Biosimilar Uptake Hinges on Prescriber, Patient, and Payer

In a Wednesday session of the SMi Biosimilars North America 2017 conference, Gary Cupit, PharmD, senior advisor to the investment bank Frontcourt Group, gave biosimilar manufacturers his perspective on the market access challenges facing biosimilar developers.

According to Cupit, decades ago, “The principles of marketing were much more simple.” Since the 1980s, providers, payers, policy makers, shareholders, and regulatory bodies have all become key players in determining whether a therapy will achieve a sizable market share. Biosimilars will have to address the unique concerns of 3 critical stakeholder groups in order to see substantial uptake:

Prescribers

“They’re the toughest audience” for biosimilars, said Cupit. In order to gain physicians’ trust, it is critical to communicate the non-inferiority of the biosimilar product in comparison to its reference. Additional areas that require greater physician education include the concepts of interchangeability, automatic substitution, and switching.

Cupit added that once physicians gain direct experience with biosimilars, they become far more comfortable with prescribing these therapies to their patients. He stated that physicians who were involved in phase 3 clinical trials of biosimilars write over 90% more prescriptions for biosimilars than do their peers who have not been involved in such studies.

Patients

Cupit claimed that one of the greatest challenges for biosimilar uptake is the so-called “nocebo” effect, a phenomenon in which patients’ low expectations of a drug lead to poor outcomes or patients incorrectly attribute adverse events to a particular therapy. Cupit estimated that the nocebo effect could be present in approximately 25% of patients. “It’s a common problem, and it’s getting worse…this is really becoming a statistical nightmare, trying to figure out how to break out those patients” in monitoring biosimilars’ safety and efficacy.

Two of the key concerns that biosimilar developers will have to address in gaining patients’ trust are loyalty to branded reference products and uncertainty about biosimilars’ efficacy. “There needs to be some PR push here,” said Cupit.

Payers

Decision-makers who affect biosimilar uptake include doctors, health systems, pharmacists, and the supply chain, said Cupit, but “Then you’ve got this beast, the [Pharmacy Benefit Manager]. The PBM is really something to deal with” in negotiating the discounts and rebates that will allow a biosimilar to gain a place on formularies. Cupit predicted that, given public opinion on the high cost of drugs, the first quarter of 2018 could hold congressional hearings with PBM executives in order to investigate their influence on the US health system.

As biosimilar developers prepare to bring the products to market, Cupid offered specific advice on how to prepare for a successful launch:

• Understand that products must address a genuine medical need.
• Be aware that rapid sales uptake in 1 market must be followed by launches in other marketplaces.
• A product’s claims must have the support of a robust body of data in order to earn physicians’ credence.
• Pre-launch brand awareness campaigns may help to speed biosimilar uptake.
• Opinion leaders should be cultivated to help educate stakeholders about the value of the biosimilar.
• Direct-to-consumer activities are not essential, but they could be useful in gaining patients’ trust.