I propose to take Questions Nos. 140 and 141 together.
Medicines play a vital role in improving the health of Irish patients. Securing access to existing and new and innovative medicines is a key objective of the health service. However, the challenge is to do this in a safe and sustainable manner. Treatment must be appropriate and proportionate and clinical decison-making, such as prescribing, should be based on both patient needs and sound medical evidence.
Lidocaine 5% medicated plasters are licensed for the localised relief of post-shingles pain in adults. This is the only licensed use for the patch in Ireland. It has been reimbursed in the community drugs schemes since 2010.
When the plasters were first introduced, the budget impact was low, because of the specific indication for which they are licensed. It was therefore a cause of clinical concern that, from 2012 on, usage increased significantly, to the point where, as a nation, we were using more plasters than the entire UK National Health Service, with ten times our population.
When a treatment is intended for a small group of patients, and evidence suggests that it is being used for many times that number, it is important and appropriate for clinicians to review its use. In 2016, the HSE Medicines Management Programme reviewed the use of the plasters. The review estimated that only 5-10% of prescribing had been for the licensed indication.
Following the clinical review, and in the interest of ensuring appropriate patient care, the HSE introduced a new reimbursement approval system for the patches from 1 September 2017. This process supports their appropriate use, ensuring that post-shingles patients continue to receive this treatment.
Under the new arrangements, all patients receiving lidocaine plasters for the licensed indication, shingles, were automatically approved on the HSE system. All of these patients continue to receive the treatment under the community schemes.
Non-shingles patients were given a three month grace period, in which their GP could move them to other treatments or apply for continued reimbursement. However, from 1 December 2017, non-shingles patients were no longer automatically reimbursed under the community drugs schemes.
In order for non-shingles patients to receive the patch through the community schemes, their GP must apply online for continued reimbursement approval. If an application is refused, the GP may appeal, making a clinical case for the patient. The HSE advises that the turnaround time for applications is three working days and for appeals it is five days.
As of 16 February, approximately 1,500 post-shingles patients have been approved, and the plaster is being provided to those patients in the normal manner.
Another 4784 non-shingles patients were registered by their GP, and 14% of these patients, 670 people, have been approved. In addition, 284 online appeals have been made, including patients who were never registered, and over 65% of these patients have been approved.
Over 2300 patients are now approved for the plaster in the drug schemes, with more than 850, over one third, approved for use other than post-shingles pain, based on the clinical case made by the GP.
It is clear that this new process supports appropriate use and prescribing and both post-shingles patients and other appropriate cases can continue to be treated with lidocaine plasters.
The introduction of the new approval system was flagged in August 2017, when details of the proposed changes were circulated by the HSE to prescribers and pharmacies. This advice has been re-issued in the last week, and information for patients and practitioners is on the HSE Medicines Management Programme website. (http://hse.ie/eng/about/Who/clinical/natclinprog/medicinemanagementprogramme/yourmedicines/lidocaine-plaster/lidocaine-medicated-plaster.html).
This decision is a matter for the HSE. However, I fully support the objectives of the HSE Medicines Management Programme.