January 2007
customer service, pharmacy distribution channels,
Counterfeit Test Strips
drug use management, formulary pharmacy and therapeutics, medication therapy management, and benefit design and administration. The launch of the standards is expected by the third quarter.
The FDA recently announced a public alert warning of counterfeit blood glucose testing strips. The strips
potentially affected are Lifescan OneTouch Basic/Profile strips and Lifescan OneTouch Ultra test strips. Affected boxes of test strips may have writing
FDA Approves New
in Greek, Portuguese or French on the outside. The affected strips may show inaccurate blood sugar
Treatments for Type 2
levels causing members to use too much or not
Diabetes
enough insulin. Members should return the affected, unused strips to the store where they were
On October 17, the FDA announced the approval of
Januvia tablets. Januvia is the first diabetes
treatment approved in a new class of drugs known as DPP-4 inhibitors that enhance the body's own ability
Januvia is approved for use, in addition to diet and
exercise, to improve blood sugar levels in patients with type 2 diabetes. Januvia may be used alone or
in combination with two other commonly prescribed oral diabetes medications, metformin and a PPAR
(peroxisome proliferator-activated receptor gamma)
agonist, when either of these drugs together with diet
and exercise, don't provide adequate blood sugar
The FDA also approved Duetact™ for the treatment of type 2 diabetes. Duetact is a single tablet
URAC Drafts its First PBM
formulation containing Actos®, a thiazolidinedione, and glimepiride, a sulfonylurea. Duetact, which is
Accreditation Program
administered once daily, will be supplied in 30mg/2mg and 30mg/4mg dosage strengths.
2007 will serve as the inaugural year for the URAC,
the Washington, D.C. – based independent accreditor of health care management, PBM accreditation program. This program will feature seven modules outlining PBM best practices and standards that consist of organizational integrity,
New Drug Approvals NitroMist – The FDA approved NitroMist for the relief
of acute chest pain due to coronary artery disease. It
is sprayed into the mouth, under the tongue at the onset of chest pain.
Key Patent or FDA Exclusivity Expirations
Zolinza – Zolina has been approved by the FDA for
the treatment of cutaneous t-cell lymphoma (CTLC),
a type of non-Hodgkin’s lymphoma. It should be
used when the disease persists, worsens or reoccurs or after treatment with other medications. The
recommended dose is 400mg once daily with the
monthly cost of therapy estimated at $7,200.
Source: Express Scripts Clinical Matters and Medco Specialty Medications in Development
According to the Pharmaceutical Research and
Manufacturers of America (PhRMA) there are 418 biotech medications in development for over 100
diseases. All of these medications are in human
clinical trials or under FDA review. The medications
in development include 210 for cancer, 50 for infectious diseases, 44 for autoimmune diseases and
The following products have either near term or
22 for AIDS/HIV related conditions. There are 125
expired patents, but for various reasons generics are
biotech medications on the market today.
The average cost of a specialty medication is
approximately $1400 a month. Today, the overall
drug spending for specialty medications ranges from
10% to 19%. By 2009, it is expected to increase to 28%.
Sources: 2006 Report –PhRMA.org Generic Watch
New Generics are Currently Available for:
Behind The Counter, January 2007
January 2007
New Drug Approvals