NICE and Roche at loggerheads (again)

 

NICE has today (8th August 2014) announced that it cannot recommend Roche’s latest breast cancer drug, Kadcyla (a combination of trastuzumab and emtansine) for routine use on the NHS because it is too expensive and hence not cost-effective.  The draft ‘no’ was actually published in May, but there has been a press release issued today following the breakdown of negotiations on a cost-sharing scheme.

This is interesting, not for the result (the treatment comes in at an eye-watering £166,000 per QALY gained), but for the clear ruling by NICE on cost, and Roche’s reaction.

In its press release this morning, whilst acknowledging that the drug is quite effective (giving on average an extra six months of life, compared with say, Avastin’s six weeks in patients with bowel cancer),  NICE said that “the high price of treatment is still unaffordable for [use] on the NHS.”

This represents a very open and in my opinion, welcome, stance, when compared with NICE’s much more cautious language the first time it ever said ‘no’ on the grounds of cost-effectiveness back in 2002:  “a recommendation to use these medicines cannot, presently, be justified, taking both benefits and costs into account”. (Beta interferon and glatiramer acetate for multiple sclerosis, NICE technology appraisal 32, January 2002).  Of note is the reaction of charities such as Breakthrough Breast Cancer.  Instead of criticising NICE for a negative ruling, their comments focus on the pricing decisions of Roche.  Compare this with Bowel Cancer UK’s reaction to the ruling on Avastin in 2010, criticising the review of effectiveness data NICE used in its appraisal.

And Roche’s reaction?  To describe NICE’s processes as “… broken, not fit for purpose and in need of a complete overhaul when it comes to advanced cancer” (Jayson Dallas, general manager of Roche).  To be fair, Roche and NICE have never been particularly chummy, and their reaction could be seen as perfectly rational: it is the managers’ legal (and arguably moral) duty to maximise the return to their shareholders, and therefore they should pursue any means within the law so to do.

In fact Roche has had considerable success in this, with “[Roche’s] chief executive and lobbyists … closely involved … in the setting up of the [coalition government’s] Cancer Drugs Fund” (according to The Guardian).  This fund, set up in 2010, ensures that sales of very expensive drugs of limited effectiveness can be maintained, transferring £200M every year away from cost-effective interventions, and preserving management bonuses and returns to shareholders.  Possibly a little bit of a cynical and provocative way of phrasing it, but the body count of lives saved with the cancer drugs fund versus lives lost from withdrawal of alternative uses of that £200M would be an interesting one.

Fundamental to this is the concept of opportunity cost:  if we spend money on Kadcyla it means we can’t spend it elsewhere.  A course of Kadcyla costs £90,000 and buys six months of life for one breast cancer patient.  However, to find that £90,000 we would for example, have to withdraw gefitinib (Iressa) from seven patients with locally advanced non-small-cell lung cancer, losing around 3 months of life per patient (21 months of life in total), or withdraw imatinib (Glivec) from four patients with chronic myeloid leukaemia for a year, losing around 10 life years each.

To ensure a ‘just’ allocation of scarce NHS resources, it is critical to consider not only those who benefit from a decision, but those who lose too.

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