Download Medicine Review - West Suffolk Clinical Commissioning Group

East & South East England Specialist Pharmacy Services
East of England, London, South Central & South East Coast
East Anglia Medicines Information Service
Medicine Review
Medicine / Trade name
Manufacturer
Indication
Document status
Date of last revision
Traffic light decision
Prescribers rating
Source of review
Midodrine (unlicensed*)
unlicensed
Postural hypotension
Reviewed at Suffolk CCGs D&TC 12th November 2013 and CPG 9th
December 2013
1/11/2013
Green – Hospital initiated, GP prescribed
Not assessed
The embedded new medicines evidence summary from NICE contains
information on – mechanism of action, class of medicines, indication,
dose, treatment alternatives, likely place in therapy, evidence for use,
side effects, comparative costs of other medicines and estimated use.
http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedi
cines/ESUOM5.jsp
midodrine
NNTs not calculated.
According to costs in the NHS Prescription Cost Analysis for England
2011 the 2 types of 2.5mg midodrine tablets listed cost £1.48 or £2.01
each, and the 2 types of 5mg midodrine tablets cost £1.04 or £1.55
each. For a dose of 10mg midodrine taken 3 times a day, this would
cost between £6.24 and £24.12 a day depending on which tablets are
taken.
Future alternatives
Potential number of
patients per 100,000
population
Decisions sought from
other bodies
Decision review date
*Midodrine does not have marketing authorisation in the UK for the
treatment of postural hypotension or for any other indication, therefore
it is an unlicensed medicine in the UK. Midodrine is licensed in the
USA, and in several EU countries, such as Germany, France, Ireland,
Italy and Spain.
Nil known
The NHS Prescription Cost Analysis for England 2011 reported that
16,500 prescription items of midodrine were dispensed in the
community in 2011. The net ingredient cost of these prescriptions was
£2,011,800. However, the prescription cost analysis does not include
information on the indications for which the drugs were prescribed.
Cambridgeshire and Peterborough CCG – Not on formulary,
however available on a named patient basis via shared care with
Papworth Hospital only ‘Midodrine for idiopathic orthostatic
hypertension or neurocardiogenic syncope’
Norfolk TAG – not considered
SMC – not considered
AWMSG - not considered
2 years following decision or unless superseded by NICE guidance or
substantial and significant new evidence becomes available.
Review prepared by Sarah Cavanagh, East Anglia Medicines Information Service
May be freely copied by NHS agencies
Not to be used for promotional purposes
Comments
Julie Brache Consultant Elderly Services IHT
I do use it for patients with falls/syncope and significant orthostatic hypotension. The evidence base
for treating OH is rather limited so I’ll describe how I use it. OH is very common in the frail elderly so
caution has to be used not to treat a drop in BP alone, only to use it for symptomatic drop
associated with a history of falls or syncope that are suggestive of a BP mediated cause. My
practise is to use it 3rd line. 1st is self management advice and medication review (this is enough for
a significant proportion of my patients, especially the younger ones), 2 nd line is fludrocortisone.
I have been prescribing it and monitoring and changing doses in clinic, once a month until
established then asking the GP to take over the prescription, I’m not currently prescribing it for
anyone. I probably start less than 12 patients a year.
Sharmistha Nadi Consultant Elderly Services IHT
I would agree completely with Julie.
Duncan McNab Cardiologist IHT
I would agree with the comments below. My experience with fludrocortisone is that it is rarely a great
success with neurocardiogenic syncope (although I do start with it as my first agent) and that in the
small numbers of patients who do require midodrine, it can be a life-changer. I have always followed
these patients up, to screen for hypertension, especially at night, whilst supine, but if there were
rigorous protocols in primary care to ensure this was done, it could be continued in Primary Care.
Gerry Rayman Consultant Physician Diabetes and Endocrinology IHT
I do not have the time to sift through the document that you have sent. Basically, I have a single
patient whose life is dependent on midodrine in whom I have to issue a repeat prescription every
three months. This has been the case for this individual for more than 5 years. It is a pain for both
me and the patient to keep corresponding re the prescription. All I want out of this is for the GP to
now be able to issue the prescription. In the next few year I may have 2 or 3 more such
prescription. The place in therapy this therapy in diabetic postural hypotension has been accepted
by diabetologists for many years.
Andrew Owen Cardiologist IHT
I would like to be able to use this occasionally, but at present it is difficult because GP’s cant/won’t
continue with the prescription. They should.
Craig Parkinson Consultant Physician Diabetes and Endocrinology IHT
I think we should bear in mind the difficulties we sometimes face with patients who have postural
orthostatic hypotension or neurocardiogenic syncope. I can think of some patients who attend
hospital on a very regular basis as a consequence and others where there quality of life and ability
to work has been dramatically impaired by these conditions.
In this context we should make available all options for treatment. There are in fact very few, and
whilst I agree that fludrocortisone should be used first line the introduction of midodrine is quite
commonly required by patients with these conditions in my experience. I believe the numbers will
be higher than those suggested so far. I have picked up approximately 4 new patients this year and
I know of other existing patients, and if we are all, individually seeing a handful of patients there is
cumulatively a reasonable patient cohort (although not clearly defined and not likely to represent
huge numbers). I am also concerned that we, as yet, have no input from the COE teams and I
certainly know that Dr Lockington see’s many patients with this problem. How much use of
midodrine takes place in that group of patients however is not clear to me.
I would suggest that a shared care document is developed, with the initiation being undertaken by a
consultant specialist, and after 3-6/12 of dose stabilisation the ongoing prescription should be picked
up by the GP. It is not a high cost drug, but these patients can be a significant challenge and as
such we must have this option available.
Review prepared by Sarah Cavanagh, East Anglia Medicines Information Service
May be freely copied by NHS agencies
Not to be used for promotional purposes
Damian Morris Consultant Physician Diabetes and Endocrinology IHT
I agree with Paul & Duncan. Will be small numbers.
Duncan Fowler Consultant Physician Diabetes and Endocrinology IHT
I agree with Paul Venables. I use it very occasionally on patients with orthostatic hypotension
resistant to other therapies. It is small numbers (I can think of just a couple of patients) and should
be consultant initiated and stabilised with then transfer of prescribing to GP with their agreement
(possibly under some shared care policy if they wish).
Paul Venables Consultant Cardiologist IHT
I think this has a place for shared care. I use the drug selectively for both Orthostatic Hypotension
and Neurocardiogenic Syncope. I would strongly advise we include the latter as Cambridge have
done. This invariably involves me prescribing the drug until I’ve seen them tolerating it well as a
follow-up, then the GP could prescribe.
I did bring this up in the last round of e-mails, was it considered?
Review prepared by Sarah Cavanagh, East Anglia Medicines Information Service
May be freely copied by NHS agencies
Not to be used for promotional purposes
Grids used to assist the NHS Suffolk PCT Drug & Therapeutics Committee in reaching a decision about new medications
For many years scientists have recognised two types of research:
 Primary: original studies, based on observation or experimentation on subjects.
 Secondary: reviews of published research, drawing together the findings of two or more primary studies.
In biomedical science there is general agreement over a hierarchy: the higher up a methodology is ranked, the more robust and closer to objective truth it is
assumed to be. The orthodox hierarchy looks something like thisRank:
Methodology
Description
1
Systematic reviews and meta-analyses
Systematic review: review of a body of data that uses explicit methods to locate
primary studies, and explicit criteria to assess their quality.
Meta-analysis: A statistical analysis that combines or integrates the results of several
independent clinical trials considered by the analyst to be "combinable" usually to the
level of re-analysing the original data, also sometimes called: pooling, quantitative
synthesis.
Both are sometimes called "overviews."
Randomised controlled trials
(finer distinctions may be drawn within this
group based on statistical parameters like the
confidence intervals)
Individuals are randomly allocated to a control group and a group who receive a
specific intervention. Otherwise the two groups are identical for any significant
variables. They are followed up for specific end points.
3
Cohort studies
Groups of people are selected on the basis of their exposure to a particular agent and
followed up for specific outcomes.
4
Case-control studies
"Cases" with the condition are matched with "controls" without, and a retrospective
analysis used to look for differences between the two groups.
5
Cross sectional surveys
Survey or interview of a sample of the population of interest at one point in time
6
Case reports.
A report based on a single patient or subject; sometimes collected together into a short
series
7
Expert opinion
A consensus of experience from the good and the great.
8
Anecdotal
Something a bloke told you after a meeting or in the bar.
2
Review prepared by Sarah Cavanagh, East Anglia Medicines Information Service
May be freely copied by NHS agencies
Not to be used for promotional purposes
Adapted from Systematic reviews, What are they and why are they useful? ScHARR 2008
To Decide if a Medication Is To Be Used In Suffolk
Criterion to be measured
Quality of evidence in the papers reviewed
Magnitude of effect inferred from trials reviewed
Are trial end-points surrogate markers or clinical outcomes?
Clinical usefulness of trial end-points
Known Side Effect Profile
Known Interactions
Concern re Possible Side Effects Not Yet Uncovered
Balance of Benefit To Harm (side effects toxicity interactions etc)
NNT
Comparison Of Effectiveness With Other Medicines In Use For The
Same Condition
Severity of Condition to be Treated
Novel drug or member of existing class
Uptake (estimated proportion of people with this condition likely to be
prescribed the medication under consideration – maximum and
minimum uptake)
Is the drug to be used in Suffolk?
Tends to poor
5
Low
Low
4
Medium
3
Medium
Medium
2
Tends to good
1
High
High
Low
High
High
High
Poor
High
Poor
Medium
Medium
Medium
Medium
Medium
Medium
Medium
High
Low
Low
Low
Good
Low
Good
Severe
Medium
Trivial
Review prepared by Sarah Cavanagh, East Anglia Medicines Information Service
May be freely copied by NHS agencies
Not to be used for promotional purposes
Prescriber’s Rating Definitions
1. Bravo! -The drug is a major therapeutic advance in an area where previously no treatment was available.
2. A real advance - The product is an important therapeutic innovation but has certain limitations.
3. Offers an advantage - The product has some value but does not fundamentally change present therapeutic practice.
4. Possibly Helpful - The product has minimal additional value, and should not change prescribing habits except in rare circumstances.
5. Judgement reserved - The Committee postpones its judgement until better data and a more thorough evaluation of the drug are available.
6. Nothing New - The product may be a new substance but is superfluous because it does not add to the clinical possibilities offered by previous
products available. In most cases these are “me-too” products.
7. Not acceptable - Product without evident benefit over others but with potential or real disadvantages.
(With acknowledgement to Prescrire)
To Decide Where A Medication Is To Be Used In Suffolk
Criterion
Skills of the
prescriber
Therapy
Experience Of The Condition
Red
4
Specific
Amber
3
Specific
Green
2
Specific
Blue
1
General
Diagnosis
Monitoring Progress Of Treatment
Specific
Difficult
Specific
Specific
Specific
General
General
General
Patient Selection
Initiation Of Treatment
Dose Titration
Monitoring Of Side Effects
Method Of Administration
Discontinuation Of Treatment
Difficult
Difficult
Difficult
Complex
Complex
Complex
Specific
Difficult
Specific
Easy
Normal
Complex
Specific
Easy
Easy
Easy
Normal
Easy
Easy
Easy
Easy
Easy
Normal
Easy
References
Jonsen A. Bentham in a box: Technology assessment and health care allocation. Law Med. Health Care. 1986;14:172-174
Suffolk Drug & Therapeutics Committee Responsibility for prescribing, Hospital Trust or GP
Review prepared by Sarah Cavanagh, East Anglia Medicines Information Service
May be freely copied by NHS agencies
Not to be used for promotional purposes