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Project Implementation Work Stream
Switching Quetiapine XL (Slow Release) to IR (Immediate Release) Formulation Project Implementation Work Stream on behalf of NSFT D & T (Asta R Prajapati, Stuart Maddock, Siri Robling, Joan Bufton, Jenny Walker)
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Contents Background Pharmacology Cost Comparison
NSFT Guidance to switch to IR D & T recommendation Further info
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Background NSFT D & T Committee approved Prescribing Information on switching patients from quetiapine XL to IR in Mar 2017 May 2017: D & T approved Implementation Plan 1st Sept 2017: All patient requiring initiation of quetiapine should be prescribed IR except in exceptional cases (e.g. for initial 3 days for acute treatment of schizophrenia or mania to reduce in-patient bed days). All patient on quetiapine XL should be considered for switching to IR. 1st Dec 2017: Quetiapine XL will be non-formulary and thus any patient still needing XL will require non-formulary drug approval by D & T. Rationale: See Prescribing Information for details. But the essence is “No expected significant efficacy difference but significant cost difference between the TWO formulations” Quetiapine patent expired in March The cost of IR formulation decreased by ≈ 95% but cost of XL remained almost the same (although some XL formulation are cheaper than others but still hugely expensive than IR). Quetiapine developed in 1985 launched in 1997 by AstraZeneca. 1997 – IR Schizophrenia 2009 – IR - Bipolar XL Preparation released in 2009 for schizophrenia and Bipolar Bipolar Depression UK patent expired 2012
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Pharmacology Quetiapine is an SGA with relatively similar chemical structure to olanzapine and clozapine. See Handy Chart Comparing Antipsychotics Suggested Similar Efficacy Kahn 2007 : Suggested similar adverse effects (AEs) profile but possibly slightly higher sedation, orthostatistic hypotension and tachyardia with IR Meulien However they are variable and dose dependent, e.g. Sedation with 400mg/day IR = 0.8% patients cf 10.6% patients in XL 400mg/day. Adverse effect may be particularly pronounced during initial period SO advise patient to be vigilant for first 2 weeks (e.g. careful while standing up, driving etc.) End-Point IR 400mg / day XL 400mg / day PANSS Total Score CGI Response rate 75.6% 73.9% Also Treatment Satisfaction Questionnaire of Medication (TSQM) score on effectiveness and convinience did not seem significant . Although overall satisfaction score on TSQM was slightly lower in IR 63.0 (19.7) 58.9 (21.1) P= – Ref: Schizophr Res. 2015; Formulation Sedation Orthostatic Hypotension Tachycardia IR % % % XL % % % Ref: Meulien 2010
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Pharmacology: Mechanism of Action
Quetiapine is an atypical antipsychotic with actions mainly on D2 and 5-HT2 antagonism. Highest Affinity: H1, A1 Moderate: 5-HT2a, M1, 5-HT 7 Lowest: 5-HT2c, D2, 5-HT1a. It has a 5-HT1a partial agonistic actions, which along with it actions on 5-HT7, 5- HT2c contribute to its anti- depressant effects Nor-quetiapine which is the active metabolite of quetiapine, has a unique pharmacologic property. It inhibits adrenalin transport. Thus contributing to the anti-depressant effects of quetiapine.
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Pharmacokinetics Metabolism: Primarily hepatic by CYP 3A4.
Excretion: Urine (Major), Faeces (Minor), Unchanged (1%) Half-Life: quetiapine ≈ 7 hours and nor-quetiapine ≈ 12 hours Time to Peak (Tmax): IR ≈ 1.5 Hrs, XR ≈ 6 Hrs C Max is the same although time is 1.5hrs vs 6hrs Receptor occupancy at D2 site is not linked with plasma levels. Plasma levels correlate with histamine and alpha receptors. Arithmetic Mean Plasma Quetiapine Concentrations (SEM) Measured Over a 24-Hour Dosing Interval for Quetiapine IR and XR. (Ref: Figuera et al. Prog Neuropsychopharmacol Biol Psychiatry. 2009;33: )
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Licensed Indication
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Please check BNF for details.
Dosing for adult Formulation Schizophrenia Mania Quetiapine IR (Oral) 25 mg BD day 1, 50 mg BD day 2, 100 mg BD day 3, 150 mg BD day 4, then, adjusted according to response, maximum 750 mg per day. 50 mg BD day 1, 100 mg BD day 2, 150 mg BD day 3, 200 mg BD day 4, then adjusted in steps of up to 200 mg daily, usual dose 400–800 mg daily in 2 divided doses; max. 800 mg per day. Quetiapine XL 300 mg OD day 1, 600 mg OD day 2, then, adjusted according to response, max. 800 mg per day. 300 mg OD day 1, 600 mg OD day 2, then adjusted according to response, usual dose 400–800 mg once daily. The rate of dose titration may need to be slower and the daily dose lower in elderly patients. Dosing is different for bipolar depression or major depression. Please check BNF for details.
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Which one should we buy for our pain relief?
Nurofen ≈ £6.5 / 24 tablets Generic ≈ £0.78 / 36 tablets
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Cost Difference of ≈ £68.4K – £200K
Cost Comparison Graph 1: Cost comparison between Quetiapine XL and equivalent dose of IR The prices are from the Drug Tariff Nov 2016 and are based on the costs for 30 days treatment at the equivalent dose. Annual cost of quetiapine XL 600mg/day per 100 patient is ≈ £72K - £204K compared to ≈ £3600 for 600mg IR (Ref: BNF 2017) Cost Difference of ≈ £68.4K – £200K
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Many other Trusts, including most of our neighbouring mental health Trusts, have already been advising the switch.
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Switching Guidance Current dose of quetiapine XL
Quetiapine IR dosing options (See Guidance for details) For those who are tolerating quetiapine well and do not have compliance concerns For those who are (or at risk of ) experiencing sedation or postural hypotension following the switch# For those who are tolerating quetiapine well but have compliance concerns.* 400mg XL OD 200mg BD 150mg OM, 250mg ON 400mg ON 300mg XL OD 150mg BD 100mg OM, 200mg ON 300mg ON 200mg XL OD 100mg BD 50mg OM, 150mg ON 200mg ON 150mg XL OD 50mg OM, 100mg ON 150mg ON 100mg XL OD 50mg BD 25mg OM, 75mg ON 100mg ON 50mg XL OD 25mg BD 25mg BD OR 50mg ON 50mg ON
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NSFT D & T Recommendation
From 1st Aug 2017 All patients should be initiated on IR (For exception see Guidance) Prescribers are requested to consider switching patients on quetiapine XL to IR – Discuss with patient (see Patient information leaflet in the Guidance) Any patient who cannot tolerate or have specific clinical need please complete Non-Formulary Request form (with specific details of intolerance or clinical need) and send to Please consider this before Nov Also, ensure to record the intolerance or specific clinical need on Lorenzo under medication Alert. From 1st Nov 2017 Quetiapine XL will be non-formulary and prescribing of XL should continue only if Non-formulary Request form has been approved by D & T.
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Further information See “Prescribing Guidelines > Quetiapine XL to IR switch” on the West Suffolk CCG website for Prescribing Information for switching Quetiapine XL to IR and Implementation Plan which include some FAQs. This power point presentation for education, training and raising awareness For medicines information and related query D & T related queries
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Quetiapine – Update on costs (1)
Strength and formulation Feb 2016 Dec 2017 Jan 2018 25mg tablets IR £1.24 £0.91 £13.84 100mg tablets IR £2.07 £1.62 £52.22 150mg tablets IR £2.58 £2.27 £61.75 200mg tablets IR £2.89 £51.30 300mg tablets IR £3.52 £3.31 £73.45 50mg tablets MR £67.66 150mg tablets MR £113.10 200mg tablets MR 300mg tablets MR £170.00 400mg tablets MR £226.20 Drug Tariff costs, for 60 tablets (MR tablets are od, IR usually bd)
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Quetiapine – Update on costs (2)
Drug Tariff, January 2018 Daily dose Cost per month IR Cost per month MR 50mg £27.68 £67.66 100mg £104.44 £135.32 200mg £102.60 £113.10 300mg £146.90 £170.00 400mg £205.20 £226.20 The prices need to stabilise again before a decision can be made regarding cost-effective prescribing choices
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