Wednesday, February 3, 2010

Annual Price for AMPYRA set at $12,850

For comprehensive information regarding Acorda Therapeutics and AMPYRA, read my HealthCentral article.

Acorda Therapeutics Announces Pricing and Patient Assistance Programs for AMPYRA (dalfampridine)

  • AMPYRA Wholesale Acquisition Price Set at $1,056 per 30-Day Supply
  • Patient Assistance Program Launched for Uninsured and Underinsured To Provide AMPYRA at No Cost
  • Co-Pay Program Implemented To Help Manage Out-of-Pocket Expenses

HAWTHORNE, N.Y.--(BUSINESS WIRE)--Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the wholesale acquisition cost (WAC) for AMPYRA™ (dalfampridine) Extended Release Tablets will be $1,056 per 30-day supply (60-count pill bottle), an annual cost of $12,850. AMPYRA was approved on January 22, 2010 by the U.S. Food and Drug Administration (FDA) as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA is expected to be available in March 2010.

Acorda is launching a comprehensive set of services to ensure broad access to AMPYRA for people with MS, including patient assistance and co-pay programs that will be open as soon as AMPYRA is commercially available.

“AMPYRA is the first medication indicated to improve walking in people with MS, one of the most debilitating challenges associated with the disease. Acorda’s goal is to ensure that cost is not a barrier to any person with MS who may benefit from this important medication, regardless of their level of income or healthcare coverage,” said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. “To that end, our assistance programs account for people who are unable to afford their medications but whose income or healthcare coverage often exclude them from other patient assistance programs. And regardless of income, people with private insurance can benefit from our co-pay program, wherever allowed by law.”

AMPYRA Patient Support Services

Acorda has established AMPYRA Patient Support Services, a dedicated resource for healthcare professionals and people with MS. Experienced customer care agents will be available to help healthcare professionals process prescriptions, work with insurance carriers to facilitate coverage, and direct patients to available assistance programs.

The AMPYRA patient assistance program is being managed by a third party organization with extensive experience in coordinating patient benefits. Patients who meet income and other requirements, regardless of their insurance status, may receive AMPRYA at no cost. This may include Individuals who have limited healthcare coverage.

Acorda has also put a program in place to help individuals with private insurance manage their co-payment costs, where allowed by law.

Healthcare professionals and people with MS can contact AMPYRA Patient Support Services at 888-881-1918 from 8:00 a.m. to 8:00 p.m. Eastern Time for more information about AMPYRA, and to learn more about the patient assistance and co-pay mitigation programs.

Important Safety Information

AMPYRA can cause seizures; the risk of seizures increases with increasing AMPYRA doses. AMPYRA is contraindicated in patients with a prior history of seizure. Discontinue AMPYRA use if seizure occurs.

AMPYRA is contraindicated in patients with moderate to severe renal impairment (CrCl≤50 mL/min); the risk of seizures in patients with mild renal impairment (CrCl 51–80 mL/min) is unknown, but AMPYRA plasma levels in these patients may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures; estimated CrCl should be known before initiating treatment with AMPYRA.

AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same.

Urinary tract infections were reported more frequently as adverse reactions in patients receiving AMPYRA 10 mg twice daily compared to placebo

The most common adverse events (incidence ≥2% and at a rate greater than the placebo rate) for AMPYRA in MS patients were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain.

For full Prescribing Information and Medication Guide, please visit: www.AMPYRA.com.

About AMPYRA (dalfampridine)

AMPYRA is a potassium channel blocker approved as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA, which was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP), which was previously called fampridine. In laboratory studies, dalfampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. AMPYRA is being developed and commercialized in the United States by Acorda Therapeutics, and by Biogen Idec in markets outside the U.S. based on a licensing agreement with Acorda. AMPYRA is manufactured globally by Elan based on a supply agreement with Acorda.

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for multiple sclerosis, spinal cord injury and other nervous system disorders. The Company's marketed products include AMPYRA™ (dalfampridine), a potassium channel blocker approved as a treatment to improve walking in patients with multiple sclerosis (MS), as demonstrated by an improvement in walking speed; and ZANAFLEX CAPSULES® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including Acorda Therapeutics' ability to successfully market and sell Ampyra in the United States and to successfully market Zanaflex Capsules, the risk of unfavorable results from future studies of Ampyra, the occurrence of adverse safety events with our products, delays in obtaining or failure to obtain regulatory approval of Ampyra outside of the United States and our dependence on our collaboration partner Biogen Idec in connection therewith, competition, failure to protect Acorda Therapeutics’ intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics' operations, and unfavorable results from our preclinical programs. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

12 comments:

  1. improve walking SPEED.
    Well, the cost leaves me out, don't have an extra $2500 for that donut hole. (not that RX would cover it anyway. When, IF, I walk again, I will be happy to go a few seconds slower than those on this drug, and not go broke.)

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  2. What they are charging for this drug is disgusting. It is another example of the GREED that is inherent within 'Big Pharma.'

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  3. Most interesting. As I understand it, Ampyra is the sustained released form of 4-aminopyridine. I get 4-AP compounded by my specialty pharmacist for under $40 a month. I guess they must have put some gold-filled ingredient in the new form of the drug to make it cost so much. Well, I'm not going to line up to buy it.
    Judy

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  4. I am also disgusted by this pricing level. Awful, horrible, terrible, disgusting!!

    And to read a JPMorgan report, it is assumed that patients using the compounded form will happily transfer to this sustained-release formulation and that neurologists will push their patients to switch.

    From what I've been told by many compounded 4-AP users is that they do not intend to switch. Some for needing a lower dosing level and some for cost and some for 'why change what works.' Estimates range from 3000-10,000 of patients who use the compounded form. Of course, Acorda isn't saying but they better know from doing market research.

    Just imagine.
    10,000 patients x $12,850 = $128.5M in sales

    How many MSers do YOU think might use this drug? Let's take numbers from the survey Acorda/NMSS conducted in 2008.

    64% surveyed experience trouble walking and of those 63% rate it disruptive or very disruptive.

    Let's assume there are 500,000 Americans living with MS (and we know that estimates are sorely underestimated). Of those, 320,000 might experience trouble walking and 201,600 may find it disruptive or very disruptive.

    During the trials, 35% to 43% of patients on Ampyra were "responders." Of 201,600 MSers, that would equate to 70,560-86,688 who might find benefit in ambulation. Split the difference - 78,624.

    78,624 x $12,850 = $1,010,318,400
    Bingo, you've got a blockbuster!!

    Now the strategy in question is how exactly to get neurologists and patients to start using this drug and keep the insurance companies reimbursing for it. Design assistance programs and plan to give some of it away (or they better).

    If Acorda were able to get even half of those patients signed-up AND gave away half of the drug in this first year, they would still bring in $250,000,000 which is about what they have in cash on hand right now and which would last them 3-4 years if they sold nothing.

    That same JPMorgan report mentioned how the MS market is price insensitive, referencing how the price of Avonex increased by 77% in 3 years and didn't experience a decrease in usage. The assumption is that it doesn't matter what drugs cost for us, we keep using them regardless.

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  5. Skip uses the compounded version of 4-AP, taking the max dose of 4 5mg capsules a day. We pay $221 for a quarterly supply of 360 capsules. I could see Skip changing to the prescription version because her co-pay costs will be much lower (she doesn't have Medicare Part D so no donut hole to deal with). But, the total cost spiking to over $3k per quarter compared to $221 today is just insane.

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  6. Thanks for sharing the information Lisa. :-)

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  7. Here's the scoop so far on the assistance programs. I called just now and although all the details haven't been worked out (so I'm told), here is what I learned.

    There will be two types of programs:

    1. the "copay mitigation" program which is only for patients who have commercial insurance. The patient would be automatically enrolled if their copay is greater than $50/month. If your copay is $40, you do not qualify for this assistance.

    How would patients be automatically enrolled? All prescriptions will go through their centralized specialty pharmacy program/insurance benefits center. You can't simply take your prescription to your neighborhood Rite-Aid and will only be able to get it mail-order in one-month supplies.

    2. the "patient assistance" program for uninsured or underinsured patients which is INCOME-BASED!! and to be administered by a 3rd party. The name of the 3rd party isn't being released, but the woman I spoke with said that NORD (national organization for rare disorders) "didn't ring a bell." She couldn't tell me about the income requirements (yet to be determined?) nor if financial resources would be taken into consideration (such as is the case with the Copaxone program administered by NORD with which I am intimately familiar).

    [In my experience with NORD, an income of 250% FPL and about $30K in savings meant that I was expected to be able to 'afford' $10K for the copaxone which NORD didn't provide. Later I discovered that it took an income of less than 200% and less in the bank to qualify for the full assistance. And this for a medication which costs about $30K now.]

    Residents of Massachusetts will not be eligible for the copay program, but might be eligible for the assistance program IF they are uninsured.

    No information yet for Medicare/Medicaid beneficiaries. It will depend upon formulary inclusion and other undetermined factors. Forgot to ask about VA beneficiaries.

    The biggest disappointment: NO SAMPLES TO NEUROLOGIST OFFICES!!!! That was the only way I was even going to try this if my neuro and I thought it might be helpful.

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  8. I was on this for a time and it truly helped my walking speed. My speed is very slow. When it was discovered not be be covered by my insurance I could not afford it.

    I am wondering if now that FDA had approved it can one still get it from a compounding pharmacy? Of course that doesn't mean I can afford it but I was just wondering.

    I do agree that there does seem to be so much greed with Accord and Ampya. It is like they say they are there to help patients, but in reality it seems they are there to suck their resources away. I makes me so mad I could spit. I don't think I'd take their Ampyra just because of their attitude.

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  9. I was on this for a time and it truly helped my walking speed. My speed is very slow. When it was discovered not be be covered by my insurance I could not afford it.

    I am wondering if now that FDA had approved it can one still get it from a compounding pharmacy? Of course that doesn't mean I can afford it but I was just wondering.

    I do agree that there does seem to be so much greed with Accord and Ampya. It is like they say they are there to help patients, but in reality it seems they are there to suck their resources away. I makes me so mad I could spit. I don't think I'd take their Ampyra just because of their attitude.

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  10. Thank you Lisa for the good information;
    Dear "Peace Be With You"
    where can I get 4-aminopyridine compounded?
    Please provide me by your pharmacist's contacts or any other way to get it cheaper.
    Ampera is too expensive for me and I think for any Ms patient.I'll never buy it.

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  11. This seems good enough reason to NOT seek FDA approval for off-label drugs like LDN. Government involvement just opens the door to their favorite bedfellow ... Corporate Greed!

    Ps: yes please provide info on obtaining 4-AP.

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  12. Obama afforsable health care for a family of 5 cost $1800.00 a month do not cover ampyra. HUMANA AND BLUE SHIELD is worthless.

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