATC Code	L01AA01
Medicne	Cyclophosphamide
Indication	Adjuvant breast cancer
NEMLC Recommendation	Approved (Cyclophosphamide plus methotrexate plus fluorouracil (CMF))
Review Indicators	n/a
Date Ratified	27 November 2008

ATC Code	L01AA01
Medicine	Cyclophosphamide
Indication	Adjuvant breast cancer
NEMLC Recommendation	Approved (Fluorouracil plus Doxorubicin plus cyclophosphamide (FAC))
Review Indicators	n/a
Date Ratified	27 November 2008

ATC Code	L01AA02
Medicine	Chlorambucil
Indication	Chronic lymphocytic leukaemia, low grade non-Hodgkin’s lymphoma
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	11 July 2019

ATC Code	L01AA03
Medicine	Melphalan
Indication	Multiple myeloma (oral-remission induction combined with steroids in older) (IV – pre-autologous stem cell transplant in multiple myeloma and lymphomas)
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	11 July 2019

ATC Code	L01AA06
Medicine	Ifosfamide
Indication	Germ cell tumours, soft tissue sarcomas, salvage therapy in lymphomas pre-autologous stem cell transplant
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	11 July 2019

ATC Code	L01AB01
Medicine	Busulfan
Indication	Pre allogeneic and autologous stem cell transplant conditioning
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	11 July 2019

ATC Code	L01AX03
Medicine	Temozolomide
Indication	Glioblastoma multiforme
NEMLC Recommendation	Not Approved
Review Indicators	- Prospective RCTs demonstrating a significant increase in effect size - Significant price reduction
Date Ratified	25 July 2013

ATC Code	L03AX03
Medicine	Bacille Calmette-Guerin (BCG)
Indication	Bladder Cancer (non-muscle invasive)
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	25 February 2016

ATC Code	L01AX04
Medicine	Dacarbazine
Indication	Hodgkin’s lymphoma
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	11 July 2019

ATC Code	L01BA01
Medicine	Methotrexate
Indication	Adjuvant breast cancer
NEMLC Recommendation	Approved (Cyclophosphamide plus methotrexate plus fluorouracil (CMF))
Review Indicators	n/a
Date Ratified	27 November 2008

ATC Code	L01BA01
Medicine	Methotrexate
Indication	Crohn’s Disease
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	20 July 2023

ATC Code	L01BA04
Medicine	Pemetrexed
Indication	Lung mesothelioma
NEMLC Recommendation	Not Approved
Review Indicators	Price changes or access programmes
Date Ratified	27 November 2008

ATC Code	L01BA04
Medicine	Pemetrexed
Indication	Non-small cell lung cancer
NEMLC Recommendation	Not Approved
Review Indicators	- Evidence of superior efficacy versus cisplatin/ gemcitabine - Price reduction
Date Ratified	29 September 2011

ATC Code	L01BB02
Medicine	Mercaptopurine
Indication	Acute leukaemia
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	11 July 2019

ATC Code	L01BB02
Medicine	Mercaptopurine
Indication	Crohn’s Disease
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	20 July 2023

ATC Code	L01BB03
Medicine	Thioguanine
Indication	Acute leukaemia
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	11 July 2019

ATC Code	L01BB05
Medicine	Fludarabine
Indication	Chronic lymphocytic leukaemia, non-Hodgkin’s lymphomas, pre-conditioning regimen for allogeneic stem cell transplant, AML salvage therapy
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	11 July 2019

Click here for the Cytarabine injection for intrathecal use May 2024 circular

ATC Code	L01BC01
Medicine	Cytarabine
Indication	Acute myeloid leukaemia (AML) and acute lymphoid leukaemia (ALL)
NEMLC Recommendation	Approved Cytarabine 100ml/ml Fresenius and Cytarabine 500mg/5ml are not recommended for use via the intrathecal route.
Review Indicators	n/a
Date Ratified	11 July 2019

ATC Code	L01BC02
Medicine	Topical 5 Fluorouracil
Indication	Actinic Keratosis
NEMLC Recommendation	Approved Approved as Historically Accepted Use
Review Indicators	n/a
Date Ratified	19 March 2020

ATC Code	L01BC06
Medicine	Capecitabine
Indication	Relapsed metastatic breast cancer (mBC) failing an anthracycline and a taxane
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	8 December 2020 (Previously reviewed 15 September 2016)

ATC Code	L01BC06
Medicine	Capecitabine
Indication	Metastatic colorectal – first-line
NEMLC Recommendation	Approved (as part of the XELOX regimen)
Review Indicators	- Availability of data for alternative oral fluoropyrimidines - Price increases not commensurate with approved SEP increases
Date Ratified	27 November 2008

ATC Code	L01BC06
Medicine	Capecitabine
Indication	First-line therapy for advanced stomach/ gastro-oesophageal junction cancer
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	27 July 2014

ATC Code	L01BC06/ L01BC05
Medicine	Capecitabine plus gemcitabine
Indication	Adjuvant chemotherapy of fully resected potentially curable pancreatic adenocarcinoma)
NEMLC Recommendation	Approved - Only for fully resected patients
Review Indicators	New adjuvant chemotherapy data in patients with R0 or R1 resected adenocarcinoma of the pancreas
Date Ratified	6 December 2018

ATC Code	L01BC52
Medicine	Fluorouracil
Indication	Adjuvant breast cancer
NEMLC Recommendation	Approved (Cyclophosphamide plus methotrexate plus fluoro-uracil (CMF))
Review Indicators	n/a
Date Ratified	27 November 2008

ATC Code	L01BC52
Medicine	Fluorouracil
Indication	Adjuvant colorectal cancer
NEMLC Recommendation	Approved (Fluoro-uracil plus Doxorubicin plus cyclophosphamide (FAC))
Review Indicators	n/a
Date Ratified	27 November 2008

ATC Code	L01CA01
Medicine	Vinblastine
Indication	Relapsed metastatic breast cancer (mBC) failing an anthracycline and a taxane
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	15 September 2016

ATC Code	L01CA02
Medicine	Vincristine
Indication	General haematology and oncology
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	27 September 2018

ATC Code	L01CA04
Medicine	Vinorelbine
Indication	Adjuvant non-small cell lung cancer (NSCLC) – completely resected
NEMLC Recommendation	Approved To be used with cisplatin for adjuvant therapy for stage IIIA NSCLC but not stage IB or stage II
Review Indicators	New evidence of efficacy of adjuvant therapy in NSCLC
Date Ratified	03 December 2009

ATC Code	L01CA04
Medicine	Vinorelbine (IV)
Indication	Relapsed metastatic breast cancer (mBC) failing an anthracycline and a taxane
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	15 September 2016

ATC Code	L01CA04
Medicine	Vinorelbine (oral)
Indication	Relapsed metastatic breast cancer (mBC) failing an anthracycline and a taxane
NEMLC Recommendation	Not Approved
Review Indicators	- Price similar to IV - Evidence of clinical superiority
Date Ratified	15 September 2016

ATC Code	L01CD
Medicine	Taxanes: Docetaxel, Paclitaxel
Indication	Adjuvant breast cancer
NEMLC Recommendation	Approved Approved for patients with high grade, node positive ER negative disease
Review Indicators	n/a
Date Ratified	23 August 2012

ATC Code	L01CD01
Medicine	Paclitaxel
Indication	Neoadjuvant/ recurrent/ metastatic head and neck cancer
NEMLC Recommendation	Not Approved
Review Indicators	n/a
Date Ratified	27 July 2014

ATC Code	L01CD01
Medicine	Paclitaxel
Indication	First-line chemotherapy in advanced non-small cell lung cancer (NSCLC)
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	22 January 2015

ATC Code	L01CD01
Medicine	Paclitaxel
Indication	Metastatic cervical carcinoma
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	11 July 2019

ATC Code	L01CD
Medicine	Taxanes
Indication	Metastatic breast cancer – first- and second-line
NEMLC Recommendation	Approved
Review Indicators	Change in the price of taxanes, specifically docetaxel
Date Ratified	16 September 2010

ATC Code	L01CD02
Medicine	Docetaxel
Indication	Squamous cell carcinoma of head and neck
NEMLC Recommendation	Approved Approved for patients with good performance status and adequate follow-up used in combination with cisplatin plus 5-fluoro-uracil
Review Indicators	None
Date Ratified	25 July 2013

ATC Code	L01CD02
Medicine	Docetaxel
Indication	Second-line therapy for advanced non-small cell lung cancer (NSCLC) in selected patients with good performance status (ECOG 0;1)
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	22 January 2015

ATC Code	L01CD02
Medicine	Docetaxel
Indication	Castrate resistant prostate cancer
NEMLC Recommendation	Approved Docetaxel 75mg/m² intravenously 3 times weekly plus prednisone 10mg orally, for 6 cycles
Review Indicators	Reduction in cost and availability of 3rd generation ARBs e.g. enzalutamide and CYP17 inhibitors e.g. abiraterone
Date Ratified	11 July 2019

ATC Code	L01CD02
Medicine	Docetaxel
Indication	Patients with hormone sensitive prostate cancer (HSPC)
NEMLC Recommendation	Approved For patients with high volume disease: defined as the presence of visceral metastases or ≥4 bone lesions with ≥1 beyond the vertebral bodies and pelvis
Review Indicators	New evidence
Date Ratified	30 January 2020

ATC Code	L01DB01
Medicine	Doxorubicin
Indication	Adjuvant breast cancer
NEMLC Recommendation	Approved (Doxorubicin plus cyclophosphamide (AC))
Review Indicators	None
Date Ratified	27 November 2008

ATC Code	L01DB01
Medicine	Doxorubicin
Indication	Adjuvant breast cancer
NEMLC Recommendation	Approved (Fluorouracil plus Doxorubicin plus cyclophosphamide (FAC))
Review Indicators	None
Date Ratified	27 November 2008

ATC Code	L01DB02
Medicine	Daunorubicin
Indication	Acute myeloid leukaemia (AML) and acute lymphoid leukaemia (ALL)
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	11 July 2019

ATC Code	L01DB06
Medicine	Idarubicin
Indication	Acute Myeloid Leukaemia
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	10 December 2015

ATC Code	L01DB07
Medicine	Mitoxantrone
Indication	General oncology
NEMLC Recommendation	Approved Indications for consideration: Advanced stage carcinomas, paediatric relapsed acute lymphoblastic leukaemia (ALL), paediatric acute myeloid leukaemia (AML)
Review Indicators	None
Date Ratified	30 June 2016

ATC Code	L01DB03
Medicine	Epirubicin
Indication	Advanced stage or metastatic oesophageal junction and gastric carcinoma
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	10 December 2015

ATC Code	L01DC01
Medicine	Bleomycin
Indication	Hodgkin’s, Kaposi, Germ cell tumours, Pleuradhesis
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	27 September 2018

ATC Code	L01DC03
Medicine	Mitomycin C
Indication	Bladder cancer
NEMLC Recommendation	Not Approved
Review Indicators	None
Date Ratified	25 February 2016

ATC Code	L01DC03
Medicine	Mitomycin C
Indication	Relapsed metastatic breast cancer (mBC) failing an anthracycline and a taxane
NEMLC Recommendation	Not Approved
Review Indicators	None
Date Ratified	15 September 2016

ATC Code	L01FA01
Medicine	Rituximab
Indication	CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma: first- line
NEMLC Recommendation	Approved For treatment in diffuse large B-cell non-Hodgkin’s lymphoma (DLBCL) patients except those with International Prognostic Index (IPI) of 0
Review Indicators	New anti-CD20 monoclonal antibodies, more data and international consensus statements in FL patients, rituximab price changes
Date Ratified	23 August 2012

ATC Code	L01FA01
Medicine	Rituximab
Indication	Rheumatoid Arthritis patient’s refractory to synthetic DMARDs
NEMLC Recommendation	Approved For patients with refractory RA, who have ailed ≥ 3 DMARDs taken for ≥ 6 months (in accordance with algorithm)
Review Indicators	Evidence of harm
Date Ratified	5 July 2018

ATC Code	L01FA01
Medicine	Rituximab
Indication	Refractory lupus nephritis
NEMLC Recommendation	Approved – Special Access - Special Access may be granted on recommendation by the PTC - Used as per NEMLC-approved treatment algorithm - Use must be monitored and managed by PTCs through a registry. Clinical outcomes to be shared with the National registry database for biological therapy
Review Indicators	- Changes in evidence of efficacy/safety - Change in cost
Date Ratified	11 April 2019

ATC Code	L01FA01
Medicine	Rituximab
Indication	CD20 positive indolent B-cell non - Hodgkin’s lymphoma
NEMLC Recommendation	Not Approved For treatment in indolent B - Cell non-Hodgkin’s lymphomas
Review Indicators	- Further evidence review - Price reduction
Date Ratified	24 June 2021

ATC Code	L01FA01
Medicine	Rituximab
Indication	B-cell indolent non-Hodgkin Lymphoma
NEMLC Recommendation	Not Approved Although the addition of rituximab to standard chemotherapy has shown to improve response rates and progression free survival in patients with indolent lymphomas, it is deemed to unaffordable at its current price in this indication
Review Indicators	Price (For reference price: refer to Rituximab review and cost effectiveness analysis documents)
Date Ratified	23 June 2022

ATC Code	L01XA01
Medicine	Cisplatin
Indication	Adjuvant small cell lung cancer
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	27 November 2008

ATC Code	L01XA01
Medicine	Cisplatin
Indication	Adjuvant lung cancer
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	27 November 2008

ATC Code	L01XA01
Medicine	Cisplatin
Indication	Relapsed metastatic breast cancer (mBC) failing an anthracycline and a taxane
NEMLC Recommendation	Approved To be used with gemcitabine
Review Indicators	None
Date Ratified	15 September 2016

ATC Code	L01XA01
Medicine	Cisplatin
Indication	Radio-sensitizer in cervical cancer
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	6 December 2018

ATC Code	L01XA01
Medicine	Cisplatin
Indication	Advanced/ Metastatic: Various cancers
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	11 July 2019

ATC Code	L01XA01
Medicine	Cisplatin
Indication	Adjuvant/ Neoadjuvant: Various cancers
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	11 July 2019

ATC Code	L01XA02
Medicine	Carboplatin
Indication	Adjuvant lung cancer
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	27 November 2008

ATC Code	L01XA02
Medicine	Etoposide
Indication	Adjuvant small cell lung cancer
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	27 November 2008

ATC Code	L01XA03
Medicine	Oxaliplatin
Indication	Adjuvant colorectal
NEMLC Recommendation	Not Approved
Review Indicators	Mature published data
Date Ratified	27 November 2008

ATC Code	L01XA03
Medicine	Oxaliplatin
Indication	First or second-line metastatic colorectal cancer
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	10 December 2015

ATC Code	L01XC07
Medicine	Bevacizumab
Indication	Sub-retinal neovascular membranes and non-resolving macular oedema
NEMLC Recommendation	Approved (off label indication)
Review Indicators	None
Date Ratified	10 December 2015

ATC Code	L01XE01
Medicine	Imatinib
Indication	Chronic phase of chronic myeloid leukaemia
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	27 March 2014

ATC Code	L01XE01
Medicine	Imatinib
Indication	Gastrointestinal Stromal Tumours (GIST) - adjuvant therapy
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	25 June 2015

ATC Code	L01XE01
Medicine	Imatinib
Indication	Approved
NEMLC Recommendation	Gastrointestinal Stromal Tumours (GIST) - metastatic therapy
Review Indicators	None
Date Ratified	25 June 2015

ATC Code	L01XE08
Medicine	Nilotinib
Indication	Chronic Myeloid Leukaemia in patients resistant or intolerant to imatinib
NEMLC Recommendation	Approved
Review Indicators	- Longer term follow-up of nilotinib versus imatinib showing clinical benefits in the first line - Reduction in cost or availability of nilotinib generics
Date Ratified	22 January 2015

ATC Code	L01XC03
Medicine	Trastuzumab
Indication	Adjuvant treatment for early stage HER-2 positive breast cancer, 6 month regimen
NEMLC Recommendation	Approved Regimen: administered 3 weekly for a period of 6 months
Review Indicators	New evidence
Date Ratified	5 December 2019 (previously reviewed: 29 June 2017)

ATC Code	L01XG01
Medicine	Bortezomib
Indication	Transplant eligible multiple myeloma
NEMLC Recommendation	Approved – Special Access Data to ensure rational use to be submitted for all patients by PTCs to the National Department of Health
Review Indicators	- New evidence - Price
Date Ratified	25 March 2021

ATC Code	L01XX02
Medicine	Asparaginase
Indication	Acute lymphoblastic leukaemia (ALL)
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	11 July 2019

ATC Code	L01XX14
Medicine	All-trans retinoic acid (tretinoin)
Indication	Acute promyelocytic leukaemia
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	27 September 2018

ATC Code	L01XX19
Medicine	Irinotecan
Indication	Adjuvant colorectal
NEMLC Recommendation	Not Approved
Review Indicators	Evidence to show benefit
Date Ratified	27 November 2008

ATC Code	L01XX19
Medicine	Irinotecan
Indication	First- or second-line metastatic colorectal cancer
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	10 December 2015

ATC Code	L02AE03
Medicine	Gonadotrophin-releasing hormone (GnRH) analogue: Goserelin, Buserelin
Indication	Endometriosis
NEMLC Recommendation	Approved for use in the following situations: - For endometriosis-associated infertility prior to in vitro fertilisation (IVF) - For medical management in situations in which a trial of adequate analgesia or the use of combined oral contraceptives is unsuccessful
Review Indicators	- New evidence based on Goserelin vs. Placebo - Large comparative trials with COCs for both “trial of hormone therapy” and for relief of pain - Comparisons with new agents such as aromatase inhibitors
Date Ratified	13 March 2008

ATC Code	L02AE03
Medicine	Gonadotrophin-releasing hormone (GnRH) analogue
Indication	Precocious puberty
NEMLC Recommendation	Approved Choice of GnRH analogue will depend on best tender price
Review Indicators	Change in price or registration of new agents which are cheaper or more efficacious, or both - New safety concerns
Date Ratified	13 March 2008

ATC Code	L02AE03
Medicine	Gonadotrophin-releasing hormone (GnRH) analogue
Indication	As bridging therapy until orchiectomy
NEMLC Recommendation	Approved Only Approved as bridging therapy - not long-term management
Review Indicators	Price
Date Ratified	25 February 2016

ATC Code	L02AE03
Medicine	Goserelin
Indication	Hormone receptor positive breast cancer in premenopausal women
NEMLC Recommendation	Not Approved
Review Indicators	None
Date Ratified	10 December 2015

ATC Code	L02BA01
Medicine	Tamoxifen
Indication	Adjuvant breast cancer
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	27 November 2008

ATC Code	L02BA01
Medicine	Tamoxifen
Indication	Metastatic breast cancer
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	27 November 2008

ATC Code	L02BA03
Medicine	Fulvestrant
Indication	Advanced Breast Cancer (ABC) Hormone Receptor Positive (HR+) [C50] – third or fourth line therapy
NEMLC Recommendation	Not Approved This status will be reconsidered if offered/contract price is comparable or lower than that of standard chemotherapy
Review Indicators	Price
Date Ratified	25 March 2021

ATC Code	L02BB01/ L02BB03
Medicine	Anti-androgens: Flutamide, Bicalutamide
Indication	Advanced prostate cancer
NEMLC Recommendation	Not Approved Orchiectomy preferred
Review Indicators	None
Date Ratified	29 October 2012

ATC Code	L01BC05
Medicine	Gemcitabine
Indication	Pancreatic cancer (unresectable or metastatic cancer)
NEMLC Recommendation	Approved Monotherapy in patients with locally advanced unresectable or metastatic cancer and have an ECOG performance status of 0-2 and a bilirubin level lower than 1.5 x ULN
Review Indicators	New evidence of efficacy and safety in this patient population group
Date Ratified	12 October 2023 (Previously reviewed 29 October 2012)

ATC Code	L01BC05
Medicine	Gemcitabine
Indication	First-line chemotherapy in advanced non-small cell lung cancer (NSCLC) in patients intolerant to paclitaxel
NEMLC Recommendation	Approved Approved in patients intolerant to paclitaxel
Review Indicators	n/a
Date Ratified	22 January 2015

ATC Code	L01BC05
Medicine	Gemcitabine
Indication	Relapsed metastatic breast cancer (mBC) failing an anthracycline and a taxane
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	15 September 2016

ATC Code	L02BG03 & L02BG04
Medicine	Aromatase inhibitors: Anastrozole & Letrozole
Indication	Adjuvant breast cancer
NEMLC Recommendation	Approved for use in women with confirmed intolerance to tamoxifen, i.e. thrombo-embolic disease or endometrial hyperplasia (proven on ultrasound) Choice of aromatase inhibitor will depend on best tender price.
Review Indicators	- Long term data - Price parity with tamoxifen - Further developments regarding tamoxifen pharmacogenetics
Date Ratified	27 November 2008 (Updated 27 February 2025)

ATC Code	L02BG06
Medicine	Aromatase inhibitors: Exemestane
Indication	Adjuvant breast cancer, with disease progression on either anastrozole or letrozole.
NEMLC Recommendation	Approved for use in women with confirmed intolerance to tamoxifen, i.e. thrombo-embolic disease or endometrial hyperplasia (proven on ultrasound) and who have experienced disease progression on either anastrozole or letrozole.
Review Indicators	- Long term data - Price parity with tamoxifen - Further developments regarding tamoxifen pharmacogenetics
Date Ratified	27 November 2008 (Updated 27 February 2025)

ATC Code	L02BG03 & L02BG04
Medicine	Aromatase inhibitors: Anastrozole & Letrozole
Indication	Metastatic breast cancer
NEMLC Recommendation	Approved for use as second-line therapy after tamoxifen in advanced breast cancer in postmenopausal women who do not have visceral metastases. Choice of aromatase inhibitor will depend on best tender price.
Review Indicators	- Long term data - Price parity with tamoxifen - Further developments regarding tamoxifen pharmacogenetics
Date Ratified	September 2010 (Updated 27 February 2025)

ATC Code	L02BG06
Medicine	Aromatase inhibitors Exemestane
Indication	Metastatic breast cancer, with disease progression on either anastrozole or letrozole.
NEMLC Recommendation	Approved for use as second-line therapy after tamoxifen in advanced breast cancer in postmenopausal women who do not have visceral metastases; and who have experienced disease progression on either anastrozole or letrozole.
Review Indicators	- Long term data - Price parity with tamoxifen - Further developments regarding tamoxifen pharmacogenetics
Date Ratified	September 2010 (Updated 27 February 2025)

ATC Code	L03AA02
Medicine	Filgrastim
Indication	Febrile neutropaenia
NEMLC Recommendation	Approved under the following conditions: - Patients must have had 3 days of appropriate antimicrobial therapy without resolution of infection - Filgrastim can be used up to a maximum of 5 days with a daily review of white cell count (WCC). Failure to respond must prompt further investigation of neutropenia
Review Indicators	None
Date Ratified	27 November 2008

ATC Code	L03AA02
Medicine	Filgrastim
Indication	ARV-induced neutropenia
NEMLC Recommendation	Not Approved This does not preclude the use of filgrastim in the management of febrile neutropenia (see above) in HIV infected patients
Review Indicators	RCTs, with improved clinically relevant outcomes, especially mortality
Date Ratified	27 November 2008

ATC Code	L03AA02
Medicine	Filgrastim
Indication	Prophylactic use in children with high-risk acute lymphoblastic leukaemia (HR-ALL)
NEMLC Recommendation	Not Approved
Review Indicators	- The emergence of evidence that routine use of GCSF improves outcomes in HR-ALL - A significant reduction in the price of GCS
Date Ratified	3 December 2009

ATC Code	L03AA02
Medicine	Filgrastim
Indication	Peripheral blood stem cell harvesting in autologous stem cell harvesting in haematological malignancies
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	24 July 2014

ATC Code	L03AA02
Medicine	Filgrastim
Indication	Chemotherapy-induced febrile neutropenia
NEMLC Recommendation	Approved for secondary prophylaxis in curable cancers requiring full dosing on-schedule, i.e. Hodgkins and germ cell tumours
Review Indicators	n/a
Date Ratified	9 February 2012

ATC Code	L03AA02
Medicine	Filgrastim
Indication	Chemotherapy-induced febrile neutropenia
NEMLC Recommendation	Not Approved for primary prophylaxis as no overall survival benefit and limited mortality benefit has been shown
Review Indicators	n/a
Date Ratified	9 February 2012

ATC Code	L04AA04
Medicine	Antithymocyte immunoglobulin ATG
Indication	Induction therapy in high risk renal transplantation recipients
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	29 June 2017

ATC Code	L04AA10
Medicine	Sirolimus
Indication	Renal transplant
NEMLC Recommendation	Approved for use only patients with biopsy- confirmed calcineurin inhibitor toxicity because of deteriorating kidney function (i.e. in patients at ongoing risk of acute rejection with no overt proteinuria and preserved GFR > 40mL/min) where mycophenolate mofetil is contra-indicated
Review Indicators	Reduction in cost or new efficacy data
Date Ratified	16 September 2010

ATC Code	L04AA06
Medicine	Mycophenolate mofetil (MMF)
Indication	Lupus Nephritis
NEMLC Recommendation	Approved for both the induction and maintenance phases of treatment of lupus nephritis
Review Indicators	None
Date Ratified	18 September 2014

ATC Code	L04AA06
Medicine	Mycophenolate mofetil (MMF)
Indication	Prevention of acute rejection post-renal transplantation
NEMLC Recommendation	Approved for prevention of acute rejection post-renal transplantation
Review Indicators	Reduction in cost or new efficacy data
Date Ratified	16 September 2010

ATC Code	L04AA13
Medicine	Leflunomide
Indication	As add-on therapy in Rheumatoid Arthritis
NEMLC Recommendation	Approved - Special Access Special access be permitted on recommendation by PTC for intolerance to standard therapy
Review Indicators	New efficacy data or reduction in cost
Date Ratified	31 March 2016

ATC Code	L04AA13
Medicine	Leflunomide
Indication	Rheumatoid Arthritis where patients are intolerant or have contraindications to methotrexate and sulphasalazine
NEMLC Recommendation	Approved Only for use in patients with intolerance to standard DMARD therapy (methotrexate or sulphasalazine)
Review Indicators	- New evidence - Safety concerns - Price change
Date Ratified	12 April 2018

ATC Code	L04AA04
Medicine	Antithymocyte immunoglobulin (ATG)
Indication	Aplastic Anaemia
NEMLC Recommendation	Approved (in combination with ciclosporin and corticosteroids)
Review Indicators	None
Date Ratified	10 December 2015

ATC Code	L04AA31
Medicine	Teriflunomide
Indication	Relapsing remitting multiple sclerosis
NEMLC Recommendation	Approved Provided offered price is comparable or lower than beta interferon
Review Indicators	- New evidence of clear benefit of efficacy of newer classes - Price changes
Date Ratified	19 March 2020

ATC Code	L04AB
Medicine	Tumour necrosis factor alpha inhibitors - Adalimumab - Infliximab
Indication	Fistulising Crohn’s Disease
NEMLC Recommendation	Approved For patients who are refractory to conventional therapy. (Both agents are to be made available however Committee recommends adalimumab as the preferred first agent. Therapeutic dose monitoring should be conducted, and agents switched if appropriate – refer to appendix: TDM of adalimumab and infliximab for fistulising Crohn’s disease).
Review Indicators	n/a
Date Ratified	14 March 2024

ATC Code	L04AB
Medicine	Tumour necrosis factor alpha inhibitors - Adalimumab - Infliximab
Indication	Luminal Crohn’s Disease
NEMLC Recommendation	Approved For patients who are refractory to conventional therapy. (Both agents are to be made available however adalimumab recommended as the preferred first agent. Therapeutic dose monitoring should be conducted, and agents switched if appropriate – refer to appendix: TDM of adalimumab and infliximab for Crohn’s disease).
Review Indicators	n/a
Date Ratified	16 May 2024

ATC Code	L04AB02
Medicine	Infliximab
Indication	Rheumatoid Arthritis
NEMLC Recommendation	Not Approved
Review Indicators	- Demonstration in randomized trials of reduction in clinically significant endpoints, e.g. hospitalizations, joint replacements, etc. - Evidence of sustained, clinically relevant improvement upon withdrawal of infliximab - A significant reduction in the price of the medicine
Date Ratified	13 March 2008

ATC Code	L04AB04
Medicine	TNF inhibitor: Adalimumab
Indication	Juvenile Idiopathic Arthritis (with or without uveitis)
NEMLC Recommendation	Approved Approved for use in patients who are refractory to conventional disease modifying anti-rheumatic drugs (DMARDs)
Review Indicators	- Change in price of adalimumab comparable to other TNF-inhibitors
Date Ratified	20 July 2023

ATC Code	L03AB07/ L03AB08
Medicine	Interferon beta
Indication	Relapsing remitting multiple sclerosis
NEMLC Recommendation	Approved
Review Indicators	- New evidence of clear benefit of efficacy of newer classes - Price
Date Ratified	30 January 2020

ATC Code	L04AC02
Medicine	Basiliximab
Indication	Induction therapy in low risk patient’s renal transplantation recipients
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	29 June 2017

ATC Code	L04AD01
Medicine	Ciclosporin
Indication	Organ transplantation
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	20 September 2007

ATC Code	L04AD02
Medicine	Tacrolimus
Indication	- Primary therapy in high immunological risk renal allograft recipients - Renal allograft recipients on ciclosporin who experience steroid resistant acute allograft rejection
NEMLC Recommendation	Approved
Review Indicators	None
Date Ratified	29 June 2017

ATC Code	L04AD02
Medicine	Tacrolimus extended-release formulation
Indication	- Primary therapy in high immunological risk renal allograft recipients - Renal allograft recipients on ciclosporin who experience steroid resistant acute allograft rejection
NEMLC Recommendation	Not Approved
Review Indicators	Price reduction
Date Ratified	20 July 2023

ATC Code	L04AX01
Medicine	Azathioprine
Indication	Crohn’s Disease
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	20 July 2023

ATC Code	L04AX01
Medicine	Azathioprine
Indication	Ulcerative colitis
NEMLC Recommendation	Approved
Review Indicators	n/a
Date Ratified	16 May 2024

ATC Code	L04AX02
Medicine	Thalidomide
Indication	Multiple myeloma
NEMLC Recommendation	Not Approved (Decision will only be applied July 2024 when new HP04-2024 contract takes effect, currently still available on contract HP04- 2022)
Review Indicators	- Price changes in comparison to lenalidomide - Changes in evidence of safety compared to lenalidomide.
Date Ratified	8 December 2022 (Previously reviewed June 2019)

ATC Code	L04AX04
Medicine	Lenalidomide
Indication	Newly diagnosed multiple myeloma
NEMLC Recommendation	Approved
Review Indicators	Price changes in comparison
Date Ratified	8 December 2022