Idis Managed Access ('Idis MA') is the global market leader in providing exclusive access to early phase, innovative medicines in those disease areas where there is high unmet medical need. While this is a relatively new market segment, there are a number of reasons why this is a very exciting area with compelling growth drivers.
Idis MA ran programmes for 19 of the top 25 pharmaceutical and biotech companies in the world, shipping 268,000 units of drugs across 107 countries. At the year end, there were 108 programmes under management and 85% of products shipped on behalf of Idis MA’s clients were provided free of charge to patients.
Pharmaceutical companies feel that ethically they should provide access to potentially life-saving medicines still in clinical trial for those patients with potentially life-threatening diseases. Diseases such as oncology, haematology, CNS, infectious disease, immunology and orphan disease all have the highest level of unmet medical need and these diseases account for the vast majority of the pharmaceutical and biotech R&D pipeline.
Managed Access programmes provide important information at the pre-launch phase for companies and are a great opportunity to engage with and educate key opinion leaders and key treatment centres while products are still in clinical trials in order to potentially accelerate uptake of the product post-launch.
There is an increasing focus from the industry and regulators on the generation of Real World (RW) data to establish the long-term safety profile of a medicine and this is the type of data that can be captured through an MA programme. An MA programme also can help better profile which patients will benefit from the products and strengthen the pricing and reimbursement dossiers for the company. Outsourcing the activities involved in setting up and managing an access programme is an increasingly attractive option for pharmaceutical companies with the complexity of the unlicensed regulatory environment and the specialist knowledge and expertise required in managing the distribution of medicines to over a 100 different countries.
1 The adjusted results exclude share based payment costs, amortisation and non-underlying costs
2 Year on year comparisons, referred to as ‘pro forma’ are calculated from the aggregated unaudited results taken from i) 12 monthly management information for Clinigen and Idis, and ii) for Link Healthcare, the eight months ended 30 June 2016 and for the eight months ended 30 June 2015