Generic Statins Make Sense In Lower CV Risk Patients, WellPoint Asserts

Generic statins can provide equal cardiovascular benefits - particularly in patients with low to moderate risk of cardiovascular events - while offering substantial cost savings over brand-name drugs, according to a study recently released by WellPoint.

The evaluation, "Therapeutic Substitution of Statins: A Real World Data Driven Approach Based on NCEP [National Cholesterol Education Program] LDL Goals," was conducted by WellPoint subsidiary HealthCore and included two branded statins - Pfizer's Lipitor (atorvastatin) and AstraZeneca's Crestor (rosuvastatin) - and four generics - simvastatin, pravastatin, lovastatin and fluvastatin.

The study specifically sought to determine the cardiovascular risk stratification and calculate the LDL reduction achieved with various statin medications and dosages in the clinical setting.

The authors used a retrospective longitudinal cohort analysis utilizing medical and pharmacy administrative claims data integrated with laboratory result data from Jan. 1, 2000 to May 31, 2006 from two southeastern U.S. health plans. A total of 33,706 patients contributed 65,948 unique statin therapy segments.

According to the study, atorvastatin was the most frequently prescribed statin (55.5 percent), followed by simvastatin (19.1 percent), pravastatin (13.6 percent), lovastatin (5.6 percent), rosuvastatin (3.6 percent), and fluvastatin (2.5 percent).

The report notes that "the majority of patients prescribed the most potent LDL-lowering statins are at the lower end of the dosing range." For instance, of the patients taking Lipitor, 58 percent were prescribed a 10 mg dose. Of the patients taking Crestor, 85 percent were taking the 10 mg dose.

The study found that a large percentage of patients taking statins - 63 percent - fell in the low and moderate CV risk categories, which "require a level of LDL reduction to attain goal status that could be achieved with multiple statins, including simvastatin."

Adjusted LDL reduction was 37 percent for Lipitor compared to 32 percent with simvastatin.

The report urges further consideration of simvastatin's place in utilization management schemes. "Use of real-world data with an evidence-based framework guiding the use of generic simvastatin could result in significant clinical benefit for patients with substantial cost savings for the patient and the overall health care system," HealthCore concludes. "This approach will facilitate health plans in developing affordable pharmacy benefit designs and programs that maximize the patient care benefits of dyslipidemia therapy."

Among the limitations of the study, HealthCore pointed out that "administrative claims data are not very reliable for detecting premature family history of CVD and smoking status, therefore the low and moderate risk categories may be overestimated and underestimated, respectively." It also noted that pill splitting and sampling appear to have affected results.

The study results support WellPoint's efforts to switch its members to generic statins. The insurer announced in March that beneficiaries would be able to receive up to four months of free generic simvastatin as an incentive to switch from branded drugs (¹ (Also see "WellPoint Offers Simvastatin Free Trial; Preferred Brand Lipitor Left In Dust?" - Pink Sheet, 26 Mar, 2007.), p. 27).

Generic versions of pravastatin (Bristol-Myers Squibb's Pravachol ) and simvastatin (Merck's Zocor ) hit the market in May and July 2006, respectively, prompting insurers to encourage adoption of those products over branded drugs. While Lipitor has long been the market-leading statin, there was concern that the introduction of generic simvastatin would lead to significant erosion, particularly in non-high-risk patients (² , p. 17).

Nonetheless, the market has been slow to shift toward generics. "Currently, more than 60 percent of prescriptions written for statins - the most frequently prescribed class of cholesterol-lowering drugs - are for brand-name drugs," WellPoint says in a June 11 press release announcing the report.

Lipitor still controls a large percentage of the cholesterol market. An analysis by the Consumers Union released in February found that Lipitor held an average of 43 percent of all statin prescriptions in the second half of 2006.

Express Scripts recently announced that it was placing Lipitor back on its preferred formulary because of improved rebate terms; Lipitor also has preferred drug status with Caremark and Medco (³ (Also see "Express Scripts Adds Lipitor Back Onto Preferred Formulary" - Pink Sheet, 11 Jun, 2007.), p. 29). In April, Express Scripts announced that its member plans had saved $230 million on cholesterol drugs due to generic utilization.

- Brooke McManus ([email protected])