Last year, journalist Adam Wishart approached me about taking part in a television documentary, The Price of Life, which aired on BBC2 last week.
It followed the process by which US company Celgene pitched its drug lenalidomide (Revlimid), a derivative of thalidomide, to the National Institute for Health and Clinical Excellence as a fourth line cancer treatment for end stage multiple myeloma.
NICE estimated lenalidomide cost £44,000 per QALY, well above its threshold of £35,000. The panel faced a tough decision as compared with many drugs, lenalidomide does at least appear to buy about another year at the end of life.
The chief executive of Myeloma UK made an impassioned plea on behalf of patients, but the panel stuck to the science. This is a very expensive drug which may ameliorate some symptoms, but does not change the ultimate outcome. Patients were devastated. Throughout the film, they talk about the drug as lifesaving.
On Christmas Eve 2008, NICE announced that the QALY threshold for drugs at the end of life would be raised to £70,000. The appeal which Celgene had launched now had a real chance of success.
The company proposed picking up treatment costs of any patient still alive after two years; a very limited risk. NICE was given no option to propose alternative pricing arrangements, and the Department of Health appears to have made no attempt to seek a price reduction. The NICE panel was hung nine votes to nine and the drug approved on the casting vote of the panel’s chair.
The NHS has an enormous budget, but we should not underestimate the impact such decisions have on prioritisation and investment. In Birmingham East and North primary care trust, about seven people will benefit from this ruling - a drug cost of around £1m.
This year, we have a range of new investments planned, largely focused on tackling premature mortality, supporting active intervention and management of long term conditions, and positive intervention at the end of life. The £1m requirement for lenalidomide will impact on all of them.
We lose an infant classroom of children each year. We planned to redesign maternity care to identify women at high risk of losing their child, so as to support them to make healthy choices about food, smoking and alcohol, and attracting and retaining them in antenatal care so we can track the baby’s development and spot problems early.
Cancer is typically a disease of older people, while premature mortality in Birmingham is driven by heart disease and stroke. This year we planned to increase investment in cardiac drugs, screening and treatment of cardiovascular disease and thrombolysis for stroke.
Over the past few years, investment in new cancer drugs has taken a lion’s share of growth money in cancer at the expense of investing in educating people about when to be worried and seek help, and screening to spot the disease early when we may be able to operate and treat it successfully.
We also need to invest more in the new generation of radiotherapy. But we shall not be able to afford these “lifesaving” treatments, if the priority is always the new drug, which too often adds just a few months at the end of life.
And perhaps, most upsetting of all, at least 2,700 local people each year would like to die at home, but we have only been able to support about 760 people to do so. This year we wanted to expand our hospice and end of life service, but lenalidomide might have to take that money.
NICE was set up to help the NHS make decisions about which new technology to adopt. This is a difficult and unpopular process. When the committee decides that a drug is not effective enough for its price, it will be challenged and attacked by drug companies and patient groups. When it approves a drug which may have only limited effectiveness for a small number of people, we in the NHS will complain.
The most heart-rending moment in the documentary is when Adam Wishart goes back to see one of the patients to celebrate NICE approving the drug, only to discover that she has died.
Her family are deeply upset. Despite being in the last phase of her illness, she and her family had clung to the belief that lenalidomide would save her. It is ironic that this drug may condemn many other families and patients to an equally traumatic death, by diverting resources from the right support at the end of life, and deferring the conversation with patient and family about the inevitable outcome of their disease.
World class commissioning requires that primary care trusts prioritise investment, requiring a concern with the relative impact of expenditure and the value of its return.
We are also expected to be local leaders of the NHS, and thus to engage in a more mature debate with public and clinicians about where our money should go.
Perhaps a real sign that “all bets are off” will be when NICE and PCTs are supported to see through the really difficult decisions and be supported when we say “No”.