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news.The pharmaceutical industry is compelled to spend more time and money to bring a drug to the market due to the existing gap gap between the information required by regulatory authorities and payers, according to PJB news.
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While Regulatory authorities are concerned with assessing the safety, quality and efficacy of a product, the healthcare technology assessment (HTA) bodies monitor the product’s relative effectiveness and potential societal impact. The difference in their perspectives results in different data requirements, which the companies increasingly find it difficult to meet, especially when seeking reimbursement status.
In addition, the data requested by the HTA bodies is often unavailable as companies usually possess data pertaining to the safety, efficacy and quality of their products rather than on their effectiveness at the time of product launches. The complexity in availability of appropriate trial candidates also affects the clinical data.
Industry experts opine that forward planning by the companies, modifications in the trial models and HTA requirements may help in cutting down the time and expenses involved in the launch of new drugs.
Cecilia Potez, EU director of international regulatory policy and intelligence at AstraZeneca, UK, said: “Therapeutic progress is achieved when a step-by-step process is taken, and the best cost containment happens with a holistic approach.”