The year in review

The year in review

The story of the pharmaceutical industry in 2008 has been a one of innovation and controversy, with NICE once again playing a lead role. We take a look at the most significant news stories of the past year.

January

The end of 2007 and start of 2008 was characterised by increased pressure on various groups: GPs were put under pressure by the government to increase their opening hours, NICE was put under pressure to speed its technology appraisals up, and sales forces felt the pressure as BMS and Novartis became the latest companies to downsize their sales teams.

On a lighter note, NICE agreed to amend its strict guidance on drugs for wet AMD, following thirteen thousand complaints. The new guidance recommended Lucentis for more than just one form of the illness and included cases where only one eye is affected. The guidance on Macugen was not changed.

The start of the year also saw many innovative drug launches:
• Bristol-Myers Squibb (BMS) and Gilead Sciences launched Atripla – the fi rst once-a-day treatment for HIV
• Trinity Chiesi launched Fostair – the first metered-dose asthma inhaler to combine belcometasone and formoterol
• Amgen’s cancer treatment Vectibix was approved in the EU – the fi rst fully human monoclonal antibody technology
• Wyeth’s Torisel for renal cell carcinoma, winner of Best New Drug at the Scrip Awards, was approved in the EU.

February

February’s headline story was the launch of the Public Accounts Committee’s (PAC) report into Prescribing Costs in Primary Care. Following the trend of recent reports by the OFT and NAO, PAC said that the NHS was spending too much on drugs, and recommended rewarding GPs and PCTs for cheaper, generic prescribing.

The innovation of early in the year continued with various approvals. New options for the treatment of moderate to severe plaque psoriasis were added, with NICE’s recommendation of Schering-Plough’s Remicade and a UK license for Abbott’s Humira. Options for cancer were improved with the indication expansion of Roche’s Avastin to include advanced renal call cancer and broader use in metastatic colorectal cancer.

An innovation in HIV treatment was also announced in February, with the UK launch of MSD’s Isentress, the first integrase inhibitor.

March

In March, the pharmaceutical industry was accused of suppressing negative clinical trial data on antidepressants SSRIs. A study at the University of Hull concluded that the drugs are only effective in the most severely depressed patients. GSK faced criticism for not revealing evidence that Seroxat was unsuitable for under-18s, though as the drug was not recommended or promoted in this patient group, no charges were brought against the company.

Also in March:
• The EMEA’s annual report revealed that it had recommended more treatments that year than any year previously
• GPs reluctantly agreed to an extended hours option where a practice will have to earn back £18,000 in resources through providing extra opening times
• Roche’s MabThera secured its fourth NICE recommendation in non-Hodgkin lymphoma
• Merck Serono’s Erbitux was awarded a Frost & Sullivan Customer Value Enhancement award.

April

April saw the launch of the campaign to mark the fiftieth birthday of the ABPI Code. However, it wasn’t all good news for pharma, as a report revealed that most companies have lost faith in the UK market. Three-quarters of the UK-based companies surveyed said they had no confidence in the UK market and the same number expect things to get worse rather than better.

On a positive note, the government launched the UK LifeScience Marketing Strategy Implementation Board to boost the LifeSciences sector, leading to hope that confidence in the industry environment would be improved. In addition, three pharma companies – BMS, Napp and Boehringer Ingelheim – were featured in the Sunday Times’ 100 Best Companies to Work for list and Procter & Gamble received an award for Corporate Sustainability at the 2008 European Business Awards.

There was a boost to the role of pharmacists, with a government white paper recommending that the services offered by these healthcare providers be extended, and that pharmacies should become ‘centres promoting and supporting healthy living and health literacy’.

May

Eisai’s victory over NICE in the appeal court in May was a significant result for the industry. It was ruled that NICE should reveal the model it used to assess Alzheimer’s drugs, though the Institute’s decision not to recommend the medicines in early-stage disease was not overturned.

In other NICE news, final appraisal determinations were issued for two cancer drugs. One recommended Erbitux for head and neck cancer, whereas the other advised against the use of Tarceva in non-small cell lung cancer, to the disappointment of patient groups.

Following accusations from the Conservatives that a fifth of GP practices would close to make room for polyclinics, Health Secretary Alan Johnson denied these claims and announced the development of 100 new practices in deprived areas.

There were also various European Commission approvals, including:
• Gilead’s Viread for hepatitis B
• Celgene’s Thalidomide Pharmion for multiple myeloma
• Astellas’s Mycamine for candidiasis
• Boehringer Ingelheim’s Pradaxa for the prevention of blood clots following hip or knee surgery.

June

In June, the NHS Cancer Screening Programme audit showed that six out of ten women whose breast cancer is detected early through screening will live as long as someone who has never had the disease. The announcement coincided with the UK launch of GSK’s Tyverb, which is indicated in combination with Xeloda for ErbR2-positive advanced breast cancer.

NICE guidance caused controversy once again, as the Institute recommended Abbott’s Humira for ankylosing spondylitis, but not Schering-Plough’s Remicade. Schering-Plough responded that it would request NICE’s economic model for review.

Also in June:
• Research by the Karolinska Institute revealed that low survival rates in lung cancer was due to late diagnosis and poor access to radiotherapy and innovative treatments
• Novartis’ Tasigna for chronic myeloid leukaemia was launched in the UK
• Schering-Plough was named as one of the Financial Times’ Top 50 UK Places to Work
• Bayer Schering’s follicular lymphoma drug Zevalin was approved in the EU as a firstline consolidation therapy.

July

GSK’s Cervarix was chosen for the government’s human papillomavirus vaccination programme in July. However, the decision was met by criticism from some experts who believed Sanofi Pasteur MSD’s Gardasil should have been chosen, as it is the only one of the two to protect against genital warts. Lisa Power, Head of Policy at the Terrence Higgins Trust, responded that the decision fated the UK to be “not just the poor man of Europe, but also the warty one”.

In another controversial decision, NICE recommended Accomplia for the treatment of obesity, despite evidence of increased risk of depression and suicide in patients taking the drug. NICE also increased its support for Abbott’s Humira, recommending the drug in patients with severe chronic plaque psoriasis.

A new PPRS scheme was also announced, following talks between the DH and pharmaceutical industry. The five-year agreement included a 5% saving in the cost of drugs sold to the NHS and a pledge to support innovative treatments.

August

The headlines for August were ‘all things NICE’ once again, as the Institute issued guidance against NHS funding for various cancer and rheumatoid arthritis treatments. NICE Chairman Professor Sir Michael Rawlings responded to the widespread outrage by blaming pharma executives’ greed for the high prices of treatments, though the ABPI returned by emphasising the huge costs incurred by the industry in developing drugs in the first place.

Despite reviewing its guidance on osteoporosis drugs, NICE was criticised by the National Osteoporosis Society for making it more difficult for patients to receive treatment. The reviewed draft guidance recommended risedronate or etidronate as alternatives to alendronate for postmenopausal women, but the National Osteoporosis Society argued that, according to the draft, patients would only qualify for these treatments once their condition got worse.

The European Medicines Agency approved various treatments, including:
• CV Therapeutics’ ranolazine for chronic angina
• Jerini’s Firazyr for acute attacks of hereditary angiodema
• Wyeth’s Relistor for opioidinduced constipation.

September

September saw controversy arise over the issue of NHS top-ups, as National Cancer Director Mike Richards reviewed the issue. Healthcare organisations expressed mixed opinions on the proposals of allowing NHS patients to top up their care, many arguing that a two-tier system, where patients that can pay have better care, goes against the principles of the health service.

There was further criticism of NICE, with reports in national newspapers that the Institute spent substantially more of its 2007 budget on marketing and communications than on technology appraisals. However, NICE returned that much of its communications budget was spent on informing doctors of its guidance and that the figure for drug appraisals did not account for the money spent by the DH.

September was also a month of innovation, with various drugs securing EU approval:
• Lilly and Boehringer Ingelheim’s Cymbalta in generalised anxiety disorder
• Jannsen-Cilag’s Velcade in multiple myeloma
• Leo Pharma’s Xamiol in scalp psoriasis
• Schering-Plough’s selective relaxant binding agent Bridion.

October

Pharma industry innovation was awarded in October with the Prix Galien 2008. At this year’s ceremony, GSK’s Cervarix and Sanofi Pasteur MSD’s Gardasil shared the top prize and Novartis’ Exjade won the first ever Orphan Drug Award, although each of the shortlisted entries were acknowledged.

October also saw the resignation of Norgine from the ABPI, accusing the trade association of not representing the interests of smaller companies in its PPRS negotiations. Norgine argued that the ABPI favoured the global multinationals to the detriment of others, but the ABPI insisted it had secured ‘signifi cant concessions’ for small companies.

Also in October:
• In a poll by Pulse magazine, the majority of GPs said that they felt pressured into prescribing generics and some felt that this was starting to interfere with patient care.
•NICE guidance recommended the use of Pradaxa in patients who have undergone hip or knee surgery, making it the first new oral anticoagulant to be approved for 50 years.
• AstraZeneca’s Seroquel for schizophrenia and manic episodes was launched in the UK.

November

Last month, GPs called for pharma to change its business model to fit the modern NHS. A study by management consultancy Hay Group revealed that 58% of GPs would like to have a closer relationship with pharma companies and 62% said their experience of working with representatives was positive. The report called for pharma to move from supplier to partner and to share commercial skills.

The most significant headline story was the removal of the NHS top-ups ban, allowing NHS patients to pay for medications without losing their core care entitlement. The DH also announced plans to increase the amount of drugs available on the NHS and asked NICE to review its pricing threshold for drugs for rare diseases.

These rulings had little impact on GSK drug Tyverb, however, which was still rejected by NICE despite the company’s offer of a unique patient access programme. Under the proposed scheme, GSK would pay for the first 12 weeks of treatment, with the NHS only taking over payment if the drug was successful, but NICE still judged the drug not be cost effective for the NHS.