NICE stumbling block to new rules

C&I Issue 22, 2007

With discussions on a value-based pricing system about to start, the Association of the British Pharmaceutical Industry (ABPI) has said that in order for such a system to go forward, the drug evaluation procedures used by the UK National Institute of Clinical Excellence (NICE) have to change.

The ABPI and the Department of Health (DH) are about to start discussions on replacing the current pricing system with one in which the price the UK National Health Service (NHS) pays for a drug reflects its value to patients.
  In February 2007, the UK’s Office of Fair Trade recommended that the current medicines pricing system (Pharmaceutical Price Regulation Scheme (PPRS)) be replaced (C&I, 2007, 4, 4). And in August, the government agreed.

PPRS is a voluntary agreement between the DH and the ABPI, allowing the DH to cap profits made on drug sales to the NHS – depending on the range of drugs made and investment in the UK. But companies can still set initial prices. The PPRS is supposed to ensure that the medicines provided to the NHS are reasonably priced. Concerns that drug prices are kept artificially high prompted an OFT investigation and the subsequent recommendation (C&I 2005, 21, 7).

But members of the ABPI board said there are several major issues concerning the way NICE evaluates new drugs that need to be addressed. NICE is, they said, basing its decisions on ‘limited evidence’ and ‘limited definitions of value’ and is not employing the best clinical brains to appraise new treatments.

NICE needs to make sensible decisions about the appropriate time to evaluate a drug, they said.  How far down the line this happens will depend on the product. For the most part, NICE is evaluating drugs at too early a stage. ‘The nature of trials is such that, initially at least, they exclude a huge proportion of the population and the study group makes up the most difficult patients who will derive the least benefit in the long run. This makes extrapolating to the general population and those who may derive the most benefit impossible,’ says David Hill, of UK company Leo Pharma. Another criticism of NICE is that it has in several incidences completely disrespected the opinions of some of the country’s leading experts. In a letter to NICE, the Dementia Guideline Development Group complained that experts views were not listened to when NICE made its controversial decision last year not to provide anti-dementia drugs to patients with early stage Alzheimer’s disease. Drug company Eisai failed in a High Court bid to get NICE to rewrite its guidance.

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