Praluent to Be Preferred PCSK9 Inhibitor in UnitedHealth Formularies

Praluent has won the battle for UnitedHealth Group’s business in ongoing PCSK9 sweepstakes, according to an announcement this morning from Sanofi and Regeneron.

UnitedHealth’s formularies will provide preferred access to Praluent, the brand name for the injectable therapy alirocumab, through OptumRx and UnitedHealthcare for commercial, Medicare, and Managed Medicaid patients, according to a statement from Sanofi and Regeneron, which jointly won FDA approval for the drug July 24, 2015.

The PCSK9 inhibitor class of cholesterol-fighting drugs were the most anticipated new therapies of 2015, after clinical trials showed they could cut low-density lipoprotein levels up to 60%. But nearly as eye-popping as their therapeutic effects was the potential fallout on health plan balance sheets.

Formulary managers braced for what would happen if PCKS9 inhibitors won broad approvals from FDA, and patients sought to abandon low-cost statins for the new, expensive drugs. Compared with European regulators, FDA granted limited approval while it awaits results of long-term cardiovascular outcomes trials; the drug is approved for patients with a genetic condition that creates high LDL cholesterol levels or those with clinical atherosclerotic cardiovascular disease.

After FDA approval of Praluent and Repatha (evolocumab) from Amgen, health plans and formulary managers went to work to negotiate discounts or exclusivity deals for the therapies to be available.

According to the statement from Sanofi, “This decision, when combined with prior favorable coverage decisions at Express Scripts, Aetna and other insurers, provides for access to flexible dosing with Praluent on formularies covering more than 100 million patients in the United States.”

Praluent is available in 75 mg and 150 mg doses, while its competitor, Amgen’s Repatha, the brand name for evolocumab, is only available in doses of 140 mg; however, that drug’s dosing schedule now indicates it can be given either every 2 weeks or in a 420 mg dose once a month.

The battle for availability of the competing PSCK9 inhibitors has been fierce. After Repatha’s approval August 27, 2015—and wholesale prices listed above $14,000—Express Scripts and CVS Health indicated they would demand price negotiations before covering either. Express Scripts ended up covering both, but CVS Health announced last month it had given the preferred position to Repatha.

Meanwhile, the price of the drugs isn’t winning fans in the United Kingdom where advisors to the National Health Service are giving Repatha a thumbs down due to its price, saying it isn’t cost-effective.

Both Sanofi and Amgen have announced assistance programs for patients who cannot pay for the therapies.