Seanad debates
Tuesday, 22 October 2019
Nithe i dtosach suíonna - Commencement Matters
Medicinal Products Reimbursement
2:30 pm
Aodhán Ó Ríordáin (Labour)
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I welcome the Minister of State, Deputy Finian McGrath. I refer to the issue of FreeStyle Libre. Thousands of adults with type 1 diabetes will have to wait until next year to find out whether the HSE is prepared to lift restrictions on them accessing the new blood sugar monitoring technology known as FreeStyle Libre. This device has been credited with greatly improving the quality of life of people with the disease since it was approved by the HSE in April 2018, but only for those aged from four to 21 years.I am advocating today on behalf of a woman who is outside of that age bracket.
The HSE promised at the time to review the situation after 12 months once it was in a position to assess the cost of making the device available to children and young adults. In August, according to a spokesperson, the HSE had 12 months of data collated for review within the coming months. This would allow for the experience of patients and the "societal aspects of benefit" to be reviewed. Members may be aware that FreeStyle Libre, made by Abbott, is a small sensor worn on the skin with readings taken by scanning a hand-held device over the sensor. Unlike the finger prick test, there is no need to draw blood and continuous information about glucose levels can be obtained.
Diabetes Ireland has described the upper age limit on availability as "unfortunate" as it means that many adults cannot access the technology despite the support of their medical team. The HSE stated that it was committed to reviewing who can access this technology within a year but 18 months later, there is still no review. The device has been made available to some adults with type 1 diabetes based on exceptional need. However, diabetes specialist Dr. Ronan Canavan has said that he has made many applications over the past year with limited success. One such application on behalf of a 22 year old patient was refused initially and again on appeal. As I said, I am making representations on behalf of an adult woman. She needs this technology but is exasperated by the delay.
Diabetes Ireland estimates that around 20,000 people have type 1 diabetes, including almost 3,000 children under 16. What is the HSE doing to ensure that adults who have this condition can access this much-needed technology?
Finian McGrath (Dublin Bay North, Independent)
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I thank Senator Ó Ríordáin for raising this important matter and for giving me an opportunity to address it.
The HSE has statutory responsibility for decisions on pricing and the reimbursement of medical devices under the community drug schemes in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE must also, under its governing legislation, manage the provision of health services within the overall resources available to it. In line with the recommendations of the HSE's health technology assessment group, the FreeStyle Libre product was made available in 2018 to children and young adults and, in some exceptional circumstances, to other patients. The health technology assessment group is a medical technology evaluation group that provides assistance to stakeholders when considering the various health technologies and innovations in the medical devices field. It includes expertise in medicine, pharmacy, health economics, devices and procurement. It reviews the clinical and cost effectiveness of innovative medical devices.
The FreeStyle Libre product is intended to be used as an alternative to current glucose monitoring methods for people who administer multiple daily injections of insulin. In contrast to self-monitoring blood glucose, this technology allows glucose readings to be taken non-invasively. Unlike continuous glucose monitoring, it does not need to be calibrated with a blood sample. On the advice of the health technology assessment group, the HSE decided that after 12 months the situation, including historical reimbursement data, would be reviewed to inform the next steps. The intention is that an update to the initial report will then be published.
In recent months, the primary care eligibility and reimbursement service of the HSE has taken steps to gather the relevant data for review by the health technology assessment group. It collated the reimbursement data on strip usage for persons approved for FreeStyle Libre, as notified to the HSE through individual pharmacy claims on a monthly basis. It liaised with the national clinical programme for diabetes and shared material received with the health technology assessment group. It collated the reasons for exceptional approvals, for example, in cases of older patients with visual impairment or dexterity issues and provided this quantitative data to the health technology assessment group for review.It provided the Diabetes Ireland survey on the use of this product to the health technology assessment group.
The HSE intends that an update to the initial report, including details of the review, will be published after the review has been completed. Although the HSE must be satisfied that the expected offset reductions in glucose monitoring ancillaries materialise, the health technology assessment process expected to be completed by year end or early next year will not focus exclusively on cost savings. The process also allows for patient experience and societal aspects of benefit to be considered, including improvements in health outcomes and the quality of life.
Aodhán Ó Ríordáin (Labour)
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I thank the Minister of State for reading that reply. Its key line is: "The HSE intends that an update to the initial report, including details of the review, will be published after the review has been completed." Would the Minister of State accept that statement if he were in my place or if he were a person with type 1 diabetes aged over 21 and waiting more than 18 months for news of this technology that could benefit his or her quality of life? If he were me or the women I am representing, would he accept that?
Finian McGrath (Dublin Bay North, Independent)
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In summary, in reviewing the availability of these products, the HSE must be satisfied that the expected offset reductions in glucose monitoring ancillaries materialise. It was anticipated that offset efficiencies would materialise to improve affordability and this is a very important aspect of the HSE's consideration of whether further expectations are possible within current financial resources. However, the process also allows for patient experience and societal aspects of benefit to be considered, including improvements in health outcomes and quality of life. In reply to the Senator's specific question, no, I would not accept that indication if I were in that situation. I will raise this issue again with the HSE. The key section of the response outlines that societal aspects of benefits can be considered. All patients should be treated with respect and dignity. I will relay the Senator's concerns to the HSE.