Novartis’ Lucentis (ranibizumab) has been recommended in final guidance as an option for treating visual impairment caused by diabetic macular oedema (DMO).

NICE completed a rapid review of the original guidance it published in November 2011 after Novartis submitted an improved patient access scheme (PAS) and updated data showing the drug’s superior relative effect in certain patients.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said the Institute reversed its 2011 guidance after analysing the updated data supplied by the manufacturer.

The injection is now recommended as an option if the eye has a certain central retinal thickness at the start of treatment and if it is supplied under the PAS terms agreed with the DH.

The terms of the revised PAS remain confidential between Novartis and the DH. However, NICE confirmed the scheme will remain in place until any review of the guidance is published.

The final guidance now replaces any local recommendations across England.

NICE has reversed its opinion on the use of Bristol-Myers Squibb’s Yervoy (ipilimumab) and Roche’s Zelboraf (vemurafenib) for the treatment of advanced malignant melanoma.

The new final draft guidance recommends the use of Yervoy in people who have received prior chemotherapy.

Zelboraf is also recommended for the treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma.

The U-turn came after both manufacturers agreed to supply the treatments at a discounted rate under the terms of separate patient access schemes with the Department of Health.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said the updated guidance was “really good news” for patients with skin cancer.

“Vemurafenib and ipilimumab are breakthrough treatments that can potentially significantly affect prognosis for these patients and we are very pleased that the manufacturers have worked with us so that we are now able to recommend both ipilimumab and vemurafenib,” said Professor Longson.

Since the publication of the first draft guidance, which NICE failed to recommend the use Yervoy due to its £80,000 price tag, BMS provided additional data and analysis surrounding the cost-effectiveness of the drug.

Roche also supplied additional analysis on the effectiveness of the drug in relation to its clinical and cost effectiveness.

Cancer patients whose disease has spread from a solid tumour to their bones have now been given a new treatment option after NICE backed the use of Amgen’s Xgeva (denosumab).

Xgeva has been recommended to treat the condition known as bone metastases in people suffering from breast cancer or solid tumours other than prostate who would otherwise be prescribed bisphosphonates.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said Xgeva was a “welcome addition” alongside existing treatment options.

Final guidance states that Xgeva should only be prescribed under the terms agreed between the Department of Health and Amgen as part of a patient access scheme.

Amgen estimates there are around 150,000 patients in the UK with solid tumours and bone metastases, of which breast and prostate cancer account for more than 80%.

“We’re pleased to be able to recommend another treatment option for people with bone metastasis from most solid cancer tumours,” said Professor Longson. “This type of metastasis can reduce a person’s mobility and quality of life in general, increasing the risk of complications from bone weakness.”

NICE has recommended the use of Novartis’ Tobi Podhaler tablets but failed to back Forest Laboratories UK’s Colobreathe tablets for treating cystic fibrosis patients with a pseudomonas lung infection.

The draft guidance recommends a nebulised version of Tobi Podhaler if it is considered appropriate when nebulised Colobreathe is contraindicated, not tolerated or has not produced adequate clinical response.

Tobi Podhaler tablets should also only be prescribed under the terms of an agreed patient access scheme between Novartis and the Department of Health.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said the Institute was “pleased to recommend” another treatment option for patients.

Cystic fibrosis is one of the UK’s most common life-threatening inherited diseases. It currently affects around 8,000 people – although more than two million people carry the faulty gene.

Sufferers are prone to lung infections by a range of pathogens. The aim of treatment is to clear the respiratory sections to maintain lung function whilst reducing inflammation and bacterial growth. Although there is no cure, treatment includes regular physiotherapy, antibiotics, and inhaled mucolytics through a nebuliser.

Tobi Podhaler is inhaled using a breath activated hand-held device which works by reducing the amount of bacteria in the lungs. NICE’s independent Appraisal Committee concluded the Podhaler was a cheaper and more effective option than a nebulised option.

However, the Committee said the economic analysis for Colobreathe was less effective and less costly than nebulised Tobi Podhaler. Additionally, analysis could not convey that Colobreathe is a cost-effective use of NHS resources.

The draft guidance is now open for consultation. NICE expects to publish final guidance in March 2013.

NICE has again backed Amgen’s Xgeva (denosumab) as a treatment option for patients with bone metastases from the majority of solid cancer tumours.

The final draft guidance recommends the treatment after NICE produced a review of available evidence and two separate stages of public consultation.

It continues to recommend Xgeva for the prevention of skeletal-related events in:

· people with bone metastases from breast cancer, and

· people with bone metastases from solid tumours who would otherwise be prescribed bisphosphonates.

The guidance also states that Xgeva must only be prescribed under the terms agreed in a Patient Access Scheme between Amgen and the DH.

Bone metastases occur when cancer spreads from its original tumour to the bone. This can lead to bones losing their strength and ultimately lead to skeletal-related events.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said the condition “can severely affect a person’s quality of life” and stop individuals from completing everyday tasks.

NICE has now given consultees another opportunity to request a factual change to the draft guidance or lodge an appeal against its recommendation. If no appeals are received, final guidance will be issued later this year.

NICE has launched a second consultation on the use of Xgeva (denosumab) for the treatment of cancer patients with bone metastases after again recommending its use on the NHS.

An independent Appraisal Committee heard evidence from clinical experts during the original consultation on the draft guidance on current UK clinical practice concerning its comparison to existing options.

As a result, the latest draft guidance now recommends Xgeva for adults with bone metastases from breast cancer and those with solid tumours other than breast and prostate only if certain other bisphosphonates would otherwise be prescribed.

The updated guidance also states the treatment must be supplied under the terms of an agreed Patient Access Scheme, and that Xgeva is not recommended for preventing skeletal-related events in those with bone metastases from prostate cancer.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said feedback from clinical experts “shed new light on the original recommendations”.

Earlier draft guidance recommended the treatment in people with bone metastasis from breast cancer; people with painful bone metastasis from hormone-refractory prostate cancer when treatment has failed; and for those with bone metastasis from other solid tumours for whom zoledronic acid is indicated.

The appraisal is considering the treatment as an alternative to bisphosphonates and as an alternative to best supporting care where they are not used.

Comments are now being invited by NICE and its Appraisal Committee on the updated draft guidance.

NICE has launched a second consultation on the use of Xgeva (denosumab) for the treatment of cancer patients with bone metastases after again recommending its use on the NHS.

An independent Appraisal Committee heard evidence from clinical experts during the original consultation on the draft guidance on current UK clinical practice concerning its comparison to existing options.

As a result, the latest draft guidance now recommends Xgeva for adults with bone metastases from breast cancer and those with solid tumours other than breast and prostate only if certain other bisphosphonates would otherwise be prescribed.

The updated guidance also states the treatment must be supplied under the terms of an agreed Patient Access Scheme, and that Xgeva is not recommended for preventing skeletal-related events in those with bone metastases from prostate cancer.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said feedback from clinical experts “shed new light on the original recommendations”.

Earlier draft guidance recommended the treatment in people with bone metastasis from breast cancer; people with painful bone metastasis from hormone-refractory prostate cancer when treatment has failed; and for those with bone metastasis from other solid tumours for whom zoledronic acid is indicated.

The appraisal is considering the treatment as an alternative to bisphosphonates and as an alternative to best supporting care where they are not used.

Comments are now being invited by NICE and its Appraisal Committee on the updated draft guidance.

NICE’s decision to recommend Janssen’s prostate cancer drug Zytiga (abiraterone) has been backed by patient groups.

Zytiga is now recommended in new draft guidance after further patient data and a revised Patient Access Scheme (PAS) convinced NICE to reconsider its previous rejection of the drug.

Dr Harpal Kumar, CEO of Cancer Research UK, said the decision is “wonderful news for patients” and believes the U-turn reflects “the public’s disappointment at the initial refusal”.

In February this year, NICE failed to recommend the treatment in combination with prednisone or prednisolone after deeming it to be too expensive – despite its clinical benefits.

At the time of the decision, Janssen said it would work closely with NICE to gain a positive recommendation. That included supplying a revised PAS and additional data on a subgroup of patients who may receive the most benefit from the cancer drug.

Janssen also submitted further information on the number of patients for whom Zytiga is licensed, enabling it to be considered under NICE’s end of life criteria.

Professor Johann de Bono from The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, who led the pivotal trials of Zytiga, said he was “thrilled” the revised data has changed NICE’s original decision.

“Abiraterone acetate is one of only a handful of life-extending drugs for these men in the UK and, importantly, it can also improve quality of life,” he said. “Some of my patients have been taking abiraterone for several years through a clinical trial and are still pain free.”

Prostate cancer is the second most common cause of cancer deaths in UK men. More than 10,000 men die each year with a further 40,000 men diagnosed annually.

Bristol-Myers Squibb has expressed its disappointment after the Scottish Medicines Consortium (SMC) failed to recommend its skin cancer drug Yervoy (ipilimumab).

The SMC decided against approving the treatment for advanced (unresectable or metastatic) melanoma in adults who have received prior therapy after questioning its clinical benefits in relation to its cost.

Amadou Diarra, European Vice-President and General Manager, BMS UK and Ireland, said the company would continue to work with the SMC to “enable Scottish patients to access this potentially life-extending treatment.”

Around 1,200 people in Scotland are diagnosed with malignant melanoma each year. Its incidence is rising in the country at an epidemic rate.

Within the appraisal submitted by BMS, the SMC recognised how Yervoy is the first licensed medicine in the UK to demonstrate survival benefits in patients with skin cancer who have received prior treatment.

Data from a pivotal Phase III trial demonstrated how almost half (46%) of patients treated with Yervoy were still alive after 12 months of treatment compared to 25% taking the vaccine gp100.

The median overall survival was 10.1 months in those receiving Yervoy, compared with 6.4 months among those receiving gp100.

However, despite BMS also providing the treatment under the terms of a Patient Access Scheme to reduce the cost of Yervoy, the SMC did not believe it offered value for money to the NHS in Scotland.

“Ipilimumab is a prime example of an innovative medicine that has the potential to offer significantly improved outcomes,” said Amadou Diarra. “We are disappointed that the SMC has failed to recognise the value of Ipilimumab.”

Since it was licensed in Europe in July last year, eligible patients in England have been able to receive the treatment. During the same period, a number of patients have attempted to access Yervoy through an Individual Patient Treatment Request (IPTR). But, as far as BMS is aware, no IPTRs have been approved.

Leigh Smith, Chair of the Melanoma Action and Support Scotland, called the decision “incredibly disappointing” and said the decision by the SMC will drive patients south of the border.

“It leaves many Scottish patients suffering from this devastating disease with no option but to consider moving to England where funding for the treatment can potentially be accessed,” she said. “We hope that the SMC will consider all options available that might enable Scottish patients to benefit from this treatment.”

Roche’s Tarceva (erlotinib) has been recommended in final draft guidance as a first-line option for people with EGFR mutation-positive non-small-cell lung cancer (NSCLC).

The decision comes after Roche provided NICE with additional data on the clinical and cost effectiveness of Tarceva when supplied under an agreed Patient Access Scheme (PAS).

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said the health regulator is “pleased to recommend another treatment” for NSCLC.

NICE recently recommended Iressa (gefitinib) as a first-line treatment for NSCLC. Roche were unable to provide any clinical data comparing Tarceva with Iressa, but specialists confirmed the two were similar and equally effective.

Tarceva and Iressa work differently to chemotherapy. The oral treatments are known as “target agents” due to the way they block certain processes in the cancer cells.

Data supplied by Roche showed Tarceva showed longer progression-free survival and similar overall survival compared with current treatment options. It expects that NICE’s recommendation will benefit approximately 11% of patients with NSCLC.

The PAS agreed between Roche and the DH may mean that Tarceva is supplied to the NHS free of charge in certain circumstances. Tarceva will be made available at a single cost of £12,200 per patient irrespective of the duration of treatment. However, Roche will only invoice the health service after the third monthly pack of Tarceva is supplied. Any patients who receive only one or two months of treatment will receive the drug without the NHS being charged.