Idis pharmaceutical global access management

Idis is a privately held, global company with US headquarters in Princeton, New Jersey and European headquarters outside of London. Idis partners with pharmaceutical and biotech companies, physicians, and pharmacists around the world to provide medicines to patients through access management strategies that include expanded access and named patient programs.

Through these programs, patients with unmet medical needs May Be able to access potentially life-saving treatment throughout the stages of the [...] lifecycle:

• Prior to a [...]’s approval
• While the [...] is in clinical trial – for patients who are unable to enter the trial
• At the conclusion of a clinical trial but prior to marketing authorization for patients who had participated in the trial
• While a phased launch is taking place and the [...] is not yet available in a patient’s home country
• In the case of a mature [...] that is no longer widely available

Idis also develops and implements programs by which pharmaceutical and biotech companies can manage mature brands and offers a range of strategic procurement solutions for comparator drugs for use in clinical trials.

Global Access Management

For patients who are terminally or seriously ill, have exhausted all available therapies, and cannot enter a clinical trial, access to an investigational [...] or biologic outside the clinical trial setting can represent a new treatment option.

Recognizing this situation, regulatory authorities around the world have established regulations that allow patients with unmet medical needs to gain access to drugs prior to their approval for general marketing. While these regulations vary from country to country, all place stringent control on the access to drugs prior to approval or launch.

Through these access programs, pharmaceutical and biotechnology companies can provide access to drugs in their pipeline to patients with serious or life-threatening conditions of all types including cancer and infectious diseases, as well as rare diseases.

Since 1987, FDA has had rules in place that have enabled patients, under specific circumstances, to access drugs or biologics that are still in development for treatment purposes. These expanded access program (EAP) rules were recently amended by FDA to ensure “broad and equitable access to investigational drugs for treatment.”

Outside the US, these access programs are known by a variety of names including “named patient programs” (in which physicians can request access to drugs on behalf of individual or “named” patients), “named patient supply” and “temporary authorization for use.” These programs facilitate access to investigational drugs for individual patients or groups of patients with unmet medical needs and also allow access, in specific circumstances, to drugs that are approved in other countries but not yet approved in a patient’s home country.

The thirty countries comprising the European Union (EU)—which fall under the jurisdiction of the European Medicines Agency (EMEA)—each have their own nationalized regulations regarding the access for individual patients and patient groups. In the EU, named patient programs are also a mechanism by which companies can manage patient access to drugs in the time period between centralized EMEA approval and launch in their home countries which can range from one year to eighteen months.

Many countries outside the U.S. and Europe also offer these programs. In Canada, the Special Access Programme allows seriously ill patients with no alternative therapy to access non-marketed drugs through their physicians. Similarly, in Australia, patients can access experimental drugs via the “Special Access Scheme.” In Japan, government sanctioned “Named Patient Access” allows access to drugs with an expectation that the [...] be approved in the exporting country. Brazil has three options for accessing unapproved drugs: continuation of clinical trial use, cohort access to Phase 3 drugs, and named patient access for an individual patient.

Strategic Clinical Trial Procurement

Governments around the world are promoting use of Comparative Effectiveness trials in an attempt to control the inflation of healthcare costs and provide additional information in support of the [...] approval process. Investment in these trials is expected to increase as [...] companies seek to better demonstrate the value of new therapies. In order to conduct such trials, trial sponsors must secure a continued, reliable supply of comparator drugs. The American Recovery and Reinvestment Act of 2009, an $825 billion economic stimulus package, earmarked $1.1 billion for federal comparative effectiveness research. The bill directed $300 million to the Agency for Healthcare Research and Quality (AHRQ), $400 million to the National Institutes of Health, and $400 million for allocation by the Department of Health and Human Services.

The National Institute for Health and Clinical Excellence (NICE) was established under the National Health Service (NHS) in the United Kingdom in 1999, and sets standards for the use of new and existing medicines, procedures and other technologies. NICE strives to define the optimal intersection of clinical and cost-effectiveness in order to determine the best available standard of care. To that end, a treatment option that may demonstrate better clinical efficacy might not receive approval if it is significantly less cost-effective than another treatment option. All drugs approved by NICE must receive payment coverage by the NHS, though local health authorities make coverage decisions on treatments not yet evaluated by NICE.

Idis develops and implements sourcing strategies to meet global comparator requirements for sponsors of clinical trials and reduce the regulatory, operational, commercial, and financial risks inherent in this process.

In many cases, Idis can work directly with a comparator’s manufacturer to source the [...]; this route offers:

• Full product documentation including certificates of analysis, certificate of conformity, package inserts, GMP compliance, equivalency data, material safety data sheets, and TSE/BSE documentation
• A secure supply chain with QA documentation reflecting the chain of custody from the source to the designated point of delivery
• Large, single lots with maximum shelf life and specific batch numbers when possible

Idis has an in-house regulatory team who consults with and advises clients on their specific regulatory questions and issues surrounding comparators. The company also maintains relationships with key regulatory bodies including the FDA and EMEA and can interface with these agencies on behalf of customers should questions arise.

External Links

• Cancer Patients Deserve Faster Access to Life-Saving Drugs Wall Street Journal, May 2, 2009.
• Fighting for a Last Chance at Life New York Times, May 16, 2009.
• Meeting Global Demand for Investigational Drugs Life Science Leader, December 2009.
• Expanded Access to Investigational Drugs Genetic Engineering & Biotechnology News, January 15, 2010.