BASINGSTOKE, England, January 23 /PRNewswire-FirstCall/ -- Shire welcomes the NICE announcement that Alzheimer’s disease (AD) drugs should remain available on the NHS for patients already prescribed treatment and for new patients diagnosed with moderate AD. Shire will work with other stakeholders to make the case that patients with mild AD should also continue to have access to these drugs on the NHS.
Shire plc “Shire is encouraged that the new NICE appraisal consultation document for AD[1] acknowledges that the acetylcholinesterase inhibitor class of drugs are both clinically effective and cost-effective for the treatment of moderate AD and that they will remain available on the NHS,” says John Freeman, Managing Director of Shire Pharmaceuticals’ UK operation, which markets Reminyl(R) and Reminyl XL (galantamine)[2] in the UK. “This is good news for new patients at the moderate stage of their disease and for their carers. However NICE also states that new patients diagnosed with mild AD will not be eligible for these drugs on the NHS until their condition deteriorates to moderate AD, which we do not agree with."[3]
“All the acetylcholinesterase inhibitors are licensed to treat mild to moderately severe AD patients. Clinical trials demonstrate that mild AD patients improve cognition skills above their baseline score more than patients with moderate AD.[4] There is also evidence in clinical practice that patients initiated on treatment earlier have a cumulative advantage in that the progression of their disease is slowed with patients remaining stable for longer and with some patients retaining treatment benefits for years,” [5] says Dr Ian Howe, Medical Director of Shire Pharmaceuticals in the UK.
Dr Howe continues: “Patients with mild AD have lost the ability to undertake many ‘activities of daily living’, such as using the telephone and public transport, handling their own bank account and driving a car. This results in a loss of independence, with the burden of care being placed on, for example, partners, close family members or other carers. The proposed guidance deprives them of the only available medication on the NHS to treat these symptoms. Being able to prescribe these drugs to these patients at the onset of AD may buy valuable time for them and their families to put their affairs in order and prepare for the inevitable consequences of AD.”
John Freeman concludes: “Shire Pharmaceuticals will be responding to the NICE appraisal consultation document welcoming the news that all existing patients and newly diagnosed moderate AD patients may continue to receive NHS prescriptions for these drugs. We will also raise our concern that newly diagnosed mild AD patients will be excluded from receiving these drugs on the NHS, depriving them of support at one of the most vulnerable times in their lives and that of their families.”
The consultation period on the NICE ACD closes on 13 February 2006. Feedback to NICE on this ACD and its recommendations is open to all.
Notes to Editors
SHIRE PLC
Shire’s strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on central nervous system (CNS), gastrointestinal (GI), general products (GP) and human genetic therapies (HGT) - all being areas in which Shire has a commercial presence. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results. Shire’s focused strategy is to develop and market products for specialty physicians. This approach aims to deliver increased returns and lower risks. Shire’s in-licensing and merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
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[1] Log on to www.nice.org.uk to view the ACD
[2] Shire markets Reminyl and Reminyl XL in the UK and Ireland. Janssen Pharmaceutica NV markets Reminyl under licence from Shire in the rest of the world.
[3] The Mini-Mental State Evaluation (MMSE) score (range 0-30) assesses mild AD as 26-21, moderate AD 20-10 and severe AD below 10.
[4] Shire Pharmaceuticals/Johnson& Johnson: submission to NICE 21 October 2005.
[5] Dartigues JF et al. Long-term effects of galantamine on cognitive function in Alzheimer’s disease: a large-scale international retrospective study. Poster presented at the European Federation of Neurological Sciences meeting; Athens, Greece, September 2005.
Shire plc
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