In today’s highly competitive, scrutinized and regulated pharmaceutical market, every drug manufacturer is looking for an edge. Eight recent industry developments offer data-driven insights that savvy manufacturers can convert into improved clinical and business results.


81% of health plans are covering at least one biosimilar pharmaceutical product on the market

That’s according to a survey of 45 health plans by Avalere Health, the Washington-based health care consulting and market research firm. The key factor in determining whether to include a biosimilar drug in an approved health plan formulary was cost, cited by 95 percent of the respondents. In other words, the biosimilar was cheaper than the original brand-name or generic drug it replaced. The second- and third-ranked reasons for covering a biosimilar were efficacy (80 percent) and safety (73 percent).

89% of health plans have or intend to have a formalized coverage strategy for biosimilars

Avalere’s survey findings were echoed in a short research article that appeared in the journal Pharmacy Today, published by the American Pharmacists Association. Researchers asked executives from 10 payer groups about their knowledge of biosimilars and how their member health plans will pay for biosimlars used by their enrollees. Some 22 percent of the executives said their health plans have a formal strategy in place for biosimilar coverage determinations. Another 67 percent said their health plans intend to have a strategy in place by 2018. “Payer groups will ultimately control the use of biosimilars, as patients might not purchase or providers may not prescribe medications that are not covered by their health plans,” the researchers said.

Clinical Trials

81% of patients say biosimilars should undergo same level of testing as biologics

Health plans may be willing to pay for biosimilar drugs, but it’s their enrollees who will take them. And patients say biosimilars should be just as safe and effective as the original biologics they replace. That’s according to a survey of 300 patients currently taking biologic drugs for their autoimmune conditions. Health Stories Project—Insights, a Seattle-based health care market research firm, conducted the survey. Some 81 percent of the patients said biosimilars and biologics should undergo the same type and intensity of clinical trial testing before market approval. Older patients felt even stronger with 92 percent of those age 55 or older saying biosimilar and biologic testing should be equivalent.

69% of patients say clinical trial participation is an opportunity to contribute to science

The need for pharmaceutical manufacturers to attract eligible patients for clinical trials of new drugs was the rationale behind a survey of about 600 patients by the Avoca Quality Consortium (AQC). The AQC is a Princeton, N.J.-based alliance of drug makers and clinical research organizations that works to improve the execution of clinical trials. Most of the patients—59 percent—said they suffered from a chronic but stable medical condition. Some 29 percent suffered from a degenerative medical condition. Yet, only 45 percent had ever participated in a clinical trial. Of those who did, the most frequently cited reason—69 percent—was the opportunity to contribute to medical science. That was followed by the opportunity to learn more about their medical condition (51 percent); they were paid to participate (39 percent); and they received free access to health care services (21 percent).

Generic Drugs

82% of prescriptions paid for by Blues plans are for generic medications

Biosimilars may be on the way, but it’s generics that carry the day. A report from the Blue Cross Blue Shield Association said prescriptions for generic medications represented 82 percent of prescription drug claims paid by Blue Cross and Blue Shield health plans in 2016. That’s up from 66 percent in 2010. Conversely, the percentage of paid drug claims for brand-name medications dropped to 18 percent from 34 percent over that same seven-year period. The report’s figures are based on $208 billion in prescription drug claims filed by more than 30 million Blues-insured enrollees from January 2010 through December 2016. “After a lower-cost generic drug is introduced, the resulting increase in the number of generic manufacturers and the generic share of the market for that drug consistently yields a reduction in total spending within a drug class,” the report said.

Competition among makers of the same generic drugs drives prices lower

Supporting the Blues report’s conclusion on generic competition and prices was a study in the Annals of Internal Medicine. Researchers from the University of Florida College of Pharmacy studied more than 1 billion prescription drug claims from 2008 through 2013 for 1,120 different generic drugs that entered the market in 2008. When competition among drug manufacturers over the same generic drug was the highest, the price of the drug dropped 32 percent over the six-year study period. When competition among drug manufacturers over the same generic drug was the lowest, the price of the drug rose 47 percent, the researchers found.

Pharmaceutical Value

24% of health plans have outcomes-based contracts with pharmaceutical manufacturers

A separate report from Avalere Health examined the interest by health plans of entering into outcomes-based contracts (OBCs) with drug makers. Under an OBC, plans pay prescription drug claims based on patient outcomes, not on the volume or type of medication. Of the 45 health plans surveyed by Avalere, 8 percent had one OBC in place, 4 percent had two to five and 12 percent had more than five. Another 30 percent said they currently are negotiating one or more OBCs with drug manufacturers. The four most-common therapeutic areas under an OBC for prescription medications are endocrine, infectious disease, cardiovascular and respiratory conditions. “Outcomes-based contracts offer the opportunity to deploy data, analytics and interventions to delivery on these goals for pharmaceuticals—particularly to better integrate therapy into medical management,” the report said.

76% of biopharma companies don’t have specialized health outcomes liaisons to work with payers

When it comes to negotiating outcomes-based contracts, health plans may have the upper hand—for now. Best Practices, a Chapel Hill, N.C.-based pharmaceutical and medical device market research firm, surveyed 29 medical affairs officers at 27 biopharmaceutical companies. Some 76 percent of the medical affairs officers said their companies don’t have a health outcomes specialist as a liaison to interact with payers. Those that do have their medical affairs officers host clinical forums for payers, serve on advisory boards with payers and make formal outcomes research presentations to payers. “With payers laying greater emphasis on patient outcomes and economic value, many pharma organizations have turned to their medical affairs function to effectively interact with payers regarding their product’s medical information,” the firm said. Some 25 percent of the medical affairs officers said they expect their companies’ payer relationship staff to grow more than 30 percent over the next 24 months.

Related: Learn more about McKesson’s distribution services for pharmaceutical manufacturers

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