PharmExec Blog

Naughty Localities Need to Obey NICE, or Else!

Like governors in the US vowing to block Medicaid expansion in their home states, local primary care trusts (PCTs) in the UK don’t always follow national guidelines on drug access due to budgetary concerns. But that may change in 2013; according to comments made by Minister David Willetts last month, NHS could face monetary penalties for not making newly approved drugs available to patients fast enough.

Minister David Willetts

Minister David Willetts

Public payer groups at the local level are calling national policy mandates too expensive for implementation, and have responded by disobeying them directly, or by simply dragging their feet, to see what will happen. Sound familiar?

Disputes between national and local healthcare institutions aren’t unique to the United States, and the access gap among certain PCTs in England will be addressed directly – in the form of monetary penalties – beginning in 2013, according to comments made by David Willetts, Minister of Universities and Science, at the BIO conference last month in Boston. The new strategy for UK life sciences, according to Willetts, will include “budgetary penalties where innovation in the NHS is not being used…and that will kick in next year,” he said.

The basis for levying budgetary penalties on NHS rests on the fact that once the National Institute for Health and Clinical Excellence (NICE) endorses the use of a new innovative drug – an accomplishment remarkable enough in its own right, from industry’s perspective – then NHS is obligated to make that drug available through its various channels, including the local PCTs. That doesn’t always happen, however. “Recent research has shown that probably one in four [PCTs] blacklist drugs that have been approved by NICE,” says Claire Gillis, CEO at the WG Group, a UK-based consulting firm. “PCTs are saying, these drugs may be approved by NICE at a national level, but actually for us, in the localities, they’re too expensive or they’re not effective in our view.”

Faced with a potential funding penalty, NHS may indeed expedite adoption of new drugs and technologies in some localities – Gillis says she expects metrics to be put in place during the fourth quarter – but in the meantime, NICE chairman Sir Michael Rawlins has publicly advised patients to file a lawsuit if they can’t get access to an approved treatment they need. Speaking with the Financial Times earlier this year, Rawlins said: “I just wish a patient organization would take a [PCT] to court for failing to comply.”

That solution is perhaps a manageable one for the courts in England, since litigation losers – those who file a lawsuit and lose – must pay the defendant’s legal fees, a strong disincentive for frivolous suits. Neither solution, however, tackles the issue of where additional funds will come from to make new drugs available faster. If PCTs can’t afford to pay for new drugs in the first place, it isn’t clear how the situation be improved by penalties in the form of budget cuts.

The problem is a critical one. As new drugs for conditions like Alzheimer’s or autoimmune diseases emerge, patients forced to wait – for years in some cases, if the system doesn’t change – will miss their window of opportunity for effective treatment. As these patients’ conditions worsen, they only get more expensive to treat.

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