Latebreakers: March 5, 2007

DEA proposes treating new ADHD drug as Schedule II
Should lisdexamfetamine dimesylate (Vyvanse, New River/Shire plc), the new molecular entity approved for ADHD, be classified under Controlled Substance Schedule II? That's what DEA proposed in a notice published in the Feb. 22 Federal Register. Lisdexamfetamine shares many pharmacological effects and abuse potential with amphetamine, DEA noted. Shire plans to launch the prodrug, which is therapeutically inactive until metabolized in the body, for the pediatric indication and to apply for an adult indication in the second quarter. Comments to DEA should be sent by March 26.

NCVHS warns industry not ready for NPI
In a report on the status of the National Provider Identifier (NPI) system to HHS, Simon Cohn, M.D., MPH, chairman of the National Committee on Vital & Health Statistics (NCVHS), warned that the group is "skeptical that the industry will be able to meet the target date for NPI compliance." NCVHS has been charged with the task of monitoring the healthcare industry's progress toward meeting the May 23 compliance date for implementation of NPI. According to the committee, some 20,000 pharmacies have not registered NPI numbers in its database. In addition, Cohn noted, HHS still has not disseminated its NPI data, making it difficult for healthcare providers, insurers, and other agencies to share NPI numbers and ensure that software systems work properly before the May 23 deadline. As a result, he concluded, "we're convinced that requiring complete compliance with the NPI standard on May 23 is unrealistic."

Increased risk of fractures with rosiglitazone
GlaxoSmithKline has notified healthcare professionals of an increased risk of fractures observed in female patients receiving one of its rosiglitazone-containing medications, such as Avandia (rosiglitazone), Avandamet (rosiglitazone/metformin), and Avandaryl (rosiglitazone/glimepiride)—all used to treat Type 2 diabetes. Final results of ADOPT, a clinical study that compared the efficacy of rosiglitazone with that of metformin and glyburide, showed significantly more fractures among women taking rosiglitazone. The majority of fractures were in the upper arm, foot, and hand. GSK said the number of patients experiencing hip and spine fractures was not increased in the rosiglitazone group. Preliminary analysis of a second, ongoing study of rosiglitazone showed results consistent with the ADOPT observations. GSK said the mechanism of the observed increase in fractures is unknown, but that the risk should be considered in female patients currently being treated with the drug.

ACPE revises CE guidelines
ACPE has announced revised definitions for qualifying continuing education programs for pharmacists and pharmacy technicians. Beginning Aug. 1, the Universal Program Number assigned to each CE will include a "P" for programs targeted for pharmacists and a "T" for technicians. There will be a transition period from Aug. 1 through Dec. 31.

New warning for asthma therapy
Omalizumab (Xolair, Genentech) labeling will now include a black box warning alerting patients to the potential for anaphylaxis, according to the FDA. Cases of anaphylaxis reported both during and after clinical trials have occurred in about one out of 1,000 patients and may include chest tightness, dizziness, difficulty breathing, swelling of the mouth and throat, fainting, itching, and hives. The reaction can occur after any dose of omalizumab and may be delayed up to 24 hours after the dose is given. Patients should be observed for at least two hours following a dose and should carry emergency self-treatment for anaphylaxis. The FDA is also requiring Genentech to update the product label and provide patients with medication guides that strengthen the existing warning for anaphylaxis. Omalizumab is approved for the treatment of adults and adolescents with moderate to severe persistent asthma who have tested positive for a perennial aeroallergen and whose symptoms are not adequately controlled with inhaled steroids.

Medication guides required for ADHD meds
FDA-approved medication guides must be developed by manufacturers for all drugs approved for the treatment of ADHD, according to the agency. The guides will alert patients to the potential risk for cardiovascular and psychiatric adverse effects when using the medications. Following an FDA review, reports of sudden death in patients with serious underlying cardiovascular conditions were revealed. Another review by the agency showed a slight increase in risk for drug-related psychiatric adverse events in patients with no previous psychiatric problems. The FDA recommends that treatment plans be developed following careful assessment of patients for a history of cardiovascular and psychiatric problems. The agency said 15 products used to treat ADHD will be affected by this latest requirement.

Nursing home patients not assigned best Part D plans
According to a report issued by the Long Term Care Pharmacy Alliance (LTCPA), most dual-eligible nursing home residents are probably not enrolled in the Medicare Part D plan that best covers their medications. The study looked at nursing home patients in all 50 states and the District of Columbia and examined the formularies for eligible plans. Two-thirds of nursing home patients are eligible for both Medicare and Medicaid and are qualified to have medicines covered at no cost. Currently CMS automatically assigns a Part D plan to the vast majority of dual-eligible low-income patients who do not choose one for themselves. CMS makes its determination based solely on premium cost, not formulary considerations or patient medical history. Regulations bar nursing homes from helping patients select a plan. A California judge recently allowed a class-action suit to go forward on behalf of dual-eligible patients against CMS over this issue.

Genentech expands PAP
Genentech is expanding its current patient assistance program (PAP), the Genentech Access to Care Foundation, to help address the needs of financially eligible Medicare beneficiaries enrolled in Part D who are prescribed Tarceva (erlotinib). The expansion allows financially eligible patients enrolled in Part D to receive assistance for Tarceva from Genentech outside of their Part D plan. Tarceva is approved for locally advanced or metastatic non-small cell lung cancer after failure of at least one chemotherapy regimen, and in combination with gemcitabine chemotherapy for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer. For more information, call 1-(888) 249-4918 or visit www.gsk-access.com or call 1-(866) 475-3678 to get information on GSK Access, which offers Rx medicines free to eligible Part D-enrolled patients. The Web site provides details on eligibility and income requirements and a list of the more than 50 GSK Rxs included in the program.