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Whether you’re a plan sponsor, doctor, patient or pharmacy benefit manager, you’re likely to be eagerly awaiting the release of new specialty medications to treat high cholesterol. Called PCSK9 inhibitors, these drugs are expected to hit the market for the first time in July. (For background information on these upcoming medications, please see a previous blog post.)

Two questions plan sponsors in particular are asking are, “For whom will this drug be approved?” and “What will it cost?” We know the drug is likely to be approved for patients with familial hypercholesterolemia ─ a genetically inherited type of high cholesterol. Word on the street also suggests the drug could be approved for other patients with high LDL-C (known as the bad cholesterol), a condition that affects as many as 71 million adults, according to the Centers for Disease Control. That’s more than one-third of the adult population in America.

Not So Fast, Says the FDA

Although these drugs have seemed on a fast track to approval, an article on (FDA Staff Says Sanofi Drug Cuts Cholesterol, Questions Benefit) suggests possible delays. While the FDA advisory committee voted on June 9-10 in favor of the new drugs, final FDA approval is not expected until later this summer.

The FDA may require Sanofi and Regeneron, the manufacturers of PraluentTM, one of the new PCSK9 inhibitors, to prove that a reduction in LDL is linked to reduced heart disease. In other words, it may not be enough that they have proven the PCSK9 inhibitor can lower LDL and is tolerated well by patients. They may have to go a step further before the drug is approved for broader indications. Amgen’s drug, RepathaTM, could likely be held to the same standards.

The three drug makers hope their drugs will be approved for patients who can’t control their high cholesterol on statins alone, something known as “statin intolerance.” Those who are statin intolerant experience side effects significant enough to affect their quality of life, such as muscle soreness and weakness or gastrointestinal issues. The FDA’s concern, and the concern of many payers who will be footing the majority of the bill, is that labeling the drug for statin intolerant patients may encourage patients to give up on statins too early.

What Will the PCSK9 Inhibitors Cost? 

While we have no definitive information and aren’t likely to until closer to product launch, analysts and industry experts estimate an annual cost per patient of as much as $10,000.  Interestingly, Sanofi’s drug may come in two dosages, allowing them to create two price points of $5000 and $10,000, which could make that drug more desirable. (Please click to read more.) There is hope that the release of the same type of drug by two manufacturers within a relatively short timeframe will create price competition, much like we saw with hepatitis C  drugs from AbbVie and Gilead.

Lockton Benefit Group’s Pharmacy Analytics Practice will continue to monitor the situation and provide updates. If you have questions about this or other specialty medications, please contact your Lockton Account Team.