The Richards Review of NHS medicines access has permitted top-ups and Health Secretary Alan Johnson announced that he was accepting all 14 recommendations of cancer czar Professor Mike Richards' report Improving Access To Medicines For NHS Patients (see list below).

Alan Johnson also announced with immediate effect the end of the ban on NHS treatment for those who choose to pay for private care or drugs not offered on the NHS - however, the private care must be offered in a physically separated ward or indeed hospital, used exclusively for private care wherever possible, and should result in no additional use of NHS resources.

Johnson summarised the proposals as likely to “substantially widen access to new drugs, and reduce the need for private payment”, emphasising repeatedly that private care should never be subsidised by NHS funds.

NHS implications
The financial implications of expensive new end-of-life drugs hitting the NHS formulary will be obvious, and concern primary carte trust (PCT) finance directors as the slowdown in health spending growth nears. As regards the exception decisions made on non-NICE approved drugs or treatments, PCTs will be “encouraged to work together to make proactive commissioning decisions”, co-ordinated by the region-wide strategic health authorities (SHAs).

Flexible pricing
The pharmaceutical industry is in discussions with the DH over risk-sharing arrangements for new products, such that initial prices to the NHS will be low, with provisions to raise them if medicines prove effective in real populations. Downwards pressure on high prices for new-to-market products is therefore delayed, though clearly (and reasonably enough, should sufficient evidence emerge) not eliminated.

The Richards Review recommendations are:
1. The measures the Government is already taking to improve the timeliness of the NICE decision-making process are extremely welcome and should be strongly supported. The DH and NICE should publish an update on the timelines for making these important commitments
2. The DH should urgently consider how PCTs can be encouraged to work together to make proactive commissioning decisions. Consideration should be given to whether collaborative processes already developed, such as in the North-East for cancer drugs, could be used as a model.
3. The commitment in the draft NHS Constitution to ensure transparency in PCT decision-making and the resulting work being undertaken by the DH to support PCTs in delivering this, is extremely welcome. The Government should set out as soon as possible more detailed plans for how it will achieve the commitment in the NHS Constitution, including the timescale for this work.
4. In developing collaborative arrangements for decision-making, the Government should also consider how PCTs can be better supported to make decisions on funding off-label drugs, whether ads a matter of po0licy or on an exception basis.
5. The DH should work:
with NICE to assess urgently what affordable measures could be taken to make available drugs used near the end of life that do not meet the cost-effectiveness criteria currently applied to all drugs;
and with the pharmaceutical industry in the context of the current Pharmaceutical Pricing Regulation Scheme (PPRS) negotiations to promote more flexible approaches to the pricing and availability of new drugs. This will require partnership working with the pharmaceutical industry an greater flexibility in approach from all parties
6. The DH should urgently undertake further work to investigate the extent and causes of international variation in drug usage.
7. The DH should clarify the policy on how the NHS should handle the situation where a patient wishes to purchase additional treatment. The objective should be to ensure consistency in practice across the NHS.
8. The DH should make clear that no patient should lose their entitlement to NHS care they would otherwise have received, simply because they opt to purchase additional treatment for their condition
9. The Government should make clear that:
clinicians should exhaust all reasonable avenues for securing NHS funding before a patient considers whether to purchase additional drugs
patients should be able to receive additional private drugs as long as these are delivered separately from the NHS elements of their care, and
providers should establish clear clinical governance arrangements to ensure that patients who do elect to purchase additional private treatment receive good continuity of care
10. SHAs, working where appropriate through cancer networks, should ensure that local policies are developed to ensure that any revised guidance issued by the Government is implemented properly. This might include using a designated hospital with private facilities for all patients wishing to purchase additional drugs, making use of homecare provision or designating an area of an NHS hospital for the delivery of privately funded treatment
11. The DH should take a lead on commissioning a national audit of demand for unfunded drugs and on the outcome of treatment, working closely with professional organisations and NHS managers
12. Doctors who are likely to have conversations with patients about treatments that are not routinely funded on the NHS should ensure that they have the necessary knowledge and skills to communicate complex information effectively and in a balanced way. This will help patients to make informed assessments about the balance of risk, cost and benefit involved in any potential treatment
The DH should commission a training programme for clinicians to enhance the quality of discussion about these difficult issues
Relevant Royal Colleges should consider how assessment of communications skills could best be incorporated into recertification processes
13. The DH should consider how patients could best be given access to balanced written information on the benefits, toxicities and where appropriate, costs of novel treatments, especially those given to patients near the end of life
14. In replying to this Review, the Government should confirm how situations where patients wish to purchase additional non-drug interventions should be handled.

Three types of drugs
Professor Richards explained that his review had grouped the drugs without NICE guidance into three broad categories: those undergoing NICE appraisal; those being used ‘off-label’ – i.e. outside the strict terms of their licence, but usually for an allied health condition; and those where a clinician believes there is a truly exceptional case to try a drug for a patient.

The tension around the issue of top-ups – the arguments in favour of individual autonomy against those for equity and solidarity – had been ever-present among those who gave evidence to his review, but Richards stressed that the overwhelming response had been that the outcome should not lead to a ‘two-tier’ NHS system.

He emphasised that his proposals were a two-part package – firstly, about improving access to high-cost medicines on the NHS, and secondly, establishing with clarity and fairness how to proceed in the cases where people want to pay for treatments the NHS – even with a more generous cost-effectiveness threshold – will not fund.

As well as the resistance to a two-tier NHS (disqualifying the idea of ‘NHS top-ups’), Richards had found public opinion equally strongly set against denying NHS care to those who chose to go outside the NHS. He clearly emphasised the need for cear and physical separation of NHS-delivered care and private, top-up care

NICE to raise price per end-of-life QALY
Chair of NICE, Professor Sir Michael Rawlins started by saying that NICE “has long-recognised that society places great value on extending the life for those with life-threatening illnesses”, noting various NICE-approved drugs that cost well over the usual £30,000 / quality-adjusted life year (QALY) threshold.

He acknowledged the difficulty of making comparable decisions for end-of-life treatments, and outlined NICE’s consultation on a new appraisal process for rarer medicines - likely to be used on no more that 7,000 patients per year in cases of terminal illness and where life expectancy is unlikely to be increased by more than two years. In these cases, the £30,000 QALY threshold would no longer predominate (see accompanying story on this elert) .

Rawlins emphasised that careful data collection and review would be used in each case to ensure that the promised benefits from clinical trials were being seen in ‘real-world’ usage.