New Highly Active Antiretroviral drugs and generic drugs for the treatment of HIV infection: a budget impact analysis on the Italian National Health Service (Lombardy Region, Northern Italy)

Restelli, Umberto; Scolari, Francesca; Bonfanti, Paolo; Croce, Davide; Rizzardini, Giuliano

doi:10.1186/s12879-015-1077-7

Cited by 24 publications

(20 citation statements)

References 15 publications

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“…Perspective: 82 studies (89%) [12][13][14][15][16][17][19][20][21][22][23][24][70][71][72]77,78,[80][81][82][83][84][85][87][88][89][90][91][92][93][95][96][97][98][99][100][101][102][103] that performed BIA were focused on the budget holder. In all, the perspective of the 92 studies was broken down as follows: the public health system (59%), health insurance companies (24%), paying parties (10%), hospitals (5%), and society (2%).…”

Section: Characteristics Of the Published Studies According To The Mamentioning

confidence: 99%

“…At least one type of scenario comparison was reported by 83 of the studies (90%) [12][13][14][15][16][17][65][66][67][68][69][70][71]73,[75][76][77][78][79][80][81][82][83][84][85][89][90][91][92][93][94][95][96][97][98]100,102,103]. Bearing in mind that the same study may have made more than one assessment: comparisons involved costs comprised 33%, epidemiologic data 17%, the use of different medicines 16%, and market share 15%.…”

Section: Scenario Analysismentioning

confidence: 99%

See 1 more Smart Citation

Budget impact analysis of medicines: updated systematic review and implications

Faleiros

Álvares

Almeida

et al. 2016

Expert Review of Pharmacoeconomics & Outcomes Research

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This evaluation determines whether published studies to date meet the key characteristics identified for budget impact analyses (BIA) for medicines, accomplished through a systematic review and assessment against identified key characteristics. Studies from 2001-2015 on 'budget impact analysis' with 'drug' interventions were assessed, selected based on their titles/abstracts and full texts, and their characteristics checked according to key criteria. Out of 1,984 studies, 92 were subsequently identified for review. Of these, 95% were published in Europe and the USA. 2012 saw the largest number of publications (16%) with a decline thereafter. 48% met up to 7 out of the 9 key characteristics. Only 22% stated no conflict of interest. The results indicate low adherence to the key characteristics that should be considered for BIAs and strong conflict of interest. This is an issue since BIAs can be of fundamental importance in managing the entry of new medicines including reimbursement decisions.

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Section: Characteristics Of the Published Studies According To The Mamentioning

confidence: 99%

Section: Scenario Analysismentioning

confidence: 99%

Budget impact analysis of medicines: updated systematic review and implications

Faleiros

Álvares

Almeida

et al. 2016

Expert Review of Pharmacoeconomics & Outcomes Research

View full text Add to dashboard Cite

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“…Others have explored whether monotherapy or dual therapy can be used safely to reduce costs [12][13][14][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][17][18][19][20][21]. De-simplifying or switching a single-tablet formulation (STF) to two or more tablets (i.e.…”

Section: Introductionmentioning

confidence: 99%

De‐simplifying single‐tablet antiretroviral treatments: uptake, risks and cost savings

et al. 2019

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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.

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“… 15 It has been calculated that generic substitution of ARVs would result in cost savings to the NHS of £1.25 billion 16 and it has been modelled to be cost saving in other health services. 17 , 18 However, it remains a controversial strategy with conflicting results presented in published cost-effectiveness analysis. 19 , 20 …”

Section: Introductionmentioning

confidence: 99%

Generic substitution of antiretrovirals: patients’ and health care providers’ opinions

et al. 2017

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There is interest in introducing generic antiretroviral drugs (ARVs) into high-income countries in order to maximise efficiency in health care budgets. Studies examining patients’ and providers’ knowledge and attitudes to generic substitution in HIV are few. This was a cross-sectional, observational study with a convenience sample of adult HIV-infected patients and health care providers (HCPs). Data on demographics, knowledge of generic medicine and facilitators of generic substitution were collected. Descriptive and univariate analysis was performed using SPSS V.23™. Questionnaires were completed by 66 patients. Seventy-one per cent would have no concerns with the introduction of generic ARVs. An increase in frequency of administration (61%) or pill burden (53%) would make patients less likely to accept generic ARVs. There were 30 respondents to the HCP survey. Concerns included the supply chain of generics, loss of fixed dose combinations, adherence and use of older medications. An increase in dosing frequency (76%) or an increase in pill burden (50%) would make HCPs less likely to prescribe a generic ARV. The main perceived advantage was financial. Generic substitution of ARVs would be acceptable to the majority of patients and HCPs. Reinvesting savings back into HIV services would facilitate the success of such a programme.

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New Highly Active Antiretroviral drugs and generic drugs for the treatment of HIV infection: a budget impact analysis on the Italian National Health Service (Lombardy Region, Northern Italy)

Cited by 24 publications

References 15 publications

Budget impact analysis of medicines: updated systematic review and implications

Budget impact analysis of medicines: updated systematic review and implications

De‐simplifying single‐tablet antiretroviral treatments: uptake, risks and cost savings

Generic substitution of antiretrovirals: patients’ and health care providers’ opinions

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