Bone cancer drug gets NICE backing

by IainBate 29. October 2012 15:52

Pharma NICE Update 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 continues to back bone metastases drug

by IainBate 17. August 2012 14:35

Pharma NICE Update 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The final draft guidance recommends the treatment after NICE produced a review of available evidence and two separate stages of public consultation.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 launches second consultation on Xgeva

by IainBate 12. June 2012 14:24

Pharma NICE Update 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 launches second consultation on Xgeva

by IainBate 12. June 2012 14:24

Pharma NICE Update 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.

A bright idea

by IainBate 11. May 2012 15:10

A bright idea - Pharmaceutical Field With the Government aiming to increase innovation within the NHS, pharma has been tasked with helping to meet the challenge. Omar Ali, in his Matrix Revolutions series, focuses on the means to help the industry find the next big thing.  

With so many documents to read – white papers, NHS initiatives and DH directives – keeping tabs on the direction of travel of the NHS, as well as the pace of change, makes life difficult; and that’s not including the latest clinical trials, review publications and NICE guidance. In this issue of the Matrix Revolutions, I want to review one of the most important and potentially game changing documents to have
crossed my desk: Innovation, Health and Wealth.

The document comes under ‘improvement and efficiency’ from the DH and has an impressive circulation list. However, if the cascade didn’t get past those at directorship level, the average GP and healthcare professional may not have received what is a very important document. It also goes hand-in-hand with a story from NICE in February – Improving access to NICE-approved drugs – which provided the NHS with a best-practice guide on the implementation of local formularies in accordance with national guidance.

Innovation, Health and Wealth calls for all NHS organisations to come to ‘action’ by starting planning processes for the implementation of innovative new treatments approved by NICE.

“…while the NHS is recognised as a world leader in invention, the spread of those inventions within the NHS has often been too slow, and sometimes even the best of them fail to achieve widespread use”

I think we would all recognise this symptom of the NHS and list numerous examples. The UK is well known in being conservative with its adoption and prescribing of new drugs. But when NICE makes deep probing evaluations of new treatments it may be disturbing to find such variation in the implementation of best practice and subsequent availability of new medicines for patients.

It’s well known that when HTA agencies reject drugs the NHS is very good at implementing rapid ‘decommissioned’ formularies, which make general prescribing and availability very limited. However, when NICE does approve a new treatment, the variable uptake observed within the NHS as a whole has resulted in this new initiative.

“The challenge both for the NHS and for its industry partners is to pursue innovations that genuinely add value but not cost”

This is interesting how it adds up… I’m supposed to work with you to find innovations that don’t add cost… The problem with documents is rhetoric and direction. In reality, implementation will come down to precise and specific details. There are not many new drugs that ‘don’t add cost’ – they all add cost! The modelling comes in finding those that may offset some of the costs (QIPP).

“This report has been developed as part of the Prime Minister’s UK Strategy for Health Innovation and Life Sciences. The aim of this strategy is to ensure that the UK maintains and builds on its world leading position for life sciences, that the potential of life sciences to contribute to UK growth is realised, and that the UK remains and grows as an attractive location for investment now and in the future”

The flavour of the document paints a clear picture of investment from pharma which will potentially deteriorate within the UK due to poor uptake/diffusion by the NHS. The difficulty lays in that ‘uptake’ criteria for the NHS doesn’t have ‘investment’ as part of the decision process. For example, if a company invests millions into UK R&D and produces a poor, non-innovative and non-cost effective drug, should we put it on formulary due to the fact they have invested in the UK economy? If the answer is ‘yes’, we all need to change the paradigm and throw QIPP out of the window. I guess the alternative is how long can pharma keep resourcing UK investment and see no return? Not long in this climate. Surely then the answer is as seen above: the challenge of making new, innovative drugs cost effective.

Having helped bring NHS payers, CCG commissioners and pharma together, it brings some common ground on market access. I have found that with all of the details, some dedicated quality time with stakeholders and some flexibility from pharma, we can always find some manner of value-added to the product and/or a financial/value proposition that changes the paradigm. The truth is we don’t spend enough quality time talking together about the real issues. We tend to spend poorly co-ordinated NHS/pharma interactions looking at insane cost-models and budget impacts that are largely irrelevant. Add to that ABPI/compliance and internal concordance issues, and the NHS and pharma are often dancing around the tables instead of having decent commercial business discussions that pave the way to a healthier, wealthier future for both.

Potential barriers
“Poor access to evidence, data and metrics”

I have been impressed with some of the data informatics I have seen that actually represent data handling with a view to Secondary Uses Service (SUS) information, hospital episodes and prescribing by the CCG sector or a PCT. Here, pharma is beginning to excel themselves and it does have an influence on working together. This approach is far better than those companies who have a black-box approach to health economics.

“Insufficient recognition and celebration of innovation and innovators”

It’s hard for NHS innovators to ‘step out’ and stick their heads above the parapets when those around them are stuck in the same old ways. Far from recognition or reward, one can expect pushing uphill and against the grain. The only way to succeed here is to believe in the cause of innovation and true improvement. My feeling is those ‘beacons of light’ are beginning to shine in healthcare – and love it or hate it – one of the strengths of the Health Bill is bringing those leaders to the forefront through sheer necessity. My observation is that the pharma culture celebrates innovation from the core – it’s what you do and what you believe in. Being an optimist, I believe pharma has a role on the ground in bringing some of that innovation to ‘rub-off’ on your NHS customers.

“Financial levers do not reward innovators and can act as a disincentive to adoption and diffusion”

You may have read my previous Matrix Revolutions ‘case’ on Prolia (denosumab) – it had a NICE TAG but saw variable uptake, even a year after its recommendation. This case clearly outlined how micro-economics and financial levers can stall the introduction of new innovative therapies. But getting the tariffs to match, commissioning to fund and finding the code to unlock prescribing took a long time… why? Partly because our own informatics is poor – an example of the NHS barrier – and partly because dealing with payer issues doesn’t come first-hand to most brand teams.
Other financial levers that will inhibit uptake include:

  • Enhanced LES & DES warfarin payments to GPs which will be a threatened source of income with new oral anticoagulants.
  • QoF cholesterol targets of 5mmol/l in the face of innovative agents which may achieve lower cholesterol targets and reduced outcomes.
  • QIPP Indicators aiming for a percentage of metformin and sulphonylurea when newer agents for type 2 diabetes reduce incidence of hypoglycaemic episodes and save money on blood glucose testing strips.

In the next issue of Matrix Revolutions, Omar Ali continues to review the DH’s modernisation plans and also focuses on what makes the diffusion of innovation happen. 

Omar Ali is the Formulary Development Pharmacist for Surrey & Sussex Healthcare NHS Trust and sits on the External Reference Group for Cost Impact Modelling for NICE. He can be reached at omar.ali@sash.nhs.uk.

NICE recommends bone cancer treatment

by IainBate 30. March 2012 14:14

Pharma NICE Update NICE has recommended the use of Xgeva (denosumab) in draft guidance for certain cancer patients whose disease has spread to their bones.

The recommendation covers patients 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.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, says the condition can have a “major impact on quality of life” and is therefore “pleased” to recommend the treatment.

The guidance stipulates that Xgeva should only be prescribed under the terms of an agreed Patient Access Scheme between Amgen and the DH.

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

The spine, pelvis, hip, upper leg bones and skull are most commonly affected by bone metastases with symptoms including pain, and weakening and eventual destruction of the bone.

The majority of patients with the condition are currently treated with bisphosphonates. NICE’s independent Appraisal Committee considered Xgeva as an alternative to standard treatment options where bisphosphonates are not used.

It noted that in clinical trials where Xgeva was directly compared to standard treatment options it improved skeletal-related outcomes. It was also shown to be more clinically effective in patients with breast, prostate and non-small cell lung cancer.

The initial recommendation is now open for consultation.

Two further indications of Prolia approved in US

by emma 20. September 2011 10:28

Pf product news

The FDA has approved Amgen’s osteoporosis drug Prolia for the treatment of bone loss associated with certain chemotherapy.

The medicine is the first for cancer treatment-induced bone loss, now indicated for women receiving adjuvant aromatase inhibitor therapy for breast cancer and men with prostate cancer who are being treated with hormone therapy.

The denosumab drug is known to reduce fracture risks in breast cancer patients taking drugs that halt oestrogen production and prostate cancer patients treated with androgen-deprivation therapies.

Matthew Smith, Director of the Genitourinary Malignancies Programme at Massachusetts General Hospital Cancer Center in Boston, said: “Bone loss and fractures are recognised adverse effects of hormone ablation therapies but we have not had an approved treatment option to prevent these problems for our patients”.

Prolia was previously approved in 2010, intended to be used in post-menopausal women with osteoporosis who were at increased risk of fractures.

Both therapies reduce hormone levels, leading to increased risk of bone loss and fracture.

Denosumab is also the active ingredient in Amgen’s Xvega, which is designed to prevent fractures in patients with cancer that has spread to the bone.

Denosumab is the first in a new class of medicines that blocks proteins that activate bone-destroying cells called osteoclasts.

Two further indications of Prolia approved in US

by emma 20. September 2011 10:28

The FDA has approved Amgen’s osteoporosis drug Prolia for the treatment of bone loss associated with certain chemotherapy.

The medicine is the first for cancer treatment-induced bone loss, now indicated for women receiving adjuvant aromatase inhibitor therapy for breast cancer and men with prostate cancer who are being treated with hormone therapy.

The denosumab drug is known to reduce fracture risks in breast cancer patients taking drugs that halt oestrogen production and prostate cancer patients treated with androgen-deprivation therapies.

Matthew Smith, Director of the Genitourinary Malignancies Programme at Massachusetts General Hospital Cancer Center in Boston, said: “Bone loss and fractures are recognised adverse effects of hormone ablation therapies but we have not had an approved treatment option to prevent these problems for our patients”.

Prolia was previously approved in 2010, intended to be used in post-menopausal women with osteoporosis who were at increased risk of fractures.

Both therapies reduce hormone levels, leading to increased risk of bone loss and fracture.

Denosumab is also the active ingredient in Amgen’s Xvega, which is designed to prevent fractures in patients with cancer that has spread to the bone.

Denosumab is the first in a new class of medicines that blocks proteins that activate bone-destroying cells called osteoclasts.

Two further indications of Prolia approved in US

by Emma 20. September 2011 10:28

Pf product news

The FDA has approved Amgen’s osteoporosis drug Prolia for the treatment of bone loss associated with certain chemotherapy.

The medicine is the first for cancer treatment-induced bone loss, now indicated for women receiving adjuvant aromatase inhibitor therapy for breast cancer and men with prostate cancer who are being treated with hormone therapy.

The denosumab drug is known to reduce fracture risks in breast cancer patients taking drugs that halt oestrogen production and prostate cancer patients treated with androgen-deprivation therapies.

Matthew Smith, Director of the Genitourinary Malignancies Programme at Massachusetts General Hospital Cancer Center in Boston, said: “Bone loss and fractures are recognised adverse effects of hormone ablation therapies but we have not had an approved treatment option to prevent these problems for our patients”.

Prolia was previously approved in 2010, intended to be used in post-menopausal women with osteoporosis who were at increased risk of fractures.

Both therapies reduce hormone levels, leading to increased risk of bone loss and fracture.

Denosumab is also the active ingredient in Amgen’s Xvega, which is designed to prevent fractures in patients with cancer that has spread to the bone.

Denosumab is the first in a new class of medicines that blocks proteins that activate bone-destroying cells called osteoclasts.

New osteoporosis option approved in Scotland

by diana 14. December 2010 17:12

Amgen's Prolia GSK and Amgen’s Prolia (denosumab) has been approved for NHS use in Scotland following an SMC recommendation.

The SMC recommended Prolia for women with osteoporosis for whom oral bisphosphonates are unsuitable due to contraindication, intolerance or inability to comply with the special administration instructions.

Prolia will provide an alternative option for these patients, who currently have to receive their medication via an infusion in hospital. In contrast, Prolia can be administered by injection every six months at a hospital clinic or GP surgery.

The drug has been designed to mimic the natural processes that control the breakdown of bone and specifically targets the cells that actively break down bones (osteoclasts), resulting in greater bone density.

Dr Stephen Gallacher, Consultant Physician & Endocrinologist, Southern General Hospital, Glasgow, said: “I am delighted that the discovery of a biochemical pathway that controls the way bones are built and broken down has meant we are able to tackle osteoporosis at the root cause of the disease.”

Amgen General Manager John Kearney added that it is “great” to see the company’s discovery “being used to transform the lives of women with postmenopausal osteoporosis for whom other treatments are unsuitable”.

Prolia was recently approved by NICE in the same indication.

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