Many expensive new drugs are expected to hit the shelves in 2016, a year in which lawmakers are ramping up attention on the steep cost of treatments for some major diseases.
The top eight new drugs treating serious illnesses, from cancer to HIV to multiple sclerosis, are projected to generate $16.6 billion in sales four years from now, after they’ve been on the market for a while, according Wall Street analysts at EP Vantage.
But while promising new treatments have scientists and doctors excited, the prices for such drugs have the public increasingly concerned and policymakers more worried about ensuring that those facing serious illnesses can access the most cutting-edge cures.
Democrats spent the last half of 2015 trying to shame Republicans for not holding investigations into pharmaceutical companies such as Turing, whose former CEO Martin Shkreli sparked broad outrage in September when he said he would raise the price of an anti-malarial drug by 5,000 percent. Shkreli resigned last month after he was charged with securities fraud.
Republicans are jumping into the issue, with the House Oversight Committee planning a hearing at the end of January where top drug executives will be asked to testify. Democrats have invited as a witness Valeant Pharmaceuticals executive Michael Pearson, who has been criticized for dramatically increasing the prices of two heart medications.
And just before leaving for the Christmas break, a group of Senate Democrats asked the Centers for Medicare and Medicaid Services to clarify the actions the agency could take to help lower drug prices.
“The choice between innovation and affordability is a false one,” wrote Sen. Mark Warner, D-Va., joined by four other lawmakers. “Inevitably, these rising costs squeeze American household budgets as well as federal and state budgets, Medicare, Medicaid and other public health care programs that use taxpayer dollars to pay for drugs.”
But while it’s easy for lawmakers to criticize specific examples of drug makers raising the price of treatments, they are divided on how much to point the finger at pharmaceutical companies, which blame much of the costs on the research and Food and Drug Administration approvals needed to get a new drug on the shelves.
Spending on retail prescription drugs grew 12.2 percent in 2014, the largest increase since 2002, the Centers for Medicare and Medicaid Services actuary reported last month. Much of that was driven by increased spending on new medicines, such as a pricey new treatment for hepatitis C.
Peter Pitts, president of the Center for Medicine in the Public Interest, stresses that the value of drugs should be based on how they affect the economy overall, like whether they reduce the number of expensive hospital visits and allow more people to get back to work faster.
“The real question you want to get to is: Is that wise spending?” Pitts said. “And then the question becomes what do drugs do that are economically sound … the earlier you get people properly medicated, the cheaper they become.”
Yet the price tags of cutting-edge drugs are nothing to sniff at. The biggest blockbuster drug approved by the FDA in 2015 was a cystic fibrosis treatment whose global sales are projected to hit $4.2 billion by 2020. The twice-daily oral tablet costs $259,000 per patient annually.
For 2016, the top-selling drug projected to hit shelves actually isn’t a new drug at all — it’s a variation on a medication used for years to treat HIV. Most of the other drugs coming down the pipeline also treat life-threatening conditions, including cancer, multiple sclerosis, hepatitis C and hypertension, but one is aimed at severe cases of dermatitis, a skin inflammation condition.
Here are the top eight new drugs expected to go on the market in 2016, according to multiple forecasts averaged by EP Vantage. Sales are global and based on projections for 2020.
1. Tenofovir Alafenamide: Gilead. $3.7 billion.
This drug from Gilead Sciences has industry-watchers somewhat surprised, as the company is best known for its drug formulations. Tenofovir alafenamide works as a single-molecule variation on a class of drugs that prevent HIV from multiplying and can reduce the amount of the virus in the body.
2. Atezolizumab: Roche. $2.6 billion.
Intended to treat lung and bladder cancers, atezolizumab has been linked with a seven-month survival advantage over chemotherapy among some lung cancer patients. Working through shrinking tumors, this drug belongs to a new type of cancer treatment that uses the body’s immune system to fight cancer.
“This class of drugs are really — I hate to use the term ‘revolutionary’ — but they are changing the way people treat cancer,” said Jonathan Gardner, a reporter for EP Vantage. “There’s a lot of excitement about using it combined with other types of drugs that can stop tumors from developing resistance.”
3. Ocrelizumab: Roche. $2.4 billion.
Ocrelizumab is joining a long list of drugs used to treat multiple sclerosis. This one has shown most effective in treating patients with severe versions of the disease who don’t experience periods of remission.
4. Grazoprevir/Elbasvir: Merck and Co. $2.1 billion.
This combination therapy is joining a set of new drugs aimed at hepatitis C, which have been widely criticized in recent years for commanding high prices. Industry-watchers say that by introducing more competition, it could help push down the prices of similar, expensive drugs such as Solvadi and Harvoni.
5. Obeticholic Acid: Intercept Pharmaceuticals. $1.8 billion.
This drug is used to treat a rare liver disease known as primary biliary cirrhosis, which results when the autoimmune system destroys the bile ducts. It affects about one in 1,000 women over the age of 40. Obeticholic acid has especially attracted the attention of industry-watchers, since it’s the first drug in 50 years that is being approved to treat the disease.
6. Dupilumab: Sanofi. $1.7 billion.
This drug stands out from among the others because it’s aimed at the fairly common skin inflammation condition dermatitis. But for patients to be prescribed this drug, they would have to have a severe version of the condition, also known as eczema, which is resistant to other types of treatment.
7. Venetoclax: AbbVie. $1.2 billion.
Aimed at treating leukemia and lymphomas, this drug already has received the “breakthrough therapy” designation from the FDA, meaning it can get approved on a faster timeframe. It has shown promising results when used in patients who received conventional treatment but then relapsed.
8. Uptravi: Actelion. $1.1 billion.
Uptravi targets a certain kind of receptor to treat hypertension and has been shown in studies to reduce the risk of mortality by 40 percent if the full treatment is followed.
