Cost control urged for new PCSK9 cholesterol drugs

Pharmacy benefits manager CVS Health has warned that the new PCSK9 inhibitor class of cholesterol-lowering drugs poses an unprecedented challenge to the US healthcare system.

In a blog post, senior figures at CVS suggest that the huge number of patients who might be eligible for treatment with Sanofi's alirocumab or Amgen's evolocumab - which could be on the market this year - could add $100-$200 billion to annual costs.

While the size of that estimate may raise eyebrows - analysts are predicting sales of a few billion dollars apiece for the two lead PCSK9 inhibitors - CVS insists that the underlying trend towards very high prices for effective new medicines must be addressed.

The resilience of the US market to absorb high prices "is about to be challenged in a manner unlike we have seen in the past," they say. "Yet, policymakers and payers appear unwilling to undertake significant cost controls on medication pricing."

The expected price of the drugs - in the $7,000 to $12,000 range - is significantly less than the $84,000-per-course Gilead Sciences changed for hepatitis C virus (HCV) therapy Sovaldi (sofosbuvir), which has become a focal point for the debate over drug pricing around the world.

However, the impact of the PCSK9 inhibitors will be much greater because they address a very large population and crucially are administered over many years, rather than being restricted to a relatively short course of treatment.

The drugs will first be indicated for a genetic form of high cholesterol known as familial hypercholesterolemia, which affects approximately 620,000 Americans. However, expanded use into other settings, such as patients who cannot tolerate statins or who cannot reach cholesterol targets using statins alone, as well as those with coronary artery disease, could put millions of people in line for treatment.

Moreover, as a biologic agent, there will not be a simple pathway to cheaper generics in a 10-15 year timeframe, points out CVS.

The PBM system in the US seems to have accommodated Sovaldi and other new drugs such as Gilead's Harvoni (sofosbuvir and ledipasvir) and AbbVie's Viekira Pak (ombitasvir, paritaprevir and ritonavir plus dasabuvir) - via a series of deals giving formulary exclusivity in return for discounts.

These have come under criticism however for reducing treatment choice, with doctors concerned they can no longer use just their clinical judgment in prescribing HCV therapy, with some claiming the new generation of oral HCV therapies are not wholly interchangeable.

"Perhaps the costs of PCSK9 inhibitors will push us to develop some consensus about the pricing of new specialty medications, as part of a more thoughtful discussion about the use of scarce resources on behalf of patients," concludes the CVS blog.

Last year, Stephen Whitehead, the chief executive of UK pharma industry's trade organisation the ABPI, suggested that one solution for making innovative new therapies available to patients would be to create a system of health bonds to spread the cost of payments for drugs.