UK - Analysis Reveals Uptake of Pharmaceuticals Following NICE Approval

A new report, Use of NICE-appraised Medicines in the NHS in England – Experimental Statistics, published by the NHS Information Centre in September 2009, has looked at the uptake of pharmaceuticals appraised by the National Institute for Health and Clinical Excellence (NICE).

The review studied 26 drugs positively appraised by NICE, covering 13 technology appraisals.

The report indicates that out of 12 appraisals where a comparison could be established, use on the NHS in 2008 was higher than expected for seven appraisals and lower for five appraisals.

The appraisals where observed use exceeded the predicted use in 2008 are:

• Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer’s disease;
• Ezetimibe for the treatment of primary (heterozygous-familial and non-familial) hypercholesterolaemia;
• Entecavir for the treatment of chronic hepatitis B;
• Zaleplon, zolpidem and zopiclone for the short-term management of insomnia;
• Varenicline for smoking cessation;
• Hormonal therapies for the adjuvant treatment of early oestrogen-receptor-positive breast cancer; and
• Alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women, plus alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women.

The appraisals where observed use was lower than the predicted use in 2008 are:

• Omalizumab for severe persistent allergic asthma;
• Natalizumab for the treatment of adults with highly active relapsing-remitting multiple sclerosis;
• Drotrecogin alfa (activated) for severe sepsis;
• Riluzole (Rilutek) for the treatment of motor neuron disease; and
• Orlistat, sibutramine and rimonabant for the treatment of obesity in adults.

In one case, the use of the drug was lower than predicted in 2008 but its use is rising and it is likely to exceed the expected level in 2009.

The Association of the British Pharmaceutical Industry (ABPI), however, has questioned the basis on which the predictions were made as it appears to be too low. The ABPI also believes that the statistics on the use of such medicines in England should be set against a comparison of uptake in other, comparable European countries.

Further reading - An in-depth review of the UK pharmaceutical market, including some background information on NICE appraisals, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)

UK - Increase in Parallel Exports Leads to Drug Shortages

There are medicine shortages in pharmacies across the UK, due to a sharp increase in parallel exports, as a result of current exchange rates.

In a survey of 150 community pharmacies, compiled by Chemist and Druggist in August 2009, nearly a third of respondents claimed patients had suffered because of delays in accessing medicines, while 89% said they were “very concerned” and 11% had “some concern” that patients would be affected.

The Association of the British Pharmaceutical Industry (ABPI) said that three pharmaceutical companies had been forced to arrange 77,020 shipments for the UK in January to May this year because of supply shortages, whereas in the same period in 2008 this amounted to just 6,134 cases.

Historically, drug prices in the UK have been comparatively high, and the country was often a destination for parallel imports from countries with lower prices, such as Greece and Spain. However, the weakening British pound against the euro has meant that prices of medicines have fallen and are now being exported to other EU countries.

The ABPI has put together a ‘watch list’ of 24 prescription drugs which pharmacies are having difficulties obtaining. However, manufacturers of these drugs have said that they provided more than enough to treat patients across the UK. For example, Novartis provided 65% more of Myfortic, a drug which prevents rejection in kidney transplant patients, than was required for patients in the UK, suggesting that much of it is being diverted for sale abroad.

Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on parallel importing and exporting in the country, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)

UK - Roche Withdraws from Industry Association

The British arm of the Swiss company Roche has decided not to renew its membership of the Association of the British Pharmaceutical Industry (ABPI), it was announced in June 2009.

Roche’s move follows a six-month suspension for a serious breach of the ABPI’s code of practice, related to selling its slimming drug Xenical (orlistat) to private clinics. Roche was also criticised for failing to stop a programme which offered incentives for patients to take its treatment for cystic fibrosis, but, in light of the suspension, no further action was taken. The suspension ended in February 2009.

Although Roche has pledged to continue to comply with the ABPI’s Code of Practice, it removes the option for the ABPI to order similar sanctions if the company breaks the code in the future.

The Medicines and Healthcare Regulatory Products Agency (MHRA) can prosecute drug companies, but up until now the majority of disciplinary action has been taken by the Prescription Medicines Code of Practice Authority, run by the ABPI.

In a statement, Roche said: “In line with any commercial business we continually review our operations, and our time away from the ABPI has enabled us to reflect upon the nature of this relationship and consideration of mutual needs in the future. We have concluded that this is something we need to review further and for that reason, we have decided not to re-join the ABPI for the time being. We will continue to review this situation.”

It also noted: “This decision in no way affects our commitment to our working practices and we are still committed to, and will be accountable for, working within the ABPI Code of Practice to ensure compliance with the high standards of our industry.”

The statement also said that a set of new processes and procedures for compliance had been put in place, with a team of eight staff dedicated to compliance, and training is now given to staff so that they fully understand the Code of Practice and the company’s internal policies for complying with it.

However the ABPI, which receives a six-figure subscription from Roche, is disputing the company’s right to leave, and crucially, the decision has raised questions over the organisation’s ability to regulate the industry at arm’s length.

Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on the regulatory environment and the ABPI, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)