By Daniel Ghinn 
The decisions of regulators and policymakers on drug approvals and spending, the route to market access, can make or break the success of a medicine, and can shape a pharmaceutical company’s own investment strategy.
In 2017, Janssen’s pipeline product sirukumab was widely hailed as a future blockbuster drug. But in October the same year, the company announced a decision to withdraw global applications for approvals of sirukumab in rheumatoid arthritis, just weeks after the FDA rejected the product in the US, asking for more evidence. Brian Kenney, Janssen’s global therapeutic area communication leader, Immunology, explained that “Janssen has made a strategic decision to prioritize other assets in our portfolio”.
The route to market access is complex and requires positive decisions by policymakers including regulators such as the FDA for the US, the EMA’s Committee for Medicinal Products for Human Use (CHMP) for EU-wide approvals, and the MHRA for the UK.
Once approved by a regulator for marketing authorisation – that is, the approval to market a medicine – getting the medicine to patients who need it is still dependent on a person or organisation paying for it, and, in the case of a prescription-only medicine, on a physician prescribing it. Who pays for a medicine – known as the “payor” – varies between nations and health systems. Payors may include health insurance companies or government healthcare systems who may pay, or “reimburse”, all or part of the cost of the medicine; and the patient themselves.
Regulator decisions about marketing authorisation, and payor decisions about reimbursement, both typically involve examination of evidence about a medicine’s benefits, risks, value and the unmet need. Decision-making teams usually bring together a range of stakeholders including healthcare professionals, and some also consult with the public and external organisations.
The role of NITAGs in vaccines market access
In the case of vaccines, a product’s route to market access also depends on the decisions of a country’s National Immunization Technical Advisory Group (NITAG), which provides scientific recommendations for evidence-based immunization policy decisions. The NITAG in the US, for example, is the Advisory Committee on Immunization Practices (ACIP), which includes experts on public health, vaccines efficacy and safety.
In many of our relationships with global healthcare clients we have supported this route to market access with insights from the conversations of healthcare professionals online. To see case studies of this work you can read our article ‘Predictive Insights for Market Access Strategy from HCP views from HCP’ or get in touch, we’d love to help.
