Build medical necessity/eligibility criteria into your UM program.

Consider implementing through your PBM:

• A prior authorization (PA) strategy that incorporates current, and any future updates to, the medical eligibility criteria outlined below;
• A step therapy program, encouraging the use of generic statins (and ezetimibe, when appropriate) before initiation of PCSK-9 inhibitor treatment;
• Quantity limits of 28 days or more to ensure proper dosage and patient tolerance and adherence;
• Initial authorization duration is one year. On the third month, check to see if the product is well tolerated and providing benefit. Continuation of PCSK-9 therapy may be approved if initial prior authorization criteria have been satisfied and official documentation of LDL reduction has been provided.
• Potential exclusion strategies.

PBM should make a note of the patient’s present and prior drug use and medical history to ensure that guideline-appropriate cholesterol control measures have been taken before initiation of PCSK-9 therapy. New guidelines now only require physician attestation on the PA form.

Below is an overview of suggested criteria that should be satisfied in order for a patient to qualify for treatment with a PCSK-9 inhibitor agent.

• 1 | Patient is 18 years of age or older and at high risk for Acute Coronary Syndrome (ACS) and has:
  • homozygous familial hypercholesterolemia (HoFH)* (with documentation provided); OR
  • heterozygous familial hypercholesterolemia (HeFH)* (with documentation provided); OR
  • a history of clinical Atherosclerotic Cardiovascular Disease (ASCVD)* (with documentation provided).
• 2 | Patient meets one of the following:
  • is on statin therapy at the maximally tolerated dose (with documentation provided); OR
  • is statin-intolerant*; OR
  • has a condition that is a contraindication for statin therapy (e.g., active liver disease).*
• 3 | Patient is on Zetia® (ezetimibe) (with documentation provided). NOTE: Many PA criteria no longer require Zetia® as a precursor to PCSK-9 treatment.
• 4 | Documentation is provided that supports that the patient has not achieved the appropriate benefit (i.e., a suboptimal lipid lowering response) from at least 90 days of compliant lipid lowering therapy and lifestyle modifications:
  • A suboptimal response for individuals where initial LDL-C is known: <50% reduction in LDL-C;
  • A suboptimal response for individuals where initial LDL-C is unknown: documented CVD and LDL-C remains ≥70mg/dl; OR no documented history of CVD and LDL-C remains ≥100mg/dl.

Consider adding an additional specialty drug tier to your formulary to house the PCSK-9 inhibitor class.

Be familiar with patient support programs offered through the drug manufacturers and decide how these will be handled in plan design.

Consider incentivizing members to utilize certain purchasing channels, or limiting pharmacy networks.

Be aware of cash prescription challenges. When paying cash for low cost statins, there is no electronic adjudication captured by plans and thus, no official knowledge/record of drug use. Consider implementing a value-based benefit design around statins so that you are capturing statin usage appropriately.

Ensure that your PBM is keeping you apprised of mortality trial results.

Inquire about new pricing arrangements that deviate from standard rebating structure and offer, through new formulary arrangements, PCSK-9 drugs at a lower list price.

Maximize savings by working with a network of specialty pharmacies or by channeling patients through the most cost effective specialty pharmacy network.

Ensure a complete understanding of the specialty pharmacy process/services, which involves:

• A full benefits investigation to determine a patient’s insurance coverage.
• An appeals process option for those who were initially denied coverage.
• Out-of-pocket payment assistance.
• Coordinated delivery. The drug may also be available for pickup at select retail locations. It is important to be aware of any geographical challenges and storage requirements here.
• Refill reminders from the specialty pharmacy.
• Self-injection training.

Ask questions to determine and understand how the distribution is actually being paid for. Ensure that you are not paying for something that the drug manufacturers might already be paying for.

Be aware of cash prescription challenges. When paying cash for low cost statins, there is no electronic adjudication captured by plans and thus, no official knowledge/record of drug use. Consider implementing a value-based benefit design around statins so that you are capturing statin usage appropriately.

For patients who prefer not to self-administer but rather to receive injections at the physician’s office, be aware of possible billing duplication. Ensure that patients are only being billed for the visit, not for the product as well.

Request quarterly reports from your PBM, broken out by national drug code (NDC) to view by class.

Examine the aggregate data to determine what is included in the service charge and to understand what your PBM, vs. its specialty pharmacy arm, is charging you for.

Cross reference medical and pharmacy reports to determine whether high cardiovascular-related medical costs (i.e., hospitalization due to an ASCVD event) are associated with a lack of statin use. It is important to link this data to ensure that the PCSK-9 inhibitor product is being delivered and used appropriately.

Educate employees about the risks of high cholesterol, the availability of traditional treatments, and the options to improve cardiovascular health via diet and exercise. Patients should be working with a physician on a treatment plan and behavior modification program, and should be on a traditional lipid-lowering regimen before even being considered for PCSK-9 inhibitor treatment. Generic statin options have long been proven safe, efficacious, and cost-effective and should be explored as a first line of drug treatment.

Encourage enhanced patient-provider interaction to ensure proper PCSK-9 inhibitor compliance and adherence.

Be sure employees fully understand their benefit coverage, copay assistance options and, in general, the cost implications of these new drugs.

Encourage employees to examine product ingredients, potential drug interactions, allergies, and side effects as they navigate PCSK-9 brand choices with their physician (NOTE: The needle cover of the glass prefilled syringe and the autoinjector of Repatha™ contain dry natural rubber (a derivative of latex) that may cause allergic reactions in individuals sensitive to latex).

Ensure that patients enroll in MyPraluent™ or RepathaReady™ (depending on the course of treatment prescribed) to receive product support, self-injection training and follow-up that will help them successfully initiate and stay on therapy.

Provide patients with the tools and knowledge to connect to these services whether it be a website or phone number.

Be aware that some manufacturers may offer six months of free access to, or a discounted cost for, the drug.

Encourage employees to examine product ingredients, potential drug interactions, allergies, and side effects as they navigate PCSK-9 brand choices with their physician (NOTE: The needle cover of the glass prefilled syringe and the autoinjector of Repatha™ contain dry natural rubber (a derivative of latex) that may cause allergic reactions in individuals sensitive to latex).