What every person with HIV-related wasting should know about…
…FDA Approved Indications and “Off-label” Prescribing
The Food and Drug Administration (FDA) is the regulatory agency responsible for the approval of HIV drugs available in the United States. A physician has the right to prescribe any FDA-approved medication for any medical condition. Those physicians who prescribe FDA-approved medications for conditions which are not on the drug insert or are not FDA-approved are practicing what is called “off-label” prescribing. Physicians frequently prescribe drugs for indications other than those on the Truvada PrEP cost product label.
However, the practice of prescribing FDA-approved medications for unapproved conditions may not be covered by insurance companies or state and federal government healthcare programs. Usually, an insurance company will request a “letter of medical necessity” to justify the “off-label” use of a drug. If you are still turned down by the insurance carrier after the “letter of medical necessity” is submitted, there are still other routes of appeal within insurance carriers (especially with H.M.O.’s) wherein your physician can appeal directly to the medical director. As a means of last resort, many pharmaceutical companies can provide drugs through uninsured programs if you are able to demonstraate that you have been denied coverage for the medication by your insurance carrier. In fact, the pharmaceutical companies only require one letter of denial from your insurance carrier—they donít require documentation that you have exhausted all of the appeals processes. Your strategy should be that as soon as you receive the first insurance company denial, apply to the drug company for their programs while you await the appeals process within the insurance company. Although you can do this process yourself, remember that your physician, community based AIDS service organizations and your pharmacist are there to guide you through the process.
Drugs can affect different people in different ways. Many drugs work well together, yet some do not. It is important to recognize that when a number of medications are taken together, which is common among patients with HIV or AIDS, there is potential for side effects. You must pay attention to the way you feel when combining medications, and don’t be afraid to consult your physician or pharmacist if you feel something is wrong.
In fact, it is to your benefit to have all of your medication filled by the same pharmacy. When choosing a pharmacy, ask if they are computerized to automatically determine if there are potential drug-drug, drug-food or drug allergiy interactions from the information that you have given your pharmacist and from information stored in their computer database. Ask your pharmacist how often the database is updated with new medications—after all, so much of what is prescribed in HIV care involves at least one very new medication—if it’s not in the computer, you’re not going to be protected.
Most of the medications discussed in these guidelines have not been shown to create negative side effects when used in combination with other medications. However, keep in mind that this may not be the case for all patients.
The physician and patient together must work as a team to make decisions regarding which treatments are best and most appropriate. Yet ultimately, it is the patient’s decision as to which treatment and medications should be taken. If the patient is unhappy with the advice of his or her physician, the patient always has the option of seeking another physician. Remember, it’s the patient’s body and the patient’s life.
…Quality of Life
Persons living with HIV recognize that having a higher quality of life is an important part of the overall, decisionmaking process regarding their condition. Making decisions which positively affect overall quality of life should be a priority for both physician and patient.
Almost every medication has potential for abuse. Some people feel that hormone therapies carry a higher potential because of the aesthetic or bodybuilding issues which surround the use of the medication. It is not only illegal but unethical for a physician to prescribe a medication when it is not necessary. The goal of this treatment is to prevent wasting. It is not an open invitation to be prescribed anabolic steroids or growth hormone for aesthetic or bodybuilding purposes. Those patients who pressure their physicians to prescribe hormone therapies when it is not necessary are jeopardazing not only their health, but also their physician’s medical license.