Drug companies need to adjust development, marketing to consumer needs, study says

Consumers are now more involved in decisions related to their care, and with shifting reimbursement and regulatory environments, pharmaceutical companies should change the way they develop, market and sell their products, according to a new report from the Health Research Institute.

While the pharmaceutical industry has historically interacted with patients through clinical trials and marketing efforts, those types of engagement may no longer be enough, the analysis found, especially as regulatory and industry changes take hold. What's needed is more proactive patient engagement that meets the wants of consumers, which can increase their chances of commercial and regulatory success.

Three trends are driving the need to engage with patients in new ways, the report said. One is consumerism; people increasingly want to take charge of their own care, and technology is enabling them to find information about their conditions, access and track their health data, hone in on information about drugs in the development phase and connect with each other through social media networks. Twenty-four percent of consumers have used Facebook for healthcare purposes, the analysis found, and 37 percent have sought information on at least one social media network.

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The shift from volume to value is another driver. Insurers and drug makers are striking outcomes-based contracts that peg reimbursement rates to a drug's effect on patients on real-world settings that aren't clinical trials. Independent groups such as the Institute for Clinical and Economical Revue and the National Comprehensive Cancer Network are starting to publicize their own judgements about drug value that take into account clinical performance and patient perspectives.

That's creating some headaches for pharmaceutical companies, which are already struggling with increased research and development costs and the difficulties of obtaining regulatory approvals to market their products, according to the report. It now costs the industry more than $1 billion in research and development spending on average to successfully develop a single drug.

Companies should find ways to measure real-world outcomes in pre-market trials, the report suggests, especially as they enter into value-based contracts. Insurers and pharmacy benefit managers -- Cigna, Harvard Pilgrim Health Care and Express Scripts among them -- have started to implement agreements that base payments for drugs on whether they work as they're supposed to.

Regulatory interest in patients is also increasing the need for better engagement, the report found. As part of the Food and Drug Administration Safety and Innovation Act of 2012, the FDA set up a Patient-Focused Drug Development program to better engage with patients; so far, the agency has held 21 disease-specific meetings in which they asked patients for perspectives on their ailments, treatments, willingness to participate in clinical research and tolerance for risk. The meetings focused on well-known conditions and diseases such as HIV and breast cancer, as well as relatively little-known conditions like female sexual dysfunction and Chagas disease.

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HRI expects this approach is likely to expand in the near future. As part of the FDA and the pharmaceutical industry's proposed revisions to the Prescription Drug User Fee Act, the FDA will be releasing several policies intended to further integrate patients into the regulatory process.

Pharmaceutical companies will have to overcome the challenges of patient trust and regulatory compliance to successfully engage patients, said HRI. Its research showed that many U.S. consumers say they're unwilling to share certain health data directly with pharmaceutical companies; while 88 percent would share this data with doctors, just 53 percent would share it with a drug company.

Drug companies may soon be required to partner with outside groups to achieve the desired end, research found. For instance, a company concerned about the ability of their patients to travel to a clinical trial might partner with a ride-sharing service to bring them to the trial site, while a company concerned about patients taking an infrequently-dosed drug might develop an app than can serve as a reminder.

There are benefits to pharmaceutical companies taking this approach, researchers said. Early engagement with patients could help them to better design their products and set up cohesive support systems for users of treatments, which could be crucial in a value-based environment that revolves around quality and costs.

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Companies should begin these discussions during the research and development phase to ensure patient perspectives can be taken into account, according to HRI. This engagement can give companies a market edge, positioning them to capture added value in the reimbursement process.

Engagement can also improve a company's chances of regulatory success, the report found. Regulators may be more willing to work with outfits that are developing a drug on close concert with engaged patients. And instead of outright rejecting certain drugs, regulators might instead offer restrictive approvals, giving access to seriously ill patients.

Companies should have the analytical capabilities to make sense of the data that's being collected, the report said. Failure to engage with patients may bring its own risks.

Twitter: @JELagasse