Supplementary letter from the Medicines
and Healthcare products Regulatory Agency (MHRA)
The Committee for Human Medicines (CHM) has
reviewed license applications for three allergy immunotherapy
products in the last two years. Each application is assessed based
on the scientific evidence provided and taking into account the
current prevailing medical/scientific opinion. One received a
positive opinion (Grazax) and the two others were unable to show
a positive benefit:risk ratio, either due to inadequate clinical
data (due to testing over only a single pollen season and no confirmation
of efficacy) or unacceptable side-effects.
The answers to your further questions are as
follows:
1. What subcutaneous and sublingual immunotherapy
products currently have a UK product licence?
Grazax (Timothy grass) is a sublingual immunotherapy
product and Pollinex (grasses and rye, or tree pollen) and Pharmalgen
(bee/wasp venom extract) are subcutaneous immunotherapy products
which currently have UK product licences.
2. For which type of patient can these approved
immunotherapy products be used, and who can administer the treatments?
Grazax is for patients with hay fever with positive
skin test to Timothy grass. Pollinex is for patients suffering
from seasonal hay fever who have failed to respond to standard
anti-allergy medication and Pharmalgen is for patients with hypersensitivity
to bee/wasp venom.
Grazax is an oral tablet for sub-lingual (under
the tongue) administration. Treatment with Grazax is initiated
by physicians with experience in treatment of allergic diseases
and the first tablet is taken under medical supervision (20-30
minutes). After this, the patient will be able to self-administer
the medicine, according to the instructions.
The Pollinex preparations are given by sub-cutaneous
injection and are therefore administered by a physician. Treatment
of patients should only be carried out where full facilities for
cardio-respiratory resuscitation are available. These preparations
are contra-indicated in patients with asthma.
Pharmalgen is administered to patients with
confirmed hypersensitivity to bee/wasp venom by sub-cutaneous
injection. Treatment of patients should only be carried out where
full facilities for cardio-respiratory resuscitation are available
and special care should be taken in patients with asthma.
3. Are there no plans in the near future
to review the 1994 decision to limit the use of immunotherapy
treatments?
CHM advises MHRA on license applications on
the basis of assessment of the scientific evidence provided by
the company and taking into account the current prevailing medical/scientific
opinion. The license for Grazax illustrates the fact that there
is no fixed view on any product class and scientific evidence
is the most important determinant of the regulatory decision(s).
4. In particular, is it true that the MHRAS
still advises that patients have to remain under medical supervision
for at least one hour after each injection whereas in most other
countries this is usually 20-30 minutes?
No. MHRA approved the recommendation in Grazax
product literature that observation for 20-30 minutes is sufficient.
Product literature for the older products, Pollinex and Pharmalgen,
recommend observation for 60 minutes after treatment, but the
Marketing Authorisation Holder is entitled to apply for a variation
to the license to change this recommendation, if required.
5. What criteria do immunotherapy products
have to meet to be granted MHRA approval, and how do these criteria
compare to those used by regulatory authorities in other countries?
The products will need to establish quality,
safety, efficacy and a favourable benefit: risk profile, as for
any medicinal product. This does not fundamentally differ from
other regulatory agencies.
6. Does the MHRA use the mutual recognition
process to assess immunotherapy products in the same manner as
other treatments, and if not, why not?
UK uses mutual recognition procedure for these
products in the same manner as other treatments.
7. What is the present MHRA policy regarding
the prescribing of unlicensed immunotherapy products (manufactured
both within the UK and abroad) on a "named patient basis"?
In the UK an unlicensed relevant medicinal product
may only be supplied in accordance with the provisions of Schedule
1 of The Medicines for Human Use (Marketing Authorisations Etc)
Regulations 1994 [SI 1994/3144], (the MA Regs) Schedule 1 exempts
from the need for a marketing authorisation a relevant medicinal
product which is supplied to fill a "special [clinical] need"
and in response to a bona fide unsolicited order, formulated in
accordance with the specification of a doctor, dentist or supplementary
prescriber and for use by his individual patients on his direct
responsibility. In the interest of public health the exemption
is narrowly drawn, because these products, unlike licensed products,
may not have been assessed by the Licensing Authority against
the criteria of safety, quality and efficacy.
In practice, subject to the normal legal requirements,
prescribers are free, on their own direct personal responsibility,
to prescribe whatever unlicensed products they believe appropriate
to meet the special clinical needs of their individual patients
in the absence of a suitable equivalent licensed product being
available. However, the MHRA recommends that wherever possible
a product licensed for the UK market should be preferred.
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