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Information on New Medicines
New Medicines Profile
Template Guidance Notes
The profile should not exceed two pages, excluding the references and appended
tables. Text should be 9-10 point size. 8.5 is an absolute minimum.
Summary
The summary is laid out in bullet points. It should accurately reflect the key
points in the text and should not introduce any new information. The summary
should include the following:
A very brief description of what the medicine is and what it is indicated
for. Information on whether it is a new class of medicine, new
indication or new formulation and why the product may have been
launched e.g. patent expiry of existing product, may also be useful.

A brief outline of efficacy and safety.

An indication of any advantages, clinical or practical, the drug may
have over existing therapies. A comment on its likely/potential place
in therapy.

Cost implications.
The summary should leave the reader with a clear message about the medicine
even if they do not read the rest of the evaluation.
Brand Name, (Manufacturer)
Cite as e.g. Exelon, (Novartis)
BNF Therapeutic Class
Use BNF wording and section number or SPC description.
Licensed Indications
As per SPC, abbreviate if necessary.
Dosage and Administration
As per SPC
Marketed
Insert month and year
New Medicines Profile: Template Guidance Notes
Cost Comparisons
Generally give the cost for 28 days but annual costs may be used for chronic
therapy. State where the prices are from (usually the latest edition of MIMs or
the Drug Tariff). Select no more than 5 comparator medicines and include midrange SPC doses or give ranges (not Defined Daily Doses).
£5
Drug 1
Drug 2
£32
Drug 3
£15
£0
£5
£10
£15
£20
£25
£30
£35
N.B. Doses shown for general comparison and do not imply therapeutic equivalence
Introduction
Briefly describe what the medicine is and what it is indicated for. Outline existing
treatment options and include prevalence of disease, if appropriate.
Evidence
Give a brief overview of the major studies (phase 3). Phase 2b studies should
only be included as a last resort. Do not include dose ranging studies.
The text should include a brief description of the trials and critique the trial data
rather than detail them in depth. Use the table (appendix 1) to present details of
the trials.







Read papers thoroughly and conduct a fair, independent critical evaluation
of the data. Ensure all statements can be corroborated.
Do not express results as relative risks if possible. Try and use absolute
risks and/or numbers needed to treat (NNTs) if appropriate. Do not rely on
published NNTs - re-calculate.
If there are no comparative trials this should be stated.
Use fully published randomised controlled trials (RCTs) where available.
State if using conference abstracts/posters or company ‘in-house’ data,
although the latter should only be quoted as a last resort. The limitations
of such data should be pointed out e.g. this requires confirmation in
published studies.
Include details of any patient impact assessments if possible e.g. quality of
life studies.
Include comment on pharmacoeconomic studies. Highlight whether studies
are independent or sponsored and state if there are none.
New Medicines Profile: Template Guidance Notes
Checklist to help critically evaluate a study:
a) Why was the study done?
b) What type of study was it?
c) If the inclusion and exclusion criteria were very strict what implication
could this have for real world clinical practice?
d) What were the outcome measures? Were they appropriate? Were they
patient orientated e.g. death, MI, or surrogate measures e.g. blood
pressure?
e) Were scoring systems e.g. QoL questionnaires etc used validated
methods?
f) Were the numbers recruited sufficient?
g) What was the drop-out rate? Were all drop-outs accounted for?
h) Was the study adequately controlled?
i) Was the study randomised - was the randomisation method described and
appropriate?
j) Was there a pre-randomisation study phase and what was the purpose of
it? Were all potential subjects exposed to the study drug and only those
who tolerated it then randomised?
k) How was the study ‘blinded’? Were there any factors that might have
jeopardised blinding e.g. was the active drug associated with a high
frequency of a particular adverse effect?
l) If there was a non-placebo comparator, was it a fair choice and used at an
appropriate dose? Was the comparator an established evidence-based
alternative?
m) Were the study groups comparable?
n) Was the analysis done on an intention-to-treat or a per protocol basis?
What influence may the latter have had on the results?
o) Has any sub-group analysis potentially introduced bias?
p) Is the study credible? What is the quality of the results? How relevant are
they to clinical practice?
q) Are there confidence intervals?
r) Are the results of the study consistent with other similar studies?
Highlight any study deficiencies in the text.
Avoid:
i.
ii.
iii.
iv.
Quotation out of context.
Biased selection of studies.
Uncritical acceptance of conclusions.
Representation of opinion as fact.
All sources should be fully referenced.
Safety
Include the major and most common adverse effects with an indication of
frequency, if possible. Refer to the SPC where appropriate. Include clinically
important interactions. State if long term safety data are lacking. Include
monitoring requirements if appropriate.
New Medicines Profile: Template Guidance Notes
NHS Impact
Briefly discuss the existing treatment option(s) of choice for the condition and
comment on the new products likely place in therapy. Include a statement as to
when (or indeed if) it should be prescribed and to whom i.e. does it offer any
advantages, clinical, service or financial, over existing therapies?
Include those issues that local decision makers need to take into consideration.
These could include:
- likely target population
- disease prevalence
- limits on licensed indications compared to existing comparators
- limits on who should prescribe it
- relevance of drug comparators used in clinical trials
- relative cost
- any service implications (positive or negative)
Recommendations should clearly reflect best available supporting evidence.
Include the status and anticipated date of any NICE guidance.
Risk Management Issues
If applicable, discuss any issues which may increase the risk of medication errors.
This could include information relating to compliance, packaging, administration
and drug name. Other issues include whether any particular disposal methods are
required, if there are environmental issues e.g. chemotherapy, or if disposal may
have an adverse effect on the environment e.g. hormonal products.
Include a picture of the product if it illustrates a risk issue or is a novel
presentation.
Author Details
Insert author and name, address, telephone number of Medicines Information
Centre.
References
Reference all sources used and highlight the key papers in bold.
References are numbered in the order they appear in the text. The citation
number should be placed in the text at the end of the appropriate sentence in
superscript, after the full stop.
References must be cited in the Vancouver style; using Index Medicus
abbreviations for journal titles (see following examples).
List the first three authors, followed by “et al” if there are more than three. Give
the full title of the article, using US spelling if in the original. This is followed by
the title of the journal, year of the publication, the volume number and the first
and last page numbers in full. References to books should be given the names of
the authors, any editors, the title, edition, place of publication and year. For
references accessible via the web include a web address together with the date
accessed.
New Medicines Profile: Template Guidance Notes
Examples:
Journal Articles
1. Janne PA and Mayer RJ. Chemoprevention of colorectal cancer. N Engl J
Med 2000; 342: 1958-1968.
Abstracts
2. Raskin P, Kapp A, Gupta K et al. The effect of HOE 901 on glycemic
control in type 2 diabetes. American Diabetes Association 58th Annual
Meeting. Chicago, Il. 13-16 June 1998. Abs 404.
Books
3. Mehta DK, editor. British National Formulary No. 52. London: British
Medical Association and Royal Pharmaceutical Society of Great Britain,
September 2006.
On-line Resources
4. Summary of Product Characteristics: Baraclude, Bristol Myers Squibb
Pharmaceuticals Ltd June 2006. Accessed via www.medicines.org.uk on
20/03/07.
5. National Institute for Clinical Excellence. Dyspepsia: Management of
dyspepsia in adults in primary care. Clinical Guideline No. 17. August
2004. Available at:
www.nice.org.uk /CG017NICEguideline. Accessed 20/03/07.
6. Exubera, European Public Assessment Report Scientific discussion.
Available at:
www.emea.eu.int/humandocs/Humans/EPAR/exubera/exubera.htm.
Accessed 25/05/06.
Personal Communication (do not include name of person unless they have
consented)
7. Personal Communication 20/03/07, Janssen-Cilag Ltd
Appendix I: Table of Clinical Trials
The table should be headed with a number and a title.
The aim of the table is to present details of the trials in a concise manner. Some
information may need repeating in the text.
The table should be fully explanatory so that it can be understood without
reference to the text. If necessary a key should be included.
The table may be adapted as necessary but should include the following data as a
minimum: ref no, trial design, trial population, treatment regimen, primary
outcomes.
Additional headings which may be required include: inclusion/exclusion criteria,
secondary outcomes, comments.
The following examples of tables illustrate appropriate alternative layouts.
Date of preparation: August 2003
Last updated: July 2007
New Medicines Profile: Template Guidance Notes
Example I: Table of key clinical trials evaluating omalizumab in patients with severe persistent allergic asthma
Ref No
Trial Design
Ref 5
INNOVATE
Multicentre, doubleblind, RCT over 28
weeks
omalizumab vs. placebo
4 phases:

1 week screening

8 week run-in

28 week treatment

16 week follow-up
(unpublished)
Ref 2
Busse et al
Multicentre, doubleblind, RCT over 28
weeks omalizumab vs.
placebo
4 phases:

4-6 week run-in

16 week stable
steroid phase

12 week ICS
reduction

24 week extension
Common Criteria - all trials Additional Criteria
Inclusion Criteria

Age 12 – 75 years

Positive skin prick test
to ≥ 1 perennial
allergen

Moderate to severe
allergic asthma*

Duration of asthma ≥ 1
year

Total serum IgE ≥ 30
IU/ml to ≤ 700 IU/ml

FEV1 ≥ 40 to ≤ 80%
of predicted normal
value and continuing
asthma symptoms

FEV1 reversibility ≥
12% from baseline
within 30 minutes after
administration of
inhaled β2 -agonist
Exclusion Criteria

Prior exposure or
sensitivity to
omalizumab

Elevated IgE levels
other than atopy
*See individual trials for
further details
n=482 at entry
n=419 efficacy analyses
Additional Inclusion Criteria

Severe persistent asthma (GINA
2002 step 4#), receiving ICS
and LABA (100% patients) and
additional controller medications
including oral corticosteroids
(22% patients)

At least 2 exacerbations
requiring systemic
corticosteroids or 1 severe
exacerbation resulting in
hospitalisation or emergency
room treatment in past 12
months
Additional Exclusion Criteria

Smoker

Treatment for an exacerbation
within 4 weeks of randomisation
n=525
Additional Inclusion Criteria

Severe allergic asthma requiring
daily ICS

Treatment with beclometasone
dipropionate 420-840mcg/day
or equivalent ICS for > 3
months prior to randomisation
Additional Exclusion Criteria

Acute upper respiratory tract
infection within 1 month

<3 months stable
immunotherapy, regular
treatment with β2 blockers

Required dose omalizumab
>750mg
Outcome Measures
Primary outcome
Rate of clinically significant
asthma exacerbations during
treatment phase
Secondary outcomes
Severe exacerbation rate (PEF
or FEV1<60% requiring
treatment with systemic
corticosteroids)
Total number of emergency
visits
Hospital admissions
Asthma-related QoL using
Juniper AQLQ instrument
>0.5-point improvement from
baseline
Improvement in FEV1
Primary outcome
Mean number of exacerbation
episodes per patient in stable
steroid phase
Secondary outcomes
% of patients experiencing at
least one exacerbation in stable
steroid phase
% of patients achieving >50%
reduction in beclometasone
dipropionate dose
Mean change in PEF at week 16
Results
Omalizumab
0.68
Placebo
0.91
P value
0.042
Rate ratio 0.738 (95% CI: 0.552-0.998)
0.24
0.48
0.002
50
93
0.038
Rate ratio 0.561 (95% CI 0.325-0.968)
13
25
Not sig
60.8%
47.8%
0.008
190ml
96ml
Omalizumab
0.28
Placebo
0.54
P value
0.006
14.6%
23.3%
0.009
72.4%
54.9%
<0.001
18.5L/min
6.9L/min
New Medicines Profile: Template Guidance Notes
Example II: Published short-term efficacy studies
Ref
No
Trial
Design
Trial Population
Treatment
1
Randomised,
open-label,
6-month
study
328 patients with type1 diabetes receiving a
stable regimen of SC
insulin
1.
2.
Morning
prandial
Morning
prandial
and bedtime SC NPH plus preINH or
and bedtime SC NPH plus preSI.
Primary Outcomes
Comments
Mean HbA1c decreased
similarly from baseline in the
two groups (8.0% to 7.7% for
INH vs. 7.9% to 7.8% for SI).
Not ITT analysis.
Mean HbA1c decreased from
baseline similarly in the two
groups (8.1% to 7.9% for INH
vs. 8.1% to 7.7% for SI/NPH).
Not ITT analysis.
Mean HbA1c decreased from
baseline similarly in the two
groups (8.1% to 7.4% for INH
vs. 8.2% to 7.6% for SI/NPH).
Not ITT analysis.
Mean HbA1c decrease from
baseline was significantly
greater with INH (9.3% to
7.9%)*, and INH plus OA
(9.2% to 7.3%)*, compared to
OA only (9.3% to 9.1%).
Changing to, or adding,
insulin is standard practice
in people with type 2
diabetes poorly controlled
on OA therapy.
Insulins were titrated to achieve pre-specified
glycaemic targets.
2
Randomised,
open-label,
6-month
study
335 patients with type1 diabetes receiving a
stable regimen of SC
insulin
1.
2.
Pre-prandial INH plus a single bedtime dose
of SC insulin zinc suspension or
Two to three daily injections of a SI/NPH
insulin regimen.
Insulins were titrated to achieve pre-specified
glycaemic targets.
3
Randomised,
open-label,
6-month
study
299 patients with type2 diabetes receiving a
stable regimen of SC
insulin
1.
2.
Pre-prandial INH plus a single bedtime dose
of SC insulin zinc suspension or
At least two mixed SI/NPH injections per
day.
Insulins were titrated to achieve pre-specified
glycaemic targets.
4
Randomised,
open-label,
3-month
study
309 patients with type2 diabetes uncontrolled
on dual OA therapy
1.
2.
3.
Pre-prandial INH only or
Pre-prandial INH plus OA (at existing doses)
or
OA only.
*(P<0.001 for difference vs.
OA only)
5
Randomised,
open-label,
3-month
study
68 patients with type-2
diabetes inadequately
controlled on OA
1.
2.
Pre-prandial INH plus OA (at existing doses)
or
OA only.
Mean HbA1c decrease from
baseline was significantly
greater with INH plus OA
(9.8% to 7.5%), compared to
OA only (9.9% to 9.8%).
(P<0.001 for difference)
As above