Each month, we round up the latest FDA approvals and regulations to give you an expert take on what you need to know.
New CMS Ruling Targets Drug Manufacturer Coupons
In an effort to encourage generic drug utilization, Centers for Medicare & Medicaid Services (CMS) has ruled that copay coupons from brand drug manufacturers will no longer be applied toward deductibles and out-of-pocket limits. Currently, if a patient uses a manufacturer coupon to lower their copay, the remaining portion of the original copay amount may still be applied toward that patient’s plan limits. This mechanism allows patients to hit their deductibles and out-of-pocket limits without actually paying those amounts out of pocket. CMS wants to ensure only the member paid portion is applied toward the annual limits.
Starting in 2020, insurers can implement copay accumulator programs that would block the use of brand drug manufacturer coupons to lower annual out-of-pocket costs for patients. This rule allows issuers and plans to exclude drug manufacturer coupons from counting toward the annual limits on cost sharing when a medically appropriate generic drug is available. This rule specifically calls out that the copay accumulator program will only exclude manufacturer coupons when an appropriate generic drug is available. This is not a blanket requirement for all manufacturers’ coupons.
During the public comment period for this rule, concerns were raised that “the proposal would increase out-of-pocket costs for certain patients with serious conditions, make medically necessary medication less affordable and accessible for them, and jeopardize their health because they find it more difficult to adhere to their drug regimen.” CMS’s position was that “coupons can add significant long-term costs to the health care system that may outweigh the short-term benefits of allowing the coupons, and counter-balance issuers’ efforts to point enrollees to more cost-effective drugs.”
Sanofi Launches Flat-Fee Program for Insulins
Sanofi is launching a subscription-style program for diabetic patients in need of insulin. Sanofi’s “Insulin Valyou Savings Program” will have a flat monthly fee of $99, and will offer diabetic patients up to 10 boxes of insulin pens or vials.
The program is expected to launch in June 2019 and will be available to patients paying full retail price with a valid prescription for Toujeo, Lantus, Admelog and/or Apidra regardless of income level. Patients insured under Medicare, Medicaid, or similar federal or state programs will not be eligible to participate in this insulin program.
Amazon is Rolling Out PillPack
Amazon has been expected to enter the healthcare market for quite some time, and its acquisition of PillPack in June 2018 seemed to position them to compete with both retail and mail order pharmacies.
Amazon has been relatively quiet about it’s plans since the acquisition, but they have been steadily acquiring state pharmacy licenses to ship prescription drugs from their 5 PillPack distribution centers across the country. Then, seemingly out of nowhere, Amazon launched a direct marketing campaign at the end of April to a select group of Amazon Prime members to “Meet PillPack.” They are touting a “simpler pharmacy” experience and “no more sorting pills, waiting in line, or chasing down refills.”
While they are also promoting patients will only pay their copays and not shipping costs, patients switching from their current mail order provider may be surprised to see their costs increase. Often times, 90-day prescriptions filled at their pharmacy benefit manager’s (PBM’s) mail order pharmacy offer a discount (e.g. the copay for a 90-day supply may be the same as two 30-day retail copays). In the case of PillPack, they do not offer 90-day prescriptions and patients should expect to pay their standard 30-day copay. In the long term, this may mean higher out of pocket costs for patients using PillPack.