Trumm Drug

September 2010 Drug News

Brand Name Drug Prices Soar; So Do PBM Profits.
According to a new AARP report, the average retail price of the most popular brand-name drugs increased by 8.3% in 2009 and by 41.5% over the past five years – rates well in excess of inflation as measured by the Consumer Price Index. At the same time, major pharmacy benefit managers (PBMs) such as CVS Caremark, Express Scripts, and Medco, hired by employers and other health plan sponsors to negotiate lower prices from drug manufacturers, experienced record profits – in some cases increasing five-fold over the past decade.
Joseph H. Harmison, PD, National Community Pharmacists Association (NCPA) president, issued the following statement in response to the AARP report:

“Drug manufacturers pay PBMs billions of dollars each year to drive brand market share, resulting in enormous PBM profits, with the remainder passed on to health plans. These rebates have become predictable costs, simply budgeted into the overall, rising cost of brand name drugs. The pursuit of more rebate revenue has been known to lead PBMs to switch patients from generic drugs to pricier name brands. In addition, among the drugs experiencing the greatest price inflation are so-called specialty drugs that PBMs often require to be dispensed solely through their own mail order pharmacies.

“AARP’s findings, combined with windfall PBM profits, make it clear why PBMs so strongly resist greater transparency requirements, such as assuming a fiduciary duty to put clients’ interests above their own.

“Congressmen Anthony Weiner (D-N.Y.) and Jerry Moran (R-Kan.) are the lead sponsors of H.R. 5234, the PBM Audit Reform and Transparency Act of 2010, which tackles some of the most egregious practices of the PBM industry and should be passed. PBMs do not have a truly vested interest in reining in prescription drug prices, because that would hurt their profits. The Weiner-Moran bill will ensure that finally happens.”

Have you hit the Medicare “coverage gap” or “donut hole.” Get information here.
Most Medicare drug plans have a temporary limit on what they will cover for prescription drugs. This limit is known as a “coverage gap” or “donut hole.” Once Medicare patients reach their plan’s initial coverage limit, they will be responsible for paying all of their drug costs until they reach a certain out-of-pocket amount, when their insurance once again kicks in. Every drug plan is required to explain the coverage gap, but many consumers are surprised when their coverage vanishes and they are required to pay 100% of drug costs. Recently passed health care reform legislation closes the hole over the next ten years.

Typically, Medicare patients are covered for drug costs of up to $2,830 in 2010 (once they pay a deductible, if their plan has one). Upon reaching that limit, many patients are shocked to find they are required to pay 100% of the cost of their prescription drugs until their total out-of-pocket cost reaches $4,550. It is important to note that the coverage gap typically does not apply to patients with limited income and resources and those who qualify for extra help with their prescription drug costs. These individuals will continue to pay the same copayment or coinsurance amounts during the coverage gap.

How the Coverage Gap Works in 2010

• Deductible Phase. If you join a Medicare prescription drug plan, you may be required to pay up to the first $310 of your drug costs, commonly referred to as the deductible.
• Initial Coverage Phase. After meeting the deductible, you enter the “initial coverage phase” where you will remain until your total drug spend reaches $2,830. During this phase of coverage, you will pay approximately 25% of the cost of your medications (through monthly premiums and copays/coinsurance) while the government subsidizes the remaining 75%.
• Coverage Gap. Once you reach $2,830 in total drug costs, you will be required to pay the full cost of your prescription medications until your total out-of-pocket cost (including your annual deductible and copay amounts) reaches $4,550.
• Catastrophic Coverage. When you spend more than $4,550 out-of-pocket, the coverage gap ends and your drug plan pays most of the costs of your covered drugs for the remainder of the year, also known as catastrophic coverage. You will be responsible for a copay of $2.50 for each generic drug and $6.30 for other drugs (or 5%, whichever is higher).

How Health Care Reform Affects the Donut Hole

The health care reform bill closes the Medicare Part D “donut hole” over the next ten years (2010-2020). Patients who hit the donut hole in 2010 will receive a one-time $250 rebate. Beginning January 1, 2011, patients will also automatically receive a 50% discount off the negotiated price for brand-name prescription drugs that are covered under Part D.

The donut hole is unique to Medicare Part D, further confusing many seniors. Most do not even know their plan has a coverage gap until they fall into it. If you have questions, please contact your trusted local community pharmacist.

FDA Approves Vaccines For Upcoming Flu Season.
The 2010-11 flu vaccine will contain killed or weakened forms of three viruses: the A/California/7/09 (H1N1)-like virus; the A/Perth/16/2009 (H3N2)-like virus and the B/Brisbane/60/2008-like virus, according to FDA. The agency approved eight vaccines made by six companies, including a high-dose product for people 65 years and over. FDA Press Release Separately, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices published its recommendations for influenza vaccination in the coming flu season. The major changes include routine vaccination for all people aged six months and older.

New prescription emergency contraceptive approved.
The FDA approved ella (ulipristal) tablets for prescription emergency contraception. The tablets, manufactured by Laboratoire HRA Pharma of Paris and distributed by Watson Pharma, are intended to prevent pregnancy when taken orally within 120 hours of contraceptive failure or unprotected sex.

The drug is a progesterone agonist/antagonist which has been available in Europe since May 2009 under the brand name ellaOne. In June 2010, an FDA Advisory Committee for Reproductive Health Drugs met to discuss ella. The committee voted unanimously that the drug application provided compelling data on efficacy and sufficient information on safety for the proposed indication of emergency contraception.

The safety and efficacy of ella were demonstrated in two Phase III clinical trials. One study was a prospective, multicenter, open-label, single-arm trial conducted in the United States; the other was a randomized, multicenter, single-blind comparator-controlled trial conducted in the United States, United Kingdom, and Ireland.

Adverse effects most frequently observed with ella in the clinical trials included headache, nausea, abdominal pain, dysmenorrhea, fatigue, and dizziness. The profile of adverse effects for ella is similar to that of FDA-approved levonorgestrel emergency contraceptives.

According to the product labeling for ella, women with known or suspected pregnancy and women who are breastfeeding should not use the drug. A patient package insert also will be provided to ensure that women are fully informed of the benefits and risks involved in the use of the drug.

FDA Issues New Warning Against Quinine Use For Leg Cramps.
Following reports of serious bleeding events, FDA approved a new risk evaluation and mitigation strategy (REMS) to warn against the off-label use of Qualaquin (quinine sulfate) for nighttime leg cramps. Qualaquin is only FDA-approved treatment for uncomplicated malaria.

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