Latelines for Aug. 20, 2001
APhA has filed a petition to be named as a plaintiff in a lawsuit challenging the legality of the Bush Administration's plan for a Medicare Rx discount card program run by pharmacy benefit managers. The lawsuit was filed July 18 by NACDS and NCPA against administration officials. APhA alleged that the discount cards would jeopardize the R.Ph.'s ability to serve Medicare beneficiaries and comply with legal mandates.
Scios Inc.'s Natrecor (nesiritide) has been approved for hospitalized patients with acutely decompensated congestive heart failure (CHF) who have dyspnea at rest so they can breathe more easily. The Sunnyvale, Calif., firm claims nesiritide is the first of a new drug class, called human B-type natriuretic peptides (hBNP), a natural protein found in the body. Nesiritide is a recombinant form of hBNP; it helps dilate blood vessels. The company warns that the injectable can cause hypotension, so it should be given only in a setting where blood pressure can be checked closely. Reportedly, each vial, or a day's treatment, will cost $380. Shipments to hospitals are expected this month.
PhRMA's lawyers are very busy. Late last month, they asked the U.S. Supreme Court to reverse a lower court ruling that upheld Maine's Rx discount law. That law seeks major rebates from manufacturers for the 325,000 residents without Rx insurance. It authorizes the state to impose price controls if the rebates aren't good enough. A preliminary injunction has stopped the law, enacted last year, from taking effect.
On Aug. 8, PhRMA went to federal court in Tallahassee to overturn a Florida law that establishes a Medicaid formulary and requires manufacturers to provide additional rebates to gain a place on it. Ironically, PhRMA's chairman this year is Pfizer CEO Henry McKinnell who negotiated a deal with the state that got all the company's drugs on the formulary without extra rebates. Pfizer promised Florida $33 million in savings from a disease management program it is running and free Rxs. PhRMA traditionally has opposed Medicaid formularies. PhRMA lawyers also are preparing briefs to defend their victory with a three-judge federal appeals panel that tossed out Vermont's Rx discount plan. Vermont wants the entire U.S. Court of Appeals for the Federal Circuit to rule.
The American Heart Association has teamed with the APhA Foundation to help pharmacies provide consumers with information, services, and programs about heart disease. A pilot project will provide pharmacies with computer kiosks featuring AHA information and a behavior modification program. A study will assess the use and effectiveness of the in-pharmacy kiosks as a way to distribute AHA materials.
Patients using Walgreens on-line pharmacy service can now have their Rx refills automatically dispensed so that they don't run out of medication if they forget to reorder, according to the Deerfield, Ill., drugstore chain. Notified by e-mail when the Rx is ready, patients can pick up their medication at their local Walgreens or have it sent by mail.
The National Association of Nurse Practitioners in Women's Health is touting a mail-order program that offers discounted oral contraceptives for women whose health insurance does not cover birth control pills. The group called on women to contact their employers and Congress about the lack of contra-ceptive coverage for women. The mail-order program is called SmartWoman Rx (www.smartwomanrx.com ).
The FDA needs to improve its analysis of gender-specific data submitted in NDAs, according to a GAO report. GAO also found signs that while more women than men appear to comprise the patient population in later-stage clinical trials, women seemed underrepresented in early stages. Moreover, the FDA cannot be sure how many women actually are involved in clinical trials.
A report by the HHS Office of Inspector General has found that nearly three dozen state Medicaid agencies have experienced major problems with PBMs, and those problems were more than with "all other types of third parties combined." The OIG didn't identify any PBMs, but it said 26 states named the same one as a particular problem. The report examined efforts to get pharmacy payments from liable third parties. It said 32 states recovered only 17% of the $440 million they were owed in 1999.
The findings of the Diabetes Prevention Program (DPP), released by NIH, show conclusively that Type 2 diabetes can be prevented or significantly delayed in onset. The landmark trial compared diet and exercise with treatment with metformin in more than 3,200 overweight patients with impaired glucose tolerance. Participants randomly assigned to intensive lifestyle intervention reduced their risk of getting the disease by 58%, while those randomized to metformin reduced their risk by 31%. The DPP also demonstrated the value of the healthcare team approach in treating patients at high risk of developing diabetes. The American Diabetes Association will consider the DPP data and issue guidelines on how healthcare professionals can incorporate prevention strategies into their practices.
Schering-Plough Corp. has received FDA approval for the use of Peg-Intron (peginterferon alfa-2b) Powder for Injection in combination with Rebetol (ribavirin) Capsules for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age. The company reports this is the first and only pegylated interferon combination therapy approved in the United States. Peg-Intron, approved January 2001, is a longer-acting form of Intron A (interferon alfa-2b, recombinant) that offers greater patient convenience with once-weekly dosing. Rebetol was granted FDA approval July 2001 as a stand-alone product for use in combination with Intron-A.
Consumers who want to save money on prescriptions should bypass their local pharmacy in favor of the Internet or mail order, according to a new self-help book from Corsair Health, an Indianapolis consulting firm. The authors also urge cash-paying consumers to order medications from Canada and to use Rx discount cards if their pharmacy participates.
Sens. Orrin Hatch (R, Utah) and Tom Harkin (D, Iowa) have introduced legislation to amend the Internal Revenue Code of 1986 to provide that amounts paid for foods for special dietary use, dietary supplements, or medical foods be treated as medical expenses. The act will be known as the Dietary Supplement Tax Fairness Act of 2001.
Supermarket pharmacies dispensed 389 million Rxs in 2000, a 60% increase from 1996, according to figures just released by the Food Marketing Institute in its Report From the 2001 Supermarket Pharmacy Survey. The survey, which was conducted by questionnaires sent in the mail, is based on 55 responses representing 3,265 stores. The report also revealed that supermarket pharmacies grew from 13% of total retail pharmacy outlets in 1996 (6,752 stores) to 17% in 2000 (8,814 stores).
HORIZON Pharmacies has filed a voluntary petition for Chapter 11 relief in the U.S. Bankruptcy Court for Northern District of Texas, Dallas division. Voluntary petitions and requests for joint administration were also filed on behalf of three subsidiaries of the company, Horizon Home Care, HorizonScripts.com, and Jones Low Priced Drugs. The company also announced that concurrent with the Chapter 11 filing, it had closed a $2 million debtor-in-possession line of credit with its senior lender, McKessonHBOC. HORIZON intends to utilize the Chapter 11 process to conduct orderly sales of its retail pharmacy operations.
One-third of seniors take medications prescribed by two or more physicians, according to an ASHP study. The survey of 275 people age 65 and older also found that 76% were taking at least three prescription drugs and about one-third were taking eight or more medications.
Bayer Corp. has announced the voluntary market withdrawal of its cholesterol- lowering drug Baycol (cerivastatin) because of postmarketing reports of rhabdomyolysis (muscle weakness) linked to 31 U.S. deaths. The risk of rhabdomyolysis appears to increase significantly by concomitant use with gemfibrozil (Lopid, Pfizer), when used in higher doses, and in the elderly. In 12 of the 31 U.S. deaths, patients were also taking gemfibrozil. The FDA advises patients taking Baycol to consult their physician about an alternative therapy. While all the statins have been associated with very rare reports of this sometimes-fatal adverse event, the incidence of fatal cases associated with Baycol has been reported more often than with any other approved statin.
The FDA has approved Abbott Laboratories' macrolide antibiotic, Biaxin XL (clarithromycin extended-release tablets), for the seven-day treatment of mild to moderate community-acquired pneumonia (CAP) in adults. The approval was based on a study that demonstrated a clinical cure with Biaxin XL comparable to that achieved with Ortho-McNeil's quinolone antibiotic Levaquin (levofloxacin) in the treatment of CAP. Biaxin XL is already approved for the treatment of acute bacterial exacerbation of chronic bronchitis and for acute maxillary sinusitis.
Marina Marketos. Latelines. Drug Topics 2001;16:5.