Article: Kukk P, Moors EHM, Hekkert MP. The complexities in system building strategies – The case of personalised cancer medicines in England. Technol Forecast Soc Change 2015; 98: 47–59. doi:10.1016/j.techfore.2015.05.019
Novel technologies often face difficulties in market uptake, especially when they differ significantly from already established technologies. In some cases, like personalised medicine, new technologies are composed of a number of parallel emerging technologies – in our case therapeutics and corresponding diagnostics – that are heavily co-dependent and cannot diffuse without each other. Therefore, actors in an innovation system need to engage themselves in complex system building strategies in order to create a more favorable environment for their emerging technologies. The bodies of literature on system building and innovation ecosystems have little overlap so far. In this article, we show how system building in a technological innovation system depends on different framework conditions in creating a market for personalized cancer therapeutics and corresponding companion diagnostics in England — such as technological complementarities, timing strategies and organizational complexity. Using this case we illustrate how notions from the literature on innovation ecosystems can complement the current system building literature.
The authors provide a theoretical overview of how innovators build systems to facilitate diffusion of technological innovations. They then analysed how two pharmaceutical companies (Roche and AstraZeneca) facilitated, in a changing environment between 2000 and 2013, the adoption of two novel targeted cancer therapies and their companion tests in England. They studied the first targeted product licensed in the country, trastuzumab (Herceptin®), initially indicated for HER2-positive metastatic, then for HER2-positive early stage breast cancer; and erlotinib (Tarceva®, Irissa®), indicated initially for non-small-cell lung cancer (NSCLC) and later for EGRF-positive NSCLC. Both products are effective only in subsets of breast and lung cancer patients, respectively. To identify patients for whom the products are indicated, new tests for specific characteristics of cancer cells (HER2 protein and EGFR mutation, respectively) and infrastructure and processes for testing needed to be developed, introduced into the system, and adopted to facilitate the adoption of the targeted cancer treatments.
Based on document reviews and stakeholder interviews, the authors identified and classified actions of the companies and other system stakeholders (including regulatory bodies, the National Institute for Health and Care Excellence [NICE], diagnostics manufacturers) over time and show timelines of changes in approval status, indications, pricing, and reimbursement status of the drugs. They highlight similarities and differences in approaches to building systems for adoption of both targeted therapies and tests needed to identify appropriate patients when a company holds the monopoly for the targeted product (Herceptin® by Roche) versus when two companies compete for the same market (Roche and AstraZeneca with Tarceva® and Irissa®, respectively).
Increasing availability globally of novel targeted therapies will require regulatory approaches, appropriate diagnostics, clinical guidelines, provider capabilities, delivery system capacity and processes, financing, reimbursement policies, and clinical practice changes to make sure that only patients who could benefit from them receive the products. Increasing testing needs will be more challenging to meet in less developed, already more burdened health systems of low and middle-income countries, which may lead to inappropriate use – associated with unnecessary toxicities and waste – of highly expensive, specialised therapeutics. Continued system building by all stakeholders to ensure appropriate – and affordable – use of novel (and existing) therapies remains a global priority.