Category Archives: Drugs

Flu Shot or No Flu Shot for MS Patients?

It’s that time of year again. The time of year where I keep seeing posts on MS social media sites asking, “should I get a flu shot?”

In my honest opinion, yes, definitely! There are certainly different opinions about this, but I think that my opinion is the same as that of nearly any doctor that you’ll ask. For example, here’s a what a couple of doctors have to say in a U.S. News and World Report article that’s specifically about MS and the flu:

Dr. Robert Shin, director of the Georgetown Multiple Sclerosis and Neuroimmunology Center: “The flu infection may stimulate the immune system, which may in turn trigger an MS attack.” Note that Shin says the flu, not the flu shot, is what should worry you. He says that getting the flu, or any illness, raises that chance that you’ll have a relapse or a worsening of your symptoms.

Dr. Amesh Adalja, an infectious disease specialist with the Johns Hopkins University Center for Health Security: “When you see flu outbreaks, you see MS relapses.” 

If you just think about what happens to your body in hot weather, or when you have a fever, then the flu-MS connection should be clear.

Docs sat the flu shot doesn’t give you the flu

Are you worried that getting a flu shot can give you the flu, or make you sick with something else? Doctors say don’t be. The flu shot uses a killed virus to protect you against the flu. So it’s highly unlikely that the vaccine will give you the flu. In fact, Dr. Shin says “infection really is impossible.”

On the other hand, the nasal flu vaccine is created from a live virus. The Centers for Disease Control and Prevention recommends against anyone using the nasal vaccine, because there are concerns about its effectiveness.

Since the flu vaccine takes about two weeks to become fully effective, it’s possible that some people who’ve had a shot will still get the flu. There have also been some years where the vaccine hasn’t been a good match for the strain of flu that was prevalent in those years. This may lead some people to believe that the shot gave them the flu when, in fact, it didn’t. It just, for whatever reason, failed to protect them from catching it.

For a lot more detail…

Here are a few places where you can obtain more information:

U.S. Centers for Disease Control and Prevention (CDC)

National Multiple Sclerosis Society

A “STAT News” story, with an international overview

Of course, you should always check with your own doctor.

We had our shots

My wife and I got our flu shots in October, just as we’ve been getting them for many years. Neither of us has ever had a problem.

 

(This post first appeared as one of my columns on http://www.multiplesclerosisnewstoday.com)

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Specialty Drugs Mean Specialty Prices

If you have MS, you’ve probably used a specialty drug. My first was Avonex, which I began to use about 1998. Several others followed.
There’s no formal definition of a specialty drug, but these therapies have several things in common. First, they’re expensive. According to the vice president in charge of specialty drugs at CVS Pharmacy, the average monthly cost is $3,000. A CVS website article says that’s about 10 times the cost of a non-specialty medication. Many specialty drugs are hard to administer, requiring an injection or infusion. And it may require special handling. My Avonex, for example, had to be shipped with dry ice to keep it cool.
So, I’m not surprised that the cost of specialty drugs is so much higher than your average prescription med. What really does bother me, however, is how fast the cost of these specialty drugs has been climbing.

Let’s look at the numbers

A few weeks ago, AARP released a lengthy report that studied 101 specialty drugs. Here are the headlines:
  • The price of the most widely used specialty prescription drugs increased substantially more than the general inflation rate in every year from 2006 to 2015.
  • From 2014 to 2015, specialty drugs had their highest annual price increase in a decade: an average hike of 9.6 percent. Inflation, on the other hand, increased by only 0.1 percent.
  • Prices for 29 chronic-use specialty drugs that have been on the market since the beginning of the study (from January 2006 to December 2015) increased cumulatively by an average of 177.3 percent. In contrast, general inflation increased by only 19.4 percent during the same period.

MS drugs are best-sellers

Multiple sclerosis drugs made up 12 of the 101 specialty drugs studied. Their average price rose 10.8 percent between 2015 and 2016, a little higher than the group average. Seven of those dozen MS drugs made the study’s list of 30 best-selling specialty drugs. (You can see the full list on page 30 of the report.)

RANK BY SALES DRUG DOSE DAILY COST 2015-16 HIKE (%)
6 Copaxone 20mg $201 7.6
7 Tecfidera 240mg $194 10.8
11 Copaxone 40mg $179 7.0
16 Avonex Auto-inject $198 15.2
17 Avonex Pre-filled $200 16.2
21 Rebif 44mcg $207 10.8
27 Betaseron 0.3mg $202 11.1

The drug that jumps out at me from this list is Avonex. Why should the price of a drug that’s been in use for nearly 20 years jump 15-16 percent in a year? Copaxone and Tecfidera both lead Avonex in sales, yet their price hikes were lower. Color me confused.

What’s the solution?

Is there a way to limit these price increases? In the CVS article I mentioned earlier, Dr. Alan Lotvin makes several suggestions, most of which don’t work for me.

Lotvin: “… Prior authorization and step therapy can be highly effective in controlling costs.”

Me: Step therapy means reducing costs by prescribing older, possibly less-effective drugs first rather than aggressively attacking MS with newer, more potent drugs. Some insurance companies insist patients follow this path, but it’s not the way that I want my MS treated.

Lotvin: “Another approach is the use of tiered formularies that require higher patient cost-sharing for more expensive therapies.”

Me: Yes, they do. And this is why many MS patients can’t afford to pay for the therapy that could be the most effective for them (though there are drug company programs that help some patients pay for these drugs).

Lotvin: “Ensuring that the drugs are administered at the lowest-cost site of care is also important — in most instances the hospital outpatient center is the highest-cost site of drug administration, while patients’ homes and doctors’ offices are typically the lowest.”

Me: Here, we agree.

The AARP study concludes:

“If recent trends in specialty drug prices and related price increases continue, it will almost undoubtedly become more difficult for patients to access and afford necessary specialty medications. The pricing patterns (price levels and price increases) for specialty drugs will lead to serious problems with respect to access and affordability issues in the future.”

Since access and affordability are already a problem, it seems to me that the future is now.

Yet, AARP offers no solutions, ending its report this way:

“Policy makers interested in reducing the impact of prescription drug prices should focus on options that drive significant innovation while also protecting the health and financial security of consumers and taxpayer-funded programs like Medicare and Medicaid.”

Well, yeah. But how do we find those options? The FDA has now approved generics for Copaxone 20mg and 40mg. That’s not an innovation, but, hopefully, it will help stick a pin in at least one specialty price balloon.

(This post first appeared as my column on http://www.multiplesclerosisnewstoday.com)

Have You Been Switched from Generic to Brand Name?

 

Insurance companies want people to use generics, rather than the more expensive brand-name drugs, right?

Maybe not. Because, at least in some cases, they’re doing just the opposite. Some patients are being forced to use brand-name drugs even when those drugs have generic equivalents. It happened to my wife last week. Not surprisingly, that means that some of us with MS could wind up having to dig deeper into our pockets to pay for some therapies.

The New York Times recently published a long story about this relatively recent, and not widely known, practice. It points a finger at both insurance companies and drug manufacturers.

Here’s what’s happening

The Times story reports that some drug manufacturers are trying to fight competition from generic versions of their products by negotiating deals with insurers and pharmacy benefit managers. (Pharmacy benefit managers are companies such as CVS Caremark and Humana that actually run the drug plans provided by Medicare and private insurance companies.)

The deals require the drug plans to stop covering some generics and instead approve only their brand-name equivalents. In exchange, the drug companies sell the brand-names to the drug plans at a discount. But, the Times reports, the discount isn’t passed along to patients. The insurers or the drug plans pocket it and patients wind up paying more for these drugs.

The impact on MS drugs

This practice also is reported to be happening with some biosimilar products that compete with the new, expensive biologic drugs, just as generics compete with brand names. (A biosimilar is a product that is almost identical to an FDA-approved biologic drug. It’s supposed to have no significant differences in terms of safety and effectiveness, and there are only small differences in its components.)

A drug called Glatopa is a biosimilar for the daily MS injectable drug Copaxone. Two years ago, Glatopa’s manufacturer predicted that Glatopa would have a wholesale list price of about $63,000 a year. That’s about 15-18% lower than the list price for once-a-day Copaxone.

According to the Times, in December, CVS Caremark, one of the largest drug benefit managers, sent a memo to pharmacies telling them that some of its Medicare drug plans would cover only brand-name versions of 12 drugs. No more coverage for their generic versions. Copaxone was one of those 12.

Out-of-pocket costs are impacted by deductibles

A spokeswoman for CVS Caremark told the newspaper that consumers never pay more for a drug when Caremark favors a brand name over a generic. But it’s not simply a case of the cost of each prescription.

According to the story, 29% of Americans with employer-provided health insurance have a high-deductible plan. They would still be hit with higher out-of-pocket drug costs if they were forced to use generic drugs because, until their deductible is met, they’re often required to pick up the full price of brand-name medications. On the other hand, they’re charged only a small percentage of the price of generics before meeting the deductible.

Also, many plans pay for a larger percent of the cost of a generic drug than they pay for its brand name.

The bottom line

Pennsylvania pharmacist Robert Frankil, quoted by the Times, said, “There’s only one reason why they’re requiring you to use a more expensive product. Because somewhere down the road, somebody is earning more money.”

Frankly, I don’t know what we patients can do about all this. But I thought you’d want to know about it.

(A version of this post first appeared as my column in http://www.multiplesclerosisnewstoday.com).

Ocrevus, Hope and a Suicide Postponed

Several months ago, I wrote a column in Multiple Sclerosis News Today about Andrew Barclay.

Barclay died in an assisted suicide in December. He’d had multiple sclerosis for many years.

Colin Campbell is a 56-year-old MS patient who lives in Inverness, Scotland. He also wanted to die. In fact, he was scheduled to end his own life, with help, on June 15 at a suicide clinic in Switzerland. But he changed his mind.

Campbell has been writing about his MS for the Sunday Herald in Glasgow since late April. (He’s also the paper’s “Beer of the Week” writer.) He describes himself as “a man on death row,” and on May 20, his MS article began, “Well, unfortunately I am still alive.”

Campbell has mobility problems, and living in a second-floor flat has been tough for him. He says he’s had no support in getting ground-floor accommodations. He complains that he was recently discharged from a hospital without the possibility of receiving home care. He has no caregivers and exists on microwave dinners.

Campbell had hoped that a stem cell transplant would allow him to live a life that was worth living, but his neurologist told him that he thought HSCT would be too risky. So, at age 56, Campbell made plans to die.

Then came a glimmer of hope. In a column he wrote two days after he had been planning to die, Campbell explained that a former police sergeant named Rona Tynan gave him a reason to live, at least a little while longer.

“Rona, who also has multiple sclerosis, was of the opinion that I should not commit suicide until having tried every other possible avenue – including soon-to-be-available multiple sclerosis treatments for folk like me with primary progressive MS. Rona persuaded me, and I agreed,” Campbell wrote.

That treatment is the disease-modifying drug ocrelizumab, sold in the U.S. under the brand name Ocrevus. The U.S. Food and Drug Administration approved it a few months ago, and it’s the only drug approved to treat progressive MS. Some neurologists refer to it as “stem-cell lite” because of the way it attacks the rogue B-cells that are believed to cause MS. Ocrelizumab is expected to be available in Scotland later this year.

“For the first time since multiple sclerosis was identified during a post-mortem 149 years ago, there now seems to be a real hope of lasting risk-free treatment for multiple sclerosis sufferers within the next few years,” Campbell writes. “The timing could not have been more perfect — although there was a fear, of course, that the developments had just come too late for me. But I wanted to remain as optimistic as possible.”

Colin Campbell’s hope, now, is that Ocrevus will halt the progression of his MS and avoid a future that he pictures as becoming bedridden, needing help to eat and bathe, and using a catheter. He’s not sure how much hope he realistically should have, but he ends his June 17 column with: “Wish me well.”

That, we certainly do.

****

(This post first appeared as my regular column on www.multiplesclerosisnewstoday.com)

My Lemtrada Journey: 6 month report

It’s been a little over six months since I completed Round 1 of my Lemtrada infusions, so it’s time again to ask myself, “How am I doing?”

The answer: I’m not sure.

For many years, my brain MRI has remained unchanged. I can’t remember the last time I had an exacerbation (something bad enough to require steroid treatments). It was, literally, in the last century. But my walking has slowly, but steadily, declined.

So, I’m really not sure how much of an impact any of the disease-modifying drugs that I’ve been on since 1996, including Lemtrada, have had on my MS. I like to think that all of the shots, pills, and infusions that I’ve been treated with over the past two decades have, at least, slowed the progression of my disease, but it’s really hard to know for sure.

Enter Lemtrada

As you probably know, Lemtrada is designed to halt further progression of MS. In addition, some patients have had some symptoms reversed. But that benefit wasn’t expected, it just sort of appeared during the clinical trials. On the other hand, more than a few patients are reporting a variety of negative symptoms following their infusions.

My 6-month timeline

The first three months post-infusion were a real roller coaster. The lowest point on the ride was at about two months post-infusion, when I developed a fever, slight headache, and a cough. Naturally, my energy level also dropped. It was diagnosed as strep, and after downing antibiotics for about 10 days, I was much better.

Around the five-month point, my wife thought I was walking better. Today, just past six months, I think I am — sometimes, but not always. I also can flex my left foot up from the ankle just a little, and I think that’s new. Cramping in the insoles of my feet, which took place almost every night when I got into bed, has been significantly reduced. So, all positive stuff.

But, on the other side of the coin, I developed an aching pain in both hips around mid-February. At times, that pain would shoot down one or both legs when I put weight on them. It’s been worse in the mornings, particularly if I’m trying to get up from squatting down. But, is this drug-related, or is it something else? My neuro says it’s not related to the infusions. Some Lemtrada patients have suggested that it’s the feeling of my body “making new bone marrow.” I just don’t know.

This pain has slowly eased since it began four months ago. That improvement may be related to receiving physical therapy treatments in April and May and getting back into the swimming pool in June. That physical therapy and the swimming may also be responsible for the mobility improvements that I mentioned earlier. Or is it the Lemtrada? Or, maybe it’s a combination of both.

The six-month mark is the time at which, I’ve been told, the ups and downs tend to level out or to swing upward. That seems to be the case with me. So, I guess it really doesn’t matter whether it’s Lemtrada, or PT, or swimming that seems to be helping, or if it’s the drug or the natural course of my MS that’s responsible for my low points. I’ll continue doing what I’m doing and hope for the best.

(A version of this first appeared as my column on www.multiplesclerosisnewstoday.com)

 

In case you missed my live FB stream…

You can see a recording of this afternoon’s live stream on the MS News Today Facebook page here. I’m sharing my experiences with various DMDs that I’ve used over the past 20 years or so.

Getting Help Paying for Your MS Drugs

With the recent approval of the multiple sclerosis drug Ocrevus, I’ve again heard the plea “but how can I afford it?” Ocrevus carries a price tag of about $65,000 a year. That’s not high compared to some other MS drugs, but it can still mean a higher co-pay than some patients with insurance can afford. And it can appear to be totally unaffordable for those without coverage. Unless you know how to get help with those drug costs.

About six months ago I wrote about the programs that various drug companies and foundations have to assist MS patients in paying for their drug. With lots of folks looking for that help I thought it would be a good idea to review some of what’s out there.

Payment help from MS drug manufacturers

In the U.S., many drug companies have programs to provide their high-costing MS drugs to patients at a deep discount or, in some cases, for free. For Ocrevus, drug manufacturer Genentech has a number of options. For other MS drugs, the National Multiple Sclerosis Society has an excellent, drug by drug, list of these programs on its website. I recommend checking it as a first stop in your search for help.

But there are rules regulating this practice in the U.S. and they don’t make a lot of sense from a patient’s viewpoint. Here’s how they work. If you have prescription drug insurance, either through your employer or as an individual, a drug company is allowed to reduce the amount of your co-pay for their drug.  When I was still working full-time, I was prescribed the drug Ampyra. At that time the average wholesale price for a 90-day supply of Ampyra was about $1,000 a month.  My insurance covered about 50% of that, so I was left with an unaffordable co-pay of about $500 a month for a drug that was really helping me walk. Fortunately, I was able to take advantage of Acorda’s patient assistance program to limit my co-pay to no more than $40 a month, and I was able to continue on that drug.

Then I retired and moved from my employer’s drug insurance plan to Medicare Part D (the section of Medicare that pays for prescription drugs).  But, under the Medicare rules, drug companies aren’t allowed to pay-down the co-pay, as they do with private insurance. They must either provide the drug totally free of charge to a patient or they can’t provide any assistance at all.  And, to receive that no-cost benefit the patient’s income must be under a certain limit. My retirement income was too high to get the drug for free, but I still couldn’t afford the big jump from a $40 co-pay to $500 a month, so I had to go off the drug.

But, there’s another way …

Help from foundations

A foundation is the good place to turn when you have private insurance or Medicare, you’re still stuck with a high co-pay and the drug company is unable to help. It takes patience and good timing to obtain help from these non-profits, but it can be worth the effort. If you qualify for the help (there’s still an income ceiling but it’s usually fairly high), a foundation will approve a monetary grant for you. The grant will cover your co-pays and be paid directly to the pharmacy that’s providing your drugs for a specific amount of time, usually a year.

At one time I was receiving a grant of $6,000 a year from a foundation which covered all of my co-pays for Aubagio for that year…a significant out-of-pocket savings. Some of these foundations limit their grants to people on Medicare, while others also include patients with private insurance. A list of some foundations that will pay for MS drugs can be found at the bottom of the National MS Society webpage that I mentioned earlier.

You’ll need patience and good timing to travel this route. The foundations help patients with many different diseases and they can quickly run out of money for a specific disease until new donations are received. The problem is, the foundations don’t announce when their coffers are replenished. So, you need to check their websites, or call them, as frequently as possible to see if they have new money, and then apply quickly when they do.

 

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