NICE consultation on key therapeutic topics: June Comments and responses: September Key Therapeutic Topic

Transcription

1 NICE consultation on key therapeutic topics: June 2014 Comments and responses: September 2014 Key Therapeutic Topic Laxatives NHS Southern Derbyshire CCG What is the purpose or benefit of this topic? Laxatives has been retained as a key therapeutic topic for the 2014 update. Prescribing in this therapeutic area remains an important issue. Key Therapeutic Topic Renin-angiotensin system drugs Nottingham West CCG No longer think this topic is relevant. Renin-angiotensin system drugs has been retained as a key therapeutic topic for the 2014 update. Prescribing in this therapeutic area remains an important issue. There is NICE guidance for the use of renin-angiotensin system drugs in heart failure, post-mi, diabetes, chronic kidney disease and hypertension that this topic summarises. Further safety advice pertaining to combination use of medicines from two classes of renin-angiotensin system blocking agents has recently been published and will be included in the update. NHS Southern Derbyshire CCG What is the purpose or benefit of this topic? Renin-angiotensin system drugs has been retained as a key therapeutic topic for the 2014 update. Prescribing in this therapeutic area remains an important issue. There is NICE guidance for the use of renin-angiotensin system drugs in heart failure, post-mi, diabetes, chronic kidney disease and hypertension that this topic summarises. Further safety advice pertaining to combination use of 1

2 Telford & Wrekin CCG Prescribing Support Unit, Royal Cornwall Hospitals NHS Trust If this indicator is to be retained consider changing to % prescribed as low cost ACEI/A2RAs. But, more focus on avoiding combinations of ACEIs and ARBs. Interesting to see how you update the evidence summary, as MeReC refs now a little out of date? medicines from two classes of renin-angiotensin system blocking agents has recently been published and will be included in the update. Any change to the renin-angiotensin system drugs prescribing comparator will be considered by the Health and Social Care Information Centre. The Health and Social Care Information Centre lead on the development of prescribing comparators and these comments have been forwarded to them for consideration. Renin-angiotensin system drugs has been retained as a key therapeutic topic for the 2014 update. Prescribing in this therapeutic area remains an important issue. There is NICE guidance for the use of renin-angiotensin system drugs in heart failure, post-mi, diabetes, chronic kidney disease and hypertension that this topic summarises. Further safety advice pertaining to combination use of medicines from two classes of renin-angiotensin system blocking agents has recently been published and will be included in the update. Key Therapeutic Topic Lipid modifying drugs including ezetimibe Nottingham West CCG No longer think this topic is relevant. Lipid modifying drugs has been retained as a key therapeutic topic for the 2014 update. Prescribing in this therapeutic area remains an important issue. An update of the NICE clinical guideline on lipid modification was published in July 2014 and the key therapeutic topic will be updated to reflect the content of this. The updated guideline covers lipid-modifying drugs including bile acid sequestrants, ezetimibe, fibrates, niacin and statins. 2

3 Merck Sharp & Dohme Ltd MSD provided a detailed response, summarised as follows. MSD considers strongly that the QIPP Key Therapeutic Topic lipid modifying drugs including ezetimibe should be amended to remove ezetimibe from the topic, to concentrate on statins. The continued inclusion of ezetimibe as described in the QIPP Key Therapeutic Topic is totally inappropriate. The use of the topic, particularly in conjunction with the QIPP prescribing comparators, undermines NICE guidance on ezetimibe and unfairly discriminates against ezetimibe, which is the only branded product to be singled out. Moreover, it is unfair and illogical to include ezetimibe in the prescribing comparators as a comparator for statins in the care pathway when it is clear from NICE guidelines that ezetimibe is prescribed only after initial statin therapy or when statin therapy is inappropriate or contraindicated. Finally, MSD is concerned about the process for developing QIPP Key Therapeutic Topics, which ordinarily takes places before the H&SCIC reviews the prescribing comparators (this consultation closed on 30 th May 2014). The issuing of QIPP Prescribing Comparators in advance of the NICE consultation on the KTTs is therefore premature and procedurally flawed. Thank you for your response describing MSD s concerns about the key therapeutic topic (KTT) lipid modifying drugs including ezetimibe. We note that your comments necessarily refer to the current wording of the KTT, which of course predates the publication of NICE s updated clinical guideline on lipid modification in July 2014, as do your comments. We must make clear that we cannot comment on the content of the prescribing comparator related to this KTT as that is a matter for the Health and Social Care Information Centre, who lead on the development of the comparators. Our comments are therefore restricted to the therapeutics content of the KTT. To summarise your comments, MSD s position seems to be that ezetimibe should not be included in the KTT because MSD is of the view that: The inclusion of ezetimibe in the recommendation to ensure that use of lipid-modifying drugs is in line with NICE guidance undermines NICE TA132 and unfairly discriminates against ezetimibe. The representation of the evidence base about ezetimibe in the KTT is skewed. Local implementation of the KTT is inappropriate. We shall address these in turn. Does inclusion of ezetimibe in the KTT undermine NICE TA132 and unfairly discriminate against ezetimibe? Following the publication of NICE s updated clinical guideline on lipid modification in July this year (clinical guideline 181), the KTT will be extensively revised. It will refer not only to statins but also to bile acid sequestrants (anion exchange resins), ezetimibe, fibrates and nicotinic acid (niacin), since these are all included in CG181. The 3

4 KTT will therefore refer to all the drugs listed in BNF section 2.12 (lipid regulating drugs) with the exception of omega 3 fatty acid supplements, which are the subject of their own KTT, and lomitapide, which is licensed only for treating homozygous familial hypercholesterolaemia. In view of this, the title of the KTT will be amended to Lipid modifying drugs. In respect of ezetimibe, and as with the current iteration, the revised KTT will clearly state the recommendations in TA132, which was included in CG181. The NICE Medicines and Prescribing Associate network has indicated that the service would appreciate clarification on how the recommendations in TA132 should be interpreted in light of other recommendations in CG181. Therefore, advice to ensure that use of all lipid-modifying drugs is in line with NICE guidance supports implementation of relevant NICE guidance, rather than undermines it. Is the representation of the evidence base about ezetimibe in the KTT skewed? The current KTT states that there remains no published evidence that ezetimibe, alone or added to a statin, reduces the risk of cardiovascular disease or mortality compared with an active comparator. The KTT notes the SHARP study, but points out that this compared simvastatin 20 mg plus ezetimibe with placebo and provides no evidence about how this combination would compare with an active comparator. These statements are factually correct. Since IMPROVE-IT will be closing in September 2014, the revised KTT will also make reference to that study, recognising that it may be some time before the investigators complete their analysis of the data and the report is published in a peer-reviewed journal. 4

5 Prescribing Support Unit, Royal Cornwall Hospitals NHS Trust Are you going to wait for forthcoming NICE CG on lipid modification? Is local implementation of the KTT inappropriate? As you state in your comments, the KTT does not give a target for ezetimibe prescribing. We would agree that setting arbitrary targets is inappropriate, and if a clinician and their patient think ezetimibe is the right treatment in accordance with TA132 it should be available on the NHS, as described in the NHS Constitution, without any local funding or local formulary restrictions. However, we do not think that the existence of examples of inappropriate local guidelines or incorrect interpretation of the KTT is a valid reason for not including ezetimibe within it. An update of the NICE clinical guideline on lipid modification was published in July 2014 and the key therapeutic topic will be updated to reflect the content of this. The updated guideline covers lipid-modifying drugs including bile acid sequestrants, ezetimibe, fibrates, niacin and statins. Key Therapeutic Topic Omega-3 fatty acid supplements No feedback on this topic Key Therapeutic Topic High dose inhaled corticosteroids in asthma No feedback on this topic 5

6 Key Therapeutic Topic Hypnotics No feedback on this topic Key Therapeutic Topic Low dose antipsychotics in people with dementia No feedback on this topic Key Therapeutic Topic First choice antidepressant use in adults with depression or anxiety disorder Telford & Wrekin CCG To account for patients taking drugs that interact with SSRIs, include mirtazapine in the numerator. Any change to the prescribing comparators associated with this therapeutic topic will be considered by the Health and Social Care Information Centre. The Health and Social Care Information Centre lead on the development of prescribing comparators and these comments have been forwarded to them for consideration. 6

7 Key Therapeutic Topic Antibiotic prescribing - especially quinolones and cephalosporins NHS Southern Derbyshire CCG Include co-amoxiclav as it is broad spectrum antibiotic with more indications/uses than cephalosporins & quinolones. HPA advises: Avoid broad spectrum antibiotics (e.g. co-amoxiclav, quinolones and cephalosporins) when narrow spectrum antibiotics remain effective, as they increase risk of C difficile, MRSA and resistant UTIs. Thus include co-amoxiclav. Yes, have total antibacterial items /STAR-PU Also measure cephs, quins & co-amoxiclav as items /STAR-PU. A percentage is not an accurate method because if practices prescribe high numbers of total antibiotic items, their percentages of cephs, quins & coamoxiclav will be lower. The key therapeutic topic, antibiotic prescribing - especially quinolones and cephalosporins, already includes the HPA (Public Health England) statement that simple generic antibiotics should be used if possible when antibiotics are necessary. Broad-spectrum antibiotics (for example, co-amoxiclav, quinolones and cephalosporins) should be avoided when narrowspectrum antibiotics remain effective because they increase the risk of methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile and resistant urinary tract infections. This topic will be updated to include specific recommendations from Public Health England around the indications for co-amoxiclav. Questions around the evidence for co-amoxiclav and first generation cephalosprins and the risk of resistance have been noted and we plan to produce a therapeutic class review on this topic to inform a future update of this key therapeutic topic. Any change to the prescribing comparators associated with this therapeutic topic will be considered by the Health and Social Care Information Centre. The Health and Social Care Information Centre lead on the development of prescribing comparators and these comments have been forwarded to them for consideration. Telford & Wrekin CCG Retain topic but, consider adding co-amoxiclav. The key therapeutic topic, antibiotic prescribing - especially quinolones and cephalosporins, already includes the HPA (Public Health England) statement that simple generic antibiotics should be used if possible when antibiotics are necessary. Broad-spectrum antibiotics (for example, co-amoxiclav, quinolones and 7

8 Prescribing support unit, Royal Cornwall Hospitals NHS Trust Retain topic but, add in a focus on co-amoxiclav as well. cephalosporins) should be avoided when narrowspectrum antibiotics remain effective because they increase the risk of methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile and resistant urinary tract infections. This topic will be updated to include specific recommendations from Public Health England around the indications for co-amoxiclav. Questions around the evidence for co-amoxiclav and first generation cephalosprins and the risk of resistance have been noted and we plan to produce a therapeutic class review on this topic to inform a future update of this key therapeutic topic. The key therapeutic topic, antibiotic prescribing - especially quinolones and cephalosporins, already includes the HPA (Public Health England) statement that simple generic antibiotics should be used if possible when antibiotics are necessary. Broad-spectrum antibiotics (for example, co-amoxiclav, quinolones and cephalosporins) should be avoided when narrowspectrum antibiotics remain effective because they increase the risk of methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile and resistant urinary tract infections. This topic will be updated to include specific recommendations from Public Health England around the indications for co-amoxiclav. Questions around the evidence for co-amoxiclav and first generation cephalosprins and the risk of resistance have been noted and we plan to produce a therapeutic class review on this topic to inform a future update of this key therapeutic topic. 8

9 NHS Trafford CCG We would like to suggest re-consideration of the Key Therapeutics Topic: Cephalosporin and Quinolone prescribing. The drive of this topic is to reduce the associated risk of Clostridium difficile infection (CDI). However, the evidence base surrounding the link between first generation cephalosporins and CDI is weak. I have attached a paper (Owens Jr. et al. 2008), and would appreciate your view on Figure 3 pg S25, a meta-analysis which shows the pooled odds ratio of CDI with first generation cephalasporins is very low. This is also the view of a local consultant microbiologist (based at Trafford General Hospital and the Manchester Royal Infirmary). In Trafford we are getting increased resistance to trimethoprim which is a first line treatment for uncomplicated urinary tract infections. Our other first line treatment is nitrofurantoin. Nitrofurantoin resistance is low, however, it is not suitable in upper urinary tract infections or in those with more severe renal dysfunction (i.e, the elderly). In such cases cephalexin would be ideal. In addition, the current cephalosporin and quinolone QIPP comparator penalises GPs for prescribing cephalexin. Would it be possible to remove/review 1st generation cephalosporins (especially cephalexin) in the updated version of Key Therapeutic Topics? Antibiotic prescribing - especially quinolones and cephalosporins has been retained as a key therapeutic topic for the 2014 update. Questions around the evidence for co-amoxiclav and first generation cephalosprins and the risk of resistance have been noted and we plan to produce a therapeutic class review on this topic to inform a future update of this key therapeutic topic. Any change to the prescribing comparators associated with this therapeutic topic will be considered by the Health and Social Care Information Centre. The Health and Social Care Information Centre lead on the development of prescribing comparators and these comments have been forwarded to them for consideration. 9

10 Key Therapeutic Topic Three-day courses of trimethoprim for uncomplicated urinary tract infection NHS Southern Derbyshire CCG SIGN, HPA advise this for females of all ages. However, I do know that some microbiologists (& GPs) advise 5 days of trimethoprim for older women (as they consider these UTIs as complicated). This key therapeutic topic focuses on uncomplicated UTI and is not intended to make recommendations on treatment duration for complicated UTI. The Cochrane review from 2005 included women with uncomplicated UTI who were otherwise healthy, aged years old and who were not pregnant. Prescribing Support Unit, Royal Cornwall Hospitals NHS Trust Individual healthcare professional (comment made during the consultation on prescribing comparators by the Health and Social Care Information Centre) Is trimethoprim resistance an increasing problem? Introduce some commentary on fact that some patients may require longer courses of trimethoprim. The HPA (Public Health England) management of infection guidance for primary care for consultation and local adaptation states, The HPA and the Association of Medical Microbiologists recommend trimethoprim and nitrofurantoin as first-line empirical treatment for uncomplicated UTI in women and men because they are narrow-spectrum antibiotics that cover the most prevalent pathogens. The choice of trimethoprim or nitrofurantoin as first line varies by locality and is dependent on resistance rates to the two agents. A MeReC Bulletin on the management of common infections in primary care (December 2006) stated that, although rates of resistance to trimethoprim have been reported to be high (20 40%), it should be remembered that resistance rates are based on urine samples from hospitals and from primary care. These samples are likely to disproportionately represent more complicated cases and treatment failures, with fewer samples collected from women with uncomplicated UTI. This key therapeutic topic focuses on uncomplicated UTI and is not intended to make recommendations on treatment duration for complicated UTI. The Cochrane review from 2005 included women with uncomplicated UTI who were otherwise healthy, aged years old and who were not pregnant. 10

11 NHS Nottingham City Clinical Commissioning Group (comment made during the consultation on prescribing comparators by the Health and Social Care Information Centre) Although local guidelines have longer treatment course for men need to be aware when discussing with prescribers. This key therapeutic topic focuses on uncomplicated UTI in women and is not intended to make recommendations on the treatment of UTI in men. The Cochrane review from 2005 included women with uncomplicated UTI who were otherwise healthy, aged years old and who were not pregnant. Key Therapeutic Topic Minocycline NHS Southern Derbyshire CCG Still appropriate to review & (if appropriate) revise prescribing of minocycline in light of its potential harms. Minocycline has been retained as a key therapeutic topic for the 2014 update. Prescribing in this therapeutic area remains an important issue. Telford & Wrekin CCG May need to retain if it s still an issue at a national level. No longer an issue locally though so possibly retire? Prescribing data shows that there is still considerable variation in the prescribing of minocycline nationally. Prescribing in this therapeutic area remains an important issue; therefore minocycline has been retained as a key therapeutic topic for the 2014 update. Prescribing Support Unit, Royal Cornwall Hospitals NHS Trust Is this still worth including? Prescribing data shows that there is still considerable variation in the prescribing of minocycline nationally. Prescribing in this therapeutic area remains an important issue; therefore minocycline has been retained as a key therapeutic topic for the 2014 update. 11

12 Individual healthcare professional (comment made during the consultation on prescribing comparators by the Health and Social Care Information Centre) The rationale for this indicator is unclear. Is it driven by financial concerns or drug toxicity concerns or concerns related to over-prescribing of systemic agents for acne? What evidence supports the view that increased prescribing of minocycline is undesirable? This key therapeutic topic outlines that there are several concerns regarding minocycline s place in therapy: there is no clear evidence that minocycline is more effective or better tolerated than other tetracyclines there are safety concerns specific to minocycline (including early-onset dose-related toxicity reactions resulting in single organ dysfunction, autoimmune disorders and hypersensitivity reactions) alternative once-daily treatments such as doxycycline and lymecycline are available minocycline has a relatively high acquisition cost. Key Therapeutic Topic Type 2 diabetes mellitus NHS Southern Derbyshire CCG Doesn t account for combination products. This comment relates to the prescribing comparator associated with this key therapeutic topic. Any change to prescribing comparators will be considered by the Health and Social Care Information Centre. The Health and Social Care Information Centre lead on the development of prescribing comparators and these comments have been forwarded to them for consideration. 12

13 Key Therapeutic Topic Non-steroidal anti-inflammatory drugs (NSAIDs) Individual healthcare professional (comment made during the consultation on prescribing comparators by the Health and Social Care Information Centre) This class of medicines need to be reviewed as a result of increasing evidence of toxicity especially when used in the elderly where there use should be routinely covered by gastro-protection with a generic PPI. However they are also known to have toxic effects on kidney function and cardiovascular risk so the impression that ibuprofen and naproxen are safe should be discouraged and their use overall should be reviewed NICE TA 27 and CG 79 provide a strategy for limiting their use in osteoarthritis, the most common indication for their use. This key therapeutic topic highlights the known gastrointestinal, renal and cardiovascular safety concerns of NSAIDs. Reviewing the appropriateness of NSAID prescribing widely and on a routine basis is recommended, especially in people who are at higher risk of both gastrointestinal and cardiovascular morbidity and mortality (for example, older people). The need to prescribe a proton pump inhibitor when appropriate in accordance with NICE guidelines on osteoarthritis, rheumatoid arthritis and low back pain is discussed. Key Therapeutic Topic Wound care products NHS Southern Derbyshire CCG Will the prescribing comparators that are in development account for off prescription scheme? Otherwise this is of not much value. Any change to the prescribing comparators associated with this key therapeutic topic will be considered by the Health and Social Care Information Centre. The Health and Social Care Information Centre lead on the development of prescribing comparators and these comments have been forwarded to them for consideration. Telford & Wrekin CCG This indicator should be retired as it has little meaning in many primary care organisations due to new commissioning models for wound care products. Any change to the prescribing comparators associated with this key therapeutic topic will be considered by the Health and Social Care Information Centre. The Health and Social Care Information Centre lead on the development of prescribing comparators and these comments have been forwarded to them for consideration. 13

14 Key Therapeutic Topic General comments on the Key Therapeutic Topics Prescribing Support Unit, Royal Cornwall NHS Trust Is there anyway of having commentary that link prescribing indicators to outcomes, even if only outputs that are described in the ever growing number of CCG profiles emerging from for instance Public Health England which tend to major on QoF achievement? For example in diabetes, when looking at the prescribing measures in the DOVE tool there is no clear relationship between those CCGs that spend the most on diabetes drugs and QoF achievements, accepting the limitations around interpreting this data. Thank you for this question. It is outside the scope of the key therapeutic topics document to include this information for the 2014 update. However, the suggestion has been noted and may be investigated in the future. 14

15 Key Therapeutic Topic Suggestions for new Key Therapeutic Topics NHS Southern Derbyshire CCG NOACs but including warfarin as well rather than as a percentage of so in line with NICE guidance e.g. anticoagulants per PU The existing 14 key therapeutic topics will be retained for the 2014 update, with no retirements or additional new topics. Consideration will be given to suggestions for new topics during the next update. Opioids (fentanyl, oxycodone, tramadol etc.) Stoma/continence care (along the lines of wound care work noting off script limitations) Dietary spend - GF, ONS? The Health and Social Care Information Centre lead on the development of prescribing comparators and comments about the comparators have been forwarded to them for consideration. A better respiratory indicator??? e.g. ratio of SABA to inhaled steroid?... Centrally retained elements and out of pocket expenses (accept these are not clinical indicators) Specials cost/item Medical devices cost & items Drugs associated with minor ailments/self-care e.g. paracetamol suspension, headlice etc. Warrington CCG Appliances (stoma and incontinence) Specials Pregabalin The existing 14 key therapeutic topics will be retained for the 2014 update, with no retirements or additional new topics. Consideration will be given to suggestions for new topics during the next update. Oxycodone NOACS this is a big new area and some data is included in the meds optimisation dashboard. Included in QIPP too, to raise profile? 15

16 Ipsen Ltd. Ipsen Ltd. would like to suggest to NICE the addition of Luteinising Hormone Releasing Hormone agonists (LHRHa) for prostate cancer as an additional therapeutic topic with a potential opportunity for improving quality, innovation, productivity or prevention because of large productivity savings and high clinician/patient interest based on the following rationale (see letter for full details). NICE clinical guidelines on prostate cancer do not recommend which LHRHa should be prescribed. Almost 66% of the cost of LHRH agonists is for goserelin (Zoladex ), which is one of the 20 drugs with the highest expenditure in primary care in England (2010 NIC 67.4 million). Considering an alternative LHRH agonist with a lower annual treatment cost and effective patient outcomes could have a significant impact on both NHS resources and patient care. As an illustration, if patients currently prescribed with leuprorelin or goserelin were to be treated with Decapeptyl SR (triptorelin) 3- or 6-monthly formulation, a primary care saving of over 95,000 per 500 prostate cancer patients treated could be achieved per annum, that s equivalent to 21,000 per 100 prostate cancer patients treated. The existing 14 key therapeutic topics will be retained for the 2014 update, with no retirements or additional new topics. Consideration will be given to suggestions for new topics during the next update. Potential new topics suggested in previous consultations Generic sildenafil out of all PDE5 inhibitor prescribing Tredaptive prescribing The existing 14 key therapeutic topics will be retained for the 2014 update, with no retirements or additional new topics. Consideration will be given to suggestions for new topics during the next update Oxycodone (first-line opioids as a percentage of all) DVT particularly use of NOACs 16