WellPoint Excluding Some Compounded Drugs From Coverage

October 30, 2013 By Brittiany Turner Leave a Comment

As of November 1, 2013, WellPoint will no longer pay for compounded medications that are made from bulk ingredients. WellPoint plans include Anthem Blue Cross and Anthem Blue Cross Blue Shield.

For a compound drug to be covered it must contain at least one ingredient/drug that requires a prescription to obtain. Additionally, that ingredient/drug must also be approved by the Food and Drug Administration (FDA). Drugs impacted include:

• Compounded bulk powders (not FDA approved)

• Pharmaceutical Adjuvants (compounding vehicles, not FDA approved)

Letters were mailed to all groups and individuals that will be affected by this change. Individuals that are impacted by this change will need to talk with their doctor about changing to a covered medication, or pay the entire cost.

Anthem Blue Cross Blue Shield Announcement

Interesting article says drug safety bill puts urgent treatment in jeopardy. I thought bad compounders like necc who refuse to follow the rules cause far greater jeopardy

There are a lot of illness for which there are no treatments or cures so I am not sure I am completely convinced with this argument although I am sure there will be some such cases.  What is the solution if not what is proposed?  Is there a way to fix the current draft without having to start over?  There have been issues with the eye med named in article. I guess it comes down to a balancing and weighing. No legislation will be perfect.  Just as there never has been  assess to meds for every person for every illness... harsh but true.

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Drug Safety Bill Puts Urgent Treatment in Jeopardy

By Craig H. KligerOct. 30, 2013, 3:30 p.m.We all remember the scenes in the film “Willy Wonka & the Chocolate Factory” where Gene Wilder nonchalantly warns, “Stop. Don’t,” as various characters try unknown products and experience unanticipated effects. Of course, each instance ends with predictably unfortunate results.Congress’ attempt to regulate compounded medications poses a Wonka-esque scenario in which potentially well-intentioned legislation may have the unintentional side effect of harming patients and adding unnecessary costs to the health care system.

read here

Fourth Question of the Day October 30, 2013 Once the Federal Drug Quality and Security Act becomes law how will this effect insurance polices and cost? Will there be a new category for outsourcing facilities?

BREAKING NEWS URGENT MUST READ--SENATE IS WORKING ON DEAL TO CONSIDER Federal Compounding Legislation TODAY, October 30, 2013!!! stay tuned for more info as it becomes available!!!

We are also working on an agreement to consider H.R.3204, a bill to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, as early as today

quoted from here

10/29/13 - PDA/FDA Joint Regulatory Conference: Great Place to Learn From Regulators

10/29/13 - PDA/FDA Joint Regulatory Conference: Great Place to Learn From Regulators

BETHESDA, Md., Oct. 29, 2013 /PRNewswire-USNewswire/ Many of the nearly 1,000 people who attended the 23rd Annual PDA/FDA Joint Regulatory Conference said the event provided them the opportunity to hear directly from regulators on the issues that affect them most, and from industry experts on how they are responding to these same issues. (Logo:http://photos.prnewswire.com/prnh/20130226/DC66667LOGO) Co-sponsored and co-planned by the PDA and the FDA, and held in Washington, D.C., the annual conference has become the place where those working in the pharmaceutical industry can join in discussions with representatives of the Food and Drug Administration to gain their perspectives. There were more than 45 FDA speakers, including Janet Woodcock, M.D., Director, CDER, FDA. Attendees come from across the globe. Many say the conference gives them more than in depth knowledge to take back to their firms. "In addition, for me as a lawyer, the many opportunities to hear directly from the FDA officials on what their current line of thinking is and what their visions on their expected policy changes are," said Daike Van de Putte, from GSK. "It was very insightful for me to learn the reasons behind such changes." Other attendees, who supply the pharmaceutical industry, said the conference helped them better understand their customers. "I came away with a deeper understanding of our customers' needs and challenges, along with critical information that enables us to become a better partner," said Ross. W. Acucena of EMD Millipore. "The 2013 PDA/FDA Joint Regulatory Conference was, as always, a priceless venue to connect with colleagues and FDA representatives," said Veronica Cruz, Ph.D., of Johnson & Johnson. The 2014 PDA/FDA Joint Regulatory Conference is scheduled for September 8-10. There is a workshop, entitled2014 PDA Drug Shortage Workshop on September 10-11. Courses from the renowned PDA Training and Research Institute will follow. About PDAThe Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide. PDA's Annual Meeting will be held April 7-9, 2014 in San Antonio, Texas. For information, visit www.pda.org and follow PDA on LinkedIn. Press ContactAmelia Townsend Director of Marketing Services, Parenteral Drug Association (PDA), townsend@pda.org, 301-656-5900, ext. 153 SOURCE Parenteral Drug Association quoted from here

IMPORTANT! Passage Of Compounding Safety Bill Positions TherapeuticsMD In Hormone Therapy Market Oct 30 2013, 13:58 | about: TXMD

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)

We continue to remain positive on TherapeuticsMD Inc. (NYSEMKT:TXMD) shares, a specialty pharmaceuticals company developing advanced-stage pharmaceutical hormone replacement therapy (HRT) products. Shares of TXMD have been on the rise after the House of Representatives passed a compounding safety bill - The Drug Quality and Security Act. While the passage of the bill has surprised many, we had predicted in a previous article that the bill would likely be passed. Although the bill still has to pass through the Senate, its passage in the House is crucial having been seen as a major hurdle. Earlier in the week, the company also announced achievement of significant proof-of-concept in phase 1, first-in-class soft gel vaginal formulation TX12-004HR. In addition, the company also hired a clinical expert. Before discussing what kind of impact these developments could have on TherapeuticsMD, let us just recap what the House bill is in essence about.

Making HRT safer

As we discussed in the previous article, drugs that address a single hormonal issue or monotherapies do not work well in hormone therapy. This is due to the fact that when a drug suppresses one problem hormone, the levels of another problem hormone increase. This issue created a need for developing combination therapies for HRT. Currently, the only drugs for HRT that have been approved by the FDA are monotherapeutic bio-identicals. As a result, doctors have been forced to send women needing HRT to compounding pharmacies that create over-the-counter hormone therapies by compounding non-FDA approved synthetic drugs. These therapies unfortunately have severe side-effects such as cancer.

Medscape Medical News FDA Report Outlines Approach to Personalized Medicine Miriam E. Tucker October 29, 2013

SILVER SPRING, Maryland — In a detailed new report, the US Food and Drug Administration (FDA) has outlined its approach for regulating new personalized therapies and devices.

The report, Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development, outlines the fundamental ways in which the FDA has modified its traditional approaches to drug and device regulation in the new era of products that are tailored toward specific patient subtypes, rather than broad diagnostic groups.

"We're very, very excited about this report because I think it captures the broad context of what's happening in science and medicine today and the role of the FDA as we enter the era of personalized medicine, and for us, personalized medical product development," FDA commissioner Margaret A. Hamburg, MD, said in a press briefing held at the FDA headquarters Monday.

Dr. Hamburg noted that the European Union's definition of personalized medicine, "Providing the right treatment to the right patient, at the right dose at the right time," has always been medicine's goal.

"Now, with the advance of science and technology and the understanding of both the underlying mechanisms and the human response to disease, we have so many more opportunities to target therapies in exciting ways and really improve the care that we can offer and the effectiveness of treatments," she said

Starting in 1998 with the approval of trastuzumab (Herceptin, Genentech) for the treatment of HER2-positive breast cancers, the FDA has approved more than 100 drugs that contain specific information about biomarkers in the labeling. Sometimes that information is added postlicensure.

continue to read here

FDA Says Brovana's Taglines Serve to Overstate Drug's Efficacy

FDA Says Brovana's Taglines Serve to Overstate Drug's Efficacy

[C’s Discount Pharmacy, Inc. et al. v. Louisiana CVS Pharmacy, LLC, No. 13-2989 Section “C”(3), E.D. La., 2013 U.S. Dist. LEXIS 140939]--

Here are the facts:  Plaintiffs in Louisiana sold two pharmacies to CVS. Part of the  agreement purchase and sales agreement included a non-competition clause prohibiting sellers from competing within 10 miles for a period of 5 years.  CVS paid a stated $1.1 million for the benefits of the non-competition agreement. The agree also included a provision for a $1 million “holdback” to assure payment of the seller’s indemnification obligations. The holdback was to be paid on March 30, 2013. CVS refused, however, to pay the holdback, claiming that plaintiffs had, contrary to the non-competition agreement, competed by directing former customers of theirs to pharmacies other than CVS. Plaintiff sued to demolish the agreement.

Be sure and read this case or the summary if you are a member of ASPL and receive their e-news.

American Society for Pharmacy Law (ASPL) is accepting nominations for the Joseph L. Fink, III, Founders Award.

Joseph L. Fink III Founders Award

The American Society for Pharmacy Law (ASPL) is accepting nominations for the Joseph L. Fink, III, Founders Award. The Founders Award was established in 2004 to recognize sustained and outstanding service and contributions to the professions of pharmacy and law. The award is named for Joseph L. Fink, III, who founded ASPL in 1974 and served as the Society’s first president.

Any ASPL member may nominate a person for the Award. The nominee need not be a current ASPL member. The Award may be awarded annually, but if no person nominated meets the criteria, the award will not be given.

The award consists of a perpetual plaque kept in the ASPL office with the names of each of the past recipients, as well as an individual award for the recipient.

The award will be presented at the ASPL Annual Meeting held in conjunction with the American Pharmacists Association (APhA) Annual Meeting & Exposition to be held March 28 - 31, 2014 in Orlando, FL.

To nominate an individual for the award, please submit a nomination form and all supporting documentation to ASPL by January 17, 2014. A nomination form may be downloaded from the ASPL website here. Nomination Form (PDF).