Draft NICE guidance does not recommend the routine use of AstraZeneca’s anti-oestrogen drug Faslodex (fulvestrant) in the NHS to treat certain types of breast cancer.

Faslodex was authorised in 2010 for marketing as an alternative to aromatase inhibitors to delay the growth of oestrogen-receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women who have already received anti-oestrogen therapy (such as tamoxifen).

NICE’s Independent Advisory Committee has concluded that the drug is not significantly more effective than existing treatments, and so its routine use would not be a good use of resources.

The Committee judged AstraZeneca’s claim that Faslodex could extend life relative to the aromatase inhibitors anastrozole and letrozole to be uncertain as network meta-analyses showed no statistically significant differences.

In addition, they found that Faslodex delayed cancer growth more effectively than anastrozole but not more so than letrozole. An incremental cost effectiveness ratio of £35,000 per QALY gained for Faslodex 500mg compared with anastrozole was estimated, but with “considerable uncertainty”.

The draft guidance thus recommends that NHS doctors should not prescribe Faslodex as an alternative to aromatase inhibitors in relevant cases – but that women who are currently receiving Faslodex should be able to continue to do so until they and their doctors decide to stop.

Sir Andrew Dillon, Chief Executive of NICE, commented: “While there is evidence that fulvestrant can delay the growth of breast cancer, our independent committee found that when used according to its marketing authorisation, its effectiveness is uncertain compared to aromatase inhibitors, which are currently the preferred treatment options on the NHS.

“As fulvestrant has not been proven to be cost-effective, we cannot justify diverting NHS funds from other areas of healthcare in order to fund its use.”

The draft guidance is open to appeal until 24 November. NICE hopes to publish final guidance in January 2012.

Final NICE diagnostic guidance on the EOS 2D/3D X-ray imaging system calls for the system’s health benefits to be further investigated in clinical research settings.

The new system (pictured) from US company EOS Imaging uses low-dose radiation imaging to produce 2D X-ray images and 3D reconstructions for bones.

Its innovative slot-scan technology, scanning a line at a time rather than taking the entire image at once, enables it to produce upright and weight-bearing whole-body images.

By showing relationships between the spine, hip, pelvis and knees, the EOS system could particularly benefit the monitoring and treatment of patients with spinal deformities or alignment problems.

The system’s reduced dose also offers potential safety advantages in the repeated imaging of patients with spinal deformities, especially children.

The new guidance encourages the use of the 2D/3D imaging system in specialist research settings to collect evidence about clinical benefits associated with weight-bearing whole-body imaging and 3D reconstruction.

Professor Carole Longson, Director of the NICE Health Technology Evaluation Centre, said: “The EOS 2D/3D imaging system was identified by the Diagnostics Advisory Committee as an important emerging technology. There is evidence showing comparable or better images and radiation dose reduction associated with using the EOS system to image patients with spinal deformities.”

However, she said, there is currently no evidence that compares the diagnostic accuracy of the EOS system with that of conventional radiological examinations. “NICE will follow up the Diagnostics Advisory Committee’s research recommendations on the EOS 2D/3D system and will assess the feasibility of this research with a view to facilitating the development of further relevant evidence.”

Full data sets evaluating the system’s benefits will trace the outcome of its use from planning through to complex surgeries such as hip replacements.

Marie Meynadier, CEO of EOS Imaging, said: “The EOS 2D/3D imaging system is subject to an extensive programme of research associating radiologists and orthopaedic surgeons. We will provide data to NICE as they are established to determine when a cost-effectiveness review based on this evidence would be appropriate.”

The new external assessment centres recently announced by NICE will help to develop and facilitate research products to assist suppliers when NICE medical technology or diagnostics guidance recommends it.

NICE has recommended Boehringer Ingleheim’s Pradaxa (dabigatran) for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF) in final draft guidance.

The positive recommendation follows the disclosure of further information from Boehringer that had been requested on a number of areas, including its cost effectiveness and use in clinical practice.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, says the medication “represents a significant potential benefit for many people with AF”.

Questions were initially raised by NICE’s Independent Appraisal Committee over the cost to the NHS and a “more plausible set of assumptions” on Pradaxa’s use were required from Boehringer.

But NICE says it is “pleased” the additional information and analysis it received has enabled the Committee to recommend the treatment as a cost-effective use of NHS resources.

“The Independent Appraisal Committee accepted evidence that showed dabigatran 150mg twice daily is more clinically effective than warfarin in reducing the risk of stroke or systemic embolism, and that dabigatran 110mg twice daily is as effective as warfarin. However, there were a number of uncertainties relating to the drug’s cost-effectiveness in the original evidence submission from the manufacturer which required clarification,” said Professor Longson.

Dr Charles de Wet, Medical Director at Boehringer Ingelheim, welcomed the revised decision by NICE. “Pradaxa is the first new oral anticoagulant in 50 years and we are committed to working closely with the NHS to ensure appropriate prescribing in suitable patients with AF who are at risk of stroke,” he said.

Pradaxa has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients aged 75 years with AF who have had a previous stroke, heart attack or systemic embolism.

It is also authorised for people with AF over 65 who have diabetes, coronary heart disease or hypertension.

Final guidance is now expected to be published next month.

Roche’s RoActemra (tocilizumab) has been recommended in draft guidance for treating systemic juvenile idiopathic arthritis (JIA).

NICE recommended the treatment after Roche provided its Appraisal Committee with further requested clinical data and it agreed a revised Patient Access Scheme with the DH.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says the recommendation is “good news for children with systemic JIA and those caring for them.”

The draft recommendation is for the use of RoActemra in children aged 2 and over where specific previous treatments have not produced an adequate response.

However, in cases where those whose disease continues to respond to methotrexate or who have not been treated with methotrexate, RoActemra is not recommended as a treatment option.

“The discount agreed as part of the patient access scheme put forward by the manufacturer, in addition to the further information they provided at the Committee’s request, has enabled the Committee to recommend tocilizumab for systemic juvenile idiopathic arthritis in today’s draft guidance,” said Professor Longson.

“The draft guidance proposes that tocilizumab should be the treatment for children aged over 2 years and young people where their systemic JIA hasn’t responded well to other treatments.”

AstraZeneca’s Brilique (ticagrelor) has been recommended in final guidance, in combination with aspirin for up to a year, as an option to treat adults with acute coronary syndromes (ACS).

NICE has also recommended the treatment as a treatment option for people admitted to hospital with unstable angina.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, says that evidence shows Brilique is “effective at reducing myocardial infarction (MI) and deaths from cardiovascular causes”.

Every year in England, around 200,000 people are diagnosed with ACS, of whom approximately 75% have unstable angina or Non-ST-segment-elevation myocardial infarction (NSTEMI).

The medication works by reducing or preventing blood clots, so that the flow to the heart muscle can be maintained to prevent further damage. It is licensed for the treatment of people with ACS who are managed medically or who are to undergo percutaneous coronary intervention (PCI) – a procedure to widen narrowed arteries in the heart.

The guidance recommends the use of anti-platelets treatment, in combination with aspirin, as a treatment option in people with STEMI who are to undergo PCI and in people with NSTEMI.

“Today’s guidance, in recommending the use of ticagrelor where clinically appropriate, is an affirmation of that effectiveness and good news for patients with ACS, wherever they live in England and Wales, because it increases the number of treatment options available to them,” said Professor Carole Longson, NICE Health Technology Evaluation Centre Director.

Eli Lilly’s diabetes injection Bydureon, exenatide prolonged release suspension, has been preliminarily recommended by NICE.

The draft guidance recommends the injection as part of a triple and duel therapy regimens for type II diabetics when their control of blood glucose remains or becomes inadequate in certain circumstances.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE says the Institute is “pleased” to recommend another treatment option for people with the condition.

The injection improves glycaemic control by lowering the rise in blood sugar from eating and prevents hyperglycaemia.

In triple therapy regimens in combination with metformin and a sulphonylurea, or metformin and thiazolidinedione, Bydureon is recommended if a person has a certain body mass index (BMI) and has specific psychological or medical problems associated with their weight, or if therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.

Bydureon is recommended in dual therapy regimens in combination with metformin or a sulphonylurea if either of the two together or separately is contraindicated or not tolerated or treatment with thiazolidinediones and DPP-4 inhibitors are contraindicated or not tolerated.

NICE says that treatment with the injection for both triple and dual therapy regimen should only be continued if a beneficial metabolic response has been proven.

Final guidance is likely to be published in February 2012.

Eli Lilly expects the drug’s increasing approval to create jobs at its US manufacturing facility in West Chester.

Bydureon was approved by the European Commission to treat type 2 diabetes in June 2011.

Roche’s RoActemra (tocilizumab) has been provisionally recommended in draft guidance to treat additional stages of rheumatoid arthritis after a rapid review of an earlier appraisal.

RoActemra was originally recommended at a later stage of the treatment pathway, but NICE has now issued new guidance of TA198 fter Roche agreed a Patient Access Scheme with the DH.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, says the provisional guidance widens the choice of treatments for patients.

A rapid review can be conducted by NICE if a new Patient Access Scheme is submitted within 16 weeks of original guidance publication. However, these schemes can only be considered by NICE after ministerial approval and confirmation by the DH.

In August 2010, NICE issued guidance TA198 recommending RoActemra as an option if there had been an inadequate response to one or more TNF inhibitors and where rituximab has also produced an inadequate response, or where it is contraindicated or has produced undesirable side effects.

The new draft guidance outlines that in specific clinical circumstances – and within the terms of the Patient Access Scheme – it’s recommended where the disease has responded inadequately to disease-modifying anti-rheumatic drugs (DMARDs) and the medication is used as described for other TNF inhibitor treatments in NICE guidance TA130.

The updated guidance also includes using the treatment as originally recommended after both rituximab and TNF inhibitors were tried, and a recommendation on using tocilizumab when rituximab can’t be used after TNF inhibitor treatment has failed.

“If TNF inhibitor treatments have failed and patients are unable to take rituximab, the guidance also provisionally recommends that tocilizumab could be a treatment option at this point, potentially widening the choice of treatments available,” said Professor Longson.

RoActemra was previously approved in Europe in August and the US in April 2011 for the treatment of childhood arthritis.

Sanofi’s prostate cancer drug Jevtana (cabazitaxel) has not been recommended by NICE in draft guidance in combination with prednisone or prednisolone as a second line treatment.

NICE’s Appraisal Committee raised concerns about the medication’s cost effectiveness, its associated adverse effects and evidence supplied by the manufacturer.

Sir Andrew Dillon, NICE Chief Executive, says that the Committee was “particularly concerned” about the uncertainty on patients’ renal and cardiac systems.

A number of factors are taken into consideration by NICE’s Appraisal Committees when assessing the cost effectiveness of a treatment. These include the medication’s clinical effectiveness, its side effects, the benefits it brings to patients and the financial cost.

This formula then enables them to determine the cost of using the drug to provide a year of the best quality of life available or quality adjusted life year (QALY). NICE says they usually recommend treatments that cost around £30,000 per QALY or less, however the cost of Jevtana was far greater than this figure.

“The manufacturer of cabazitaxel provided one study on the effectiveness of the drug; in this study cabazitaxel was shown to extend life by approximately 10 weeks,” said Sir Andrew. “Although cabazitaxel has been shown to be effective, it is also associated with a number of adverse events.”

He added that the Appraisal Committee was also concerned about the “validity” of the health related information supplied by Sanofi after it provided one study which demonstrated a median overall survival gain of 2.4 months and an mean overall survival gain of 4.2 in its model.

“The Committee also felt that the treatment did not meet the criteria to be considered under NICE’s special arrangements for end of life, as based on the current data the length of the life extension could not be considered robustly proven to be at least three months,” added the Chief Executive.

“Once all these factors had been taken into account it was estimated that the cost per QALY would be more than £89,000. Therefore the committee concluded that cabazitaxel would not be a cost effective use of limited NHS resources.”

If a drug does meet the criteria to be considered under the Institute’s supplementary advice for end of life treatments, a higher cost per QALY may be accepted by NICE. There is currently no set threshold cost per QALY that meets this criterion, but since the supplementary advice was introduced, the only drug recommended under this method has been Sunitinib for renal cell carcinoma at a cost of £50,000.

NICE said that Javtana did not meet this criterion because the Committee did not consider the length of the life extension to be “sufficiently robust”.

Anti-bee or wasp venom treatment Pharmalgen has been recommended in preliminary draft guidance by NICE.

It has been recommended as a treatment option for those who have had a severe systemic reaction to being stung or a moderate reaction with additional complications.

Professor Peter Littlejohns, Clinical and Public Health Director at NICE, says Pharmalgen is an “effective, preventative treatment”.

Less than 0.5% of the population in the UK who are stung by a bee or wasp experience a severe reaction, known as anaphylaxis. Each year in the UK, up to nine people die as a result of anaphylaxis.

Pharmalgen works by gradually increasing doses of the allergen by injection, which over a period of time, desensitises a person with the allergy by altering their immune system. It is carried out in two phases: the first initial phase after a sting and the maintenance phase which last for three years.

“The reactions that some people experience to stings from bees and wasps can be distressing, frightening and sometimes life-threatening,” said Professor Littlejohns. “People who have had a serious reaction to a sting can often experience extreme anxiety about possible future stings, and this can affect their daily lives.”

Final guidance is now expected to be issued to the NHS in February next year.

The CHMP has given a positive opinion to Novo Nordisk’s basal insulin analogue Levemir as an add-on treatment in patients with type 2 diabetes.

The opinion is based on a clinical trial where, as an add-on therapy to Victoza, in combination with metformin, reduced glycated haemoglobin (HbA1C) and sustained weight loss were demonstrated.

Alan Moses, Global Chief Medical Officer at Novo Nordisk, says the decision provides an “additional treatment option” for patients who need more options to achieve personalised glucose targets.

Meanwhile, the Committee has also adopted a positive opinion on the extended use of the insulin in children aged between two and five years old with type 1 diabetes.

It reviewed data that showed children treated with Levemir plus a fast-acting insulin analogue experienced a lower rate of all-day and nocturnal hypoglycaemia when compared to those taking human basal insulin and insulin aspart.

Dr Nandu Thalange, Norfolk and Norwich University Hospital, says that when treating children their safety must always come first and welcomed the CHMP’s decision. “Reducing risk of hypoglycaemia – particularly at night – is a vital part of modern management of young children with diabetes,” said Dr Thalange. “Children under six years are at the highest risk of severe hypoglycaemia and other acute diabetes complications, and any treatment which improves safety – not least in this group – is to be welcomed.”

Novo Nordisk now anticipates that the European Commission will shortly approve the usage of Levemir as an add-on therapy to Victoza in patients with type 2 diabetes and extend the marketing authorisation to make the insulin detemir the only basal insulin analogue for the use in this young patient group with type 1 diabetes.

Levemir, Victoza and NovoRapid, another insulin therapy by Novo Nordisk, contributed to a profit increase of 27% for the company in 2010.