The pharmaceutical industry has now entered the Outcomes Era where compounds must supply convincing evidence of a new drug’s value, with proof of the best possible health outcomes and additional benefits if it is to achieve attractive price and reimbursement levels, says new research.

As many as 60% of pharmaceutical executives surveyed for the report agree that, in the Outcomes Era, product launches can no longer be driven by a blockbuster mindset focused solely on regulatory approval pre-launch and a strong salesforce post-launch. Yet as many as 30% of the respondents – working mainly in drug companies located in the USA and Europe – said they expect to continue to launch new products in the blockbuster style, with little change to the launch process, says the report, from Camelot Management Consultants.

Worryingly, respondents do not expect to see an increase in the number of new drug introductions – yet the industry needs to be increasing the number of truly innovative launches and introducing them more speedily if the sector is not to shrink, the firm warns.

Moreover, approval by the regulatory agencies is no longer the only concern – today it is about market access, acceptance and usage, says Camelot. The major challenge facing life sciences companies as they prepare to launch a novel drug today is “how to satisfy different stakeholder needs at the same time”, the survey shows.

Looking at how these developments are playing out around the world, Camelot notes that among the mature markets, the German system, for example, now draws a direct connection between additional benefit and reimbursed price – setting off a domino effect beyond Germany, as lower prices are adopted through international reference pricing – while the UK plans to introduce value-based pricing for new drugs from next year.

Further afield, emerging markets such as the BRIC (Brazil, Russia, India and China) nations are adapting both to FDA/EMA standards and to recent pricing and market access developments. The Brazilian Government already manages its healthcare spending by relating market prices to reference prices in other countries, and has now launched the National Commission for Incorporation of Technologies in the Unified Healthcare System (CONITEC), a health technology assessment body that bases its strict reimbursement requirements on a product’s safety, efficacy, cost-effectiveness and impact on the national drugs budget against comparators.

Within this new stakeholder-driven environment, says Camelot, successful product launches will need to:

- Expand the market, rather than just gain market share

- Re-define therapy guidelines

- Develop excellent cross-functional collaboration and teamwork

- Develop smarter pre-launch activities, with increased investment in the early launch phases

- Have stakeholders awaiting the product and its differentiated positioning at launch

- Win recognition for creating multi-stakeholder value

- Exceed peak sales expectations.

Companies must also be “highly alert” to the fact that their environment will be undergoing continuous change, and this will inevitably force the launch process to adapt, Camelot advises.