Activity Transcript

Kim Birtcher, MS, PharmD, AACC, FNLA: Hello and welcome. I'm Dr Kim Birtcher, a pharmacist and adjunct clinical professor at the University of Houston College of Pharmacy. Welcome to the program, Successful Dyslipidemia Management: Tips and Tricks to Overcome Access Issues. Joining me today is Dr Anandita Kulkarni who is a preventative cardiologist and women's heart specialists at the cardiovascular division at Baylor Scott and White Heart Hospital Baylor Plano. Welcome. Dr Kulkarni, please start a discussion by talking about some of the things known about gaps and lipid management.

Anandita Kulkarni, MD: Thank you for the introduction, Dr Bircher. What we have noticed across the board, in primary and secondary prevention categories is that patients are routinely being undertreated for hyperlipidemia. When we look at this more granularly through data from national cohorts, we find several areas in which there are gaps in treatment. Statins are not always prescribed when they are indicated or not prescribed at the appropriate dose. Patients at high risk for atherosclerotic cardiovascular disease (ASCVD) often, do not receive high intensity statin therapy to reduce their low-density lipoprotein cholesterol (LDL-C) by at least 50% from baseline.

Furthermore, even when statin therapy is prescribed appropriately, patients may still have residual risk for ASCVD events. In these cases, we find that non-statin therapies are not routinely being prescribed, in addition to maximally tolerated statin therapy. Taken together, the gaps that we see are related to either, undertreatment or lack of treatment with guideline-based medical therapy, across both primary and secondary prevention categories.

Dr Birtcher: You have raised some really great points. The 2018 ACC/AHA multisociety cholesterol guidelines actually provide recommendations to address many of the gaps you mentioned. In general, patients with clinical ASCVD and familial hypercholesterolemia should receive maximally tolerated statin therapy, preferably high intensity statin therapy. The goal is to reduce the LDL-C ≥ 50% from baseline. The guidelines encourage clinicians to use LDL-C thresholds when considering the addition of non-statins. We actually have some guidance on when to put those non-statins into practice.

For patients with very high-risk clinical ASCVD, it is reasonable to add a PCSK9 inhibitor to maximally tolerated statin and ezetimibe therapy if the LDL ≥ 70 mg/dL or the non-HDL ≥ 100 mg/dL. For those patients with FH, it may be reasonable to add a PCSK9 inhibitor to maximally tolerate a statin therapy ezetimibe therapy, if the LDL remains a 100 mg or more.

Dr Kulkarni: Certainly, even with these guideline recommendations, using PCSK9 inhibitors can be quite challenging in the real world. The first hurdle that we're met with when initiating PCSK9 inhibitor therapy is the prior authorization process. While there have been improvements to simplify the process over the last several years, patients and clinical practices are still met with the challenge of completing this process, which can often be tedious, time-consuming, and have varying requirements based on insurance type and company.

There is no standardized process for prior authorization, which makes it less predictable and limits efficiency. Furthermore, there are instances in which the insurance company may not approve PCSK9 inhibitor use, in which case, the clinician may need to appeal the decision. When completing documentation for approval for therapy, one may encounter step therapy or fail first therapy that needs to be followed and documented, such as ensuring that patients are on maximally tolerated statin therapy or have been prescribed ezetimibe before a PCSK9 inhibitor may be prescribed.

After the pre-authorization process is complete, there may be issues with regards to access. For example, dispensing of PCSK9 inhibitors may require the use of a specialty pharmacy or follow-up documentation may be needed for continued authorization. Financial constraints may also limit accessibility to PCSK9 inhibitor therapy for some patients. Copays for government sponsored health insurance plans tend to be higher than those of private insurance plans. Thankfully, however, some of these patients may qualify for patient assistance programs offered by the drug companies.

Dr Birtcher: Goodness gracious. These challenges can certainly be discouraging for both the clinician and the patient and overcoming them can be very daunting for both. After the clinician confirms that the patient's willing to take the PCSK9 inhibitor, the clinician needs to be really upfront with the patient, letting the patient know the insurance company will likely require that extra paperwork you describe, and that it be done before the patient's able to start taking the medication. Processing the paperwork can sometimes take a week or more, which can be quite frustrating.

Now the good thing is, the patient can be involved in the prior authorization process and take some of the burden off the clinician. If needed, the patient can call the number on the back of the insurance card to determine which PCSK9 inhibitor is on the formulary. The patient can also be instructed to ask if that step therapy you mentioned, is required, or if certain medications need to be used before receiving a PCSK9 inhibitor. The patient can also ask if the PCSK9 inhibitor will need to be filled at a specific pharmacy.

The patient can also ask about the co-pay. The patient has that information up front. If the copay is too expensive for the patient, then the patient may be eligible to use the co-pay card. But if the patient isn't eligible, to you use the co-pay card, as you mentioned, with the government-sponsored plans, then the patient may be able to get patient assistance from the manufacturer. The patient needs to continue taking the other lipid-lowering medications too. It is really important for the clinician to emphasize that, and that occasional lipid panels will also need to be done.

Dr Kulkarni: Those are some great points. I will add to that, that the clinician can also facilitate the prior authorization process. Often, the insurance company will require that a copy of the clinician's note be sent with the prior authorization form. It will be important for the clinician to write a complete progress note that clearly documents the need for therapy. A comprehensive progress note may include features such as, the specific FDA indication, for which the PCSK9 inhibitor is being prescribed, that the patient has followed the initial steps that lead up to PCSK9 inhibitor therapy.

This would include counseling on lifestyle interventions, such as, exercise and following a heart healthy diet, documentation of maximally tolerated statin therapy. If the patient is not on statin therapy, a documentation of why they are not on it, including any side effects they may have had, whether or not they're on ezetimibe. And if not, the reason for not being on it. The note should also include results of a recent lipid panel. In order to facilitate this process, clinicians may consider implementing a smartphrase or template to ensure that each of these items are addressed in a systematic manner.

Dr Birtcher: You have made some great points. Initiating the PCSK9 inhibitors can be quite time consuming for the prescriber. In practices with the lipid clinic, the prescriber could be a physician, a pharmacist, a dietician, or a nurse practitioner. However, a general cardiology office oftentimes, does not have access to a lipid clinic or lipid clinic staff. Team-based care is very important in lipid management, and the team members can be trained to help facilitate the prior authorization steps. The workload can be shared with the other team members within the practice, taking some of that burden off of the prescriber.

This can be done several different ways. For example, a medical assistant could show the patient how to find the website with instructions on how to administer the PCSK9 inhibitor, or information about the patient assistance programs. A dietician with the health system could provide instructions on how to follow a heart-healthy diet. The nurse or the pharmacist could use the manufacturer provided demo pen or device to teach the patient how to administer the PCSK9 inhibitor while the patient is in the clinic and emphasize the importance of continuing other lipid-lowering therapy.

Some practices have taken this a bit further. Someone in the office or the specialty pharmacist associated with the health system could be designated as the prior authorization expert. This person could be responsible for submitting complete prior authorization forms and the required documentation to the insurance company. This person will become familiar with what is covered on the common insurance plans and the insurance companies’ prior authorization requirements. Data actually shows that practices that have implemented the designated expert, these practices spend less time on prior authorizations and increase approval ratings, compared to practices that don't have a designated prior authorization expert.

Dr Kulkarni: We should not forget the importance of a follow-up fasting lipid panel, as well. The fasting lipid panel should be done 4 to 12 weeks after initiating the PCSK9 inhibitor therapy to assess for adherence and response to therapy. At some point, the insurance company will request this information as well.

Dr Birtcher: That's absolutely an important point, and that's something that's emphasized in the 2018 Cholesterol Guideline as well. Well, Dr Kulkarni, thank you so much for this great discussion. I will now summarize for our audience, some of the key things we talked about today.

Despite guideline recommendations, there are many gaps in care when it comes to lipid management. One of the gaps is that, many eligible patients are not receiving PCSK9 inhibitor therapy. The PCSK9 inhibitor prior authorization process is quite cumbersome and daunting, and often delays care. Both the clinician and the patient can share the responsibilities for the prior authorization duty, taking some of the burden off of each of the parties. Then the team-based care is important in lipid management and the team members can and should be engaged in the prior authorization process. By designating a team member to be the prior authorization expert, the practice may save time in processing the prior authorizations.

Dr Kulkarni, we've talked about lots of things that the clinician can do or the prescriber can do to facilitate the prior authorization process. What are some things that have been particularly helpful in your practice?

Dr Kulkarni: We tend to plan ahead and have our team proactively address the questions that we anticipate will be asked during the prior authorization process. This really seems to streamline efforts. We've actually had pretty good success with this in our practice.

Dr Birtcher: That's great. That helps us as well. You had mentioned that template that people can use in their medical record. That's something that's been quite successful in our practice. I actually have a template that I bring up and it has all the points that you mentioned, so these aren't separate smart phrases that we pull in. This lists everything you mentioned, the diagnosis, past medications, adherence to a heart-healthy diet, intolerances. We order the lab.

I actually put in there which drug is on the formulary and what the copay is, and what the patient's doing, if they're seeking copay or the patient assistance programs.

Dr Kulkarni: Absolutely. We have had great luck using the templates in our electronic medical record system as well, with this.

Dr Birtcher: I want to thank you for participating in this activity today, and please continue on to answer the questions that follow and complete the evaluation.

This is a verbatim transcript and has not been copyedited.