Suffolk PCT Drug & Therapeutics Committee New Medicine Report
This drug has been reviewed because it is a product that may be prescribed in primary care.
Medicine Azilsartan medoxomil▼ (Edarbi®, Takeda) Document status Draft for review at September 2012 Suffolk D&TC meeting Date of last revision 8/10/12- post CPG Traffic light decision Double Red – Prescribing not supported in either general practice or secondary/tertiary care Prescribers rating Nothing New -The product may be 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
Mechanism of action Azilsartan medoxomil is an orally active prodrug that is rapidly converted to the active moiety, azilsartan, which selectively antagonises the effects of angiotensin II by blocking its binding to the AT1 receptor in multiple tissues. Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Blockade of the AT1 receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increases in plasma renin activity and angiotensin II circulating levels do not overcome the antihypertensive effect of azilsartan. [1]
Peak plasma concentrations of azilsartan are reached within 1.5 to 3 hours post-dose. The elimination half-life is 11 hours. Near-maximal antihypertensive effect is evident at 2 weeks, with maximal effects attained by 4 weeks. [1]
Medicine class BNF 2.5.5.2 angiotensin II receptor antagonist
Indication Treatment of essential hypertension in adults. [1]
Dosage The recommended starting dose is 40 mg once daily. The dose may be increased to a maximum of 80 mg once daily. [1]
Additional blood pressure reduction can be achieved by co- administering other antihypertensive medicinal products, including diuretics (such as chlortalidone and hydrochlorothiazide) and calcium channel blockers. [1]
No initial dose adjustment is necessary in elderly patients, 20mg can be used as a starting dose in the very elderly ( 75 years), who may be at risk of hypotension. [1]
There is no experience of use in patients with severe renal impairment and end stage renal disease. Hemodialysis does not remove azilsartan from the systemic circulation. No dose adjustment is required in patients with mild or moderate renal impairment. [1]
This is an NHS Suffolk document that has been adopted by the WSCCG.
Azilsartan use is not recommended in patients with severe hepatic impairment as it has not been studied. There is only limited experience in patients with mild to moderate hepatic impairment. Close monitoring is recommended and consideration should be given to 20 mg as a starting dose. [1]
For patients with possible depletion of intravascular volume or salt depletion (e.g. patients with vomiting, diarrhoea or taking high doses of diuretics), azilsartan should be initiated under close medical supervision and consideration can be given to 20 mg as a starting dose. [1]
Exercise caution in hypertensive patients with congestive heart failure as there is no experience of use of azilsartan in these patients. [1]
No dose adjustment is required in the black population, although smaller reductions in blood pressure are observed compared with a non-black population. Consequently, uptitration of azilsartan and concomitant therapy may be needed more frequently for blood pressure control in black patients. [1]
The safety and efficacy of azilsartan in children and adolescents 0 to < 18 years have not yet been established. [1]
Treatment Other ARBs: candesartan, eprosartan, irbesartan, losartan, alternatives olmesartan, telmisartan, valsartan. [2]
Place in therapy The current NICE clinical guideline for hypertension (see below) recommends using low cost ARBs – candesartan, losartan and valsartan are currently available as lower cost generic ARBs. [2-4]
NICE Hypertension Clinical Guideline [4] Age Step 1 Step 2 Step 3 ≤ 55 years ACE inhibitor or Add calcium low cost ARB channel blocker Add thiazide ≥ 55 years OR Calcium Add ACE like diuretic black person channel inhibitor or low of African / blockers cost ARB Caribbean family origin
Azilsartan is structurally related to candesartan but it is more lipophilic, which potentially increases its oral bioavailability. [3] It appears to be an overwhelmingly selective AT1 antagonist, with greater potency and longer-lasting pharmacologic effect compared with other ARBs. [3]
It is suggested that azilsartan may be a useful treatment option giving enhanced blood pressure control in patients already taking an ACEI or ARB, before trying dual or triple antihypertensive therapy. In most cases it may be a more expensive option than the addition of a calcium channel blocker or diuretic. Patient adherence to a multiple-drug treatment regimen may need to be taken into consideration. [3]
Future alternatives None known
Evidence for use 7 phase III clinical trials assessing the efficacy of azilsartan are tabulated in appendix 1.[3] Review prepared by Katie Smith, East Anglia Medicines Information Service for NHS Suffolk May be freely copied by NHS agencies Not to be used for promotional purposes
The surrogate endpoint change in 24 hour ambulatory blood pressure monitoring (ABPM) was used in most studies as the primary endpoint. This provides a good insight into blood pressure changes during everyday activities and is recommended for the evaluation of new antihypertensive drugs, but there are insufficient data to accept it as the sole basis for efficacy in an approval process. [3]
Azilsartan was shown to lower systolic blood pressure to a greater degree than olmesartan, valsartan and ramipril. [3] However, although the differences in mean 24 hour SBP by ABPM between azilsartan and olmesartan/valsartan are statistically significant, they are only a few mmHg (2.5 to 4.3) and this may not be clinically significant. Response rates (SBP<140mHg and/or reduction of ≥20mmHg) were generally higher in patients treated with azilsartan. [3]
The combination of azilsartan plus amlodipine was more effective at lowering systolic BP than amlodipine alone, with a reduced incidence of peripheral oedema. [3]
The mean age of patients in the studies was over 55 years of age; according to NICE guidance treatment would be initiated with a calcium channel blocker. [3]
NNT Not calculated Cautions / side Contraindications - Hypersensitivity to the active substance or to any effects of the excipients; use in the second and third trimester of pregnancy. [1]
Concomitant use with lithium not recommended. [1] Caution required with concomitant use of: non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day), and non-selective NSAIDs. potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels. [1] No clinically significant interactions have been reported in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, and warfarin.[1]
Azilsartan at doses of 20, 40 or 80 mg has been evaluated for safety in clinical studies in patients treated for up to 56 weeks. In these clinical studies, adverse reactions associated with treatment with azilsartan were mostly mild or moderate, with an overall incidence similar to placebo. Common adverse reactions are diarrhoea, dizziness and increase in blood creatine phosphokinase. Uncommon adverse reactions are hypotension, fatigue, peripheral oedema, increased blood creatinine and blood uric acid and hyperuricemia. [1]
The incidence of adverse reactions with Edarbi was not affected by gender age or race [1]
Cost within PbR Yes tariff?
Review prepared by Katie Smith, East Anglia Medicines Information Service for NHS Suffolk May be freely copied by NHS agencies Not to be used for promotional purposes
Cost & comparative See appendix 2 costs Potential number of The NICE Hypertension Costing Template allows calculation of patients & usage in costs for treating hypertension in adults ≥ 35 years and makes a Suffolk PCT number of assumptions. [15] For NHS Suffolk the assumptions are as follows: 529,933 adults ≥ 35 years old 47.5% have hypertension = 251,718 60% have a doctors diagnosis = 151,031 81.58% with a diagnosis on antihypertensive drugs = 123,211 Number of adults taking 1 drug = 50,517 (41%) Number of adults taking 2 drugs = 50,517 (41%) Number of adults taking 3 drugs = 22,177 (22%)
Use of azilsartan is likely to be low due to its aquisition cost in comparison with other low cost ARBs already available.
Review prepared by Katie Smith, East Anglia Medicines Information Service for NHS Suffolk May be freely copied by NHS agencies Not to be used for promotional purposes
Is the drug on the West Suffolk Hospital - TBC WSH or IHT Ipswich Hospital – No, not considered formularies? Decisions from other Cambridgeshire JPG - Double Red Not Funded for Prescribing in bodies Primary or Secondary Care. Additional benefit for the additional cost was not felt to be value based. (July 2012) Norfolk TAG – not considered yet. SMC - in the absence of a submission from the holder of the marketing authorisation: azilsartan medoxomil (Edarbi®) is not recommended for use within NHS Scotland. (July 2012) AWMSG - in the absence of a submission from the holder of the marketing authorisation, azilsartan medoxomil (Edarbi®) cannot be endorsed for use within NHS Wales for the treatment of essential hypertension in adults. (March 2012)
Points for Azilsartan is the 8th ARB to be launched in the UK. consideration Azilsartan is structurally related to candesartan but it is more lipophilic, which potentially increases its oral bioavailability and has greater potency and longer-lasting pharmacologic effect compared with other ARBs. Azilsartan was shown to lower systolic blood pressure to a greater degree (2.5 to 4.3 mmHg) than olmesartan, valsartan and ramipril in clinical studies. Although the differences are statistically significant, they may not be clinically significant. The mean age of patients in the studies was over 55 years of age; according to NICE guidance treatment would be initiated with a calcium channel blocker. The current NICE clinical guideline for hypertension recommends using low cost ARBs – azilsartan is considerably more expensive than candesartan, losartan and valsartan. It is suggested that azilsartan may be a useful treatment option giving enhanced blood pressure control in patients already taking an ACEI or ARB, before trying dual or triple antihypertensive therapy. In most cases it may be a more expensive option than the addition of a calcium channel blocker or diuretic. Patient adherence to a multiple-drug treatment regimen may need to be taken into consideration. Other decision making bodies have not approved azilsartan for use. Comments sought
Decision review date Sept 2014
References 1. Summary of Product Characteristics. Edarbi tablets. Date of first authorisation/renewal of the authorisation 07/12/11. Takeda UK Ltd www.emc.medicines.org.uk 2. Martin J, editor. British National Formulary No 63. London: British Medical Association and The Royal Pharmaceutical Society of Great Britain; March 2012. Accessed 02/08/12 via http://www.bnf.org/bnf/ 3. Denby A. Azilsartan Medoxomil Primary Care Briefing. London New Drugs Group, July 2012. 4. Hypertension: clinical management of primary hypertension in adults. August 2011. Clinical guidelines CG127. NICE and British Hypertension Society http://guidance.nice.org.uk/CG127
Review prepared by Katie Smith, East Anglia Medicines Information Service for NHS Suffolk May be freely copied by NHS agencies Not to be used for promotional purposes 5. Bakris GL, Sica D, Weber M et al. The comparative effects of azilsartan medoxomil and olmesartan on ambulatory and clinic blood pressure. J Clin Hypertens 2010; 13:81-88. 6. Sica DA, White WB, Weber M et al. Comparison of the novel angiotensin II receptor blocker azilsartan medoxomil vs. valsartan by ambulatory blood pressure monitoring. J Clin Hypertens 2011; 13 (7):467-472. 7. Sica D, Bakris GL, White WB et al. Blood pressure-lowering efficacy of the fixed-dose combination of azilsartan medoxomil and chlorthalidone: a factorial study. J Clin Hypertens 2012; 14 (5):284-292. 8. Weber MA, White WB, Sica D et al. Antihypertensive efficacy of the novel angiotensin receptor blocker azilsartan medoxomil in combination with amlodipine. J Hypertens 2010; 29:e279-e280. 9. White WB, Weber M, Sica D et al. Effects of the angiotensin receptor blocker azilsartan medoxomil versus olmesartan and valsartan on ambulatory and clinic blood pressure in patients with stages 1 and 2 hypertension. Hypertension 2011; 57:413-420. 10. Bonner G, Bakris GL, Sica D et al. Comparison of antihypertensive efficacy of the new angiotensin receptor blocker azilsartan medoxomil with ramipril. J Hypertens 2010; 28:e282; doi.10.1097/01.hjh.0000379038.73342.22. 11. Cushman WC, Bakris GL, White WB et al. Azilsartan medoxomil plus chlorthalidone reduces blood pressure more effectively than olmesartan plus hydrochlorothiazide in stage 2 systolic hypertension. Hypertension 2012; doi: 10.1161/hypertensionaha.111.188284. 12. WHO Defined Daily Doses: ATC/DDD Index 2012. WHO Collaborating Centre for Drug Statistics Methodology, Oslo Norway http://www.whocc.no/atc_ddd_index/ 13. MIMS July 2012. Haymarket., 2012.www.mims.co.uk 14. Department of Health, Welsh Government. National Health Service England and Wales. Drug Tariff July 2012. TSO, London., 2012.http://www.ppa.org.uk/edt/July_2012/mindex.htm 15. Hypertension Costing Template - Implementing NICE guidance, August 2011 http://guidance.nice.org.uk/CG127/CostingTemplate/xls/English
Review prepared by Katie Smith, East Anglia Medicines Information Service for NHS Suffolk May be freely copied by NHS agencies Not to be used for promotional purposes
Appendix 1 – Summary of phase III clinical trials evaluating the efficacy of azilsartan
No. of patients Ref Dose, titration, power calculation Results : Primary endpoint Results: other parameters (BP measured in mmHg) Inclusion criteria
Mean change in 24-hour mean SBP (mmHg) by ABPM at week 6 Placebo (difference vs. OLM) Reductions in sitting trough SBP were -14.3 (AZL20mg), -14.5 (AZL40mg), - AZL 20mg, 40mg or 80mg OD 1275 pts (mean age 58) 17.6 (AZL80mg, p=0.043 vs. OLM) and -14.9 (OLM40mg). OLM 40mg OD with sitting trough clinic AZL AZL AZL OLM Early morning SBP at week 6 demonstrated trend towards greater Placebo 5 SBP ≥150 to ≤180mmHg 20mg 40mg 80mg 40mg reduction with AZL80mg (-12.2) than with OLM40mg (-9.9, p=0.054). 90% power to detect a difference of and 24-hour mean SBP -12.2* -13.5* -14.6* Changes in DBP were consistent with those for SBP. 5.5mmHg between AZL and placebo -1.4 -12.6* ≥130 to ≤170mmHg. (0.4) (-0.9) (-2) Responder rates were 48%, 50% and 57% with AZL 20mg, 40mg and 80mg, and a 4mmHg difference between AZL and 53% with OLM40mg. - p=NS† p=NS† p=0.038† - and OLM. Side effects were similar to those observed in placebo group. * p<0.001vs. placebo; †p vs. olmesartan AZL lowered SBP to a larger extent than VAL 320mg at each hour. 984 pts (mean age 57) Forced titration after 2 weeks Mean change in 24 hour SBP (mmHg) by ABPM at week 24 Mean decreases in ABPM tended to be smaller during 16-24 hour interval with clinic SBP ≥ 150 to AZL 20mg titrated to 40mg or 80mg. OD (difference from VAL) than during 1-15 hour interval in all groups. ≤180mmHg and 24-hour VAL 80mg titrated to 320mg OD. Overall changes to DBP were similar to those for SBP. 6 mean SBP ≥130 to AZL 40mg: AZL 80mg VAL 320mg Response rates were higher with AZL40mg (56%, p=0.016) and 80mg ≤170mmHg. 90% power to demonstrate non- (59%, p=0.002) than with VAL320mg (47%). Mean age 57 years. 15% inferiority between AZL and VAL on -14.9* (-3.6) -15.3* (-4) -11.3 Adverse events incidences were lower in AZL groups (~65%) than in the black. primary endpoint. *p<0.001 vs. VAL VAL group (59.2%). Mean change in trough SBP by ABPM (mmHg) week 8
AZL 20mg, 40mg or 80mg OD Combination therapy reduced SBP and DBP to a significantly greater AZL 20 AZL 20/CLD 12.5 AZL 20/CLD 25 CLD 12.5mg or 25mg extent than either monotherapy. -12.1 -22.9* -26.3* Combination of the above: 20mg or Target BP (SBP<140 and DBP<90mmHg) achieved in significantly more AZL 40 AZL 40/CLD 12.5 AZL 40/CLD 25 1714 pts (mean age 57) 40mg or 80mg /12.5mg or 20mg treated with AZL/CLD (70-85%) than with AZL or CLD alone (30-52% and 7 with clinic SBP ≥160 to -12.8 -24.4* -29.8* 34-51%) (p<0.05, AZL/CLD vs. both monotherapies). ≤190mmHg. 90% power to detect a difference of AZL 80 AZL 80/CLD 12.5 AZL 80/CLD 25 Adverse events including dizziness and raised serum creatinine were 5mmHg between fixed dose -15.1 -26.3* -28* higher with AZL/CLD than CLD monotherapy and may reflect the direct combinations and highest doses of each CLD 12.5 CLD 25 randomisation to higher doses, rather than slow titration (as would occur monotherapy. in clinical practice). Hypotension occurred in 0.6-3.1% of patients. -12.7 -15.9 * p<0.05 vs. ALZ monotherapy and vs. CLD
Review prepared by Katie Smith, East Anglia Medicines Information Service for NHS Suffolk May be freely copied by NHS agencies Not to be used for promotional purposes
No. of patients Ref Dose, titration, power calculation Results : Primary endpoint Results: other parameters (BP measured in mmHg) Inclusion criteria
Mean change in 24-hour mean SBP (mmHg) by ABPM at week 6 (difference from placebo + amlodipine) Conference abstract only. 562 pts (mean age 58) Placebo Reductions in SBP were -15.9 (placebo), -27 (AZL40mg) and -25.5 with stage 2 hypertension 8 AZL 40mg or 80mg OD (AZL80mg), p<0.001 AZL vs. placebo. (clinic SBP ≥160mmHg). Placebo AZL 40mg: AZL 80mg All received amlodipine 5mg OD Peripheral oedema occurred in 4.9% (n=9) taking placebo + AML vs. 2.1% Mean age 58 yrs. -13.6 -24.8* (-11.2) -24.5* (-10.9) (n=4) taking AZL + AML. * p<0.001 vs. placebo. All received amlodipine Forced titration after 2 weeks Placebo Mean change in 24-hour mean SBP (mmHg) by ABPM at week 6 Hourly reductions in ambulatory SBP were lower than those of placebo at AZL 20mg or 40mg titrated to 40mg or all time-points with all 4 active treatments. 1285 pts (mean age 56) 80mg OD. AZL AZL VAL OLM Placebo Changes in trough SBP were significantly greater with AZL40mg (-16.4) and with clinic SBP ≥150 to VAL 160mg titrated to 320mg OD, 40mg 80mg 320mg 40mg AZL80mg (-16.7) than with VAL320mg (-11.3) and OLM40mg (-13.2) at week 9 ≤180mmHg and 24-hour OLM 20mg titrated to 40mg OD. -0.3 -13.4*† -14.5*†‡ -10.2* -12.0* 6 (p<0.001, AZL vs. VAL, p≤0.018 AZL vs. OLM). mean SBP ≥130 to Response rates achieved in 58% (AZL80mg), 22% (placebo), 49% ≤170mmHg. ≥90% power to detect a difference of Differenc VAL -3.2 VAL -4.3 (VAL320mg) and 49% (OLM40mg), p=0.05. 5.5mmHg between AZL and placebo es OLM -1.4 OLM -2.5 Adverse events occurred to similar extents between groups. and of 4mmHg between AZL and *p<0.001 vs. placebo †p<0.001 vs. VAL ‡p=0.009 vs. OLM VAL/OLM, in 24hr ABPM. Mean change in trough sitting clinic SBP (mmHg) at week 24 Conference abstract only. (difference from RAM) Baseline BP was similar in each group. 884 pts (mean age 57) Forced titration after 2 weeks Response rates higher with AZL40mg (54%) and 80mg (53.6%) than with 10 with clinic SBP 150- AZL 20mg OD titrated to 40mg or 80mg. AZL 40mg AZL 80mg RAM 10mg RAM10mg (33.8%), p<0.001. 180mmHg. RAM 2.5mg OD titrated to 10mg OD. Adverse events leading to discontinuation (2.4%, 3.1% and 4.8%) and -20.6* (-7.8) -21.2* (-9) -12.2 cough (1%, 1.4%, 8.2%) were less frequent with AZL40mg and 80mg than * p<0.001 vs. RAM with RAM10mg.
Mean change in clinic SBP (mmHg) at week 12 (difference from
OLM/HCZ) Abstract only. 1071 pts (mean age 57) AZL/CLD 40/25mg or 80/25mg OD Hydrochlorothiazide has traditionally been the thiazide used in 11 with clinic SBP 160- OLM/HCZ 40/25mg OD AZL 40mg/ CLD AZL 80mg/ CLD OLM/HCZ combination products, but chlorthalidone has a longer half-life and can 190mmHg. 13 -42.5* (-5.4) -44.0* (-6.9) -37.1 lower BP more effectively, which may partly account for these results. * p<0.001 vs. OLM/HCZ AML: amlodipine AZL: azilsartan CLD: chlorthalidone HCZ: hydrochlorothiazide OLM: olmesartan RAM: ramipril VAL: valsartan
ABPM: ambulatory blood pressure monitoring SBP: systolic blood pressure DBP: diastolic blood pressure Responder = reduction in SBP to <140mmHg and/or reduction of ≥20mmHg
Review prepared by Katie Smith, East Anglia Medicines Information Service for NHS Suffolk May be freely copied by NHS agencies Not to be used for promotional purposes
Appendix 2 – Cost of selected antihypertensive drugs
Examples of combinations, cost/year WHO Defined Daily Dose Cost per month Drug Cost / year + amlodipine + [12] [13, 14] + amlodipine bendroflumethiazide
28x40mg: £16.80 Azilsartan 40-80mg OD (not listed) £218.40 – £259.35 - 28x80mg: £19.95
28x8mg: £9.89 Candesartan 8mg OD £125.57 – £165.36 £137.66-£286.26 £147.41 – £296.01 28x16mg: £12.72 Losartan 50mg OD 28x50mg: £1.83 £23.79 £35.88 £62.14 Olmesartan 20mg OD 28x20mg: £12.95 £168.35 £180.44 £190.19 Valsartan 80mg OD 28x80mg: £4.07 £52.91 £65 £74.75 Ramipril 2.5mg OD 28x2.5mg: £1.17 £15.21 £27.30 £37.05 Bendroflumethiazide 2.5mg OD 28x2.5mg: £0.75 £9.75 - Furosemide 40mg OD 28x40mg: £0.78 £10.14 - Amlodipine 5mg OD 28x5mg: £0.93 £12.09 -
Review prepared by Katie Smith, East Anglia Medicines Information Service for NHS Suffolk 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 this-
Rank: 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 Individuals are randomly allocated to a control group and a group who receive a specific 2 (finer distinctions may be drawn within this intervention. Otherwise the two groups are identical for any significant variables. They are group based on statistical parameters like the followed up for specific end points. confidence intervals)
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. Adapted from Systematic reviews, What are they and why are they useful? ScHARR 2008
Review prepared by Katie Smith, East Anglia Medicines Information Service for NHS Suffolk May be freely copied by NHS agencies Not to be used for promotional purposes
To Decide if a Medication Is To Be Used In Suffolk
Criterion to be measured Tends to poor Medium Tends to good 7-8 5-6 3-4 2 1 Quality of evidence in the papers reviewed Low Medium High Magnitude of effect inferred from trials reviewed Low x Medium High Are trial end-points surrogate markers or clinical outcomes? Surrogate Clinical usefulness of trial end-points Low Medium x High Known Side Effect Profile High Medium x Low Known Interactions High Medium x Low Concern re Possible Side Effects Not Yet Uncovered High Medium x Low Balance of Benefit To Harm (side effects toxicity interactions etc) Poor Medium Good NNT – not calculated High Medium Low Comparison Of Effectiveness With Other Medicines In Use For The Poor Medium Good Same Condition Severity of Condition to be Treated Severe Medium Trivial Novel drug or member of existing class Existing class Uptake (estimated proportion of people with this condition likely to be < 2% prescribed the medication under consideration – maximum and minimum uptake) QIPP Rating Not recommended for use in Suffolk
Prescriber’s Rating Definitions Bravo! -The drug is a major therapeutic advance in an area where previously no treatment was available. A real advance - The product is an important therapeutic innovation but has certain limitations. Offers an advantage - The product has some value but does not fundamentally change present therapeutic practice. Possibly Helpful - The product has minimal additional value, and should not change prescribing habits except in rare circumstances. Judgement reserved - The Committee postpones its judgement until better data and a more thorough evaluation of the drug are available. 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. Not acceptable - Product without evident benefit over others but with potential or real disadvantages.
(With acknowledgement to Prescrire)
Review prepared by Katie Smith, East Anglia Medicines Information Service for NHS Suffolk May be freely copied by NHS agencies Not to be used for promotional purposes
To Decide Where A Medication Is To Be Used In Suffolk
Criterion Red Amber Green Blue Skills of the Experience Of The Condition Specific Specific Specific Genera prescriber Diagnosis Specific Specific Specific Genera Monitoring Progress Of Treatment Difficult Specific General Genera
Therapy Patient Selection Difficult Specific Specific Easy Initiation Of Treatment Difficult Difficult Easy Easy Dose Titration Difficult Specific Easy Easy Monitoring Of Side Effects Complex Easy Easy Easy Method Of Administration Complex Normal Normal Normal Discontinuation Of Treatment Complex Complex Easy Easy
References Jonsen A. Bentham in a box: Technology assessment and health care allocation. Law Med. Health Care. 1986;14:172-174 1 Suffolk Drug & Therapeutics Committee Responsibility for prescribing, Hospital Trust or GP Attached as Appendix 1 & Appendix 2
Review prepared by Katie Smith, East Anglia Medicines Information Service for NHS Suffolk May be freely copied by NHS agencies Not to be used for promotional purposes