With three potential MS disease-modifying drugs awaiting FDA approval, drug companies are jockeying for position in grabbing their corner of the MS market. Sanofi-Genzyme filed for FDA approval of Aubagio (teriflunomide) in August 2011. Biogen Idec filed for BG12 (dimethyl fumarate) in February 2012. Most recently, Sanofi-Genzyme filed another approval request for Lemtrada (alemtuzumab) in June 2012.
Biogen already has MS disease-modifying drugs on the market including Avonex (interferon beta-1a) and Tysabri (natalizumab). For Sanofi-Genzyme, Aubagio and Lemtrada will be their first foray into the MS drug scene. Both companies are already gearing up for their expected product launches.
Besides getting a drug approved and then educating the doctor and patient communities about their product (and why you might want to use their drug instead of a competitor’s), companies must also decide how much to charge for the medication.
The Rise in Cost of MS Drugs
When once-daily oral pill Gilenya (fingolimod) was launched in September 2010, Novartis shocked the MS community by pricing it well above - at $48,000 per year - any of the MS drugs available on the market at that time. In September 2010, the average annual price of the "CRAB" medications (ie. Copaxone, Rebif, Avonex, Betaseron) was $36,600. Include Gilenya and the average immediately rises to $38,880.
Six months later, as other companies chased the higher price point, the average price reached $40,992 or $39,240, including or excluding Gilenya, respectively. In July 2011, the average of the self-administered medications was $43,854. (My personal records do not incorporate price data for Tysabri, as that information was not available to me at the time.)
In essence, Novartis appears to have single-handedly encouraged an increase in the annual cost of MS drugs in the United States by releasing Gilenya at such incredible cost. The current average of $50,925 includes Avonex, Betaseron, Copaxone, Extavia, Gilenya, Rebif, Tysabri. Extavia has the lowest price at $45.077 and Gilenya is still the most costly at $61,298 according to DestinationRx.com, which provides drug price comparisons among its services online. That’s a 39% increase in just under two years.
Price of New Drugs To Come
One of the speculative questions regarding the new medications, if/when they receive FDA approval, is - What will be the cost? Judging by the effect of Novartis’ pricing decisions on the MS market at large, it would seem reasonable that the new medications will be priced accordingly.
One interesting move made in preparation for an increase in the price of a currently-available medication has occurred this week. Sanofi-Genzyme markets alemtuzumab as Campath, a drug used for B-cell chronic lymphocytic leukemia (B-CLL) since 2001. The annual cost of Campath is approximately $60,000 in the US, according to a report by DataMonitor published in November 2011. Campath is packaged in 30 mg/mL vial doses and a 12-week course of treatment requires fewer than 36 doses. DestinationRx puts the price of one vial at $1906.
Lemtrada (alemtuzumab) for MS is the same medication as Campath for B-CLL, but used at much lower doses and less quantity. In the trials for Lemtrada, patients received five daily infusions of 12 mg/mL followed by three additional infusions one year later. Total course of treatment for MS requires only 98 mg/mL of alemtuzumab.
Sounds dirt cheap, right? Only three vials (valued at $6000) would be necessary. Hot dog! Finally something affordable. But wait, Sanofi-Genzyme announced on August 21, 2012 their intention to withdraw Campath from the commercial market.
- "The Campath Distribution Program was developed to ensure continued access to Campath ® (alemtuzumab) for appropriate patients. Effective September 4, 2012 Campath will no longer be available commercially, but will be provided through the Campath Distribution Program free of charge. In order to receive Campath, the healthcare provider is required to document and comply with certain requirements. Please contact the numbers below to learn more." - Campath.com, accessed August 22, 2012.
The assumption now is that Sanofi-Genzyme will set the price of Lemtrada in the same neighborhood as other MS disease-modifying drugs once it receives FDA approval for use in MS. If so, the price of alemtuzumab might increase from $63.50 per 1 mg/mL to anywhere from $508 to $635 per 1 mg/mL.
My questions to you this week:
1. Have you personally seen an increase in your out-of-pocket expense related to your MS disease-modifying drug in the past 2 to 4 years? If so, please describe.
2. If your out-of-pocket expense is limited or covered by an assistance program, does it matter to you what the actual cost of the drug is?