[Viva] Fwd: De-simplifying single-tablet regimens for HIV treatment

Tue Feb 5 14:14:59 PST 2019

Indeed. Hugs Tami

On Tue, Feb 5, 2019, 1:25 PM Tami Starlight <tamistarlight at gmail.com wrote:

> Interesting.
>
> --
> Hiy Hiy/Thank you/Merci
> *Tami M. Starlight*
> Unceded Coast Salish Territory
> Vancouver, Canada
> tamistarlight at gmail.com
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>
> A Calgary HIV clinic offered patients a cheaper drug regimen with more
> than one pill
> [image: CATIE News]
>
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> De-simplifying single-tablet regimens for HIV treatment
>
>    - A Calgary HIV clinic offered patients a cheaper drug regimen with
>    more than one pill
>    - Over half of participants chose to switch and achieved high rates of
>    viral suppression
>    - The clinic reduced drug costs 16% in 2017, and projected $3 million
>    in savings in 2018
>
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> In the late 1980s, early formulations of HIV drugs required taking pills
> frequently, in one case, every four hours. In the mid-to-late 1990s, when
> potent combination HIV treatment (ART) became available, pill-taking became
> less frequent, usually three times daily. However, HIV-positive people
> often had to swallow a fistful of pills at each dosing interval.
>
> About a decade ago, pharmaceutical companies began to put entire regimens
> in one pill (single-tablet regimens) that could be taken once daily. The
> marketing departments of these companies touted the “simplification” that
> such single-tablet regimens could bring to patients. Today, single-tablet
> regimens are widely used as first-line and even second-line treatment, as
> they simplify dosing and cut down the number of pills a patient needs to
> take. The latest versions of single-tablet regimens are also generally very
> well tolerated.
> Growth, money and drug costs
>
> In the aftermath of the financial-economic crisis in 2008, the rate of
> economic growth in Canada and other high-income countries generally fell
> and governments received less revenue. One policy response to the
> financial-economic crisis that many governments have chosen is the
> imposition of austerity programs. As a result, government spending on
> healthcare and other needed services is constrained compared to earlier
> decades when economic growth rates were more robust and inequality was less
> prominent. One important service that many governments in high-income
> countries provide is subsidized access to medicines for catastrophic
> conditions such as cancer, hepatitis C virus and HIV infection. As a
> result, the cost of drugs for these and other conditions tends to concern
> policy makers, hospitals, clinics and departments and ministries of health.
>
> There are several steps that have been taken around the world to help
> reduce the burden of HIV drug prices on payers, such as the following:
>
>    - Low- and middle-income countries generally buy generic formulations.
>    - In some countries, particularly in southern Europe, some clinics
>    privilege the use of functional mono- or dual-therapy in people who have a
>    suppressed viral load with combinations such as darunavir (Prezista) +
>    low-dose ritonavir or atazanavir (Reyataz) + low-dose ritonavir with or
>    without the addition of 3TC (lamivudine).
>    - Canada’s provinces and territories engage in bargaining with
>    pharmaceutical companies about the price of new drugs for HIV and many
>    other conditions. Despite this bargaining, the resulting prices still eat a
>    large amount of money from provincial and territorial healthcare budgets.
>    As a result, some HIV clinics still strive to further reduce drug costs.
>
> De-simplification
>
> The Southern Alberta Clinic (SAC) in Calgary provides care and treatment
> for the majority of HIV-positive people in that region. Researchers at SAC
> have modelled the impact of what they call “de-simplification,” which they
> define as “switching a single-tablet formulation to two or more tablets of
> the same drugs with one or more drugs being generic…”
>
> After surveying doctors and participants at SAC about de-simplifying HIV
> treatment, researchers at SAC began what they called a “soft rollout
> program of voluntary de-simplification.” That is, participants were offered
> the option of de-simplification. The researchers focused on one particular
> single-tablet regimen—Triumeq, which contains the following drugs:
> dolutegravir + abacavir + 3TC. They chose Triumeq because it was widely
> used in their clinic and is relatively easy to de-simplify, as generic
> abacavir + 3TC have been available in Canada for several years.
>
> Researchers offered participants who were either on Triumeq or initiating
> ART with Triumeq the option of one of the following regimens:
>
>    - continue taking Triumeq (taken as one pill once daily)
>    - de-simplification – one pill containing dolutegravir (Tivicay) and
>    one pill containing generic abacavir + 3TC; both pills taken once daily
>
> The rollout began in November 2016 and data were collected up to April 1,
> 2018.
>
> Participants were told of the price difference between the two regimens
> and were allowed to freely choose one of the regimens. Furthermore, if a
> participant later decided to change their mind, they were allowed to return
> to Triumeq (if their initial regimen was Triumeq).
>
> Importantly, the researchers stated that the patient as well as their
> pharmacist and doctor all had to agree that the switch to or initiation
> with a de-simplified regimen was appropriate for the patient. The
> researchers stated: “No extra resources, incentives or reimbursement to the
> participants, physicians, pharmacists, before or after the program were
> offered.”
> Results
>
> Researchers approached different groups of participants about
> de-simplification, as follows:
>
>    - 321 participants who were already taking Triumeq. Of these people,
>    55% (177 people) agreed to de-simplify their regimen.
>    - 67 participants who were initiating ART with Triumeq. Of these
>    people, 63% chose a de-simplified regimen.
>    - 41 participants who were talking multi-tablet regimens (usually
>    based on protease inhibitors). All of these participants chose to switch to
>    a de-simplified regimen.
>
> Who switched?
>
> According to the researchers, participants who chose to de-simplify their
> regimens were “more likely to be male, older and white and were gay or
> bisexual and lived longer with HIV” than participants who rejected
> de-simplification.
> Why did some people not de-simplify?
>
> A total of 144 people chose to not de-simplify their regimen; the most
> common reason (86%) for not de-simplifying was a preference for a
> single-tablet regimen. According to the researchers, participants who
> declined to de-simplify “were predominantly female, younger, people of
> colour, had fewer years of education, more likely to be heterosexual”
> compared to people who did switch their regimen.
> Virological control
>
> During the study, 3.4% of participants who were taking Triumeq developed
> viral loads greater than 500 copies/mL. Furthermore, two participants who
> initiated ART with Triumeq never achieved viral suppression. In contrast,
> among people who either switched to or initiated ART with a de-simplified
> regimen, only 1.2% had a viral load greater than 500 copies/mL three months
> after they began taking a de-simplified regimen.
> Money saved
>
> In 2017, the researchers found that moving to a de-simplified regimen
> resulted in a 16% decrease in drug costs for SAC. The clinic projects
> further savings in 2018 as the de-simplification process continues and
> expects to save $3 million.
> Bear in mind
>
> According to the research team, participants who decided to remain on or
> initiate treatment with Triumeq “valued the convenience of single-tablet
> regimens.”
>
> Achieving and maintaining an undetectable viral load is the main goal of
> HIV care and treatment today. The researchers were pleased that the vast
> majority of participants taking a de-simplified regimen achieved and/or
> maintained a suppressed viral load.
> Drug development in the private sector
>
> Pharmaceutical companies, like all corporations, are by their nature
> profit driven. They will expand into therapeutic areas where their profit
> is high and avoid investment in therapeutic areas where profit is likely
> low. An example of this strategy is that more pharmaceutical companies are
> investing in developing and marketing novel anti-cancer drugs. The price
> for some of the latest cancer drugs can range from about US $100,000 to
> about $500,000 per person per year. Another example is the area of
> antibiotics. Most antibiotics that are commonly used now are generic and
> there has not been major large-scale private investment in the discovery
> and development of many new antibiotics as there has been with the
> development of new drugs for cancer. Any new antibiotic developed would
> have to compete against cheaper generic formulations. Also, antibiotics are
> usually used only for a short time, and doctors may reserve the use of new
> antibiotics only for very ill patients. All of these factors affect
> for-profit companies, which see them as disincentives for investment in
> antibiotic drug development.
>
> In the area of HIV treatment, the main companies are Gilead Sciences,
> Merck and ViiV. They are still conducting research on new drugs and new
> formulations (long-acting) for the treatment of HIV and expect new drugs to
> be approved over the next several years. However, there will likely be
> pressure on these (and other companies) to keep prices for new drugs in a
> range that is sustainable for departments and ministries of health.
>
> *Resources*
>
> Will de-simplification of HIV treatment become common in high-income
> countries?
> <https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=30008c686f&e=0f7b6f861c>
> – CATIE News
>
> *—Sean R. Hosein*
>
> REFERENCES:
>
>    1. Krentz HB, Campbell S, Lahl M, et al. De-simplifying single-tablet
>    antiretroviral treatments: uptake, risks and cost savings. HIV Medicine.
>    2019; *in press*.
>    2. Martin EG, Schackman BR. Treating and preventing HIV with generic
>    drugs – Barriers in the United States. *New England Journal of
>    Medicine*. 2018 Jan 25;378(4):316-319.
>    3. Tooze A. How a decade of financial crises changed the world. 1st
>    ed. New York: Viking; c2018.
>    4. Godman B, Bucsics A, Vella Bonanno P, et al. Barrier for access to
>    new medicines: Searching for the balance between rising costs and limited
>    budgets.  *Frontiers in Public Health*. 2018 Dec 5;6:328
>    5. Gupta R, Shah ND, Ross JS. Generic drugs in the United States:
>    Policies to address Pricing and Competition.  *Clinical Pharmacology
>    and Therapeutics*. 2019; *in press*.
>    6. Pataky R, Tran DA, Coronado A, et al. Cancer drug expenditure in
>    British Columbia and Saskatchewan: a trend analysis. *CMAJ Open*. 2018
>    Jul 27;6(3):E292-E299.
>    7. Rosenberg M, Chai G, Mehta S, et al. Trends and economic drivers
>    for United States naloxone pricing, January 2006 to February 2017. *Addictive
>    Behaviours*. 2018 Nov;86:86-89.
>    8. Sehested TSG, Bjerre J, Ku S, et al. Cost-effectiveness of
>    Canakinumab for prevention of recurrent cardiovascular events. *JAMA
>    Cardiology*. 2019; *in press*.
>    9. Tay-Teo K, Ilbawi A, Hill SR. Comparison of sales income and
>    research and development costs for FDA-approved cancer drugs sold by
>    originator drug companies. *JAMA Network Open*. 2019 Jan
>    4;2(1):e186875.
>    10. Engelhard EA, Smit C, Vervoort SC, et al. Patients' willingness to
>    take multiple-tablet antiretroviral therapy regimens for treatment of HIV. *Drugs
>    – Real World Outcomes*. 2016 May 2;3(2):223-230.
>    11. Foreman C, Gazzard B, Johnson M, et al. Maintaining cost-effective
>    access to antiretroviral drug therapy through a collaborative approach to
>    drug procurement, consensus treatment guidelines and regular audit: the
>    experience of London HIV commissioners and providers. *Sexually
>    Transmitted Infections*. 2012 Mar;88(2):112-115.
>    12. Rex JH, Outterson K. Antibiotic reimbursement in a model delinked
>    from sales: a benchmark-based worldwide approach. *Lancet Infectious
>    Diseases*. 2016 Apr;16(4):500-5.
>    13. Savage P, Mahmoud S, Patel Y, et al. Cancer drugs: An
>    international comparison of postlicensing price inflation. *Journal of
>    Oncology Practice*. 2017 Jun;13(6):e538-e542.
>    14. Harbarth S, Theuretzbacher U, Hackett J, et al. Antibiotic
>    research and development: business as usual? *Journal of Antimicrobial
>    Chemotherapy*. 2015;70(6):1604-7.
>    15. Bettiol E, Wetherington JD, Schmitt N, et al. Challenges and
>    solutions for clinical development of new antibacterial agents: results of
>    a survey among pharmaceutical industry professionals. *Antimicrobial
>    Agents and Chemotherapy.* 2015 Jul;59(7):3695-9
>
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