Prescription-drug policy: Remove obstacles keeping alternatives from reaching the market

We’ve focused in the first two posts of this three-part series addressing prescription-drug policy (here and here) on proposals in the United States Senate which offer solutions in search of problems, harm competition and allow brand-name drug companies to continue keep life-saving generics off the market for longer periods of time – all  with costly effects on Kentuckians and all Americans.

Such impact is brought home when you consider the available data regarding “abandonment,” which occurs when a patient brings or call in his prescription to the pharmacy but doesn’t actually end up collecting the medicine. Kentuckians abandon prescriptions containing brand-name drugs more than 23% of the time compared to less than 9% for generic-medicine orders.

Today, we offer a couple of important positive alternatives which would create a more vigorous marketplace by increasing competition, lowering prices and improving access to health- and life-giving drugs, particularly generic and biosimilar medicines which filled nine out of every 10 prescriptions in America in 2017 yet represented only 23 percent of prescription spending. Generics have saved our health-care system nearly $1.8 trillion over the past decade, addressing America’s biggest healthcare problem: cost.

• CREATES Act

Those savings could increase dramatically if, as the U.S. Senate is considering in the CREATES Act, loopholes used by brand-name drug makers to limit accessibility to their generic competitors long beyond patent periods are closed and reforms are injected into the process so that the prescription drug-making landscape becomes a bustling marketplace with lots of competitors instead of a stifling monopoly controlled by crony capitalists.

We in the past have supported attempts made by the CREATES Act, which got nowhere during the Obama administration but has been reinserted into Lower Health Care Costs Act (S. 1895), the omnibus healthcare bill being considered by the Senate. It would end what Scott Gottlieb, President Trump’s first Food and Drug Administration Commissioner, called “shenanigans” by brand-name drug companies to deny access to samples needed to generate alternatives to more-expensive drugs. CREATES would, for example, make it easier for the manufacturers of generics to bring legal action against brand-name companies who attempt to block such access even after patents expire.

While it’s important to vigorously maintain current patent laws, which rightly protect drug creators from generic competition for 14 years – allowing them to recover their often-huge financial investments in creating these wonders of modern medicine and turn a healthy profit – generics must not be shut out forever, especially with rising health-care costs and lives at stake.

• Eliminating copays for biosimilar medicines

One such way of doing this would be to eliminate the 20% cost-sharing requirements for biosimilars in the Medicare Part B program, which, even though these are lower-priced alternative medicines, are barriers to affordability and access for many patients.

Evidence suggests that a lack of incentives for the physician, patient and payer are impeding the use of biosimilars, blocking the savings that likely would result with their increased use and ultimately leading to poorer health outcomes and increases costs to the healthcare system.

This likely is a primary contributing factor to the fact that U.S. market adoption of biosimilars has been slow, despite the fact that these alternative medicines hold great promise for cost savings. The seven biosimilars currently on the market at this early stage have demonstrated savings, on average, of 20% of their originator biologic’s net price and are expected to save the nation as much as $54 billion over the next decade.

The Biosimilars Council proposes jumpstarting the marketplace for these alternative medicines by eliminating cost-sharing for Medicare Part B patients when their healthcare provider administers a biosimilar. It’s likely that the resulting offsetting savings would more than cover the cost of such a policy. Plus, the momentum it would give the biosimilars marketplace would rev the engines for future research, development and entry into the marketplace of these life-changing medical therapies.

While such a proposal isn’t included in any proposed legislation at this point, it’s a policy change worthy of consideration. Considering the approach is widely supported by generic and brand manufacturers, including Pfizer and Merck, alike, strong bipartisan support is a very likely possibility.

If the Senate wants to give Americans access to, and encourage providers to prescribe, more affordable drugs, ensuring patients have no out-of-pocket costs for cheaper biosimilars – perhaps at least for a set period of time – would be a commonsense starting point.