Latest NCPE Advice

Ketoconazole (Ketoconazole HRA®). HTA ID: 21046

Assessment Status Rapid Review Complete
HTA ID 21046
Drug Ketoconazole
Brand Ketoconazole HRA®
Indication For the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.
Assessment Process
Rapid review commissioned 26/10/2021
Rapid review completed 13/12/2021
Rapid review outcome A full HTA is not recommended. The NCPE recommends that ketoconazole not be considered for reimbursement at the submitted price*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE has approved reimbursement following confidential price negotiations, December 2022.

Lacosamide (Vimpat ®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Lacosamide
Brand Vimpat®
Indication As monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.  The Applicant is seeking reimbursement for an extension to the product license to cover children (≥4 years of age) and adolescents (≤ 15 years of age).
Assessment Process
Rapid review commissioned 11/09/2017
Rapid review completed 31/10/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended at the submitted price

Lanadelumab (Takhzyro®)

Assessment Status Assessment process complete
Drug Lanadelumab
Brand Takhzyro®
Indication For routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
Assessment Process
Rapid review commissioned 19/03/2019
Rapid review completed 23/05/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of lanadelumab compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 28/05/2019
Pre-submission consultation with Applicant 20/06/2019
Full submission received from Applicant 04/10/2019
Preliminary review sent to Applicant 14/02/2020
NCPE assessment re-commenced 13/03/2020
Factual accuracy sent to Applicant 22/05/2020
NCPE assessment re-commenced 03/06/2020
NCPE assessment completed 26/06/2020
NCPE assessment outcome The NCPE recommends that lanadelumab not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations September 2021

 

Lapatinib (Tyverb®)

Assessment Status Assessment process complete
HTA ID -
Drug Lapatinib
Brand Tyverb®
Indication For the treatment of women with previously treated advanced or metastatic HER2 positive breast cancer.
Assessment Process
Full pharmacoeconomic assessment commissioned by HSE 03/12/2007
NCPE assessment completed 28/01/2008
NCPE assessment outcome Reimbursement recommended.

Lapatinib could be considered cost-effective in Ireland. However in view of the uncertainty surrounding the ICER, we (NCPE) suggest conditional reimbursement under the High Tech Drugs scheme.

Technical Summary

Latanoprost/Timolol (Fixapost®). HTA ID: 21053

Assessment Status Rapid Review Complete
HTA ID 21053
Drug Latanoprost/Timolol
Brand Fixapost®
Indication In adults (including the elderly) for the reduction of intraocular pressure in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta‐blockers or prostaglandin analogues.
Assessment Process
Rapid review commissioned 16/11/2021
Rapid review completed 06/12/2021
Rapid review outcome A full HTA is not recommended. The NCPE recommends that Fixapost® not be considered for reimbursement at the submitted price*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods Act) 2013.

The HSE has approved reimbursement April 2022.

Ledipasvir/sofosbuvir (Harvoni®)

Assessment Status Assessment process complete
HTA ID -
Drug Ledipasvir/sofosbuvir
Brand Harvoni®
Indication For the treatment of Chronic Hepatitis C (CHC) infection (Genotye 1, 3 and 4)  in adults.
Assessment Process
Rapid review commissioned 14/11/2014
Rapid review completed 18/12/2014
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 18/03/2015
NCPE assessment completed 20/11/2015
NCPE assessment outcome Reimbursement Recommended for Genotype 1 and 4.

Technical Summary

Lenvatinib (Kisplyx®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Lenvatinib
Brand Kisplyx®
Indication In combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.
Assessment Process
Rapid review commissioned 05/05/2017
Rapid review completed 18/05/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended

The company has not submitted a HTA dossier to the NCPE therefore the cost effectiveness of the technology could not be proven.

Lenvatinib (Kisplyx®). HTA ID: 22057

Assessment Status Rapid Review Complete
HTA ID 22057
Drug Lenvatinib
Brand Kisplyx®
Indication For the treatment of adults with advanced renal cell carcinoma, in combination with pembrolizumab, as first-line treatment
Assessment Process
Rapid review commissioned 15/08/2022
Rapid review completed 22/09/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of lenvatinib in combination with pembrolizumab for first-line treatment of patients with advanced RCC compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

Lenvatinib (Lenvima®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Lenvatinib
Brand Lenvima®
Indication For the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine.
Assessment Process
Rapid review commissioned 05/05/2015
Rapid review completed 09/07/2015
Rapid review outcome Full pharmacoeconomic assessment recommended at the submitted price.

The HSE has approved reimbursement following confidential price negotiations. January 2016.

Lenvatinib (Lenvima®) for HCC

Assessment Status Rapid Review Complete
HTA ID -
Drug Lenvatinib
Brand Lenvima®
Indication As monotherapy for the treatment of adult patients with advanced or unresectable HCC who have received no prior systemic therapy.
Assessment Process
Rapid review commissioned 07/08/2018
Rapid review completed 16/08/2018
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of lenvatinib compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

The HSE has approved reimbursement following confidential price negotiations May 2021.

Lesinurad (Zurampic®)

Assessment Status Assessment process complete
HTA ID -
Drug Lesinurad
Brand Zurampic®
Indication For the treatment of hyperuricaemia in adult patients with gout who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor.
Assessment Process
Rapid review commissioned 15/03/2017
Rapid review completed 20/03/2017
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended
Full pharmacoeconomic assessment commissioned by HSE 29/03/2017
Pre-submission consultation with Applicant 22/05/2017
Full submission received from Applicant 07/06/2018
Preliminary review sent to Applicant 18/07/2018
NCPE assessment re-commenced 15/08/2018
Factual accuracy sent to Applicant 15/11/2018
NCPE assessment re-commenced 21/11/2018
NCPE assessment completed 06/12/2018
NCPE assessment outcome The NCPE recommends that lesinurad not be considered for reimbursement*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Technical Summary

Letermovir (Prevymis®)

Assessment Status Assessment process complete
HTA ID -
Drug Letermovir
Brand Prevymis®
Indication For the prophylaxis of cytomegalovirus (CMV) reactivation or disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).
Assessment Process
Rapid review commissioned 12/03/2018
Rapid review completed 10/05/2018
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 29/05/2018
Pre-submission consultation with Applicant 09/07/2018
Full submission received from Applicant 02/04/2019
Preliminary review sent to Applicant 29/08/2019
NCPE assessment re-commenced 27/09/2019
Follow-up to preliminary review sent to Applicant 25/11/2019
NCPE assessment re-commenced 05/12/2019
Factual accuracy sent to Applicant 24/04/2020
NCPE assessment re-commenced 01/05/2020
NCPE assessment completed 19/05/2020
NCPE assessment outcome The NCPE recommends that letermovir be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations March 2021.

Levodopa 20mg/ml + carbidopa monohydrate 5mg intestinal gel (Duodopa®)

Assessment Status Assessment process complete
HTA ID -
Drug Levodopa 20mg/ml + carbidopa monohydrate 5mg intestinal gel
Brand Duodopa®
Indication For the treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. A positive test of the clinical response to Duodopa® administered via a temporary nasoduodenal tube is required before a permanent tube is inserted.
Assessment Process
Rapid review commissioned 13/03/2013
Rapid review completed 16/04/2013
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 25/06/2018
Pre-submission consultation with Applicant 05/07/2018
Full submission received from Applicant 10/09/2018
Preliminary review sent to Applicant 05/12/2018
NCPE assessment re-commenced 14/01/2019
Follow-up to preliminary review sent to Applicant 30/01/2019
NCPE assessment re-commenced 15/02/2019
Factual accuracy sent to Applicant 19/03/2019
NCPE assessment re-commenced 02/04/2019
NCPE assessment completed 14/06/2019
NCPE assessment outcome The NCPE recommends that levodopa and carbidopa intestinal gel (Duodopa®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*. 

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Technical Summary

Levodopa/carbidopa/entacapone intestinal gel (Lecigon®). HTA ID: 21068

Assessment Status Rapid Review Complete
HTA ID 21068
Drug Levodopa/carbidopa/entacapone intestinal gel
Brand Lecigon®
Indication For the treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available oral combinations of Parkinson’s medicinal products have not given satisfactory results.
Assessment Process
Rapid review commissioned 20/12/2021
Rapid review completed 17/02/2022
Rapid review outcome A full HTA is not recommended. The NCPE recommends that levodopa/carbidopa/entacapone intestinal gel not be considered for reimbursement at the submitted price*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE has approved reimbursement following confidential price negotiations-November 2022.

Levofloxacin (Quinsair®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Levofloxacin
Brand Quinsair®
Indication For the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with Cystic Fibrosis.
Assessment Process
Rapid review commissioned 10/02/2016
Rapid review completed 01/03/2016
Rapid review outcome Full pharmacoeconomic assessment recommended at the submitted price.

The HSE has approved reimbursement following confidential price negotiations.

Levonorgestrel Intrauterine System (Levosert®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Levonorgestrel Intrauterine System
Brand Levosert®
Indication For contraception and for the treatment of heavy menstrual bleeding.
Assessment Process
Rapid review commissioned 28/08/2019
Rapid review completed 23/10/2019
Rapid review outcome A full HTA is not recommended. The NCPE recommends that levonorgestrel-IUS (Levosert®) be considered for reimbursement.

Levonorgestrel intrauterine system LNG-IUS (Jaydess®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Levonorgestrel intrauterine system LNG-IUS
Brand Jaydess®
Indication For contraception for up to three years.
Assessment Process
Rapid review commissioned 07/03/2013
Rapid review completed 25/03/2013
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Lidocaine 5% plasters (Versatis®)

Assessment Status Assessment process complete
HTA ID -
Drug Lidocaine 5% plasters
Brand Versatis®
Indication For the symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN).
Assessment Process
Rapid review commissioned 09/09/2010
Rapid review completed 22/10/2010
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 10/06/2015
NCPE assessment completed 24/09/2015
NCPE assessment outcome Reimbursement Not Recommended

The NCPE concludes that the cost effectiveness of the 5% lidocaine plaster has not been demonstrated.

Technical Summary

Linaclotide (Constella®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Linaclotide
Brand Constella®
Indication For the treatment of symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults.
Assessment Process
Rapid review commissioned 28/05/2013
Rapid review completed 28/06/2013
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Linaclotide (Constella®) is to be reimbursed under the Community Drugs Schemes subject to conditions.

Linagliptin (Trajenta®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Linagliptin
Brand Trajenta®
Indication For treatment of type 2 diabetes mellitus to improve glycaemic control in adults, as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment, as combination therapy in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control, in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Assessment Process
Rapid review commissioned 18/08/2011
Rapid review completed 06/09/2011
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Lipegfilgrastim (Lonquex®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Lipegfilgrastim
Brand Lonquex®
Indication For reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Assessment Process
Rapid review commissioned 20/08/2013
Rapid review completed 20/09/2013
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Lipegfilgrastim (Lonquex®). HTA ID: 23080

Assessment Status Rapid Review Complete
HTA ID 23080
Drug Lipegfilgrastim
Brand Lonquex®
Indication Lipegfilgrastim is indicated in adults and in children two years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Lipegfilgrastim is currently reimbursed on High Tech Drug Arrangement for use in adults and reimbursement is sought for children two years of age and older.
Assessment Process
Rapid review commissioned 21/12/2023
Rapid review completed 27/02/2024
Rapid review outcome A full HTA is not recommended. The NCPE recommends that lipegfilgrastim not be considered for reimbursement at the submitted price*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Liposomal daunorubicin and cytarabine (Vyxeos Liposomal®)

Assessment Status Assessment process complete
HTA ID -
Drug Liposomal daunorubicin and cytarabine
Brand Vyxeos Liposomal®
Indication For the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes.
Assessment Process
Rapid review commissioned 28/09/2018
Rapid review completed 08/11/2018
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 14/11/2018
Pre-submission consultation with Applicant 15/01/2019
Full submission received from Applicant 31/05/2019
Preliminary review sent to Applicant 02/10/2019
NCPE assessment re-commenced 06/11/2019
Factual accuracy sent to Applicant 28/02/2020
NCPE assessment re-commenced 09/03/2020
NCPE assessment completed 16/04/2020
NCPE assessment outcome The NCPE recommends that Liposomal daunorubicin and cytarabine (Vyxeos Liposomal®) not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations February 2021.

Liquid Paraffin Ointment (VitA-POS Opthalmic®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Liquid Paraffin Ointment
Brand VitA-POS Opthalmic®
Indication For the treatment of mild to moderate form of dry eye.
Assessment Process
Rapid review commissioned 15/01/2014
Rapid review completed 27/01/2014
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Liraglutide (Saxenda®) in adolescent patients. HTA ID: 24001

Assessment Status Rapid Review Complete
HTA ID 24001
Drug Liraglutide
Brand Saxenda®
Indication Liraglutide is indicated as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with: • obesity (body mass index (BMI) corresponding to ≥30 kg/m2 for adults by international cut-off points) and • body weight above 60 kg*
Assessment Process
Rapid review commissioned 05/01/2024
Rapid review completed 09/02/2024
Rapid review outcome A full HTA is not recommended. The NCPE recommends that liraglutide not be considered for reimbursement at the submitted price*.

*The Applicant is requesting reimbursement in a subgroup of the licensed population, namely:

Adolescent patients between the ages 12 to 16 years with a BMI greater than the 99.5th percentile and two or more of the following co-morbidities:

  • Uncontrolled metabolic complications.
  • Biomechanical complications requiring treatment or limited mobility.
  • Shortness of breath.
  • Significant psychosocial complications or concerns.

 

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Liraglutide (Saxenda®). HTA ID: 19039

Assessment Status Assessment process complete
HTA ID 19039
Drug Liraglutide
Brand Saxenda®
Indication As an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial body mass index (BMI) of ≥30kg/m2 (obese), or ≥27kg/m2 to <30kg/m2 (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea. The Applicant is seeking reimbursement in a subgroup of the licensed population, that is,  as an adjunct to a reduced calorie diet and increased physical activity for weight management in adult patients with an initial body mass index of ≥35kg/m2 with pre-diabetes and high risk of cardiovascular disease.
Assessment Process
Rapid review commissioned 18/09/2019
Rapid review completed 24/10/2019
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of liraglutide (Saxenda®) compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 29/10/2019
Pre-submission consultation with Applicant 12/11/2019
Full submission received from Applicant 08/06/2020
Preliminary review sent to Applicant 21/08/2020
NCPE assessment re-commenced 23/10/2020
Follow-up to preliminary review sent to Applicant 30/11/2020
NCPE assessment re-commenced 08/12/2020
Factual accuracy sent to Applicant 15/01/2021
NCPE assessment re-commenced 22/01/2021
NCPE assessment completed 09/02/2021
NCPE assessment outcome The NCPE recommends that liraglutide 3mg (Saxenda®) not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations January 2023.

Liraglutide (Victoza®)

Assessment Status Assessment process complete
HTA ID -
Drug Liraglutide
Brand Victoza®
Indication For treatment of adults with type 2 diabetes mellitus.
Assessment Process
Rapid review commissioned 01/09/2009
Rapid review completed 07/10/2009
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended
Full pharmacoeconomic assessment commissioned by HSE 26/10/2016
Pre-submission consultation with Applicant 21/02/2017
Full submission received from Applicant 29/08/2017
Preliminary review sent to Applicant 17/08/2018
NCPE assessment re-commenced 30/10/2018
Factual accuracy sent to Applicant 07/02/2019
NCPE assessment re-commenced 18/02/2019
NCPE assessment completed 07/03/2019
NCPE assessment outcome The NCPE recommends that liraglutide (Victoza®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*. 

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013

Technical Summary

Lisdexamfetamine dimesylate (Tyvense®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Lisdexamfetamine dimesylate
Brand Tyvense®
Indication For Attention Deficit Hyperactivity Disorder in children aged 6 years and over when response to previous methylphenidate treatment is considered clinically inadequate.
Assessment Process
Rapid review commissioned 09/02/2013
Rapid review completed 28/02/2013
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Lomitapide (Lojuxta®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Lomitapide
Brand Lojuxta®
Indication As an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH).
Assessment Process
Rapid review commissioned 09/09/2014
Rapid review completed 15/09/2014
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.

The company has not submitted a HTA dossier to the NCPE therefore the cost effectiveness of the technology could not be proven.

Loncastuximab tesirine (Zynlonta®). HTA ID: 23053

Assessment Status Rapid Review Complete
HTA ID 23053
Drug Loncastuximab tesirine
Brand Zynlonta®
Indication Loncastuximab tesirine (Zynlonta®) is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.
Assessment Process
Rapid review commissioned 17/08/2023
Rapid review completed 01/09/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of loncastuximab tesirine compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.

Lorlatinib (Lorviqua®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Lorlatinib
Brand Lorviqua®
Indication 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.
Assessment Process
Rapid review outcome A full HTA is not recommended. The NCPE recommends that lorlatinib not be considered for reimbursement at the submitted price*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE has approved reimbursement following confidential price negotiations (October 2019).

Lorlatinib (Lorviqua®) for 1L ALK positive NSCLC. HTA ID: 21071

Assessment Status Rapid Review Complete
HTA ID 21071
Drug Lorlatinib
Brand Lorviqua®
Indication As 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.
Assessment Process
Rapid review commissioned 22/12/2021
Rapid review completed 13/01/2022
Rapid review outcome A full HTA is not recommended. The NCPE recommends that lorlatinib not be considered for reimbursement at the submitted price*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE has approved reimbursement following confidential price negotiations – October 2022.

Lornoxicam (Xefo®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Lornoxicam
Brand Xefo®
Indication For the short-term relief of acute mild to moderate pain and symptomatic relief of pain and inflammation in osteoarthritis and symptomatic relief of pain and inflammation in rheumatoid arthritis
Assessment Process
Rapid review commissioned 23/06/2011
Rapid review completed 07/07/2011
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Lotemax 0.5% eye drops suspension (Loteprednol)

Assessment Status Rapid Review Complete
HTA ID -
Drug Loteprednol
Brand Lotemax 0.5% eye drops suspension
Indication For treatment of post-operative inflammation following ocular surgery.
Assessment Process
Rapid review commissioned 15/11/2011
Rapid review completed 05/12/2011
Rapid review outcome Full Pharmacoeconomic Assessment Not Recommended

Loxapine inhalation powder (Adasuve®)

Assessment Status Rapid Review Complete
HTA ID -
Drug Loxapine inhalation powder
Brand Adasuve®
Indication For the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder.
Assessment Process
Rapid review commissioned 21/06/2016
Rapid review completed 28/07/2016
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.

Not considered cost-effective due to non-submission of full pharmacoeonomic evaluation.

Lutetium (177Lu) Oxodotreotide (Lutathera®)

Assessment Status Assessment process complete
HTA ID -
Drug Lutetium (177Lu) Oxodotreotide
Brand Lutathera®
Indication For the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor (SSTR) positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.
Assessment Process
Rapid review commissioned 23/10/2018
Rapid review completed 16/11/2018
Rapid review outcome Full Pharmacoeconomic Assessment Recommended.
Full pharmacoeconomic assessment commissioned by HSE 21/11/2018
Pre-submission consultation with Applicant 17/12/2018
Full submission received from Applicant 23/05/2019
Preliminary review sent to Applicant 04/10/2019
NCPE assessment re-commenced 01/11/2019
Follow-up to preliminary review sent to Applicant 22/11/2019
NCPE assessment re-commenced 02/12/2019
Factual accuracy sent to Applicant 10/01/2020
NCPE assessment re-commenced 20/01/2020
NCPE assessment completed 07/02/2020
NCPE assessment outcome The NCPE recommends that lutetium (177Lu) oxodotreotide (Lutathera®) not be considered for reimbursement*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Technical Summary

Plain English Summary

The HSE has approved reimbursement following confidential price negotiations February 2021.

Lutetium (177Lu) vipivotide tetraxetan (Pluvicto®). HTA ID: 23002

Assessment Status NCPE Assessment Process Complete
HTA ID 23002
Drug Lutetium (177Lu) vipivotide tetraxetan
Brand Pluvicto®
Indication Lutetium (177Lu) vipivotide tetraxetan in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition for the treatment of adult patients with progressive prostate specific membrane antigen (PSMA) positive metastatic castration resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy.
Assessment Process
Rapid review commissioned 09/01/2023
Rapid review completed 10/02/2023
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of Lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 01/03/2023
Pre-submission consultation with Applicant 09/05/2023
Full submission received from Applicant 19/07/2023
Preliminary review sent to Applicant 06/02/2024
NCPE assessment re-commenced 05/03/2024
Factual accuracy sent to Applicant 11/07/2024
NCPE assessment re-commenced 19/07/2024
NCPE assessment completed 12/08/2024
NCPE assessment outcome The NCPE recommends that 177Lu vipivotide tetraxetan (Pluvicto®) not be considered for reimbursement *.

Plain English Summary

Technical Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013

Melatonin (Slenyto®). HTA ID: 22048

Assessment Status Rapid Review Complete
HTA ID 22048
Drug Melatonin
Brand Slenyto®
Indication For the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome (SMS), where sleep hygiene measures have been insufficient.
Assessment Process
Rapid review commissioned 05/07/2022
Rapid review completed 09/08/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of prolonged release melatonin (Slenyto®) compared with the current standard of care.

Melphalan flufenamide (Pepaxti®). HTA ID: 23067

Assessment Status Rapid Review Complete
HTA ID 23067
Drug Melphalan flufenamide
Brand Pepaxti®
Indication Melphalan flufenamide (Pepaxti®) is indicated in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least three years from transplantation.
Assessment Process
Rapid review commissioned 09/11/2023
Rapid review completed 15/12/2023
Rapid review outcome A full HTA is not recommended. On the basis of current evidence, the NCPE recommends that melphalan flufenamide in combination with dexamethasone not be considered for reimbursement *.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Methyl aminolevulinate (Metvix®). HTA ID: 19049

Assessment Status Rapid Review Complete
HTA ID 19049
Drug Methyl aminolevulinate
Brand Metvix®
Indication For the treatment of: thin or non-hyperkeratotic and non-pigmented actinic keratoses on the face and scalp, when other therapies are considered less appropriate; superficial and/or nodular basal cell carcinoma unsuitable for other available therapies; and squamous cell carcinoma in situ (Bowen´s disease) when surgical excision is considered less appropriate.
Assessment Process
Rapid review commissioned 06/11/2019
Rapid review completed 18/12/2019
Rapid review outcome A full HTA is not recommended. The NCPE recommends that methyl aminolevulinate (Metvix®) not be considered for reimbursement at the submitted price*.

* This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Midostaurin (Rydapt®) for AML

Assessment Status Assessment Process Complete
HTA ID -
Drug Midostaurin
Brand Rydapt®
Indication 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.
Assessment Process
Rapid review commissioned 13/08/2018
Rapid review completed 10/09/2018
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of midostaurin compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 19/09/2018
Pre-submission consultation with Applicant 15/10/2018
Full submission received from Applicant 20/12/2018
Preliminary review sent to Applicant 25/06/2019
NCPE assessment re-commenced 12/08/2019
Factual accuracy sent to Applicant 24/10/2019
NCPE assessment re-commenced 11/11/2019
NCPE assessment completed 04/12/2019
NCPE assessment outcome The NCPE recommends midostaurin (Rydapt®) for AML not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments. *

Technical Summary

Plain English Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE has approved reimbursement following confidential price negotiations October 2021

Migalastat (Galafold®)

Assessment Status Assessment Process Complete
HTA ID -
Drug Migalastat
Brand Galafold®
Indication For the long term treatment of adult and adolescent patients 16 years and older with a confirmed diagnosis of Fabry disease and who have an amenable mutation.
Assessment Process
Rapid review commissioned 14/07/2016
Rapid review completed 18/08/2016
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full submission received from Applicant 03/01/2017
NCPE assessment completed 01/06/2017
NCPE assessment outcome Reimbursement Recommended

Technical Summary

The NCPE recommends reimbursement of Migalastat (Galafold®) subject to the continuing availability of a patient access scheme.

Mirikizumab (Omvoh®). HTA ID: 23040

Assessment Status Rapid Review Complete
HTA ID 23040
Drug Mirikizumab
Brand Omvoh®
Indication Mirikizumab (Omvoh®) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
Assessment Process
Rapid review commissioned 19/07/2023
Rapid review completed 24/08/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that mirikizumab not be considered for reimbursement at the submitted price*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Molnupiravir (Lagevrio®). HTA ID: 21060

Assessment Status Rapid Review Complete
HTA ID 21060
Drug Molnupiravir
Brand Lagevrio®
Indication For the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
Assessment Process
Rapid review commissioned 30/11/2021
Rapid review completed 24/12/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of molnupiravir compared with the current standard of care on the basis of the proposed price.

Mometasone furoate plus olopatadine (Ryaltris®). HTA ID: 21051

Assessment Status Rapid Review Complete
HTA ID 21051
Drug Mometasone furoate plus olopatadine
Brand Ryaltris®
Indication Is indicated for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis in adults and adolescents aged 12 years and older.
Assessment Process
Rapid review commissioned 15/11/2021
Rapid review completed 22/12/2021
Rapid review outcome A full HTA is not recommended. The NCPE recommends that mometasone furoate plus olopatadine (Ryaltris®) not be considered for reimbursement at the submitted price*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE has approved reimbursement May 2022.

Naloxone (Nyxoid®) intranasal spray. HTA ID: 20019

Assessment Status Rapid Review Complete
HTA ID 20019
Drug Naloxone
Brand Nyxoid®
Indication Intranasal spray is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings. Nyxoid® is indicated in adults and adolescents aged 14 years and over. Nyxoid® is not a substitute for emergency medical care.  
Assessment Process
Rapid review commissioned 14/04/2020
Rapid review completed 12/05/2020
Rapid review outcome A full HTA is not recommended. The NCPE recommends that naloxone (Nyxoid®) intranasal spray be considered for reimbursement*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE has approved reimbursement March 2021.

Naltrexone / bupropion (Mysimba®)

Assessment Status Assessment Process Complete
HTA ID -
Drug Naltrexone / bupropion
Brand Mysimba®
Indication Is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥ 18 years) with a BMI of ≥30 kg/m2 (obese) or ≥27 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities.
Assessment Process
Rapid review commissioned 12/03/2017
Rapid review completed 28/03/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 29/03/2017
Pre-submission consultation with Applicant 29/05/2017
Full submission received from Applicant 06/11/2017
Preliminary review sent to Applicant 05/01/2018
NCPE assessment re-commenced 01/02/2018
Factual accuracy sent to Applicant 24/04/2018
NCPE assessment re-commenced 01/05/2018
NCPE assessment completed 09/05/2018
NCPE assessment outcome The NCPE recommends that naltrexone/bupropion (Mysimba ®) should not be considered for reimbursement.

Technical Summary

This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

Neratinib (Nerlynx®). HTA ID: 19057

Assessment Status Assessment Process Complete
HTA ID 19057
Drug Neratinib
Brand Nerlynx®
Indication For the extended adjuvant treatment of adults with early-stage hormone receptor-positive, HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.
Assessment Process
Rapid review commissioned 18/12/2019
Rapid review completed 30/01/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of neratinib compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 05/02/2020
Pre-submission consultation with Applicant 21/04/2020
Full submission received from Applicant 04/08/2020
Preliminary review sent to Applicant 17/12/2020
NCPE assessment re-commenced 26/01/2021
Factual accuracy sent to Applicant 16/04/2021
NCPE assessment re-commenced 22/04/2021
NCPE assessment completed 12/05/2021
NCPE assessment outcome The NCPE recommends that neratinib (Nerlynx®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE has approved reimbursement following confidential price negotiations March 2022.

 

Nintedanib (Ofev®). HTA ID: 20034

Assessment Status Assessment Process Complete
HTA ID 20034
Drug Nintedanib
Brand Ofev®
Indication For the treatment of other progressive, chronic fibrosing interstitial lung diseases (PF-ILD) in adults.
Assessment Process
Rapid review commissioned 17/07/2020
Rapid review completed 28/08/2020
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of nintedanib compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 01/09/2020
Pre-submission consultation with Applicant 05/10/2020
Full submission received from Applicant 10/11/2020
Preliminary review sent to Applicant 16/03/2021
NCPE assessment re-commenced 15/04/2021
Follow-up to preliminary review sent to Applicant 21/04/2021
NCPE assessment re-commenced 30/04/2021
Factual accuracy sent to Applicant 28/05/2021
NCPE assessment re-commenced 04/06/2021
NCPE assessment completed 24/06/2021
NCPE assessment outcome The NCPE recommends that nintedanib (Ofev®) not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.