London HIV patients will start treatment with Kivexa (abacavir and 3TC) rather than
tenofovir and FTC for at least the next two years in a bid to save money, the
NHS in London
Similarly, if a patient needs a protease inhibitor for the
first time, they will start with atazanavir/ritonavir rather than any other
boosted protease inhibitor.
The change in prescribing practice for first-line treatment will
not initially affect patients on current regimens but will be applied to new
patients and to patients who need to change to a second-line protease
However, patients already taking a protease inhibitor other
than atazanavir will be reviewed to see whether they can be switched to
Patients starting treatment will still be offered efavirenz as the first option alongside two nucleoside reverse transcriptase inhibitors (NRTIs), with nevirapine or atazanavir/ritonavir as alternative options.
The decision was made by the London HIV Consortium Drugs
& Treatments sub-group after primary care trusts in London told HIV prescribers that their budget would not grow this year. This meant that hospitals needed to save £9 million on drugs in order to accommodate other HIV
patient and clinic costs. HIV patient numbers rose by 5.3% in London in 2009 alone.
These changes are the result of a new two-year purchasing
agreement between the London HIV Consortium (LHC) and the drug companies. The
LHC represents the majority of London’s hospital
and primary care trusts and, since 47% of people with HIV accessing care in England live in London, has considerable negotiating power
when it comes to the prices paid for drugs.
Although a maximum ‘list price’ is set by each country for
drugs licensed in Europe, an aspect of HIV care that gets little scrutiny is
that NHS bodies ranging from individual trusts to large consortia like the LHC
are free to negotiate their own deals with each drug supplier. The LHC has
managed over the years, due to its economic position, to pay about 25% below
list price for antiretrovirals.
Although in terms of cost per lives saved HIV treatment is a
cost-effective intervention, its sheer cost to the NHS these days is
staggering: in London, with a higher HIV prevalence than the rest of the
country, 19% of the entire London NHS drugs budget in 2009 was spent on
antiretrovirals and 29% of the budget for specialist conditions.
Clinicians at all hospitals in London agreed the changes after a number of
companies submitted significantly lower bids. It is understood that
substantially lower prices would be offered in return for a guaranteed volume
of purchase, an approach similar to the deals arranged by the Clinton HIV/AIDS
Initiative to achieve very large reductions in the price of generic
antiretroviral drugs for developing countries.
The changes are based on current clinical practice and no
patient will be forced to take a drug with significant side-effects or which is
detrimental to their quality of life. They are also in accordance with the most
guidelines issued by the British HIV Association (BHIVA),1
although these guidelines are now three years old and new ones are expected
later this year.
They are, however, bound to cause some controversy. The
biggest area of concern surrounds the use of abacavir. In some large studies
such as the D:A:D
and the SMART
the use of abacavir was found to be associated with a 70 to 80% increase in the
number of heart attacks in patients, other studies have found no
pooled analysis of randomised controlled trials published at this
February’s Conference on Retroviruses and Opportunistic Infections5
found no increased risk associated with abacavir. The difference may be due to
the fact that large cohort studies like D:A:D cannot establish why some patients took one regimen
rather than another and may therefore miss a factor that impacted on both
health and choice of drug regimen.
There is also evidence that abacavir may
not be as potent as tenofovir in suppressing HIV in patients with a high
and with a low CD4 count7 although again this evidence is
Because of these concerns, tenofovir instead of abacavir
will be prescribed to patients with a viral load over 100,000 or with a high
heart attack risk score (over 10% in the next ten years). It will also be
prescribed for patients with chronic hepatitis B infection or those about to
start hepatitis C treatment.
In terms of whether having to take two pills a day impacts
on adherence or health, one
study presented last year found a difference between one- and two-pill
regimens, but this has not been found in other studies, and this study did not
control for the reasons why patients may not have been on one pill.9
In terms of protease inhibitors, atazanavir does not raise
blood lipids (fats) as much as other protease inhibitors and is taken as one
capsule, once a day. It has been linked to kidney stones in a few patients and
causes a harmless but sometimes marked form of jaundice; darunavir (Prezista) is recommended as the
alternative for patients who cannot tolerate atazanavir or have resistance to
The new agreement also imposes tight conditions on the use
of raltegravir, which will be reserved for short-term use in first-line
treatment only for patients with very complex drug interactions, or for pregnant
women who are diagnosed with HIV late in pregnancy, and where there is a need
for very rapid viral load reduction. As soon as the clinical need has passed,
the patient will be switched to another, less expensive drug.
Raltegravir use will also be permitted in patients with
extensive drug resistance, and in those with long-term drug interaction issues
which preclude the use of a boosted protease inhibitor or a non-nucleoside
reverse transcriptase inhibitor.
The purchasing agreement has been signed by London’s lead HIV consultants
and holds until April 2013. It can be changed if new clinical evidence comes
along that changes prescription guidelines but it cannot now be altered if a
company makes a new price offer.
The LHC and its parent body the London Specialised
Commissioning Group can withhold all or
part of the HIV drugs budget from any clinic seen to fail to achieve the
cost savings expected, though commissioners stressed that this was a "final resort", and would be seeking to work in partnership with clinics to meet the requirements of the agreement.
The LHC plans to audit the clinical effect of these changes in
prescribing practice on a three-monthly basis in order to determine what effect
they have on patient outcomes.