Patient Reported Outcomes, also called PRO’s, are gaining in popularity among pharmaceutical companies. Rather than present scientific results of clinical studies, this qualitative assessment presents patients’ opinion about a drug or treatment, and they can have a big impact on healthcare costs. For insurance companies, PRO’s can inform which drugs to pay for. For pharmaceutical companies, PRO’s help market a drug. And for patients, PRO’s affect the drugs we have access to. When filling a prescription, there’s a list of drugs that an insurer will pay for called a formulary list. PRO’s provide some clue as to which drugs make the cut.
“Many times medications all look the same– it lowers your blood pressure, improves your cholesterol by a little bit,” said Dr. Edmund Pezalla, Aetna’s Director of Pharmacy Policy and Strategy. Pezalla says that in addition to the clinical data, another factor payers like Aetna consider is what patients say about the drug.
To solicit this information, pharmaceutical companies issue questionnaires asking patients if they feel better. This question, and others like it about quality of life, is important for something subjective like pain. The recorded answers make their way into the PRO’s. “They really enhance the process because otherwise the data is sort of sterile. It tells us a better story,” said Pezalla.
Ari Gnanasakthy, the PRO expert at the pharmaceutical company Novartis says the patient’s perspective complements clinical data and a doctor’s assessment. “Patients who feel abdominal pain — on a scale of 0 to 10 they might feel that it’s 8,” he explained. “Whereas a physician having seen thousands of patients might not feel that way, might underestimate the pain of the patient.” A company may refer to PROs when making a pitch to add their drug to the formulary list.
Susan Ellenberg, professor of bio-statistics at the University of Pennsylvania, acknowledges the benefits. “A company is going to do as much as it can if they believe in their product,” she said. “They’re going to want to get it out there. And they certainly want payers to pay for it. It’s undoubtedly true that sometimes they cross the line. But it’s very hard to know exactly where that line is sometimes.”
Ellenberg says that this line is harder to cross when PRO’s are validated by objective measures. For example if someone reports feeling less pain, the data should also indicate how long they were experiencing the pain and how much medication it took to make them feel better.
This week, Pezalla and Gnanasakthy will present their research at the Philadelphia at the Health Outcomes and Pharmaeconomics Research Conference.
Gnanasakthy’s research will focus on a new field called Patient Report Information, which includes informal stories and anecdotes about a medication often found on the Internet. Pharmaceutical companies are starting to pay attention to this chatter about their products on message boards,Twitter and in chat rooms. By following these conversations, companies can learn about the unknown benefits and harms of their drugs, which can ultimately have a big impact on sales.
“Pharmaceutical companies are now beginning to think beyond the labels and letting the patients and the marketplace decide the aspects of drugs that may be good for them,” said Gnanasakthy. The conference will also address ways of accessing and using this patient reported information to market products.