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PPi - Publications


Orphan drugs: pricing, reimbursement and patient access

Abstract
To provide a description of principal aspects of policy and practice associated with orphan drugs and treatments of rare diseases, and give perspectives on new and emerging approaches for addressing patient access. Information has been synthesized from a wide variety of sources including the authorís experience and familiarity with this topic, having over the past 13 years developed market access strategies for many orphan drugs. This is supplemented by pertinent information from conferences, meetings and articles published over the last twenty years and from policy documents released by relevant regulatory bodies.

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Pharmaceutical Pricing: Overview of the Impact of genericisation

Abstract
Patent expiry signals a fundamental shift in the way in which drugs are marketed and purchased. The entry of generic competitors requires a variety of different healthcare stakeholders to implement an alternative set of objectives and approaches in order to take advantage of the new opportunities which genericisation brings about. This paper concentrates on two perspectives, that of the original brand manufacturer and the payer. It examines through the use of international examples, how approaches to pricing change pre- and post-patent expiry in view of the altered objectives and regulatory framework. It is demonstrated that manufacturer and payer alike have a number of alternative pricing approaches which could be implemented, each having a different set of aims and consequences.

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Pricing policies to handle patent loss or expiry

Abstract
Generics provide improved access to drugs for developed and developing world markets and offer payers and governments the opportunity to reduce the costs of their healthcare provision. Their main threat is the dramatic reduction in revenues for the original manufacturer. This paper looks at the matter from the point of view of pharmaceutical companies and outlines some of the ways in which pricing can be used to counter this threat and maximise revenues when patent protection is lost.

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