Insurers spending millions on drugs with an eye on medical inflation
NHS patients seeking access to cancer drugs continue to face a postcode lottery, with the proportion of funding requests approved ranging from 0% to 100% across England, according to a Health Insurance investigation, carried out under the Freedom of Information Act.
We asked England’s 152 primary care trusts (PCTs) how many exceptional case funding requests for cancer drugs they received in 2009. These requests are made by patients or doctors seeking access to a treatment not routinely funded on the NHS. This includes cancer drugs not yet approved, or explicitly not recommended, by the National Institute for Health and Clinical Excellence (NICE), the independent body which makes decisions about what treatments the NHS should fund, based on their clinical and cost effectiveness.
Of the 122 PCTs who responded to our questions, a third (41) approved 50% or less of the requests for cancer drugs they received in 2009. However, 18 approved every request they received. The number of requests received by each PCT also varies enormously, from none to 112.
Professor Karol Sikora, medical director of CancerPartnersUK, who continues to work in the NHS, described the variation in the proportion of requests approved as “staggering”.
“[The response to requests] varies enormously but if you don’t ask you don’t get,” he said. “It’s very much the type of patient. The elderly and the poor on the whole don’t bother. I suspect that the appeals process is the preserve of white, middle-class, educated patients that can spend hours on the phone and fill in the blurb about why they are exceptional very well. This is patently unfair.”
David Stout, PCT network director at the NHS Confederation, which represents NHS organisations, said the research showed that the number of requests received by PCTs had reduced since two years ago when some PCTs received “hundreds and hundreds”.
When asked about private medical insurers’ responses to requests for cancer drug funding, Professor Sikora said he had been “so far mostly successful”.
“Most insurers are very reasonable and are quite right to query,” he said. “Most of their claims advisers seem knowledgeable, pleasant and easy to deal with, the antithesis of most PCT bureaucrats. The usual restriction – which is fair – is that I assess the patient after two months of therapy for response then make another request.”
Insurers contacted by Health Insurance stressed that they routinely fund drugs not approved for use on the NHS by NICE, but also outlined challenges not dissimilar to those faced by PCTs.
The three largest health insurers in the UK, Bupa, AXA PPP healthcare and Aviva UK Health will all fund drugs that have a licence from the European Medicines Agency, within the terms of that licence. This will include drugs not yet approved for use on the NHS.
“Bupa makes decisions regarding the funding of drugs in a similar way to NICE,” said Dr Katrina Herren, medical director at Bupa Health and Wellbeing. “However, Bupa’s decision time for new therapies is 48 hours. In addition, we look at clinical indication in isolation and do not carry out a health economics assessment. This means we usually fund drugs ahead of NICE and we fund a wide range of cancer chemotherapeutic agents”.
However, all three insurers pointed out that some limitations apply. Members may choose a policy that excludes cancer or will cover a limited period of treatment. Fergus Craig, commercial director at AXA PPP healthcare, said that most AXA customers selected a policy that would pay for cancer treatment up to 12 months. Aviva covers targeted drug therapies treatment for up to 12 months per condition although corporate customers can increase this to three years, reduce it to six months or exclude targeted drug therapies altogether.
Like PCTs, they may also turn down requests to use drugs outside the terms of their licence (see ‘Why do cancer patients’ box opposite). Dr Doug Wright, principal clinical consultant at Aviva UK Health, said such requests would be decided on a “case by case basis”.
“It may be a very rare tumour which can only respond to a certain drug,” he explained. “In this case, our clinical team will research the options fully and may well recommend cover outside of the licensing.”
Claims for cancer drugs are a growing cost for private medical insurers. AXA PPP healthcare spent £16m on just two drugs (Herceptin and Avastin) in 2009 and £35m overall while Bupa’s spending on cancer has gone up 40% in five years, much as result of funding targeted therapies.
THE QUESTIONS WE PUT TO ENGLAND’S PRIMARY CARE TRUSTS
We asked England’s 152 primary care trusts – the organisations which hold NHS budgets at a local level and commission services – the following questions under the Freedom of Information Act and 122 responded. We asked:
1. HOW MANY EXCEPTIONAL CASE FUNDING REQUESTS IN 2009 RELATED TO CANCER DRUGS?
2. WHAT PERCENTAGE OF THESE REQUESTS WERE GRANTED?
A PARTY POLITICAL ISSUE
The funding of new cancer treatments was raised onto the political agenda in the build-up to the general election. The Conservative Party has proposed removing the power to make decisions on the funding of off-label drugs from PCTs and passing it to clinical experts at strategic health authorities (NHS bodies responsible for large regions of England). It has also proposed establishing a £200m Cancer Drugs Fund which it claims will ensure that no cancer patient is refused access to drugs that have been licensed since 2005 and recommended by their doctor. In the long-term it has pledged to reform the way pharmaceutical companies are paid for drugs.
WHY DO CANCER PATIENTS HAVE TO MAKE REQUESTS FOR DRUGS?
1. Their doctor may prescribe a drug without a licence Most new cancer drugs must be licensed by the European Medicines Agency, which assesses their safety and efficacy. Until a new drug is licensed it cannot be assessed by NICE or widely prescribed within the NHS. The licence will be for a specific use of the drug, for example, to treat a particular form of cancer. However, a doctor may recommend an “off-label” use of the drug. For example, he may wish to use it to treat a different kind of cancer.
2. NICE may not yet have issued guidance on the drug Once NICE has issued guidance on a drug, PCTs have three months in which to make funding available to implement it. However, there is a time lag between a drug being licensed and NICE producing guidance. The government has said that in 2010 this should be reduced to six months.
3. NICE may have approved the drug but their doctor may wish to use it outside the terms of this guidance NICE guidance will either approve a drug for use on the NHS or decline it. However, the approval is also subject to certain criteria being met. For example, it will be approved for a certain type of cancer and perhaps only for patients whose cancer has progressed to a certain point. If a doctor wants to give the drug to a patient who falls outside this criteria they may need to appeal to the PCT in order to secure funding.
APPLYING TO A PCT FOR EXCEPTIONAL FUNDING: THE STEPS
1. Written request to PCT, usually made by specialist or GP on patient’s behalf
2. PCT confirms application received and date for hearing
3. Decision made by panel of PCT board members – patient and doctor may be permitted to attend
4. Decision made within set period of time (usually four to eight weeks, but can be much quicker for urgent cases)
5. Patient and doctor receives written decision
6. If request denied an appeal can be made (usually must be made within 28 days)
LIVER CANCER: A CASE STUDY
Sorafenib is a drug which can be used to treat advanced liver cancer. In November 2009 NICE issued draft guidance on using sorafenib in patients for whom surgery or therapies in the region where the cancer arose have failed or are not suitable. At this time it did NOT recommend the drug. The chief executive of NICE, Andrew Dillon, said that it did not provide enough benefit to patients to justify its high cost and that NHS money could be spent on “better value” cancer treatments.
Final guidance is expected to be published this year. In the meantime, PCTs have been told to make decisions locally. Health Insurance research shows that while some are approving the use of sorafenib for the treatment of liver cancer, others are not. In 2009:
Camden and Hertfordshire both rejected four requests
Bromley rejected two requests
Coventry, Brighton & Hove and Manchester all rejected a request
Northamptonshire, Stockport, Redbridge and Torbay Care Trust each approved a request