Good Day BIO: New study says price controls devastate drug R&D, patient access

With drug price controls under consideration in the Senate, new analysis shows how they would devastate drug development and new treatments. On World Hepatitis Day, we look at why this preventable, treatable virus is still a threat. (740 words, 3 minutes, 42 seconds)

 P.S. The BIO Impact Agriculture & Environment conference is right around the corner. Be sure to register today.

Price controls would devastate drug development, patient access, says new analysis

If drug price controls under consideration in the Senate had been enacted during the last decade, only 6 of 110 currently approved therapies would have made it to patients, says new analysis published today by Vital Transformation.

The legislation: The proposed Build Back Better Act—yesterday renamed the Inflation Reduction Act and packaged with climate and tax legislation—would enact price controls on the drugs on which Medicare spends the most, if they lack generic equivalents. The bill would regulate 20 drugs by 2029.

The 20 drugs likely to be hit with price controls are produced by 12 companies—which have invested more than $588 billion in R&D over the last 10 years, says Vital Transformation.

If price controls had been in place between 2012-2021, only six of 110 drugs developed by these 12 companies would have made it to market, as drugs with less than 50% probability of market entry would not be considered.

Why? Because six of the 12 companies would see net earnings drop by more than 70%, and three would see 100% of earnings disappear, finds the analysis—meaning companies would not have the necessary funds to invest in R&D and partnerships with small biotech.

Price controls would also cut jobs—more than 590,000 U.S. biopharma jobs in 2031.

We’ve seen this happen in Europe: EU price controls show a 10% drop in drug prices yields a 14% drop in venture capital, the analysis explains.

BIO’s take: The legislation “would drastically reduce critical investment in innovative therapies and cures that patients depend on, at a time when smaller biotech companies are facing tremendous pressure in the capital markets,” says Nick Shipley, BIO EVP and Chief Advocacy Officer. “The consequences will all but ensure that many potential groundbreaking cures die in labs. Patients, as a result, will be ill-equipped to combat a variety of debilitating illnesses with the scientific solutions that could significantly improve—or even save—their lives.”

Hepatitis: Preventable, treatable, and still a threat

In a triumph for biotechnology, hepatitis C virus (HCV) became curable within 25 years of its discovery—but hepatitis remains a threat.

The disease: “Viral hepatitis—a group of infectious diseases known as hepatitis A, hepatitis B, hepatitis C, hepatitis D, and hepatitis E—affects millions of people worldwide,” causing liver diseases and more than 1 million deaths annually, says the CDC.

The common U.S. varieties are preventable or curable: hepatitis A and B, preventable by vaccine, and HCV, now curable for more than 90% of patients.

The challenge: “HCV remains a worldwide epidemic with over 70 million people chronically infected, and as many as 2.8 million infected with HCV in the United States,” says HealthHCV.

Awareness matters: Almost half of the people in the U.S. with HCV are unaware of their status “and only 11% of those infected have been cured,” says HealthHCV.

Today is World Hepatitis Day, the start of Hepatitis Awareness Week, which raise awareness and encourage hepatitis testing and treatment.

“Getting tested for hepatitis C is important, because treatments can cure most people with hepatitis C in 8 to 12 weeks,” CDC says. HealthHCV’s latest survey of health care providers found inadequate levels of testing.

But we need to eliminate barriers: HealthHCV’s survey also identified challenges with administration of health care policies, finding “nearly one-third of providers were unable to treat a patient with HCV due to payer/insurance limitations and restrictions.”

What you can do: Spread awareness—and learn more from groups like HealthHCV, the Hepatitis C Association and the Hepatitis B Foundation.

More Health Care News: 

POLITICO: Biden administration expected to soon declare monkeypox a health emergency
“The Biden administration is expected to declare monkeypox a public health emergency in the coming days, according to two people with knowledge of the matter. ... By designating the outbreak an emergency, HHS could then take a slew of actions, including accessing new money and appointing new personnel, according to the law that dictates how and when the federal government can declare such an emergency.”

President Biden’s Thursday: A speech on the economy and updates from CEOs at the White House. A phone call with Chinese leader Xi Jinping is likely, Reuters reports.

What’s Happening on Capitol Hill: With Sen. Joe Manchin (D-WVa) now saying he’ll back the addition of climate and tax measures to the Democrats’ drug price control plan, House Republicans may oppose the CHIPS-Plus bill that passed the Senate yesterday, The Hill Reports. The Senate Energy & Natural Resources Committee has a hearing on several bills, including S.4038, to increase production and use of renewable diesel and sustainable aviation fuel. The House Committee on Oversight and Reform has a hearing on the dangers of leaded aviation fuel. The Committee on Agriculture’s Subcommittee on Biotechnology, Horticulture, and Research has a hearing on the USDA Hemp Production Program.