Last updated on Jul 26, 2024

What are the potential risks and challenges of patient access schemes for drug development and innovation?

Patient access schemes (PAS) are arrangements between drug manufacturers and payers that aim to improve the affordability and availability of new medicines for patients. However, PAS also pose some risks and challenges for drug development and innovation, both for the industry and the health system. In this article, you will learn about the main types of PAS, their potential benefits and drawbacks, and some of the key issues that need to be addressed to ensure their effective and ethical implementation.

1 Types of PAS

PAS can be classified into two broad categories: financial-based and outcome-based. Financial-based PAS involve discounts, rebates, or price caps on the drug price, depending on the volume or duration of use, or the patient population. Outcome-based PAS link the payment to the clinical or economic outcomes achieved by the drug, such as response rates, survival, quality of life, or cost savings. Both types of PAS aim to reduce the uncertainty and risk associated with new medicines, but they have different implications for the stakeholders involved.

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THARIQ RAFEEQ

Strategic Marketing Specialist ⚡️ Cultivating Strategic Business Relationships
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Patient access schemes in drug development and innovation come with inherent risks and challenges. Navigating these waters involves addressing potential financial risks, as implementing access schemes may impact revenue streams. Striking a balance between affordability and sustainability poses a challenge, ensuring accessibility without compromising the financial viability of the drug development process. Additionally, there's the risk of complex administrative burdens and regulatory hurdles, requiring careful navigation. Transparency in communication is crucial to manage expectations and potential backlash from stakeholders.

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2 Benefits of PAS

PAS can offer several advantages for drug development and innovation, such as facilitating faster access to new medicines for those with rare or serious conditions, providing more flexibility and choice for payers and prescribers, allowing for the generation of more evidence and data on the real-world performance of new medicines, and encouraging collaboration between drug manufacturers and payers. These benefits can result in better value for money and tailored treatments that are suited to the patient's needs and preferences, as well as foster trust and transparency.

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3 Drawbacks of PAS

Partnership arrangements (PAS) in drug development and innovation can have some drawbacks, such as increasing complexity and administrative burden of managing and monitoring the schemes, which can result in additional costs and resources for both parties. Furthermore, PAS may create potential conflicts of interest or ethical dilemmas, especially for outcome-based PAS. Additionally, PAS may reduce the incentives for innovation by lowering expected returns or increasing uncertainty for drug manufacturers. Lastly, PAS can create inequities or inefficiencies in the health system if they are not aligned with overall goals and priorities of the system, or if they create variations or disparities in access or quality of care.

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Anirudh M
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Patient access schemes can increase the financial burden on drugmakers. Also, shared risk agreements may result in low profitability. To develop patient access schemes requires sensitive data pertaining to patients. Privacy becomes an issue to invest in. For patient access across demographics, the company has to meet the regulatory requirements of multiple nations making the regulatory filings quite complex. Also, when there are price ceilings on certain drugs, the drugmaker cannot profit enough to invest in new drug development.

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4 Key issues for PAS

To effectively address the risks and challenges of PAS, it is essential to consider criteria and processes for selecting and evaluating the medicines eligible for PAS, as well as the role and involvement of stakeholders such as regulators, health technology assessment agencies, clinicians, patients, and civil society. Additionally, the design and implementation of schemes should be taken into account, including the type, duration, and terms of the agreement, data collection and analysis methods, mechanisms of payment and review frequency, and contingency plans or exit strategies. Lastly, transparency and accountability should be ensured by disclosing agreements, evidence and data generated, outcomes achieved, impacts produced, lessons learned, and best practices identified.

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