Download Area - Wyre Forest CCG

Quarterly Report for Clinical Executive/Management Teams
TITLE OF REPORT:
Worcestershire Area Prescribing Committee (APC)
Recommendations: April 2014 – June 2014
PURPOSE OF REPORT:
For information
REPORT PREPARED FOR:
SWCCG Clinical Executive; WF Management Team & R&B
Management Team
REPORT PREPARED BY:
Danielle Clark; Medicines Assurance Pharmacist
DATE:
19th June 2014
The following is a summary of final Worcestershire APC formulary decisions made during April
2014 to June 2014, followed by a KPI report for that period:
APPROVED:
Canagliflozin [Invokana®▼; JanssenCilag] 100mg strength only
in accordance with its licensed
indication for Type 2 diabetes
mellitus.
Members present supported the addition of the 100mg strength
only of canagliflozin to the formulary for consultant initiation at the
current time to gain experience, with GPs to pick up the on-going
prescribing of the 100mg strength i.e. no prescribing of the 300mg
dose.
It was requested that it be highlighted to GPs within the Medicines
Commissioning Newsletter that the dose should be reviewed and
stopped if not effective. This decision would be reviewed within
three months of the expectant NICE TA being published, over which
time local experience would have been gained with this product,
ascertaining the appropriate criteria for escalating the dose from
100mg to 300mg.
A request for local prescribing guidance of oral antidiabetics was
(New Medicines Application)
requested and is currently being drafted.
®
Sayana Press (medroxyprogesterone The APC clinically supported the addition of Sayana® Press to the
acetate injection; Pfizer) for long-term Worcestershire formulary as an option for long-acting reversible
female contraception
contraception (LARC), but do not have delegated authority for the
Local Authority. LARCs are commissioned by the Public Health
team in the Local Authority (LA), therefore the decision to use this
medicine would need to be taken by the LA on this occasion.
This recommendation was taken through an internal process;
subsequently the LA supported the APC recommendation as the
responsible commissioner of this product both via the Sexual Health
(New Medicines Application)
Services through WHCT and for GP prescribing.
Tociluzumab subcutaneous
The APC supported the addition of the tociluzumab subcutaneous
preparation [RoActemra®; Roche]
(SC) preparation [RoActemra®; Roche] to the formulary for the
same formulary indications in rheumatoid arthritis as tocilizumab
intravenous (IV) infusion.
This is a new weekly SC preparation that can be self-administered
at home by appropriate patients as an alternative option to the 4
weekly IV infusion and can also be offered as an alternative to
existing patients receiving this IV infusion on the DayCase Unit;
such patients would still need to fall in line with NICE TA 247 or the
recently APC approved indication as monotherapy in case of
intolerance to methotrexate or where continued treatment with
methotrexate is inappropriate.
The manufacturer has agreed that this preparation can be provided
as part of the patient access scheme (PAS) in line with the criteria
set out in NICE TA 247. The annual IV drug cost (£7235 + VAT inc.
PAS*) is cheaper than the annual SC drug cost (£9318.40 + VAT
inc PAS*) but the IV annual cost does not include monthly infusion
and hospital attendance costs.
*PAS information is not confidential in this case but should not be
(New Medicines Application)
disclosed outside of the NHS.
Decapeptyl® SR (triptorelin) 22.5mg 6 Goserelin and triptorelin are the formulary approved choices in
monthly preparation
Worcestershire, with triptorelin being the most cost effective choice
for the three month injection.
The 6 monthly 22.5mg triptorelin preparation is the same price as
double the 3 monthly injection and has the advantage of saving on
(WAHT Consultant request to consider) both GP and patient consultation time.
Vesomni® (solifenacin
The APC supported the niche use of Vesomni® only in men who are
6mg/tamsulosin; Astellas Pharma)
stabilised on both solifenacin and tamsulosin. In these cases there
would be a small cost saving by prescribing the combination
(WAHT Consultant request to consider) product.
Alogliptin (Vipidia®▼; Takeda UK Ltd) There does not appear to be any significant clinical advantages of
in accordance with its licensed
alogliptin over other DPP-4 inhibitors available on the formulary but
indication for Type 2 diabetes
overall it appears that this is the most cost effective option. It was
mellitus.
agreed that alogliptin and the combination product Vipdomet ®▼
should be added to the formulary as another option in their class.
& Vipdomet®▼ (alogliptin/metformin; It was explained that on local audit it appears that DPP-4 inhibitors
Takeda UK Ltd)
are often not stopped when they should be, in line with NICE
criteria; this has been highlighted to prescribers within the
(Proactive appraisal by the APC)
Medicines Commissioning News, reinforcing the stopping criteria.
Fostair® (beclometasone dipropionate Fostair® now has a license for COPD, becoming the first licensed
100 micrograms, formoterol fumarate metered dose inhaler (MDI) for COPD.
6 micrograms/metered inhalation) for The APC agreed that Fostair® provided a more cost effective and
COPD
licensed option for where an MDI is appropriate and therefore
should be included on the formulary for COPD.
The local
management of stable COPD guidelines will be updated
(Proactive appraisal by the APC)
accordingly.
Xigduo®▼ (dapagliflozin/metformin;) in The APC approved the addition of the product to the formulary as
accordance with its licensed
most patients prescribed dapagliflozin would be taking metformin
indication for Type 2 diabetes
concurrently; the cost of the combined preparation being the same
mellitus.
as dapagliflozin alone i.e. Foxiga®▼.
(Proactive discussion)
Ocular Lubricant Guidance
(New APC Guidance)
A new guidance specific to the treatment of dry eye has been
written. These simple prescribing guidelines for managing dry eye
syndrome had been written as an opportunity to rationalise
prescribing across the Worcestershire Health Economy; currently
there are over 60 different ocular lubricant preparations.
The aims of treatment are to restore the ocular surface and improve
ocular comfort and the guidance has been classified as mild,
moderate and severe based on both symptoms and signs, but with
an emphasis on symptoms over signs.
DECLINED:
Denosumab (Prolia®▼; Amgen) for the
treatment of bone loss associated
with hormone ablation in men with
prostate cancer at increased risk of
For an informed decision to be made, members present felt that,
although the new medicines application was submitted by WAHT
Rheumatologists, the current local treatment pathway and how a
specific treatment group (i.e. those at greater risk of fracture) are
fractures.
currently ascertained, as well as an estimate of the patient number
within this cohort, needed to be established from the local
urologists.
As this information had not been forthcoming, the APC felt that
there was insufficient information to make a decision for the new
medicines application. Until the requested information was made
available for consideration, the default position was that denosumab
for the treatment of bone loss associated with hormone ablation in
men with prostate cancer at increased risk of fractures was not
(New Medicines Application)
supported.
®▼
®
Relvar Ellipta [fluticasone furoate The APC raised a number of points:
(FF), vilanterol; GSK] 92/22mcg and There is no evidence of clinical superiority over existing treatments
184/22mcg dry powder inhalers for
available on the Worcestershire formulary.
the treatment of asthma in adults and
 FF is approximately ten times the potency of BDP, therefore both
adolescents aged 12 years and older doses represent Step 4 of the BTS Asthma guidelines, and there is
where a combination inhaled
no option for stepping down the dose.
corticosteroids(ICS)/long-acting beta
 2 The device is contained within a sealed foil pouch, once opened,
agonist (LABA) is appropriate i.e.
the shelf life is 6 weeks, which may increase the risk of patients
patients not adequately controlled
using expired inhaler.
with inhaled corticosteroids and 'as Although dosing is once a day, the SPC notes that if a dose is
needed' inhaled short-acting beta2
missed, no dose should be taken before the next day’s dose is due.
agonists.
 The cost of these inhalers are less than existing combination
products (albeit the price of Seretide® may change in 2014 following
patent expiry); despite this, it is important to note that wider
management of asthma is more than just simple drug acquisition
cost and should include the tailoring of treatment and the
management of exacerbations and hospitalisation.
The relatively limited comparative data does not suggest that there
are likely to be important differences in efficacy compared to other
combination products and there is no safety data beyond 52 weeks.
Although Relvar® Ellipta® is more cost effective than existing
combination inhalers it was noted that FF is a more potent steroid
than FP, currently available in Seretide® and Flutiform®. Due to the
safety implications of this as well as the efficacy and the place of
Relvar® Ellipta® at these doses in the BTS guidelines, the APC
agreed that there was no benefit to add this product to the armoury
(New Medicines Application)
already available within the Worcestershire formulary.
®▼
Relvar Ellipta® [fluticasone furoate The APC understood that Seretide® and Revlar® Ellipta® contain
(FF), vilanterol; GSK] 92/22mcg dry
different chemical moieties –FP and FF respectively.
powder inhaler for the symptomatic
Pharmacokinetic studies have indicated that the latter has a longer
treatment of adult patients with
time for absorption from the lung, suggesting longer lung retention
Chronic Obstructive Pulmonary
times in once-daily dosing; cases of pneumonia, some fatal, were
Disease (COPD) with a FEV1 <70%
reported in the trials used for licensing.
predicted normal (postMembers present raised a number of points:
bronchodilator) with an exacerbation
 There is no evidence of clinical superiority over existing treatments
history despite regular bronchodilator available on the Worcestershire formulary.
therapy.
 No comparative studies versus Seretide, or versus other
established bronchodilators, have been conducted to appropriately
compare the effects of Relvar® Ellipta® on COPD exacerbations.
 The device is contained within a sealed foil pouch, once opened,
the shelf life is 6 weeks, which may increase the risk of patients
using expired inhaler.
 Although dosing is once a day, the SPC notes that if a dose is
missed, no dose should be taken before the next day’s dose is due.
 The cost of these inhalers are less than existing combination
products (albeit the price of Seretide® may change in 2014 following
patent expiry); despite this, it is important to note that wider
management of COPD is more than just simple drug acquisition
cost and should include the tailoring of treatment and the
management of exacerbations and hospitalisation.
The relatively limited comparative data does not suggest that there
are likely to be important differences in efficacy compared to other
combination products and there is no safety data beyond 52 weeks.
Although Relvar® Ellipta® is more cost effective than existing
combination inhalers it was noted that FF is a more potent steroid
than FP. Due to the safety implications of this as well as the
efficacy and the place of Relvar® Ellipta® in the local COPD
treatment pathway, the APC agreed that there was no benefit to
add this product to the armoury already available within the
(New Medicines Application)
Worcestershire formulary.
To allow patients with ankylosing
Firstly the APC wished to clarify that NICE TA 143 does not include
spondylitis (and axial
the treatment of axial spondyloarthropathy and therefore did not
spondyloarthropathy) to switch to an support the treatment of this indication. The APC did not support
alternative anti-TNF agent if only
the application to switch to an alternative anti-TNF agent if only
partial response is achieved.
partial response is achieved due to the lack of supporting clinical
effectiveness data. It was requested that this decision be reviewed
if new evidence was published or when the NICE TA 143 revision
(New Medicines Application)
was published; whatever came sooner.
The use of any ‘new drugs’ in Worcestershire, that being either those that have been newly launched or
existing drugs that have acquired a new non-formulary indication, is not currently supported. This decision will
be reviewed if a new drugs application for a specific new product is received or national guidance is made
available.
Key Performance Indicator (KPI) Report - April 2014 to June 2014
The internal functions of APC are monitored using the following key performance indicators (KPIs):

Meeting is quorate – standard 100%

New drug applications completed and supporting information provided – standard 100%

Resources checklist completed – standard 100%

APC papers circulated at least five working days before meeting – standard 100%

Decision-making criteria applied to all new drug applications – standard 100%

Rationale for decision made documented within checklist for new drug applications – standard
100%

Applicant informed of APC recommendation within seven working days of final decision being
made – standard 100%
KPI
Standard:
Meeting is quorate
100
New drug applications completed
and supporting information provided
100
Resources checklist completed
100
APC papers circulated at least 5
working days before meeting (paper
based or electronic)
Decision-making criteria applied to
all new drug applications
100
Rationale for decision made
documented within checklist for new
drug applications
Applicant informed of APC decision
within 7 working days of final
decision being made
100
100
100
01/04/2014
06/05/2014
03/06/2014
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