Latelines for March 18, 2002
Only a few months after being named to head the SureScript electronic connectivity firm, David Weinstein has bowed out as its CEO. NACDS said Weinstein left to pursue other opportunities. SureScript was jointly formed by NACDS and NCPA last summer to electronically connect pharmacists and physicians to make transactions such as Rx refill authorizations more efficient.
To avoid the specter of patients carrying myriad discount Rx cards, NACDS has proposed a PharmacyCareOneCard program. The program would allow low-income seniors to carry a single card to participate in the growing array of Rx card programs from drug manufacturers. NACDS is negotiating with Argus Health Systems in Kansas City to be the first administrator of the card. To rally support for the program, the association has formed the Pharmacy Care Alliance and named Bill Sittmann as executive director of the group. He can be reached at firstname.lastname@example.org or by phone at (703) 549-3001.
CMS has finally published a proposal, in the March 6 Federal Register, on a Medicare-endorsed Rx discount card program. NACDS and NCPA question whether the Bush Administration has authority to propose its revised plan for Medicare Rx discount cards issued by private companies. When the original Rx card proposal was announced last summer, NACDS and NCPA went to court to stop it. The judge sided with community pharmacy and halted the plan until the government could prove it has the necessary authority. NACDS is calling for an open debate in Congress on the issue of an Rx benefit for Medicare patients.
Eli Lilly unveiled a discount card program that will charge low-income seniors $12 per month per prescription for its drugs sold at retail, including Evista, Humulin, and Zyprexa. The Indianapolis-based firm estimates five million seniors will qualify for the LillyAnswers program, which could save participants an average of $600 per year. In the absence of a Medicare Rx benefit, NACDS commended the Lilly move but raised concerns about operational problems created when drugstores have to handle all the cards created by drug companies in recent months.
A position statement on the management of postmenopausal osteoporosis was published by the North American Menopause Society (NAMS). The document defines current clinical practice standards relevant to the diagnosis, prevention, and treatment of postmenopausal osteoporosis. Fracture risk increases among women with the disease. Hip and spine fractures in particular are associated with significant morbidity and mortality. Osteoporosis management focuses on identifying and reducing risk factors through lifestyle modification and pharmacologic therapy, if necessary. The NAMS position statement will be published in the March-April 2002 issue of Menopause, the society's peer-reviewed journal, and can be downloaded on the NAMS Web site at www.menopause.org.
The FDA has accepted supplemental New Drug Applications to switch all indications and market all formulations of the nonsedating antihistamine Claritin (loratadine) as OTC products, according to the manufacturer, Schering-Plough. The applications to switch Claritin to OTC status have been assigned a "standard review" by the FDA, with a target date of Nov. 28, 2002.
The interferon beta-1a drug Rebif (Serono) has been approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS). Rebif delays the agglomeration of disabilities and decreases the frequency of clinical complications in those with relapsing forms of MS. The recommended dosage of Rebif is 44 mcg t.i.w., injected subcutaneously. Common adverse effects include injection-site reactions, flulike symptoms, and abdominal pain. Rebif could not previously be marketed in the United States because another interferon beta-1a product, Biogen's Avonex, had been granted orphan drug status and exclusivity under the Orphan Drug Act (ODA). Marketing approval was granted under the terms of the ODA only after Rebif demonstrated clinical superiority compared with Avonex at 24 weeks in the EVIDENCE study.
Seventeen percent of consumers said they have haggled with their pharmacy for lower drug prices in the past year, according to an on-line survey of 2,118 adults conducted by Harris Interactive. Among consumers in only fair or poor health, 28% tried to get a price reduction. Of those who asked for lower prices, 48% were successful. Thirteen percent of those polled had haggled with their doctor, compared with 12% with their dentist and 10% with a hospital. More than half of those polled said it's likely or very likely that they will haggle in the next two years if their out-of-pocket medical costs increase substantially.
PhRMA has urged Congress to renew the Prescription Drug User Fee Act, which was originally passed in 1992. The law ensures prompt FDA review of new drug applications. The user fees pay for the 1,000 additional drug reviewers hired by the FDA. The law is scheduled to sunset on Sept. 30 unless Congress reauthorizes it. In a related move, the drug companies reached a tentative agreement with the FDA to increase the user fees in order to hire more drug reviewers. The FDA's costs have exceeded user fee income for the past three years, with a $30 million shortfall this year.
Infliximab (Remicade/ Centocor), in combination with methotrexate (Rheumatrex/Lederle), has become the first drug approved by the FDA to improve physical function, inhibit the progression of structural damage, and reduce signs and symptoms in patients with moderate to severe rheumatoid arthritis (RA) that is insufficiently responsive to methotrexate monotherapy. A monoclonal antibody, infliximab targets and binds to TNF-alfa. Overproduction of TNF-alfa may play a role in RA, Crohn's disease, and many immune-mediated inflammatory disorders, including ulcerative colitis and psoriasis. Reports exist of serious infections, including sepsis, and of serious infusion reactions in those taking infliximab. Other effects of infliximab therapy experienced by patients in clinical studies include upper respiratory infection and headache. According to the Arthritis Foundation, the approval of infliximab provides further evidence that drug therapy plays an increasingly important role in improving the lives of RA patients.
The FDA has approved clopidogrel (Plavix, Sanofi-Synthelabo and Bristol-Myers Squibb) for the treatment of acute coronary syndrome (ACS), defined as unstable angina and non-Q-wave MI. The approval of clopidogrel for this new indication is based on the findings of the CURE study, which demonstrated that those with ACS taking clopidogrel had a significantly reduced risk of heart attack, stroke, or cardiovascular death compared with those given placebo. The most common side effects of clopidogrel therapy observed in clinical trials included pruritus and purpura.
A new dosage counter intended to promote consistent use of mometasone (Nasonex/Schering) and assist patients in keeping track of the need to refill their medication was recently introduced by Schering Laboratories. The device features an alarm that reminds patients to administer the medication at the correct time every day and alerts users as to exactly how many sprays remain at any given time, so the prescription can be refilled as necessary. Schering is providing the dosage counters to physicians nationwide for distribution to patients free of charge.
The Department of Labor may classify pharmacists as a shortage occupation at the urging of NACDS. Such a designation would streamline immigration for pharmacists by lopping up to three years off the process to acquire a green card for permanent employment in the United States. Labor officials asked for more data about the R.Ph. shortage.
Despite fierce opposition by psychiatrists and other medical doctors, the governor signed a bill making New Mexico the first state to allow psychologists to prescribe drugs for mental illnesses. Psychologists, who do not have medical degrees, would have to complete 450 hours of specialized training in medicine and pharmacology and pass an exam. They would then have to spend two years seeing patients under the supervision of a psychiatrist or physician before they could independently prescribe. Similar bills are pending in Georgia, Hawaii, Illinois, and Tennessee.
The HHS OIG agreed to release an AWP calculation for various categories of Medicaid drugs, such as single-source brands and innovator multiple-source brands without federal upper limits. NACDS has argued that OIG miscalculated the average estimated acquisition cost to community pharmacies for brand-name drugs at AWP minus 21.8% because it included many drugs as brands that are in reality branded generics. However, since that meeting, some chains have complained that OIG is still sending out the inflated AWP figure to states trying to set Medicaid reimbursement rates.
A co-lead plaintiff attorney representing pharmacies in the drug price-fixing lawsuit negotiated a deal with GlaxoSmithKline to pay $5 million in cash in lieu of 20 million cimetidine certificates. Pharmacies that originally opted to take the certificates will get cash instead. Claimants can expect a check equal to about 1% of the amount they previously received. Approved claimants do not have to file additional papers or even respond in order to receive their share of the final distribution. However, Pharmacy Freedom Fund president Bob Gude said if the judge approves the deal, it could take months for the checks to be sent.
Marina Marketos. Latelines. Drug Topics 2002;6:7.