REMS requirement was required education at ECRM Specialty Pharmacy event
BRASELTON, Ga. A lunchtime discussion on managing “REMS and the RFP Process” proved a timely and relevant addition to the one-on-one meetings between providers and manufacturers at the ECRM Specialty Pharmacy meeting, held here last week at the Chateau Elan resort.
High-profile drug safety issues such as those caused by Vioxx and Tysabri in recent years, has caused Congress to pay closer to scrutiny to FDA and the process by which it allows new drugs to come to market, resulting in the Food and Drug Administration Amendment Act of 2007. One key provision. Risk Management and Mitigation Strategies, or REMS, is becoming a major part of the regulatory approval process, explained D2 Pharma Consulting principal Dean Earhardt.
Subject to FDA review, the REMS requirement “may range from a simple medication guide to a communication plan to Elements to Assure Safe Use (ETASU),” D2 noted in a company white paper, “REMS Challenges and Real World Solutions,” which was authored by Earhardt in conjunction with D2 partner, Dan Steiber. “These more comprehensive REMS programs with ETASU may include such components as a patient registry, physician and pharmacy certification, to name a few.”
For specialty pharmacy/biotech manufacturers some sort of REMS requirement will likely prove the rule rather than the exception in any new drug approval process. However, FDA has the authority to require a REMS program for any NDA it reviews, and moreover, it can also mandate a REMS requirement post-approval.
In all, more than 100 retailers and suppliers attended the two-day meeting, marking a respectable showing for one of the newest meetings on the ECRM calendar—and a most productive one, attendees told Drug Store News.
“In the span of two days we were about to have over two dozen meetings,” noted David Suchanek, SVP Biotechnology and Specialty Services, D2 Pharma Consulting. “It would have taken three months and thousands of dollars in travel to organize and attain the meetings that we had in a 48 hour period.”
Suchanek co-presented with Earhardt during the session on REMS.
Rite Aid to auction surplus properties
TULSA, Okla. Williams & Williams, a real estate auctioneer, on Tuesday announced it will auction 34 surplus real estate properties in 14 states for Rite Aid via single property auction events Dec. 8 to 10.
“Auction is a time-definite sale that secures real-market value through free market competition,” stated Pam McKissick, president and COO of Williams & Williams. “Auctioning these assets via our global platform will deliver the maximum benefit to Rite Aid Corp.”
Each auction will be conducted through Williams & Williams’ exclusive Live From The Lawn auction platform, in partnership with Auction Network, which enables interested buyers around the world to compete in real time while bidding on site or online.
The properties include a shopping center adjacent to the Las Vegas strip, commercial and residential properties, retail properties and land parcels.
Rite Aid Surplus Property auctions will be held in the following states: Alabama, California, Connecticut, Indiana, Louisiana, Maine, Michigan, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania and South Carolina.
CVS Caremark partners with Generation Health
WOONSOCKET, R.I. CVS Caremark is partnering with Generation Health, a genetic benefit management company, to expand pharmacogenomic clinical and testing services for CVS Caremark’s PBM clients who are either nonresponsive or who have adverse reactions to their medications.
As part of the agreement, CVS Caremark is making a minority equity investment in Generation Health. Financial terms of the partnership were not disclosed. Troyen Brennan, M.D., EVP and chief medical officer of CVS Caremark, will join Generation Health’s board of directors.
CVS Caremark currently provides PGx intervention services in its specialty pharmacy business but this partnership expands upon those offerings to specialty pharmacy and introduces them for targeted drugs dispensed under the traditional PBM setting. The new pharmacogenomic clinical services are expected to be introduced to CVS Caremark’s PBM clients in the second quarter 2010.
“Personalized medicine is a fast-growing field, but the process for providing relevant and systematic clinical delivery of service needs to improve and evolve,” stated Brennan. “We will integrate Generation Health’s unique skills in genomic medicine with the experience in benefit management of both companies to provide clients with a sophisticated, evidence-based clinical approach.”
The proper application of pharmacogenomic medicine can help doctors evaluate a patient’s genetic make-up to determine whether a specific medication will be effective. Medical studies have found that in some instances, people get little benefit and even face harmful and costly side effects from medications they take. Through this partnership CVS Caremark will use genetic testing to apply greater precision to client prescription management.
Initially, the companies will focus on PGx clinical and testing programs that predict how a patient will respond to medications in areas of oncology, cardiovascular, medicine, treatment of HIV and others.
The programs can help prevent disease progression and avoid recurrences, as well as help reduce overall medical costs by determining where some therapies will not be effective. That information allows doctors to determine and prescribe the most precise medication therapy treatments for their patient’s treatment.
Going forward, the companies will explore programs in the medical diagnostics arena to encourage appropriate and cost-effective testing for certain hereditary diseases, and eliminate unnecessary testing where evidence for clinical validity and utility is lacking.