Kieran O'Donnell (Limerick City, Fine Gael)
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108. To ask the Minister for Health the status of the Freestyle Libre2 application for reimbursement on the HSE's long-term illness scheme through the community-funded aids and appliances. [55668/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medical devices in the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE’s Primary Care Reimbursement Service (PCRS) has responsibility for the administration of and reimbursement under the community drug schemes. The FreeStyle Libre 2 Continuous Glucose Monitoring (CGM) devices for those with Type I Diabetes are funded under a separate funding mechanism locally. Hence, applications for the reimbursement of such devices do not go through the PCRS.

There is a national tender arrangement in place for Aids and Appliances, such as CGM devices, under the community funded schemes and the hospital must apply for funding for those patients where a CGM device is warranted.  In order for the FreeStyle Libre 2 CGM device to be added to the CGM devices available under the community funded schemes national tender arrangements, the marketing authorisation holder for the FreeStyle Libre 2 CGM device will need to apply through the national framework application process.

Kieran O'Donnell (Limerick City, Fine Gael)
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109. To ask the Minister for Health the status of the 2021 application to HSE to have the NovoPen 6 and the NovoPen Echo Plus smart insulin pens included for reimbursement on the long-term illness scheme; and the reason that this particular application still has not concluded over 12 months after the application was submitted. [55670/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medical devices in the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE’s Primary Care Reimbursement Service (PCRS) has responsibility for the administration of and reimbursement under the community drug schemes. The PCRS advise that consumable products classified as non-drug (medical devices), including for personal diagnostic, monitoring and delivery devices for diabetes, can be reimbursed. The reimbursement guidelines for these can be found at:

www.hse.ie/eng/about/who/cpu/non-drug-reimbursement-applications/.

Given that NovoPen 6 and NovoPen Echo Plus smart pens are pieces of equipment which last between 4-5 years, they are not reimbursable under the community drug schemes, including the Long Tern Illness Scheme. PCRS deal with consumable products that are dispensed on a monthly basis and do not reimburse equipment.

Therefore, the pricing and reimbursement application submitted to the PCRS in 2021, by the Marketing Authorisation Holder for NovoPen 6 and the NovoPen Echo Plus smart insulin pens, does not fall under the non-drug reimbursement application process. The Marketing Authorisation Holder was informed in early September 2022 that the product did not satisfy the criteria for reimbursement of non-drug items under community drug schemes.

Kieran O'Donnell (Limerick City, Fine Gael)
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110. To ask the Minister for Health if the HSE plans to include the omnipod tubeless, wireless insulin patch pump on the list of approved insulin pumps that have been added to the insulin pump and transmitter pricing agreement. [55669/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medical devices in the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. 

The HSE previously approached the manufacturer of the Omnipod tubeless, wireless insulin patch pump regarding making an application to be added to the list of approved Insulin pumps on the Insulin Pump and Transmitter Pricing Agreement. However, the company have not as yet availed of this opportunity.