Head-to-head: Nice and the SMC

pharmafile | August 16, 2006 | Feature | Research and Development, Sales and Marketing |  NICE, SMC, healthcare 

The announcements on NHS budget deficits and the debates surrounding the prescribing of costly drugs, such as in the  Herceptin controversy earlier this year, have caused many in the health industry to take a long and hard look at the processes by which new drugs are made available to patients across the UK, and to raise questions concerning the relevant implications in terms of cost and patient benefit.

The bodies responsible for issuing guidance on drugs, their uses and availability are NICE (the National Institute for Health and Clinical Excellence) in England and Wales and the SMC (Scottish Medicines Consortium) in Scotland, and both have come under close scrutiny in response to recent events.

Although ostensibly doing the same job, the routes to the issuing of guidance taken by the agencies show a number of differences; NICE runs an extensive, time consuming, yet thorough, evidence-based review of each product, while the SMC makes speedier decisions, but at the expense of carrying out such in-depth research.

But now, changes are afoot and NICE looks likely to adopt many of the methods of the SMC, which are proving to be more effective in saving both time and money during the review process. These changes include a fast-tracking system for prioritised drugs similar to the SMC's approach to appraisal, and a greater say by the agency in which products are to be selected for review.

Taking a different route

The differing approaches of the two agencies to the review process mean that the SMC is able to issue guidance far more rapidly than NICE. Compared with the three months the SMC takes to reach a decision, an average NICE review process currently takes 62 weeks, but the Institute is now finding it difficult to maintain even this timeframe, which many say is already too protracted, due to the disbanding of one of its appraisal committees and also the growing demand for certain drugs to be fast-tracked (as with the recent Herceptin case).

Opinions within the industry are divided; some have said that a faster guidance process will help PCTs to plan their budgets, while others claim that approving drugs too readily could lead to the destablisation of NHS funding when expensive drugs are recommended without giving due consideration to the financial consequences.

Set up in 1999, the aim of NICE was to advise the NHS in England and Wales on the clinical and cost effectiveness of drugs and treatment, as a way of tackling the accusation being levelled at the health service of 'postcode prescribing'. Frank Dobson, the UK Secretary of State for Health at the time, introduced the agency saying: "Its evidence-based guidelines will be used right across the country, so NICE will help end the unacceptable geographical variations in care that have grown up in recent years. Since then, its remit has expanded when, in April 2005, it took over the public health functions of the former Health Development Agency."  

Similarly, the SMC was set up some two years later in 2001, with its task being to advise on new products in terms of clinical and cost effectiveness, but with reference to any existing treatments which would be replaced as a consequence.

New mechanisms

Since early 2004, it has acquired a strengthened role to agree a national programme for unique drugs. This includes a requirement for every local health board to make these medicines available at the same time across Scotland, a new mechanism to give the SMC up to 12 months' notice of innovative drugs which are in the pipeline, and improved methods of implementing decisions nationally. However, despite these changes, a NICE decision will take precedence in Scotland in cases where it supersedes and differs from that of the SMC, and it can, therefore, override any SMC guidance already issued.

Once guidance is issued, the NHS in England and Wales is obliged to provide, wthin three months, funding for medicines that are recommended for use by NICE, but no such requirements are made of the NHS in Scotland regarding SMC approval.

The SMC only considers guidance for new medicines or new uses of existing medicines, but in contrast, NICE can be asked to look at a whole host of medical products, which are referred to it by the Secretary of State for Health and the Welsh Assembly Government.

The selection process of these products is lengthy,however, with a number of stages, including looking at the importance of the medicine in terms of health benefit, its impact on other government policies (such as links to health inequality policy), the financial impact on the NHS, and whether guidance will add value to existing information on treatment and its cost effectiveness.

But, this situation looks set to change in the near future as NICE is to be handed more autonomy by the Department of Health. Up until now, ministers were involved in the selection of topics right from the initial stages, but plans to give greater authority to NICE mean that their involvement will be limited to the final decision stages only. As a result of this policy change, three or four months could potentially be cut off the total review process.

NICE has two technology appraisal committees, which look at costs and benefits of new medicines, and it then commissions an independent academic centre to review the published evidence on the medicine and prepare an assessment report. Decisions within the SMC are made by a New Drug Committee, and, unlike NICE, the SMC draws primarily on the submission of the licence holder for the evidence to be assessed.

The dilemma of the so-called 'NICE blight'

The length of appraisal is the key difference between the two agencies. The SMC takes 119 days to produce guidance in around 90% of applications and has an explicit objective to provide guidance as soon as possible following launch, which, typically, is within two to four months. NICE's appraisal process, on the other hand, can take as long as two years following launch and it can have up to 21 steps depending upon whether appeals are lodged against decisions along the way.

This delay has led critics to coin the term 'NICE blight' and it is seen as a double whammy to the pharmaceutical industry because a drug first has to get through the regulatory approval process and then through the NICE appraisal process.  

In its defence, however, NICE would argue that the extra time involved is a result of more sophisticated and comprehensive reviews, and greater public consultation, and, indeed, according to some commentators, this is a failing of the SMC, which does not have such strong mechanisms in place.

Comparisons and contrasts have been made between the two agencies, and these include the conclusions and timeliness of the guidance emerging from them.

The race against time

The SMC compared its own performance against NICE, and it found that by October 2005, of 18 products that were reviewed by both the SMC and NICE, for 17 of these, the advice from the SMC and NICE was similar, while one product was rejected by the SMC but approved by NICE. But the crux of the matter was that, although the overall advice was similar, the SMC's advice came out some 10 months earlier than that of NICE.

With cancer drugs, speed is often of the essence, and the patient group Cancerbackup has carried out a comparison on the performance of NICE and the SMC for these types of products. Its findings highlight the relative speed of the SMC as it found that of 23 products awaiting NICE appraisal in September 2005, 16 had already been reviewed by the SMC, while the decisions of NICE for these were still pending.

Looking at the remaining seven products in October 2005, advice from the SMC was expected some 21 months before that of NICE. So, in terms of speed, the SMC was clearly in front. Cancerbackup also noted that for some products, the time for NICE guidance can be as long as two years or more.

Commentators have also noted that NICE takes a longer, more expensive route to reach its decision, but at the same time, a comparison of guidelines shows a high level of concurrence between the two agencies once decisions are issued. While that comparison is not entirely fair, as the bodies serve populations which differ in size, density and lifestyle, it does raise questions of whether the NICE approach gives value for money, particularly as a cost of 80,000 per appraisal has recently been estimated.

In response to pressure for faster decisions, NICE has now announced a new fast-track procedure known as the Single Technology Appraisal (STA). It is hoped that the STA will produce guidance more quickly on some new medicines, aided by the fact that it is specifically designed for the appraisal of single products, with single indications. In an approach similar to that of the SMC, the STA will draw primarily on evidence submitted by manufacturers, in an effort to issue guidance within six to 14 weeks.

Slow on the uptake

But guidance alone, without implementation, is of limited value, and there is some evidence of poor implementation of NICE guidance across England, especially in the case of cancer medicines. The National Cancer Director, Professor Mike Richards, reviewed implementation of NICE guidance for cancer medicines in 2004 and found that while the use of a cancer medicine increases following a positive appraisal by NICE, variations continue to exist, which cannot solely be attributed to differences in case mix.

This conclusion followed a Roche audit released in October 2003, which found a dramatic variation in the availability of Herceptin for advanced breast cancer across the UK, and an announcement from Cancerbackup that of women who would benefit from the drug, only 33% actually receive it.

The evidence was backed up by research commissioned by NICE itself in 2004, which found that within a selection of 28 NICE appraisals, 12 guidance decisions were classed as being reasonably implemented, a further 12 were classified as under-implemented, and  the last four showed implementation that was above the expectations of the NICE guidance.

The Audit Commission also carried out an assessment of the implementation of NICE guidance, in September 2005, and its findings showed that, in general, implementation was less comprehensive and timely than desired.

The assessment also showed funding to be a key issue in implementation, and the Audit Commission highlighted the potential for Payment by Results (a new system of paying for each procedure in secondary care) to have an impact in the future on the funding of NICE guidance and, therefore, subsequently on access to new technologies.  

Too many agencies?

But NICE and the SMC are not the whole story – Wales also has its own agency concerned with medicines and prescribing activity, called the All Wales Medicine Strategy Group (AWMSG). It is usually excluded from comparisons of the SMC and NICE because its remit is less focused on cost effectiveness, but rather on the cost implications of making new drugs routinely available in the NHS. Consequently, the AWMSG provides guidance quickly to the NHS in Wales, at around six months after launch.

Furthermore, the AWMSG only considers around eight products a year, and so one might say that if the SMC is the little brother of NICE, then the AWMSG is its even smaller sister.

Recent discussions have focused on whether Wales should adopt SMC guidance, but how this would be put into operation is not clear; for example, how would guidance issued by the SMC be made available to Wales and how would it avoid duplication with guidance issued by the AWMSG?

While much can be learned from comparing the activities and outcomes of these agencies, there is a more important consideration – does the UK really need separate agencies, all providing essentially the same advice, albeit at different times?

The pharmaceutical industry has rightly questioned the need for separate agencies that require much of the same information. While the applications to the UK's different populations may need separate analysis, it is important to recognise that much of the basic information is the same.

Instead, a single agency could cover all regions, acting as the central collator of evidence and providing a single port of call for the pharmaceutical industry, the NHS, patient groups and the public. However, this is a scenario unlikely to occur in the devolved NHS, but it might be a better finish line for all the parties concerned.

Leela Barham is a consultant at NERA Economic Consulting. For more information visit www.nera.com

NICE, the SMC and Glivec

NICE's actions in a number of high-profile cases have attracted the ire of pharma and patient groups anxious to see new treatments brought to market.

Cancer drugs have been particularly affected, among them Femara, Xeloda, Arimidex and MabThera. However, until the (still on-going) controversy over access to Herceptin in early-stage breast cancer, one of the most prominent examples was Novartis' Glivec.

The treatment for gastrointestinal stromal tumours (GIST) is considered to be a breakthrough cancer treatment and one of a handful to target tumours effectively and spare patients the harsh side-effects of traditional chemotherapy.

It was approved in the UK to treat Kit-positive unresectable (inoperable) and/or metastatic malignant GISTs in May 2002.

This was followed in August of that year by a recommendation for its unrestricted use by the SMC.

A full two years after its UK approval, NICE gave an initial recommendation that Glivec be used for 12 weeks and then withdrawn if patients appear to be unresponsive; this was confirmed in its final decision in October 2004.

Commenting in May 2004, Novartis' head of oncology medical affairs Dr Shazia Hasan said: "We are extremely alarmed by the initial NICE recommendations, which clearly ignore the weight of clinical evidence.

"Many patients will be denied the only available and effective therapy if these recommendations are upheld."