Tag: <span>Food and Drug Administration</span>

If you’ve ever wondered how new Multiple Sclerosis drugs are developed, evaluated, and finally approved for the market, Bloomberg.com offers a link to the video of the FDA Committee Meeting on Novartis’s new Gilenia, the first pill for Multiple Sclerosis.

After drug testing and before the FDA approves a new medication, a panel of health experts considers the drug studies and, if the panel is satisfied, recommends approval to the FDA for approval. The FDA usually does as the panel suggests.

The panel reviewing Gilenia recommends it as safe and effective for controlling tremors, concentration problems and other symptoms of relapsing remitting MS.

If the medication’s side effects do not derail the FDA’s approval later this year, Gilenia will be a welcomed medication for MS patients because it is the first MS treatment available in pill form. Approval would mean no more routine injections or infusions for those who take it — no more needles or injection site reactions.

Reported side effects of Gilenia include eye disorders, heart problems and lung problems. In spite of these, the panel recommend approval of the drug for the treatment of Multiple Sclerosis.

With each medication they choose to take, MS patients are faced with the persistent question, “Will my MS treatment be worse for me than the long term effects of the disease?” Because this is a new medication, there really isn’t an answer to this question yet. Not enough people have taken it for enough time for researchers to know the long term effects.

In light of the side effects, the panel did recommend Novartis study the effectiveness of lower doses of Gilenia.

More information about Gilenia:

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I’ve written before about my annual pre-authorization hassles for Provigil®.  You can read more in “MS Medications, Insurance Coverage and 2 Ounces of Gold“.

This year I learned about a new tool.  It’s called a “plan sponsor override“.  And, in my experience, it works.

Here’s how it worked.

First, Provigil is not a Food and Drug Administration-approved medication for the treatment of Multiple Sclerosis.  Many medications used in the treatment of Multiple Sclerosis are not FDA-approved for MS.

While the injectible medications like Copaxone®, Avonex®, Betaseron®, etc. were designed for MS and have been tested and approved by the FDA for treatment of Multiple Sclerosis, Provigil has not been.  However, Provigil is commonly prescribed for MS patients because neurologists find it helps with fatigue, one of the most common symptoms of Multiple Sclerosis.  Another example of an “off label” prescription is Aricept®, which is FDA-approved for the treatment of Alzheimer’s.  Neurologist often prescribe it for MS patients to aid with memory and cognitive difficulties.

It may be too simple, but I think about it like this: imagine that Pepto-Bismol® required a prescription (it doesn’t … we’re imagining).  Imagine, too, that it had been tested and was FDA-approved for treatment of nausea, but not for heartburn.  Your insurance company would cover your prescription if you had nausea, but would decline it if you had heartburn.  Even though, it is highly effective against both!

That’s how prescription coverage works.  Insurance companies use the FDA as their excuse to deny coverage.

Second, my health insurance company outsources the medication and prescription benefits to a third company, Medco, a $20 billion dollar, public corporation listed on the NYSE as MHS.  In their efforts to return value to shareholders, Medco denies coverage for my wife’s medications prescribed by her neurologist for non-FDA-approved purposes.

On one hand, this practice makes sense (from a capitalistic perspective).  Why should an insurance company pay for medications being used for purposes not approved by the U.S. Food and Drug Administration?

On the other hand, who wants to assume a government agency knows as much about the treatment of a disease as neurologists do?

Looking at both hands, I believe Medco is more interested in shareholder value than in patient care.  They’re a public corporation, they have to be.

Anyway, after several denials, appeals and denials, I finally heard a Medco employee say something I had never heard, “Perhaps you should request a plan sponsor override.”

“What’s that?”, I asked.

“Ask your insurance company to override our denial,” she replied.

“That’s it?”

“We’ll honor it.”

I called my insurance company and spoke with several people until they found someone who could speak to me about requesting a plan sponsor override.  Long story, short: I faxed my insurance company the last appeal letter I had sent to Medco.  Two days later Medco agreed to cover the medication.

Caregiver Tip:  If prescription coverage is repeatedly denied by a third party, ask your health insurance company about a plan sponsor override.

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Use the FDA’s MedWatch for the Latest Drug Safety Information. If a medication you take requires additional warnings, you can learn about it on this web site of the U.S. Food and Drug Administration.

MedWatch is the FDA’s web site for reporting current medication safety information about drugs and medical products which are regulated by the U.S. Food and Drug Administration. The “What’s New” column on the left side of the home page is where the news is posted as it becomes available. You can subscribe to receive safety alerts by email.

On 10/24/2007 the FDA and Cephalon (manufacturer of Provigil) notified healthcare professionals of an updated WARNINGS section of the prescribing information for the drug. According to the posting,

“Physicians should instruct their patients to immediately discontinue the use of Provigil and contact them if a rash or other hypersensitivity reaction occurs. Healthcare professionals and consumers should also be aware that Provigil is not approved for use in pediatric patients for any indication. In addition, psychiatric adverse experiences (including anxiety, mania, hallucinations, and suicidal ideation) have been reported in patients treated with Provigil. Caution should be exercised when Provigil is given to patients with a history of psychosis, depression, or mania.”

Obviously, this is good information to know. Other than the specific side effects, it means Provigil is like any medication. One must balance the side effects (and potential side effects) against the good the medication does. The information about these additional side effects serve as a reminder than any chemical one uses to modify the way a brain works may hold unexpected dangers.

It’s good to know that should my wife suddenly experience any of these side effects, her Provigil may be the reason. Of course, these additional potential side effects are also listed in the prescribing information for a couple of her other medications, too. Modifying brain chemistry is a tricky thing.

Here’s what surprises me. I did not learn of the FDA’s updated warnings from a healthcare provider. Nor did my wife receive information about the updated warnings from a doctor, pharmacist or the drug manufacturer.

I first learned about the new prescription warnings by reading it on a financial news web site.  TheStreet.com posted an article on 10/24/07, by Elizabeth Trotta, titled “FDA Warns on Cephalon’s Provigil”.  The Multiple Sclerosis Foundation has a good article about this issue, too: “New Warnings for Provigil“.

Cephalon’s “Newsroom”, the page on their corporate web site for news releases, provides no mention of the updated warning (I’m exploring the Cephalon site on 11/04/07). Cephalon’s web site has a page of corporate information for investors, but nothing there is about the 10/24/07 FDA announcement of the updated prescription warning.

Cephalon also has a product-specific web site for Provigil at www.provigil.com. The Provigil.com web site offers a lot of good information about the medication and its uses. If you or someone you know takes Provigil, the Provigil.com web site is a great resource for you. The important information for patients about side effects and medication use is available from the upper right hand link, “Patient Information”. The information is dated August 2007 (before the FDA MedWatch notice).

The lesson for patients and caregivers? Use MedWatch AND the web sites of drug manufacturers to stay on top of important drug safety information.

How Drug Safety Information Seems to Flow

MedWatch is the official place to read the latest drug safety information. Generally, this seems to be how drug safety information flows: Drug safety news appears initially on MedWatch. Next, the news media (medical news and financial news) pick up on the MedWatch postings and write articles to inform the public of significant drug safety news. Then drug manufacturers and medical professionals inform patients.

However, in Cephalon’s case with Provigil, the drug manufacturer was ahead of the FDA MedWatch posting. The Provigil FDA Approved Labeling (PDA File) was updated on August 17, 2007 and on September 12, 2007, a “Dear Healthcare Provider” letter (PDF File) was produced which details the updated information and warnings.

Good job, Cephalon.

Caregiver Tip: Know the names of all the drugs taken by the MS patient for whom you care. Check MedWatch regularly to learn about drug safety news related to these medications. I’ve added a link to MedWatch in the right hand column. Also, visit the web sites of the drug makers for current information. As they say, “knowledge is power”.

Caring for Yourself MS Medications