The decision on whether to allow free prescriptions for certain patients will now be put on hold till the autumn, due to financial pressures.

A new report by Professor Ian Gilmore, President of the Royal College of Physicians, has recommended that all patients with long-term conditions should be exempt from prescription charges.

However, Health Minister Simon Burns has said that a decision cannot be made until after the spending review in the autumn.

Gilmore suggests that eligibility for the scheme could be decided by doctors and that the changes could be phased in over three years to spread out the extra yearly £430 million cost to the NHS.

He told the BBC that the report “represents a useful way forward for exempting patients with long-term conditions from prescription charges”. He added: “The report outlines a way in which exemptions could be phased in in the fairest way possible when the financial landscape allows it.”

Commenting on the report, Dr Hamish Meldrum, Chairman of Council at the BMA, described the current prescription charge system as “a mess”. He said: “Changes to the system short of abolition would still be unfair on the reduced number of patients who do not qualify for exemption.

“We really have to question whether the small financial benefit of retaining charges outweighs the many disadvantages of taxing the sick.”

Prescription charges have been completely abolished in Wales and Northern England and are currently being phased out in Scotland.

A first-in-class biological for the treatment of osteoporosis has been granted marketing authorisation in the UK. 

Prolia (denosumab), which is indicated to treat post-menopausal women, has been shown to reduce fractures by up to 68% and can be given as six-monthly injections in a GP surgery.

Denosumab has an innovative mode of action compared with the existing osteoporosis treatments, as it has been specifically designed to inhibit the osteoclast formation, function and survival.

Dr Alun Cooper, a GP in Crawley, West Sussex, said: “Fractures related to osteoporosis are common and can have a significant impact on my patients’ daily lives. Denosumab is a convenient and simple, six-monthly injection that can be administered in my surgery and, for me, is a promising development in the management of this disease.”

In the UK osteoporosis is estimated to affect more than two million women and cause around 230,000 fractures each year. However, 68% of patients stop taking their medication within one year.

Mary Elliot, Lead Fracture Liaison Nurse Specialist, Crawley, West Sussex, said: “A post-menopausal fracture, such as a hip fracture, has such huge impact on daily life activities, often forcing sufferers to become housebound and lose their independence. Many women I see find it difficult to adhere with their current medication, partially due to the complexity or inconvenience of their treatment. I welcome any new treatments that can minimise this issue and improve my patients’ quality of life.”

Thirty-two international MDS Centres of Excellence have written to the National Cancer Director to support better access to Vidaza (azacitidine) for UK patients.

International haematologists and cancer specialists from the hospitals expressed their concern at the NICE decision not to recommend Vidaza for the treatment of myelodysplastic syndromes (MDS), a group of debilitating bone marrow diseases.

They argue that barriers to patient access for treatments for rarer diseases are still too high in the UK, especially as Vidaza is already widely available to clinicians in Europe.

Azacitidine is the only licensed medicine proven to prolong survival for people with higher risk MDS and could be suitable for 700 patients per year in England and Wales. It has been shown to improve patients’ quality of life, reduce dependence on blood transfusions and be less toxic than chemotherapy.

The MDS UK Patient Group will be one of eight organisations appealing against the NICE decision on 1 June. The letter urges NICE to allow the appeal and to re-appraise and recommend azacitidine as a ‘highly valued, innovative treatment’ for higher-risk MDS.

David Hall, Chairman of the MDS UK Patient Support Group and MDS patient, said: “It is very heartening to have this level of international support from such respected clinicians and centres which have been designated Centres of Excellence for the treatment of MDS.

“We believe that the NICE decision was unreasonable given the evidence available and that it was incompatible with human rights. In Monday’s appeal hearing we will be clearly stating that there is a strong case for NICE to re-appraise azacitidine.”

NICE has issued its first recommendation for a biosimilar product, advising that seven somatropin products should be funded by the NHS.

The drug is recommended to treat child growth deficiencies. NICE has recommended that when more than one product is suitable, the least costly option should be chosen.

The Appraisal Committee noted that there were no differences in terms of safety or efficacy between the biosimilars and the reference product.

Sandoz’s Omnitrope (liquid somatropin for injection), first approved in the EU in 2006, was one of seven recommended somatropin products.

“This is an important decision, the ramifications of which go far beyond the UK,” said Ameet Mallik, Global Head Sandoz Biopharmaceuticals. “Biosimilars, pioneered by Sandoz, are recognised around the world as having comparable safety, efficacy and quality to existing biopharmaceuticals following loss of patent protection. This latest guidance further reinforces the confidence that leading authorities have in our products.”

Dr Richard Stanhope, Consultant Pediatric Endocrinologist, added: “I have 10 years of clinical experience using Omnitrope with my pediatric patients and I believe it is both effective and well tolerated. I welcome the decision by NICE to recommend the option of a biosimilar; it will benefit patients by providing an alternative, equally effective treatment option as well as offering much needed cost savings to the NHS.”

Sandoz is a Division of the Novartis group and has a portfolio of approximately 1000 compounds.

Michael Cann, Director Generics at Actavis, has taken over as Chairman of the British Generic Manufacturer’s Association (BGMA).

Cann took over his new role at the Association’s AGM in London on 26 May. He replaces Kim Innes of Teva, who will serve as Vice Chair for a year.

He said he was honoured to accept the new role. “Our contribution is more than people realise,” he said. “It’s not just about reducing the drugs bill—though we provide two thirds of the NHS’s medicines at a fifth of the overall medicines cost. Generic competition also acts as a strong incentive for the research based industry to develop much needed, new, truly innovative medicines; and the security of supply of medicines to patients is enhanced when many manufacturers market the same product.”

Cann added that he looks forward to continuing the relationships that his predecessors enjoyed in Whitehall to the mutual benefit of patients, the NHS and the industry.

The British Generic Manufacturers Association represents the interests of UK-based manufacturers and suppliers of generic medicines and promotes the development and understanding of the generic medicines industry in the UK.

The Coalition Government’s plans to introduce ‘value-based pricing’ for medicines could mean that price controls will be imposed.

Industry analysts predict that the UK could soon lose its position as one of the few markets in the world where pharma is free to set the price of its products.

The ABPI has not expressed any concern, however. Spokesperson Richard Ley told Reuters: “Value-based pricing is one way of doing it. We are not opposed to the principle. It is a question of how it is achieved to get it right.”

The current Pharmaceutical Price Regulation Scheme regulates the profits companies make on sales to the NHS, while NICE assesses drugs for cost effectiveness. The Coalition has promised to “reform NICE and move to a system of value-based pricing” in its Programme for government.

It is predicted that cost controls will have a significant impact on the industry, especially as many countries look to the UK market as a reference for pricing.

Janet Knowles, partner at international law firm Eversheds, commented that value-based pricing “may give rise to drugs being taken up by the NHS earlier”. She added: “This could counter some of the challenges made in the press that newer drugs are widely available in other countries but not in the US. This is not entirely unexpected as the government has to cut costs and needs to find a way of doing this without harming the NHS and patient care.”

NICE has issued draft guidance recommending Iressa (gefitinib) as an option for the first-line treatment of people with locally advanced or metastatic non-small cell lung cancer.

Patients will qualify to receive the treatment if they test positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation.

The guidance has been issued following the submission of further data on the drug’s effectiveness and cost effectiveness from manufacturer AstraZeneca, along with a revised patient access scheme.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “Non-small cell lung cancer is the most common type of lung cancer, accounting for around 80% of all cases. NICE has already recommended a number of treatments for this condition and we are pleased to add gefitinib as an option for patients and their clinicians to consider.

“Gefitinib offers an advantage because it is taken in tablet form, can be taken at home, and would allow patients to carry on with normal daily activities. This draft is now with consultees who have the opportunity to appeal against the proposed recommendations before final guidance is published later this year.”

Under the new patient access scheme the drug will be provided at no cost for patients who are treated for up to two months and at a single fixed cost irrespective of the duration of treatment for all other patients.

NICE has said it is unable to recommend Nexavar (sorafenib) for treating advanced hepatocellular carcinoma (HCC) due to its high cost and limited benefit.

NICE’s final guidance is that the drug should not be funded by the NHS, despite an appeal and proposals to implement a patient access scheme by the manufacturer, Bayer.

Andrew Dillon, Chief Executive of NICE, said: “We were disappointed not to have been able to recommend the use of sorafenib, but after carefully considering all the evidence, including the proposed ‘patient access scheme’, in which the manufacturer offered to provide every fourth pack free, sorafenib does not provide enough benefit to patients to justify its high cost.”

The only potentially curative treatment for HCC is surgery, but only a small proportion of patients will be eligible for this. Normal life expectancy for these patients is less than 24 months.

In trial data seen by NICE’s independent committee sorafenib increased survival by an average further 2.8 months, but at a cost of £27,000 per patient. In addition, half of the patients who gained some benefit received less than this amount of additional life.

Dillon added: “We have changed our approach to appraising high cost treatments which can potentially extend life for terminally ill patients. This has meant that more of them are now being recommended. We looked at sorafenib in just the same way but the price is simply too high to justify using NHS money which could be spent on better value, more effective cancer treatments.”

A total of 720 orphan designations have been granted to medicines for rare diseases in Europe over the last 10 years.

The European Medicines Agency (EMA) has celebrated the 10^th birthday of orphan regulation and reviewed the success of the system to date.

A two-day conference to mark the anniversary brought together representatives from the European Parliament, the European Commission, international and European regulatory agencies, members of the Committee for Orphan Medicinal Products (COMP), patient groups, health professionals and the pharmaceutical industry.

Since April 2000, the Agency has received more than 1100 applications. Out of these there has been a success rate of 65%, with a total of 62 orphan designated medicines approved for use in the EU, giving treatment options for 53 rare diseases.

The COMP was also the first of the Agency’s scientific committees to include representatives from patient organisations.

“The collaboration in the assessment of applications for orphan designation has led to a process of cross-fertilisation between regulators and patients, and ultimately to improved decision-making by the Committee as a whole,” said Kerstin Westermark, Chair of the COMP.

Over the next few years the period of market exclusivity (10 years) will expire for the first authorised orphan medicines, opening up the market for older orphan-designated medicines for competition.

European Medicines Agency Executive Director Thomas Lönngren said: “We are looking at how to increase the transparency of our scientific decision-making so that those bodies within the EU Member States who decide about the pricing of orphan medicines can also use our knowledge when making their decisions.”

Abbott was one of several pharma companies to be named the Best Workplaces in Europe 2010 by the Great Place to Work Institute.

The company was honored for workplace leadership in Denmark, Ireland and Norway.

Other companies to be featured included Roche in Denmark, Procter & Gamble Austria, GSK in Denmark, Bristol-Myers Squibb in Greece and Poland, Novo Nordisk in Finland and the UK, Johnson & Johnson Germany and Lundbeck in Denmark.

“Being named one of the Best Workplaces in Europe is a tremendous honor for Abbott, especially given the award is based primarily on employee feedback. It’s clear that Abbott employees are passionate about the work they do to improve the health of people in Europe and around the world,” said Eckhard Hofsaess, Senior HR Director, Europe, Abbott.

“We focus on connecting people with their potential through training, mentoring and leadership development programs, and by providing employees with the flexibility and support they need to build extraordinary careers.”

So far in 2010 Abbott has been honored as a top employer in 16 countries across Europe, including the UK.

“These honors in Europe highlight Abbott’s efforts to provide a consistent global approach to people management across all its businesses, while also providing flexibility for targeted initiatives that meet the local needs of employees and Abbott’s growing businesses in Europe and around the world,” added Hofsaess.