Radar on Drug Benefits

The COVID-19 pandemic has dramatically altered health care delivery patterns. Hospitals have had to exhaust their resources caring for COVID patients, while other important health care services, like cancer screening, have taken a back seat.

While the pandemic is not over, vaccination efforts continue and lockdown orders have eased, allowing experts the chance to look back at how the pandemic has affected the patient journey and what this means for a post-pandemic world. Health care stakeholders, including life sciences companies, are starting to ask about lessons learned and what changes need to be made to provide better patient support.

✦ The FDA approved an additional indication for Jardiance (empagliflozin), allowing the drug to be used to “reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF),” according to a press release from Boehringer Ingelheim and Eli Lilly and Co. According to an Aug. 18 press release, the drug was already approved to “lower blood sugar along with diet and exercise in adults with type 2 diabetes, reduce the risk of cardiovascular death in adults with type 2 diabetes who also have known cardiovascular disease, [and] reduce the risk of cardiovascular death and hospitalization for heart failure…in adults with heart failure.”

✦ The National Association of Medicaid Directors (NAMD) called on CMS to approve Aduhelm (aducanumab) for Medicare reimbursement. Jack Rollins, the director of federal policy for NAMD, the national group comprising each state and territory’s most senior Medicaid civil servants, wrote that leaving Medicaid programs to cover the Alzheimer’s drug by themselves could cause serious financial strain. While Medicare can opt not to cover certain drugs, Medicaid is required by law to cover any FDA-approved drug. “NAMD estimates that Aduhelm will cost Medicaid $1 billion in state and federal dollars if Medicare covers the drug. If Medicare doesn’t and Medicaid is forced to do so, then state and federal costs for this unproven product will skyrocket to $2.6 billion — an increase of over 250%,” Rollins wrote.

In OptumRx’s latest Drug Pipeline Report, the UnitedHealth Group-owned PBM highlights a pair of drugs that offer long-sought treatments for two forms of liver disease. Because those diseases are so uncommon, the price of those drugs is likely to be quite high.

The drugs in question are Bylvay (odevixibat), which the FDA approved on July 20, and maralixibat, which the agency is expected to approve in late September. Bylvay, which is manufactured by Albireo Pharma, Inc., is the first drug approved for treating pruritus — or persistent itchiness — in all subtypes of progressive familial intrahepatic cholestasis (PFIC), a group of three related genetic disorders. Mirum Pharmaceuticals, Inc.’s maralixibat, if approved, would be the first treatment for patients ages 1 year and older with Alagille Syndrome (ALGS), a rare genetic disorder in which bile ducts are abnormally narrow, malformed and reduced in number.

Prime Therapeutics LLC saw telemedicine schemes contribute to a 60% year-over-year increase in reported false claims from 2020 to 2021. The Blue Cross Blue Shield affiliate-owned PBM, which is in its second full year of an artificial intelligence-powered fraud, waste and abuse (FWA) reduction program, reported that the program saved its health plan clients $285 million in 2020, in part because it detected telemedicine-driven schemes.

Elan Rubinstein, Pharm.D., head of pharmacy benefits consulting firm EB Rubinstein Associates, says it’s unsurprising that increased telemedicine led to a spike in prescription fraud.