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Achieving Accelerated Patient Access to Life-Saving Medicines by Revising the Conditional Marketing Authorisation

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Much needed refinements to the EU Conditional Marketing Authorisation (CMA) could play a vital role in increasing access to patients in urgent need of effective medicines that have not yet been subject to a full assessment by the European Medicines Agency. However, adequate incentives must be put in place to encourage companies to request conditional marketing upfront as a prospectively planned pathway.

Speed is of the essence, given the rapid evolution of concepts such as “Medicines Adaptive Pathways to Patients” (MAPPS), which itself would promote accelerated access and expanded approval based on outcomes.

The conditional marketing authorisation, coupled with an accelerated assessment process, were designed to speed access to innovative medicines that target a disease for which no treatment is available, or for those that provide patients with a major therapeutic advantage over existing treatments.

However, the mechanism has been fraught with problems, including: unnecessarily long assessment timelines; a lack of acceleration in practice; a focus almost entirely on the oncology sector; difficulty in getting new indications approved for existing conditional marketing authorisations; problems converting a CMA to a full MA; a perceived complexity of discussions with HTA bodies and subsequent reimbursement; and ultimately a lack of attractiveness due to a questionable balance of administrative complexity and incentives.

To improve significantly the CMA to benefit patients, we will need to revise the current meaning of “seriously debilitating” and “life threatening diseases” to include long-term chronic disease areas such as Alzheimer and Parkinson Disease. Similarly, the definition of “unmet medical need” must evolve to include major improvements in patient care as a quality criterion. Accelerating the process via a rolling review, accelerated assessment by the CHMP and accelerated decision-making by the European Commission will doubtless play a vital roll in improving the offering. Accelerated patient access will also benefit from timely, planned and consistent involvement of HTA bodies the dialogue process.

Incentivising companies to opt for the CMA could be achieved through promoting early scientific advice and considering within the benefit risk-ratio evolving science and integrated evidence generation over the product lifecycle. It will also be desirable to amend the annual frequency of the renewal and to revise the current limited company benefit from the data protection incentive, which at present starts with the CMA and not the full authorization.

EFPIA wants to be part of a constructive dialogue on the CMA revision process, including on developing and fine-tuning criteria and processes for the “European early stage innovative medicines designation” concept.

The revised EMA Guidelines, which are open to consultation until 30 September 2015 can be accessed here.

EFPIA welcomes the fact that the revision addresses several of the areas that require improvement. EFPIA is reviewing the revisions and will be providing comments to EMA.


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