NKF Campaigns Zone:
Dialysis

Scottish Medicines Consortium

Patient Interest Groups

Submission of Evidence Template

Name of organisation submitting information	National Kidney Federation (UK) (Known as NKF) Charity number 1106735
Contact Details: Name Designation Address Telephone Number	Timothy F Statham OBE Chief Executive
Product to which this submission relates	Lanthanum carbonate (Fosrenol)
Date of SMC meeting (if known)	Not Known

Should you have any queries regarding the completion of this form,
please contact the SMC secretariat:
Telephone: 0141 225 6989/6874

Please also send a copy of your completed submission form, by post, to the following address:

Scottish Medicines Consortium
Secretariat
Delta House
50 West Nile Street
GLASGOW
G1 2NP

Section 1 – General Information

1.1 Submitting Organisation

Please provide an overview of the organisation making the submission, including the aims of the organisation and an outline of membership. Although SMC has access to epidemiological data, you may wish to provide additional information on numbers affected.

The NKF is the only UK charity run by Kidney patients for kidney patients. Its aim is to promote, throughout the United Kingdom, the best renal medical practice and treatment, the health of persons suffering from Kidney Disease or Renal failure, and to support the related needs of those relatives and friends who care for kidney patients.

The Federation comprises of 78 Kidney Patient charities throughout the UK. Currently there are 40,000 Established Renal Failure patients, of which 20,000 are on Dialysis and 20,000 are Transplanted. The National Kidney Federation represents them all – and their carers. We anticipate a rise in patient numbers of 7% per annum.

1.2 Declarations of Interest

It is essential that you read the information on declarations of interest contained within the Patient Interest Group Guidance on submission of evidence before you complete this section.

B. We have the following declaration(s) of interest in respect of corporate members and joint working/sponsorship:

The National Kidney Federation receives sponsorship from 15 Industry partners. These partners include Amgen, Genzyme and Shire. The Federation adheres strictly to the following policy, passed by its controlling council 28^th September 2002

PHARMACEUTICAL COMPANIES

The National Kidney Federation (NKF) has a working relationship with many pharmaceutical companies and this works to great advantage.  The nature of the support that an industry partner may give can vary, but essentially it usually comprises of an annual donation to assist with the costs of our core activity, office and staffing, plus assistance either practical or financial with a particular project that will assist kidney patients.

The NKF always likes to establish a close working relationship with these industry partners and in particular likes to encourage the relationships to be long term.  It is of prime importance to the NKF that its commercial neutrality is scrupulously preserved so that the interests on one company over another are not advanced by the NKF, or the interests of an industry partner are not put before the interests of kidney patients or carers.  The independence of the National Kidney Federation is one of its most important assets, and is one reason why Government is prepared to listen to the NKF over and above commercial bodies.  This independence will never be sacrificed in return for financial support.

1.3 Currently available medicines

From a patient/carer perspective, please outline their experiences in respect of medicines currently available, including perceived advantages and disadvantages, preferences and needs both met and currently unmet. Provide us with any information that you feel will help SMC understand how this health problem affects patients/carers. Please identify how you obtained this information, e.g. helpline, existing database, published/unpublished research and user-perspective literature, focus groups, one-to-one conversations with a number of patients, etc.

The NKF makes the following information available to its patient members via its website and in patient leaflets:-

About your medicine

Phosphate is a mineral that affects the health of bones. When someone has kidney failure they tend to have high phosphate levels. This puts them at risk of bone problems. Too much phosphate in your body can also make you itchy.

Treatment includes eating a diet low in phosphate, taking phosphate binders, and dialysis helps a little.

Calcichew, Titralac and Alucaps are a group of medicines used to stop your body from absorbing phosphate from your food. Newer types of binders include Renagel and Phosex:-

• Alucaps are a phosphate binder which contains aluminium. It is very effective at binding phosphate, but if taken over a long period of time, aluminium can build up in the body possibly causing memory problems. Side effects of Alucaps include constipation. Alucaps should be swallowed whole 10-15 minutes before meals.
• Calcichew, Titralac and Phosex (calcium acetate) are phosphate binders which contain calcium. Side effects include a chalky taste in the mouth, or sometimes the level of calcium in your blood can rise. Calcichew and titralac tablets should be chewed, and Phosex should be swallowed whole, 10-15 minutes before meals
• Sevelamer (Renagel) is a new type of phosphate binder. It doesn’t contain calcium or aluminium. The capsules need to be swallowed whole with meals.

Reducing the amount of phosphate in your body can only be done in combination with controlling your diet, these tablets will not work alone.

Taking your medicine

These tablets are best taken about 10 minutes before meals. You should chew the tablets before swallowing, or let them dissolve in your mouth. Alucaps, Renagel and Phosex should be swallowed whole.

Phosphate binders only work if taken with foods containing phosphate.

They should be taken with meals or snacks which include meat, fish, eggs, cheese, milk or pulses.

They should not be taken with meals or snacks which do not include protein foods, such as toast, jam or salad sandwiches, biscuits or fruit.

This may mean that you take more binders with a main meal or include one with a snack. You should still aim to take the total number prescribed each day.

Other Medicines

Phosphate binders should not be taken at the same time as iron tablets, or some antibiotics, as this makes both ineffective. Take binders before a meal and iron tablets one hour after the meal.

Only take tablets prescribed for you by your doctor. Some medicines such as indigestion remedies contain calcium or Aluminium and should  not be taken as well as binders.

Check with your pharmacist before taking any new medicines.

Unwanted effects

The most common side effects with these tablets are constipation or diarrhoea, feeling sick and a chalky taste in your mouth.

If you really don’t like the taste you can swallow them whole 15 minutes before meals.

Storing your medicine

Store the tablets in their original packet in a cool, dry place out of the reach of children. Only remove the tablets from the container when it is time to take them.

We also provide the following (renal related) information:-

What is calcium?

Calcium is a mineral that is found throughout the body. It makes up, together with phosphate, the main strength in the bones. Calcium is also used to help ‘power’ muscles, and is carried around the body in the blood. The blood calcium level must be kept very tightly controlled for the body to work normally, and PTH (see below) is important in this. Calcium gets into the body from food, and is found particularly in dairy products, green vegetables and eggs.

The normal calcium level in the blood is between 2.2 and 2.6 mmol/l (millimoles per litre).

What is phosphate?

Phosphate is a mineral in the body, and together with calcium makes up most of our bones. Phosphate, like calcium, is also used in other parts of the body to ‘power’ muscle and is used in many other chemical reactions. Phosphate gets into the body in food. Diary products, nuts and meat are three types of food that can contain a lot of phosphate.

The normal level of phosphate in the blood is 0.8 to 1.4 mmol/l.

What is PTH and why is it important?

Parathyroid hormone (PTH for short) is a hormone (chemical messenger) which is very important in controlling the level of calcium in the blood. PTH is produced in the parathyroid glands. There are usually four parathyroid glands, each the size of a pinhead (0.1cm). They are found in the neck, behind the thyroid gland. The thyroid gland has completely different functions from the parathyroids, they just happen to be next to each other.

If the level of calcium in the blood falls, the parathyroid glands normally produce more PTH, which pulls some calcium from the bones into the blood, normalising the level. If the calcium level in the blood rises above normal, PTH secretion falls, and the level of calcium in the blood falls back to normal.

The normal range for PTH depends on the technique used by an individual laboratory.

Section 2 – Product Specific Details

2.1 Potential Impact

If this new medicine were to be made available how would it match up to user needs and preferences; what would be its advantages and disadvantages over currently available medicines: and how might it impact upon the lives of patients and carers? Please identify how you obtained this information, e.g. helpline, existing database, published/unpublished research and user-perspective literature, focus groups, one-to-one conversations with a number of patients, etc.

The National Kidney Federation is fully aware that the major reason for death amongst its kidney patient members is not renal failure but cardiac failure due in the main part to calcification of the heart muscle and arteries. This matter is continually discussed by patient members at the majority of NKF meetings and conferences.

Originally it was felt that the phosphate binder “Calcichew” played a part in the increased calcification of the patient, and the NKF was relieved when another phosphate binder Renalgel began to be prescribed instead. Renalgel does not increase Calcium levels and is not aluminium based.

The NKF has been disappointed that Renalgel is not always prescribed instead of Calcichew – we believe that the reason for this may be cost.

Whilst the NKF has no experience of the new drug Fosrenol we have high hopes that it also will not increase Calcium levels. We are hopeful that this drug will be efficacious and will be prescribed by Nephrologists caring for our members.

This issue is of serious (Life preserving) importance to 40% of our Dialysis patients whose phosphate levels are not being adequately managed – 8,000 patient in the UK – 720 in Scotland.

2.2 Additional information

Please include any additional information you believe would be helpful to SMC.

This submission has been made by the Chief Executive of the National Kidney Federation, representing patients, therefore you should not regard this submission as being a “medical opinion”. It is however the commonly held view of all renal patients, as discussed continually at their meetings. Renal patients are kidney patients for life. They form organisations and become communities. They are well informed about their disease and very knowledgeable about their own condition.

T F Statham
28 February 2006