Petition Number Main Petitioner: Robert Thomson on behalf of LDN Now Scotland Subject: NHS availability of Low Dose Naltrexone Calls on the Parliament to urge the Scottish Government to make Low Dose Naltrexone (LDN) readily available on the NHS to auto-immune disease sufferers as well as other conditions not classified as auto-immune such as HIV/AIDS, cancer and fertility, in each NHS board area thereby reducing the danger of sufferers having to access riskier alternatives and also incurring higher costs by purchasing the drug through private medical providers and to provide guidance to all GPs on LDN protocol and require them to collect LDN clinical data. Background Naltrexone is licensed in the UK for use in a number of treatments, including in the fields of addiction and mental health. The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK-wide licensing authority responsible for ensuring the safety, quality and efficacy of all UK licensed medicines. It has advised that where naltrexone is licensed, it is as a 50mg tablet for particular indications. Naltrexone at lower doses, and for the indications discussed by the petitioner, is not licensed. MHRA is only able to grant a marketing authorisation for a given indication once supporting data from the manufacturer has been submitted to demonstrate that the quality, safety and efficacy of the product are satisfactory for the intended use. However, there is provision in both UK and European legislation which allows doctors to prescribe a medicinal product, specially prepared and for administration to a particular patient to meet a special clinical need, on their own direct responsibility. It would appear that some UK doctors are already prescribing low dose naltrexone for their patients. It is possible for a pharmaceutical company to produce low dose naltrexone formulations to supply pharmacists, at the request of a doctor, for use on a “named patient basis”. This would be a matter for the individual patient and their doctor to discuss and consider whether the use of low dose naltrexone is appropriate for their particular clinical need. The issue in connection with the NHS Board is whether or not the Board would be prepared to fund the treatment. NHS Boards are expected to meet the costs of prescribing medicines where NHS guidance states it is
1 Personal communication 2 November 2009
appropriate for them to do so (in Scotland, this principally comes through the Scottish Medicines Consortium). However, such guidance is only relevant for the medicine and the indication it is licensed for. As there is no license for LND under the indications noted in the petition, there is no guidance on its use for the NHS. Thus, the NHS Board is not obliged to meet the cost of the prescription. However, NHS Boards will consider requests put to them for the funding of an unlicensed medication. Whilst each NHS Board will have its own procedures for dealing with such requests, one standard route is for the prescribing clinician to make a case through the Board’s Area Drug and Therapeutics Committee. This Committee will consider the case and provide advice based on the circumstances of the case. This process is separate to the individual patient treatment (exceptional prescribing) request route that is used to consider requests for licensed and SMC not recommended medicines.
Scottish Parliament Action In June 2008, the Public Petitions Committee published a inquiry it held into the availability of cancer drugs on the NHS, which was the result of a petition by Tina McGeever, on behalf of her husband Michael Gray. It should be noted that in this particular case the medicine in question had a license but was not recommended for use in the NHS by the SMC or NICE. The Committee made a number of recommendations, some of which focussed on obtaining greater clarity on exceptional prescribing. It also reflected on the ability for patients to access NHS and private treatment concurrently in circumstances where patients chose to pay privately for medicines that were not routinely available on the NHS. Scottish Government Action Following the Public Petitions Committee report, the Scottish Government published, in December 2008, new guidance to provide greater clarity for NHS Boards when patients wished to pay for private treatment while receiving NHS care. In addition, new guidance on a variety of issues, including the need for written policies on exceptional prescribing and the processes for prescribing unlicensed medicines is due to be published in the near future. Jude Payne Senior Research Specialist 4 October 2009
2 It should be noted that NICE guidance for England and Wales can supersede SMC guidance if the guidance is adopted for Scotland by NHS Quality Improvement Scotland.
SPICe research specialists are not able to discuss the content of petition briefings with petitioners or other members of the public. However if you have any comments Every effort is made to ensure that the information contained in petition briefings is correct at the time of publication. Readers should be aware however that these briefings are not necessarily updated or otherwise amended to reflect subsequent changes.
Principal Investigator/Program Director (Last, first, middle): Llovet, Josep M. BIOGRAPHICAL SKETCH Provide the following information for the key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FOUR PAGES. Professor of Research, University of Barcelona. JLLOVET EDUCATION/TRAINING (Begin with baccalaureate or other initial professional e
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