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Supply of TB drugs to patients – changes to regulations and advice on implementation

  • Last modified date:
    3 September 2007
  • Gateway reference:
    8714

The Chief Medical Officer first identified TB as one of the major public health issues to be tackled when he published Getting Ahead of the Curve in 2002, and followed this with the publication of The National TB Action Plan - Stopping Tuberculosis in England - published in 2004.

The CMO stated in his TB Action Plan that the Department of Health would:

“explore ways of reducing the cost of TB drugs to patients and of facilitating their dispensing”.

The NHS (Charges for Drugs and Appliances) Regulations 2000 (the Charges Regulations) have now been amended to allow medication for the treatment of tuberculosis to be provided free of charge in TB clinics or via a patient group direction from 1 September 2007.

Regulations 5 (supply of drugs by HAs, NHS Trusts and PCTs) and 6A (supply of drugs under patient group directions) of the The National Health Service (charge for Drugs and Appliances) and (Travel Expenses and Remission of Charges) have been amended as follows:

“No charge shall be made and recovered under this regulation from a patient who is accepted by the person supplying the drug as suffering from tuberculosis in respect of any drug supplied to that patient for the treatment of tuberculosis”

For action

TB services and hospital pharmacies should make arrangements to ensure that drugs supplied to treat TB should be free of prescription charges for patients attending TB clinics or treated under a patient group direction. FP10 forms cannot be used under this arrangement. If FP10 forms are currently used in the community, you may wish to consider moving to a PGD.

Background

  • Tuberculosis (TB) is a curable airborne infectious disease which can be passed from an infectious person to anyone with whom they are in long-term close contact, such as a family member or a work colleague. Although a course of modern anti-TB drugs is extremely effective they have to be taken for at least six months.
  • Patients who do not complete a full course of treatment run a high risk of a relapse or developing drug-resistant disease, which is more difficult and slower to cure and therefore much more costly to the NHS.

  • The medical profession treating TB patients has long identified that failure to complete treatment is not just a problem for the patient – TB can recur, or drug resistant TB can develop – but more importantly, affects public health more widely, and has lobbied to remove any cost barriers to patients needing TB drugs.
  • Patients on low incomes are likely to be entitled to free prescriptions already but those who are not may see prescription charges as a barrier to seeking or completing treatment.
  • In London, a drug resistant outbreak still continues some seven years after initial detection, typically among transient people and people who use illegal drugs.  Failure to prevent drug resistant strains developing presents a major threat to public health.
  • The cost of implementing this change to the regulations has been estimated as less than £70 per TB patient who is not exempt from charges.  Against the total annual running costs of the NHS of £80 billion this is a small price to pay for improved public health protection.
  • Cost of treatment of a ‘normal’ case of TB is around £5000; cost of treatment of a drug resistant case can be £50k - £70k or more per patient.

Q and A - Implementation

Should existing arrangements continue to be used for the supply of TB drugs from a hospital pharmacy?

Yes - the amendment to the Charges Regulations applies only to drugs supplied by the Trust or via a PGD.

The exemption does not apply to an FP10 prescription form as this is used to order supply via pharmaceutical services

Does this change apply to drugs used for chemoprophylaxis in cases of TB infection, or to other drugs such as anti-emetics for people on TB treatment?

This applies to any drug supplied for the treatment of TB. The intended purpose of this change is to remove the cost of prescription charges, which may deter patients from completing a full course of TB treatment.

What about patients prescribed TB drugs by GPs?

If an FP10 form is used by a GP to prescribe TB drugs then that patient will have to pay prescription charges unless they are exempt. However, patients with TB should ideally always be treated in specialist TB clinics where the drugs can be supplied free, or could be given TB drugs in the community by a TB nurse specialist under a patient group direction.

Where can I get more information about this?

Contact Valerie Aston or Ed Davis at the Department of Health on 0207 972 1034 or 0207 972 3790 or email:

Q and A – Background

Why have you made this change to the regulations?
What evidence was there that prescription costs were a deterrent?

Robust data is hard to find, because if people stop taking treatment they have probably stopped making contact with TB services. However, anecdotal evidence from the TB specialists cites prescription costs as a barrier both to starting treatment early, and to completing treatment. The patient may feel better after only a few weeks treatment and see no need to complete the 6-month course. Improved surveillance and enhanced collection of data on completion of treatment, currently being implemented by the Health Protection Agency, may provide better evidence on numbers of patients discontinuing treatment before completion.

Prior to the change to the regulations, the TB charity, TB Alert, has reported many instances where patients have applied to them for financial support to meet prescription costs – particularly so whilst the patient either seeks exemption from charges or applies for a prescription season ticket (PPC). TB Alert has supported such patients by paying costs and ensuring rapid start of treatment pending a decision about exemption or waiting for a PPC.

How much will this change to the regulations cost the NHS?

The cost of implementing this has been estimated as less than £70 per TB patient who is not exempt from charges.

Are there additional funds to cover this?

No – but compared to the annual NHS costs of £80 billion, this is a small additional cost for an investment for improving public health protection.

Will this encourage overseas people to travel to England for free TB treatment? What about failed asylum seekers? What about illegal immigrants?

We do not believe so. Under the National Health Services (Charges to Overseas Visitors) Regulations 1989 (amended), treatment for certain specified communicable disease including TB must be provided free of charge to all irrespective of the patient's residency status in the UK. Failed asylum seekers and illegal immigrants with TB are therefore already eligible for free NHS treatment of the condition.

Free treatment means that if they are referred to a hospital by a GP, or to outpatients or to A&E the costs of diagnosis, in-patient stays and all treatment within a hospital environment, including drugs to treat TB, incur no charge to the patient. Overseas patients, asylum seekers and illegal immigrants already receive this.

However, patients are usually treated for TB in an outpatient setting and medication prescribed to take home is chargeable unless the patient is exempt. Some patients would therefore benefit from the changes we are making. The maximum loss of charge revenue is estimated to be around £70 per patient who currently pays prescription charges for these drugs. Since the £5,000 average cost of treating that person has always been met by the NHS anyway, the additional cost is minimal compared to the total cost and the public health benefit.

Why have you made people with TB a special case?

We have not: this is a public health protection measure. Failure of an individual to complete treatment increases the risk of development of drug-resistant TB in that individual, and also increases the risk that they will infect others. The wider gain here is in protecting other people from contracting TB from infected people who could be cured completely.

Why have you made these drugs exempt from prescription charges and not other drugs?

We have not made these drugs generally exempt from prescription charges. What we have done is made the drugs available free of charge only in certain circumstances – in a dedicated TB clinic or via a patient group direction where a qualified person is authorised to distribute the drugs. This encourages people with TB to be seen regularly in TB clinics where they can be properly assessed and their treatment supervised by TB experts.

Additional links

Immunisation

Immunisation

Symptom and prevention information for TB. The Immunisation website is published by the Department of Health and for the NHS.

Health Protection Agency: Tuberculosis

Health Protection Agency: Tuberculosis

General information, advice and updates on TB from the Health Protection Agency (HPA).

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