BASINGSTOKE, England, August 10 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) the global specialty biopharmaceutical company is disappointed that the main thrust of the NICE Guidance stands in light of the judgment handed down today in Court by Judge Linda Dobbs. This Guidance means that the majority of patients with Alzheimer's disease of mild severity remain excluded from NHS treatment.
However, Shire welcomes the decision that NICE acted unlawfully by not having due regard to the anti-discriminatory legislation in the formulation of their Guidance, potentially resulting in discrimination against patients with learning or language difficulties.
The Judge has directed NICE to consult with parties to the case within 28 days on the revised wording in the Guidance, to clarify when the clinician's judgement can take precedence over exclusive reliance on an MMSE score for those with learning disabilities, linguistic or comparable difficulties. Shire looks forward to contributing to the revised text.
"Despite this revision, nothing has changed in practical terms," says Professor Stephen Curran,(1) Old Age Psychiatrist and Lead Clinician at Wakefield Memory Service.
"The anticipated revised Guidance is welcome for those patients with learning and language difficulties, but the total numbers who will benefit are very small. In my clinic, and in my judgement, this would amount to just a handful of patients each year who will qualify.
"I will not be able to do the best for many newly diagnosed patients in the early stages of the disease and their families under this NICE Guidance. In particular, I will not be able to offer a treatment that works for many patients with mild Alzheimer's disease, even though many of my patients with mild illness have had significant benefit from treatment under the previous NICE guidance.
"Patients and carers I see are distressed and concerned enough - and in my opinion this ruling will only add to that distress."
Dr Ian Howe, Medical Director of Shire says:
"It is a tragedy for the majority of patients in the early stages of the disease and their carers as treatment at this critical time can stabilise the patient and slow the rate of decline. This treatment provides a relative degree of normality for the patient for an extended period and enables the family to stay together for longer.
Let us not forget that these drugs are licensed for use in these early stages of AD and are recognised by NICE as clinically effective."
Dr Howe continues: "The Government has recently announced its commitment to a national dementia strategy that advocates high quality treatment and support, together with early and accurate diagnosis. It is hoped that the work of the new Dementia Strategy Group, announced by the Government, will result in more evidence to ensure appropriate medication and support are provided for patients in the early stages of the disease."
Dr Howe concludes:
"However, the judgment handed down today will inevitably create a two-tier health system - those able to pay for these effective drugs will do so; those who can't will lose out."
Note to editors:
In the UK and Ireland, Shire markets REMINYL(R) (galantamine hydrobromide) and REMINYL XL(R) (galantamine hydrobromide) an acetylcholinesterase inhibitor that is licensed for the symptomatic treatment of mild and moderately severe dementia of the Alzheimer's type.
SHIRE PLC
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. 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. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company's website: http://www.shire.com.
(1) Professor Stephen Curran is Old Age Psychiatrist, Lead Clinician at Wakefield Memory Service and Visiting Professor at the University of Huddersfield. Professor Curran leads the Ageing and Mental Health Research Group at the University of Huddersfield
