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Volume 1, Issue 2
Insights on Access
Insights and news on access to medicines outside the clinical and commercial framework
Volume 1 •
Issue 2
Feature Article
Partnering with Advocacy Groups to Facilitate Access
Patients are more educated and empowered with regard to their health than ever before. Coupled with greater transparency of drug pipelines, patients with unmet medical needs, their advocates and physicians are increasingly and aggressively seeking access to drugs via alternative routes rather than waiting for the traditional process of approval to run its course.
Regulatory Report
Currently in Japan, there is debate regarding introduction of a formal program for compassionate use of investigational-stage drugs. These programs would allow patients with life-threatening illnesses who cannot enter a clinical trial and have no available treatment options the possibility of gaining access to drugs that are still in development. A named patient program, which is another term for a compassionate use program, does exist in Japan and allows doctors and hospitals to legally import small quantities of unapproved drugs for patients' personal use; however the scope of the program is complex and limited in scale.
Policy Perspective
The UK Health & Social Care Act, the most extensive reorganization of the structure of the National Health Service (NHS) in England to date, was finally passed in March following some of the most controversial debates ever seen in Parliament. The implications of the reform program continue to be debated by the healthcare policy community and further announcements are due from the Department of Health on how the NHS Commissioning Board will operate in practice.
Conference Report
Access Programs for Investigational, Pre-launch Drugs
An engaged and diverse audience from around the world joined Idis for the fifth annual conference on access programs for investigational drugs in July. Attendees and speakers represented industry, FDA, patient advocacy groups, and law firms with expertise in such programs. As in prior years, a wide range of topics were covered including worldwide regulations, educating stakeholders, strategies for more effective interaction with advocacy groups, pricing, reimbursement and charging mechanisms.
New Resources from Idis
Access articles, webinars, and podcasts at www.idispharma.com/resource-center.
Case Study: Addressing Pre-Approval Global Demand Learn more about how Idis partnered with a large U.S. biotech company to successfully address growing global demand for pre-approval access to a promising new treatment option, so that internal resources could stay focused on US/EU approvals and commercial launch.
Podcast: Patient Access to Investigational Drugs: Removing Barriers
Simon Estcourt, Senior Vice President, Strategy and Corporate Development
Article and Podcast: Successful importation of cytarabine into the United States during a critical national drug shortage
Dee Hunnisett-Dritz, Park Nicollet Methodist Hospital, St. Louis Park, Minnesota
American Journal of Health-System Pharmacy, August 2012
In 2005, 61 drug shortages were recorded by the Food and Drug Administration (FDA); this number more than quadrupled in 2011, with 250 drug shortages reported. The subject of national drug shortages has left pharmacists and other health care professionals in a difficult position; they must prioritize rationed drugs, administer an alternative therapy that may not be optimal, or turn patients away because a drug is not available.
Idis can assist in identifying and securing sources for drugs that are in short supply. Through networks and relationships, Idis is able to quickly identify and obtain alternatives on behalf of physicians and pharmacists so that patients do not experience a gap in their treatment.
Access the following article and podcast for a case study of how Idis was able to secure a supply of cytarabine during a recent shortage.
Article: Providing Access Now
John Lagus and Kelly Fearn, Idis
Pharmaceutical Executive, April 2012
In the news: RARE Corporate Alliance
Recently, Idis joined the RARE Corporate Alliance, a collaboration of stakeholders committed to helping advance efforts benefitting the rare disease community and its constituents. The goal of the RARE Corporate Alliance is to help facilitate collaboration and catalyze information exchange among patients, patient advocacy organizations, health-related organizations, industry, payers, policy makers, and regulatory agencies for the ultimate benefit of the rare disease patients and their families.
As a member of the RARE Corporate Alliance, Idis will provide insight and expertise in addressing the challenge rare disease patients often face when seeking access to innovative new therapies.
Copyright Idis 2012 ©
