The back story of how the 12-year period of marketing exclusivity became part of healthcare reform also speaks to how difficult it often is to get hard facts behind drug costs in the US. Part of the reason that the biopharma industry has been largely successful in its efforts to promote measures like the biologics approval pathway that ended up in the final law, is due to the massive PR resources it can deploy at all levels, from lobbying members of Congress, healthcare providers, patients, health NGOs, and the general public. But just when we may think there is common understanding of what biologic drugs are, and what generic biologics or biosimilars, could be, another type of costly biologic– a me-too drug— has come on the scene, and apparently for no good medical reason.
In August 2009, Novartis got FDA approval for a “new” drug for multiple sclerosis called Extavia (Betaseron), a self-injectable form of interferon beta-1b. In 1993, Betaseron was launched as a Schering product, and through subsequent pharma mergers, acquisitions and negotiations, it became a Novartis branded drug in 2007, at the same time that the company announced it would launch a new version in 2009.
According to one industry observer quoted in a recent pharmacy trade publication, Extavia offers no known therapeutic advantage over existing medications:
“It may sound silly, but at a basic level, there does not appear to be any unmet medical need met by the introduction of Extavia — the reality is that Betaseron is already filling any need,” says Richard Tinsley, a partner at Putnam Associates, a pharmaceutical and biotechnology consulting firm. He adds that “we have not heard of any medical need or even drug transition strategy that would explain the introduction of a ‘me-too’ Betaseron.”
It appears that the sole reason that Novartis created Extavia was to have an MS drug for which it could develop a marketing campaign to cultivate contacts with physicians, MS groups, and patients, in preparation for the future launch of a genuinely new MS drug in oral form, FTY720, which has been undergoing clinical trials. Novartis has not been much involved in the neurosciences “market”, nor subspecialty field of MS, until now, so the company has much interest in building its promotional network. According to statements by Joe Jimenez, the Novartis exec who a few months ago became the company’s CEO :
The company aims for at least $1 billion in sales for its multiple sclerosis franchise, Joe Jimenez, the head of Novartis’ drug unit, said in an interview before the approval. Novartis plans to set up a network of sales people, nurses, as well as support hotlines to help sell Extavia and “build our commercial capability,”
In other words, Extavia is a me-too biologic, which offers no new medical benefits nor apparently any major price advantage over Betaseron, Technically, it’s called a bioidentical , not to be confused with bioidentical hormones.
The MS market in the wealthy countries is a lucrative one. According to Pharma Solution’s inThought Research newsletter, sales of the existing drugs for MS totaled almost $10 billion in 2009, bolstered by hefty price increases. The Party Continues for MS Drug Companies: Double Digit Price Increases in 2009 Pay Off was the feature article in February 18, 2010 issue of this Wolter Kluwer publication. Extavia is different only because it’s brand name doesn’t fit into the acronym by which these disease-modifying drugs are popularly known : “CRAB” for “Copaxone,, Rebif, Avonex, and Betaseron”. It’s price falls into the same range of $20,000 to $33,000 per year, or a typical retail price of $2600/month, per patient. Apparently to promote the switch to the “new” drug, Novartis is offering the sweetener of a slight price discount. For the same price, patients can purchase Extavia in a package with 15 vials (a 30-day supply) versus Betaseron’s 14 vials ( a 28-day supply). Some insurers have taken note, such as the Blue’s RegenceRx PBM, which now allows formulary prioritization for Extavia after Avonex and Rebif, but before Betaseron, due to the cost saving.
Novartis is not only ramping up its Extavia sales force and patient support services , but it is also actively deploying patient relationship marketing strategies in the MS community. Early this year the company launched its We Keep Moving campaign, based on a contest for people living with MS to submit personal stories to compete for participant spots in a nationwide, reality road trip to be filmed. The journey and interviews are now underway, with the videos being broadcast in multimedia presentations and a website. The program began in early March, to coincide with National Multiple Sclerosis Week. So far, I have not found any references to the budget for any of these promotions.
What does the advent of Extavia mean for access to medicines in general? With the new biologics marketing exclusivity rules passed for now, we will need to stay alert to the possibility that this could mark the start of a trend. Since Extavia is not a new drug, it’s launch cannot be considered a typical case of evergreening, unlike the recent situation of Avastin and Lucentis ,used to treat macular degeneration. We don’t know yet if the Extavia scenario is a one-time event, or if it signifies a new approach that we’ll be seeing more of: companies seeking approval for other me-too biologics in all therapeutic areas. If Novartis is successful with the marketing plan for Extavia as a way to position itself ahead of competitors for oral MS drugs in development, this strategy may be repeated. And while better therapies for MS and so many other conditions are sorely needed, the potential for creation of new access barriers through evergreening-like maneuvers cannot be discounted. In the biologics arena, it is still unknown if, or how, this could impact or even replace the traditional industry tactics of making minor changes to old drugs and paying-to-delay the launch of generics.
If anyone has new information on this topic, please share it here, along with your thoughts and comments.