Avastin still covered regionally on Medicare during appeal

One regional Medicare provider has decided to continue to cover Avastin, a breast cancer drug, reversing their decision from last week’s announcement to refuse coverage.

Questions about coverage of the pricey drug were sparked by the Food and Drug Administration (FDA)’s12-1 ruling in July to revoke approval of the drug for use to treat breast cancer. Genentech, the manufacturer of the drug, is appealing the decision.

A spokesperson for Medicare contractor Palmetto GB, a subsidiary of Blue Cross Blue Shield of South Carolina, reported in the New York Times that Palmetto “has suspended consideration of changes in its reimbursement policy for Avastin as a treatment for breast cancer” while the appeal process continues.

Last week, in a notice posted on its website, Palmetto GB, a regional company that determines Medicare coverage for South Carolina, Ohio, West Virginia, California, Nevada and Hawaii had said that it would stop paying for the use of Avastin for breast cancer treatment as of Jan. 29. That notice was updated this week to state it will “continue coverage of Avastin under current policy.”

In July, the F.D.A. decided to revoke approval of Avastin, also called bevacizumab, because the F.D.A. said follow up studies had found the drug was not effective and had dangerous side effects.

In 2008, the expensive drug was a part of the F.D.A.’s accelerated approval program, according to the FDA’s website. The approval was based on a trial of patients who had not received chemotherapy for mestatic breast cancer.

“Under the accelerated approval program, a drug may be approved based on clinical data that suggest the drug has a meaningful clinical benefit, with more information being needed to confirm this.  The program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted.”

According to the F.D.A., follow-up trial results submitted by Genentech only showed a small effect on “progression-free survival.”

The F.D.A.’s decision to revoke approval for use of the drug for breast cancer treatment will not affect its approval for use for treating other cancers.

E-Prescriptions May Be in Your Future

Many doctors have already chosen to use electronic prescriptions because they see the many benefits of this practice.  Electronic prescriptions (e-prescriptions) will help to eliminate many dilemmas that arise with paper prescriptions.  For example, e-prescriptions reduce the chance of a paper prescription being misplaced or misread (since doctors are notorious for their bad handwriting).  They will also be faster because the doctors can send the prescription directly to the pharmacy and it should be ready when you arrive.  E-prescriptions will be able to forewarn if the patient is allergic to the prescribed medication. Importantly, the Drug Enforcement Administration (DEA) has approved the use of e-prescriptions for the time being as they prove themselves beneficial to the world of medicine.

E-prescriptions can prevent medical incidents before they happen, such as asthma attacks.  One of the many advantages of using this new system is it gives doctors the ability to regularly track patients’ use of medications.  A doctor can automatically refill the prescription and alert the patient about the refill.  This could prevent an asthma attack because the patients’ meds won’t run out and their inhaler will always be ready at hand.  A full prescription will get patients in the habit of routinely using their inhaler; therefore, reducing the risk of asthma attacks.  By monitoring a patient’s routine use of an inhaler, doctors can also decide if the prescribed medication is the best one for the patient.

Additionally, electronic patient records seem to be the next step for hospitals.  In fact, hospitals will be required to have most of their records filed electronically by 2015.  This will endure prompt and correct information.  Patients will receive better care because electronic records will be able to alert a doctor before they make a mistake.  This will help to eliminate medical malpractice and medication mistakes that may be otherwise overlooked.  Also, hospitals and doctors will benefit from the use of electronic records because they will receive money from Medicare and Medicaid for complying with the electronic system.

One concern that has arisen from the practice of electronic prescriptions and health records is confidentiality.  Patients have expressed fear that personal information will be exposed to public access.  However, the electronic information is secure.  Doctors and hospitals can ensure confidentiality and privacy to its patients.  Hence, the future of electronic healthcare looks bright.  Now that the journey is underway for many, we will wait and see if the hectic schedules of remaining doctors and hospitals can allow time for conversion to electronic healthcare.

that since 1999, it has received over 130 reports of loss of smell associated with Zicam use. The type of smell-loss they cause is called anosmia, and in some cases occurred after only one dose. Though long-term scientific studies into the effects of Zicam are not available, the FDA is concerned that consumers will use the product which could unknowingly cause themselves serious harm, hence the warning to immediately stop using these products. The FDA has notified Matrixx Initiatives (makers of Zicam) that the products can no longer be marketed without FDA approval. Matrixx argues that the allegations that Zicam is dangerous (resulting in a number of lawsuits) are false and unsubstantiated. The FDA asks consumers experiencign any loss of smell or taste after using nasal products containing zinc should see their physician.

People and doctors for the drug changes in the Medicare rules believe that the spending is worth it because if the drugs work, it can enhance the understanding of which drugs work and which don’t against various forms of cancer. Opponents of the changes believe that it is a waste of money and can expose people to side effects that are not known and not approved by the FDA. They also believe that doctors are using patients as guinea pigs for unproved drugs and therapies.

Medicare officials have also canceled an analysis of the costs of these changes so predictions of the amount being spent on these drugs are hard to determine. One of the products called Gemzar, costs $2,500 to $5,000 a month. The new rules can guarantee Medicare to use the drugs for many types of cancer even though the FDA has only approved it for use on 4 types of cancer.

A spokesman for the Pharmaceutical Research and Manufacturers of America said the new rules ensured “that cancer patients have access to the treatments they need.” Like this man, doctors think that they need greater flexibility since getting a drug approved can take years. Some of these people don’t have years to spare and are willing to try any drug that may help them.