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Having a Heart to Heart Conversation with Your Patient: Access to Innovative Medicines

Susan Halli DemeterThanks to Susan Halli Demeter DNP, FNP-BC, CLS for writing this helpful article.

Advances in modern medicine and the development of new medications to treat chronic disease states bring both excitement and a challenge to the patient/provider visit.

Patients eagerly present to the clinic asking about the pharmaceutical commercial they saw as a treatment option for their condition. Reality sets in when the provider starts talking about the prior authorization process, insurance coverage and potential out-of-pocket expenses once approved, and the pros and cons of the medication (including possible side effects). PCSK9 inhibitors cost about $14,000 a year without insurance coverage, a price that is likely not affordable for a typical family with a median income of $52,000 year. Medicare patients often do not have a supplement that covers these medications and have to spend thousands of dollars to get them through the doughnut hole before going into catastrophic coverage. Initial monthly payments can range from $300 to $500 per month or more. Patient assistance foundations supported by the pharmaceutical companies can be an option for financial aid but are often underfunded and unable to be utilized.

My role as a nurse practitioner in a lipid clinic has led to several discussions and shared decision-making with patients before we engage in the prior authorization process for access to PCSK9 inhibitor therapy. My initial question is “How important is it to you to manage your cholesterol and reduce the risk for future cardiovascular events and what length are you willing to go to achieve this?”  The patient needs to be on board with the prior authorization process and be willing to talk to the insurance provider to plead their case. This also helps the patient understand that this is a novel treatment option and difficult to access because it is not a first line agent for hypercholesterolemia. Some patients have been candid with me at the initial visit and stated they were not interested in pursuing PCKS9 inhibitor therapy for a variety of reasons. The decision is ultimately theirs and saves a lot of time and effort.

The patient also needs to meet the clinical criteria before consideration for therapy. The insurance plan will ask if the patient is on maximally tolerated statin therapy (plus ezetimibe in some cases). The LDL requirement can vary from one insurance plan to the other (despite the provider following current national guideline criteria) and should be investigated in efforts to avoid a denial. Statin-intolerant patients may need to have tried two or more statins before deemed statin intolerant by the insurance plan.  

Patients also need to consider that the medication is accessed through a specialty pharmacy and often shipped directly to their home, requiring a signature upon receipt.  This can be a challenge for patients who travel frequently or have a post-office mailbox.  The medication also needs to be refrigerated until prior to administration. PCSK9 inhibitor therapy is an injectable medication, which can also raise concern in patients who are afraid of needles or to give themselves an injection. These topics should be included in the initial discussion because they can be reasons a patient opts out of treatment.

Innovative medicines such as PCSK9 inhibitor therapy are a valuable treatment option for patients. Our job is to ensure these medications are accessible and get to the right patient.

Thank you to program sponsors for PCNA's Access to Innovative Medicines campaign: Amgen, Inc