Notes from css project meeting at sovereign house york
POLICY RECOMMENDATIONS FROM TREATMENT ADVISORY GROUP meetings 8th April 2012 (Formal y Medicines & technologies Board) In attendance from CCGs: no representative from a CCG was present at this meeting The enclosed policies represent DRAFT recommendations to CCGs. It is proposed that individual CCGs consider the summaries and policies enclosed within their relevant decision making groups and respond to the CCG with a decision regarding adoption/amendment of the policy – please use the attached form. Further advice on the contents of the draft policies can be sought from the contacts list at the end of the document. 1. Dapagliflozin for the management of type 2 diabetes mel itus to improve glycaemic control. Recommendation: It is not recommended for the management of type 2 diabetes at this time. The decision was taken to wait for NICE guidance in June 2013 to identify its place in therapy. Key points which were discussed include:
• Dapagliflozin is a first-in-class, orally-active, competitive, reversible inhibitor of the
human sodium-glucose co-transporter 2 (SGLT2) to be licensed in the UK.
• NICE are expected to publish the technical appraisal at the end of June 2013
• SMC have approved it but restricted to dual therapy in combination with metformin
only when a sulphonureas is inappropriate. Did not support use in combination with
• Monotherapy clinical trials showed dapagliflozin to be more effective than placebo
but no head to head trials showed that it would be superior to metformin.
• Combination of dapagliflozin with metformin was shown to be more effective
• It has the added benefit of causing weight loss so may be of benefit to obese
• It should be noted that there smal numbers of elderly patients included in clinical
• Dapagliflozin increases diuresis and is not recommended in patients receiving loop
• Safety concerns relate to increase risk of UTIs and genital infections. FDA is also
looking into a potential increase risk of breast and bladder cancer.
not recommended with CrCl<60ml/min. Not recommended in over 75s. Monitoring of renal function – baseline then yearly and if approaching
moderate/ severe renal impairment then consider every 2-4 times a day.
Not recommended with loop diuretics Risk of falls in combination with ant-hypertensives or elderly with history of
Not recommended with pioglitazone. Not studied in combination with DPP-4 inhibitors and GLP analogues
• Views from local consultants were not very supportive of this treatment and
recommended to await NICE guidance so identify clear place in treatment pathway.
Tadalafil for the treatment of the signs and symptoms of benign prostatic hyperplasia in adult males
Recommendation; Tadalafil is not recommended for the treatment of benign prostatic
hyperplasia in adult males. There is no evidence to show it to be more effective than
Key points which were discussed include:
• Evidence shows that tadalafil may improve lower urinary tract symptoms associated
with benign prostatic hyperplasia but is no more effective than the standard
treatments recommended by NICE for this indication.
• It is unlikely that this treatment would be shown to be cost effective compared to
standard treatment such as alpha blockers and 5-alpha reductase inhibitors.
• Both NICE and SMC were unable to provide a recommendation because of no
evidence submission by the manufacturer.
• Tadalafil may be beneficial in patients who suffer from both benign prostatic
• Drug treatments for the management of erectile dysfunction can be provided on the
NHS for the fol owing conditions: diabetes, multiple sclerosis, Parkinson’s disease,
poliomyelitis, prostate cancer, prostatectomy, radical pelvic surgery, renal failure
treated by dialysis or transplant, severe pelvic injury, single gene neurological
disease, spinal cord injury, spina bifida ( Ref HSC 1999/148.
Aflibercept for the treatment of wet age-related macular degeneration
Recommendation: It was not possible to provide a single recommendation that covers all
• It will be required to determine how local ophthalmologists wil treat patients with
aflibercept in clinical practice (ie number of injections, monitoring visits.
• It is not known whether the confidential discounted price for aflibercept is the same
• Locally agreed costs of current activity which includes monitoring visits and
intravitreal administration will differ across all CCGs.
• Therefore to calculate the cost impact of aflibercept compared to ranibizumab will
need to be done on an individual CCG basis.
Key points which were discussed include:
• Aflibercept is a humanised VEGF receptor fusion protein which binds to all forms of
VEGF-A and placenta growth factor. It is an alternative treatment to ranibizumab for
the management of Wet age related macular degeneration.
• Evidence from the VIEW studies, shows Aflibercept 2mg administered monthly for 3
months, fol owed by 2mg every two months up to one year, fol owed by PRN dosing
between 1-3 monthly is as effective as ranibizumab.
• At present the predicted number of injections over the first two years is likely to be
similar in clinical practice but there is scope with aflibercept to extend the period
between injections which may result in some patients needing fewer injections. This
in turn could result in a reduction in administration associated adverse events.
• Overall patients will need less monitoring appointments with aflibercept compared
to ranibizumab, this will have a positive impact on clinical capacity and may prove
• NICE are due to publish guidance at the end of August 2013. Since the TAG meeting,
SMC have published their guidance which accepted alfibercept as a treatment option
in Wet AMD in patients not previously treated with anti-VEGF therapy.
• It was highlighted that was a regional procurement process been carried out at the
moment which may result in a further reduction in price in ranibizumab.
• Ophthalmologists may also wish to consider using aflibercept in the following group
Patients requiring frequent retreatment with ranibizumab. Aflibercept may
well reduce the frequency of treatments/ monitoring visits.
Patients who have lost response to ranibizumab (ie second line treatment). Patients who are resistant or refractory to treatment with ranibizumab.
It should be noted that the main clinical trials (VIEW 1 and 2) excluded patients who
had previously been treated with anti-VEGF treatment so the evidence to support the
use of aflibercept in these patient groups is very limited.
NICE TA 276: Colistimethiate sodium and tobramycin dry powders for inhalation for treating pseudomonas lung infection in cystic fibrosis
NICE recommend both tobramycin DPI and colistimethate sodium DPI for treatment of
chronic pulmonary infection caused by Pseudomonas aeruginosa in people with cystic fibrosis
within criteria set out within the appraisal and the manufacturer provides it at the discount
agreed as part of the patient access scheme.
It should be noted that cystic fibrosis services are commissioned and funded by NHS England.
The present national policy for cystic fibrosis inhaled treatments states that the discount rate
on the dry powder inhalers is only available if supplied via hospital or home delivery services.
Therefore GP shared care prescribing is not supported for the inhalers.
Date of next meeting: Monday 8th July 2013 Health House, Willerby Contacts for more information on individual policies Christopher Ranson Diane Tomlinson Senior Pharmacist Senior Pharmacist 01423 876404 01904 601630 Christopher.ranson @nhs.net Diane.tomlinson@nhs. net
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“MEDIDAS TECNOLÓGICAS DE PROTECCIÓN DE LA PROPIEDAD INTELECTUAL EN INTERNET - LOS ACTOS ELUSIVOS - LA PROTECCIÓN JURÍDICA CONTRA LA ELUSIÓN” Texto completo del trabajo presentado en el Congreso MERCOSUR de Derecho Informático celebrado en Córdoba, Argentina entre el 9 y 11 de Agosto de 2006 AUTOR: HORACIO FERNANDEZ DELPECH firstname.lastname@example.org