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October 4, 2019

Pharma brands once saw patent cliffs as their greatest challenge. They sought to establish as many “good years” in the market as possible to recoup years of drug development investment. Today, brand-building challenges start years before the Food and Drug Administration grants a company approval to market. No longer is the communicator’s goal simply creating awareness and “see your doctor” moments during the lead-up to launch. Now, among their changing tasks are helping clients to define why their medication should be easy-to-access on formulary, or acting to shield the product from non-medical switches.

Historically, health public relations and investor relations pros tailored their communications to three main audiences: those most likely to benefit from a particular medication, physicians or investors. Communication must now include those who determine access: from payers to regulators, and everyone who influences both. Understanding how to navigate the health ecosystem, and working to build connections among decision makers, reduces the risk of falling victim to fragmentation among the myriad of players who determine access to care.

Fragmentation within the medical community has become more than just the “left hand not knowing what the right is doing.” Now, it often appears as though the left hand is actively working against its right. In this climate, rising costs are the bi-partisan decision-maker’s primary concern, but this focus misses the real—and necessary—expense of keeping people healthier, happier and out of the hospital.

Economist Dr. Alain C. Enthoven wrote more than a decade ago: “Our healthcare system is fragmented, with a misalignment of incentives, or lack of coordination, that spawns inefficient allocation of resources. Fragmentation adversely impacts quality, cost, and outcomes.” Not much has changed since these words were penned.

Fragmentation rears its head at every level of care. Imagine a patient with prescription in hand going into a pharmacy, only to be told that their physician’s medication recommendation isn’t covered by their health insurance formulary. Imagine people adherent on a medication for a life-threatening condition told unexpectedly that, due to a non-medical switch decision, they’re being shifted to another therapy. It happens every day. Fragmentation carries a cost. It results in diminished patient care. It can result in death.

Market approval is no longer bench-to-bedside expressway

The frequent refrains of “requiring prior authorization,” “fail first” or “step therapy”—which require the least expensive drug to be prescribed first, even if a physician believes a different therapy is in the best interest for their patient—result in kicking the proverbial can of cost toward someone else in the medical chain. Those extra calls to inform patients, lost time from work to see a physician about a new medication, or the time gap caused by obtaining the new medication —all increase costs in the end, negating the intended savings from a “less expensive” medication. The hassle factor can even result in a higher societal cost, such as loss of life.

Among the most high-profile lifesaving drugs that recently failed to secure market traction have been the cholesterol reducers called PCSK9 inhibitors. Financial analysts predicted blockbuster sales for PCSK9s, reaching $6 billion annually. Companies saw these predictions as a signal that payer and provider were aboard. But insurers and pharmacy benefit managers balked, refusing to pay for these high-priced medicines. They required doctors and patients to jump through “prior authorization” hoops to secure access. Even a massive outcomes trial of almost 20,000 patients that showed PCSK9s could reduce deaths as much as 29 percent for people with the highest cholesterol level was not enough to make insurers open the gates. And, when their developers finally slashed prices for these cholesterol-lowering drugs, payers responded only lethargically.

Innovators, providers and patients face access challenges

The system creates all sorts of winding curves for patients along the path to care, and communicators need to be far more aware of the access land mines awaiting brands. For example, people taking medications for irregular heartbeat confront all-too-frequent unplanned treatment interruptions due to non-medical switching. The seemingly innocuous decision by payers to change their formularies carries real impacts: a five-fold increase in a patient having a stroke and a two-to-three-fold increase in their hospitalization. These outcomes of non-medical switching increase both financial and human costs, but who tracks total cost of patient care when someone inside a formulary group makes a non-medical decision to change access to a particular drug? No one.

Organized chaos within the health system isn’t part of any master plan. It’s the result of inwardly focused economic structures centering around four decision-making health sectors: payers, policymakers, product innovators and providers. But the fifth sector, the one which everyone is focused on “helping”—patients—doesn’t have a reserved seat at the decision-making table. While their interests are often left outside the conference room, patients undoubtedly have the most skin in the life-preserving game.

Years before becoming FDA Commissioner, Dr. Scott Gottlieb, then with the American Enterprise Institute, saw how a range of drug development policies between regulators and drug developers interfered with patient care. He argued that FDA caution is hazardous to public health, that the system needed to streamline and find common connection. While he made considerable progress during his tenure at the Agency, there’s much more to be done to reduce fragmentation among health sectors.

Communicators who are savvy about how the ecosystem operates—from securing a seat at the table for patient advocacy to recognizing the importance of the Center for Medicare and Medicaid Part D system, as well as acting on the need for more give and take in the commercial formulary system—must speak out. They must begin to outline how demonstrating and supporting brand value across the health ecosystem chain, years before a drug is even determined to be safe and effective, is crucial to patient outcomes as well as reducing overall system costs. Their work might well prevent life-enhancing and -saving medicines from ending up on the formulary cutting room floor.

 

 

 

Gil Bashe, Kristie Kuhl, JD and Fern Lazar co-authored this piece that originally published O'Dwyer's Oct. '19 Heathcare & Medical PR Magazine.

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Finn Partners

 

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