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Clinical Practice Guidelines and Patient Access

By David Charles, MD and Mary Ann Chapman, PhD When patients experience health problems, they trust their physicians to recommend the best possible treatments, taking into account their medical history, symptoms, and preferences. Physicians rely on their training and experience to make these important decisions. To assist physicians and help promote evidence-based health care, clinical […]

Multimodal Analgesia: Acute Pain Relief for the Whole Patient

In the last few decades, rising concerns about the misuse and abuse of opioids have brought pain and pain management to the forefront as a public health concern. In response, the National Institutes of Health and the Institute of Medicine released in 2015 the first-ever National Pain Strategy, calling on healthcare providers to customize pain […]

Improving Patient Access to Immuno-Oncology Therapies

By Alan Marks, MD, and Mary Ann Chapman, PhD Despite major advances in cancer medicine (oncology), cancer remains a deadly disease, accounting for nearly 600,000 deaths in the US annually. For many years, the primary treatments for cancer have been surgery, chemotherapy, and radiation therapy. Over the past decade, medications have been developed that act directly […]

Unresolved Policy Issues Impact Patient Access to Biosimilars

By David Charles, MD and Mary Ann Chapman, PhD More than five years have passed since Congress approved an abbreviated regulatory pathway for biosimilars under the Biologic Price Competition and Innovation Act as part of the Patient Protection and Affordable Care Act. Biosimilars are biological medications deemed highly similar, but not identical to, those already […]

Access to Integrated Care for Chronic Pain

Approximately one in five Americans suffers from chronic pain, with more than 60% of these reporting that their pain is constantly present. Although many therapies are available for chronic pain, up to two-thirds of patients are inadequately treated. Read the Paper

Abuse-Deterrent Opioid Formulations: Promising Technology, Unique Challenges

Prescription pain medications such as opioids offer important treatment options for people with severe pain, often providing relief and allowing some to resume their daily activities. Unfortunately, these drugs can be misused, abused, or diverted to others for illicit use—problems that have become pervasive across the country. Each year approximately 4.5 million Americans use prescription […]

What is Indication Extrapolation and Should it be Allowed with Biological Medications?

By David Charles, M.D. and Mary Ann Chapman, Ph.D. If a prescription medication is approved for the treatment of a specific disease or condition, do you assume that it has undergone full testing for that condition? Tis assumption is usually valid: New medications approved in the United States must undergo extensive testing for the conditions […]