May 12, 2015
InsideHealthPolicy.com Health Reform Insider: “As E&C Prepares Cures Bill Markup, Negative Press On Drug Prices On The Increase”
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“The House Energy & Commerce Committee will begin marking up 21st Century Cures legislation Thursday (April 14), but those paying for drugs worry that speeding drug and device approvals will cost too much and there’s been an increase lately of negative press on drug prices. This week, there are several events related to breakthrough medicine and its cost to the health care system. FDA advisers consider whether to recommend approval of a cystic fibrosis drug, which analysts expect could be the next blockbuster, GlaxoSmithKline announces it’s partnering with the University of North Carolina to cure HIV, a group of payers and providers hosts an event on drug pricing, and the President’s Council of Advisors on Science and Technology discusses the White House’s Precision Medicine Initiative.
The debate over drug prices and the House Energy & Commerce Committee’s 21st Century Cures legislation have proceeded separately for the most part, although Medicaid directors are lobbying lawmakers to include measures in the bill to help them with the cost of expensive new products. They want Congress to either increase Medicaid rebates or let states defer covering some new treatments envisioned by the Cures bill until post-market studies are done.
However, as the legislation gains momentum in the House, news stories contrasting the public’s concern with high drug prices and the House’s work to speed drug and device approvals, without controlling the price of those products, have become prevalent.
“The uptick is real and concerning,” a drug lobbyist said, referring to the negative press on drug prices. The lobbyist added that the Cures bill is reasonable.
Drug makers are expected to make great strides in coming years as they near the end of developing cures that not long ago seemed highly unlikely. GlaxoSmithKline and the University of North Carolina announced Monday that they are opening the HIV Cure center and jointly forming a company dedicated to curing HIV/AIDS. An HIV cure could take many years, but in the past researchers only talked of treating the deadly infection.
“This unique public-private partnership will redefine the traditional way of conducting research and create a new model to seek the breakthroughs needed to tackle an extraordinarily challenging global health issue,” GlaxoSmithKline states in a release.
In the nearer term, a breakthrough drug is expected for cystic fibrosis. An FDA advisory committee on Tuesday will consider whether to recommend approval of Vertex Pharmaceuticals’s cystic fibrosis drug, brand-named Orkambi, which analysts predict could cost the health care system several billions of dollars in the first four years on the market.
When the president announced the Precision Medicine Initiative during his past State of the Union address, he highlighted cystic fibrosis as an area of promise. While an Illinois senator, Obama and Sen. Richard Burr (R-NC) introduced the Genomics and Personalized Medicine Act of 2007.
“Duke University’s Institute for Genome Sciences and Policy, and the University of North Carolina at Chapel Hill’s Institute for Pharmacogenomics and Individualized Therapy are both conducting significant research efforts in this area and support a stronger federal focus on genomics,” states a Burr release from 2007.
The bill aimed to advance the study of human genes to customize medical treatments. This week, the President’s Council of Advisors on Science and Technology will discuss the personalized medicine initiative. The agenda includes a 45-minute panel of four participants.
Despite the promise that decades of research might lead to actual cures, those paying for drugs worry that they’ll cost too much if Congress doesn’t also include policies to curb drug prices. The Partnership for Quality Care, which includes providers and payers, holds a conference Friday on the effect of rising drug prices on patients, providers and public programs.
Second Cures Draft Scrapped Several Medicare Coverage Measures, Added Beneficiary Appeals to Lock-In Pharmacy Measure
The second draft of the House Energy and Commerce Committee’s Cures bill scrapped several Medicare measures that were in the first iteration, including language on coverage of breakthrough technologies, telemedicine services and disposable medical devices, as well as provisions on add-on payments for new technologies and coding. The device industry is hopeful E&C will reinsert many of the missing pieces and is also upset new coverage language it proposed wasn’t included, but some sources suggest the omissions may be due to the Ways & Means Committee’s role on such issues.
House Energy & Commerce members also added a beneficiary-appeals measure to a provision in 21st Century Cures draft legislation that would let plans limit which pharmacies may dispense drugs prone to abuse, such as pain medicine; but seniors’ advocates and independent pharmacies say the committee didn’t significantly amend the pharmacy-network provision and the language could make it difficult for beneficiaries to obtain medicine they desperately need.
FDA officials, meanwhile, told lawmakers that the updated Cures bill’s provisions to lift hiring caps and raise salary caps would help them attract senior biomedical researchers, and agreed that Congress could do even more by cutting bureaucratic red tape in the hiring process and allowing new employees to put stock holdings in blind trusts.”