Abstract and Introduction
Abstract
Objectives: As more HIV-positive individuals receive antiretroviral therapy (ART), payers are seeking options for covering these increased and sustained drug costs. Strategic use of available generic antiretroviral (ARV) formulations may be feasible. De-simplifying a single-tablet co-formulation (STF) into two or more tablets using both brand and generic drugs has been proposed. We determine if voluntary de-simplification of one STF could be utilized as a cost-saving strategy. We report on the challenges, uptake, outcomes and cost savings of this initiative.
Methods: Patients stable on the most commonly used STF (Triumeq®) were offered the option of remaining on Triumeq® or switching to generic abacavir/lamivudine and Tivicay®between 1 January 2015 and 1 January 2018; those starting ART consisting of abacavir/lamivudine/doulutegravir in the same period were offered the option of starting Triumeq® or generic abacavir/laminvudine and Tivicay®. No incentives were provided. We examined the acceptance/decline rates, patient satisfaction, health care outcomes and annual cost savings.
Results: Of 626 patients receiving Triumeq®, 321 were approached; 177 (55.1%) agreed to de-simplify. Of patients initiating ART, 62.7% chose the generic co-formulation. Patients switching to or starting on the generic co-formulation were more likely to be male, > 45 years old, Caucasian, men who have sex with men (MSM) and more HIV-experienced, and to have more comorbidities (all P < 0.05). Preference for STF was cited for declining de-simplification. No concern about generic ARVs was expressed. The rate of viral load > 500 HIV-1 RNA copies/mL after baseline was 2.7% in switched patients compared with 7.0% in those declining to switch. No de novo resistance occurred. A saving of Cdn$1 319 686 was achieved in the first year.
Conclusions: Reliance on altruism, while respecting patient autonomy, achieved de-simplification in > 50% of patients approached, and generated immediate cost savings with no increased risk of adverse events, viral breakthrough or resistance.
Introduction
The number of individuals living with HIV and taking antiretroviral therapy (ART) has increased significantly.[1,2] Patients now initiate ART sooner and remain on treatment longer after HIV diagnosis, substantially decreasing their morbidity and mortality.[3–5] While the clinical benefits are clear, the impact of the cost on payers of this expanded lifelong ART use is less well understood.[6–9] Some low/middle-income countries have used generic ART formulations to address the cost challenge.[10,11] Others have explored whether monotherapy or dual therapy can be used safely to reduce costs.[12–15] Strategic use of newly available generic antiretroviral (ARV) drugs has now entered the cost discussion in high-income countries, with modelling studies projecting significant savings from any increased use of generic ART.[16–21] De-simplifying or switching a single-tablet formulation (STF) to two or more tablets (i.e. multiple-tablet regimens) of the same drugs with one or more being generic may be one option for reducing costs.[22–25] Walensky et al.[18] projected a potential saving of > US$1 billion from de-simplifying one commonly used branded STF regimen. However, diverse concerns of both physicians and patients about the efficacy of generic drugs, the increase in pill burden, the risk of switching successful regimens, and patient acceptability may impact the uptake and use of generic ART.[25–34] Increasing pill burden may be seen as a step back.[35–37]
With an increased number of less expensive generic ARVs now available, at least four options are available to payers.[38] Option 1: payers (e.g. public payers, insurance providers, not-for-profit organizations, or individuals) can continue paying for branded STF at current market prices. Option 2: payers can unilaterally and arbitrarily mandate, through policy and reimbursement coverage, that all patients on branded STFs switch any components to available generic options. Option 3: payers can mandate that patients starting ART must use any available de-simplified options for that regimen, while continuing to fund those already successfully taking a branded STF. Option 4: branded STF drugs can be used for difficult-to-treat patients at risk of poor adherence, while voluntary de-simplified ART is offered to others on eligible STF regimens. The four options have varying risks and benefits both to the patient and to the payer of the drug plan.
Few studies have examined the interest of patients, physicians and health care providers in de-simplifying STF for cost-saving reasons, or examined the challenges, uptake, risks and outcomes of implementing such options in a routine clinical setting. Following an earlier survey of the patient and physician acceptability of offering ART de-simplified from an STF,[38] the Southern Alberta Clinic (SAC) initiated, for cost control, a 'soft' rollout programme of voluntary de-simplified ART. Patients stable (i.e. virologically suppressed) on the most commonly used STF drug (Triumeq®, ViiVHealthcare, Brentford, Middlesex, UK), or starting abacavir/lamivudine/dolutegravir as ART, were offered the option of taking therapy either as Triumeq® or as a two-pill regimen of the same antiretroviral drugs (i.e. generic co-formulated abacavir and lamivudine and Tivicay®, ViiVHealthcare, Brentford, Middlesex, UK). We implemented option 4 as listed above. We report on the challenges, uptake, outcomes and cost savings of this initiative.
HIV Medicine. 2019;20(3):214-221. © 2019 Blackwell Publishing
