Pharmacists in Smoking Cessation

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POLITICS Michael Moynihan Fianna Fáil Weekend Pharmacy Services Deputy Michael Moynihan (Fianna Fáil, Cork North-West) asked the Minister for Health if his Department has a structure in place to provide weekend pharmacy cover in rural areas where the only pharmacy stores were often closed from Saturday afternoon until Monday morning. The Minister said this was an operational matter for the HSE which, in a subsequent reply to the Deputy, said that “while there is no formal rota structure in place, business imperatives in the pharmacy marketplace have ensured that most large towns and cities have at least one pharmacy open on a Sunday. Furthermore, GP out-of-hours centres hold small quantities of emergency pharmaceuticals to ensure that patients can start antibiotic treatment or pain relief treatment immediately, if required.” Calls to extend availability of CF drug to younger children The National Centre for Pharmacoeconomics (NCPE) reported to the HSE last October that, following its assessment of a pricing proposal from the manufacturer of Ivacaftor (Kalydeco) for the treatment of cystic fibrosis patients aged two years and older weighing less than 25kg, the manufacturer failed to demonstrate costeffectiveness of the drug for the intended cohort of 18 eligible patients. This was stated in the Dáil recently by the Minister for Health in reply to a Parliamentary Question from Deputy Jan O’Sullivan (Labour, Limerick City), who asked what negotiations were taking place with the company that produces Kalydeco “to reimburse the drug costs for children aged from two to five years in view of the fact that it is already being reimbursed for persons aged six years and over”. A series of related questions on the issue were also tabled by the Sinn Féin Leader, Deputy Gerry Adams (Louth). The Minister added that since the HSE was responsible for the negotiations with manufacturers, he had asked them to respond directly to the deputies on the status of negotiations with the manufacturer and on the issue of the number of patients currently receiving Kalydeco, and the cost per patient. Wider availability of emphysema drug urged The NCPE was conducting an assessment of Respreeza as maintenance treatment of emphysema in adults with documented severe alpha1- proteinase inhibitor deficiency and, once completed, the HSE would consider it as part of its decision-making process when considering the drug for reimbursement. The Minister was replying to the Fianna Fáil Spokesperson on Disability, Deputy Margaret Murphy O’Mahony (Cork South-West), who asked if the clinical trial of Respreeza would continue to be made available to the 21 patients involved and if it would be made available to 40 more patients if current assessments were favourable. A related question on the issue was raised by Deputy Peter Fitzpatrick (Fine Gael, Louth). The Minister said that for patients currently accessing Respreeza on a compassionate use basis, the company CSL Behring would continue to provide and administer the drug until the end of the year. “However, the operation of compassionate access schemes are at the discretion of manufacturers. I have previously asked manufacturers to show compassion to reopen or maintain compassionate access schemes to patients during the assessment process by the HSE,” he added. Jan O’Sullivan Labour Gerry Adams Sinn Féin Margaret Murphy O’Mahony Fianna Fáil Peter Fitzpatrick Fine Gael ” I have previously asked manufacturers to show compassion to reopen or maintain compassionate access schemes to patients during the assessment process by the HSE.” Simon Harris, TD, Minister for Health 56 IPUREVIEW FEBRUARY 2017
ME drug not authorised by European Medicines Agency John Brassil Fianna Fáil Marc MacSharry Fianna Fáil Kathleen Funchion Sinn Féin John Curran Fianna Fáil Ruth Coppinger Anti-Austerity Alliance TDs want new diabetes treatment included in Long-Term Illness Scheme A number of TDs have called on the Minister for Health to make the new Freestyle Libre glucose monitoring system for diabetes patients available under the Long- Term Illness Scheme. These include Deputies John Brassil (Fianna Fáil, Kerry), Marc MacSharry (Fianna Fáil, Sligo-Leitrim), Kathleen Funchion (Sinn Féin, Carlow- Kilkenny), John Curran (Fianna Fáil, Dublin Mid-West) and Ruth Coppinger (Anti-Austerity Alliance, Dublin West). The Minister for Health said the manufacturer of the product must make a completed application to the HSE for reimbursement of the device under the Community Drugs Schemes and a health technology assessment may then be required to assess its clinical benefits and costeffectiveness. Rintatolimod (brand name Ampligen), which is an experimental drug in development for the treatment of a variety of chronic diseases and viral disorders, including Chronic Fatigue Syndrome, or Myalgic Encephalomyelitis (ME), has not been authorised by the European Medicines Agency for the treatment of ME in the European Union. This was stated by the Minister for Health in the Dáil recently when he was replying to a question about the drug from Deputy Peter Burke (Fine Gael, Longford-Westmeath). He said that if the drug received marketing authorisation in Ireland, it would then be open to the marketing authorisation holder to make the drug available for prescribing and to apply to the HSE to have the product reimbursed under the State drugs schemes. “I understand that the US Food and Drug Administration (FDA) has declined to approve rintatolimod for use in the US despite conducting several reviews of the drug over the last decade,” he added. €300 million rebate under pharmaceutical deal The Labour Party Health Spokesperson, Deputy Alan Kelly (Tipperary), asked the Minister for Health how the rebate scheme, which forms part of the current medicine pricing agreement between the Department and the Irish Pharmaceutical Healthcare Association, would operate; the total revenues that the Department anticipated would be generated by these rebates over the lifetime of the agreement; the amounts expected to be raised each year of the Peter Burke Fine Gael Alan Kelly Labour agreement by this rebate scheme; and how these moneys would be collected. Replying, Minister Harris said the estimated value of the rebate under the agreement was €300 million and the breakdown of the amounts expected to be raised each year were as follows: “My Department, in consultation with the HSE and the Department of Public Expenditure and Reform, is currently monitoring the implementation of the Agreement and associated savings, and will give consideration to the publication of the savings achieved on a yearly basis,” he added. Year 1 Year 2 Year 3 Year 4 Estimated Value of the Rebates €65m €70m €80m €85m * Rounded to the nearest €5m IPUREVIEW FEBRUARY 2017 57
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