Governments have integrated incentives to accelerate and promote the approval of orphan drugs and the interest among pharmaceutical companies to develop these products is rising. However, expedited regulatory approval is by no means an assurance that orphan drugs will succeed in the marketplace.
One-size-fits-all has become an outdated and non-recommendable approach in pharma business. During the period of blockbuster medical products, this approach was applicable – the wider drug developers cast their net, the greater the chances of expanding their market share. Another merit to this approach was that it made strategy development relatively less complex for pharma […]
Patient-centricity is a key focus for drug and device development. While they may not be the customers, the patients are the final end-users of the drug development, promotion and distribution processes. And if the patients don’t adhere to their treatment, or don’t persist in taking the drug or using the device, this can have a […]
Pricing therapeutics is challenging. Price too low, and the pharmaceutical business model is not sustainable as R&D costs are high and few products deliver significant sales volumes. Price too high and health technology assessment (HTA) bodies will not list the drugs, payer strategies will delay reimbursement and funding, and the media and public will hit back. […]
Seeking advice from a health technology assessment (HTA) body, whether alone or in combination with a regulatory body, can help companies to focus on the payer perspective at an early stage of clinical development, and shape the therapy development and access strategy based on the feedback. By ensuring that the clinical trials include the types […]
Drug prices are rising across the European Union, and in economically-difficult times this is having an impact on drug affordability and accessibility. The European Union health ministers have met to discuss the impact of the situation, and make decisions that could change the way that drugs are priced across the region. These conclusions were published […]
All of the stakeholders involved in drug development and market access would like the right treatments to be available to the right patients, but in times of increasing austerity drug costs make this challenging. Payers need to see the value of a drug outside a clinical trial and in a real-world setting, in order to […]
For many years, the route to market access has been focused around completing clinical trials and meeting the safety and efficacy data needs of the regulators. This data is then used to persuade payers that the therapeutic is safe and works, and is therefore worth paying the price demanded. However, as budget cuts bite, competition […]