Merck KGaA’s Erbitux (cetuximab) and Janssen’s Zytiga (abiraterone) came second and third respectively, with 11.9 per cent (about 1,284) and 11.8 per cent (about 1,274) of total requests.

However, this looks set to change following NICE’s recommendation for Zytiga in the treatment of advanced prostate cancer, meaning the drug is available for mainstream NHS use.

Completing the top five most requested drugs were Roche’s MabThera (rituximab), which had 5.3 per cent of all requests (about 572) and GlaxoSmithKline’s Tyverb (lapatinib), which had 5.2 per cent of all requests (about 561).

The ten most commonly used drugs accounted for 80 per cent of the total number of applications.

Most requested drugs using cancer drugs fund

Elsewhere in its bulletin, the first since the launch of the cancer drugs fund in April, 2011, NCAT acknowledged concerns regarding regional variations in the number of applications made to the fund.

This was picked up by the UK Department of Health, which published a breakdown of applications by strategic health authority (SHA).

During April 2011 to May 2012, the SHA with the most funding requests was NHS West Midlands with 1,658, while the NHS North East had the fewest number of requests with 696.

“By publishing this data, patients can see how the Fund is being used in their area and across the country,” said care services minister Paul Burstow.

These regional concerns were also mentioned in the Rarer Cancers Foundation (RCF) report on the cancer drugs fund, which claimed that once population size has been adjusted for, NHS South East Coast had an approval rate over 50 per cent higher than that in NHS North West.

“The reasons for this require further exploration but suggest that significant variations in access existed prior to the cancer drugs fund,” said the report.

The RCF also highlighted the need to take action before the Fund is set to close in March 2014, three months a new value-based pricing drug reimbursement system is due to take effect in the UK.

“We estimate that the result of this change would be to deny over 16,000 cancer patients life-extending treatment every year. Over the course of the next Parliament (expected to be 2015-2020), this would mean that over 80,000 patients could be denied clinically effective cancer treatments,” the RCF said.

Recommendations suggested by the RCF to overcome such issues include a mechanism to enable treatments currently reimbursed through the Cancer Drugs Fund to be appraised as part of value-based pricing (VBP), with the discussions on how this would work in practice to begin by early 2013.

If such a process is not in place by early 2013, the Fund should be maintained as a transitional measure so as to ensure continuity of access, according to the RCF.

Such concerns follow comments from Roche in June, 2012, when the pharma company called for the Department of Health to quicken the process towards pricing negotiations or patients would miss out.

Since then, the DH and the Association of the British Pharmaceutical Industry (ABPI) have confirmed the drug pricing negotiations will begin next month.

As part of these negotiations, the possibility of using a new VBP assessment on drugs currently funded through the cancer drugs fund will be assessed as per RCF’s recommendations.

Published: 30/08/2012

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OF course with our politicalized health-care system, scientific, evidenced based review of treatments and drugs in contrary to the spirit of free enterprise.  Free to do harm for the sake of the dollar. 

http://www.pmlive.com/pharma_news/nices_international_footprint_419223

NICE’s International Footprint

NICE International is a little known arm of the UK health technology assessment (HTA) body, the National Institute for Health and Clinical Excellence (NICE), but its varied collaborations across Europe and into emerging markets have given it a global reach.

Set up in 2008 NICE International has grown from founding member Kalipso Chalkidou to a team of five working within the cost-effectiveness body’s offices in London’s Holborn. Run as a not-for-profit organisation it is, nevertheless, income-generating to ensure costs are recouped and do not eat into either National Health Service (NHS) or NICE funds.

It was established in response to a growing number of overseas requests from policy makers, academics and practitioners who wanted to know more about the way NICE works, on both a technical and a strategic level.

“We genuinely think there’s something in what we do that can help decision makers in other countries that are faced with very similar questions, even though the setting might be different,” explains Chalkidou.

As well as offering the ‘NICE way’ to other countries, NICE International actively looks for areas where it can learn from what other countries are doing, particularly when so many health reforms are being planned and enacted. But primarily its role is to take its thinking and approach to HTA and clinical guidelines to other countries.

“There’s a lot of demand out there,” Chalkidou notes, and points to NICE’s website, which, although intended for a UK audience, nevertheless gets half of its traffic from abroad.

The Work
One strand of NICE International’s work is to provide fast-track training for a Ministry of Health or national insurance agency. This focuses on critically evaluating and appraising evidence, looking at economic analyses and how they could critically review industry submissions.

NICE International is also involved with partners, reviewing the available evidence for a drug or condition and then adapting it for the local setting.

Naturally, there is also a lot of interest in the activity for which NICE is perhaps best known, its approach to technology assessments, with countries outside the UK wanting to learn from NICE how to assess new medicines. But there is also demand for advice on how countries can build HTA capacity and make sure they get the right data sets and choose the right efficacy measures.

“People are interested in what others are doing,” says Chalkidou, pointing to the growing number of HTA networks as evidence of this appetite. In Europe this takes the form of EUnetHTA, of which NICE itself is a member. Earlier in 2012, the network was championed by European Commissioner for health and consumer policy John Dalli as a potential way to ease the region’s financial crisis. “Sharing safety, effectiveness and costs analyses will help health managers and politicians make better informed choices,” he said.

This process is being replicated outside the EU with, as Chalkidou points out, networks like HTAsiaLink, which involves Thailand, Taiwan, China and North and South Korea and also has links with Japan.

Europe
The main focus of NICE International has been on flagship projects in countries like China and Brazil, but it has also been reasonably active in Europe, working with Albania, Estonia, Romania, Serbia and Turkey.

“What Turkey has achieved, for instance, with much less funding, in universal coverage and offering primary care services to its very rural population, is really wonderful,” Chalkidou enthuses.

There are two common aspects of NICE International’s work in Europe – clinical guideline standards and technologies. “People are interested in the standards for practice for professionals – ‘How do we know we’re getting quality? What does good practice look like when it comes to people with diabetes?’, for example.”

Industry Engagement
On the subject of whether or not countries should look to build a relationship with the pharmaceutical industry, Chalkidou is emphatic.

“We’re very much for engaging with industry, and our advice to our partners in other countries is to engage in a controlled and managed space and wait, but engage with industry rather than go ahead and make decisions without involving anybody.”

She acknowledges that a lot of the organisations or countries NICE International works with have “a jaundiced view of industry” because of past or current experiences, but she says NICE International is “very much for engaging with people who promote products”.

She concludes: “What would really be worth doing, and would be a comparative advantage for those companies that do it well and do it first, is to gain the trust of the decision makers.”

The Interviewee
Kalipso Chalkidou is the founder member of NICE International. She holds a PhD in molecular biology from Newcastle, UK, and spent almost five years working in NICE’s methods division before travelling to the US for a year at Baltimore’s Johns Hopkins hospital. She was interviewed by Dominic Tyer, managing editor of PME and PMLiVE. 

• This article is part of PME's Inside Market Access supplement - a guide to market access for the pharmaceutical industry

Published: 29/08/2012