Access to Innovative Medicines

Innovative Medicines

As new treatments for CVD and stroke are found to be scientifically valid and improve outcomes and are incorporated in evidence based guidelines, it is imperative that innovative therapies are available to all eligible patients who agree to these treatments.
This page contains a number of resources to address the issue of access to innovative medicines. Resources include:


Read about the barriers, role of nurses in overcoming these barriers and PCNA position in the statement below.

Reducing Barriers Position Statement


In this 35 minute video, we share all the tips we've collected during our year-long campaign on how to help patients access the innovative medicines they need. Watch the video below or view it in full screen on YouTube. 

Patient Tip Sheet

Getting the Medicines You Need: Partnering with Your Health Care Team

Access to Innovative Medicines Patient tip sheet

Clinicians can share this reference with their patients to help them better understand the prior authorization (PA) process, and their role in getting—and taking—innovative medicines. The tips include how the PA process differs from a typical prescription filled at a neighborhood pharmacy, potential challenges and solutions—including resources related to costs—and how patients can leverage their influence and power to effect change in the system, as well as the importance of medication adherence.

Download the four-page tool below. You will be prompted to log into your PCNA account before you are able to download this tool.

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This is a critical reference includes tips and resources for how to navigate administrative systems, maximize efficiency of the prior authorization process, and improve nurse job satisfaction and adherence/patient outcomes. Particularly focused on PCSK9, NOAC and new heart failure therapies.

Download the five-page tool below. You will be prompted to log into your PCNA account before you are able to download this tool.

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Having a Heart to Heart Conversation with Your Patients: Accesc to Innovative Medicine

Thanks 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.


Approved Rejected Denied - Prior AuthorizationA primary goal for clinicians is to try to get patients on optimal doses of guideline-directed medical therapy. However, there are often multiple barriers which interfere with this process. Completing prior authorization forms and navigating the various medication assistance programs are two frequent challenges that clinicians and their office staff face when working to ensure patients can access and afford prescribed medications. 

When new medications are available and require a prior authorization (PA), there is often a learning curve to understand what documentation will meet the requirements. The PA forms required by each insurance company vary slightly and are often complex, requiring a dedicated person or small group of educated clinicians in the office to review and gather data from patient medical records, complete the required forms and submit them accurately and timely to avoid rejection. If resources and funds are not available to support PA completion, this often leads to patients not getting prescribed guideline indicated medications and can place strain on the clinician-patient relationship. 

In early 2017, members of a variety of organizations convened to discuss the barriers to obtaining PCSK9s for patients due to the PA process. They made recommendations for streamlining the PA process, such as single PA forms for all insurance companies and companies having case managers to speak directly with clinicians and office staff. This team ultimately developed two templates for use by clinicians: a PA form with the necessary documentation to obtain approval and an appeal cover letter. Both forms can be modified as needed and used to increase the likelihood of approval from insurance companies. These resources were published in the March 2017 issue of the open access Clinical Cardiology. If such recommendations could be implemented and more people worked together to share best practices in obtaining PA, the process could be less daunting, and more patients could get the medications they need for improved management of their medical conditions.

Many of the newer to market medications are expensive. Uninsured or underinsured patients may not have coverage for important, evidence-based, yet costly medications. Even if a medication is approved and covered by a patient’s insurance, the co-pay can exceed what the patient can afford, especially since cardiac patients are usually on multiple medications, each with their own co-pay. A variety of assistance programs are available to help patients with co-pays or the entire cost of the medication, including: Patient Access Network (PAN) foundation to help underinsured people with a variety of diseases; medication specific patient assistance programs through the pharmaceutical companies, or organizations such as the Patient Advocate Foundation which provide tips and other websites that can help patients grant access.

Helping patients gain access to the right medications consumes considerable professional staff time and knowledge, adding significant cost to clinics and health systems without financial reimbursement. Nevertheless, allocating qualified staff and resources to obtaining PAs and identifying patient assistance programs will likely result in improved adherence to life-saving, evidence-based medications and improved health outcomes. Cardiovascular nurses are perfectly situated to help patients access needed medications while making the process less burdensome for the health care system; because in the end, most nurses would rather spend their time with their patient instead of on the computer, completing burdensome paperwork

Video: Improved Access to Innovative Medicine through Effective System Navigation

Thank you to program sponsors for PCNA's Access to Innovate Medicines campaign: Amgen, Inc., Bristol-Myers Squibb/Pfizer, Novartis Pharmaceuticals, Sanofi/Regeneron.