Dabigatran and rivaroxaban prescription for atrial fibrillation in Catalonia, Spain: the need to manage the introduction of new drugs

Troncoso, Amelia; Diogène, Eduard

doi:10.1007/s00228-013-1593-6

Cited by 21 publications

(24 citation statements)

References 3 publications

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“…It is envisaged health authorities will become more critical in their reimbursement deliberations for new medicines given concerns with the limited health gain of most new medicines alongside ever increasing requested prices and their associated budget impact. Post-launch activities include assessing the effectiveness, safety and value of new medicines in clinical practice especially if patients in clinical practice will be older and more co-morbid than those enrolled into Phase III studies (135,136). They also include assessing prescribing against agreed guidance and in line with any developed quality indicators, and subsequently instigating additional activities including educational initiatives if needed.…”

Section: Proposed Models and Advice To Optimise The Utilisation Of Nementioning

confidence: 99%

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Godman

Malmström

Diogène³

et al. 2014

Expert Review of Clinical Pharmacology

111

132

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Are new models needed to optimise the utilisation of new medicines to sustain healthcare systems?Godman B 1,2,3 , Malmström RE 4 , Diogene E 5 , Gray A 6 , Jayathissa S 7 , Timoney A 8 , Acurcio FA 9,10 , Alkan A 11 , Brzezinska A 12 , Bucsics A 13 , Campbell S 14,15 AbstractIntroduction: Medicines have made an appreciable contribution to improving health. However, even high income countries are struggling to fund new premium-priced medicines. This will grow necessitating the development of new models to optimise their use. Objective: Review case histories among health authorities to improve the utilisation and expenditure on new medicines. Subsequently, use these to develop exemplar models and outline their implications. Challenges and proposed models: A number of issues and challenges have been identified including the limited innovation level of new medicines alongside increasing requested prices for their reimbursement especially for oncology, orphan diseases, diabetes and HCV. Models centre on the three pillars of pre-, peri, and post-launch including critical drug evaluation and multi-criteria models for valuing medicines for orphan diseases alongside potentially capping pharmaceutical expenditure Discussion: Proposed models which involve all key stakeholder groups are critical for the sustainability of healthcare systems or enhancing universal access. The models should help stimulate debate as well as restore trust between key stakeholder groups.

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Section: Proposed Models and Advice To Optimise The Utilisation Of Nementioning

confidence: 99%

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Godman

Malmström

Diogène³

et al. 2014

Expert Review of Clinical Pharmacology

111

132

View full text Add to dashboard Cite

show abstract

“…For example the off label uses of DE are: age >80 years, patients with liver or kidney disease, with previous bleeding, with previous ischemic heart disease or severe renal impairment, patients with a CHADS 2 score of 0 and patients with coadministration of systemic ketoconazole, cyclosporine, itraconazole, tacrolimus, dronedarone and aspirin [36–41]. …”

Section: Prevention Of Major Bleeding In Patients Receiving Noacsmentioning

confidence: 99%

Preventive Strategies against Bleeding due to Nonvitamin K Antagonist Oral Anticoagulants

Lessire

Dincq

Douxfils

et al. 2014

BioMed Research International

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Dabigatran etexilate (DE), rivaroxaban, and apixaban are nonvitamin K antagonist oral anticoagulants (NOACs) that have been compared in clinical trials with existing anticoagulants (warfarin and enoxaparin) in several indications for the prevention and treatment of thrombotic events. All NOACs presented bleeding events despite a careful selection and control of patients. Compared with warfarin, NOACs had a decreased risk of intracranial hemorrhage, and apixaban and DE (110 mg BID) had a decreased risk of major bleeding from any site. Rivaroxaban and DE showed an increased risk of major gastrointestinal bleeding compared with warfarin. Developing strategies to minimize the risk of bleeding is essential, as major bleedings are reported in clinical practice and specific antidotes are currently not available. In this paper, the following preventive approaches are reviewed: improvement of appropriate prescription, identification of modifiable bleeding risk factors, tailoring NOAC's dose, dealing with a missed dose as well as adhesion to switching, bridging and anesthetic procedures.

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“…A recent follow-up of patients with AF prescribed dabigatran in Catalonia showed the following (Troncoso and Diogène, 2014):…”

Section: Resultsmentioning

confidence: 99%

“…These include information to prescribers, electronic tools to support physicians' decision-making as well as greater monitoring of the prescribing of NOACs (Troncoso and Diogène, 2014). …”

Section: Resultsmentioning

confidence: 99%

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Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs

et al. 2014

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Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction.Objective: To (i) review authority activities across countries, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications based on post-launch activities.Methodology: (i) Descriptive review and appraisal of activities regarding dabigatran, (ii) development of guidance for key stakeholder groups through an iterative process, (iii) refining guidance following post launch studies.Results: Plethora of activities to manage dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions and monitoring of prescribing post launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. Post-launch activities include increasing use of patient registries to monitor the safety and effectiveness of new drugs in clinical practice.Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

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Dabigatran and rivaroxaban prescription for atrial fibrillation in Catalonia, Spain: the need to manage the introduction of new drugs

Cited by 21 publications

References 3 publications

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Preventive Strategies against Bleeding due to Nonvitamin K Antagonist Oral Anticoagulants

Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs

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