Cancer Drugs Approved for Reimbursement

 

The demand for the introduction of new cancer drugs is growing internationally and Ireland is no different.  These drugs tend to be expensive and their introduction presents a particular challenge during difficult budgetary circumstances.  Several new cancer drugs have been introduced in Ireland and it is hoped that these drugs will improve outcomes for patients.

Since 2012 the HSE has put a robust assessment process in place for new medicines, including cancer medicines. The intention of this process is to ensure that the HSE can provide access to as many new and existing medicines as possible, at sustainable prices and from within the resources which government and taxpayers have provided. The NCCP Technology Review Committee makes recommendations on reimbursement to the HSE Drug Committee.

More information on the assessment process for new cancer drugs

As each new drug is approved for use, a regimen is made available to ensure national consistency for clinicians in the use of the drug.

The following drugs are approved for reimbursement:

Last updated 04/09/2023

Drug Effective date for reimbursement Funding stream Approved Indications
Abiraterone June 2012 PCRS Community Schemes (PCRS) Treatment of mCRPC which has  progressed on or after a docetaxel-based chemotherapy regimen
Abiraterone May 2015 PCRS Treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
Acalabrutinib (tablets) July 2023 PCRS

As monotherapy for the treatment of previously untreated CLL in the presence of 17p deletion or TP53 mutation in adult patients unsuitable for chemoimmunotherapy.

As monotherapy for the treatment of adult patients with CLL who have received at least one prior therapy.

Acalabrutinib

(capsules)

October 2021 PCRS

As monotherapy for the treatment of previously untreated CLL in the presence of 17p deletion or TP53 mutation in adult patients unsuitable for chemoimmunotherapy

As monotherapy for the treatment of adult patients with CLL who have received at least one prior therapy

Afatinib January 2014 PCRS Afatinib as monotherapy is indicated for the treatment of EGFR TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s)
Aflibercept April 2014 Individual hospital budgets In combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy is approved for use in adults with metastatic colorectal cancer that is resistant to or has progressed after an oxoliplatin-containing regimen.

Alectinib

November 2017 PCRS Treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib

Alectinib

June 2019 PCRS As monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC

Apalutamide

April 2023 PCRS For the treatment of patients with metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy.

Apalutamide

August 2021 PCRS Treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease
Atezolizumab March 2022 ODMS

Atezolizumab  in combination with carboplatin and etoposide is indicated for first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Atezolizumab March 2022 ODMS

In combination with nab-PACLitaxel for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥
1% and who have not received prior chemotherapy for metastatic disease

Atezolizumab July 2021 ODMS

Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are considered cisplatin ineligible and whose tumours have a PD-L1 expression ≥5%

Atezolizumab October 2021 ODMS

As monotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PDL1
expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltratingimmune cells (IC) and who do not have EGFR mutant or ALK-positive
NSCLC

Atezolizumab March 2021 ODMS

Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) after prior platinum-containing chemotherapy

Atezolizumab March 2019 ODMS

Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy.

Avelumab

May 2019 ODMS Treatment of adult patients with metastatic Merkel cell carcinoma who have received 1 or more lines of chemotherapy for metastatic disease
Avelumab September 2022 ODMS

First-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum based chemotherapy[HD1] 

Axicabtagene ciloleucel

April 2022 ODMS For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy
Axitinib March 2013 PCRS Treatment of adult patients with advanced RCC after failure, on a previous line of therapy, i.e. treatment with SUNItinib, or a cytokine.
Blinatumomab May 2022 ODMS For the treatment of paediatric patients aged 1 years or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor acute lymphoblastic leukaemia (ALL) as part of consolidation therapy.
Blinatumomab February 2021 ODMS As monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%
Blinatumomab May 2019 ODMS Treatment of adult patients with relapsed or refractory B cell precursor (BCP) Philadelphia chromosome negative acute lymphoblastic leukaemia (ALL) who have received no prior salvage treatment for relapsed/refractory (R/R) disease and are considered eligible for transplant (i.e. as a bridge-to-transplant)
Blinatumomab May 2019

ODMS As monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation
Bosutinib January 2014 PCRS Treatment of adult patients with chronic phase, accelerated phase, and blast phase Ph+CML previously treated with one or more TKI(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Brentuximab vedotin December 2022 ODMS Treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy.
Brentuximab vedotin December 2022 ODMS Treatment of adult patients with CD30+ Hodgkins Lymphoma (HL) at increased risk of relapse or progression following an autologous haematopoietic stem cell transplant (ASCT).
Brentuximab vedotin December 2022 ODMS In combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL).
Brentuximab vedotin August 2014 ODMS

The treatment of adults with

-         Relapsed or refractory CD30 positive Hodgkin Lymphoma who have

o        failed at least one autologous stem cell transplant (ASCT) or

o        at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.

- Relapsed or refractory systemic anaplastic large cell lymphoma.

Brentuximab vedotin and Bendamustine October 2019 ODMS

Treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL)

Brentuximab vedotin and etoposide, CISplatin, cytarabine  (ESHAP) September 2019 ODMS

Treatment of adult patients with relapsed/refractory CD30+ Hodgkin’s lymphoma.

Brentuximab vedotin, and CARBOplatin, etoposide, ifosfamide (ICE) September 2019 ODMS

Treatment of adult patients with relapsed/refractory CD30+ Hodgkin’s lymphoma.

Brigatinib October 2020 PCRS Monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor
Brigatinib June 2019 PCRS For the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib
Cabazitaxel March 2013 ODMS Treatment of mHRPC previously treated with docetaxel containing regimen.
Cabozantinib January 2019 PCRS Treatment of advanced renal cell carcinoma (RCC) in adults following prior VEGF targeted therapy
Carfilzomib October 2020 ODMS In combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
Carfilzomib September 2018 ODMS Carfilzomib,  lenalidomide and dexamethasone therapy is indicated  for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
Ceritinib December 2016 PCRS Treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib
Cobimetinib April 2018 PCRS Cobimetinib in combination with vemurafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Crizotinib June 2014 PCRS For the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Dabrafenib September 2014 PCRS Treatment of adult patients with unresectable or metastatic melanoma with the BRAF V600 mutation
Dacomitinib November 2019 PCRS Monotherapy, for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations

Daratumumab

June 2022 ODMS Daratumumab in combination with bortezomib, thalidomide and dexamethasone for the treatment of adults with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant

Daratumumab

October 2020 ODMS Daratumumab in combination with bortezomib and dexamethasone in adult patients with multiple myeloma who have received at least one prior therapy

Daratumumab

April 2018 ODMS As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy

Darolutamide

March 2022 PCRS Treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease
Decitabine January 2014 ODMS Treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary AML, according to the WHO classification, who are not candidates for standard induction chemotherapy.

Durvalumab

Durvalumab 10mg/kg Monotherapy

Durvalumab 1500mg Monotherapy

February 2021 ODMS As monotherapy for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 ≥1% on tumour cells and whose disease has not progressed following platinum-based chemo-radiation therapy (CRT).
Encorafenib and Binimetinib May 2019 PCRS Treatment of adult patients with advanced (unresectable or metastatic) melanoma with a BRAF V600 mutation
Enzalutamide January 2016 PCRS Treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) in whom chemotherapy is not yet clinically indicated.
Enzalutamide August 2014 PCRS The treatment of adults with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel.
Entrectinib June 2022 PCRS As monotherapy for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors
EriBULin January 2014 ODMS Treatment of LABC or MBC which has progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.
Fedratinib December 2022 PCRS

For the treatment of disease-related splenomegaly or symptoms in adult patients with:primary myelofibrosis (PMF),post polycythaemia vera myelofibrosis (PVMF) or post essential thrombocythaemia myelofibrosis (ET MF) who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib

Gemtuzumab ozogamicin

November 2020 ODMS As combination therapy with DAUNOrubicin and cytarabine for the treatment of patients age 15 years and above with previously untreated, de novo CD33 positive Acute Myeloid Leukemia (AML), except acute promyelocytic leukaemia
Ibrutinib August 2016 PCRS

Treatment of adult patients with chronic lymphocytic leukaemia who have received
at least one prior therapy, or in first line in the presence of 17p deletion or TP53
mutation in patients unsuitable for chemo‐immunotherapy.

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.

Treatment of adult patients with relapsed or refractory mantle cell lymphoma.

Idelalisib

Idelalisib with Ofatumumab

January 2017 PCRS

Monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.

In combination with riTUXimab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
 who have received at least one prior therapy
or
 as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.

In combination with Ofatumumab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
 who have received at least one prior therapy
or
 as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.

Inotuzumab May 2019 ODMS Monotherapy for the treatment of adults with relapsed or refractory CD22- positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+ ) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI)
Ipilimumab May 2012 ODMS Treatment of adults with advanced (unresectable or metastatic) malignant melanoma.
Ixazomib December 2018 PCRS

Ixazomib in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy

Lenvatinib May 2021 PCRS

As monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy

Lenvatinib January 2016 PCRS Treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine.
Lorlatinib October 2019 PCRS

As monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), following disease progression on

(i)   alectinib or ceritinib as the first ALK-targeted treatment

or

(ii) crizotinib and at least one other ALK-targeted treatment

Lorlatinib September 2022 PCRS As monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously not treated with an ALK inhibitor.
Midostaurin October 2021 PCRS

Midostaurin is indicated in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive

Mifamurtide March 2013 ODMS Treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection, in children, adolescents and young adults.
Mogamulizumab May 2023 ODMS As monotherapy for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
nab-PAClitaxel February 2016 ODMS nab-PACLitaxel in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Neratinib March 2022 PCRS Extended adjuvant treatment of adults with early-stage hormone receptorpositive,HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.
Nintedanib Therapy February 2017 PCRS In combination with docetaxel for the treatment of adult patients with locally advanced, metastatic of stage IIIB or IV, or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy.
Niraparib April 2023 PCRS As  monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
Niraparib March 2021 PCRS As monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in response (complete response or partial response) to platinum-based chemotherapy
Nivolumab September 2023 ODMS For the adjuvant treatment of oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy.
Nivolumab July 2023 ODMS In combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell programmed death ligand 1 (PD-L1) expression ≥1%.

Nivolumab 240mg

Nivolumab 480mg

February 2021 ODMS As monotherapy for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
Nivolumab May 2018 ODMS

As monotherapy for the treatment of squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy

Nivolumab September 2018 ODMS

As monotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults

 

Nivolumab 240mg 

Nivolumab 480mg

 October 2017  ODMS

As monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults

As monotherapy for the treatment of advanced renal cell carcinoma (RCC) after prior therapy in adults

As monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin

Nivolumab Ipilimumab June 2023 ODMS

In combination with ipilimumab for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer (MSI-HmCRC) after prior fluoropyrimidine-based combination chemotherapy.

Nivolumab Ipilimumab April 2023 ODMS

Nivolumab combination with ipilimumab for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma

Nivolumab Ipilimumab March 2022 ODMS

Nivolumab and ipilimumab plus PEMEtrexed and CISplatin therapy for the first-line treatment of metastatic non-squamous non-small cell lung
cancer (NSCLC) in adults whose tumours have no sensitising EGFR mutation or ALK translocation.

Nivolumab Ipilimumab March 2022 ODMS

Nivolumab and ipilimumab plus PEMEtrexed and CARBOplatin therapy for the first-line treatment of metastatic non-squamous non-small cell lung
cancer (NSCLC) in adults whose tumours have no sensitising EGFR mutation or ALK translocation

Nivolumab Ipilimumab March 2022 ODMS

Nivolumab and ipilimumab plus CARBOplatin and PACLItacel therapy for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in adults whose tumours have no sensitising EGFR mutation or ALK translocation.

Nivolumab Ipilimumab February 2021 ODMS

Nivolumab in combination with ipilimumab for the first-line treatment of adult patients with intermediate-/poor-risk advanced renal cell carcinoma

Nivolumab Ipilimumab October 2017 ODMS

Nivolumab in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults

Obinutuzumab August 2015 ODMS In combination with chlorambucil for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy.
Obinutuzumab November 2017 ODMS

Obinutuzumab in combination with bendamustine is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.

Obinutuzumab November 2017 ODMS

Obinutuzumab maintenance therapy is indicated in patients with follicular lymphoma (FL) who have responded to induction treatment with obinutuzumab and bendamustine or have stable disease

Obinutuzumab May 2019 ODMS

Obinutuzumab, in combination with chemotherapy, followed by maintenance treatment in patients achieving a response, for previously untreated advanced follicular lymphoma (FL).

Olaparib Tablets September 2023 ODMS

In combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.

Olaparib Tablets March 2023 PCRS

As monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.

Olaparib Tablets December 2020 PCRS

Maintenance treatment of adult patients withadvanced (FIGO stages III and IV) BRCA1/2‐mutated (germline and/or somatic)

high grade  epithelial ovarian cancer
fallopian tube cancer
primary peritoneal cancer
who are in response (complete response or partial response) following completion of first‐line platinum based chemotherapy.

Olaparib Tablets November 2017 PCRS

As monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA-mutated ovarian cancer (including fallopian tube or primary peritoneal) who are in response (complete response or partial response) to platinum-based chemotherapy

Osimertinib July 2020 PCRS

Treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC)

Osimertinib October 2020 PCRS

First-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations

Palbociclib June 2018 PCRS

Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor

Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in women who have received prior endocrine therapy

Pembrolizumab 200mg Monotherapy

Pembrolizumab 400mg Monotherapy

June 2016

 

 ODMS

As monotherapy for the treatment of adults with unresectable or advanced melanoma

For the treatment of ipilimumab-refractory patients with unresectable or advanced metastatic melanoma

Pembrolizumab 200mg Monotherapy

Pembrolizumab 400mg Monotherapy

April 2018

 

ODMS

 

First-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.

Pembrolizumab 200mg Monotherapy

Pembrolizumab 400mg Monotherapy

November 2018

 

ODMS

 

As monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who are transplant-ineligible and have failed brentuximab vedotin

Pembrolizumab

June 2023

ODMS

Pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy, for the first line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with CPS≥10

Pembrolizumab 200mg

Pembrolizumab 400mg

 April 2023

ODMS

 First-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in adults.

Pembrolizumab 200mg Monotherapy

Pembrolizumab 400mg Monotherapy

 February 2022

ODMS

 As monotherapy for the treatment of adult patients with relapsed or refractory (R/R) classical
Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) or following
at least two prior therapies when ASCT is not a treatment option

Pembrolizumab 200mg

December 2021

ODMS

As monotherapy for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1

Pembrolizumab 400mg

December 2021

ODMS

As monotherapy for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1

Pembrolizumab

December 2021

ODMS

Pembrolizumab is indicated, in combination with CARBOplatin and 5-fluorouracil, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1.

Pembrolizumab

December 2021

ODMS

Pembrolizumab is indicated, in combination with CISplatin and 5-fluorouracil, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1.

Pembrolizumab 200mg

Pembrolizumab 400mg

 May 2021

ODMS

 As monotherapy for the adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection

Pembrolizumab

February 2021

ODMS

In combination with pemetrexed and carboplatin chemotherapy, is indicated for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.

Pembrolizumab

February 2021

ODMS

In combination with pemetrexed and cisplatin chemotherapy, is indicated for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.

Pembrolizumab 200mg

Pembrolizumab 400mg

 

February 2021

ODMS

As monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy

Pembrolizumab 200mg

Pembrolizumab 400mg

February 2021

ODMS

As monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy whose tumours express PD-L1 with a combined positive score (CPS) ≥10

Pembrolizumab

February 2021

ODMS

In combination with carboplatin and paclitaxel for the first-line treatment of patients with metastatic squamous Non-Small Cell Lung Cancer (NSCLC)

Pertuzumab February 2014 ODMS Treatment of adult patients with HER2- positive MBC or  locally recurrent unresectable breast cancer, who have not received previous anti- HER2 therapy or chemotherapy for their metastatic disease
Pertuzumab July 2020 ODMS Pertuzumab in combination with trastuzumab and
chemotherapy for the neoadjuvant treatment of adult
patients with HER2-positive, locally advanced,
inflammatory, or early stage breast cancer at high risk of
recurrence
Pertuzumab/ trastuzumab (Phesgo®) December 2022 ODMS Use in combination with chemotherapy as: neo-adjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
Pertuzumab/ trastuzumab (Phesgo®) December 2022 ODMS Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
Pixantrone August 2015 ODMS Monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin B-cell Lymphomas (NHL).
Polatuzumab Vedotin December 2021 ODMS In combination with bendamustine and riTUXimab for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant
Pomalidomide February 2016 PCRS In combination with dexamethasone in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy
Pomalidomide December 2022 PCRS Pomalidomide in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior treatment including lenalidomide.
Ponatinib December 2016 PCRS

Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation

Treatment of adult patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Radium 223 May 2015 ODMS Treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases
Regorafenib April 2015 PCRS Treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy
Treatment of adult patients Unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.
Ribociclib February 2019 PCRS

Treatment of postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer as initial endocrine-based therapy in combination with an aromatase inhibitor.

Ruxolitinib February 2014 PCRS

The treatment of disease-related splenomegaly or symptoms in adult patients with:

  • Primary myelofibrosis (chronic idiopathic myelofibrosis)
  • Post polycythaemia vera myelofibrosis
  • Post essential thrombocythaemia myelofibrosis
Siltuximab August 2015 ODMS Treatment of adult patients with Multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpes virus 8 (HHV-8) negative.
Talazoparib May 2021 PCRS Talazoparib is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy or be considered unsuitable for endocrine-based therapy.
Teysuno February 2013 PCRS Treatment of advanced gastric cancer when given in combination with cisplatin
Tisagenlecleucel July 2021 ODMS Treatment of paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse
Tisagenlecleucel July 2021 ODMS Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy
Tivozanib October 2019 PCRS Tivozanib for the first line treatment of adult patients with advanced renalcell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior
treatment with cytokine therapy for advanced RCC
Trametinib April 2018 PCRS  Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Trametinib December 2021 PCRS Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.
Trastuzumab Emtansine August 2015 ODMS

Treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.

Patients should have either:

  • Received prior therapy for locally advanced or metastatic disease, or
  • Developed disease recurrence during or within six months of completing adjuvant therapy.
Trastuzumab Emtansine December 2021 ODMS

As a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy

Trifluridine and Tipracil (Lonsurf®) Therapy February 2017 PCRS

Treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.

Vandetanib June 2014 PCRS The treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
Vemurafenib March 2013 PCRS Treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma
Venetoclax March 2022 PCRS In combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)
Venetoclax July 2020 PCRS  In combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy
Venetoclax December 2018 PCRS

Treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor

Treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor

Vismodegib November 2017 PCRS

Treatment of adult patients with Symptomatic metastatic basal cell carcinoma (MBCC),

Treatment of adult patients with Local advanced basal cell carcinoma inappropriate for surgery or radiotherapy.

Vxyeos liposomal® (DAUNOrubicin and cytarabine)

Induction Therapy

Consolidation Therapy

04 February 2021 ODMS

For the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)

 Zanubrutinib

 September 2023  PCRS

As monotherapy

  • for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who are treatment naïve and have del(17p) and/or TP53-mutated positive disease

for the treatment of adult patients with chronic lymphocytic leukaemia with relapsed and/or refractory disease following at least one line of prior therapy

Zanubrutinib

May 2022 PCRS

For the treatment of for adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy, or as first-line treatment for patients unsuitable for chemo-immunotherapy.