[Viva] Fwd: CATIE-News - Financial stress: impact on HIV adherence, HCV, and prescribing patterns

[Tami Starlight]

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    CATIE-News - Bite-sized HIV/AIDS news bulletins
       CATIE-News - Financial stress--impact on HIV adherence, HCV, and
prescribing patterns

Adherence—taking medicines exactly as prescribed—is critical to the success
of medications and treating illness, particularly infections. In order for
potent combination anti-HIV therapy (commonly called ART or HAART) to
result in sustained improvement in health, a very high rate of adherence—at
least 95%—is required. There are many factors that can affect adherence in
people with HIV and other conditions, including depression,
medication-related side effects and competing priorities such as substance
use.

Cost issues have been identified as one potential barrier that can affect
adherence to ART—certainly this is the case in low- and middle-income
countries. In contrast, in high-income countries such as Canada, Australia,
the U.S. and Western Europe, the cost of HIV treatment is heavily
subsidized by governments. Thus the cost of care and treatment is not
expected to affect adherence, as in many high-income countries universal
health care is available to citizens and permanent residents.

In high-income countries, a large proportion of HIV-positive people are on
disability support payments because they are unable to work (as such, their
income is low). It is likely that they experience financial stress, though
how this might affect adherence to HIV treatment has not been explored in
detail until recently.

Australia’s leading clinic for HIV, other infections and immunological
disorders is at St. Vincent’s Hospital in Sydney. There, researchers keep
track of Australia’s HIV epidemic. They noticed that for the past several
years about 3% of Australian HIV-positive patients appeared to be dropping
out of care. Motivated by this and also by reports from their patients
about financial stress, a research team at the hospital launched a study to
explore the issue of financial stress and adherence within a larger survey
about health and care.

The Sydney team found that a significant proportion of patients were
experiencing financial stress and were delaying the purchase of medicines.
Furthermore, some patients disclosed that as a result of financial stress
they had stopped taking and/or buying prescribed medicines. Patients also
disclosed that the cost of transportation to the HIV clinic was a financial
barrier. Researchers also found that transportation costs had caused some
patients to interrupt ART—a decision that can be fraught with serious
health consequences.

The cost of health care is something that is drawing concern not only at
the individual level but also at the regional and national level in many
countries. Already in Western Europe, much of which is experiencing a
recession, proposals are being floated to further reduce the costs of
treatment, including the use of simplified anti-HIV regimens. Such
proposals may become more widely discussed in the future if the
financial-economic crisis continues.
 Study details

Researchers invited clinic patients to participate in an anonymous survey
about care and treatment issues, including financial stress. A total of 500
people completed the survey. Limited information was available on the
profile of participants, as follows:

   - 96% male, 4% female
   - average age – 52 years
   - 67% were HIV positive
   - 10% had viral hepatitis only
   - 23% had an immunological disorder or other infectious disease
   - most patients (76%) attended the clinic every three or six months

 Results – Focus on HIV-positive patients

Among the 335 HIV-positive patients, the following proportion acknowledged
problems meeting pharmacy-dispensing costs as follows:

   - 20% (65 participants) stated that paying dispensing fees was difficult
   or very difficult

 Participants acknowledged the cost of paying for transport to meet clinic
appointments with the following impacts:

   - 14% disclosed that they delayed purchasing prescribed medicines
   - 9% disclosed that they had stopped taking medicines

 Of the 65 participants who stated that they had a degree of difficulty
paying pharmacy costs, nearly 30% stopped taking their medicines. In
contrast, of the remaining 270 HIV-positive patients who did not disclose
financial stress, only 4% said that they stopped taking medicines (for
unknown reasons). This difference in rates of discontinuation was
statistically significant.
 Talking about money

At clinic visits, doctors often asked patients about their health and
medicines. For instance, 60% of participants reported that they were always
or frequently asked if they were experiencing side effects because of
medication. Only about 5% were often asked if they had difficulty meeting
the costs of medicines.
 Limitations

The design of the study was cross-sectional in nature. This is analogous to
a snapshot taken at one point in time. Cross-sectional studies are cheaper,
faster and simpler than other types of studies (such as those that run for
many years). Cross-sectional studies cannot provide definitive answers to
research questions. However, their findings can be explored in studies of a
more complex (and expensive) design.

Another limitation of the present study is that the vast majority of
participants were male. The research team noted that women “generally earn
less money than men,” and so financial stress on them would likely have
been greater.

Despite these limitations, the Australian study is very important and will
have a major impact on future studies of adherence in high-income countries.
 Money and access

Co-payments such as dispensing fees are not unique to Australia. In Canada,
some pharmacies waive such payments and some provincial and territorial
health plans as well as private insurers cover all or part of such fees.
Also, the cost of medicines to treat catastrophic illnesses such as HIV and
hepatitis C virus (HCV) infection is generally covered by Canada’s
provinces and territories, though specific coverage of particular drugs may
come with restrictions that can vary from one province or territory to
another.

A 2007 survey of 5,723 Canadians found that about 10% reported
non-adherence to prescription medicines because of drug costs. People most
likely to report non-adherence to medicines because of cost generally had
the following profile:

   - poor health
   - low income
   - no drug payment insurance

 Issues related to hepatitis C virus

In 2008, researchers in Halifax, Nova Scotia, interviewed 50 participants
with HCV infection. They found that participants took a range of prescribed
medicines to treat multiple conditions, including the following:

   - mental health issues, particularly anxiety and depression
   - higher-than-normal blood pressure
   - inflammation

 Nearly 60% of participants were concerned about financial stress and their
ability to pay for prescribed medicines. Participants developed a variety
of strategies to cope, including borrowing money, delaying the purchase of
drugs and asking their health care provider for a cheaper substitute for an
expensive drug. Some participants were uncomfortable discussing cost issues
with their physician and instead sought such discussions with their
pharmacist.

Many participants also purchased supplements and complementary therapies,
which increased their financial stress.
 Cost and adherence in HIV-negative people

A recent American study in HIV-negative people who did not have severe
mental health conditions or engage in substance use found that adherence to
medications for chronic conditions such as cardiovascular disease and
diabetes was affected by out-of-pocket costs. In the same study,
researchers stated that they found “robust evidence that reduced
out-of-pocket expenses improved medication adherence across clinical
conditions.”
 Changes to therapy – the London experience

The UK has been experiencing a severe recession for several years. As a
result of rising health care costs and overall budget cuts, health spending
is under significant financial stress. In 2010, the cost of ART for the
30,000 HIV-positive people living in London was approximately £170 million
($267 million). Each year there are approximately 1,800 new HIV-positive
people, so costs will rise. The local health commissioners (who oversee
health care spending) brought together key stakeholders, including
clinicians and patient advocates, and created a subgroup tasked with
reducing the cost of buying ART. Whatever course of action the subgroup
took had to be in line with HIV treatment guidelines and the results should
not negatively impact the health of patients. The following fundamental
principles guided the decisions of the subgroup:

“The freedom of the individual clinician to prescribe the most appropriate
drug for the patient and full involvement of the person living with HIV in
treatment decision-making processes [was] confirmed as [a fundamental
principle].”

The subgroup created a multidisciplinary team of doctors, health
commissioners, pharmacists, public health workers and patient advocates to
meet with pharmaceutical companies. This team invited companies to submit
bids for providing discounted ART. The winning bid resulted in doctors and
patients considering using following drugs when initiating ART:

   - nukes: Kivexa – a fixed-dose formulation of abacavir + 3TC
   - protease inhibitors: atazanavir (Reyataz) + ritonavir (Norvir)

 These drugs will be supplied at reduced cost for two years. During this
time, spending will be audited to assess savings, estimated to be between
£8 million and £10 million (between $13 million and $16 million). Also,
auditing of health outcomes of HIV-positive patients will be done to ensure
that quality of care is maintained.
 Other ideas for reducing costs

In the UK, a group of researchers has published a paper with ideas of how
the cost of HIV treatment may be further cut. They proposed two broad
themes:

   - substituting generic formulations of medicines once the patent on the
   branded formulation has expired
   - simplifying treatment by reducing the number of drugs in a regimen;
   specifically, relying on combinations that use a combination of ritonavir
   plus another protease inhibitor called darunavir (Prezista). Such greatly
   simplified combinations are called protease inhibitor monotherapy.

 Most trials of protease inhibitor monotherapy using either
ritonavir-lopinavir (in Kaletra) or darunavir-ritonavir have enrolled
carefully selected participants who had little or no history of treatment
failure. Furthermore, participants are usually very motivated and highly
adherent. All this is to say that treatment simplification to protease
inhibitor monotherapy will not be suitable for every HIV-positive patient.

In general, protease inhibitor monotherapy regimens do not have the same
effectiveness as currently recommended combinations of ART.

Another issue with HIV treatment simplification is that of the health of
the brain and spinal cord—the central nervous system (CNS). HIV-infected
cells of the immune system reside within the CNS. Some anti-HIV drugs have
difficulty penetrating the CNS, and simplified therapy raises a concern of
insufficient suppression of HIV in the CNS. So care needs to be taken when
considering or using such regimens, particularly their long-term impact on
neurocognitive health. Perhaps for these and other reasons, protease
inhibitor monotherapy is not generally recommended in major HIV treatment
guidelines. An upcoming *CATIE News* bulletin will explore recent reports
of injury to brain cells detected in some HIV-positive people who were
using protease inhibitor monotherapy.
 The looming future

The International Monetary Fund (IMF) has predicted a period of slow
economic growth for many countries in the short-term and medium-term. This
means that financial stress at the individual and institutional level may
become an increasing concern. Researchers who aim to assess adherence to
HIV or HCV therapy need to take financial stress into account in future
studies, particularly when such studies are done in high-income countries.
At the institutional level, agencies that subsidize the cost of HIV
treatment (and other medicines) will increasingly be seeking a reduction in
costs. Doctors and pharmacists may also need to take financial stress into
account when prescribing medicines.

*—Sean R. Hosein*

REFERENCES:

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   antiretroviral therapy promotes residual HIV-1 replication in the absence
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   3. Schwimmer EJ, Rosen DL, Sista P, et al. Interventions to improve
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   6. Roehr B. Cost keeps one in 10 Canadians from filling prescription. *
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