Denis Naughten
Question:1752. Deputy Denis Naughten asked the Minister for Health when adjuvant abemaciclib will be approved to reduce the risk of breast cancer for patients; and if he will make a statement on the matter. [38364/23]
View answerMonday, 11 September 2023
Questions (1752)
Written answers
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). 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.
In terms of the specific details of the application for pricing and reimbursement of Abemaciclib (Verzenios®), the HSE have advised:
Advanced or Metastatic Breast Cancer
The HSE received an application for pricing / reimbursement for Abemaciclib (Verzenios®) on the 3rd July 2020 from Eli Lilly (the applicant) for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or Fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
• 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 HSE commissioned the Rapid Review process on the 6th July 2020.
• The NCPE Rapid Review assessment report was received by the HSE on the 27th August 2020. The NCPE advised the HSE that a full HTA was recommended to assess the clinical effectiveness and cost effectiveness of Abemaciclib (Verzenios®) compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. (www.ncpe.ie/drugs/abemaciclib-verzenios-hta-id-20033/)
• The HSE commissioned a full Health Technology Assessment (HTA) on the 1st September 2020 as per agreed processes.
• To date a HTA submission has not been received by the NCPE.
• Eli Lilly communicated to CPU in January 2022 that, at this point in time, they did not intend to progress their application for pricing and reimbursement for Abemaciclib (Verzenios®) for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or Fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
Early Breast Cancer
The HSE received an application for pricing / reimbursement on the 11th April 2022 from Eli Lilly (the applicant) for a new indication for Abemaciclib (Verzenios®) in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node positive early breast cancer at high risk of recurrence.
• 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 HSE commissioned the Rapid Review process on the 11th April 2022.
• The NCPE Rapid Review assessment report was received by the HSE on the 6th May 2022. The NCPE have advised the HSE that a full HTA is recommended to assess the clinical effectiveness and cost effectiveness of Abemaciclib (Verzenios®) compared with the current standard of care.
• The HSE commissioned a full Health Technology Assessment on the 26th May 2022 as per agreed processes.
• The NCPE publishes details of medicines where the HSE has commissioned a Rapid Review assessment and/or a full health technology assessment on their website. The website is updated at regular intervals and includes assessment outcomes and updates on reimbursement for each individual medicine and indication listed. Details of the assessment(s) of Abemaciclib (Verzenios®) are available at (www.ncpe.ie/drugs/abemaciclib-verzenios-for-adjuvant-hr-positive-her2-negative-node-positive-early-breast-cancer-hta-id-22020/)
• 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.
The application for the early breast cancer indication remains under consideration. The HSE cannot make any comment on possible outcomes from the ongoing process.