So many times I have heard that ACTH is expensive, so I wanted to see just how expensive drugs can be. Here's a list of other Orphan drugs and How much they cost to insurers per treatment.
Soliris, $400,000 per year
Elaprase, $375,000 per year
Naglazyme, $365,000 per year
Cinryze, $350,000 per year
Folotyn, $320,000 per year
Arcalyst, $250,000 per year
Ceredase/Cerezyme, $200,000 per year
Fabrazyme, $200,000 per year
Most of these drugs are for rare diseases. Very few need these treatment that why the cost is extremely high. In most cases these drugs are life saving and drugs of last resort.
These prices are not confirmed but believed to be accurate as of 2012.
Achtar is also expensive in terms at 24k a vial and needing about 3-4 vials in a treatment for IS in children.
These prices may seem high, and they are to the insurance companies who pay them. What you will find is that in most cases the copays are far less.
Here's an excerpt from an article from The Myositis Association:
Questcor, the maker of Acthar, has the Acthar Support & Access Program (A.S.A.P.) which offers a wide range of support. A.S.A.P. is a free service provided by Questcor that works directly with your healthcare provider to secure the best possible insurance coverage for you with the lowest possible patient copay. Typical copayments for Acthar have been, on average, $50 or less. A.S.A.P offers 100 percent copay assistance for qualifying patients. Acthar is available at no cost for qualified uninsured or underinsured patients through Questcor's patient assistance programs. To learn more about A.S.A.P. visit wwwdotacthardotcom or call A.S.A.P. at 1-888-435-2284.
Hope this help with understanding that costs or expense of drugs are relative to the supply and demand based on the diseases taking in account the cost of research and manufacturing, while still maintaining profitability to the Biotech company. .Most of these costs are not felt by the consumer, but to the Health Insurers. If you feel bad about Health Insurers having to pay these prices, you need to check out the earnings report for your particular insurer. Pay special attention to their net profits. And if you think that they are going to lower your paycheck deduction because they made too much money, you better get a grip.
Don't forget you are quoting "per year" prices for all those other treatments and "per vial" costs for Acthar. How many vials does it take for those drugs to treat a patient for a year, and thus what is their per-vial cost?
IMHO the different units for prices make sense if the other orphan drugs are used to treat chronic conditions but Acthar is used to treat acute outbreaks like IS or MS. But a push into some of the chronic conditions which are on-label, eg rheumatoid arthritis, leading to year-round usage of Acthar looks like it would make Acthar much more expensive than any of those orphan drugs at current prices (say 26 vials/yr x $24K). And the emphasis of the recent sales force expansion suggests this direction is where QCOR wants to go. So resistance by insurers should not be surprising - if they don't resist now, it could become too late.
Me, Here is part of the prescribing information from Acthar's website.
- - - - - - - - - - - - - - - - - - - - DOSAGE AND ADMINISTRATION - - - - - - - - - - - - - - - - - - - -
• In the treatment of infantile spasms, the recommended dose is 150 U/m2 divided into twice daily
intramuscular injections of 75 U/m2. After 2 weeks of treatment, dosing should be gradually
tapered and discontinued over a 2-week period. (2.1)
• In the treatment of acute exacerbations of multiple sclerosis, daily intramuscular or subcutaneous
doses of 80-120 units for 2-3 weeks may be administered. It may be necessary to taper the dose.
• In the treatment of other disorders and diseases, dosing will need to be individualized depending
on the disease under treatment and the medical condition of the patient. It may be necessary to
taper the dose. (2.3)
- - - - - - - - - - - - - - - - - - - - DOSAGE FORMS AND STRENGTHS- - - - - - - - - - - - - - - - - - - -
• 5 mL multi-dose vial containing 80 USP units per mL (3)
They even go further to recommend the actual tapering off of the doses over these periods. You can view this by going to the website.
In any case, the point to be made is that Acthar is not alone or the most expensive medication on the market.
QCOR's initial rheumatology target is DM/PM.
In a clinical trial of five patients, patients had suffered an exacerbation of the condition and the treatment regimen was once or twice weekly injections for 12 weeks--three or four vials from memory. All responded positively to the treatment.
As posters know by now--I believe this is the script driver of the near future for Acthar Gel. My guess is QCOR will announce a significant increase in DM/PM scripts while other indications hold steady or ramp incrementally. If I am correct, this is big.
Nothing much on the horizon by way of novel therapies that I could find, unlike MS and NS, where there are potent new therapies in late stage trials that may take a slice out of Acthar's patient population.
Sentiment: Strong Buy
The issue over drug pricing isn't focused on the orphan drug designation of IS. The pricing is fine for IS.
The issue is the IS pricing applying to other indications where competing treatments cost half to 1/10th the current Acthar price.
Go back through your list of orphan drugs and see how many are used outside their orphan designation. Any? or are they focused drugs?
Very good point, Mike. Is marketing for all on label uses in question? Due to the fact that ACTH is grandfathered in because of its existance prior to the FDA, I think not. Should the pricing for Acthar vary for each indication or does Orphan designation in one area of application extend the ability to charge the rates approved for the other label uses? So far, and not to be seen changing in the near future. Approval of Orphan status was intend for the drug to become commercially profitable to market and develop enabling the availability of the drug for those rare cases. There would be a strong argument that by forciably reducing the price of Acthar would have a negative impact on the availability for IS. In addition, as said before, Achtar is not subject to FDA regulations for development, marketing for on label uses.
Regulations concerning drug pricing are regulated by some complex Federal and State laws. This price issue, since unique to Acthar, has not been addressed on those levels. It is highly unlikely that it ever will be ruled upon by the state or federal government in near future. Why? Well first, it would take longer then 7 years. The purposes that these pricing laws have been put into place to prevent drug companies from overcharging Seniors and Medicaid. Questcor has been actively discounting/ rebating to Medicare and the less fortunate. I think it would be smart to continue to do so. I think there needs to be a flexiblity and balance between Health Insurers and the company. If the company wants to expand Acthars usage into other on label applications that are not rare, then negociating with Health Insurance providers must take place and are taking place daily. In any case, these negociations should not negatively effect the profitability only increase the bottom line in the long term.
Nomad--you may be correct on the "fiddlin" for first line therapy scripts, but this would be selling contrary to the published package insert, and I doubt it would go very far with prescribers, who are routinely scrutinized for prescribing expensive drugs.
If a doc is prescribing Acthar as first line therapy, they likely have a solid clinical justification for doing so.
My wild guess on the subject of the DOJ investigation would be off-label discussion (e.g. related inflammatory disorders not part of the label indication), or distribution of unapproved literature or data.
Sentiment: Strong Buy