Two years into existence, Colorado’s Prescription Drug Affordability Review Board on Friday selected its first five drugs to undergo an affordability review — including one that doctors, patients and its pharmaceutical manufacturer pleaded to keep out of the first-of-its-kind process.
The selection of the drugs — two of which treat psoriasis and one each that treats HIV, a range of autoimmune diseases and cystic fibrosis — does not mean that the board will automatically seek to cap the prices for which they can be sold in Colorado. Officials with the Colorado Division of Insurance now will undertake studies that will help the board to determine if the drugs are unaffordable, and if they are, the board will have to take a further step and decide whether it wants to impose an upper payment limit on the pharmaceuticals.
But after years of deliberation and a narrowing process produced a quintet of drugs from a list of 604 prescription drugs deemed eligible for review because of their high prices and significant annual increase in costs, the board took what was arguably its first major action. Now consumer advocates and bioscience leaders will watch the next steps closely to see just how far the appointed board is willing to go to try to curb the hike in pharmaceutical prices that legislators and Gov. Polis have cited as a major cause of health-care unaffordability.
History of the PDAB
“I feel that our staff has done a very good job,” board chairwoman Dr. Gail Mizner said of the process, which pharmaceutical industry leaders charged was rushed. “We recognize that it is not perfect … I think we need to move forward.”
The PDAB was created in 2021, to give the state unprecedented power to limit the amount that designated drugs could be sold for in Colorado and to use the limited power state government has over such international pharmaceutical manufacturers to force prices down. The original bill limited the number of drugs that could be price-capped to 12, but a follow-up law this year expanded that number to 18 and extended the end date for the board from 2026 to 2031.
Bioscience and pharmaceutical industry leaders have warned for two years, however, that the effect of the bill is more likely to be that manufacturers whose prices are capped will choose not to sell drugs in Colorado, leaving patients without access to life-saving medication. Elyse Blazevich, president/CEO of the Colorado Bioscience Association, told board members in June that the average medication takes 10 years of research and development at a cost of $2.5 billion and said that concern around potential price caps in Colorado already has caused investors to pull back on funding for local companies.
The choice of prescription drugs
PDAB members prioritized drugs for review based on the highest per-patient annual costs of the pharmaceuticals, the highest patient-usage counts for each drug and the largest change in the wholesale cost of the drugs in recent years. They excluded drugs with marketed biosimilars and therapeutic equivalents, determining that the market already offered patients with lower-cost options in those cases.
The five drugs that members selected Friday for affordability reviews were Enbrel (which treats autoimmune diseases), Genvoya (used by HIV patients), Cosentyx and Stelara (both drugs for skin-disease psoriasis and psoriatic arthritis) and Trikafta (which treats cystic fibrosis). But it was the choice of Trikafta that came against the most protest and demonstrated the ideological debates ensconcing this process.
Trikafta is what is known as an “orphan drug” — one for which there are no competitors or biosimilars — and has been proven to be incredibly effective in helping sufferers of the rare disorder that cripples the lungs to avoid hospitalization and live longer lives. But it has an average annual cost of $203,924.
Why Trikafta’s choice is controversial
The PDAB’s advisory committee recommended that drugs for rare disorders like cystic fibrosis — those diseases affecting less than 200,000 Americans — not be considered in this first round of affordability reviews for fear that users have no alternatives if manufacturers limit access. But the staff for the PDAB advised against such action, saying that such reviews can assess whether existing prices have impacts on drug access for patients with these rare diseases, and four of the five board members agreed that Trikafta should be reviewed.
This came only after 12 people specifically asked the board not to review Trikafta, noting that its costs offset hospital bills that stretched into the millions of dollars annually for some of them and that the drug allowed them to recover most lung capacity and return to work.
Dr. Scott Sagel, director of the University of Colorado Cystic Fibrosis Center, warned that any move that limits access to the drug would have “devastating consequences” for patients in this state. And Patrick Sosnay, senior medical director for drug maker Vertex Pharmaceuticals, begged caution in capping prices for a drug that cost $20 million to bring to market while noting that the majority of patients taking Trikafta receive financial help from Vertex.
“Limiting what a market can define as a cost will limit biopharma from investing in other drugs for small populations” added Brian Callanan, a 47-year-old with cystic fibrosis who argued that allowing Trikafta on the market saves the state millions of dollars in care costs.
Review of prescription drugs
But Hope Stoner, policy manager for the Colorado Consumer Health Initiative, argued oppositely, saying that pre-emptively removing all rare-disease drugs from the review process would hinder the board’s ability to see if there are ways to make them more affordable. And Mizner tried to calm such fears by saying the review is only a first step.
“If for some reason a rare drug should get on our list of drugs to be reviewed for affordability, that in no way means that it would get put on our list of drugs to receive an upper price limit,” she said before the vote.
Lila Cummings, Colorado prescription drug affordability director, said they program leaders will begin the process of affordability reviews on Enbrel, Genvoya and Cosentyx swiftly and will dig into Stelara and Trikafta only after that work is done. She said the division will be “over-inclusive in reaching out to stakeholders” to understand how the affordability affects patients, manufacturers and anyone else with a connection to the drugs.