Perspective on the Rx Pipeline
High cholesterol, at any age, can increase a person’s lifetime risk for heart disease and stroke, also known as atherosclerotic cardiovascular disease (ASCVD), and patients who have diabetes are at an increased risk of experiencing a cardiovascular (CV) event or stroke. The first steps to improving cholesterol and reducing ASCVD risks are healthy lifestyle interventions, including reducing low-density lipoprotein (LDL) or the “bad” cholesterol that can become plaque and clog arteries. Consequently, lipid management and reduction in cardiovascular risk factors are the cornerstones of diabetes care.[1-2]
In November 2018, the American College of Cardiology and the American Heart Association (ACC/AHA) released a new guideline for cholesterol management. The previous guidelines were released in 2013 and shifted the focus from LDL-based goals to focusing on risk groups and prescribing the appropriate moderate- to high-intensity statin. The emphasis of the 2018 guideline is establishing a more personalized risk assessment and broadening the options for people at the highest risk for cardiovascular complications.
The American Diabetes Association (ADA) also updates their standards of diabetes care every January. In the 2019 update, the ADA is in agreement with the 2018 ACC/AHA cholesterol guidelines and how to treat patients that are at the highest risk for an additional cardiovascular event.
The Updated Guidelines: The mainstay of pharmacological therapy remains statin treatments (i.e., atorvastatin, pravastatin, simvastatin, rosuvastatin), however, the 2018 ACC/AHA guidelines support add-on therapy for the high-risk patient population. High-risk patients are defined as patients who have already experienced a heart attack or stroke and are at the highest risk of having another event. These patients are known to have ASCVD. In previous guidelines, the focus was getting these patients on a high-intensity statin and maintaining adherence. In the most recent 2018 guideline, we are now back to targeting an LDL goal of 70 mg/dL or less with a statin at the highest dose tolerated by the patient. If high-risk patients are not achieving this LDL goal on the maximally tolerated statin dose, the next step in therapy would be adding Zetia® (ezetimibe). If LDL cholesterol levels are still not met despite medication adherence, the next step in therapy is adding one of the PCSK9 inhibitors (i.e., Praluent® (alirocumab) or Repatha® (evolocumba)) for further risk and LDL reduction.[1,3-4]
Guidelines Bring New Low-Cost Options: During the time the guidelines were being released, Amgen came out with new National Drug Codes (NDCs) for Repatha that offer a 60% reduction from previous pricing. With the updated guidelines emphasizing PCSK9 inhibitors and Repatha’s updated pricing, EnvisionRx knew it was time to take action and was able to negotiate equivalent pricing for Praluent via rebates.[3-4]
Impact to the Pharmacy Care Experience
Formulary: With the new lower cost offered in the market, both Praluent and Repatha (low-cost NDCs) were moved to the preferred brand tier for both Envision Standard and Select formularies. The high-cost NDCs for Repatha have been moved to the non-preferred list as a cost-saving measure. Both agents still require prior authorization.
Pharmacy Network: For those plans that required fulfillment through EnvisionSpecialty, that will no longer be necessary and EnvisionSpecialty will support transitioning each patient to an in-network pharmacy of their choice. In order to prevent any member disruption of therapy, EnvisionSpecialty will provide one 30-day supply if necessary.
Member Engagement: PCSK9 inhibitors will no longer require filling at EnvisionSpecialty, but may be subject to maintenance drug rules based on specific plans. Members who currently receive medication from EnvisionSpecialty will be coached on how to make the transition to an in-network pharmacy. If members are currently receiving the high-cost NDC of Repatha, messaging at the point of sale has been updated to alert the processing pharmacist that the member needs to be changed to the lower cost NDCs for coverage from EnvisionRx.
Clinical Support: Based on the changes to guidelines, we anticipate a potential increase in utilization of second- and third-line lipid-lowering therapies for patients that are at highest risk (i.e., Zetia, Repatha and/or Praluent). EnvisionRx has maintained our prior authorization process on both Praluent and Repatha to ensure that the appropriate patients are receiving guideline-driven therapy for their cardiovascular disease.
Payer Action Plan
Review Formulary Design: EnvisionRx recommends that plan sponsors review their formularies to ensure preferred coverage of the new low-cost Repatha NDCs. It is also important to review your formulary strategy for other add-on therapies recommended in the guidelines, such as Zetia and Praluent. Please note, for those using EnvisionRx Select and Standard formularies, no action is required.
 Introduction: Standards of Medical Care in Diabetes—2019. (2018). Diabetes Care, 42(Supplement 1), S1-S2. doi: 10.2337/dc19-sint01
Our Clinical Steering Committee
The Envision Clinical Steering Committee brings together leaders across our national pharmacy care company to monitor the drug landscape, provide recommendations on how to address changes, and to ensure our clients and patients are prepared—in advance.
With any new development, we partner with our Pharmacy & Therapeutics (P&T) Committee and consult with our best-in-class specialty pharmacy, to provide a balanced perspective on the clinical effectiveness of all available options, the cost impact to our plan sponsors and patients, and the impact on the overall patient experience.
Kel Riley, MD
Chief Medical Officer