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.
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.
