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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 01/01/2016 Title: PCSK9 Inhibitors
Revision Date: 11/01/2019 Document: BI496:00
CPT Code(s): None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Repatha (Evolocumab) and Praluent (alirocumab) require prior authorization.


Medical Statement

PCSK9 Inhibitors are covered for members meeting the following criteria for each indication. Please note covered drugs for each indication as not all drugs are covered for each indication. The initial authorization will be for 3 months.

Homozygous Familial Hypercholesterolemia (HoFH) – Repatha only

1)    13 years of age or older, AND

2)    Diagnosis of homozygous familial hypercholesterolemia (HoFH) confirmed by one of the following:

a.    Genetic confirmation of 2 mutant alleles at the LDL receptor, ApoB, PCSK9, or autosomal recessive hypercholesterolemia (ARH) adaptor protein gene locus, OR

b.    Untreated/pre-treatment LDL > 500mg/dl with at least one of the following:

                                          i.     Cutaneous or Tendinous Xanthoma before age 10 years;

                                         ii.    History of early vascular disease (men < 55 years of age, women < 60 years of age) on both sides of the family if parental LDL–C unknown;

                                       iii.    Elevated LDL cholesterol levels before lipid-lowering therapy consistent with heterozygous FH in both parents where LDL levels are known (> 250mg/dl in a patient aged 30 or more, >220 mg/dl for patients aged 20 – 29, > 190mg/dl in patients under age 20).

3)    Medication is used as adjunct to a low-fat diet and exercise, AND

4)    Documented 3 months prior therapy with at least one high-intensity statin (atorvastatin 40-80mg/day or rosuvastatin 20 – 40mg/day).

Atherosclerotic Cardiovascular Disease (ASCVD) – Repatha and Praluent

1)    18 years of age or older, AND

2)    ASCVD as evidenced by at least one of the following:

a.    Acute coronary syndrome;

b.    History of myocardial infarction;

c.    Stable or unstable angina;

d.    Coronary or other arterial revascularization procedure (such as PTCA, CABG);

e.    Stroke;

3)    Laboratory report or medical records of LDL–C of 70mg/dL or greater in the past 60 days, AND

4)    Failure (defined as an LDL–C >70mg/dL) of 2 different treatment regimens used for at least 12 weeks each, consisting of a high-potency statin (atorvastatin 40 – 80mg/day or rosuvastatin 20 – 40mg/day) at the maximum tolerated dose despite optimal adherence with regimens, OR

5)    Member has experienced ONE of the following:

a.    Rhabdomyolysis or muscle symptoms with CK elevations > 10 times upper limit of normal on any statin; or

b.    Myalgia (muscle symptoms with CK elevations < 10 times upper limit of normal with TWO different statins; or

c.    Hepatotoxicity secondary to statins defined as increased transaminases > 3 times upper limit of normal; or

d.    Concurrent liver disease documented by ONE of the following:

                                          i.    Child Pugh A or worse,

                                        ii.    Persistent elevation in transaminases (> 3 times upper limit of normal) for at least 6 weeks

6)    Not used in combination with another PCSK9 inhibitor, Juxtapid, or Kynamro; AND

7)    Will be used in combination with statin unless meeting one of criteria in #5 above.

8)    Member is following low–fat diet and exercise regimen.

Peripheral Arterial Disease – Repatha and Praluent

1)    18 years of age or older, AND

2)    Peripheral arterial disease presumed to be of atherosclerotic origin:

a.    History of claudication and abnormal ABI AND

b.    Findings from CT angiogram or catheterization consistent with clinical ASCVD, OR

c.    History of prior peripheral angioplasty and/or atherectomy, OR

d.    History of ischemic ulcers/gangrene or amputation, AND

3)    Laboratory report or medical records of LDL–C of 70mg/dL or greater in the past 60 days, AND

4)    Failure (defined as an LDL–C >70mg/dL) of 2 different treatment regimens used for at least 12 weeks each, consisting of a high-potency statin (atorvastatin 40 – 80mg/day or rosuvastatin 20 – 40mg/day) at the maximum tolerated dose despite optimal adherence with regimens, OR

5)    Member has experienced ONE of the following:

a.    Rhabdomyolysis or muscle symptoms with CK elevations > 10 times upper limit of normal on any statin; or

b.    Myalgia (muscle symptoms with CK elevations < 10 times upper limit of normal with TWO different statins; or

c.    Hepatotoxicity secondary to statins defined as increased transaminases > 3 times upper limit of normal; or

d.    Concurrent liver disease documented by ONE of the following:

                                          i.    Child Pugh A or worse,

                                        ii.    Persistent elevation in transaminases (> 3 times upper limit of normal) for at least 6 weeks

6)    Not used in combination with another PCSK9 inhibitor, Juxtapid, or Kynamro; AND

7)    Will be used in combination with statin unless meeting one of criteria in #5 above.

 

Heterozygous Familial Hypercholesterolemia (HeFH) Repatha and Praluent

1)    18 years of age or older, AND

2)    Diagnosis of heterozygous familial hypercholesterolemia (HeFH) confirmed by one of the following:

a.    Genetic confirmation of a LDL–receptor mutation, Apo B, or PCSK9 mutation, OR

b.    Pre-treatment LDL–C >190mg/dL

3)    Laboratory report or medical records of LDL–C of 70mg/dL or greater in the past 60 days, AND

4)    Failure (defined as an LDL–C >70mg/dL) of 2 different treatment regimens used for at least 12 weeks each, consisting of a high–potency statin (atorvastatin 40–80mg/day or rosuvastatin 20 – 40mg/day) at the maximum tolerated dose despite optimal adherence with regimens, OR

5)    Member has experienced ONE of the following:

a.    Rhabdomyolysis or muscle symptoms with CK elevations > 10 times upper limit of normal on any statin; or

b.    Myalgia (muscle symptoms with CK elevations < 10 times upper limit of normal with TWO different statins; or

c.    Hepatotoxicity secondary to statins defined as increased transaminases > 3 times upper limit of normal; or

d.    Concurrent liver disease documented by ONE of the following:

                                          i.    Child Pugh A or worse,

                                        ii.    Persistent elevation in transaminases (> 3 times upper limit of normal) for at least 6 weeks

6)    Not used in combination with another PCSK9 inhibitor, Juxtapid, or Kynamro, AND

7)    Will be used in combination with statin unless meeting one of the criteria in #5 above.

8)    Member is following a low–fat diet and exercise regimen.

Reauthorization (6 month increments)

1)    Documentation provided indicating the reduction in LDL–C (i.e. chart notes, medical record, and/or laboratory reports), AND

2)    Continued use of statin (unless previously documented intolerance to statin) with monitoring of adherence, AND

3)    No dual therapy with another PCSK9 inhibitor, Juxtapid, or Kynamro, AND

4)     Patient continuing low–fat diet and exercise regimen.

If LDL–C levels are < 30 mg/dL on a PCSK9 inhibitor, the amount approved will be reduced. Since PCSK9 inhibitors come in only fixed dose formulations, the way to reduce the dose is through changing the frequency of dosing or the formulation used. In this situation the standard dosing of 140 mg injection every 2 weeks can be reduced to 140 mg injection once a month. If using a 420 mg Repatha injection monthly, this could be changed to the 140 mg injection every 2 weeks. In either case, repeat lipid testing should be performed to ensure the LDL–C remains below 70 mg/dL. If the LDL–C level rises above 70 mg/dL the dose can be increased at the next reauthorization.   

Background

PCSK9 inhibitors (including Repatha/Evolocumab and Praluent/arilocumab) are a tremendously powerful class of medications available to help reduce dangerously elevated cholesterol levels in patients who have a genetic predisposition to elevated cholesterol. For patients with homozygous or heterozygous familial hypercholesterolemia, the genetic predisposition to elevated cholesterol dramatically increases the risk of atherosclerotic cardiovascular disease (ASCVD). Dietary modifications and high doses of potent cholesterol lowering medications (statins and ezetimibe) are often insufficient to reduce the increased risk of ASCVD in these genetically predisposed individuals. PCSK9 inhibitors can be an excellent addition to treatment regimens for this patient populations to achieve the aggressive LDL cholesterol lowering target of less than 70 mg/dL.   

For patients with documented ACSVD who do not have the above noted genetic predisposition to dangerously high cholesterol levels, there are multiple modifiable risk factors that come into play. While research shows this group also benefits from reducing LDL cholesterol levels below 70 mg/dL (a reduction of 15–20% in ACSVD–related events with Repatha)4, this is less than the 30% risk reduction associated with smoking cessation5,6,7.

The Institute for Economic Research (ICER) has done an analysis of the cost–effectiveness of Repatha/Evolucumab specifically for patients with ACSVD (not those with genetic hypercholesterolemia) and estimated a cost of $1.2 million per Quality Adjusted Life Year (QALY) gained. This is in contrast with the widely accepted cost-effectiveness threshold of $100,000–$150,000 per QALY. In order to meet the widely accepted cost–effectiveness threshold, the cost of Repatha would need to be discounted 85% – 88% from the current wholesale acquisition cost (WAC) of $14,523 annually8.  Since the ICER analysis, prices have decreased 60-65% so cost-effectiveness has improved.  

In contrast to the cost–effectiveness of Repatha, the estimated cost–effectiveness for smoking cessation varies from as low as $106 per QALY9 to as high as $9,777 per QALY10. It is easy to see even the most expensive smoking cessation interventions are much more cost–effective then Repatha. The mortality from coronary heart disease is reduced more through smoking cessation than by other secondary preventive therapies such as cholesterol lowering7. 


Reference

1)    Repatha Prescribing Information. Amgen, Inc. December 2017.

2)    Praluent Prescribing Information. Sanofi. July 2017.

3)    Clinical Pharmacology. Accessed online 04-25-2019.

4)    Raal FJ, Honarpaour N, Blom DJ, et al.  Inhibition of PCSK9 with Evolocumab in homozygous familial hypercholesterolemia (TESLA Part B): a randomized, double-blind, placebo-controlled trial. Lancet. 2015[b]; 385(9965):341-50.

5)    Sabatine, MS, Giugliano, RP, et al.  Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med 2017; 376:1713-1722.

6)    Critchley J, Capewell S. Smoking cessation for the secondary prevention of coronary heart disease. Cochrane Database Syst Rev. 2003; (4):CD003041.

7)    Critchley JA, Capewell S. Mortality risk reduction associated with smoking cessation in patients with coronary heart disease: a systematic review. JAMA. 2003; 290(1):86–97.

8)    Erhardt L. Cigarette smoking: an undertreated risk factor for cardiovascular disease.  Atherosclerosis. 2009 Jul; 205(1):23-32.

9)    Institute for Clinical and Economic Review. Updated Economic Analyses for PCSK9 Inhibitor Evolocumab, Finds Less Favorable Cost-Effectiveness. Sept. 11, 2017. 
https://icer-review.org/announcements/pcsk9-neu/  (accessed 9/14/2017)

10)     Javitz HS, Swan GE, Zbikowski SM, et al. Cost-effectiveness of different combinations of bupropion SR dose and behavioral treatment for smoking cessation: a societal perspective. Am J Manag Care. 2004 Mar; 10(3):217-26.

11)     Gilbert AR, Pinget C, Bovet P, et al. The cost effectiveness of pharmacological smoking cessation therapies in developing countries: a case study in the Seychelles. Tobacco Control. 2004; 13:190–5.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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