GSK has been accused by the Office of Fair Trading of protecting its Seroxat revenues from 2001–2004 by illegally paying off three generic competitors.

The OFT claims that GSK abused its market position by making “substantial” payments to Alpharma, Generics (UK) and Norton Healthcare to delay their launch of generic paroxetine.

The deals meant that the NHS, which paid £100m for Seroxat in 2001, lost an opportunity for “significant” cost savings, the UK trading watchdog said.

Paroxetine, an SSRI that targets anxiety-based depression, has already caused GSK some anxiety.

In 2002, the company was fined $2bn by the US Government for illegally promoting the drug’s off-label use in children and young adults. CEO Sir Andrew Witty said GSK’s actions had been “unacceptable” and would “never” happen again.

The current OFT accusations relate to deals that applied from 2001 to 2004 – since which time, GSK’s paroxetine brands (Seroxat in the UK, Paxil in the US) have steadily lost ground to generic equivalents.

If found guilty of breaking competition law, GSK faces a UK fine of up to £2.6bn, 10% of its annual global revenue.

The OFT’s Ann Pope commented: “The introduction of generic medicines can lead to strong competition on price, which can drive savings for the NHS.

“It is therefore particularly important that the OFT fully investigates concerns that independent generic entry may have been delayed in this case.”

In a public statement, GSK said: “We very strongly believe that we acted within the law, as the holder of valid patents for paroxetine, in entering the agreements under investigation.”

It also noted that the European Commission had reviewed these issues and declared that it would take no action against GSK.

The company has until August to respond to the OFT’s charges.

NICE draft guidance does not recommend Afinitor (everolimus), a treatment for advanced breast cancer that can increase progression-free survival by four months.

The Novartis drug, described by charity Breakthrough Breast Cancer as “one of the biggest advances in breast cancer treatment in many years”, does not meet NICE’s criteria for an ‘end of life treatment’.

The decision will heighten concern over NICE’s QALY metric for value, which the European Commission recently declared to be scientifically invalid.

Afinitor, an oral formulation of everolimus (which is already widely used as an immunosuppressant), is licensed for use in post-menopausal women with advanced HER-2 negative breast cancer, which will not respond to Herceptin.

The drug inhibits the division of tumour cells and the growth of blood vessels around a tumour, thereby inhibiting tumour growth and metastasis.

Clinical trial results published in September 2012 found that Afinitor could ‘stall’ advanced breast cancer by four to five months.

Dr Rachel Greig of Breakthrough Breast Cancer said: “Everolimus is one of the biggest advances in breast cancer treatment in many years.”

Though “by no means a cure,” she commented, “it could give patients several extra months of good quality of life with their families.”

Sir Andrew Dillon, NICE’s Chief Executive, explained: “While the independent Appraisal Committee acknowledged that everolimus may offer a step change in treatment by restoring sensitivity of the tumour to hormone therapy, the evidence highlighted uncertainty relating to how much the treatment extends overall survival.”

The failure to extend overall survival was only considered crucial because Afinitor did not meet NICE’s criteria for an ‘end of life drug’, since its target patients had a life expectancy slightly over two years.

Consultation on the draft guidance will remain open until 22 April 2013.

NICE will be responsible for assessing the value of medicines in the new value-based pricing (VBP) system to be implemented in 2014.

The Government’s decision to make NICE central to VBP follows recommendations by the Health Select Committee (HSC).

It also follows a report by the European Commission stating that NICE’s QALY metric, the basis of its current value appraisals, is unfit for purpose.

The new role in VBP assessment will enable NICE to broaden the scope of its appraisals of the costs and benefits of drugs.

This will simplify the current routine of NICE declaring a drug too expensive in draft guidelines and then revising its verdict when the company offers a confidential patient access scheme.

Health Minister Lord Howe said: “We are delighted to announce the central role NICE will take in assessing the value of new medicines. This will allow us to draw on NICE’s world-leading expertise as we develop the Value-Based Pricing scheme.”

From April, NICE will be led by new Chairman David Haslam (pictured). It will have responsibility for social care as well as the NHS and public health, enabling it to play a major role in the integration of care.

The Government approved three other HSC recommendations: NICE should develop healthcare quality standards for patients with long-term conditions, co-morbidities or complex needs; NICE should promote better-integrated commissioning and care; and industry should be more transparent as regards clinical trial data.

Stephen Whitehead, Chief Executive of the ABPI, commented: “What will determine whether value-based pricing works for the pharmaceutical industry, the NHS and most importantly patients is not who does the assessment, but how it is done and what goes into it.

“NICE has an important role in supporting growth, which is often overlooked. NICE needs to be an enabler of innovation by the NHS and this is lacking from the Government’s response.

“We urge the Government to keep its foot on the pedal in spreading innovation through the NHS and ensuring that NICE helps to deliver its part of the growth agenda.”

Lundbeck’s Selincro (nalmefene) has been granted a marketing authorisation by the European Commission to reduce alcohol intake in adults with alcohol dependency.

The decision was based on the results of three pivotal trials which showed Selincro helped reduce alcohol consumption by 40% within the first month and by around 60% after six months.

Anders Gersel Pedersen, Head of Research & Development and Executive Vice President at Lundbeck, called the drug the “first major innovation in the treatment of alcohol dependence in many years.”

The authorisation applies to all 27 European Union member states. Lundbeck now expects to launch the drug in the next few months.

The tablet will be available to the patient each day when they feel at risk of drinking. Selincro will be provided as part of a novel treatment concept that includes continuous psychosocial support focused on the reduction of alcohol consumption and treatment adherence.

“The approval of Selincro is exciting news for the many patients with alcohol dependence who otherwise may not seek treatment,” said Anders Gersel Pedersen.

Bayer HealthCare has founded a new pan-European consortium for drug discovery, the European Lead Factory (ELF).

The five-year project will create a small molecule library to resource drug discovery projects based on targets from pharma and academic researchers.

Working with six other European pharma companies, Bayer will co-ordinate the compilation of 300,000 substances and contribute 50,000 of these.

A further library of 200,000 compounds will be developed by industry SMEs and academics.

The two libraries will make up a Joint European Compound Collection that will be accessible to all project partners, and to health organisations and SMEs.

Targets for drug discovery will be selected, through competitive calls, from those proposed by pharma companies and health providers.

“The European Lead Factory is an outstanding example of a project in which public-private partnerships enable collaborative drug discovery,” commented Hanno Wild, Senior VP and Head of Candidate Generation & Exploration at Bayer HealthCare Global Drug Discovery. “The platform brings together academia and industry as well as SMEs in a unique partnership aiming to discover innovative medicines.”

The project is part of the European Innovative Medicines Initiative (IMI), a partnership that supports industry and academics in collaborative research.

Michel Goldman, IMI Executive Director, said: “This unique project will give European researchers unprecedented access to industry chemical collections and facilitate the translation of their findings into actual treatments for patients.”

The ELF has 30 member organisations from pharma companies, SMEs and academia. Inspired by the increasingly successful ‘open innovation’ model, it aims to achieve a sustainable role in European drug development.

The project’s five-year budget of €196m is made up of €80m from the European Commission, €91m from participating pharma companies and €25m from other participants.

NICE has issued preliminary guidance not recommending a drug for myelofibrosis, a rare blood cancer, which it says is clinically effective but too costly.

Jakavi (ruxolitinib) from Novartis is provisionally refused for NHS treatment of enlarged spleen caused by myelofibrosis.

Novartis has said it is encouraged by NICE’s acceptance of the drug’s clinical value and will work to reach agreement with the Institute on cost issues.

Myelofibrosis causes scarring of the bone marrow tissue, affecting their ability to produce blood cells. The spleen becomes enlarged to compensate, which has debilitating effects.

The NICE appraisal committee concluded that Jakavi offered a “step change” in treating the condition: it reduced spleen size and symptoms such as fatigue, pain and itching.

However, it did not consider the drug, which costs £43,200 per patient per year, more cost-effective than the next best alternative.

NICE’s value model – recently criticised by the European Commission – sets a threshold price of £30,000 per quality-adjusted life year (QALY) gained. Novartis claims a price per QALY of £74,000, but NICE claims the true figure is twice that.

Professor Carole Longson, Director of NICE’s Health Technology Evaluation Centre, said: “It is disappointing not to be able to recommend this new treatment in our preliminary recommendations, but in order to do this we have to be sure that the treatment is both clinically and cost effective.”

Consultant haematologist Professor Claire Harrison commented: “The lives of patients affected by myelofibrosis are improved with ruxolitinib therapy. In many cases this improvement is dramatic with long-lasting tangible benefits.”

“We are encouraged that the Committee considers ruxolitinib to be an innovative treatment and Novartis is committed to working alongside clinicians and patient groups in this area to address all queries raised by NICE,” said Panos Alexakos, Oncology General Manager, Novartis UK & Ireland.

Final guidance is expected in June 2013.

The European Parliament has voted for measures to speed up patient access to generic medicines.

The proposal to shorten the period for decisions on pricing and reimbursement of generic drugs from 180 days to 60 days was backed by 559 votes to 54.

Some member state governments are expected to resist the change, which could enable generic drug manufacturers to negotiate higher prices.

The deadline for new (branded) drugs would remain set at 180 days from regulatory approval, under rules that date back to 1989.

Bulgarian MEP Antonyia Parvanova, an architect of the new legislation, commented: “It is unacceptable that delays in the pricing and reimbursement of medicines can sometimes reach more than 700 days.”

The draft legislation would also require national health systems to publish an annual list of medicines available within each system and their prices, as well as the names and declarations of interest of the experts consulted.

While accepting that pricing and reimbursement are national responsibilities, the European Commission has stated the legislation will clarify these procedures and help to avoid unnecessary delays in access to generic drugs.

The proposed change may favour generic drug manufacturers in terms of pricing negotiations, as well as making the ‘patent cliff’ steeper for branded drugs.

The European Commission has granted a marketing authorisation in the EU for Zaltrap to treat adults with metastatic colorectal cancer that is resistant or has progressed after initial treatment.

The decision was based upon evidence from Phase III trial data which showed Zaltrap to be the first and only agent to statistically significantly improve survival in combination with FOLFIRI chemotherapy after an oxaliplatin regimen.

Colorectal cancer is the most common cancer in both men and women in Europe and is the second leading cause of cancer death.

The treatment is marketed by Sanofi and Regeneron Pharmaceuticals.

Dr Debasish Roychowdhury, Senior Vice President and Head, Sanofi Oncology, thanked “physicians, patients and their families” for their efforts in getting the injection approved.

“We are thrilled to provide a new therapy that further extends the lives of patients with metastatic colorectal cancer and look forward to working with European health authorities to ensure patients have access to Zaltrap,” he said.

Dr George Yancopoulos, Chief Scientific Officer of Regeneron and President of Regeneron Laboratories, added that the treatment “provides a new option to address the unmet medical need” across Europe.

Zaltrap received approval by the US FDA back in August 2012 following a priority review by the agency. It is also under review with other health regulators across the world.

The Quality Adjusted Life Years (QALY) system for deciding which drugs should be available on the NHS is worthless, according to a European Commission report.

The three-year ECHOUTCOME project found that the key assumptions underlying NICE’s QALY evaluations are false, and decisions based on them are dangerously unreliable.

The report recommends that prescribing decisions be made relative to specific conditions and patient groups, rather than relying on a general algorithm.

NICE’s evaluation system is being considered by other European health technology assessment bodies, but ECHOUTCOME advises against its use.

The QALY system estimates the number of years of healthy life gained by the patient, with adjustments for the likely impact of the patient’s symptoms, to reach a figure for the number of Quality Adjusted Life Years (QALYs).

If the cost per QALY for each patient is estimated to be below £30,000, NICE will usually recommend the treatment.

But according to the European researchers, NICE is basing its quantitative assessments on factors that are both qualitative and ill-conceived.

The ECHOUTCOME study, conducted by six universities and several research agencies, analysed data from 1,300 respondents in Belgium, France, Italy and the UK and concluded that QALY cannot capture medical outcomes accurately.

QALY relies on four key assumptions: time and quality of life can be measured in consistent intervals; life years and quality of life are linked; patients have a neutral attitude towards risk; and willingness to sacrifice life years for quality of life is constant over time.

According to the study, these assumptions are all false, and so QALY has no valid empirical basis.

Gerard Duru, Emeritus Research Director in Mathematics at the French National Centre of Scientific Research, commented: “The underlying assumptions of the QALY outcome are very theoretical and are not verified in a real population. It is impossible to know what we are measuring, and therefore impossible to base a formula upon it.”

According to ECHOUTCOME’s Project Leader, Ariel Beresniak, a different approach is needed: “Each case is different and each should use adequate evaluation tools. There should be a list of adequate validated tools to make these decisions with guidance on when to use each.”

For example, the report recommends using a cost per remission approach to evaluate drugs treating rheumatoid arthritis, and a cost-benefit approach to evaluate drugs for wide-scale vaccinations.

AstraZeneca has lost its appeal to the European Court of Justice against a €52.5m fine for its tactics to delay generic versions of Losec (omeprazole).

The company was fined by the European Commission in 2005 for manipulating regulatory approval in order to block generics.

According to the Commission, AZ launched a tablet version of the ulcer drug in 2001 and asked for the capsule’s authorisation to be withdrawn.

As a result, generic companies planning to launch their own capsule versions of omeprazole were blocked.

The Commission also claimed that AZ had deceived patent offices, courts and lawyers in several EU states over the date of Losec’s authorisation.

Losec, a proton pump inhibitor, was the world’s best-selling drug in 2000, but its European patent expired in 2001.

The European Commission commented that the appeal decision would prevent other companies from misusing drug regulatory procedures in order to protect their drug patents.

According to Ana Nicholls, Healthcare Analyst at the Economist Intelligence Unit, “This case exposed some of the strategems that pharma companies have used to delay the launch of cheaper generic versions of their drugs.

“By upholding the ruling, the court confirmed that pharma companies have to stamp out these practices or risk a substantial fine.”

Jonas Koponen of London law firm Linklaters commented that the decision was representative of “the European Commission’s policy of removing obstacles to competition from generics”.