Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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639. To ask the Minister for Health if he will report on the availability of a drug (details supplied); and if he will make a statement on the matter. [49572/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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I thank the Deputy for clarifying that he wishes to ask about the use of Nivolumab (Opdivo®) for the treatment of oesophageal cancer.

The HSE is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.

The HSE robustly assesses applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.

There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.

The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Pharmacoeconomics (NCPE) for assessment. The NCPE may advise that a full Health Technology Assessment (HTA) is recommended, which would then be commissioned by the HSE as per the agreed processes.

The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications.

The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members. The pharmacoeconomic report will be reviewed by the HSE Drugs Group along with the outputs of commercial negotiations, and any patient group submission(s) received. The HSE Drugs Group will consider all of the evidence and make a recommendation to the HSE Executive Management Team.

The decision-making authority in the HSE is the HSE Executive Management Team. The HSE Executive Management Team decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new use of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013.

1. In terms of the specific details of the application(s) for pricing and reimbursement of Nivolumab (Opdivo®) received by the HSE (as of 10th October 2022) for licensed indications in oesophageal cancer are listed below. The HSE cannot make any comment on possible outcomes from the ongoing assessment processes.

- The HSE received an application for pricing / reimbursement of a new indication for Nivolumab (Opdivo®) monotherapy on the 14th December 2020 from BMS (the applicant) for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum-based combination chemotherapy.

- The HSE commissioned the Rapid Review process on the 15th December 2020. The assessment report was received by the HSE on the 13th January 2021. The NCPE did not recommend a full HTA and recommended this application not be considered for reimbursement at the submitted price. CPU engaged in commercial negotiations with the applicant in March 2021. The Rapid Review report?was reviewed by the HSE Drugs Group, along with the outputs of commercial negotiations. The HSE Drugs Group did not recommend in favour of reimbursement of Nivolumab (Opdivo®) for this indication at their September 2021 meeting.

2. The HSE received an application for pricing / reimbursement of a new indication for Nivolumab (Opdivo®) on the 30th June 2022 from BMS (the applicant) for Nivolumab (Opdivo®) 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 PD-L1 (programmed death ligand 1) expression ≥1%.

- The HSE commissioned the Rapid Review process on the 1st July 2022. The assessment report was submitted to the HSE on the 29th of July 2022. The NCPE recommended a full HTA for this indication, which was commissioned by the HSE on the 31st of August 2022. The HSE Drugs Group will consider all of the evidence and make a recommendation to the HSE Executive Management Team.

3. The HSE received an application for pricing-reimbursement of a new indication for Nivolumab (Opdivo®) on the 21st September 2021 from BMS (the applicant) for Nivolumab (Opdivo®) as monotherapy for the adjuvant treatment of adult patients with oesophageal, or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy.

- The HSE commissioned the Rapid Review process on the 21st September 2021. The assessment report was received by the HSE on the 20th October 2021. The NCPE recommended a full HTA for this indication, which was commissioned by the HSE on the 28th of October 2021. The HSE Drugs Group will consider all of the evidence and make a recommendation to the HSE Executive Management Team.

4. The HSE received an application for pricing / reimbursement of a new indication for Nivolumab (Opdivo®) on the 29th October 2021 from BMS (the applicant) for Nivolumab (Opdivo®) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first line treatment of adult patients with HER2 negative advanced or metastatic gastric, gastro oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥5.

- The HSE commissioned the Rapid Review process on the 1st November 2021. The assessment report was received by the HSE on the 29th November 2021. The NCPE recommended a full HTA for this indication, which was commissioned by the HSE on the 7th of December 2021. The HSE Drugs Group will consider all of the evidence and make a recommendation to the HSE Executive Management Team.

5. The HSE has not received an application (as of 10th October 2022) for ‘Nivolumab in combination with Ipilimumab indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%’.