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 is available here.

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:

Drug Effective date for reimbursement Funding stream Approved Indications
Aibraterone 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.
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

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
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 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 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.

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 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 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
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.
Encorafenib and Binimetinib May 2019 PCRS Treatment of adult patients with advanced (unresectable or metastatic) melanoma with a BRAF V600 mutation
Enzalutamide August 2014 PCRS The treatment of adults with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel.
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.
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.

Idelalisib

Idelalisib with Rituximab

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.
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.

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 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

Mifamurtide March 2013 ODMS Treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection, in children, adolescents and young 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 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 Ipilimumab October 2017 ODMS

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

Nab-Paclitaxel February 2016 ODMS Abraxane® in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
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.
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 November 2017 PCRS

Maintenance treatment of adult patients with platinum -sensitive relapsed BRCA-mutated (germline and/or somatic) -

  • high grade serous epithelial ovarian cancer
  • fallopian tube cancer
  • primary peritoneal cancer

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)

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

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

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
Pixantrone August 2015 ODMS Monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin B-cell Lymphomas (NHL).
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
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.
Teysuno February 2013 PCRS Treatment of advanced gastric cancer when given in combination with cisplatin
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.
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.
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 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

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

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.

Last updated 6th July 2020