Gilenya priced at $4000/month, 30-50% higher than MS self-injections

If you haven't seen the news yet, Novartis has announced their wholesale price for the newly-approved oral MS drug, Gilenya (aka Fingolimod).

$4,000/month or about $48,000/year

Since the packaging which was being tested in surveys was organized to hold the medication in four one-week supplies, I wonder if truly Gilenya will be priced as $1000/week....making it $52,000/year in all practicality.  [update: It seems that the per box price is set below $4000 and the annual cost is approximately $48,600 in March 2011.]  A Bloomberg article posted yesterday did quote "about $48,000" for the medication.

Novartis Gilenya MS Pill to Cost $48,000 a Year
By Eva von Schaper
Sep 30, 2010

Novartis AG’s multiple sclerosis pill Gilenya will cost $4,000 a month in the U.S., according to a company spokesman.

Novartis has set a wholesale price at about $48,000 annually, Eric Althoff, a spokesman for the Basel, Switzerland- based company, said by e-mail. The company has programs to help patients with the cost of the drug, he said.

Gilenya, the first multiple sclerosis pill on the U.S. market, will be more expensive than injectable competitors such as Biogen Idec Inc.’s Avonex, Merck KGaA’s Rebif and Teva Pharmaceutical Industries Ltd.’s Copaxone, which cost between about $2,800 and $3,200, for a standard month’s supply, according to the Web site destinationrx.com.

“Gilenya pricing is based on the value it will deliver patients, the scientific innovation it represents and our investment in studies to support the product,” Althoff said.

The U.S. Food and Drug Administration approved Gilenya on Sept. 22.

To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net;
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net.

I'm practically at a loss of what to say, especially since I was in the process of writing an article regarding Gilenya for HealthCentral.  This news brings such disappointment and ire from within that I need to step back and take a few breaths.

Back in 2008, we were having discussions on the blog regarding the various prices which patients (or rather their insurance companies) were being charged for Tysabri infusions.  The billed amounts varied tremendously and one of the differences was related to the infusion centers themselves.  From the MS patients who shared their billed and allowed charges regarding Tysabri infusions, the average total allowed rate was $3500/infusion.  I do not know how much the price of Tysabri may have gone up in the past two years.

According to drugstore.com, a website I like to use for comparisons of cash drug prices, lists the following prices for other MS disease-modifying medications:

Copaxone:   $3403/box or $39,928/year
Rebif:          $2854/box or $36,825/year
Betaseron:   $2950/box or $34,980/year
Avonex:       $2680/box or $34,667/year

For medications which are packaged at 4-weeks supplies, I used the drugstore.com calculator to figure the yearly cost based on 13 boxes of medication.  Back in 2005, I am aware that Copaxone cost $18,000/year.  It has more than doubled since I was diagnosed with MS.

Just to try to be consistent with using numbers based on 4-week packaging, Novartis has chosen a price-point which is 30-50% higher than that of the current MS self-injectible meds.  And it is probably equivalent to the price of Tysabri infusions.  I'm sure that they did their homework and someone at Novartis knows the exact details of their calculations and comparisons.

It disappoints me considerably, too, when I read that analysts are now doubling their initial estimate of Gilenya reaching $1.4 billion in peak sales.  This just reminds me how much money pharmaceutical companies glean from the MS market overall.  It probably doesn't help my viewpoint since I struggled terribly through the patient assistance programs when I fought for affordable access to Copaxone.  Makes my stomach churn.

Novartis Gains FDA Approval for Gilenya Multiple-Sclerosis Drug
By Eva von Schaper
Sep 22, 2010

Novartis AG won U.S. regulatory approval to sell its multiple sclerosis medicine Gilenya, beating Merck KGaA in a race to market the first pill to slow the crippling disease.

The Food and Drug Administration cleared the treatment for use against relapsing forms of multiple sclerosis, the Basel, Switzerland-based company said in a statement. A doctor will have to watch patients for six hours after their first dose of Gilenya, Novartis said.

Regulators also recommend checking patients’ blood and eyes before treatment, a demand less restrictive than expected, said Karl-Heinz Koch, an analyst at Helvea SA in Zurich.

“We were like ‘Wow,’” Koch said in a telephone interview. “This is a very good outcome for Novartis. They’ll really be able to stir up the MS market.” Koch said he now believes Gilenya can achieve double his estimate of $1.4 billion in peak annual sales.

Regulators said doctors can prescribe the drug as the first treatment for MS patients, making it competitive with standard drugs such as Biogen Idec Inc.’s Avonex, Merck’s Rebif and Teva Pharmaceutical Industries Ltd.’s Copaxone. The drug “certainly has multibillion potential,” Trevor Mundel, Novartis’s head of drug development said in a telephone interview today.

Current Therapies
Multiple sclerosis affects 2.5 million people worldwide, many of whom have trouble sticking with current therapies because they’re difficult to use or have side effects, according to the National Multiple Sclerosis Society, a New York-based patient group.

Novartis fell 1 Swiss franc, or 1.8 percent, to 55.45 Swiss francs at 5:30 p.m. in Zurich trading. Merck fell 1.57 euros, or 2.2 percent, to 70.65 euros in Frankfurt, the biggest drop since July 16.

A Novartis spokesman didn’t immediately return a call seeking comment on the price of the drug. Gilenya probably will cost about $30,000 a year in the U.S., said Koch, based on the price of the existing treatments, which ranges from $20,000 to $30,000.

Novartis changed the spelling of the pill’s name to Gilenya from Gilenia during the FDA’s review.

The review, initially set for six months, was delayed by three months when Novartis said May 25 that the FDA requested additional analysis of current data. Rival medicine cladribine, from Darmstadt, Germany-based Merck, won a priority review in July, reducing to six months from 10 the time it will take the FDA to decide on approval, after the agency rejected an earlier application in November. Merck expects a decision on cladribine in the fourth quarter.

European Approval
Novartis expects European regulators to decide on Gilenya’s approval within six months. The European approval is “on track,” Mundel said.

Multiple sclerosis causes the body to attack nerve cells through the immune system. Gilenya, known by the chemical name fingolimod, and cladribine blunt the attack by targeting white blood cells that harm the protective coating of nerve cells. Gilenya keeps lymphocytes, a type of white blood cell, from being released into the immune system, while cladribine works by killing lymphocytes.

Cladribine was cleared more than a decade ago to fight leukemia and has been approved as an MS treatment in Russia and Australia. Gilenya won approval in Russia on Sept. 10.

Three studies released this year showed both pills reduce the risk of relapses and worsening disease, with the Novartis drug also providing a greater benefit than an established interferon therapy in 12 months of treatment. Though the medicines work differently, both suppress the immune system, and patients who took the drugs had higher rates of infections including herpes and shingles.

To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net.

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

I am excited for the MS community that the long-awaited oral pill has finally arrived.  There will certainly be more coming very soon.

Although it is the insurance companies and government payors who will carry the brunt of Gilenya's price, I'm sure that many, many patients are going to be challenged with high copays or inadequate coverage or are not insured at all.  These are the folks for whom my heart screams.  I've been there, done that....and blogged it!!

To be completely upfront and honest, I am acquainted with a few folks who are involved in marketing for Novartis.  We are connected on Twitter.  Last night I sent out a message to two of those folks and one did respond.  Although he couldn't speak regarding the pricing, he did ask me about contributing ideas for "Prescription Assistance Program Best Practices."  I thought that this was an excellent idea.

So let's turn this discussion into a proactive one.  What would be your suggestions as to how assistance programs could best be set-up, arranged, carried out, etc, etc.?  What have you learned in your own experiences with PAPs?  Please do share in the comments below.

If our ideas help to establish (or change) a system which many other MS patients will navigate, then it is worth it in my mind for us to gather these ideas together.  And, by doing it out in the open, other companies might read our feedback and take it back to the folks who can make adjustments to make the process less painful, or "hellish" as was the term I used last night.