Context Matters

Does the Patient Voice Really Impact Reimbursement?

Health Technology Assessment (HTA) agencies have been widely promoting their interest in taking relevant patient data into account during the drug review process. The effort to make a place for the patient voice in reviews is promising in an economic climate where the cost of innovation is under constant scrutiny. However, it raises two critical questions:

  • How much weight does the patient data have in the HTA decision process?
  • Are submissions by patient and professional groups associated with positive decisions? 

How Can the U.S. Healthcare System Better Measure Cost-Effectiveness?

The recent and frequent outcry over expensive drugs has made evident the gap in the United States’ healthcare system. While no perfect system exists, other countries have health technology assessment (HTA) agencies to evaluate efficacy and/or cost-effectiveness and inform reimbursement decisions.

What might the U.S. learn from countries like England, Germany, and France in structuring a methodology for evaluating drugs?

ASCO Conceptual Value Framework Demonstrates Gap in US Healthcare Valuation Process

The ongoing debate around the high cost of drugs in the United States, especially in oncology, has produced interesting responses from special interest groups. The American Society for Clinical Oncology (ASCO) is the latest to enter the fray, believing they may have found a solution for drug valuation in the United States. Does ASCO’s new framework solve a problem in the drug evaluation process in the United States, or does it expose a serious and still unmet need?

How are Comparators Changing for Biologics in Rheumatoid Arthritis (RA)?

While biologics are emerging as the standard of care for rheumatoid arthritis (RA), they continue to be compared to methotrexate frequently in health technology assessments (HTAs). We examined comparators used by HTA agencies for RA drugs, both tumor necrosis factor (TNF) drugs and disease-modifying, anti-rheumatic drugs (DMARDs), and compared each drug’s HTA decision to its European label. We also assessed the change in comparator categories for RA drugs over time.

Regulatory Restrictions on Biologic Rheumatoid Arthritis Drugs

A drug’s market share is dependent on several external factors, one of which is the drug’s health technology assessment (HTA). We analyzed HTA decisions from NICE, HAS, IQWiG, HIS, and SMC for rheumatoid arthritis (RA) drugs, specifically examining the subpopulations established by the HTA agencies through restrictions against the European label, and noting whether these restrictions changed over time.