NICE to Take Little Action After Examining Parliamentary Report

NICE has taken a close look at a parliamentary report into its workings, but the institute's response suggests that little change will be made.

Global Insight Perspective
Significance	NICE has issued its comments on a parliamentary report into its workings. Emphasis was put on speeding up access to medicines and getting value for money for the NHS.
Implications	The institute has taken criticism on board and has weighted the feasibility of all suggestions. However, little action will be taken by NICE.
Outlook	The government is currently considering the report and could decide to amend the institute's methodology. However, what is suggested with the best intentions at national level will still face implementation problems at local level, due to the decentralised and disparate management of the NHS budget.

The U.K. National Institute for Health and Clinical Excellence (NICE) has assessed the recommendations issued by the Health Select Committee in January 2008 (see United Kingdom: 10 January 2008: U.K. MPs Call for a Tougher NICE) and published a set of answers. Although the institute has taken some comments on board, it will not implement many of the suggestions as they either fall outside its jurisdiction or are already in place.

Highlights of NICE's Comments on Health Select Committee Recommendations
Health Select Committee Recommendations	NICE's Answers
On Evaluation Process and the use of Quality Adjusted Life-Years (QALYs)
Evaluate drugs in parallel with licensing process so that NICE guidance is available at launch	Parallel evaluation would result in NICE releasing guidance three months after drug launch
Superficial but quick assessment of all drugs at time of launch followed by revised binding guidance at later time	NICE thinks this is unnecessary but accepts that its guidance is sometimes delayed Would require additional financial resources NICE would not have sufficient time to provide meaningful guidance
Lower QALY threshold for rough assessment of all drugs	Would restrict patient access to clinically effective treatments
Widen the type of drug assessed and stop focusing on new, expensive treatments	Out of NICE's control The DoH picks which drugs are to be assessed by the institute - Only 50% of guidelines concern new, expensive drugs
Review cost-effectiveness threshold used by NICE	Threshold is not rigid NICE considers a range of incremental cost effectiveness ratios (ICERs) when ruling NICE in favour of further research on the subject - Amendments on threshold determination fall under DoH's jurisdiction
Take Primary Care Trust (PCT) budgets into account when making recommendations	Parliament has forbidden NICE from taking such considerations into account
Guidance to take benefit to society into account	Out of NICE's control: Assessment guidelines are established by government and parliament
Post marketing analysis to ensure that cost-effectiveness assessment is correct	NICE will look into implementing this suggestion
- Access to regulator's clinical data	In place U.K. regulator warns NICE on drug safety European regulator publishes clinical data it uses in public domain
Provide greater guidance on and encourage disinvestment	In place Old technologies are reviewed regularly for cost-effectiveness Publishes Recommendation Reminders that highlight potential savings to the NHS These publications will be given "greater prominence in the future"
Greater collaboration between NICE and industry to collect relevant cost effectiveness data	Efforts in place NICE is co-designing a clinical trial with Novartis
On Guidance Implementation
Provide PTCs with guidance on implementation	Already in place NICE publishes Commissioning Guides to this effect Use of implementation consultants
Greater PTC involvement in guidance development
Greater expert and stakeholder involvement in guidance development	Efforts in place
Change "guidance" to a "directive" for single technology approvals	NICE is concerned that this would dampen the impact of its clinical guidelines scheme
Make part of its clinical guidelines compulsory	Out of NICE's control: This falls under the DoH's jurisdiction
On Risk-Sharing Schemes
"Caution" required, should not be a means to alleviate "uncertainty over a drug's benefit"	NICE cannot suggest such schemes, only the manufacturer
Source NICE

The workings of NICE have been at the centre of public attention for multiple reasons, but mostly for controversial decisions on access to treatment (see United Kingdom: 14 June 2007: NICE Courts More Controversy in U.K. with Latest Ruling on Blindness Drugs). The last piece of parliament's report was published in January and called for amendments in the way NICE works. The report acknowledges the importance of NICE being an independent body and its important role in prioritising limited NHS budgets. Significant attention was put on the threshold that the institute uses for cost effectiveness decisions, with the report arguing that it was empirical and had not been reviewed since NICE's establishment in 1999, despite expansions in the NHS budget.

Outlook and Implications

Few changes are expected to be made by NICE as a result of the January 2008 Health Select Committee report. Most suggestions actually fall under the DoH or parliament's jurisdiction and it remains to be seen if they will take action. The most important information is that NICE has rejected the idea of a "quick and dirty" cost effectiveness assessment of drugs based on lower ICERs, in order for guidelines to be published prior to or at the time of a drug launch. This is good news for the industry and patients alike, as a lowering of the threshold would prevent a number of cost effective drugs from being used in the NHS. The institute stressed that it needed time to critically assess all the evidence submitted, consult with stakeholders and to allow all concerned parties to appeal decisions. Interestingly, the cost effectiveness watchdog revealed that it cannot base its decision on manufacturers' economic analyses and instead requires independent analyses, as manufacturers tend to provide estimates on the ICER that are an average of £5,000 per QALY cheaper than NICE's assessment. It currently takes 18 months for NICE to release guidance.

The Health Select Committee report was primarily focused on getting value for money in healthcare and drug availability. Expenditure on drugs has been at the centre of the debate on reining in public spending, although the NHS's drug expenditure stands at a stable 11% of its total budget. The United Kingdom has often been accused of trailing behind its European counterparts on the drugs available at public expense. It is however, worth wondering if NICE really is the culprit on this latter issue. Although it plays a role in prioritising utilisation of the NHS's limited budget, it makes decisions centrally when health budgets are managed locally. PCTs receive funding based on their performance and the number of patients that they treat. There are thus disparities in different trusts' budgets and disparities in access to treatment for patients. PCTs do not always have the means to implement NICE's recommendations. The conundrum is that centralised intentions and decentralised capabilities, although both working towards the public good, sometimes conflict.

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NICE to Take Little Action After Examining Parliamentary Report

NICE to Take Little Action After Examining Parliamentary Report

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