It has never sat well with doctors that one of medicine’s most potent and widely used weapons against stroke is a blood-thinning agent first developed to poison rats. Warfarin’s unpleasant side-effects and fiddly monitoring requirements have won it few friends. Most GPs will be delighted that an alternative is finally within reach.
But NICE’s approval of dabigatran – for patients with atrial fibrillation and one additional risk factor – has not been without controversy. The institute, with a hitherto unsuspected talent for hyperbole, claimed its recommendation would have ‘one of the largest impacts on the NHS to date’. GP commissioners, meanwhile, have been more concerned with the likely impact on their prescribing budgets, with one warning use of dabigatran could send the GP drug bill soaring by 20%.
That tension threatens to make dabigatran’s approval momentous for more than just the obvious clinical reasons. It brings to a head a controversy over drug access that has been rumbling for several years, and especially so in recent weeks.
Serious questions will now be asked about whether decisions that commit huge sums of commissioning cash should be made at the national level, by NICE, or locally by clinical commissioning groups. On one side will be those who fear worsening postcode lotteries in care – on the other, champions of local decision making.
Both sides will probably agree that the current rules over drug access are a mess. There is a legal obligation to fund treatments recommended in NICE technology appraisals, but not those in clinical guidelines. Whether a drug is approved in an appraisal or a guideline is arbitrary – statins were assessed by NICE in the former, hypertension drugs the latter.
To muddle matters further, the NHS Constitution simply states that patients ‘have the right to drugs recommended by NICE for use on the NHS, if your doctor says they are clinically appropriate’.
The Government seems to sense it should do something about this muddle, but isn’t sure what. So in the last few weeks, Pulse has revealed that ministers plan to simultaneously require drugs approved in NICE appraisals to be added to GP formularies within 90 days, while also asking the Future Forum to look at the whole question of whether the NHS Constitution should guarantee drug access.
Most GPs believe minimum requirements for drug access should be set nationally. But there is a problem with how NICE takes its national decisions – because while it must assess the cost-effectiveness of treatments, it is free to impose costs on CCGs without having to stick within any kind of notional budget. As NHS budgets get tighter, NICE spends other people’s cash they don’t have.
There are a number of ways in which the Government could clarify this muddle. It could, for instance, ask NICE when making legally binding national rulings to take decisions within a cash envelope, just as everyone else has to, and to then place a second rank of approved medicines on a menu from which CCGs could choose.
But the current confusion over which drugs will be offered nationally is unfair on GPs and patients. There must be a better way to wean the NHS off rat poison.