Senior Health Policy Specialist Foley Hoag LLP, USA
While mergers and acquisitions, partnerships and collaborations still offer avenues for growth for the pharma industry, many feel that the concept of personalised medicine, if used intelligently, will set the industry on the right path.
By enabling highly-customised therapies to treat diseases based on the patients' genetic makeup, personalised medicine offers companies alternative avenues for growth in terms of niche markets often left unexplored because of feasibility issues. It also provides an opportunity to eliminate unfavourable products much earlier in the development stages, save investment by testing medicines on targeted sub-populations and avoid failures by eliminating inappropriate patients whose genetic makeup does not suit the medicines.
Right drug for the right patient and benefits without toxicity offers a viable business model to the industry. Personalised medicine effectively tackles the issues of toxicity, side effects and medical errors due to wrong dosages or incompatibility while offering patients effective therapies. The industry has a lot to benefit by leveraging the rapid developments in biomarker usage strategies for personalised healthcare.
Experts opine that the biomarkers used to optimize clinical study designs could be eventually used to conduct smaller trials and allow a combination of medicine to be prescribed based on the outcome of a specific diagnostic test for the patient. Additionally, personalised medicine can help create and enhance product differentiation and potentially extend the life cycle of drugs.
Though the benefits are immense, challenges abound. Optimising the drug development for target patient populations-usually small-at low cost while satisfying the tough regulatory guidelines and reimbursement procedures is a daunting task. Many healthcare payers now demand evidence-based medicine to avoid unnecessary costs and low-yield interventions for patients. However, most reimbursement procedures tend to fix a ceiling for tests. Developing the tests, an important element of the personalized medicines concept, is a costly and unfeasible affair with the ceilings.
Enough support from healthcare insurers is paramount for the growth of personalised medicine. Experts, however, hope that realising the long-term savings in treating a disease or preventing it will offer enough incentive to payers to support personalized medicine on a greater scale.
At the moment, its greatest advantage lies in its capability to maximise the effectiveness of medicines used to treat diseases affecting a specific population with documented cases of toxicity and side effects. The cover story "Future of Medicine - Personalised" discusses some important issues: how targeted therapies can offer a sustainable business model, the changing business models and how biomarkers are leading the way in the development of personalized medicine.