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30% of pharma executives expect business as usual, as they admit to expecting blockbuster-type launches to continue to be the norm within the pharmaceutical industry.

By Ben Steele on May 16, 2013

The pharma industry is entering the Outcomes Era, according to a new report – yet remarkably, in an environment where demonstrating added value and proving health outcomes is more important than ever, as many as 30% of pharma execs surveyed for the report said they expect to continue launching new products in the blockbuster style.

The report, published by Camelot Management Consultants, shows that approval from regulatory agencies is no longer the only concern for pharma companies, with market access, acceptance and usage all factoring in to a successful launch. According to the survey, the major challenge faced by life sciences companies today is figuring out is “how to satisfy different stakeholder needs at the same time.” In this new stake-holder driven market, successful product launches will have to tick multiple boxes – these include expanding the market rather than simply gaining market share; re-defining therapy guidelines; and having stakeholders awaiting the product and its differentiated positioning at launch.

As many as 60% of execs surveyed for the report agreed that in the Outcomes Era, product launches can no longer follow the blockbuster mind-set which is geared towards regulatory approval, followed by a strong salesforce pushing the product to physicians. Yet strangely enough, nearly one third of execs – working mainly in European and North American companies – revealed that they expected to see little change to their blockbuster-style launch process.

Companies may be stalling over implementation of a more outcomes-aware launch strategy due to concerns about the right way to go about demonstrating added value to their stakeholders. As the report notes, the stakes in this game are high, with Germany already having implemented its AMNOG price reforms and the U.K looking to follow suit in 2014 with its own Value-Based Pricing reforms. The AMNOG system draws a direct connection between added value and the level of reimbursement for pharma companies in its system – failure to satisfy the requirement of “added benefit” against a comparator will have a knock-on effect for the price of the drug in other countries through the international reference pricing system.

The report also sets out how the Outcomes Era is affecting emerging markets. The BRIC countries (Brazil, Russia, India, China) are in the process of adapting to FDA/EMA standards, and to recent price and market access developments. The Brazilian government manages its healthcare spending by comparing market prices to reference prices in other countries, and has recently launched the National Commission for Incorporation of Technologies in the Unified Healthcare System (CONITEC). CONITEC is a Health Technology Assessment body which scrutinises a product’s safety, efficacy and cost-effectiveness versus comparators in order to decide the reimbursement rate.

Lastly, those surveyed in the report did not expect to see an increase in the number of new drug introductions, even though Camelot Management Consultants warned that the industry should be increasing the number of truly innovative launches and introducing them faster if the sector was not to shrink.