A conversation on eHealth Radio

Recently, I had the privilege of a thought-provoking conversation on eHealth Radio to discuss rare and orphan disorders, the therapies to treat them — and the challenges to get properly diagnosed and gain access to treatment. Since 2012, show’s host Eric Dye  has featured some of the leading innovators in healthcare. So having the opportunity to shed light on the trends in rare and orphan patient communities was an honor.

During our conversation, I discussed how these disorders are often misunderstood and incorrectly diagnosed. Even specialists, who may have studied a particular rare or orphan disease in medical school, may have never actually treated a patient with the condition. Payers may have little if any experience with the disorder as well, which can make it difficult to gain coverage for what can be a very costly therapy.

What can manufacturers do to help patients gain reliable access to these life-changing — and in many cases life-saving — drugs? To get to the answer, I encourage you to listen to my full interview on eHealth Radio.

In the meantime, here’s a sample of what you’ll learn.

The uncertain path of the patient journey

During my discussion on eHealth Radio, I share my personal story with rare and orphan disorders. My family has a long history of alpha-1 antitrypsin deficiency, an inherited condition that can lead to serious lung and liver disease. So I know first-hand what these patients face to gain an accurate diagnosis.

The patient likely has endured seven to 10 years of symptoms—has seen three to five different physicians—and been tested for multiple disorders. The patient may even have received treatments that had some underlying connection to the patient’s symptoms; but the disorder was misdiagnosed and the treatment failed.

Then you may hear, “I’m going to test you for an extremely rare condition that I don’t think you have, but I want to rule it out.” But you do have the condition. Finally, you have an accurate diagnosis — but don’t know where to turn next. You’ve never heard of the disease, much less the therapy prescribed to treat it.

At that specific point in the patient journey, manufacturers and commercialization executives can make the biggest impact for a patient’s future care. In a recent article we published, I interviewed two leading manufacturing executives on the steps they are taking right now ­— even during a pandemic — to raise awareness of rare conditions and act as a catalyst for helping patients to find the resources they need to know they are not alone.

Additionally, there are nine major steps for improving patient access to rare and orphan drugs. Here’s a summary of each; you can learn more by listening to my eHealth Radio interview.

Nine steps to gain patient access

  1. Patient education: What can you do to help patients understand the disorder and drug prescribed to treat it? They need to know what’s going to happen and why, so they’ll take their medication as directed.
  2. Payer reimbursement: First, you need to demonstrate that the patient is properly diagnosed to ensure the therapy is covered. Otherwise, reimbursement may be denied.
  3. Authorizations: Depending on the payer, there could be as many as 15 or more different authorizations to demonstrate the medical necessity of the therapy: not only proper diagnosis, but also health measures such as body mass index (BMI), age and many others. Some payers may also require an authorization to be referred to a specialist for diagnosis.
  4. Financial assistance: Even when a therapy is covered, patients will typically have an out-of-pocket cost that can be substantial, given the relatively high cost of these drugs. What copay assistance is available from manufacturers or others? More importantly, how do you access those programs?
  5. Diagnostics: Which tests need to be conducted to demonstrate that the therapy has been prescribed for the correct disorder? These could include blood, urine and genetic tests. What ongoing tests are required as well?
  6. Letters of medical necessity: What information and format will the payer require to document medical necessity? Every payer’s parameters are different.
  7. Medication delivery: What are the logistics of ensuring the patient has the right medication in the right place at the right time? If it’s an infusion therapy, will it be administered in the hospital or at home? What if the patient travels — how do you ensure access then for an infusion or oral therapy? How do you manage the logistics of cell therapy?
  8. Ongoing clinical education: No clinician can keep pace with new developments across some 4,000 rare and orphan drugs. What can you do to help clinicians stay informed about new learnings that could impact patient care?
  9. Product refills: Every month, how do you ensure prior authorizations remain in place, the therapy is still covered, patients can afford it and the drug is being delivered when and where needed? As patients have more questions, how can you ensure they remain comfortable and confident with the therapy?

Nine steps, one solution

To pave the way to patient access, you need to build a care team that’s 100% dedicated to the patient, caregiver, healthcare provider, disease state and drug. By taking this patient-first approach, you can better navigate an extraordinarily complex process to connect patients with the right products.

During the radio interview, I talk about how this navigation begins with the “gatekeeper” of the entire process, the payers. The care team focuses on understanding payer requirements to ensure coverage, such as gaining all of the necessary authorizations. The heart of the care team is the care coordinator, who rallies all of the resources to demonstrate medical necessity, such as the prescribing clinician and sometimes the pharmacist.

Because the care team is dedicated exclusively to a particular rare or orphan drug, the team can focus on the nuances of each payer’s requirements, so treatment isn’t unnecessarily delayed. Then, once therapy begins, the team works directly with the patient to provide support and help ensure compliance.

This is the approach we take at Optime Care: building a 100% dedicated team for a particular drug and patient population—and then navigating the access process on behalf of providers and their patients.

To learn even more, download our white paper, “How to create a patient-first strategy.” Or contact me directly at help@optimecare.com or call 888-287-2017.

About eHealth Radio:

The eHealth Radio Network produces health information, news and advice featuring some of the leading innovators in healthcare and wellness. Visit ehealthradionetwork.com.