What is Health Technology Assessment (HTA)?
Health technology assessment is the systematic evaluation of medical technologies for cost-effectiveness. It is often a necessary part of gaining access through government payers in Western countries outside of the US. The National Institute for Health and Care Excellence (NICE) in the UK is one of the more prominent organizations and decides drugs what the UK National Health Service will pay for based on whether or not they are deemed to be cost-effective.
The Institute for Clinical and Economic Review (ICER) is a US non-profit which conducts cost-effectiveness analyses from a US perspective, but coverage is not currently dependent on a positive review from any major payers in the country.
HTA bodies use various criteria to determine whether or not they consider a drug to be cost-effective. NICE uses a standard willingness-to-pay threshold approach which is used as a cut-off for determining cost effectiveness for drugs across therapeutic areas. Some HTA bodies like IQWiG in Germany uses an approach that leads to different thresholds being used in different therapeutic areas.
How does a pharmaceutical company submit their drug for reimbursement approval by an HTA body?
Submission to HTA bodies for reimbursement is a major process involving many different teams in pharma. The strategic leader is the market access team with affiliate-specific (i.e. country-specific) teams often driving the day-to-day decision-making with guidance and boundaries set by Global team members including the Global Value and Access and Global Pricing teams for the brand.
The actual cost effectiveness analysis or model submission is usually comes form Global Health economics and outcomes research teams. These models can be modified at the affiliate level and are often used in discussions or HTA submissions for reimbursement approval.
The HTA submission process usually includes some negotiation component where manufacturers and countries can go back-and-forth on discounts, eligible population for reimbursement, etc. Companies may choose to offer confidential discounts if their product is not considered cost effective in order to reach the threshold and obtain coverage.