Download Borders Formulary Committee Meeting Minute 09 12 15

MEETING OF THE BORDERS FORMULARY COMMITTEE HELD
ON WEDNESDAY 9th DECEMBER 2015 @ 12.30 P.M. IN THE ESTATES MEETING ROOM
MINUTE
1. In attendance: Alison Wilson (Chair; Director of Pharmacy); Liz Leitch (Formulary Pharmacist); Dr Paul Marynicz (GP); Dr Paul Neary
(Consultant Cardiologist); Keith Maclure (Lead Pharmacist - Medicines Utilisation & Planning); Dr Craig Wheelans (Associate Medical Director of
Clinical Governance & Equality); Allison Carruthers (Clinical Pharmacist); Dr Lindsey Burton (Registrar); Kate Warner (BFC Minute Secretary)
2. Apologies: Catherine Scott (Senior Pharmacist);
Item
No.
Situation, Background & Assessment
Recommendation
Person
Responsi
ble
Timescale
2.
3.
Declaration of Interest: - Dr P Neary declared an interest in Apixaban.
BFC meeting Draft Minute from BFC meeting 14th October 2015 was read for accuracy and
approved.
Matters Arising From Previous Minute:
Borders Joint Formulary App is still waiting for IM&T credit card to enable setup of store
accounts required to upload it. – no date for this as yet - Shona Milne chased this last week with
provider of credit card.
Patients started on drug that is not cost effective because the information is not available. IM&T
refused to have formulary on PCs as a desktop icon in wards. Issues have been reported with the
search function of the Formulary. If not resolved, ongoing maintenance fees should be
questioned as BJF currently unusable.
Request update from
Procurement.
Request search facility
update from Nugensis.
Look at different ways to
make the information
available to staff.
KW
05.01.16
DR
05.01.16
LL
10.02.16
4.
Midodrine – not a shared care protocol. MCN List not up to date now and not included in agenda.
5.
New Medicine Applications:
Page 1 of 6
a)
b)
c)
Insulin degludec/liraglutide 100 units/mL / 3.6mg/mL solution for injection (Novo nordisk) Applicant: Dr Rachel Williamson, supported by Dr O Herlihy
Indication: Treatment of adults with type 2 diabetes mellitus to improve glycaemic control in
combination with oral glucose-lowering medicinal products when these alone or combined with
a GLP-1 receptor agonist or with basal insulin do not provide adequate glycaemic control;
Generic Name: Insulin degludec/liraglutide 100 units/mL / 3.6mg/mL solution for injection
Brand Name: Xultrophy; Dosage: Insulin degludec/liraglutide is given once daily by
subcutaneous (SC) administration, administered at any time of the day, preferably at the same
time of the day. Detail in application (NMA); Cost per month: £51.5-£161; Number of patients
in first year: 20. This application is in line with SMC advice, slightly out with advice from
manufacturers to SMC. Benefits were reviewed by the Committee. It was agreed that it should
be prescribed in restricted setting as described by SMC as patient will already have maximised
efficacy of this combination. Drug would lead to an increased cost and the costs were outlined in
supporting evidence and discussed. It was asked if patients react differently and if that had been
taken into account. Changed basal insulin and added in GLP-1; Degludec not approved on own.
It has been requested as an addition for a small number of consultants’ patients.
Clarification requested from the GP point of view. Does not specify that GPs are not required to
make adjustments.
Insulin Glargine (Eli Lilly) - Applicant: Dr Rachel Williamson
Indication: Diabetes mellitus; Generic Name: Insulin Glargine 100 units/ml; Brand Name:
Abasaglar; Dosage: According to patients insulin requirements; Cost per month: £35.28 / 5 x3ml
cartridges or pens; Number of patients in first year: 20, BFC thought maybe more. The
Committee heard that there would be a saving of approximately 20%; that the intention is for
new starts only and there is no intention to transfer existing patients. Currently used in this way
in NHS Lothian. This gives the team the opportunity to trial and come back for full adoption.
Recording of batch numbers, which may impact on community pharmacies, was discussed. In
future this will be within the bar-coding (2016/17) and the wider process of recoding should be
explored in future.
Ulipristal acetate (Esmya) - Applicant: Dr Kate Darrow, supported by Dr Brian Macgowan
Indication: Pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult
women of reproductive age. The duration of the treatment is limited to three months; Generic
Name: Ulipristal acetate; Brand Name: Esmya; Dosage: 5mg orally once daily for up to 3
months; Cost per month: £114.13; Number of patients in first year: 10. The Committee heard
that his drug shrinks the fibroids before surgery. Study shows that it reduces menstrual bleeding
and size of fibroids; it is as effective as conventional treatment without side effects. Supporting
evidence and safety studies were included. Adverse events similar in both groups have been
Page 2 of 6
Approved Category F - for
Consultant initiation and
subsequent general use –
hospital and general
practice
Letter to applicant. Include
in letter:Only transferred to GP
when patient on stable dose.
Approved Category F – for
Consultant initiation and
subsequent general use –
hospital and general
practice.
Letter to applicant
Review quantities used
currently.
Approved Category B - for
specialist use only.
Letter to applicant
KW
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KW
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KMacl
10.02.16
KW
18.12.15
d)
e)
f)
g)
compared. Oral route may be preferred by some patients. SMC advice from 2013; service did
not want to apply at that time. Marginal cost increase; with a saving in staff time.
Methylphenidate XL (Sandoz) - Applicant: Diana Leaver, CAMS Physciatrist
Indication: ADHD; Generic Name: Methylphenidate XL; Brand Name: Matoride XL; Dosage:
18mg – 54mg daily; Cost per month: £24.95 - £60.48; Number of patients in first year: see
application. The Committee heard that this move to a different brand would result in a cost
saving of 20% with an identical product. Only difference is that the 27mg is not available but
that this strength is rarely used. Plan to switch current patients and any on 27mg would stay with
original drug. There is no SMC advice however it was reported that NHS Fife has changed to
this with no issues. The majority of prescribing is Primary Care; NHS Borders costs are high in
this area so saving would be welcomed.
Denosumab - Applicant: Dr Andrew Pearson
Indication: Osteoporotic fractures, needs bone protecting medication, High fracture Risk;
Generic Name: Denosumab; Brand Name: Prolia; Dosage: 60mg every 6 months; Cost per
month: £30 per month; Number of patients in first year: 1 Male patient; this came to BFC for
noting as has been discussed previously and agreed.
Medroxyprogesterone acetate (Pfizer) - Applicant: Dr Alisa Wylie
Indication: Contraception; Generic Name: Medroxyprogesterone acetate; Brand Name: Sayana
Press; Dosage: every 13 weeks; Cost per month: £6.90 / injection (approximately £2.30/month);
Number of patients in first year: In 2014/2015, there were 2738 DMPA injections prescribed in
the whole of NHS Borders. It is highly unlikely that all these women would want to be changed
onto sub-cut MPA. The application and likely benefits were discussed and the SMC advice was
attached to the application. This option is slightly more expensive however there is a reduction
in injection/appointment time.
Ivermectin (Galderma) - Applicant: Dr Andrew Mackenzie
Indication: Treatment of moderate to severe inflammatory lesions of rosacea where a topical
treatment is considered appropriate; Generic Name: Ivermectin; Brand Name: Soolantra;
Dosage: Cutaneous application of a pea-size amount of medicinal product to each of the five
areas of the face: forehead, chin, nose, and each cheek once daily for up to four months. The
medicinal product should be spread as a thin layer across the entire face, avoiding the eyes, lips
and mucosa. The treatment course may be repeated. In case of no improvement after three
months, the treatment should be discontinued; Cost per month: £34/ course; Number of patients
in first year: 50. This application is in line with SMC advice; supporting studies have
Page 3 of 6
Approved Category C - for
Shared Care between
hospital and general
practice.
Letter to applicant.
Ensure that in EMIS the
correct choice is made.
Approved Category C - for
shared care between
hospital and general
practice for this patient.
(Approval is specialist off
label)
Letter to applicant.
Approved Category A - for
general use – hospital and
general practice.
Letter to applicant
Patient safety: alert/
reminder for women to
prompt self injection.
Request clarity on adding to
current formulary; if
augmenting – what is it
augmenting? Await
response before approval.
KW
18.12.15
KMacl
10.02.16
KW
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KW
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LL
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h)
i)
6.
demonstrated superiority against treatments used. Side effect profile is similar; it is likely to
increase costs. Currently in the Formulary we have topical treatments which were discussed.
Committee asked if it was necessary to add another option as there is already 1st, 2nd and 3rd line
options. Could it replace the use of oral antibiotics? It was agreed that clarity was required.
Apixaban (Bristol, Myers, Squibb) - Applicant: Dr Paul Syme
Indication: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and
prevention of recurrent DVT and PE in adults; One phase III study showed non-inferiority of
apixaban versus standard anticoagulant therapy including a low molecular weight heparin in
combination with a vitamin K antagonist for treatment of DVT/PE. In a 12 month phase III
study apixaban demonstrated superiority versus placebo for the prevention of recurrent
DVT/PE; Generic Name: Apixaban; Brand Name: Eliquis; Dosage: Treatment of DVT or PE:
10mg twice daily for the first 7 days then 5mg twice daily. Prevention of recurrent DVT and/or
PE: 2.5mg twice daily (following completion of 6 months of treatment for DVT/PE); Cost per
month: £66; Number of patients in first year: Not specified in the application. The Committee
heard that SMC advice was issued in February 2015. There is a need for an alternative for PE. It
was felt that it was not clear in application which should be first and second line treatment.
Rosie Jones putting together an anti-coagulation committee and decisions should be made by
them on whether this is the right treatment for patients and the protocol required. Differences
were discussed by BFC and it was agreed there must be clarity on the dosage; single NOAC to
be 1st and 2nd choice. This to be a formulary request with the first choice decided by the new
committee.
Rituximab off label use - Applicant: Dr Simone Laube
Indication: Systemic follicular lymphoma. Treatment of symptomatic cutaneous lesions on back
with intralesional Rituximab; Generic Name: Rituximab; Brand Name: ; Dosage: 10-30mg / per
lesion for 3 days at 4 week interval; Cost: 100mg/10ml per vial £174.63/100mg; Estimated cost
£523.89 - £3143.34 (cost dependant on number of cycles); Number of patients in first year: 1
Additional supporting information for this sent in agenda - this application had previously been
approved virtually by BFC 27-30/11/2015. Dr Laube has been informed by email of decision.
SCOTTISH MEDICINE CONSORTIUM RECOMMENDATIONS:
Table of SMC
Decisions with NHS Bo
Table of SMC Decisions with NHS Borders notes included in agenda and added here.
Page 4 of 6
Approved Category A - for
general use – hospital and
general practice with
comments raised here in
letter.
Letter to applicant.
Protocol / guidance to be
developed by new AntiCoagulation Committee.
Approved Category B – for
specialist use only for one
patient.
Confirmation Letter of
decision to applicant
KW
18.12.15
KW
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Item
No.
Situation, Background & Assessment
7.
a)
Borders Joint Formulary Updates:
Insulin formulary amendment - This formulary amendment consists of the bullet points
supporting appropriate clinical use of Humalog 200 units/ml pre-filled quick pen and Toujeo
(glargine 300 units/ml). Changes were highlighted and outlined to the Committee with
information on reason for change and implication for pharmacy. Humalog - Diabetes keen to
have available for patients on a high dosage, to be available for small group of patients. Safety
issues were discussed and should be resolved with the pre-filled quick pen and the dial-a-dose is
less open to error. Toujeo – again a pre filled pen with more concentrated insulin for small
patient group. BFC heard that any safety concerns should have been addressed. The
dangers/risks of withdrawing insulin from cartridges was discussed and this practice should be
discouraged. There is request to add to the Formulary.
It would be useful if a protocol for action if insulin pump malfunctions was available and could
be included in refhelp & also be available on the intranet for secondary care staff. There should
be guidance on this/protocol online.
NHSB Border Joint Formulary – The first draft of an abbreviated formulary document to
support prescribing of first & second choices for common formulary medications was included
on the agenda for comment. It is intended as a PDF for prescribers to download and refer to
when online is unavailable to them. Request to BFC for admin support to format the abbreviated
document. The move away from Formulary books to online was discussed and the current
Nugensis issues in having this online version available as a downloadable app. There is to be a
move away from paper copies so that selections are accurate and updates are easy to manage. It
was also suggested that access to Formulary should be added to all Inductions (not just FY1
training). Committee discussed options and agreed that a summarised list of drug choices
without dosage and other information would be appropriate for this purpose.
NOACs – The Committee were asked to note the Apixaban, Dabigatrin & Rivaroxaban spend
comparison and attached email responses to spreadsheet. Comparison highlights NHS Borders
against other Boards, for information.
New BNF Categorisation - There was a meeting of stakeholders at NICE last week and
complaints have been made about the changes with concerns that we may need to reformat our
formularies.
Report - SMC Not Recommended Drugs; Volume and Cost per 1,000 Population; by
Prescribing Health Board; April - June 2015 from Prescribing Information System, ISD
b)
8.
9.
10.
Page 5 of 6
Recommendation
Person
Responsi
ble
Timescale
The formulary amendment
was approved.
An evening session to be
organised for Dr
Williamson to present
information about the
changes in diabetes
treatment for secondary
care, Practices and
Community Pharmacists.
Review protocol availability
LL
31.12.15
LL
Dr W
LL
10.02.16
Re-format current
abbreviated document and
look at way of making
easier to update (macros).
Review NHS Lothian doc.
Request for document to be
on Intranet in pull-down
lists (as alternative to
desktops).
KW
18.12.15
BFC noted
BFC Noted
BFC Noted
10.02.16
KW/LL 18.12.15
KW/LL 10.02.16
11.
12.
13.
14.
Scotland.
Tissue Viability Group - Action tracker of meeting held on 28th September 2015.
Wound Formulary Group - Action plan, updated at meeting on 19th November 2015
Lothian Formulary Committee - Minute from LFC meeting held on 11th November 2015
To note – new anti-retro viral mixes approved; previously if NHSB only have 1 or 2 patients
requiring we do not ask for a separate NMA if they are approved by LFC. It was agreed that the
application should come through BFC to note.
A.O.C.B. Next Meeting: Wednesday 10th February 2016 at 12:30 in the Estates Meeting Room
Page 6 of 6
BFC Noted
BFC Noted
To add the
application/report on this
agenda in future
KW
10.02.16