THIS MEETING WAS QUORATE Milton Keynes, Oxfordshire, Berkshire East, Berkshire West & Buckinghamshire (MOBB) Priorities Committee
Minutes of meeting held on Wednesday 25 January 2012, Jubilee House, Oxford Business Park South, Oxford, OX4 2LH Present: Committee Members
Head of Medicines Management, NHS Bucks
Associate Medical Director, Bucks Hosp NHS Trust
Clinical Effectiveness Principal, NHS Oxfordshire
Professor of Health law, Reading University
Medical Director, NHS Bucks and Ox Cluster
Medical Director, Heatherwood and Wexham Park
Patient Representative, Buckinghamshire
Deputy for Director of Finance, NHS Bucks & Ox
Consultant in Neurological Rehabilitation, NOC
Medical Director, Berkshire Healthcare NHS FT
Observing: For Item B2:
Consultant Radiologist, John Radcliffe Hospital (via
Consultant Vascular Surgeon, John Radcliffe
THIS MEETING WAS QUORATE
SECTION A – MATTERS ARISING A1 Welcome from the Chair
Alan Penn welcomed the Committee and explained that Dr Ramon Uberoi would be participating in item B2 via the teleconference facility. A2 Apologies
Caroline Gregory, Eleanor Mitchell, Ivo Haest, Mark Sheehan, John Quinn and Jane Wells. A3 Declarations of interest
Interest in item B1 was expressed by one member. A4 Draft minutes of the MOBB meeting held on 14 December 2011
The minutes were approved with the following amendments:
Page 1 – remove Catriona Khetyar from the attendance list, as she was not present at the
Page 4, under „Mr Little contributed”, bullet point 4 –- after treatment, insert ‟that‟ is
The Committee was informed that all actions in the December minutes had been completed. A5 Matters Arising Private Scripts for Viagra The question discussed by the Committee was whether GPs can issue a private prescription for NHS patients, for a drug that is prescribable through the NHS? The following points were discussed:
The Committee confirmed that the current policy in operation applied to those patients
able to receive Viagra by NHS prescription.
The Commitee considered the distinction between medical „need‟ and „recreational want‟.
The Committee considered a GP‟s ability to „top up‟ the recommended amount of Viagra
for an NHS patient and discussed at what point it should become a private prescription.
The Commitee discussed the impact on patients suffering from diabetes who had
historically been prescribed a higher than recommended amount of the drug.
Possible litigation issues were discussed by the Committee.
A related issue of “penile rehabilitation” was also discussed. It was suggested by the
Committee that this topic was referred to the OWG for a review for men who had undergone radical prostatectomy, so that a formal policy could be developed. It was noted that it is unlikely there is sufficient evidence to support the current provision of viagra for this indication, as used by some clinicians (literature review undertaken in Oxfordshire PCT).
Summary The Commitees views were summarised by the Chair as follows: 1) The Committee agreed that the topic of penile rehabilitation following radical prostatectomy. could be considered for Priorites Committees work programme. 2) Acknowledgment that GPs have the discretion to prescribe Viagra over and above the doses recommended in the current policy to patients on the NHS list. 3) The issue of “can GPs issue private prescriptions, for an NHS drug, to their NHS patients”, is not for the MOBB PC to resolve.
THIS MEETING WAS QUORATE
Draft terms of reference In the context of the current organisational and structural changes, some of the governance processes for priorites committees (PCs) have become somewhat unclear. Therefore, amended draft Terms of Reference are to be dissussed at the next Operational Working Group (OWG) meeting on 14 February. The following issues were discussed: Responsibilities – The Committee asked for clarification as to who the MOBBB and SHIP committees report to. It was suggested that the OWG take on governance for the PCs and that this is discussed at the February meeting. The Committee requested that OWG subsequently inform the MOBBB Priorities Committee whom they should be reporting to. It was recognised that the commissioning decisions sit with the commissioning bodies and that OWG‟s role needs to be clearly defined. The following amendments were sugested:
Bullet point 4 of this section, amend as follows: to make recommendations on the
information they receive, informed by the South Central Ethical Framework.
Bullet point 5 of this section, add the following: with regards to topics presented to
Bullet points should appear in process order.
Membership – The nomination of the Chair by the Committee and appointment by OWG needs to be made clear under this section. Membership Representation – The Committee discussed that, due to the high number of members, commissioners could easily be out-voted. A reservation was also raised regarding the inclusion of five lay representatives; the current three members represent each of the cluster areas. Who nominates members for the Committee; should these be approved by OWG? Decision Making Process - In instances where, due to lack of consensus, the Committee decides to take a vote, the Committee agreed it should be written in the ToR that the Chair has the casting vote. Clarity is also needed as to how the voting will work – does a simple majority carry the decision? Deputies – It was stressed again that Committee members should ensure their deputies cover their absence whenever necessary. LS asked Committee members to submit any other relevant points to her following this meeting. Action: LS to take MOBB comments back to OWG. A6 Bisphosphonate therapy in breast cancer 02a-b/2012
The Committee approved the policy recommendation for Bisphosphonate therapy in breast cancer with no amendments. Agreed:
The Committee approved the policy recommendation with no amendments.
JF to circulate the policy to the Committee as final.
A7 Facet joint injection and medial branch blocks for chronic spinal pain 03a-g/2012 SC presented a combined response from clinicians involved in this treatment. Following the discussion of the evidence at the October MOBBB meeting, the Committee requested that the THIS MEETING WAS QUORATE clinicians agreed the pathway/ clinical criteria for facet joints injections,. SC asked for the Committee‟s feedback on the pathway provided, and to agree a final policy recommendation. The Committee discussed the following:
It would have been helpful for SPH to provide a summary cover sheet, in order to
place the additional work on the pathway in the context of the previous recommendations.
The Committee appreciated the work undertaken by the clinical specialist group
The Committee questioned the clinicians‟ inclusion of radio frequency ablation in their
pathway, as this treatment had not been part of the original evidence review.
The Committee found the clinicians‟ submission helpful and interesting, but concluded
that the information did not support the commissioning of facet joints injections.
Agreed: The Committee agreed to recommend Option 1 - LOW PRIORITY. Actions:
1) HE to provide a LOW PRIORITY policy recommendation based on the Committee‟s original choice.
2) LS to contact the clinicians, who provided the additional information, to inform them of the Committee‟s recommendation.
Steroid injections for joint pain and disability - elbow
The Committee approved the draft policy recommendation for Corticosteroid injections for lateral elbow tendinopathy (tennis elbow). Agreed: The Committee approved the above policy recommendation with no amendments. Action: JF to circulate to the Committee as final. Steroid injections for joint pain and disability - knee
The Committee approved the policy recommendation for Corticosteroid injections for patellar tendinopathy (jumper‟s knee). Agreed: The Committee approved the above policy recommendation with no amendments. Action: JF to circulate the policy to the Committee as final. A10 Intravenous oral steroids for exacerbations of multiple sclerosis
The Committee approved the policy recommendation for Intravenous versus oral steroids for exacerbations of multiple sclerosis. Agreed:
The Committee approved the above policy recommendation with no amendments.
JF to circulate the policy recommendation to the Committee as final.
SECTION B - POLICY REVIEW/NEW PROPOSALS B1 Aesthetic Surgery - Children
SPH were asked: In children with perceived external abnormalities or disfigurements (congenital or acquired) which do not cause functional impairment or have other physical health impacts, is there a significant improvement in the child‟s social and/or educational development and/or psychological and mental health following aesthetic surgery or any other non-psychological treatment?
THIS MEETING WAS QUORATE TD summarised the paper as follows:
Background Children with a perceived unusual or abnormal appearance, or their parents, may seek
treatment, but the circumstances in which the NHS should fund such treatment are uncertain.
Clinical effectiveness This review only covers the conditions and interventions for which we found evidence of
the impact of the condition or its treatment on quality of life, social or educational development or mental health.
The National Institute for Health and Clinical Excellence has recommended that the
evidence for the use of an operative treatment for pectus excavatum is adequate to support its use, provided that normal arrangements are in place for clinical governance, consent and audit.
Several studies report improvements in physical and psychological functioning after
corrective surgery for pectus excavatum.
We found no evidence comparing any outcome in children who had surgery to correct cleft
lip with those who did not, nor any comparing children before and after surgery.
The evidence suggests that treated cleft lip is not associated with diminished quality of life,
though even after treatment the condition may have indirect adverse cognitive effects. Treatment shortly after birth appears to improve psychological outcomes more than treatment after three to four months of life.
Two studies indicated that, even without treatment, a haemangioma does not adversely
Surgery for prominent or otherwise abnormally shaped external ears appears to have little
Cost effectiveness SPH found no health economic analyses. Safety These procedures appear safe, though correction of pectus excavatum can occasionally Activity and cost Several hundred cosmetic procedures are carried out on children in South Central each
year, most at a cost of between £1000 and £1500.
Equity SPH identified no specific equity issues.
The Committee were hopeful that there would be some studies for them to draw on, but
were not surprised to learn that there is insufficient published research.
The Committee discussed the sensitive nature of this topic.
The Committee discussed the condition of pectus excavatum and cleft lip and palate and
whether treatment for these conditions should be a separate category from other aesthetic surgery procedures
There is no significant evidence of psychological benefits in treating pectus excavatum in
patients without cardio-respiratory issues.
Due to lack of published studies, the effect on children‟s development, education and well-
being could not be quantified in SPH‟s evidence review.
The evidence does not generally support that an exception be made for treating children
with these conditions as opposed to adults.
It as acknowledged that such funding requests should continue to be considered as exceptional cases through an IFR route. The current Oxfordshire policy will be amended and shared with colleagues and circulated to the Committee. (There is no need for SPH to provide a new draft policy) Agreed:
The Committee supported to continue with the existing policy
JF to circulate the amended Oxfordshire policy to Committee members.
B2 Fenestrated endovascular aortic stent grafts Mr Simon Bays, Mr Jeremy Perkins and Mr Edi Sideso attended for this item. Dr Ramon Uberoi joined via teleconference for the beginning of the clinicians‟ comments, but due to technical difficulties was unable to participate in the subsequent discussion.
SPH were asked: Is there a group of patients with abdominal aortic aneurysms in whom fenestrated endovascular stent-grafts are clinically and cost-effective? TD summarised the paper as follows:
Background
Abdominal aortic aneurysms arise when the main artery running through the abdomen
Once established, an abdominal aortic aneurysm tends slowly to enlarge, usually without
causing symptoms. It is often detected opportunistically.
As it enlarges, the risk of an aneurysm rupturing increases. Rupture leads to a major
internal haemorrhage, which is often fatal.
Standard treatment for an abdominal aortic aneurysm is elective open surgical repair.
A newer alternative treatment is endovascular repair. This involves inserting a stent-graft
Some more complex aneurysms – known as juxta-renal aneurysms – require individually
manufactured fenestrated stent-grafts. These are newer, less well-researched, riskier and more expensive than conventional aortic stent-grafts.
In July 2010, the South Central Priorities Committees recommended that the use of
fenestrated stent-grafts for the treatment of abdominal aortic aneurysms should be low priority because of limited evidence of clinical effectiveness and a lack of evidence of cost effectiveness.
Clinical Effectiveness
SPH found two systematic reviews of endovascular repair with a fenestrated stent-graft,
both of which had methodological weaknesses. There were no randomised controlled trials, nor any studies comparing outcomes after the two procedures. Both reviews suggested that risks of endovascular repair with a fenestrated stent-graft were low, and that mortality, complications and lengths of ITU and inpatient stay after the procedure were lower than after open repair. The number needed to treat to prevent one death was estimated at 46. No specific selection criteria were applied in the studies used in these reviews.
The reviews may be subject to important confounding, and selection and publication
SPH found three uncontrolled studies published since the more recent systematic review.
Their results are consistent with the systematic reviews. Cost effectiveness
We found no health economic analyses.
Endovascular repair with a fenestrated stent-graft appears safer than the open alternative.
Activity and cost
There are few recorded endovascular repairs of juxta-renal aneurysms in South Central,
and the low priority policy with respect to fenestrated stents appears to be followed.
Open repair of an abdominal aortic aneurysm costs between £4637 and £6515 plus ITU or
HDU bed days and market forces factor. Endovascular repair with a fenestrated stent costs £6667 plus the cost of the stent-graft, bringing the total to about £20,000, plus ITU or HDU days if required.
Equity SPH found no specific equity issues.
The clinicians contributed the following:
The cost of the (bespoke) fenestrated stents has fallen recently. Indications are that „off
the shelf‟ stents would be available by next year and that the market place was becoming increasingly competitive. Therefore, prices are expected to fall further.
The cost of the devices has come down to meet that of thoracic devices, which are already
Some studies performed in France and the USA were missing from the evidence review. There is now good evidence of technical success in using fenestrated stents
All major vascular centres in England are now using these stents
The risk to the patient is increased the further up the renal aorta the procedure is
The fenestrated stent-grafts are performed with an epidural anaesthetic rather than
If the cost of a patient‟s recovery time in ITU is factored in, the gap in price as opposed to
The Committee acknowledged that Oxford University Hospitals Trust‟s specialist vascular
centre should be able to offer this procedure to the small number of patients who might benefit
The Committee agreed that the length of recovery time was very important. NICE has recommended that patients with infra-renal aneurysms should have the choice
Currently, between 25- 40% of these patients undergo stenting.
Impact of AAA screening is likely to increase the number of patients undergoing elective
The Committee agreed that the operative risks for patients with juxta-renal abdominal
aortic aneurysm were lowered with the use of a fenestrated stent-graft.
The Committee agreed option 2 as follows:
NHS funding for endovascular repair with a fenestrated stent-graft is recommended as a treatment option for people with a juxta-renal abdominal aortic aneurysm in whom the procedure poses a significantly lower risk than open repair
TD to draft a policy recommendation for discussion at the next meeting in February.
Breast Cancer Pathway – endocrine drugs
What is the relative clinical and cost-effectiveness of the various NICE-recommended
aromatase inhibitors in post-menopausal women with early breast cancer? In particular, how do anastrozole and letrozole compare in clinical and cost-effectiveness?
What is the relative clinical and cost-effectiveness of switching from tamoxifen to
aromatase inhibitors after a period of tamoxifen treatment? What is the appropriate time to switch, and how long should aromatase inhibitors be continued?
What is the clinical and cost-effectiveness of continuing aromatase inhibitors for more
or less than 5 years in post-menopausal women with early breast cancer?
What is the clinical and cost-effectiveness of continuing aromatase inhibitors beyond
relapse in post-menopausal women with early breast cancer?
HE drew the Committee‟s attention to comments from Ms Ellen Copson, Oncologist, Southampton, who raised serious concerns about the paper. However, attempts to engage with Ms Copson, to provide more specific information relating to her complaint, had proved fruitless. The Committee heard that all the drugs recommended by NICE, have now – or will shortly – fallen in price. The Committee therefore agreed that there was no need to discuss the topic further and no policy is was required: NICE recommendations should continue to be implemented. It was therefore agreed to withdraw this paper. Agreed: The Committee agreed that, due to the significant price decrease across the range
of aromatase inhibitors, a policy recommendation was not required.
SECTION C – IMPLEMENTATION PLANS No items SECTION D – POLICY AND PROCEDURE Updated work programme
The Committee noted the draft work programme. SECTION E – ANY OTHER BUSINESS TD explained that TAVI had been added to the MOBB agenda for meeting in March 2012. Date and time of next meeting: Wednesday 29 February 2012, 1.00pm - 4.00pm Jubilee House, Oxford Business Park South, Oxford, OX4 2LH
CURRICULUM VITAE NAME John DATE OF BIRTH MARITAL STATUS CHILDREN UNIVERSITY St. George's Hospital Medical School, London, UK AWARDS 1960 Anna Selina Fernee Scholarship: St. George's Hospital Medical School. Medical Research Council Clinical Research Fellow, St. Thomas' Hospital. Wellcome Research Fellowship: MRC Tropical Metabolism Research Unit, University of t
Step Therapy Criteria Drug Name Step Therapy Criteria Step 1- PATIENT NEEDS TO HAVE A DOCUMENTED TRIAL OF ANY TWO OF THE FOLLOWING DRUGS IN THE PREVIOUS 120 DAYS BEFORE MOVING TO STEP 2. : Allegra OTC, Allegra D OTC, Astelin, Astepro, Beconase AQ, Cetirizine, Cetirizine-D, Clemastine Fumarate, Cyproheptadine Hcl, Diphenhydramine Hcl, Fluticasone Propionate, Singulair Hydroxy