NICE’s decision not to recommend the use of Benlysta (belimumab) for the treatment of systemic lupus erythematosus (SLE) in final draft guidance has been called ‘devastating’ by GSK.

Benlysta failed to get NICE backing after its clinical benefits compared with standard options and cost effectiveness to the NHS were both questioned by the regulator – weeks after the SMC came to the same decision.

Simon Jose, General Manager, GSK UK, says the recommendations are “devastating decisions for patients with lupus whose disease is currently uncontrolled by existing therapies”.

SLE is an incurable autoimmune condition which currently affects around 15,000 people in England and Women – 90% of whom are women.

Benlysta is the first new treatment licensed in the UK for lupus in half a century after the European Commission granted marketing authorisation in July 2011.

But NICE questioned the health benefit for patients and the cost of the treatment in relation to its clinical effectiveness after analysing evidence and consulting with people with the condition and clinical specialists.

Sir Andrew Dillon, NICE Chief Executive, commented: “Whilst recognising the severity of the disease, the Committee concluded that based on this evidence, belimumab could not be considered a good use of NHS resources compared with current clinical practice.”

GSK insist that failure to recommend Benlysta sees patients being left behind those from Germany and Spain, where the treatment is already approved for use. “We remain committed to creating solutions that will help ensure that the small number of patients across the UK who we believe will benefit most, are able to access this important new medicine,” Simon Jose said.

New guidelines to promote positive collaboration between health organisations and the pharmaceutical industry have been backed by the ABPI.

The guidance comes as ABPI President Simon Jose predicts the relationship between NHS and UK pharma will evolve to make them partners within the next three to five years.

Engagement between pharma and the NHS would, he said, develop to become one that is “less transactional and much more based on partnership.”

Guidance on collaboration between healthcare professionals and the pharmaceutical industry outlines best practice through a series of ‘dos and don’ts’ and highlights that active collaboration can deliver improved outcomes of care.

Stephen Whitehead, Chief Executive of the ABPI, said the document will “help assure professionals of the good work they are doing and make all sides aware of their responsibilities”.

The guidelines have been backed by several healthcare organisations, including the Department of Health, the Scottish Government and the Welsh Government. A number of royal colleges have also given their support.

Developed by the Ethical Standards in Health and Life Sciences Group the guidelines provide a clear framework for HCPs and industry. HCPs are advised to treat pharma as a healthcare partner, to seek and develop joint working opportunities and to understand the ABPI Code of Practice. They are asked not to expect or request any items which breach the Code, accept any negative accusations or myths against the industry when cooperating, or tolerate any unacceptable practices from pharma.

Alternatively, pharma is encouraged to be clear on its objectives when collaborating with HCPs, to ensure all activities are in line with the Code, and to keep up to date with the requirements of the Bribery Act.
The industry is warned not to collaborate without demonstrating the value of the partnership, not to expect healthcare professionals to participate in actions that are outside their professional code of ethics, and not to engage in collaboration with HCPs without first ensuring that there is a written agreement or contract in place.

“The NHS and pharmaceutical industry share a common agenda to improve patient care and clinical outcomes through high quality and cost effective treatment and care management,” said Stephen Whitehead. “This collaborative way of working is becoming increasingly common and we already have many examples that show how effective it can be. The publication of this statement by a broad base of health organisations will help assure professionals of the good work they are doing and make all sides aware of their responsibilities. Ultimately, we hope this will encourage further collaborative working and in turn, greater strides will be made in improving the health of patients.”

Following the publication, Simon Jose said that greater collaboration across disease pathways was anticipated as the industry seeks to promote its products and services, and the NHS looks to meet quality and efficiency targets.

“For me, it all starts with the fact that we are pursuing the same mission – improving the health and care of patients,” he said. “I think you’ll see the industry think much more about patient pathways instead of thinking about products. And you’ll see more collaboration across the pathway.

“Our role is about partnering with the NHS to ensure they and their patients can get the best out of our medicines, rather than seeing this as a transactional supplier/procurer relationship – which I think is one we’ve come from in the past.”

ABPI President Simon Jose believes the UK pharmaceutical industry and the NHS will become partners within the next three to five years.

The President predicts a change in the relationship between the industry and the health service will result in improved levels of patient health and care.

See the full interview below.

ABPI President Simon Jose believes the UK pharmaceutical industry and the NHS will become partners within the next three to five years.

The President predicts a change in the relationship between the industry and the health service will result in improved levels of patient health and care.

He commented that the relationship between pharma and the NHS will “evolve to one that’s less transactional and one that is much more based on partnership”.

Greater collaboration across disease pathways, he said, is expected as the industry looks to promote its services and products and the NHS extracts value for money where possible.

“For me it all starts with the fact that we are perusing the same mission which is essentially improving the health and care of patients,” he said.

“I think you’ll see the industry think much more about patient pathways instead of simply thinking about products and I think you’ll see more collaboration across the pathway.

“For me our role is partnering with the NHS to ensure that they and their patients can get the best out of our medicines, rather than seeing this as a simply as a transactional, supplier, procurer relationship, which I think is one we’ve come from in the past.”

Mr Jose also discussed the recent collaboration guidelines formulated by the Ethical Standards in Health and Life Sciences Group.

The guidelines, which promote positive collaboration between health organisations and the pharmaceutical industry, were backed by the Association.

“The power you get when you bring all of the constituent parties together, when you start talking to each other, understanding each other, and suddenly finding there is an awful lot that unites us than divides us is really powerful,” he said.

Click here to view the full interview.

Deepak Khanna, UK Managing Director of Merck Sharpe & Dohme and Senior Vice President of its US-based parent company Merck & Co, has been elected President of the Association of the British Pharmaceutical Industry (ABPI).

Khanna will take over the role from Simon Jose of GSK after the ABPI’s next AGM in April 2012. He will serve initially for one year, with a possible re-election for a further 12 months.

Born in the UK, Khanna holds dual British and American nationality.

After starting his pharma career with Merck & Co in 1988, Khanna managed all aspects of the US Merck/Schering-Plough joint venture, including the US marketing and sales of the drugs launched by it.

He is currently Chair of the ABPI HTA Taskforce, a member of the ABPI Board of Management and Chair of the American Pharmaceutical Group.

Khanna commented: “The Government’s proposals for a new pricing system for branded medicines, the reforms of the NHS, and the recommendations of the Nicholson Review of Innovation mean it is vital for the industry to have a strong and united voice.

“I am looking forward to working with the Government, the NHS, patient groups and life science companies to ensure that the industry continues to make a significant contribution to the health and wealth of the UK.”

“With ongoing economic challenges, increased global competition, the largest ever patent cliff and NHS reforms, Deepak’s appointment comes at a crucial time for our industry,” commented Stephen Whitehead, CEO of the ABPI.

“We have had to evolve. Our industry has changed, and I expect it to continue to change. We are moving in the right direction, and I very much look forward to working together with Deepak to ensure this progress continues.”

The SMC has recommended Votrient (pazopanib) as a first-line treatment for advanced renal cell carcinoma, a type of kidney cancer.

The Scottish approval, which follows positive advice from NICE, means that the drug is now recommended for use in this indication throughout the UK.

Dr Rob Jones, Consultant Medical Oncologist at The Beatson West of Scotland Cancer Centre, commented: “Today’s advice from the SMC on pazopanib means that patients in Scotland now have the same access to two effective treatment options each with different side effect profiles as for patients in England and Wales.

“The availability of a choice of first-line oral treatments for advanced renal cell carcinoma is hugely significant for oncologists and the advanced kidney cancer patients under their care.”

The SMC has agreed the same Patient Access Scheme (PAS) as that available in other parts of the UK.

The PAS offers a straight discount and makes provision for a potential partial rebate to NHS Scotland in the future, conditional upon the outcome of the ongoing head-to-head trial versus sunitinib, the current standard-of-care.

Simon Jose, General Manager, GSK UK, said: “We are pleased that the SMC recognised the benefits of Votrient for this devastating disease. It’s great news that the SMC could see the value in our pricing scheme, enabling advanced kidney cancer patients in Scotland rapid access to Votrient.”

NICE has recommended GSK’s Votrient (pazopanib) to treat kidney cancer, under a scheme that guarantees the NHS a 12.5% discount.

The drug has been approved as a first-line treatment option for people with advanced renal cell carcinoma who have not received prior cytokine therapy and have an Eastern Cooperative Oncology Group performance status of 0 or 1.

GSK has agreed to provide pazopanib with a 12.5% discount on the list price and a possible future rebate dependent on the outcome of a head-to-head trial comparing pazopanib and sunitinib.

Simon Jose, General Manager, GSK UK, said: “Advanced kidney cancer is a devastating disease and we are pleased that through this pricing scheme we are able to offer patients rapid access to Votrient whilst delivering value for money to the NHS.”

Renal cell carcinoma is a kidney cancer (tumour) that starts in cells lining the small tubes that help to make urine. In advanced disease, the tumour has spread inside the kidney, but may or may not have spread to nearby lymph glands.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “Pazopanib will offer patients an additional option to sunitinib, which is also recommended by NICE. Although a direct comparison of pazopanib and sunitinib is not yet available, a trial comparing the two drugs is currently underway and the current patient access scheme proposed by the manufacturer makes pazopanib a cost-effective option for the NHS.”