Etanercept and Infliximab for the Treatment of Rheumatoid Arthritis

Funding application for Riluzole for the treatment of Motor Neurone Disease (MND), NICE TA 20, January 2001 Only fully completed forms will be accepted for consideration The completed form must be sent by the hospital commissioning team to the High Cost Drugs Team at [email protected]

If the patient does not fulfil NICE criteria  The responsible commissioner will not normally fund any treatment where the patient does not meet the agreed criteria as outlined in this patient specific funding application form.  Following a clinical trial, the responsibility for ongoing funding remains with the provider or pharmaceutical company. The commissioner will only fund treatment that meets the commissioned pathway.  Applications can be made via the Individual Funding Requests process ONLY where the patient has exceptional clinical circumstances. Please check the commissioner websites for contact details of the IFR team.

Patient NHS No. Trust: GP Name: Consultant Making Patient Hospital No. GP Practice code: Request: Patient initials & DoB: Consultant Contact Details: GP Post code: Please indicate which aspect of NICE guidance applies for this patient Please tick 1. Does patient have Motor Neurone Disease (MND)? Yes No 2. Does patient have Amylotropic Lateral Sclerosis (ALS) form of MND? Yes No 3. Is this patient an adult (i.e. aged 18 years or older)? Yes No 4. Will a neurological specialist with expertise in the management of MND initiate treatment? Yes No

5. Do you intend to seek shared care prescribing arrangements with the GP, once the patient is stabilised? Yes No 6. If yes to point 5, please state anticipated period for prescriptions to be provided by the

Trust: 7. What is acquisition cost of drug to be prescribed by Trust including VAT (if applicable)? £ per month

Pharmacy and Medicines Optimisation Team East & North Herts Clinical Commissioning Group (ENHCCG)

Proforma adapted from MSW PCTs work Proforma updated 03/06/2013 Clinician’s Declaration If this patient is being jointly managed by a second consultant, please state name I confirm that I have discussed with the patient and that they understand and consent to here: their personal information being shared with commissioning organisations. I have also recorded this discussion in the patient’s notes. Name: I confirm the risks and benefits of treatment have been fully discussed with the patient and documented. Date: I confirm that funding approval is subject to initiation and follow up of treatment response Signature (or email confirmation) by Trust Chief Pharmacist (or deputy) being undertaken by a specialist neurology team. Name: I acknowledge and adhere to the cost effective use of riluzole as advocated in NICE TA Signature: 20 and believe that within this Trust the above patient would be best managed using the Date: agent as requested above. Name of supervising consultant:

Signature: Date:

National Institute of Clinical Excellence – Technology Appraisal Guidance (No. 20) January 2001 Guidance on the use of Riluzole (Rilutek) for the treatment of Motor Neurone Disease 1. Guidance

1.1 Riluzole is recommended for the treatment of individuals with the amyotrophic lateral sclerosis (ALS) form of Motor Neurone Disease (MND). 1.2 Riluzole therapy should be initiated by a neurological specialist with expertise in the management of MND. Routine supervision of therapy should be managed by locally agreed shared care protocols undertaken by general practitioners.

The term ‘Motor Neurone Disease’ is used to describe variants of the disease – namely progressive muscular atrophy (PMA) and amyotrophic lateral sclerosis (ALS) which includes Progressive Bulbar Palsy (PBP). ALS, which is characterised by both upper and lower motor neurone signs, is the most common form of MND, accounting for 65% to 85% of all cases. Adult onset MND usually starts insidiously with symptoms and signs including stumbling, foot drop, weakened grip, slurred speech, cramp, muscle wasting, twitching and tiredness. Other symptoms of MND include muscle stiffness, paralysis, in-coordination and impaired speech, swallowing and breathing. Most individuals die from ventilatory failure, resulting from progressive weakness and wasting of limb, respiratory and bulbar muscles within approximately 3 years of the onset of symptoms.

This NICE Technology Appraisal refers to ALS specifically in accordance with the terminology used in the current product license for riluzole.

Patients with the progressive muscular atrophy (PMA) form of Motor Neurone Disease are excluded from NICE guidance and therefore local routine funding arrangements.