Latelines for Jan. 1, 2001
A state-based Rx plan for the low-income elderly, similar to the SenioRx Gold proposal developed by NACDS, is one of Texas Gov. George W. Bush's top legislative priorities now that he officially is on his way to the White House. The President-elect calls his approach "an immediate helping hand" to be put in place quickly with federal block grants while long-term Medicare reform with Rx coverage for all is debated. During the Presidential campaign, Bush proposed spending $48 billion over four years to pay all Rx costs for seniors with incomes below 135% of the federal poverty level and sliding-scale aid for those between 135% and 175%. Catastrophic coverage would kick in when a beneficiary's Rx bill hits $6,000 in a year.
A public interest law firm has sued Kaiser Permanente over its patient pill-splitting policy, arguing that the practice is inaccurate and dangerous. Trial Lawyers for Public Justice filed a class action suit in Superior Court in Oakland, Calif., to stop the practice. Kaiser said cutting certain double-dose Rxs in half by patients is voluntary and that it has guidelines to determine when it is appropriate. APhA and ASCP are among the organizations on record against the practice of pill-splitting.
Michigan has become the 43rd state to pass legislation requiring state-regulated health insurers to cover diabetes supplies and self-management training, according to the American Diabetes Association. The supplies and services still are subject to co-pays and deductibles.
PhRMA has sued HCFA for approving a Vermont plan that would allow seniors without Rx coverage and other uninsured residents with incomes below $25,000 to buy Rxs at the same rate the state does for Medicaid beneficiaries. That amounts to about AWP minus 17.5%, including a rebate. Beneficiaries would have to pay the remaining 82.5% of the cost. PhRMA companies would be required to pay the same rebate as they do under Medicaid. The plan was scheduled to start Jan. 1.
Next door to Vermont, Maine has decided to postpone its Rx discount program, already under legal fire from PhRMA. The Maine plan, originally set to kick off Jan. 1, is based on negotiated rebates with the threat of price controls. Most of the law was blocked by a temporary order won by PhRMA in federal court. Maine's appeal will be heard in March.
The American Medical Association is exploring legal options to prevent pharmacies and third-party payers from releasing physician-specific prescribing information. The AMA house of delegates last month expressed concern about Rx makers gaining access to individual prescribing patterns and using the information in targeted marketing efforts. The delegates ordered the AMA staff to report on possible remedies by June.
Tamiflu (oseltamivir phosphate), which picked up a new indication for flu prophylaxis this past November, has gained yet another indicationto treat children one year and older who have been symptomatic for no more than two days. To accommodate this new indication, the Hoffmann-La Roche capsule will be available in a liquid suspension, so it can also be taken by adults who cannot swallow a capsule. The antiviral was originally approved for treating adults with influenza types A and B.
There's a new alternative to heparin for anticoagulation. It's Angiomax (bivalirudin), just approved for the Medicines Co., Cambridge, Mass. To be administered with aspirin, the drug serves as an anticoagulant for patients with unstable angina undergoing percutaneous transluminal coronary angioplasty. The drug is packaged in 250-mg vials for IV injection.
More than 14,000 technicians have met the Texas pharmacy board's New Year's Day deadline to be certified by the Pharmacy Technician Certification Board. Another 5,000 techs had signed up for PTCB's November exam, but results are not in yet. Texas has somewhere between 16,000 and 20,000 techs, said pharmacy board executive director Gay Dodson. Techs who miss the deadline can still work but will be classified as "techs in training" for one year. People who have been employed as techs since 1991 or who work in rural counties can apply for exemption to the certification rule.
Employer health insurance plans that pay for similar preventive drugs cannot discriminate by refusing to cover oral contraceptives (OCs), according to a ruling by the Equal Employment Opportunity Commission. The directive, which is not binding on the courts, applies only to two nurses who filed a discrimination case through Planned Parenthood. However, the EEOC ruling gives employers and the courts guidance on the law. Still pending is a similar case filed by Planned Parenthood last summer on behalf of Jennifer Erickson, a Seattle pharmacist seeking to force her employer, Bartell Drug Co., to include OCs in its health plan.
Schering-Plough is seeking regulatory approval to sell the two components in its Rebetron Hepatitis C treatment kit separately. The move to break up the kit follows criticism from patients, doctors, and legislators about the kit's high price, which is nearly $18,000. In addition, the product's unusual packaging restricted doctors from experimenting with one of the two products in the kit.
The FDA has cleared expanded use of FreeStyle, a blood glucose monitoring system developed by TheraSense, Alameda, Calif. The product allows people with diabetes to obtain a blood sample from places other than fingertips. The new clearance permits the use of FreeStyle on the upper arm, thigh, calf, and anywhere on the hand, in addition to the previously cleared forearm testing site.
Abbott Laboratories has agreed to pay $6.9 billion for the pharmaceutical operations of BASF, including the global operations of Knoll. Abbott expects the cash deal to boost sales as well as its research and development capacity, which includes monoclonal antibody technology and an immunology drug candidate to treat rheumatoid arthritis. BASF Pharma's top drugs include Synthroid and Meridia.
The University of New Mexico College of Pharmacy plans to develop a distance-learning Web site to train nuclear pharmacy students. The site will be developed by the XREX unit of NMxS, an Albuquerque Internet technology firm. The problem-based curriculum will include diagnostic-quality medical images and magnified viewing capabilities for pharmacy school undergrads and practicing R.Ph.s seeking advanced training in nuclear pharmacy. The site will be accessible through a regular modem connection and will not require special software to zoom in on the clinical images.
New products to treat lupus are on the way. Until now, lupus, an autoimmune disorder that affects mostly women, has been treated with high doses of corticosteroids and chemotherapy drugs. But these medications, while effective, can be very toxic. For this reason, patients are looking forward to new treatments, including DHEA and antibody therapyboth under development. (For more on lupus management, see our upcoming issue.)
Alza Corp.'s Concerta (methylphenidate HCl) for attention deficit hyperactivity disorder will be available in a new 54-mg form as of mid-January. The once-daily drug, which lasts through 12 hours for patients age six and older, is now available as 18-mg and 36-mg tablets. The new dosage provides greater dosing flexibility, said the firm.
Marina Marketos. Latelines. Drug Topics 2001;1:5.