PHARMACY

Arxcel survey points to manufacturers as main reason for high drug costs

BY Drew Buono

WILLIAMSVILLE, N.Y. Arxcel, a consulting group for pharmacy benefit managers, has released the results of its sixth annual Arxcel Prescription Benefit Research Survey. The survey is aimed at gathering information as to why drug costs are skyrocketing and what solutions can be implemented to impede them.

One of the main results from the survey showed that according to 70 percent of survey respondents, drug manufacturers are to blame for the high cost of prescription benefit programs. The respondents to the survey were benefit managers, human resource executives and pharmacy benefit managers, who were asked to participate for the first time.

When respondents were asked to name the most significant cause of rising prescription costs, direct-to-consumer advertising ranked first with 45.5 percent. Research and development ranked second with 24.6 percent. When combined, these numbers revealed that 70.1 percent of those surveyed blamed drug manufacturers for the high cost of prescription benefit programs. The aging population was the third most popular reason with 16.8 percent.

The survey showed a split perception of the PBM industry. Half of the respondents rated the industry as “positive” or “very positive” while the other half rated it “neutral” to “very negative.” While the industry received mixed reviews, individual PBMs fared somewhat better. Nearly two-thirds rated their PBM favorably with 52 percent trusting their PBM is operating in their company’s best interest.

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PHARMACY

Mylan, Forest get FDA approval of Bystolic for hypertension

BY Drew Buono

WASHINGTON The Food and Drug Administration has approved Mylan and Forest Labs’ new drug, nebivolol, for the treatment of high blood pressure. Forest will market the drug under the prescription name Bystolic.

Nearly 1-in-3 adults in the United States has high blood pressure, also called hypertension, which can increase the risks for stroke, heart failure, heart attack and kidney failure. “High blood pressure is often called the ‘silent killer’ because it usually has no symptoms until it causes damage to the body,” said Douglas Throckmorton, the FDA’s deputy director of the Center for Drug Evaluation and Research. “Bystolic offers a new treatment option for people who need to control their high blood pressure.”

More than 2,000 people received Bystolic during clinical trials. The drug’s efficacy was similar to that of other approved beta blockers, the FDA said. The most common reported side effects were headache, fatigue, dizziness and diarrhea.

On Dec. 2 of this year, Forest and Mylan had said that final approval was contingent upon resolution of manufacturing deficiencies at a plant in Belgium.

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Genzyme gets expanded approval for Thyrogen from FDA

BY Drew Buono

CAMBRIDGE, Mass. The Food and Drug Administration has granted expanded approval for Genzyme’s thyroid cancer drug Thyrogen, according to published reports.

The new indication allows for Thyrogen (thyrotrophin) to be used in combination with radioiodine, a radioactive iodine used to treat thyroid cancer, to destroy the remaining thyroid tissue in patients who have had their cancerous thyroids removed.

Thyrogen was initially approved in the U.S. in 1998 for use as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer. The drug helps increase the sensitivity of testing while allowing patients to avoid the potentially debilitating symptoms of thyroid hormone withdrawal.

“This new indication extends the significant benefits of Thyrogen to patients during their initial treatment for thyroid cancer, in addition to its current use in follow-up diagnostic procedures to detect recurrence,” said Mike Heslop, senior vice president and general manager of Genzyme’s endocrine business.

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