An uncertain economy and regulatory reform continue to create downward pressure on the healthcare industry. As healthcare spending outpaces economic growth, healthcare budgets in many countries will be impacted, resulting in increased pricing pressures.
Novartis is adapting to these changes by shifting from a transactional approach to a more integrated approach, where we work together with physicians and customers to enable better patient outcomes. Novartis is working closely with hospitals, payors and physicians and initiating pilot programs to determine how to best meet changing customer expectations.
Holistic clinical trial design
Novartis consults extensively with health authorities, payors and health technology assessment agencies in designing clinical trials. The approach to these trials is holistic, looking at the outcomes and benefits for both patients and payors.
For example, a heart failure development program aims to investigate potential reductions in mortality and heart failure symptoms, as well as improvement in physical function. However, other key measures include reductions in the rate of hospitalization, the average length of hospital stay and time spent in either intensive care or coronary care units.
Such trials are designed to provide data that inform listing and reimbursement decisions by governments, other payors and health technology assessment agencies. The goal is to enable payors to make decisions on access quickly, without needing to request additional data, so these new drugs reach patients as soon as possible.
Pricing and reimbursement
Although regulatory approval is a major milestone for any new medicine, further negotiations over pricing and reimbursement with individual countries are necessary before patients gain broad access to a new drug. Those negotiations can take months - or even years - to conclude. While reimbursement talks are underway, patients often find themselves with no treatment options despite the approval of a new medicine.
We feel a particular responsibility to address access issues for Novartis medicines that are first-in-class. To speed access to one particular cancer medicine, Novartis established an expanded access program in collaboration with more than 60 clinics in nine countries. An estimated 150 patients in the expanded access program will receive treatment at no cost until the medicine becomes commercially available.
Through these expanded access programs, Novartis is committed to bridging the gap between regulatory trials and the commercial availability of a drug. Novartis has also established expanded access programs for certain rare cancers.
In conjunction with expanded access programs, Novartis is working with European medical societies and patient advocacy organizations to establish registries for tuberous sclerosis complex, myelodysplastic syndrome and myelofibrotic syndrome. Hospitals and clinics participating in the expanded access programs are expected to provide data about diagnosis and case management of more than 5 000 patients. All research performed conforms to relevant European Union legislation relating to implementation of good clinical practice, processing of personal data and free movement of such data.
The idea behind the registries is first to identify where the patients are and then to understand their previous clinical history and unmet medical needs. Where possible, Novartis consults with patient advocacy groups about design of the registries as well as the expanded access programs. In some cases, initial designs are modified to enhance access and improve convenience for participating patients. By working together with key stakeholders, Novartis can go beyond the normal role of a company in simply providing a drug.
In addition to these initiatives, Novartis collaborates with governments worldwide on new pricing arrangements, including money-back guarantees and other types of performance-based pricing, to accelerate reimbursement negotiations and ensure patients early access to new medicines.