The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Plavix

Preventing Bias in Comparative Effectiveness Research

Comparative effectiveness research has the potential to avoid wasteful spending and create net benefits for patients if approached properly, but it’s expensive.  Many of the large-scale comparative effectiveness studies include industry funding, and benefits managers are no strangers to the game, but giving those partners a say in study design risks introducing bias. 

An interesting example comes from today’s report that pharmacy benefits giant Medco is planning a head-to-head study of nearly-off-patent Plavix versus brand-new Effient.  The interesting tweak here is that the study will exclude people with a genetic variant (of the CYP2C19 polymorphism) who can’t metabolize Plavix.

This seems like another great example of personalized medicine informing a comparative effectiveness decision.  But, as the In Vivo Blog pointed out in an August post about Plavix and Effient, the effect of the CYP2C19 polymorphism on Effient efficacy is unknown.

So the PBM, with cost-saving incentives, is setting up a study to make payment decisions in which the efficacy of the (cheap) generic is boosted by excluding patients with the CYP2C19 polymorphism, with the validity of the comparison based on the untested assumption that there is no systematic bias to the branded product’s efficacy in the excluded population.  Am I missing something here?

The moral of the story: fund comparative effectiveness research through neutral parties and keep a careful eye on genetic and phenotypic subgroups to maximize the value of these important studies.

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Trends Update — Comparative Effectiveness: To Head-to-Head or Not To Head-to-Head?

Goats_butting_heads_in_GermanyOne of the challenges of comparative effectiveness implementation is figuring out when to look for comparative data. Two developments this week shed light on current comparative effectiveness thinking by regulators and pharma:

  1. Vanda’s new antipsychotic, iloperidone (Fanapt) was approved by the FDA last week without any head-to-head comparison against competitors (Zyprexa, Risperidol).  This approval indicates that so far, as the In Vivo Blog points out, the FDA is sticking to the view expresed by Bob Temple last year to the RPM Report that “[i]n most settings, especially for symptomatic treatments, we [the FDA] do not get or ask for comparative data and are perfectly willing to approve a drug that is shown effective.” (emphasis added).
  2. Nevertheless, reports today indicate that AstraZeneca decided to find out at Phase III whether its heart drug Brilinta is more effective than Plavix.  AZ conducted one of the largest head-to-head studies ever undertaken before regulatory approval.  FierceBiotech says that “offers a clear indication of the path developers will be more willing to take as they angle for market share among increasingly cost-conscious payers.”

Would Vanda have had an easier time if it had done a head-to-head trial? Could they have sustained the company long enough to find out? Maybe the only moral of these two trials is to look for comparative data as soon as you can afford to.

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M&A Update 2

Here’s the latest collection of M&A news we’ve found since the last update.  No new mega-deals, although Sanofi is shopping in the €15 billion range and Roche sold $16 billion of debt (which has seen high demand in subsequent trading) in the largest offering ever to raise cash for its Genentech bid.  Also, CV Therapeutics‘ (Nasdaq: CVTX) Board rejected Astellas’ $16 per share bid on the same day CV Therapeutics released its year-end results.

more deal info after the jump…

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