Rationing of HIV drugs and other care is
already with us and looks set to get worse, writes Amanda Elliot
HIV
drug rationing is already with us. So says a recent THT survey that found
more than a third of clinicians restricting, or talking about restricting,
choice of antiretrovirals in HIV clinics.
In their Disturbing Symptoms report, THT are clear: “Our results show
us drug rationing is an increasing feature of HIV treatment, and urgently
needs further scrutiny.”
The charity calculates these restrictions could potentially affect more than
24,000 people living with HIV in the UK. These headline figures suggest cause
for concern, but what is really happening and how do doctors decide which
HIV drugs you get and which side effects you will be expected to put up with?
Because you’re worth it
HIV drug treatments are cost effective. At around £7,000 a year in the
UK, they are cheaper than kidney dialysis or treatments for comparable disease.
Thanks to effective therapies, many more people living with HIV can work,
pay taxes and even raise the next generation of workers.
Yet the cost of HIV meds has always been an issue. When the first proper HIV
drug, AZT, arrived activists successfully forced manufacturers Burroughs Wellcome
to cut its $7,000 price tag. As new HIV drugs became available, higher prices
were typically set to reflect innovative, life-saving therapies.
You may not care which name is on your blister pack if your CD4 count
is climbing or holding firm, or you have an undetectable viral load and suffer
few or no side effects. But, if you are one of the 25 per cent whose HIV drugs
fail because of resistance or unbearable side effects, the need for the widest
possible choice of drugs becomes critical.
Ten years of HAART have taught us one size does not fit all when it comes
to HIV therapy. If a regimen is failing or giving you intolerable diarrhoea
or peripheral neuropathy, the importance of drug choice is thrown into much
sharper focus.
Rationing; does it matter?
The good news is there are now over 25 HIV drugs licensed for use in the UK.
Most work well; some have proved more potent than others and most have side
effects of varying degrees of severity, tolerability and seriousness. Some
cannot be used together. But still, there are enough to allow HIV doctors
across the UK to put together highly potent combinations tailored to the clinical
and lifestyle needs of most people living with HIV needing therapy.
Thankfully, drug rationing in the UK does not (yet) dictate whether you get
therapy or not - unless of course you are an undocumented migrant with HIV.
It is more subtle. At stake is the ability of clinicians and drug companies
to tailor therapy as closely as possible to people’s clinical and lifestyle
needs so they can live long, well and productively.
Nothing new
Treatment advocate Simon Collins, of HIV i-base, says rationing has always
existed in the NHS, including for HIV: “It’s nothing new. Just
look at the waiting lists for New-Fill for facial lipoatrophy and what’s
happened to the availability of L-carnitine for peripheral neuropathy. It
used to be more widely prescribed but now I know of only one London clinic
where it is used and they can only prescribe it to existing patients.
“There isn’t widespread restriction of essential treatments. But
there are a lot of restrictions in terms of treatments options that are not
proactively offered by clinicians. The most active and informed patients probably
get what they want. But there isn’t the leeway to give everyone what
they might want,” he says.
UKC trustee Gus Cairns agrees: “We are unlikely to see any of the overt
rationing in HIV drugs seen with the breast cancer drug Herceptin. The impact
people fear especially is that less well-informed patients, who believe their
doctor will prescribe the best drug for them regardless of cost, will get
prescribed mildly and, in a few cases, seriously substandard regimens because
they are cheaper.”
Who decides?
The first and most powerful arbiter of whether any drug can be used in Europe
is the European Agency for the Evaluation of Medicinal Projects. This agency
also sets a ceiling price (list price) over which the drug companies cannot
charge. But across Europe the amount hospitals pay for HIV drugs below this
varies enormously depending on their purchasing power.
In the UK, BHIVA guidelines, which recommend treatment protocols based on
expert opinion informed by clinical trial results, carry great weight. Local
clinics also have guidelines based on what their doctors have experience of
prescribing and feel comfortable with. In the UK, guidelines are also issued
by a few large NHS purchasing consortia - and it is these guidelines that
are increasingly influenced by cost. They include the London HIV consortium
(providers across London) and Manchester’s managed clinical network.
Sometimes these groups can pack considerable punch.
Gus Cairns said: “This gives these often fairly ad-hoc groups a lot
of power to negotiate drug prices. Last year Gilead did not want to lower
its price for Truvada so the consortium issued an explicit threat not to prescribe
their drug and give everyone the B5701 abacavir hypersensitivity test and
prescribe Kivexa to everyone who didn’t have B5701.” A year on
and Truvada’s price is now approaching that of Kivexa.
New drugs
This year will see the system tested once again with the arrival in the UK
of several new and potentially expensive drugs including the experimental
integrase inhibitor, raltegravir. This new class of HIV drug has had remarkable
results in highly treatment experienced patients. Its apparent ability to
rapidly suppress viral load means it could also be extremely attractive for
first line therapy too. But if it is priced too high doctors will probably
stick with cheaper drugs.
When
cost makes a difference
One area where restrictions are already having an effect is in prescribing
the dual nuke Combivir (AZT and 3TC). This combo was recommended first-line
therapy by the BHIVA until it fell from grace in 2005. This was due to its
association with costly-to-treat fat loss in some patients. After that demotion,
observers expected prescriptions for Combivir to fall.
But Peter Sharrot, head pharmacist of the London HIV commissioners’
consortium, recently told colleagues that Combivir prescriptions weren’t
going down “as fast as we’d expected”. Last year AZT’s
patent expired, making it cheaper and along with its already cheap sister
drug, 3TC, it became financially attractive.
Simon Collins is unsurprised: “HIV doctors still prescribe AZT routinely
as first line because Combivir is cheap and easy.”
But Gus Cairns is concerned that BHIVA has so far insisted on keeping Combivir
in its current (2007) draft guidelines as a third NRTI (nuke)-backbone alternative.
“Will there be pressure to prescribe Combivir, despite the fact that
AZT causes lipoatrophy and severe anaemia in many patients?” he asks.
Collins said it was important BHIVA based their recommendations “on
the results of clinical trials, not on cost”.
“Efavirenz-based combinations are not the cheapest but they are the
recommended first-line therapies. UK guidelines were the first to caution
against using AZT in first-line therapy because of the risk of fat loss, while
the equivalent US guidelines still don’t refer to this as one of the
side effects.”
Why restrictions?
Over the past year hospitals across England and Wales have been forced to
make cuts across a range of services to make sure the NHS overall balance
its books by the end of this month. HIV services took their fair share of
hits, the knife falling variously on clinic staff, in-clinic counselling,
monitoring tests, access to appropriate mental health services and provision
of support medication. It is here, rather than on drug budgets, that people
with HIV have felt cuts most keenly. On the surface it seems drug budgets
were unaffected.
But HIV clinics have also been hit with unexpected and massive overspends
on their drug budgets. The THT survey found more than half of the clinicians
in the survey expected their drug budgets would be overspent by the end of
this financial year. More than a quarter could not predict whether they would
overspend or not.
This is a problem for wider HIV services, Gus Cairns points out: “Even
a one per cent NHS overspend is a lot money and creates a lot of publicity.
There is therefore no slack in the budget for pricier new drugs and huge pressure
to keep costs down.”
So what is going on? THT thinks PCTs are not planning properly for HIV services
and underestimating demand: “This unpredict- ability and the continuing
level of overspend on drugs raises questions about the quality of local planning
and the accuracy with which budgets correspond to levels of need The uncertainty
about drug budgets that has been a trend in the last three years has continued.
“Given that more than two in five responding PCTs indicated that they
had not undertaken a local sexual health needs assessment in the previous
three years, this mismatch between drugs budgets and the needs of local populations
is not surprising,” it concludes.
Under pressure
Cuts have hit hard in many places. A group of people with HIV in Southampton
petitioned their local Royal South Hants hospital after the trust’s
£26 million deficit led to cut backs at their clinic. These cutbacks
included losing their highly experienced HIV counsellor service, shortening
GUM clinic opening times and ending cross-hospital referrals. Now if an HIV
patient needs to see a non-HIV specialist they have to seek a referral through
their GP who may not know their status.
One patient told PN: “It’s difficult getting through on the phone
and our GUM clinic is closed Fridays due to a shortage of staff.”
Another said the loss of the counsellor was a “devastating blow”
that had left patients adrift without mental health support.
Another fed up patient said: “More often than not when you go to pick
your prescription up, there is something out of stock due to restrictions
on stockholding, which means that I have to come all the way back into the
hospital again... it costs time and money.”
Elsewhere, pressure to save money is having an effect. The Bloomsbury Clinic,
University College London’s HIV unit, is now suggesting patients stable
on therapy only have CD4 tests once a year - subject to agreement with their
doctor.
Another friend tells me his doctor was absolutely explicit about putting him
on the cheapest drug after he sought a change because his existing combo made
him excessively sick and gave him diarrhoea.
Resistance to resistance tests
Another form of rationing that directly influences prescribing is the lack
of routine resistance testing of people straight after they are diagnosed
and before they start HIV therapy. One Southampton activist was particularly
concerned that his local HIV clinic failed to do this.
“Resistance testing is inconsistent at the clinic. It should be routine
at the time of diagnosis, not only when your regime starts to fail when it
is a bit pointless.”
Collins agrees: “BHIVA has been clear on this since 2003: resistance
testing should be carried out at diagnosis and before starting therapy. It
is the one chance to find out which drugs are going to work and identify the
10-20 per cent who are resistant to at least one drug.”
Patient power
Given the subtle and complex nature of HIV drug rationing in the UK can people
with HIV do anything to ensure they receive the best treatments when they
need them?
“Patients should always ask about alternatives; for most people there
should be two or three options, especially when starting treatment. You should
not put up with side effects when there are alternatives. Ask for resistance
testing when diagnosed and before starting treatment or changing from one
that has failed,” says Collins.
PN treatments editor Robert Fieldhouse said: “Despite BHIVA guidelines
being explicit about when drug resistance testing is recommended, we’ve
plenty of evidence from the patient groups we work with across the UK that
in reality it’s a lottery dependent upon where you live.
“But compared to other patients we have a lot of autonomy; if your clinic
is not able to provide you with what you need, vote with your feet if you
can, and seek services elsewhere.”
Future
Treatment advocates have mixed feelings about the future. Gus Cairns is optimistic:
“We now have enough drugs that with reasonable adherence people can
have at least three, probably four bites of therapy, each of which could last
a decade before failure. It’s not like breast cancer and Herceptin or
Alzheimer’s and Aricept. We have drugs that work, we have quite a lot
of them, and that may drive prices down.”
But Robert Fieldhouse is alarmed: “In the future we may have far fewer
specialised HIV clinics, meaning people in more remote areas could have to
travel further for their care. Less access to your consultant may be acceptable
if you’re stable on treatment but it’s not if your care needs
are greater.
“Ten years ago there we had a postcode lottery for access to monitoring
tests such as viral load testing. Patients would travel to the Chelsea and
Westminster Hospital from all around the UK to get their viral load done.
This situation seems preposterous now. Let’s not risk turning back the
clock.
“When HIV funding lost its ring-fencing, we clearly did not do enough
to voice the need to keep it. People living with HIV may be worse off for
HIV having been integrated into a broader sexual health policy agenda. Having
HIV is not like simply having the clap. Now we are paying the price as Choosing
Health money is diverted to pay for the competing concerns of the NHS.
“We should focus on the lives HIV treatments have saved and the NHS
beds which drug therapy has freed up. HIV treatment is one of the major successes
of modern medicine.
“The future, far from being orange, has a distinctly green hue. People
with HIV diagnosed in the future will look back with envy at the services
available to those of us living with HIV today.
“The government is actively against postcode prescribing. BHIVA has
just published standards for clinical care that aim to ensure everyone with
HIV gets the same care regardless of where they live.
“But next year the government begin introducing payment by results,
a process by which hospitals will be paid a fixed price for every treatment
they deliver, and be penalised if they exceed that price. Cuts are likely
to be an important way hospitals attempt to maintain their competitiveness.
“At last year’s BHIVA conference, Dr Jane Anderson from the Homerton
told me: ‘We need more activist doctors’, and she’s absolutely
right. But the NHS is sometimes less good at listening to its staff and rather
better at listening to the patients. Do yourself and your clinic a favour;
get involved and speak up for HIV services.”
• Supported by an unrestricted educational grant from Abbott
Virology
• Latest BHIVA guidelines can be viewed at www.bhiva.org
• Get Disturbing Symptoms from www.tht.org.uk/informationresources/publications
