Praluent: A Fair Price or Wreaking "Havoc" in Health Plans?

How one views the $40-a-day price tag for alirocumab, being marketed as Praluent by Sanofi and Regeneron, definitely depends on your point of view.

That is clear based on earnings calls from the past 2 days for Sanofi and for Express Scripts, the nation’s largest pharmacy benefits manager, which has been out front for months about efforts to not be caught flat-footed when the new cholesterol-fighting class, the PCSK9 inhibitors, hit the market.

With the sting of Sovaldi, the $1000-a-day cure for hepatis C, still fresh for benefits managers, Express Scripts and other PBMs have been up front about their effort to be proactive with drugmakers on behalf of customers. So it’s no surprise that the PBM expressed its displeasure during Wednesday’s earnings call with the $14,600 annual cost for the monoclonal antibody, which came in above projections of $7000 to $12,000 a year.

Alirocumab is the first of a class of drugs that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), an enzyme that when blocked results in dramatically lower levels of low-density lipoprotein (LDL) cholesterol. PCSK9 stymies the liver from effectively eliminating LDL cholesterol on its own. When it was found that persons who lacked this enzyme had abnormally low cholesterol levels, researchers immediately recognized the therapeutic potential and began looking for ways to block PCSK9.

Given either once or twice a month by injection, alirocumab and its chief rival, evolocumab, made by Amgen, have reduced LDL cholesterol levels by up to 60%. Evolocumab, to be sold as Repatha, has an August 27, 2015, approval deadline.

“While these drugs are being viewed as breakthroughs, they also have the potential to wreak financial have on clients who do not proactively manage their specialty (pharmacy) trend and spend,” Express Scripts President Tim Wentworth said during the conference call. He called for ensuring that that the drug gets to the “right” patients. In other words, cardiologists may grumble at Express Scripts’ demands for documentation of their diagnosis, cholesterol levels, diet and that they have exhausted tolerable statin therapy.

It’s clear Express Scripts is going to be proactive in strictly following the FDA approval, which called for prescribing the drug only for patients with one form of a hereditary high cholesterol condition and for patients with high cholesterol who known heart disease and have been unable to lower their low-density lipoprotein (LDL) or “bad” cholesterol on maximally tolerated statins.

Express Scripts officials have said the FDA approval means that less than 10% of the estimated 70 million Americans with high cholesterol meet its indications. FDA’s language is open to enough interpretation that such estimates have varied, with one conclusion: the payers will have the last word.

During today’s earnings call, Sanofi CEO Olivier Brandicourt repeated the thinking behind the pricing that was laid out in last Friday’s press release. “We took a valued-based approach that strikes the right balance between the medical benefits to individual patients, as well as the overall total value to the healthcare system.

“I remind you that cardiovascular disease is still the number one killer in the US and worldwide. The annual cost of acute coronary syndrome in the US ranges from $50,000 to $119,000. The overall burden of CVD is estimated to cost the US healthcare system around $315 billion a year, and is projected to exceed $900 billion by 2030.”

In announcing the price within an hour of FDA approval, Sanofi and Regeneron noted it was much less expensive that other monoclonal antibodies. But the concern of formulary managers has been that PCSK9 inhibitors are not like most other biologics—if used for all imaginable indications, such as for all patients who cannot tolerate statins—they could replace a low-cost drug with a long track record for an uncertain period, and for millions of patients.

In an interview with AJMC’s Evidence-Based Diabetes Management that appeared just before the FDA action, Express Scripts’ chief medical officer, Steve Miller, MD, said the problem today is that pharmaceutical companies and investors see no reason to connect prices to what consumers, health plans, and employers can afford. A social contract that once held prices in check is broken, he said.

Sanofi’s Brandicourt said the company is working “around the clock” to get the drug to US patients. While the wholesale price is $40 a day, health plans will negotiate discounts, especially if evolocumab is approved for similar indications next month. And the companies announced that programs will make the drug available to those without insurance who demonstrate need.