The PM Society gets new chiefs

Thursday, August 26th, 2010

The Pharmaceutical Marketing Society has elected a new chair and vice-chair to its Executive Committee.

Sandy Royden, who has been an active member of the Society for the last ten years, has been named as the new chair. Dr Beverly Barr joins Rachel Farrow as vice-chair.

Royden has more than 20 years’ experience in the pharma industry covering clinical research and development, marketing and sales and was previously the CEO Europe at Huntworth Health.

“I am delighted to be appointed as chair,” said Sandy. “It’s a great honour to be able to work with the PM Society Committee to drive forward our educational initiatives in an ever changing environment and recognise the great work the Pharmaceutical industry delivers.”

She succeeds Steve Clark as chair.

Novartis gains majority stake in Alcon

Thursday, August 26th, 2010

Novartis has completed its majority takeover of Alcon, the world’s largest and most profitable eye care company.

The Swiss company now owns 77% of Alcon shares, following the acquisition of Nestlé’s 52% stake for $28.3 billion.

A full takeover by Novartis still hangs in the balance, however, as minority shareholders dispute the price they have been offered for their 23% stake.

The companies have complementary eye car portfolios – Alcon is a global leader in ophthalmic surgical products, while Novartis has a broad contact lens portfolio and advanced technologies.

“We are delighted to become majority owners of Alcon. Together, both companies can achieve their strategic priorities to deliver against patient needs through innovative and differentiated products,” said Joseph Jimenez, CEO of Novartis.

“I believe that Alcon will benefit from having a majority owner that is a global leader in health care,” added Kevin Buehler, President and CEO of Alcon. “With this change, Alcon and Novartis can seek out opportunities to create greater value through arm’s-length agreements that leverage our combined strengths and capabilities.”

The companies are already forging plans to combine their complementary field forces for the potential launch of Novartis drug Lucentis in the treatment of Diabetic Macular Edema.

Novartis has also offered to buy the remaining 23% of Alcon held by minority shareholders, many of which are Alcon employees. A direct merger of Alcon into Novartis AG is proposed under the Swiss Merger Act at a fixed exchange ratio of 2.8 Novartis shares for each remaining Alcon share.

However, the three independent directors on Alcon’s board have resisted this final stage of the takeover, insisting that minority shareholders should receive the same rate for their shares as was offered to Nestlé.

NHS bonus scheme under review

Wednesday, August 25th, 2010

The bonus scheme for NHS consultants is to be reviewed by the Government.

More than £200 million was paid to NHS consultants in Clinical Excellence and Distinction Awards last year.

Health Minister Andrew Lansley said the Department of Health wanted to continue to reward staff but the new system must be ‘effective and affordable’.

The scheme was introduced in 1948 to reward research and innovation or outstanding commitment to leadership and patient care, and has since remained largely unchanged.

New awards for more than 500 consultants accounted for £20 million of the total sum last year, with nearly 60% of the 29,000 consultant-grade doctors receiving bonus payments of up to £76,000 a year.

The DH said the review would bring the scheme ‘up-to-date and in line with other public sector pay schemes’. It will be led by the independent review body on Doctors’ and Dentists’ Remuneration (DDRB); recommendations will be published by July 2011.

“We want to continue to reward and recognise those individuals who give outstanding patient care and go beyond the call of duty, but we must ensure that the system is effective and affordable,” said Andrew Lansley.

“The NHS must recognise its responsibilities in the current financial climate as the largest public service in the country and this review will ensure that Clinical Excellence and Distinction Awards are in line with other public sector pay and incentive schemes.

“A more transparent and sustainable awards system will allow the NHS to focus its resources to benefit patients and drive up standards to give us a health service that delivers outcomes among the best in the world.”

The Health Minister added that any savings would be used to enhance patient care and choice.

Bill McMillan, Head of Medical Pay and Workforce for NHS Employers, said consultants welcomed the review and hoped to achieve a fairer system for all.

“We welcome the announcement, which reflects the view of NHS organisations that a review is needed into the system of rewarding clinical excellence,” he said. “We will be consulting them about the fairness, efficacy and affordability of the current arrangements.
“The question is very much alive regarding whether a consistent scheme can be devised that provides employers with the flexibility to reward consultants in a way that is integrated into local systems and needs.”

QOF suggestions welcome

Wednesday, August 25th, 2010

NICE has issued an open invitation for suggestions on potential indicators for the 2013/14 Quality Outcomes Framework (QOF).

Anybody with an interest in health is welcomed to submit their ideas for potential new topics based on NICE guidance or NHS Evidence accredited sources in a new online facility.

Dr Fergus Macbeth, Director, NICE Centre for Clinical Practice, said the invitation would allow a variety of people and groups from all backgrounds and interests to make their ‘opinion heard’.

The move comes after a number of potential diabetes indicators for the 2011/12 QOF were questioned by Diabetes UK for contradicting clinical guidelines.

The first phase of topic suggestions commences on 23rd August for a four-week period. When the period closes, NICE has said each suggestion will be reviewed against criteria provided in the submission form and suitable suggestions will be presented to an independent advisory committee to consider.

“We recognise the importance of making sure professional groups, patients and community and voluntary organisations have a clear opportunity to contribute to the development of indicators at every stage of the NICE process for QOF,” said Dr Macbeth.

“For this reason, our topic suggestion facility will encourage anyone with an interest in health to make their opinion heard. We actively encourage any recommendations and look forward to considering them at the QOF advisory committee meeting in December 2010.”

QOF indicators were initially introduced in 2004, and NICE took over the management and development of them in April 2009.

NICE will publish a proposed list of indicators for the 2013/14 QOF, together with recommendations on indicators to be considered for retirement, in 2012.

UNISON takes DH to court for ‘unlawful’ consultation

Wednesday, August 25th, 2010

UNISON, the UK’s largest public service union, has started legal action against the Secretary of State for Health as part of a campaign to save the NHS.

The union claims that the Government’s refusal to consult the public on the proposals in its White Paper, Equity and Excellence: Liberating the NHS, is unlawful and “lip service of the worst kind”.

The day after the White Paper was published, NHS Chief Executive Sir David Nicholson told all NHS chief executives to start implementing the proposals “immediately”. UNISON wrote to Sir David arguing that no steps should be taken until the public have had the opportunity to consider them.

The plans include handing £80 million to GPs to commission care and abolishing Strategic Health Authorities and PCTs.

Sir David agreed that no changes should be made until after the consultation period, but added that the consultation only covers to how the proposal should be implemented, not whether it should be implemented at all.

Karen Jennings, UNISON Head of Health, said: “I find it incredible that the NHS Chief Executive would say he believes there is no legal duty on the Secretary of State to consult on the merits of the proposals in the White Paper.

“The White Paper contains sweeping changes to the NHS and how it should be run. The NHS Constitution enshrines the principle that the public, staff and unions have an absolute right to be consulted. The Department of Health’s refusal to recognise this clear and important legal duty leaves us no option but to issue legal proceedings as a matter of urgency.”

The Government has rejected the accusations and says that it will defend against the legal action. A spokesperson said: “The Government has already launched public consultations on specific elements of the White Paper, and further documents will be published this year.”

UNISON has said that this legal action is the start of its campaign to prevent such large-scale changes to the NHS. In a statement it said: “This must be supported by health workers and public sector workers across the country. The true message of what is happening must be exposed to the public so they can hold this Government to account for its broken promises, and to stop the decimation of the NHS.”

WHO prequalification for pneumococcal vaccine

Wednesday, August 25th, 2010

The World Health Organization (WHO) has recommended Prevenar 13 for use in UN national immunisation programs.

Prequalification has been granted to Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine) for the immunisation of infants and children from six weeks to five years of age against the 13 pneumococcal serotypes contained in the vaccine.

This decision applies to global use of the vaccine in a single-dose vial and allows for the use of vaccine in national programs by United Nations agencies, including the United Nations Children’s Fund (UNICEF), governments and other organisations.

“We are pleased to receive WHO prequalification as recognition that Prevenar 13 meets the organisation’s high standards for quality,” says Emilio Emini, Chief Scientific Officer, Vaccine Research, Pfizer. “This is an important step towards our goal of making Prevenar 13, which offers the broadest serotype coverage of any pneumococcal conjugate vaccine, available to infants and young children globally.”

Pfizer previously entered into a 10-year agreement to provide Prevenar 13 to infants and young children in the world’s poorest countries under the terms of the Advance Market Commitment (AMC) for pneumococcal disease, a program piloted by the GAVI Alliance.

WHO prequalification applies unified standards of acceptable quality, safety and efficacy to vaccines and other medicinal products and will mean Prevenar 13 can participate in this program.

“Now that we have WHO prequalification for Prevenar 13, Pfizer will work with GAVI and UNICEF to finalize arrangements for first orders and shipments under the AMC,” added Mark Swindell, President of Vaccines, Pfizer.

NICE under fire over Avastin decision

Tuesday, August 24th, 2010

NICE has come under attack following its decision not to recommend bowel cancer drug Avastin.

Manufacturer Roche and Bowel Cancer UK both questioned the decision after tests showed an increased survival rate of almost two years.

Critics argued the decision would see the UK fall ‘even further behind’ other countries for cancer treatment and hoped the new Interim Drugs Fund would finally bring widespread access to patients.

NICE’s independent Appraisal Committee considered the treatment too expensive and questioned Roche’s calculations on a proposed Patient Access Scheme.

The UK is now one of a handful of developed countries that don’t provide Avastin to patients. Roche said the decision was ‘further evidence’ the current system was not appropriate after the cost-effectiveness and not clinical effectiveness of the drug contributed to the outcome of the appraisal.

“The recent International Variations Report has shown that patients in the UK have significantly poorer access to cancer medicines when compared to their European counterparts,” a statement from the pharma company said.

“The launch of the Interim Cancer Drugs fund will help address this ‘passport prescribing’ situation in the short term and is further recognition that the current drug evaluation process disadvantages end of life cancer medicines.”

Roche also highlighted how NICE has failed to recommend more than half of cancer drugs since January 2007 and hoped to see a ‘pricing and reimbursement system in the longer term that may be more mindful to the challenges of evaluating end of life therapies’.

Bowel Cancer UK revealed its disappointment at NICE’s decision, claiming the effectiveness of Avastin far outweighed its cost.

“I know that NICE has to be rigorous in its appraisal of treatments and that it looks in detail at individual drug trials to assess cost-effectiveness,” said Rob Glynne Jones, Chief Medical Adviser of the charity.

“However, as a practicing oncologist, if we simply look at survival in the UK, I can see that in even the most up-to-date national drug trials, such as COIN, patients with advanced bowel cancer have an average 19 months’ survival. This compares to up to 27 months’ survival for patients in countries that use bevacizumab (Avastin), such as in mainland Europe and the United States.
“I can’t argue with NICE’s decision, but I am disappointed. These statistics tell their own story and imply that we are likely to fall even further behind in worldwide league tables.”

It is estimated that around 6,500 patients a year in the UK could benefit from Avastin. The drug is currently used in the US and across Europe, but patients in the UK have to purchase the treatment privately or appeal to their local health authority for funding.

Trio breach ABPI code

Tuesday, August 24th, 2010

A trio of pharma companies have breached the ABPI’s Code of Practice.

ProStrakan Group plc, Cephalon UK Ltd and GlaxoSmithKline Consumer Healthcare will now be highlighted in advertisements after the breach of Clause 2 of the Code – bringing discredit upon and reducing confidence in the pharmaceutical industry.

In total, five clauses were broken by ProStrakan and GSK in relation to the promotion of Abstral and the mailing of NiQuitin respectively. Cephalon breached three clauses for providing free stock of Effentora without sufficient controls.

Only Cephalon decided to appeal against the decision.

Alongside Clause 2, the ABPI ruled that ProStrakan and GSK had both been making misleading claims, failing to maintain high standards and failing to comply with an undertaking.

The complaint about the promotion of Effentora related to the product being sent to an NHS nurse instead of directly to a pharmacy department. The ABPI agreed that a representative had failed to maintain high standards.

The adverts will be included in the medical, pharmaceutical and nursing press.

IMS gets new CEO

Tuesday, August 24th, 2010

IMS Health has appointed Ari Bousbib as its new Chief Executive Officer.

Mr Bousbib succeeds current Chairman and CEO David Carlucci, who will continue to serve as Chairman for a transitional period.

“I welcome the opportunity to help grow this franchise,” said Mr. Bousbib. “Through the innovative use of information, IMS Health has become an integral part of global healthcare. David has built an impressive organisation, and I look forward to leading this team as we continue to enhance the depth, scope and reach of our offerings and as IMS seeks new ways to make a difference in healthcare.”

Mr Bousbib joins after a successful 14-year career with United Technologies Corporation (UTC). In May 2008, he was also appointed by the President of the United States to serve on the President’s Commission on White House Fellowships, America’s most prestigious program for leadership and public service.

Risk-sharing schemes too complex, says NICE Chairman

Tuesday, August 24th, 2010

NICE Chairman Professor Sir Michael Rawlings has questioned the growing use of Patient Access Schemes, suggesting that simple discounts on drug prices would be better for the NHS.

In an interview with the Financial Times, Sir Rawlings said that taking a third off the price of drugs sold to the NHS would be simpler than complex pricing schemes and rebates.

“These schemes can sometimes be complicated for NHS trusts to implement due to factors such as difficulties of measurement or associated costs,” he said. “In such cases, a simple discount may eliminate the need to put in place complicated schemes that require substantial management input.”

However, pharma companies have responded that it is in their interests to maintain these high prices for international sale, while at the same time, providing discounts for the NHS.

The first risk sharing scheme of this type was agreed for multiple sclerosis treatments in 2002, when it was decided that the drugs would be provided but the price would be cut if it was later proved they did not meet the claims of the manufacturers. There has never been substantial evidence of their failure, so the price has remained consistent, the Financial Times points out.

The DH has promised that the way drugs are paid for will be reviewed in 2013 when the current Pharmaceutical Price Regulations scheme comes to an end.

“It is essential that any proposed discounts also be fair to the pharmaceutical industry and so would need to be balanced by pharma companies being able to recover some of that discount if the drug proves cost effective for the NHS,” comments Janet Knowles, partner and head of the UK BioPharma team at international law firm Eversheds.

“NICE has pressed for patient access schemes to be based on the cost effectiveness of a drug but Sir Michael’s comments seem to suggest that the NHS is not yet able to easily determine this. Perhaps the NHS should shift its focus towards developing ways to easily and effectively do this, which would satisfy both the NHS and the pharmaceutical industry.”