COMMENTARY

Tips for Navigating Prior Authorization and Out-of-Pocket Costs for HFrEF Medications

Larry A. Allen, MD, MHS; Sarah J. Sarni, BSN, BA

Disclosures

May 11, 2021

Editorial Collaboration

Medscape &

Resources for Patient Out-of-Pocket Costs

Estimating out-of-pocket patient costs for authorized drugs can be quite challenging. With thousands of insurance products, each with its own set of rules, clinicians cannot reasonably know or even predict medication costs. Furthermore, for the approximately 46 million patients covered under a Medicare Part D plan, payments for many prescription drugs change over the course of a year on the basis of cumulative out-of-pocket expenses.

Here is an overview of the standard Medicare Part D plan for 2021:

  • The subscriber pays a required monthly premium.

  • The subscriber covers 100% of drug costs until they meet $445 deductible.

  • Upon meeting the deductible, the subscriber must pay 25% of the cost of drugs until reaching total patient and plan spending of $4130.

  • After an initial coverage period, when a certain limit is met by the subscriber and the plan, the subscriber enters a coverage gap (ie, the "donut hole") wherein they are again responsible for the full cost of drugs until the total annual out-of-pocket spending reaches $4550.

  • The subscriber reaches a catastrophic coverage phase after which they pay $6550 out-of-pocket for drugs covered in the plan (usually with 5% cost-sharing for the remainder of the year or a minimum copay of $3.70 for generic drugs and $9.20 for brand-name drugs).

For commercial plans, the federal government establishes limits on how much a person or family will pay out of pocket annually. In 2021, those limits for out-of-pocket medication costs were $8,550 for individuals and $17,100 for families.

Now let's apply this standard Medicare Part D plan to the newer medications for HFrEF. With respect to sacubitril-valsartan, out-of-pocket copayments ("copays") average approximately $50 per month under Medicare Part D plans, though the cost varies significantly by plan and is influenced for the individual on the basis of total expenses meeting deductibles. Whereas the monthly Medicare Part D out-of-pocket costs for SGLT2 inhibitors are similar to that of sacubitril-valsartan, ivabradine has more variable coverage. Regarding vericiguat, because this drug was just approved by the US Food and Drug Administration earlier this year, coverage for use in HFrEF is currently limited.

For commercial insurance plans, patient copays may be partially waived by the manufacturer for qualifying patients. For example, the manufacturers of sacubitril-valsartan provide a $10 copay card to eligible patients under commercial plans — not Medicare Part D plans. Likewise, coupon or voucher offers by manufacturers do not apply to Medicare Part D subscribers. Other patient assistance programs exist, including means-tested provision of discounted or free medications to patients who are unable to afford them; however, these programs have limitations and administrative burdens. Help with navigating such patient assistant programs is available, through nonprofit organizations such as NeedyMeds and GoodRx.

To help patients anticipate out-of-pocket costs for HFrEF medications, the ACC partnered with the Colorado Program for Patient Centered Decisions (CPPCD) to develop a decision aid for renin-angiotensin inhibitor drug options for patients with heart failure. Two pages of this four-page decision aid are dedicated to helping patients obtain estimated out-of-pocket costs for sacubitril-valsartan because that is the main risk burden of this drug. The decision aid suggests two options to help patients find out what portion of drug cost they will be responsible for based on their insurance coverage — contacting their insurer or having the prescription for the drug run through the pharmacy. Greater interoperability of electronic health records with insurers' databases has begun to enable real-time estimates of out-of-pocket costs provided at the time an electronic prescription is written, but such functionality is currently limited.

Although it's not used in heart failure, tafamidis, a transthyretin stabilizer for amyloid cardiomyopathy, warrants brief mention to provide further insight into prior authorization processes. Because tafamidis was developed for a rare disease, the manufacturer's list price for this medication is $225,000 per year. Needless to say, this hefty price tag led to no coverage by some insurance companies, a need for prior authorization by others, and out-of-pocket challenges for patients who might benefit from the drug. In addition to prior authorization being required for tafamidis in the majority of cases, such requests are generally handled through a specialty pharmacy.

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