Servier and patient groups are celebrating a High Court decision which states that the UK’s healthcare watchdog has acted unlawfully in restricting access to osteoporosis drugs, notably the French firm’s Protelos.

A judge has ruled that the National Institute for Health and Clinical Excellence failed to disclose the economic model used to make a decision to restrict the use of Protelos (strontium ranelate) on the National Health Service. Last year, NICE recommended Merck & Co’s Fosamax (alendronate) as the first-line option, with Procter & Gamble’s Didronel (etidronate) and Actonel (risedronate) as first alternatives if the patient is intolerant to alendronate. Next in line is Protelos which is recommended only if the woman cannot take any of the above bisphosphonate drugs.

Servier argued that this would leave the 15% of women with osteoporosis who cannot take bisphosphonates unprotected from the risk of fracture - potentially for many years. It appealed the guidance on the grounds that there had been a lack of transparency around the economic model used to make the decision. The firm also claimed that NICE misinterpreted hip fracture data that Servier had compiled and infringed rights under European Union and UK discrimination law on the basis of disability.

NICE not transparent enough
In the High Court, Mr Justice Holman rejected those last two claims but did agreed that NICE has failed to be as transparent as it should have been. As a result, the watchdog must disclose the economic model it used in the guidelines to Servier and interested parties, as well as consult experts again.

However Justice Holman said that “no one should gain false hope from this judgment", noting that if NICE follows correct procedures but comes to the same conclusion, it would not necessarily mean that the earlier guidance is unlawful.

Servier “expressed satisfaction” with the ruling and the judgement was also welcomed by the National Osteoporosis Society. Nick Rijke, the latter’s director of public and external affairs, said it will “force NICE to change the way they work and take public scrutiny more seriously”. David Reid, chair of the NOS, added that seeing as “annual treatment has come down to as little as £20 as opposed to the £95 quoted by NICE, we will be able to ensure that more patients can get effective and inexpensive treatment”.
Prof Reid concluded by saying that “the truth is that we are spending £2.3 billion a year treating hip fractures, but spend very little preventing those fractures from occurring in the first place”.

Peter Littlejohns, NICE's clinical and public health director, said “we are very pleased to have won on the two grounds of discrimination and handling clinical data. This is a clear endorsement of the NICE process for assessing technologies”. He also noted that the judge agrees that NICE was correct in not releasing “in confidence” information about the economic model used but the watchdog could have done more to arrange for that information to be available.

Model covered by intellectual property rights
NICE said that it will now make “every endeavour to encourage the owner of the information to allow us to release this information”. The author of the economic model supplied is John Kanis, professor emeritus in metabolic bone diseases at the University of Sheffield and he supplied the unpublished data, based on his own research and in which he owned the intellectual property rights, on conditions of strict confidentiality.

Prof Kanis, described as a distinguished physician of "integrity", had since stated he is still open to discussion about disclosure of his data to restricted groups of persons on confidential terms, Justice Holman said. Prof Littlejohns added that once NICE receives Prof Kanis’ agreement, "we will put in place arrangements for consultees to receive executable versions of our model”. NICE “will consider those comments and reconsider the guidance with an open mind, as we have been ordered to do”, he added.