PHARMACY

Brand medicines at retail pharmacy to no longer be covered by Tricare for Life

BY Michael Johnsen

FALLS CHURCH, Va. — Tricare for Life beneficiaries soon will receive letters guiding them to Tricare Pharmacy Home Delivery or a military pharmacy for some prescriptions as part of a congressionally mandated pilot program, officials of the military healthcare plan reported Tuesday.

Tricare for Life is secondary coverage for Tricare beneficiaries who have both Medicare Parts A and B in the United States and U.S. territories.

Beginning the week of Feb. 17, officials will send letters to affected Tricare for Life beneficiaries notifying them of the pilot program. The pilot program starts March 15, and it requires beneficiaries who use Tricare for Life to get certain medications through home delivery or at a military pharmacy. The program applies to refills of maintenance medications taken regularly for chronic conditions, officials said.

As part of the pilot program, officials added, Tricare will stop paying for these medications from a retail pharmacy. But they noted that the program does not apply to medications for acute conditions taken for a limited time, such as antibiotics or pain medications or any generic medications. 

At this time, they said, it also does not apply to generic drugs.

Congress mandated the pilot program in the 2013 National Defense Authorization Act. It will last for five years, but beneficiaries may choose to opt out after filling an affected prescription under the pilot program through home delivery for one year.

Beneficiaries will be notified if they are taking a medication covered under the program. They will have two “courtesy fills” available through a retail pharmacy before they are responsible for the entire cost of their medication.

Some people are exempt, including people with another prescription drug plan or people living overseas. People living in a nursing home may contact Express Scripts to request a waiver from the pilot program.

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FDA initiates Secure Supply Chain Pilot Program with 13 prequalified pharmaceutical distributors

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. 

In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.

The goal of the program is to enable the FDA to evaluate resource savings that will allow the agency to focus imports surveillance resources on preventing the entry of high-risk drugs that are the most likely to compromise the quality and safety of the U.S. drug supply.

“By creating incentives for manufacturers to adopt best practices for supply chain integrity, we can enhance the quality and safety of imported drugs,” stated Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers.”  

During these next two years, the FDA will evaluate the program’s effectiveness at enhancing imported drug compliance with FDA regulations and the security of the drug supply chain. If the FDA determines the program to be effective, a more permanent program may be established and possibly extended to additional participating companies.

The prequalified companies accepted into the program that will receive expedited entry, are the following:

  • AbbVie;
  • Allergan;
  • Astellas U.S. Technologies;
  • Bristol-Myers Squibb Company;
  • Celgene Corporation;
  • GE Healthcare;
  • GlaxoSmithKline;
  • Merck Sharp & Dohme Corporation;
  • Mylan Pharmaceuticals;
  • Novartis Pharmaceuticals;
  • Pfizer;
  • Teva Pharmaceutcials USA; and
  • Watson Laboratories.

Each of the 13 companies met multiple participation conditions, including:

  • Committing to comply with requirements of the Food, Drug, and Cosmetics Act;
  • Having a validated secure supply chain protocol per the U.S. Customs and Border Protection’s Customs-Trade Partnership Against Terrorism program;
  • Having a plan in place to quickly correct potential problems the FDA identifies regarding importation of specific products;
  • Having effective recall and corrective action plans in place; and
  • Maintaining control over their drugs from the time of manufacture abroad through entry into the United States.

 

 

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FDA approves Northera

BY Ryan Chavis

SILVER SPRING, Md. — The Food and Drug Administration announced that it has approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension.

NOH is a rare, chronic drop in blood pressure upon standing that’s associated with Parkinson’s disease, multiple-system atrophy and pure autonomic failure. Symptoms include dizziness, lightheadedness, blurred vision, fatigue and fainting when a person stands.

“People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing,” said Norman Stockbridge, M.D., Ph.D, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “There are limited treatment options for people with NOH, and we are committed to helping make safe and effective treatments available.”

Northera received orphan-product designation from the FDA; it is made by Charlotte-based Chelsea Therapeutics.

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