Health HCP Template

Quick Reference Guide for a Formulary Application
Indications
Licensed
Indication
Anoro Ellipta 55/22mcg is indicated as a maintenance bronchodilator treatment to
relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Licensed
Dose
One inhalation once daily
Evidence for use
In three head-to-head efficacy studies Anoro Ellipta improved trough FEV1 by 112mL (p<0.001), 90mL (p<0.001), and 60mL
(p=ns*) respectively compared to tiotropium. (Data on File UK/UCV/0021/14, Anzueto et al. 2013, Decramer et al. 2013)
Anoro Ellipta demonstrated a reduction in rescue medication use by -0.5 (p<0.001), -0.6 (p=0.022), and -0.6 (p=ns) mean
puffs/day respectively compared to tiotropium (Data on File UK/UCV/0021/14, Anzueto et al. 2013, Decramer et al. 2013)
Both Anoro Ellipta and tiotropium demonstrated improvements in total SGRQ score from baseline (>4 unit change). In two
studies Anoro Ellipta improved SGRQ score by -6.87 and -9.95 units from baseline. The differences between Anoro Ellipta
and tiotropium were not significant (p=ns) (Anzueto et al., 2013, Decramer et al., 2013). In one study, Anoro Ellipta
improved SGRQ score by -7.27 from baseline, and improved SGRQ score by 2.10 units compared to tiotropium (P=0.006)
(Data on file: UK/UCV/0021/14).
TDI focal scores was evaluated in two studies. In both studies Anoro Ellipta improved TDI focal score by 2.3 units from
baseline. Comparisons between Anoro Ellipta and tiotropium were not statistically significant (p = ns) (Anzueto et al., 2013
Decramer et al., 2013, Data on file: UK/UCV0021/14).
* p=ns due to statistical hierarchy
Exercise Studies
Two studies, identically designed and analysed, multicentre, randomised, double blind, incomplete block design cross-over
studies were conducted comparing Anoro Ellipta with placebo. Treatments were given once daily using the Ellipta dry
powder inhaler. These studies compared Anoro Ellipta with placebo in improvement in Exercise Endurance Time (EET) and
lung volume parameters.
Anoro Ellipta improved EET by 69.4 seconds (p=0.003) versus placebo. In another study EET was improved by 21.9 seconds
but this result was not statistically significant (p=ns), this was due to a greater placebo response observed. However the
improvement from baseline for Anoro Ellipta was similar across both studies for EET. (Maltais et al., 2013)
Safety Profile
The safety profile of Anoro Ellipta is based on safety experience with umeclidinium/vilanterol and the individual
components from the clinical development program comprising of 6,855 patients with COPD.
This includes 2,354 patients who received umeclidinium/vilanterol once daily in the Phase III clinical studies, of whom
1,296 patients received the recommended dose of 55/22 micrograms in 24-week studies, 832 patients received a higher
dose of 113/22 micrograms (unlicensed dose within the UK) in 24 week studies and 226 patients received 113/22
micrograms in a 12 month study.
Please refer to the SPC for full safety information and special warnings and precautions.
Prescribing Information can be found on the last page of this document
UK/UCV/0005/14v(1)
Date of Prep: July 2014
This document has been produced by GlaxoSmithKline
Quick Reference Guide for a Formulary Application
Ellipta device and patient experience
Every time the Ellipta inhaler cover is opened one dose of medicine is prepared. The Ellipta inhaler has a large dose counter
which shows how many doses of medicine are left in the inhaler.
In 2 six month studies (n=1020) 63% patients preferred the Ellipta inhaler to the HandiHaler® device on the basis of time to
use and the number of steps required. (Riley et al. 2013)
The inhalation profiles generated by a range of COPD patients (42-129mL/min) were recorded and replicated using an
electronic lung (GSK) breathing simulator. In vitro, drug delivery via the Ellipta device, to the electronic lung was consistent
across the full range of PIFRs, 42-129mL/min. (Hamilton et al. 2012)
Cost
The 30-day cost of Anoro Ellipta 55/22mcg is £32.50.
LAMA
LABA
Cost of Licensed COPD Inhaled Therapies (MIMS July 2014)
Brand Name
Strength
Atimos Modulite*
12 mcg
Easyhaler Formoterol*
12mcg
Foradil*
Dose
Pack Price
Actuations
30-day cost
£30.06
100
£18.04
1 inhalation twice daily
£23.75
120
£11.88
12mcg
1 cap inhaled twice
daily
£23.38
60
£23.38
Onbrez Breezhaler
150 mcg
1 inhalation once daily
£29.26
30
£29.26
Onbrez Breezhaler
300 mcg
1 inhalation once daily
£29.26
30
£29.26
Oxis Turbohaler*
12 mcg
12 microgram once or
twice daily
£24.80
60
£24.80
Serevent Evohaler
25 mcg
2 puffs twice daily
£29.26
120
£29.26
Striverdi Respimat
2.5 mcg
2 puffs once daily
£26.35
60
£26.35
Vertine
25 mcg
2 puffs twice daily
£27.80
120
£27.80
Eklira Genuair
322 mcg
1 inhalation twice daily
£28.60
60
£28.60
Seebri Breezhaler
50 mcg
1 daily by inhalation
£27.50
30
£27.50
Spiriva Handihaler
18 mcg
1 daily by inhalation
£33.50
30
£33.50
Spiriva Respimat
2.5 mcg
2 puffs once daily
£33.50
60
£33.50
1 puff morning and
evening; max 4 puffs
daily
Prescribing Information can be found on the last page of this document
UK/UCV/0005/14v(1)
Date of Prep: July 2014
This document has been produced by GlaxoSmithKline
Quick Reference Guide for a Formulary Application
Brand Name
Strength
Dose
Pack Price
Actuations
30-day cost
55 mcg
1 puff daily
£27.50
30
£27.50
55/22mcg
1 puff daily
£32.50
30
£32.50
Fostair
100/6
mcg
2 puffs twice daily
£29.32
120
£29.32
Symbicort
200/6
mcg
2 puffs twice daily
£38.00
120
£38.00
Symbicort
400/12
mcg
1 puff twice daily
£38.00
60
£38.00
Seretide Accuhaler
500/50
mcg
1 puff twice daily
£40.92
60
£40.92
92/22
mcg
1 puff daily
£27.80
30
£27.80
ICS/LABA
LAMA/LABA
LAMA
Incruse®▼ Ellipta
(umeclidinium bromide)
Anoro®▼ Ellipta
(umeclidinium
bromide/vilanterol))
Relvar®▼ Ellipta
(fluticasone furoate/
vilanterol)
*All formoterol preparations are assumed to be dosed at 12mcg twice a day.
Potential drug cost-savings
Data to calculate the budget impact of use of Anoro Ellipta, specific to a locality, can be provided by your local GSK account
manager and health outcomes specialists if required.
Drug interactions
For information on drug interactions refer to the Anoro Ellipta 55/22mcg summary of product characteristics, available at
www.medicines.org.uk/emc for full prescribing information.
GSK does not recommend, endorse or accept liability for sites controlled by third-parties.
Prescribing Information can be found on the last page of this document
UK/UCV/0005/14v(1)
Date of Prep: July 2014
This document has been produced by GlaxoSmithKline
Quick Reference Guide for a Formulary Application
References
Anoro Ellipta 55/22mcg SmPC 2014.
Anzueto et al. The efficacy and safety of umeclidinium/ vilanterol compared with tiotropium in COPD. Annual
Congress of the American Thoracic Society (ATS), Philadelphia, PA, USA, 2013 , Poster No: 42837. 17-5-2013.
Decramer et al. Efficacy and Safety of umeclidinium/vilanterol compared with umeclidinium or tiotropium in COPD.
European Respiratory Congress of the European Respiratory Society (ERS), Barcelona, Spain , Poster No: P3640. 7-92014.
GSK Data on File: Anoro Ellipta 55/22mcg vs. tiotropium UK/UCV/0021/14 Date of Prep: Mar 2014.
Maltais et al. Effects of a t of vilanterol and umeclidinium on exercise endurance in subjects with
COPD: two randomised clinical trials. European Respiratory Congress of the European Respiratory Society (ERS),
Barcelona, Spain, Poster No: P761. 1-9-2013.
MIMS online, Accessed 17th July 2014.
Riley J et al. Use of a new dry powder inhaler to deliver umeclidinium/vilanterol in the treatment of COPD. Eur Respir
J. 42, 880s. 2013.
Prescribing Information can be found on the last page of this document
UK/UCV/0005/14v(1)
Date of Prep: July 2014
This document has been produced by GlaxoSmithKline
®
Anoro
®
▼Ellipta
(umeclidinium bromide/vilanterol [as trifenatate]) Prescribing information
(Please consult the full Summary of Product Characteristics (SmPC) before prescribing)
Anoro® Ellipta® 55/22mcg (umeclidinium
bromide/vilanterol [as trifenatate]) inhalation powder.
Each single inhalation of umeclidinium bromide (UMEC) 62.5
micrograms (mcg) and vilanterol (VI) 25mcg provides a
delivered dose of UMEC 55mcg and VI 22mcg. Indications:
COPD: Maintenance bronchodilator treatment to relieve
symptoms in adult patients with COPD. Dosage and
administration: Inhalation only. COPD: One inhalation once
daily of Anoro Ellipta. Contraindications: Hypersensitivity to
the active substances or to any of the excipients (lactose
monohydrate and magnesium stearate). Precautions: Anoro
Ellipta should not be used in patients with asthma.
Treatment with Anoro Ellipta should be discontinued in the
event of paradoxical bronchospasm and alternative therapy
initiated if necessary. Cardiovascular effects may be seen
after the administration of muscarinic receptor antagonists
and sympathomimetics therefore Anoro Ellipta should be
used with caution in patients with severe cardiovascular
disease. Anoro Ellipta should be used with caution in
patients with urinary retention, narrow angle glaucoma,
convulsive disorders, thyrotoxicosis, hypokalaemia,
hyperglycaemia and severe hepatic impairment. No dosage
adjustment is required in renal or mild to moderate hepatic
impairment. Acute symptoms: Anoro Ellipta is not indicated
for acute episodes of bronchospasm. Warn patients to seek
medical advice if short-acting inhaled bronchodilator use
increases, a re-evaluation of the patient and of the COPD
treatment regimen should be undertaken. Interactions with
other medicinal products: Interaction
studies have only been performed in adults. Avoid βblockers. Caution is advised when co-administering with
strong CYP3A4 inhibitors (e.g. ketoconazole,
clarithromycin, itraconazole, ritonavir, telithromycin).
Anoro Ellipta should not be used in conjunction with
other long-acting β2-adrenergic agonists or medicinal
products containing long-acting muscarinic antagonists.
Caution is advised with concomitant use with
methylxanthine derivatives, steroids or non-potassiumsparing diuretics as it may potentiate possible
hypokalaemic effect of β2-adrenergic agonists. Fertility,
pregnancy, and breast-feeding: No available data.
Balance risks against benefits. Side effects: Common:
Urinary tract infection, sinusitis, nasopharyngitis,
pharyngitis, upper respiratory tract infection, headache,
cough, oropharyngeal pain, constipation and dry mouth.
Uncommon: Atrial fibrillation, supraventricular
tachycardia, rhythm idioventricular, tachycardia,
supraventricular extrasystoles and rash. Legal category:
POM. Presentation and Basic NHS cost: Anoro® Ellipta®.
1 inhaler x 30 doses. Anoro Ellipta 55/22mcg - £32.50.
Marketing authorisation (MA) nos. 55/22mcg 1x30
doses [EU/1/14/898/002]; MA holder: Glaxo Group Ltd,
980 Great West Road, Brentford, Middlesex TW8 9GS,
UK. Last date of revision: April 2014. Anoro® and Ellipta®
are registered trademarks of the GlaxoSmithKline group
of companies. All rights reserved. Anoro® Ellipta® was
developed in collaboration with Theravance,Inc. Anoro
UK/RESP/0077/14
Adverse events should be reported. For the UK, reporting forms and information can be
found at www.mhra.gov.uk/yellowcard. For Ireland, adverse events should be reported
directly to the IMB; Pharmacovigilance Section, Irish Medicines Board, Kevin O'Malley
House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Tel: +353 1 6764971. Adverse events
should also be reported to GlaxoSmithKline on 0800 221 441 in the UK or 1800 244 255 in
Ireland.
Prescribing Information can be found on the last page of this document
UK/UCV/0005/14v(1)
Date of Prep: July 2014
This document has been produced by GlaxoSmithKline

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