Millions of insured Americans find themselves facing the full cost of medication each year, not because they lack coverage, but because their drug has been quietly dropped from their plan’s approved list.
A formulary, the official list of medications a health insurance plan agrees to cover, is not fixed. Drugs can be removed at any point if a plan determines that a generic alternative exists, that a biosimilar has become available, or simply that a cheaper option is preferable. The result is that patients with ostensibly comprehensive coverage can find themselves liable for the entire cost of a prescription they may have been taking for years.
Alternatives, Exceptions, and Assistance Programmes
The first practical step, according to GoodRx, is to speak directly with a prescribing physician about covered alternatives. Doctors are not automatically aware of what a patient’s plan covers, which means patients must raise the issue themselves. In some cases, a generic or biosimilar equivalent may serve the same clinical purpose at a fraction of the cost. Where no suitable alternative exists, a prescriber may recommend requesting a 90-day supply rather than a monthly fill, or where medically appropriate, splitting a higher-dose pill to extend the supply.
If alternatives prove inadequate, patients can formally request a formulary exception from their insurer. This typically requires the prescribing physician to submit a letter of medical necessity, confirming that covered alternatives are either ineffective or likely to cause harmful side effects. Some plans also require patients to undergo “step therapy“, trialling a lower-cost covered drug first, before an exception is approved. A separate tier exception can be requested when a drug remains on the formulary but sits in a higher, more expensive cost bracket.
Several major pharmaceutical manufacturers operate patient assistance and copay programmes for those who cannot afford their medications. Lilly Cares, run by Eli Lilly, provides more than 20 medications at no cost to financially eligible patients, including several insulin formulations and Trulicity for type 2 diabetes, for which new applications are once again being accepted without the need for a medical exception.
AstraZeneca’s AZ&Me program offers free medication to uninsured patients and those on Medicare who cannot meet their costs, with eligibility open to anyone who has experienced a significant life change in the past year. Johnson & Johnson’s J&J withMe programme covers several dozen medications, including treatments for autoimmune conditions, with no income requirements for its commercial insurance tier.
Appealing a Denial, and What Comes After
When all other avenues have been exhausted, patients retain the right to formally appeal a coverage denial. The internal appeal process requires completing insurer-specified forms and submitting supporting documentation, including a physician’s letter confirming medical necessity. Plans must complete the review within 30 days for medications not yet started, and within 60 days for those already in use. In urgent circumstances, an expedited appeal must receive a decision within four business days.
Should the internal appeal fail, patients may request an independent external review through their state’s insurance regulator. According to GoodRx, a significant proportion of such appeals are ultimately approved. The process can take up to 60 days, and whilst most states manage their own external reviews, cases in states without such a mechanism are handled by the US Department of Health and Human Services at no charge to the patient, or through a private review organisation for a fee of up to $25.
Resources for navigating the appeals process are available through HealthCare.gov, the Patient Advocate Foundation, and the Centres for Medicare and Medicaid Services.
