Expect More From... Drug Pipeline!

From… Drug Pipeline! Has a holy grail medication been found for a significant number of patients? One author recently posed this question when referring to the drug pipeline. No, this alert is not about a specialty condition, nor does it pertain to the ever-popular weight loss drugs. This week’s good news is specific to a potential novel class of anticipated safer anticoagulants (drugs used to prevent blood clots). Anticoagulants are prescribed to decrease a patient’s risk for heart attacks, strokes and other cardiovascular events.

After injectable heparin, warfarin was the oral drug of choice. Warfarin led to many serious bleeding complications, frequent lab monitoring, significant drug interactions and need of adherence to a consistent diet. The next medical evolution produced Direct Oral Anti-Coagulants (DOACs), like Eliquis, Pradaxa, Xarelto to name a few. Much patient relief was noted by the newer DOAC class due to fewer labs and lack of dietary concerns, but left clinicians with a continued concern for bleeding. Regardless of those available treatment options, millions of patients avoided drug therapy due to their required heavy acceptance of responsibility and risks.

Therefore, science has continued to chase the eluding “safe” anticoagulant(s). Will this newly identified Factor XI target be the answer we’ve been awaiting? Even better news, is it possible that multiple promising agents targeting Factor XI varying in both a long-acting injectable formulation and short acting oral agents are being reviewed within the same reasonable time frame? Yes, the possibility abounds! A recent trial stopped early due to an overwhelming reduction in major bleeding with the trial drug, abelacimab, compared to Xarelto. Phase 3 trials for effectiveness are in progress for this drug and several other competitors.

If the holy grail for increased effectiveness and safety has been found for these cardiovascular patients, will millions now agree to treatment that was previously foregone? A looming obstacle must be addressed head-on in the form of financial access. The environment is rich in speculation. Yes, the market expectation set before us is that new drugs with novel mechanisms are expensive. Will we be held hostage to improving safety and quality by a forced hand to sign a blank check? Instead, let’s proactively start the conversation regarding health equity. Let’s apply economic pressure to tamp down those costs due to the anticipated high volume of eligible patients. Let’s argue prices should be held reasonable due to the competition of multiple Factor XI agents and formulations coming to market within a reasonable time. Let’s leverage the soon-to-be generic availability of the DOACs to create a cost-benefit analysis. Let’s start the conversation now about how we EXPECT MORE from drug manufacturers and PBM partners to strike a fair deal rewarding innovation but not at unfair pricing practices. We can learn from today’s hot trends of diabetes and obesity spend. Being reactive to the market has not benefited society by means of access or affordability. Instead of waiting for Federal legislative action, such as insulin, let’s start with a low point-of-sale deal that is affordable for patients, plan sponsors and tax payors.