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insights LIFESCIENCELEADER.COM MARCH 2014 64 PHARMA BUSINESS is to prepare a list of questions to be asked throughout the process. The first question should obviously ask what patient population will be using the device. Once that is known, determine if there is already a device on the market that is appropriate for that population and is readily available. "You can't use a pen that was designed for diabetics needing insulin and expect it to be used by an elderly patient with rheumatoid arthritis," says Lipp. "However, if there is already a device available tailored to the needs of arthritis patients, it would make sense to use that device. Then you can build on it going forward if you believe there are improvements that need to be made. Of course if a device is not read- ily available and the target population cannot easily handle a prefilled syringe, then a more sophisticated device should be considered." GO TO MARKET OR WAIT? A dilemma faced by many pharma com- panies is whether to get a drug to market as quickly as possible or wait until a better delivery device is developed. If a medicine can be put on the market quickly, it is good for patients who need the drug, and it provides a quicker eco- nomic return for the firm. But releasing the drug with an inappropriate delivery device could also cause the whole effort to backfire. This is a decision moment that must be considered, and there are two schools of thought. "If there is a similar drug already on the market with a sophisti- cated device, are you willing to go into that market with a new biologic and an inferior delivery device?" asks Lipp. He recommends taking a close look at the market to see what medicines are already available, along with the devices available to deliver them. One should only go ahead quickly if the new bio- logic/device combination-product offers patients advantages over already exist- ing combination-products, otherwise one should consider further investment into device optimization. Unfortunately, this approach may also create additional risk. Nielsen believes many manufacturers will have a differ- ent perspective. "When you are in clini- cal development, the goal is to demon- strate the safety and efficacy of the drug; everything else is secondary to that," he says. "Once you launch it and get some clinical experience with it, only then will most companies look at the product to consider how they can make it better. Companies have a lot to worry about when submitting a drug for FDA approval. Once they prove the safety and efficacy of the drug to the FDA and payers, they may go back and make incremental improvements or break- throughs with the device, but not until after the approval." Including the device design step into this process, and proving that it works in a clinical study, certainly entails tak- ing on an additional risk. According to Nielsen, that is a risk 9 out of 10 compa- nies would likely not want to take. "There is enough risk in showing the safety and efficacy of a drug," he adds. "For many executives, laying an additional layer of risk on top of that goal would be a step in the wrong direction." WILL THE PAYERS BE WILLING TO PAY? Even if you develop a safe and effective drug in a delivery device appropriate to your patient population, there is no guarantee insurance companies will be willing to pay for it. Becker believes pay- ers in the U.S. and around the world are looking for measurable improvement in patient outcomes as the criteria for new device acceptance. "The trend among payers is to look more comprehensively at the range of benefits a drug provides to the health of patients and the economic impact of a disease," he states. "If we are improving adherence to a drug with our technolo- gies, patients can better manage their conditions, and the cost of care goes down. Insurance companies want to be able to measure that improvement. If we can show them how much of an impact patient-centric dosage formulations can have, they will be more apt to reimburse more of the cost. They just need to rec- ognize the value the medication and the delivery method brings." Nielsen agrees payer coverage is an industry concern. Still, he believes it can be easy to overcome. "If patient adher- ence is 50 percent when using a pre- filled syringe, and your studies show adherence to be 80 or 90 percent with a new device, that will cause the payers to take note," he adds. "Payers will ulti- mately benefit from the patient having fewer relapses, fewer emergency situa- tions, and fewer hospital and home care visits. If the device costs an additional $5 or $10, but the savings to the insurer is in the hundreds or thousands, that is something you can quantify. It is an economic argument that is easy to make, but you need to have the data to prove it. Managed care is built on the premise that if you have the right interventions with physicians and are taking medications, symptoms can be alleviated without hos- pitalization or emergency care. That is the primary reason for having devices patients can use to self-administer, and which they will continue to use in the future." L There is enough risk in showing the safety and efficacy of a drug. For many executives, laying an additional layer of risk on top of that goal would be a step in the wrong direction. K U R T N I E L S E N CTO and SVP of R&D; at Catalent PATIENT-CENTRIC DESIGN: THE NEXT FRONTIER IN DRUG DELIVERY By E. 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