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Bringing hay fever immunotherapy back to primary care

A number of deaths has led to immunotherapy becoming rarely used for hay fever in the UK – but newer, safer treatments should change that. Consultant chest physician Dr Alaisdair Stewart describes his attempts to extend its use into primary care, while GP Dr Bruno Capone shares his experience of extending his allergy expertise.

A number of deaths has led to immunotherapy becoming rarely used for hay fever in the UK – but newer, safer treatments should change that. Consultant chest physician Dr Alaisdair Stewart describes his attempts to extend its use into primary care, while GP Dr Bruno Capone shares his experience of extending his allergy expertise.

Allergic rhinitis affects 13% of the UK population, with increasing numbers of people getting worsening hay fever symptoms due to a lengthened high-pollen season running from early April to mid August. Hay fever is not trivial – it increases the risk of accidents and impairs schooling, with symptomatic children having a 40-70% chance of dropping at least one grade per paper at GCSE1.

41227512Despite a range of antihistamines and nasal steroids, and a plethora of eye drops, few hay fever sufferers get relief, and the NHS has sidelined allergy and hay fever over the years. There are only 26.5 trained consultant allergologists, only 94 clinics providing any form of allergy advice in the UK and only six clinics run by a full-time allergologist2. Few patients have access to specialist services or diagnostic skinprick testing and this needs to change.

Identifying primary care allergy specialists

In Kent we are encouraging each practice-based commissioning cluster to identify at least one GP and nurse keen to develop expertise. They will perform skinprick tests and provide local treatment, following agreed and funded treatment guidelines.

At the Medway Allergy Clinic we offer training and support and are available to give advice by telephone or email. Only the more complex cases will be referred to us.

Access to immunotherapy

One of the main goals of this effort to extend access to allergy services is to increase access to immunotherapy.

This type of therapy – in the form of desensitising injections for hay fever – started in 1912 but went out of vogue in the UK in the early 1980s when there was a spate of deaths and severe reactions in asthma patients treated in primary care.

A 1986 Committee on Safety of Medicines report identified poorly standardised, often multiple allergen extracts – frequently given to asthma patients with no post-injection supervision – as the main problem.

It stipulated that all future injections be performed in facilities with full CPR support with patients observed for two hours after the injection – rendering one useful therapy impractical overnight.

Safer, standardised allergens

In recent years the development of purer, cleaner, safer, standardised monoallergen extracts and, more recently, sublingual or nasal modes of delivery that can be taken at home, is leading to a renaissance in this form of therapy.

Many studies show that it is effective in minimising symptoms and reducing the need for other therapies for rhinitis and asthma – even though poorly controlled asthma is a relative contraindication3,4.

Allergen immunotherapy – through year-round exposure to a high dose of allergen – switches off the allergic response, leading to the development of tolerance and the production of blocking factors, and leading to an immune response similar to that in non-atopic individuals.

Desensitisation in children may prevent the development of asthma. Subcutaneous injection immunotherapy for grass and tree allergy in children with rhinitis has been shown not only to improve their rhinitis but also to reduce their development of asthma by almost 50% over the three-year injection course5, with this difference being maintained seven years after therapy.

Studies with sublingual therapies are producing similar results, raising the possibility of a treatment that may prevent asthma in many young people.

Injections versus sublingual

Injection immunotherapy requires an induction programme of weekly injections for eight to 16 weeks then four-weekly injections for three years, each being done in a hospital with full CPR facilities and observation for at least one hour. Although it is still highly effective seven years after completing the therapy, it is impractical for busy working people. It is also costly.

The new sublingual or intranasal therapies are much easier to use and appear safe for home use, but currently only Grazax has a licence in the UK. This is a sublingual dissolvable tablet taken on a daily basis for three years that produces comparable results to that of injection immunotherapy. Only the first dose needs to be taken in hospital. Although many get some mouth symptoms, to date there have been no recorded incidents of life-threatening reactions or severe asthma.

Its licence is for grass pollen-allergic adults who are severely affected despite best medical practice, but was recently extended for use in children aged five to 17.

Reserving for the most severely affected

The treatment is not cheap – £66.50 per month for three years – but is cheaper than injection immunotherapy and falls well below the NICE cost-effective threshold with a cost per QALY of £4,3196.

Even so, this cost would put financial pressure on PCT budgets if the treatment was made available to all patients with hay fever. For example, my clinic in Kent covers a population of 1.7 million and we estimate there are 230,000 adults with hay fever. Even if only 1% of them are severe enough to merit this treatment the cost would be £5.5m for the tablets over three years. Furthermore one subspecialist clinic would not be able to handle that workload.

In Kent, to ensure fairness and that only the most severely affected are treated, we have agreed with the local PCTs the following funded process. All patients with treatment-resistant hay fever are referred to the allergy service where skinprick tests confirm the diagnosis, identify other allergens that might prevent benefit or that can be avoided (such as allergy to domestic animals) and confirm a true failure of medical treatment. Quality-of-life questionnaires are used during the pollen season to confirm severe impairment.

The treatment pathway we've developed is available to download (right).

If all criteria are met, Grazax therapy starts in the autumn – as the longer the therapy before the season, the greater the year-one benefit. A repeat of the peak-season questionnaire and telephone follow-up determines whether there is benefit – if not, the treatment is stopped.

To date both trials and local anecdotal evidence shows great improvement in quality of life.

Immunotherapy as a treatment for hay fever is going to become a major treatment modality, particularly if it is confirmed that treating children with it may prevent them from going on to develop asthma. This will require a significant enhancement in allergy services in the UK.

Dr Alaisdair Stewart is a consultant chest and allergy consultant at Medway NHS Foundation Trust

Competing interests: Dr Stewart has been engaged as a speaker and has been sponsored to attend scientific conferences by ALK-Abello, Astra Zeneca, GSK, MSD and Schering Plough.

A GP's view of the service A GP's view of the service

Dr Bruno Capone has been working on setting up a primary care allergy clinic within his practice

Even with antihistamines, nose sprays and eye drops, the symptoms of many of my patients are not well controlled.
I have a 35-year-old taxi driver struggling to drive because of his watering eyes and sneezing, and a 42-year-old sufferer whose asthma spirals out of control during the hay
fever season. For both I have given the occasional dose of oral steroids.
These are the sort of people I'd like to refer to a specialist allergen service but our closest clinic is 30 miles away and there is a long waiting list.
So my practice decided to learn more about allergy testing and immunotherapy. Our local consultant was very happy to teach us skinprick testing and explained how to initiate sublingual therapy.
Last year we were able to help some patients who were struggling with their grass allergy by initiating immunotherapy and we're looking forward to seeing if they have fewer symptoms this year.
I personally think doing skinprick testing and showing someone that their body is reacting to an allergen is improving their understanding and their concordance to symptomatic treatment. Skinprick testing takes time but is
a positive experience for me and the patient. I believe this testing should be part of a primary care service and we are now in the process of offering skinprick testing as an enhanced service to our PCT. I've some reservations over immunotherapy as it's expensive, so I'm pleased to hear more long-term results are coming through.
We hope that by choosing a very select population of the most severe sufferers our intervention will not only improve their life but also will be cost-effective in the long term.

Dr Capone is a GP in Tunbridge Wells, Kent

key points SEM of grass pollen Immunotherapy treatment pathway Immunotherapy treatment pathway

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