Why Patient Access Remains a Health Care Challenge

For 20 years, the Alliance for Patient Access (AfPA) has worked to ensure that patients can access the treatments their doctors prescribe. According to founder and chief medical officer David Charles, M.D., progress has been made through advocacy efforts that have improved policies and empowered physicians to become stronger patient advocates. However, he says significant barriers to care remain.

As health insurers increasingly rely on tools such as prior authorization, step therapy, formulary exclusions and copay accumulator programs, many patients face delays, denials and financial challenges when trying to obtain needed medications. In recognition of AfPA’s 20th anniversary, Charles reflected on how the health care landscape has changed, why patient advocacy matters more than ever and what reforms could help create a fairer system for patients.

As the AfPA marks its 20th anniversary, how has patient access to care changed over the past two decades?

David Charles, M.D.: It’s a story of both good news and bad news. On the positive side, the Alliance for Patient Access has had a significant impact on improving patient access to approved therapies and empowering clinicians to advocate more effectively for their patients.

The challenge is that insurance companies have steadily added more utilization management techniques that can restrict access to care. Prior authorization and step therapy have been around for years, but now we’re also seeing things like formulary exclusions, where an insurer simply decides it won’t cover a medication at all.

Another example is copay accumulator programs. Many patients use manufacturer copay assistance programs to help cover out-of-pocket costs. Under a copay accumulator, however, the insurance company accepts that assistance but does not apply it toward the patient’s deductible or out-of-pocket maximum. As a result, patients can suddenly face large costs later in the year despite believing they had already met those requirements.

While we’ve seen many advocacy successes over the last 20 years, the barriers patients face have also become more complex.

Can you explain what prior authorization and step therapy are and how they affect patient care?

DC: Prior authorization occurs when a physician prescribes a treatment but the insurance company requires additional approval before the medication can be dispensed. The physician’s office must submit medical records and justify the prescription before the insurer decides whether it will be covered.

This process can delay treatment for days, weeks or even longer. If the request is denied, patients often face multiple rounds of appeals before receiving a final decision.

Step therapy is different. In medicine, step therapy can be evidence-based and guided by professional medical societies. For example, high blood pressure treatment may appropriately begin with lifestyle changes before moving to medications.

When insurers use step therapy, however, it can become a “fail first” requirement, forcing patients to try and fail less expensive treatments before gaining access to the medication their physician originally recommended.

Why has patient advocacy become so important?

DC: As insurers add more barriers to care, patient advocacy has become increasingly important. Patients often need to participate in appeals and communicate with their health care teams to navigate coverage challenges.

Advocacy organizations can also play a vital role. Whether it’s multiple sclerosis, cancer or another chronic condition, patient groups help educate individuals and advocate for policy changes that improve access to care.

What policy changes would make the biggest difference?

DC: One of my biggest concerns is that utilization management disproportionately affects vulnerable patients.

A patient with financial resources, legal expertise or family support may eventually overcome repeated denials. A single parent working multiple jobs may not have the time or resources to fight those same battles.

Health care policies should be fair and should not place the greatest burden on people who are already disadvantaged.

I also believe there are opportunities to rethink utilization management altogether. Rather than creating barriers before patients receive treatment, insurers and physicians could review prescribing patterns after care is delivered and work collaboratively to identify cost-effective approaches. That could reduce administrative costs, improve patient access and create a less confrontational system.

What message would you like to share with patients and policy makers at this 20-year milestone?

DC: For patients, the message is simple: The Alliance for Patient Access remains committed to fighting for access to approved therapies.

For policy makers, the current utilization management system is not working well for patients. We need innovative solutions that balance responsible health care spending with timely access to care. Most importantly, both physicians and patients must have a seat at the table when health care policies are developed and implemented.