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Each issue will include an editorial on a topic that is important for the profession of pharmacy, as well as a review of a new drug that includes a comparison of the new drug with previously marketed drugs that are most similar in activity, and a New Drug Comparison Rating (NDCR) for the new drug. Read on for this month's issue.
November 2008 Issue
New Drug Review
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The Health Care PRETENDERS
Health Insurance Companies Should Stick to Providing Insurance and Not Attempt to be Health Care Providers
I recently received a letter from Independence Blue Cross, the insurance company with which our family has had medical and other health care insurance plans for a number of years. The letter was to remind me that I had not completed a health care assessment form that had been sent to me earlier. Another copy of the form was included with the letter along with a postage-paid envelope.
The health care assessment form includes 83 questions, many of which pertain to potentially sensitive topics. Some of the questions inquire about physical health and pain but a number of them addressed "emotional problems" (such as feeling depressed or anxious). The following are examples of the questions for which respondents are asked to select one of the answer options noted:
"Have you been a nervous person?"
"Have you felt so down in the dumps that nothing could cheer you up?"
"Have you felt downhearted and blue?"
"Have you been a happy person?"
"During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of any emotional problems?
Cut down on the amount of time you spent on work or other activities
The following statement is included at the end of the assessment form:
Accomplished less than you would like
Didn't do work or other activities as carefully as usual."
"I understand that my responses to some of the questions in the Health Care Assessment Form may indicate that I may benefit from an evaluation by a behavioral health specialist."
Respondents are then asked to indicate whether they consent, or do not consent, to the disclosure of the responses to the questions in the form to the insurance company's contracted behavioral health provider for evaluation and possible telephone contact.
Reading through the assessment form raised enough concerns that I went back to read the cover letter again. One of the statements in this letter is:
"Our staff is comprised of physicians, nurse case managers, and clerical support, all part of our case management team who will work to assist you."
It is noteworthy that there is no mention of pharmacists, but an even larger issue became apparent. I and my employer (that covers most of the cost for my health benefits) are paying very high premiums for insurance to cover the cost of health care services and products provided by individuals whom we should be able to choose. I have not asked for and I and my employer should not have to pay for my insurance company attempting to be involved in decisions and services regarding my health care. Questions and services of the type included in its assessment form should be none of their business! Their business is insurance, not the provision of health care.
The letter with the assessment form identified a telephone number that individuals with questions could call. I decided to call the number to do my own assessment of this program by initially requesting the name and telephone number for the physician with whom I might speak. After responding to a number of prompts in the automated telephone system, I eventually reached an actual person who identified herself as a "health coach." To her credit, she was very courteous and wanted to be helpful. However, when I asked for the name and telephone number for the physician who would speak with me, she responded that she would need to transfer me to another office. She transferred my call to what turned out to be the same number I called first, and I was greeted again with the same recorded message. Apparently the physicians in this program prefer to remain anonymous and inaccessible rather than engage in personal discussion with the subscribers to their insurance plans. I did not persist further on the phone call and also did not complete and return the form.
Health insurance companies attempt to justify programs such as those addressed in the assessment form by suggesting that they do this for the purpose of improving the health of their subscribers. But can they really believe that responses on a form and possible telephone communication with a behavioral health specialist will be as effective as personal interaction with local health care professionals? I must also conclude that programs like this add significantly, but unnecessarily, to the already staggering cost of health insurance premiums.
The intrusion of insurance companies into health care decisions and programs is even more egregious when one considers how they treat the health care professionals on whom they depend to be the primary and personal providers of health care for their insurance subscribers. Pharmacists, physicians, and other health professionals are extremely frustrated by the non-negotiable policies, restrictions, and inadequate compensation imposed on them by the insurance companies, as well as the red-tape and time required to resolve questions and other issues pertaining to services to be provided to patients. Most health professionals would quickly agree that the health care "benefits" provided to insurance subscribers are actually reduced in scope and quality because of the terms dictated by the insurance companies. There can be no question that the programs and policies mandated by insurance companies are primarily influenced by economic and revenue considerations, and not by a commitment to provide the best health care for their subscribers. Perhaps part of the motivation for programs such as the health assessment form is the recognition that their insurance subscribers, and society in general, will eventually recognize and be highly critical of the fact that the insurance companies extract a huge amount of money from the health care system but contribute nothing to the quality and scope of health care.
Insurance companies want even more power
Through mergers, acquisitions, and other means some health insurance companies have managed to acquire even more power in a manner that reduces the ability of other companies to compete with them. In my state of Pennsylvania two Blue Cross companies, Independence Blue Cross and Highmark, that already dominate their respective markets, have requested approval to merge. It has been estimated that a merger would create a company that would have a statewide market share of 70 percent. The primary beneficiaries of a merger would be most of the top executives of the two organizations who would receive substantial salary increases. Not so fortunate are the approximately 1000 current employees who would lose their jobs if the companies were allowed to merge. The proposed membership of the board of directors for a merged organization is also of interest. The business and financial communities are well represented on the proposed 22-member board. Only one individual, a family physician, is a health professional.
Many have spoken against the merger of these companies, including an independent health economics company retained by the State Insurance Department that concluded that both consumers and health care providers benefit more if the two companies are not permitted to merge.
Pharmacists, physicians, and other health professionals must take several actions to prevent further encroachment on our autonomy and rights, as well as those of our patients, in the provision of optimal health care:
Daniel A. Hussar
- We must strongly oppose mergers and other initiatives of insurance companies that give them more power, stifle competition, and give them more lobbying influence against legislation and other initiatives proposed by health professionals.
- We must insist on greater representation on the boards of directors of the companies providing health insurance.
- We must reject efforts of insurance companies to try to provide health care themselves, rather than working with and supporting the health professionals whom patients have chosen to provide such services.
- We must obtain federal legislation that removes the restrictions that prevent health professionals from working collectively to negotiate terms of their participation in health care programs.
- We must insist on the removal of provisions in health care programs that compromise our efforts to provide optimal health care for individual patients, and we must insist on equitable compensation for our services.
New Drug Review
(Xenazine - Ovation; Prestwick)
Agent for Chorea in Huntington's Disease
New Drug Comparison Rating (NDCR) = 5
in a scale of 1 to 5, with 5 being the highest rating
Treatment of chorea associated with Huntington's disease.
- First drug to be demonstrated to be effective in treating chorea associated with Huntington's disease.
Most important risks/adverse events:
- May increase risk of depression and suicidality.
Depression and suicidality (boxed warning; a Risk Evaluation and Mitigation Strategy [REMS] and Medication Guide have been developed); contraindicated in patients who are actively suicidal or in patients with untreated or inadequately treated depression; also contraindicated in patients with impaired hepatic function, and patients treated with a monoamine oxidase inhibitor or reserpine (at least 20 days should elapse following the discontinuation of reserpine before initiating treatment with tetrabenazine); hypotension; dysphagia; neuroleptic malignant syndrome; tardive dyskinesia; hyperprolactinemia; QT interval prolongation (should not be used concurrently with other drugs that prolong the QT interval or in patients with congenital long QT syndrome or a history of cardiac arrhythmias); activity is increased in patients who are poor metabolizers and in patients who are concurrently taking a strong CYP2D6 inhibitor (e.g., fluoxetine [e.g., Prozac], paroxetine [e.g., Paxil]).
Most common adverse events:
Sedation/somnolence (31%; patients should be cautioned about engaging in activities requiring mental alertness), fatigue (22%), insomnia (22%), depression (19%), akathisia (19%), anxiety (15%), nausea (13%), parkinsonism/bradykinesia (9%), balance difficulty (9%), irritability (9%).
Should be individualized; initial dosage - 12.5 mg once a day in the morning; after one week, the dosage should be increased to 12.5 mg twice a day; the dosage may be increased at weekly intervals by 12.5 mg; if a dosage of 37.5 mg or greater per day is needed, the drug should be administered in a three times a day regimen; maximum recommended daily dosage is 100 mg, and the maximum recommended single dose is 37.5 mg; patients who are considered likely to need a daily dosage above 50 mg should be genotyped for CYP2D6; in patients who are CYP2D6 poor metabolizers, or if treatment is to be initiated in patients already being treated with a stable dosage of a strong CYP2D6 inhibitor, the maximum recommended daily dosage is 50 mg and the maximum recommended single dose is 25 mg.
Tablets - 12.5 mg, 25 mg.
Huntington's disease is a rare, inherited neurological disorder that is passed from parent to child through a gene mutation. The disease is associated with excessive activity of monoamines, primarily dopamine. Changes in personality or mood may be the earliest signs of the disease, followed by problems of memory and chorea (jerky, involuntary movements). Tetrabenazine is the first drug to be approved for the treatment of chorea associated with Huntington's disease. It reversibly inhibits the human vesicular monoamine transporter type 2 (VMAT2), resulting in depletion of monoamine stores. Its therapeutic benefit is thought to be primarily due to the depletion of dopamine. The effectiveness of tetrabenazine was demonstrated in a placebo-controlled study in which 50% of the treated patients attained the primary efficacy endpoint (improvement in the total chorea score) compared with 7% of those receiving placebo.
Although tetrabenazine is well tolerated by many patients, it may increase the risk of depression and suicidality and cause other serious adverse events. Appropriate precautions must be observed. Tetrabenazine is rapidly and extensively metabolized in the liver to alpha-dihydrotetrabenazine and beta-dihydrotetrabenazine that are pharmacologically active and the major circulating metabolites. These metabolites are further metabolized via the CYP2D6 pathway, and their activity is increased in poor metabolizers and in patients also taking a strong CYP2D6 inhibitor.
Daniel A. Hussar