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The new class of oral anticoagulants - comprising the Factor Xa inhibitors Xarelto (Bayer/Johnson & Johnson), Eliquis (Bristol-Myers Squibb) and Savaysa (Daiichi Sankyo) and the thrombin inhibitor Pradaxa (Boehringer Ingelheim) - generated combined global sales of $5.8 billion in 2014.
While these products have gained share from warfarin at a slower rate than many analysts had modelled pre-launch, there is an expectation of continued growth through to the end of the decade and beyond as usage continues to expand, likely helped by the launch of reversal antidote products (Physician Views Poll Results: Can Portolas reversal agent act as a growth catalyst for novel anticoagulants?) and ViewPoints: Boehringer Ingelheim poised to leverage idarucizumab to re-energise Pradaxa). Consensus forecasts indicate that combined sales will have expanded to around $12 billion by 2020.
Sharpening focus on the US market, two key trends will drive commercial dynamics over the next few years: acceleration in share gain for Eliquis (2014 sales increased to $774 million from $146 million the previous year) and entry of Daiichi Sankyos third-to market Factor Xa inhibitor Savaysa.
While Pradaxa was the first of the novel oral anticoagulants to launch, rapid accumulation of additional indications (it has the broadest label) and once-daily dosing have propelled Bayer and Johnson & Johnsons Xarelto into a position of market leadership; whereby more prescriptions are written for the drug each week versus its competitors combined. Eliquis initially failed to meet early launch expectations, heightened by a perception that Bristol-Myers Squibb and Pfizers drug has a superior clinical profile, however, subsequent uptake appears to have been helped by approval in additional indications and an effective promotional campaign.
In a recent note to investors, Bernstein analysts wrote that while Eliquis share gain has come primarily at the expense of Pradaxa, continued expansion has also adversely affected Xarelto, with Bayer management having conceded earlier this year that new patient starts on Eliquis were now higher than its own brand in the US market. While the primary objective remains share gain at the expense of warfarin, should Bristol-Myers Squibb and Pfizer choose to launch a secondary front against Xarelto - most likely as share gain from warfarin slows - this could exert pressure on Bayer and Johnson & Johnson.
Another factor to consider is the availability of Savaysa, which has a broadly comparable clinical profile to the other Factor Xa inhibitors. Given both the size of the oral anticoagulant market and anticipated growth rates over the next five to ten years, Daiichi Sankyo could have a sizeable product on its hands. Uptake may be limited by a black box warning which restricts usage of Savaysa to patients with a creatinine clearance lower than 95ml/min; it is estimated that around 20 percent of patients fall outside of the approved guideline. While the boxed warning adversely differentiates Savaysa versus competitor Factor Xa inhibitors, it may act as the catalyst for a more aggressive pricing strategy, suggests Bernstein analyst Ronny Gal.
With these factors in mind, FirstWord is polling US-based cardiologists and primary care practitioners with the following questions
- Eliquis (apixaban) looks to have gained notable market share over the past year. What factor do you think has primarily driven this?
- Versus competitor products, how would you expect your usage of Eliquis to evolve over the next five years?
- A fourth novel anticoagulant - Savaysa (edoxaban) - has entered the US market this year. What is your assessment of Savaysas competitive profile?
- Would aggressive discounting for Savaysa compensate for its black box warning and drive an increase in your usage of the product?
- Based on its other clinical credentials, such as once-daily dosing, if post marketing analysis supported removal of the black box warning would you expect your usage of Savaysa to increase over the next five years?
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