Launching a new provider-administered drug in competitive spaces: what practices are thinking about 

Ten years ago, provider-administered drug launches existed in a radically different world. There were few branded provider-administered drugs to begin with. Biosimilars weren’t approved in the US. Outside of oncology and rheumatology, launching a provider-administered drug meant educating an entire specialty on the mechanics of buy-and-bill.

That world has passed. Now, there are more provider-administered drugs than ever. More healthcare organizations (HCOs) in more therapeutic areas are familiar with the process of submitting drug claims through the medical benefit drugs, navigating buy-and-bill, or working with specialty pharmacies and white-bagging requirements. But even as HCOs have become more familiar with medical benefit drugs, they face an explosion of administrative complexity: more drugs are available in more competitive classes of therapy with more nuanced payer rules and processes. To better understand how our system is managing this complexity, we spoke to a dozen administrators from health systems and private practices to hear their perspectives on dealing with newly launched provider-administered drugs.

Clinical considerations still weigh most heavily as  the top  factor for adoption… but providers have to think about the administrative and financial questions more than ever before.

Clinical factors still matter, and will continue to predominate. But the non-clinical factors have grown in importance. They are even more important in two environments:

1. Where there is little clinical differentiation (e.g., biosimilars).
2. Where there is a very entrenched brand that’s already in the market, it’s an uphill battle.

The non-clincial factors considerations for the practice include considering whether using the drug will put the HCO financially underwater, or whether the operational cost from complicated processes such as prior authorizations make it prohibitively difficult to administer a treatment. Every group we talked to emphasized the priority of delivering great care first, but all noted the need to consider the other factors that could harm the viability of the practice.

There is a wide spectrum of provider eagerness to jump on the newest treatment.

Reimbursement during the early days of a drug creates enormous financial risk for HCOs. HCO willingness to use (or not use) a new physician-administered drug in its early days varies widely based on their risk appetite.

HCOs really want great partnership from pharmas.

HCOs truly value strong partnerships with pharmaceutical companies. However, they can feel that pharma teams tend to promote a narrow perspective, focusing primarily on the unique benefits of their specific drugs. That’s natural — pharma teams are obviously going to be excited to talk about why their drug is special. But there are ways that pharmas can be really great partners. 

Pharmas can enhance their partnerships by actively engaging in discussions about the challenges providers and patients encounter, such as the complexities of prior authorization processes or adherence issues, and seeking ways to make script-to-therapy journey easier. Ultimately, by embracing a more holistic view and working collaboratively to address these challenges, pharmas can establish itself as a valuable partner in advancing patient care.

HCOs don’t just think about post-launch as a single stage, but as a series of gates.

When the drug is first released with a temporary J-code, only Medicare Fee-for-Service has a policy. Eventually other commercial payers create policies for the drug, which, at least theoretically, means a patient with that payer can get access to the drug (but as a dear old frenemy once told me, in theory, theory and practice always match; in practice, they rarely do).

Then, the permanent J-code is approved, which  some practices will take as a signal to expand use of the drug. Success! Right? Well not exactly — even with that shiny new permanent J-code, all is not quite well in launch-world. Payers take time to add the permanent J-code to their internal Utilization Management systems, putting providers and patients in a confusing no-man’s land where the temporary J-code is no longer appropriate, but the payer is not yet ready to accept prior authorizations (PAs) or claims with the permanent J-code. Worst of all, in this limbo state, the payer might even respond to a prior authorization request with the permanent J-code with an (incorrect) “No Prior Authorization Needed”, so when the HCO submits the claim, they receive a denial for “No Prior Authorization on File” (and the payers scratch their heads as to why providers would get frustrated with them…).

Finally, the permanent J-code has some stability, usually 6 months after being made permanent. We heard from some HCOs who told us they have a rule never to use a drug until the permanent J-code has been around for at least six months, because they’ve been burned for being more aggressive.

So what can pharmas do to smooth this transition?

• Know that it’s likely to be a slow burn — at first. Med benefit drugs are always going to have unique limitations right out of the gate, so it’s critical to plan for the long haul.
• Stratify HCOs by willingness to try new therapies early on in the launch lifecycle. Some providers will not use a drug until the J-code has been out for several months. Some will be fine using the drug for Medicare FFS patients early on. And others will try the drug early. Getting the launch right means properly stratifying these patients and building around them.
  • Just because an HCO has a low early willingness to try a new drug doesn’t mean that they and their patients will be resistant to the new therapy, once the reimbursement has stabilized more.
• Find ways to create reimbursement and coverage confidence targeted based on the stage.
  • Find ways to alert HCOs, and especially their administrative staff, about new payer policies coming online.
  • Identify in the data where new payers are actually applying their policy to PAs or claims, not just having a policy that doesn’t get used (e.g. in theory = in practice).
  • Provide guidance, as close to within the administrative workflow as possible, on payer policies and step-throughs. This is the point where it matters most.
• Make the clinical consideration the only piece that matters.
  • The script-to-therapy journey — everything from the benefits verification (BV) to the PA to getting patients scheduled — is extremely complicated for HCOs. And as a new drug, it’s even more so for your therapy, because the HCOs do not have familiarity or processes in place to make it easier. Within the obvious note of staying compliant, it’s your job to ensure that all of the other non-clinical factors don’t prevent patients from getting on therapy.
• Meet your providers where they are, in the tools they already use. It’s not enough to simply replicate what your competitors have done, because your drug is additional to what your HCOs have already been struggling to deal with.
• Embrace extreme partnership
  • Yes — your sales reps are obviously selling. HCOs understand that, and won’t begrudge you for it. But being a great partner means finding ways to creatively help practices solve the inevitable challenges that crop up around your drug. Make sure that you truly understand what challenges your HCO customers face, rather than letting a whole new slew of challenges get created for them.

Launching a provider-administered product is hard, but so much of the innovation in prescription drugs — in our entire healthcare system — depend on these launches going well.

Thanks to Christine Mann and Nicole Ast at DENT Neurological Institute; Paul Lucas at EyeSouth Partners; Amy Knighton at Savannah Neurology Specialists; Erin Bishop at Associated Retinal Consultants; Don Groff at Kettering Health; and our very own Becca Wysong.