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Archive for March, 2010

Time for some quick news updates in advance of my next blog entry. It’s extra special when there is people-friendly news to share in the healthcare arena, even more so when it comes in multiples. These have been highlights of my week so far:

Washington’s Governor to Sign Interpreter Bill into Law on April 1

Physician Payment Sunshine Act become Law as part of Healthcare Reform

Court Rules that Human Genes Cannot Be Patented

It’s quite fitting that the ruling on gene patents came shortly after the release of  Rebecca Skloot’s  book  The Immortal Life of Henrietta Lacks, the  true story of how cells secretly acquired some 50 years ago from a vulnerable patient, became the building blocks of a multimillion dollar biomedical industry.  Author Skloot is now on a national speaking tour, and accepting more invitations.  I’m looking forward to hearing her in Seattle in a few weeks

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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.

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As we celebrate the passage of the health care reform legislation, we can’t rest yet. Vigilance is needed  to ensure  the best provisions are fully implemented, and to continue to work for the full public option and rational use of resources. Alas, a biologics pathway was created in the package, but it is the industry-backed plan for 12 years of market exclusivity.

We’d had some hope in the new year that reason would prevail, as the last version of  the President’s healthcare reform package  included the creation of a biologics approval pathway, but did not specify details.  The President’s Proposal on the Whitehouse.gov website said:

Title VII. Improving Access to Innovative Medical Therapies

Promoting Biologics Price Competition and Innovation

The Act creates a new pathway to create generic versions of biological products so that Americans have access to effective, lower-cost alternatives.

This meant that the final version was still to be determined, which opened a new window of opportunity to advocate for a rational, patient-centered alternative.   Anthony So and Samuel Katz, both physicians professors of medicine at Duke, did just that with an eloquent op-ed that ran in the New York Times on March 8.  Biologics Boondoggle explained the issue succinctly , and made the case for limits on  marketing exclusivity for new biologics as a health promotion and cost-saving  measure:

Of course, one reason why the pharmaceutical industry would like 12 years of protection for biologics is that it would set the stage for lengthening the period of monopoly protection for conventional drugs as well. GlaxoSmithKline has already called for 14 years of exclusivity for conventional drugs.

Congress should allow biologics no more than five years of protection. That would provide drug makers plenty of incentive for innovation, and still protect consumers from the high prices that extended monopolies allow. Striking the right balance will ensure that Americans can afford the most effective medicines available.

So far, there has been relatively little commentary on the effects of the new biologics pathway provisions for patients, and  some mentions related to biotech research.   It’s  certainly positive that the doughnut hole in Medicare part D will eventually be eliminated,  but without price controls on medicines nor a reasonable avenue for generic biologics to become available to consumers, the costs of Rx drugs will only continue to skyrocket and seriously compromise access in the US and worldwide.

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Urgent  messages  to the California State Board of Pharmacy asking them  approve regulations upholding the mandates of  SB 472, which was signed into law by Governor Schwarzenegger in 2008, are needed by close of business tomorrow,  Wednesday, March 10.

This law spoke to the need for readily-readable  (in minimum 12-point font) Rx labels, and required both translated labels and  use of interpreter services to offer personal  medication information to patients at pharmacies.   Advocacy groups  for senior citizens, consumer protection, health and safety, and immigrants, plus  pharmacy professionals, all supported the proposed  measures. all While the CSBoP ‘s original draft of regulations mandated these improvements, the version approved on Feb. 17 , reversed the changes and would  allow 10-point  font to be used, would not require use of translated labels, and would make pharmacy-level  interpreter services optional.  Reversal of the health-protective provisions of the law is attributed to intense lobbying  (and major gubernatorial campaign contributions)  by  national pharmacy chains and pharmaceutical companies. To make matters worse, the day before the Feb. 17 vote, Gov. Schwarzenegger appointed an executive from a major chain drug company to fill an open position on the CSBoP, and her vote swung the Board’s recommendations, as reported by the LA Times:

Drug executive cast key vote to kill labeling law

Pharmacy board was poised to OK measure opposed by one of the governor’s major donors until he named a CVS/Pharmacy official to the panel……

For more background on the issues, please visit the websites of the California Pan Ethnic Health Network,   Gray Panthers California, Consumer Union’s Safe Patient Project. The CSBoP website contains the text of the law and relevant materials on pending Patient-Centered Prescription Label regulations.

Send  your  by comments March 10 directly to Carolyn Klein, Manager, Legislation and Regulations for the CSBoP at:
carolyn_klein@dca.ca.gov

California residents can send comments  via the online form on Consumer Union’s Safe Patient Project .

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