ArticleFrontiers in pharmacology2016
Payers' Views of the Changes Arising through the Possible Adoption of Adaptive Pathways.
Article in Frontiers in pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.
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Who cites it
29 citing papers in PubMed.
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- The Role of Regulator-Imposed Post-Approval Studies in Health Technology Assessments for Conditionally Approved Drugs.International journal of health policy and management · 2022Article
- The value of anticancer drugs - a regulatory view.Nature reviews. Clinical oncology · 2022Review
- Current landscape of clinical development and approval of advanced therapies.Molecular therapy. Methods & clinical development · 2021Review
- Strategies to Improve Antimicrobial Utilization with a Special Focus on Developing Countries.Life (Basel, Switzerland) · 2021Review
- Can adaptive clinical trials help to solve the productivity crisis of the pharmaceutical industry? - a scenario analysis.Health economics review · 2021Article
- Reinforcing Collaboration and Harmonization to Unlock the Potentials of Advanced Therapy Medical Products: Future Efforts Are Awaited From Manufacturers and Decision-Makers.Frontiers in public health · 2021Review
- Methodological Characteristics of Clinical Trials Supporting the Marketing Authorisation of Advanced Therapies in the European Union.Frontiers in pharmacology · 2021Review
- A novel method for predicting the budget impact of innovative medicines: validation study for oncolytics.The European journal of health economics : HEPAC : health economics in prevention and care · 2020Article
- Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe.Clinical pharmacology and therapeutics · 2020Article
- Review of Ongoing Activities and Challenges to Improve the Care of Patients With Type 2 Diabetes Across Africa and the Implications for the Future.Frontiers in pharmacology · 2020Review
- Mapping of Current Obstacles for Rationalizing Use of Medicines (CORUM) in Europe: Current Situation and Potential Solutions.Frontiers in pharmacology · 2020Article
- Response to the Novel Corona Virus (COVID-19) Pandemic Across Africa: Successes, Challenges, and Implications for the Future.Frontiers in pharmacology · 2020Review
- Key enablers and barriers to implementing adaptive pathways in the European setting.British journal of clinical pharmacology · 2019Review
- Medicines Adaptive Pathways to Patients: Why, When, and How to Engage?Clinical pharmacology and therapeutics · 2019Review
- Innovation in Regulatory Science Is Meeting Evolution of Clinical Evidence Generation.Clinical pharmacology and therapeutics · 2019Article
- Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs.Clinical pharmacology and therapeutics · 2019Article
- Improving Patient Access to New Drugs in South Korea: Evaluation of the National Drug Formulary System.International journal of environmental research and public health · 2019Article
Corrections and comments
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Authors and funding
31 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Payers are a major stakeholder in any considerations and initiatives concerning adaptive licensing of new medicinal products, also referred to as Medicines Adaptive Pathways to patients (MAPPs). Firstly, the scope and necessity of MAPPs need further scrutiny, especially with regard to the definition of unmet need. Conditional approval pathways already exist for new medicines for seriously debilitating or life-threatening diseases and only a limited number of new medicines are innovative. Secondly, MAPPs will result in new medicines on the market with limited evidence about their effectiveness and safety. Additional data are to be collected after approval. Consequently, adaptive pathways may increase the risk of exposing patients to ineffective or unsafe medicines. We have already seen medicines approved conventionally that subsequently proved ineffective or unsafe amongst a wider, more co-morbid population as well as medicines that could have been considered for approval under MAPPs but subsequently proved ineffective or unsafe in Phase III trials and were never licensed. Thirdly, MAPPs also put high demands on payers. Routine collection of patient level data is difficult with high transaction costs. It is not clear who will fund these. Other challenges for payers include shifts in the risk governance framework, implications for evaluation and HTA, increased complexity of setting prices, difficulty with ensuring equity in the allocation of resources, definition of responsibility and liability and implementation of stratified use. Exit strategies also need to be agreed in advance, including price reductions, rebates, or reimbursement withdrawals when price premiums are not justified. These issues and concerns will be discussed in detail including potential ways forward.
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