hiv drug costs and effectiveness. are we going in the wrong direction?

An observational cohort study looked at patients on antiretroviral therapy (ART) for HIV, finding that some of the most effective yet cheapest regimens are not being recommended for use today (see hiv drug costs AIDS2016​ in dropbox, or Eaton EF. AIDS 2016; 30: 2215). I have included the 340b pharmacy pricing, which is the reduced federal pricing available since 1992 to eligible health care organizations (mostly Federally-funded clinics and public hospitals) vs the AWP, average wholesale price, used in private pharmacies. details:

--491 patients (mean age 36, 83% men, 61% African-American) initiating anti-retroviral therapy (ART) between 2007-2013, at the University of Alabama at Birmingham

--durability (time from regimen initiation to discontinuation), used as a surrogate for the combo of effectiveness and tolerability.

--results for the 5 most common ART regimens used during that time:

    --TDF/FTC (tenofovir disoproxil fumarate/emtricitabine) with efavirenz (atripla): durability 40.1 months; 340b price $726.26

    --TDF/FTC with raltegravir: durability 47.8 months (longest); 340b price $1080.60

    --TDF/FTC with darunavir/ritonavir: durability 47.8 months (longest); 340b price $​1153.00

    --TDF/FTC with atazanavir/ritonavir: durability 31.9 months (shortest); 340b price $1070.88

    --TDF/FTC with rilpivirine: durability 36.3 months; 340b price $917.50

--overall, combining durability with price, the efavirenz (atripla) regimen dominated, with the rilpivirine one following closely behind

commentary:

--several of the older treatments have been downgraded in recent guidelines, including atripla (TDF/FTC/EFV) for neuropsych effects of dizziness, anxiety, lack of concentration, vivid dreams and suicidality (though large observational studies have not found increased suicidality) and complera (TDF/FTC/rilpivirine) since it is less effective in those with high HIV viral loads. 

--The new guidelines do attach a comment that we should consider cost in determining the regimen, but they formally downgraded the cheapest regimens. For a review of the guidelines, see http://gmodestmedblogs.blogspot.com/2016/07/2016-hiv-treatment-guidelines.html  for the Intl Antiviral Society--USA guidelines, or go to https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf for the DHHS updated guidelines (these 2 do differ slightly, with the first one suggesting the TAF (tenofovir alafenamide) regimens only, but the first-line regimens are basically the most expensive of the list below)

--i did get today's 340b pharmacy costs for common HIV meds, for a 30-day supply (note: the 340b cost is much lower and does not track well with the AWP)

    --atripla (TDF/FTC/EFV): $688.93 (generic is still not available, but should be soon, which should drive down this cost)

    --truvada (TDF/FTC): $428.61 (generic is still not available, but should be soon, which should drive down this cost)

    --raltegravir: $591.58

    --descovy (TAF/FTC): $428.61 (ie, same price as brand-name truvada, and probably because the drug company wants us to continue with this product instead of the switching to the generic truvada when available. And though TAF does not have the long clinical trials of TDF, it does offer some real potential advantages in terms of decreasing the renal and bone toxicities of TDF)

    --tivicay (dolutegravir): $832.44

    --odefsey (TAF/FTC/rilpivirine): $1716.13

    --genvoya (elvitegravir/cobicistat/TAF/FTC): $1893.68

    ​--stribild (elvitegravir/cobicistat/TDF/FTC): $1638.87 (though here, substituting TAF for TDF does seem to increase the cost....)

    ​--prezcobix (darunivir/cobicistat): $759.39

    --evotaz (atazanavir/cobicistat): $700.70

    --triumeq (dolutegravir/abacavir/3TC): $1580.35

--just to put all of this in perspective:

    ​--the new drugs are really great, with excellent acceptability (I have had to stop dolutegravir only once for GI effects), along with remarkable efficacy, combined with much more "leniency" than the older drugs such as efavirenz (one can miss more doses but maintain continued viral suppression, without developing resistance so easily)

    ​--but the old drugs (especially atripla) were the ones which were able to turn the AIDS from almost uniformly fatal to almost uniformly a chronic disease

    ​--and, the vast majority of patients tolerated these drugs well. The +/- 90%  who were able to continue on them had the same remarkable great outcomes as with the new drugs (I have rarely had to change my old patients on atripla to one of the newer formulations)

    --and, these old regimens are likely to get much cheaper when generics become available

--so, what does this all mean? we live in an extremely expensive health care system (1/3 of Massachusetts spending is for healthcare/Medicaid), yet we have the remarkably opaque system where clinicians providing the care are "shielded" from its cost. Hospitals do not provide us with the cost of MRIs or colonoscopies, or the fact that at one hospital it is 2-3x the price of another. It is not easy to find the actual costs of medications, and this cost can vary considerably from one pharmacy to another (again, it is a lot of work for us to find out the actual costs). Drug companies and hospitals, in these cases, have no interest in advertising costs -- drug companies promote the "newest and best" to us through sponsoring the studies and advertising aggressively (and expensively) to us and directly to consumers, highlighting their new cancer drug which increases life expectancy a couple of months at $100,000 per injection, etc etc. Ironically, we clinicians as consumers would (mostly, I assume) never tolerate buying other consumer products without knowing their price and their relative value compared to other items of the same class. so, though I have been prescribing these new HIV drugs to my newly diagnosed patients, I think this article really does give pause and highlights the strange situation we are in in our increasingly expensive, increasingly unaffordable, intentionally cost-opaque health care system, which in many ways does not lead to major improvements in community health or health care outcomes, yet with us as clinicians inadvertently being put in the position of how $$ is spent: a perfectly devised system to maximize the profits of the drug companies, hospitals, etc. And many of the people sitting on the committees writing the new guidelines in medicine are financially supported by drug companies, etc, both for their research and personal financial gain, which really should be seen as an unacceptable conflict-of-interest.

see http://gmodestmedblogs.blogspot.com/2016/04/life-expectancy-and-income.html  , a recent blog which includes reference to the book The Health Care Paradox, which argues well that we in the US spend huge amounts of money per capita on medical care but reap really poor-to-mediocre improvements in health outcomes (eg, infant mortality or life expectancy being lower than almost any other industrialized country), because we devote the vast majority of the medical care $$ specifically to health care and such a low percentage to public health/social programs that promote the prerequisites for good health: good employment, housing, food, supportive social environments, exercise programs, day care/elder care......)