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Reuters/Robert Galbraigh
We have a blockbuster on our hands.

New cholesterol meds may be the costliest drugs in US history

By Max Nisen

Cholesterol lowering statins like lipitor are some of the most widely taken drugs of the last century. They’ve prevented countless episodes of heart disease, and do so relatively cheaply. But that might be thrown into disarray by the approval of two effective yet expensive new drugs, so called PCSK9 inhibitors called Preluant (manufactured by Regeneron) and Repatha (from Amgen), the second approved last week.

They’re both biologic drugs (created by cells) and cost north of $14,000 a year, compared to the average $42.69 someone pays per month now. Currently, both drugs are only recommended for people that have a particular genetic form of high cholesterol, and those who are unable to lower their cholesterol effectively through conventional means.

But the use of these drugs seems likely to spread beyond that. Some 25% of people on statins report muscle pain, despite large clinical trials that found minimal and rare side effects, Gina Kolata at the New York Times points out (paywall). Others complain of things like memory problems that have never shown up in studies.

“Even with their limited initial indications, PCSK9 inhibitors have the potential to grow over the next several years to become the costliest therapy class our country has seen,” Steve Miller, chief medical officer of Express Scripts (the largest US pharmacy benefit manager), wrote in a blog post on the drugs.

These drugs are particularly expensive because they’re brand new to the market, patent protected for years to come, and unique so far. Biologic drugs tend to be more expensive because they’re more difficult to make, and generally have to be injected rather than swallowed.

The numbers could get truly astronomical if long term studies under way now show a reduction in heart disease risk from these drugs.

Online health-policy journal Health Affairs did a cost estimate. If these drugs are prescribed to large numbers of people who have a history of heart disease (the widest possible market), they could add more than $150 billion a year to US drug spending.

Right now, new hepatitis C drugs are a scapegoat for rising costs. But even though Gilead’s drugs cost $80,000 plus a year, they offer a cure within months. Cholesterol meds are often taken for decades.

This highlights a tension in health care—managing costs while providing good care. Patients with good health insurance pay a fraction of the price of even expensive branded drugs like these, so they’re not price sensitive. In this case, doctors have to decide how seriously to take reported side effects.

Insurers and pharmacy benefit managers will use everything in their toolbox to keep people on statins. They may require lab evidence of muscle damage, for example, as proof that someone is statin intolerant.

But those are exactly the sort of moves that provoke consumer backlash when used in a wide population, so they may end up being cautious in exercising their power. The memory of the 90s, when a series of lawsuits, public anger, and government actions rolled back more aggressive (and effective) managed care looms large.

Even if we don’t end up in the $100 billion plus a year scenario, we’re likely to see a large and sustained spending boost in what was until a year ago one of the most cost-effective drug classes on the market.