Seanad debates

Wednesday, 21 February 2018

Versatis Medicated Plasters: Statements

 

10:30 am

Photo of Jim DalyJim Daly (Cork South West, Fine Gael) | Oireachtas source

I thank the Leader and Members for the opportunity to address this important issue on behalf of the Minister, Deputy Harris, who is unable to be here, and I look forward to hearing the Senators’ contributions. People are rightly concerned about this issue, and I am conscious of the impact which a change in reimbursement arrangements has had on individual patients.

As Minister of State at the Department of Health, I have tried in everything that I do to put the interests of patients first. Of course I can empathise with people who are experiencing all sorts of pain, whether post-shingles or otherwise, and who are of the belief that lidocaine plasters offer the best course of treatment. That is why the Minister, Deputy Harris, has worked with the HSE over the last couple of weeks to seek to make the new arrangements as compassionate as possible, all the time accepting that clinical evidence and patient safety must be the first consideration. In that context, I will outline the background to the decision by the HSE's medicines management programme to change the arrangements that had applied. I will also outline the process that is now in place to enable patients to seek continued access to the lidocaine plasters.

Lidocaine plasters are licensed for localised post-shingles pain in adults. This is the only licensed use in Ireland. The plasters have been reimbursed through 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 a cause of clinical concern when, from 2012 on, usage increased significantly, to the point where we were using more plasters than the entire UK National Health Service, which serves 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. That is what happened in 2016 when the HSE medicines management programme reviewed the use of the plasters. The review estimated that only 5% to 10% of prescribing had been for the licensed indication.Following the clinical review, and to ensure the most appropriate patient care, the HSE introduced a new reimbursement approval system from 1 September 2017. This was a clinical decision made by the HSE in the interest of appropriate prescribing and patient safety, which should always outweigh all other considerations.

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 gave practitioners time to inform patients about the changes and, where appropriate, to change treatment or seek continued treatment. This advice has been re-issued in the last week, and information for patients and practitioners is on the HSE medicines management programme website page.

Under these new arrangements, all patients who were receiving lidocaine plasters for the licensed indication, shingles, were automatically approved on the HSE system. All these patients continue to receive the treatment under the community schemes. Patients who had been prescribed lidocaine plasters for other indications were given a three month grace period. They would continue to receive the lidocaine plasters up to the end of November but were required to be registered by their GP for continued reimbursement approval after 1 December. In other words, from 1 December 2017, non-shingles patients no longer automatically qualified for the lidocaine plasters. The system put in place enabled their GPs to apply, using a dedicated online system, for continued use. 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. I want to stress that non-shingles patients can still be approved for plasters through the community schemes, where their GP can make a clear clinical case. As of last Friday, approximately 1,500 post-shingles patients have been approved and the plaster is being provided to these patients in the normal manner. Another 4,784 patients were registered by their GP for use other than post-shingles pain, and 14% of these, or 670 people, have been approved. In addition, 284 online appeals have been made, including patients who were never registered and over 65% of these appeals have been approved.

This means over 2,300 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 their GP. It is clear this new process supports appropriate use and prescribing. Both post-shingles patients and other appropriate cases can continue to be treated with lidocaine plasters.

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