Nov 30, 2022

Patient Advocates Warn Access to Egregiously Priced Treatments at Risk

Drug company Vertex manufacturers four key cystic fibrosis (CF) treatments, Trikafta, Symdeko, Orkambi, and Kalydeco that all carry price tags far exceeding estimates for a fair price — threatening access to these lifesaving medicines for patients.

Vertex set list prices on three of the treatments between $270,000 to $310,000 per year, including Trikafta that costs less than $5,700 to produce. A 2020 review by the Institute for Clinical and Economic Review (ICER) found a fair annual price for Trikafta would fall between $67,900 and $85,500. In fact, ICER found that all four of Vertex’s CF treatments on the market have list prices that are significantly higher than a fair price justified by their clinical value for patients.

Fueled by revenue boosted by the out-of-control pricing on these life-saving treatments, the brand name drug company recently beat Wall Street expectations for the third quarter of 2022. The company announced a 29.2 percent increase in sales for Trikafta year-over-year. Last year, Vertex brought in over $7.57 billion in revenues and $2.3 billion in profits. The company made it onto the Fortune 500 list for the first time this year.

Vertex also recently announced changes to the company’s copay assistance program, Vertex GPS, decreasing the amount the company will provide to help some patients afford their treatments. The decision highlights how Big Pharma’s patient assistance programs are designed to boost sales of certain high-priced brand name products, not based on what is best for patients. In other words, drug companies change these programs on a whim based on business interests, not the interests of patients.

The Boomer Esiason Foundation sent an alert to CF patients warning them of the changes, and the Cystic Fibrosis Foundation sharply criticized what the decision from Vertex will mean for patients.

“The existence of life-changing treatments means nothing, however, without the ability to access them,” the Cystic Fibrosis Foundation said in a release. “The recent decision by Vertex to significantly decrease the amount they provide patients and families through copay assistance programs threatens the ability of individuals with CF to benefit from these modulators.”

A recent study in Health Affairs demonstrated how Big Pharma companies skirt anti-kickback protections in federal law by using these so-called patient assistance charities to undermine competition in the market and pad their bottom line. The study found Big Pharma’s share of sales for brand name medicines used to treat specific conditions covered by these charities increased over time. For the 10 costliest treatments, the brand name manufacturer’s share of sales increased from 67 percent in 2010 to 89 percent in 2017, demonstrating that “manufacturers could effectively assist in the purchase of their own medications by contributing to condition-specific charities.”

According to the study’s authors, overall “donations by the leading manufacturer of drugs for each condition were often likely to be profitable.” The authors argue that “the current regulations or enforcement permit donations that violate the spirit of Medicare’s Anti-Kickback Statute.”

Big Pharma’s so-called patient assistance programs are designed to boost profits, not help patients. To ensure the accessibility of key CF treatments for patients, Vertex should simply lower their egregious price tag. Policymakers in Washington must also build on recent positive progress with additional market-based solutions to hold Big Pharma accountable to sustainably lower prescription drug prices.

Read more about Big Pharma’s so-called patient assistance programs designed to boost profits HERE and HERE.

Read more on bipartisan, market-based solutions to hold Big Pharma accountable HERE.