Generics in HIV, a Pharmacoeconomic Reality: How to Manage Change in Europe?

PARIS, March 28, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) announced highlights from its Symposium, "Antiretrovirals (ARVs) & Generics, a new Challenge for Pharmacists: how will we manage change in Europe?," which was held during the 18th Congress of the European Association of Hospital Pharmacists (EAHP) in Paris, France on March 14, 2013.

Today, more than 34 million people are infected with HIV and approximately 14.8 million need treatment; yet only about 8 million receive any (WHO 2012). The symposium aimed to raise awareness on the pharmacoeconomic and therapeutic issues related to generics of HIV treatments and enable professionals and experts to share perspectives and experiences. Three major issues emerged:

Provision of ARVs, a pharmacoeconomic challenge
"Due to the success of HAART (Highly Active Antiretroviral Therapy), people living with HIV are now considered to have a long-term chronic illness. However, patient numbers will continue to increase annually creating a rising financial burden on national healthcare systems. The availability of generic ARVs will provide significant cost reduction opportunities in an increasingly challenging financial environment without detriment to patient care," said Peter Sharott, Chairman of the Symposium (London Specialised Commissioning Group).

"Generic fixed-dose-combinations are becoming the standard of care in 1st line Antiretroviral Therapy in low and middle income countries and help to simplify complex live-long combination treatment," added Dr. Thomas Mertenskoetter (T.O.M. Life Science Consulting, Hamburg, Germany). "Major aspects of treatment strategies are antiviral efficacy, safety, convenience of dosing, and now, with the entry of generic high quality products in high income countries, economic considerations will be further factored in."

Patient adherence to treatment is fundamental in chronic diseases
"It is crucial to give specific consideration to the needs of patients when introducing any change to their existing ARVs regimens to ensure that they continue to take their medicines correctly," noted Peter Sharott.

Neal Marshall (Royal Free London NHS Foundation Trust and HIV Pharmacy Association, London, UK) agrees: "Although the availability of the same molecule produced by a wide range of companies can drive down price, this does have the potential to confuse patients and might lead to short term compliance issues if no proper counseling and information is given. Engaging both patients and doctors in cost-based therapy switches is key for their safe and effective implementation, and pharmacists play a key role within this."

Generic vs originator: a proven bioequivalence
Regarding questions on the efficiency of generics, Dr. Albert Darque (Hopital de la Conception, Marseille, France) noted, "Generic drugs are required to have the same active ingredient, dosage, and route of administration as the reference product and must scientifically demonstrate that their product is bioequivalent to the originator by comparing their respective bioavailabilities."

Mylan and HIV/AIDS
Mylan has been a leading global player in the ARV arena for more than a decade. In 2003, Mylan Laboratories Limited (formerly Matrix Laboratories Limited) began providing reliable supplies of ARV active pharmaceutical ingredients to generic drug makers. In 2007, the company began offering finished dosage forms and launched a line of pediatric ARVs. Today, Mylan is widely respected for the quality, dependability and affordability of its ARVs. Mylan supplies ARVs to more than 120 countries around the world and nearly 40% of HIV/AIDS patients receiving treatment in developing countries depend on one of the company's ARV products.

About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of approximately 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com