ADA issues statement of concern over prescription drug formulary trends – August 16, 2017

Executive Highlights

  • On Tuesday morning, the ADA has issued a statement of concern regarding prescription drug formulary design.
  • Specifically, the Association urges PBMs, payers, and employers to prioritize continuity of care, maximum therapeutic choice, and patient-centricity (there’s no one-size-fits-all solution for diabetes management). The statement underscores that coverage decisions should be grounded in clinical evidence, with particular attention to CVOTs showing cardioprotective benefits to certain diabetes drugs. We’re very pleased to see the ADA take a strong stance on this set of critically important issues.

Yesterday, the American Diabetes Association released an official statement of concern over prescription drug formulary design that frequently changes coverage for individuals with diabetes, impeding continuity of care and limiting therapeutic choice. The statement urges pharmacy benefit managers (PBMs), payers, and employers to recognize that diabetes cannot be effectively managed with “one-size-fits-all” solutions, and that formulary exclusions and preferences can thus be extremely damaging for some patients. The ADA also calls upon PBMs, payers, and employers to prioritize patient-centricity and continuity of care. All too often, they say, patients are forced to switch out their therapy for another agent in the same class, which can interfere with optimal diabetes management and can even lead to someone being on an inappropriate medication for them. The statement asks for all coverage decisions to be based on clinical evidence (particularly clinical trial data that shows CV benefits to certain advanced agents). Moreover, the announcement pushes for a standardized and expedited process for exception requests, if the trend of formulary exclusions/preferences is going to continue.

We don’t see the formulary landscape changing much – but we’re very happy to see the ADA take a strong stance on this persistent issue and we look forward to better understanding the PBM landscape (they, of course, seem to benefit from all the negotiating and the secrecy behind all the agreements that enable more “net” funds to go to them). The current system of PBM-led negotiations with manufacturers can fail to account for the heterogeneity of patients, and often leads to particular products becoming unaffordable for many. We continue to highlight the need for more transparency from PBMs, particularly regarding pricing/rebate decisions and the value they may or may not add to the healthcare system (at CMHC 2016, the renowned Dr. Irl Hirsch called PBMs “the pituitary gland growing this whole mess”). Ultimately, we’d love for all people with diabetes to have maximum therapeutic choice within and between drug classes – “affordability” as determined by formulary positioning should not be a factor.

  • The most recent example is the exclusion of Lilly/BI’s SGLT-2 inhibitor Jardiance from the CVS Health national formulary for 2018, with J&J’s Invokana (canagliflozin) preferred. Given that Jardiance (empagliflozin) is indicated for the reduction of CV death, and that the ADA recommends the drug for people with type 2 diabetes facing high CV risk in its 2017 Standards of Care, it’s unfortunate that CVS Health will restrict coverage to this effective therapy and may force many patients currently doing well on empagliflozin to switch to canagliflozin (even though canagliflozin also showed statistically significant risk reduction for CV events in the CANVAS trial, we have heard from KOLs that some patients do better on blood glucose management or weight loss with some compounds). Express Scripts has no SGLT-2 inhibitor exclusions on its formulary, with Jardiance, Invokana, and AZ’s Farxiga (dapagliflozin) all on equal footing, though this doesn’t necessarily mean obtaining reimbursement for all three products is easy. Moreover, this raises an important question of how much weight should be given to class effects at this stage: On the one hand, it’s exciting that two SGLT-2 agents have now demonstrated cardioprotection, and CANVAS will help corroborate findings from EMPA-REG OUTCOME as more than fluke in the minds of real-world HCPs. On the other, we’re very wary of PBMs and payers approaching products within the same class as interchangeable. In this case, canagliflozin may be associated with heightened risk for lower limb amputations for very high-risk patients based on the CANVAS dataset, while no similar safety signal has been seen for empagliflozin although we are cautious about direct comparison between trials and wish very much that larger outcomes trials could be done where the design and execution is the same and the “n” is big enough that compounds can be directly compared. We realize this would not be easy but also recognize that the SGLT-2 class is now a multi-billion dollar class and growing quickly so $200 million over multiple years compared to $10-$20 billion in revenue is actually not as large as it may seem at the outset. It also may be relevant to consider patient preferences for dosing frequency if one believes this relates to adherence (this applies especially to the GLP-1 agonist class, which features once-daily and once-weekly options), ancillary effects like weight loss and lipid-lowering, side-effects, etc., all of which may differ among agents in the same drug class.
  • As another example, MannKind’s inhaled insulin Afrezza is excluded from the UnitedHealthcare formulary in favor of Novo Nordisk’s NovoRapid (insulin aspart). As CEO Mr. Michael Castagna recently explained, despite MannKind’s concerted efforts to negotiate with UnitedHealthcare, the PBM will only reimburse Afrezza for patients who are physically or visibly disabled. This is incredibly troubling from our view, and a poignant blog post written by a patient who couldn’t get coverage for Afrezza despite benefiting enormously from the product illustrates how damaging the current paradigm of PBM formulary design can be – not all of that is the PBM’s fault and it is actually more about how other manufacturers are involved in formulary development.


-- by Ann Carracher, Payal Marathe, and Kelly Close