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.
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.
Cite as e.g. Exelon, (Novartis)
Use BNF wording and section number or SPC description.
As per SPC, abbreviate if necessary.
As per SPC
Insert month and year

New Medicines Profile: Template Guidance Notes
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).
Drug 1
Drug 2
£5
£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
Briefly describe what the medicine is and what it is indicated for. Outline existing treatment options and include prevalence of disease, if appropriate.
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.
Quotation out of context. ii.
Biased selection of studies. iii.
Uncritical acceptance of conclusions. iv.
Representation of opinion as fact.
All sources should be fully referenced.
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
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.
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.
Insert author and name, address, telephone number of Medicines Information
Centre.
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 58
Meeting. Chicago, Il. 13-16 June 1998. Abs 404. th Annual
Books
3.
Mehta DK, editor. British National Formulary No. 52. London: British
Medical Association and Royal Pharmaceutical Society of Great Britain,
4.
September 2006.
On-line Resources
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
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

Ref No
New Medicines Profile: Template Guidance Notes
Ref 5
INNOVATE
Ref 2
Busse et al
Trial Design
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)
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
 FEV
1
≥ 40 to ≤ 80% of predicted normal value and continuing asthma symptoms
 FEV
1
reversibility ≥
12% from baseline within 30 minutes after administration of inhaled β
2
-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 β
2
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 FEV
1
<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 FEV
1
Results
Omalizumab Placebo
0.68
0.24
0.91
P value
0.042
Rate ratio 0.738 (95% CI: 0.552-0.998)
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
0.48
96ml
0.002
Primary outcome
Mean number of exacerbation episodes per patient in stable steroid phase
Secondary outcomes
Omalizumab
0.28
% of patients experiencing at least one exacerbation in stable steroid phase
% of patients achieving >50% reduction in beclometasone dipropionate dose
14.6%
72.4%
Mean change in PEF at week 16 18.5L/min
Placebo
0.54
23.3%
54.9%
6.9L/min
P value
0.006
0.009
<0.001

New Medicines Profile: Template Guidance Notes
Ref
No
1
2
3
4
5
Trial
Design
Randomised, open-label,
6-month study
Randomised, open-label,
6-month study
Randomised, open-label,
6-month study
Randomised, open-label,
3-month study
Randomised, open-label,
3-month study
Trial Population Treatment Primary Outcomes Comments
328 patients with type-
1 diabetes receiving a stable regimen of SC insulin
335 patients with type-
1 diabetes receiving a stable regimen of SC insulin
299 patients with type-
2 diabetes receiving a stable regimen of SC insulin
309 patients with type-
2 diabetes uncontrolled on dual OA therapy
1.
Morning and bedtime SC NPH plus preprandial INH or
2.
Morning and bedtime SC NPH plus preprandial SI.
Insulins were titrated to achieve pre-specified glycaemic targets.
1.
Pre-prandial INH plus a single bedtime dose of SC insulin zinc suspension or
2.
Two to three daily injections of a SI/NPH insulin regimen.
Insulins were titrated to achieve pre-specified glycaemic targets.
1.
Pre-prandial INH plus a single bedtime dose of SC insulin zinc suspension or
2.
At least two mixed SI/NPH injections per day.
Insulins were titrated to achieve pre-specified glycaemic targets.
1.
Pre-prandial INH only or
2.
Pre-prandial INH plus OA (at existing doses)
or
3.
OA only.
68 patients with type-2 diabetes inadequately controlled on OA
1.
Pre-prandial INH plus OA (at existing doses)
2.
or
OA only.
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).
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).
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).
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%).
*(P<0.001 for difference vs.
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)
Not ITT analysis.
Not ITT analysis.
Not ITT analysis.
Changing to, or adding, insulin is standard practice in people with type 2 diabetes poorly controlled on OA therapy.
As above