Cures — Senate HELP Committee Chairman Lamar Alexander is now looking at September as the target for advancing the biomedical innovation bill. That’s music to the ears of Cures cheerleader-in-chief Fred Upton, chairman of the House Energy in Commerce Committee, who has worked up a new list of pay-fors that he says is “pretty close” to providing the NIH funding needed to seal a deal with Democrats.
But Upton said he won’t unveil the list until after recess. A Senate Democratic aide said it hadn’t been shared with Democrats and the two sides haven’t even agreed on a firm number for the NIH. In other words, there’s enthusiasm aplenty but no concrete progress to report.
… Ahead of the break, the National Organization for Rare Disorders said it was “disappointed” at the latest delay but will keep pushing for Cures over recess. And some critics of Cures re-upped their concerns in Health Affairs last week.
Zika — The blame game over Congress’s failure to fund a response to the virus will vault to a whole new level if Zika starts to transmit locally in the U.S. this summer, Pro’s Jen Haberkorn reports. On Thursday, Democrats for a second time voted down Republicans’ $1.1 billion proposal, citing partisan GOP riders and controversial offsets, including Ebola funds. Republican appropriators asked the White House to “aggressively use funds that are already available to mount a strong defense” against Zika.
CARA — The Senate last week overwhelmingly passed the first major overhaul of substance abuse prevention and treatment policy in decades. But it didn’t include any money. Senate Democrats on Thursday introduced their latest proposal to spend $920 million to battle the opioid epidemic and the White House pledged to press Republicans for money (though it has said President Barack Obama will sign CARA.). Physician groups and addiction advocates praised the bill’s passage – and immediately began calling for funding to back it up. Brett’s story on how deferring to appropriators for money – potentially until next March, under one temporary spending bill scenario – will delay the impact the bill will have on the ground as the epidemic claims lives: http://politico.pro/29TciWv
…Said an aide to HELP ranking member Patty Murray: “Unfortunately, the case for additional funding is only going to get stronger.”
… Nonetheless, CARA was a HUGE legislative victory for GOP Sen. Rob Portman and fellow co-sponsor Kelly Ayotte, both of whom are running on their opioid work in their tough reelection bids. Many down-ballot Republicans incumbents are embracing a broader and more positive health care agenda – on opioids and medical research, for instance – than the single-issue anti-Obamacare platform that dominated the last few cycles, Brett reports with our Pro colleague Nancy Cook. But Obamacare’s hardly going away. That story: http://politico.pro/29Wd19q
Good Monday to you and welcome to Prescription PULSE — and summer recess! The physician and novelist A.J. Cronin was born in Scotland this week in 1896. His international best seller "The Citadel," published in 1937, describes the struggles of an idealistic doctor working in 1920s and 1930s in a corrupt and ineffective health care system, and is thought to have directly influenced the founding of the National Health Service in 1948. http://bit.ly/29OgRCy
Brett is taking off a few weeks of delayed paternity leave (Baby #2 you’ll recall was born in April). Sarah is here so send her news and tips to get us through August. SKarlin-Smith@politico.com and @sarahkarlin.
PDUFA VI AGREEMENT DROPS — FDA outlined Friday the agreement it reached with the drug industry covering the agency’s performance goals and industry user fees from fiscal years 2018 to 2022. It’s the culmination of months of closed door negotiations and represents an important step toward the reauthorization of user fee legislation that Congress must pass by October 2017. FDA is requesting more than $110 million in new user fees, much of which will go to support 230 new staff. Overall, FDA will collect billions over the five-year fee cycle. In return it commits to reviewing drugs under particular time frames. The deal also offers a roadmap of how the agency will modify drug review and approval, and prioritize resources and staffing. Patient-reported data, real-world evidence and combination drug and device products are all set to get more attention and resources. The popular “breakthrough” therapy program will receive additional funding and FDA plans to expand the Sentinel System, which pulls from large amounts of EHRs, insurance claims and registries to monitor the safety of approved drugs. A 30-day clock now starts ticking on public input. The agreement: http://bit.ly/29ARF3j. The FR notice: http://bit.ly/29XmOzh. More details from Sarah.
…If you’re keeping score — we are still waiting on user fee agreements on biosimilars, generic drugs and medical devices that will be incorporated into the same legislation.
MEDICAID’S COSTLIEST DRUGS — The antipsychotic Abilify tops the list of a new Kaiser Family Foundation analysis that looked at the 50 most costly outpatient drugs to Medicaid from January 2014 through June 2015. The list takes into account how frequently the drugs are prescribed as well as how expensive they are at the prescription level. Abilify beat out Gilead’s hepatitis C drug Sovaldi, which took the number two slot. Gilead’s other pricey hepatitis C drug Harvoni is number four on the list. Antiviral drugs for the treatment of HIV/AIDS accounted for 20 percent of the 50 most costly drugs, asthmatics and bronchodilators 16 percent.
… The often pricey biologics accounted for 12 percent, or six of the 50 mostly costly drugs, including Humira Pen and Enbrel Sure Click, both used for some types of arthritis and psoriasis. Nearly one-quarter (11) of the most costly drugs had an orphan designation meaning they are approved for use in a rare disease.
Not all drugs made the KFF list because they were pricey – 28 of the drugs were deemed not expensive at the prescription level, but were listed because of the high volumes prescribed. And 17 were both frequently prescribed --and expensive. One drug that made the list due to high utilization-only was hydrocodone-acetaminophen -- an opioid, and Medicaid’s most prescribed drug during this time period.
The analysis also has a list of the most expensive drugs by spending per prescription, too. It offers hints into the discounts Medicaid programs are receiving off the list prices of drugs before additional rebates they might receive. For example, average Medicaid spending before rebates for Harvoni is less than $29,000, about one-third the list price for 12-week treatment with the drug. This indicates hepatis C treatments may be becoming more affordable for Medicaid programs.
REPORTS: DRUG SPENDING GROWTH MODERATES — CMS projects prescription drug spending will grow by 6.7 percent per year through 2025, according to the National Health Expenditures report released last week. That’s down from a record spike of 12.2 percent in 2014 and 8.1 percent in 2015, but still higher than overall health care spending, which is projected to grow at 5.8 percent through 2025 on average. The NHE report: http://go.cms.gov/1J3iyc9
… Altarum meanwhile reported that year-over-year prescription drug spending growth fell to 5.2 percent in May. More: http://bit.ly/1Ujrn4G
TEVA JOINS PhRMA — ICYMI, the world's largest generic drug company is officially one of the newest members of the brand-drug lobbying powerhouse PhRMA. The lobby’s board approved Teva’s membership last week, despite opposition from some members to admitting a company that often takes opposing policy positions to those drug companies that primarily make branded medications. But Teva’s joining PhRMA at a time when the lines between generic and brand drug companies are increasingly blurring, with many companies known for their innovative products, pursuing biosimilars. PhRMA also approved membership for Alexion Pharmaceuticals and Jazz Pharmaceuticals, and it elevated Horizon Pharma and AMAG Pharmaceuticals from research associates to full members. PhRMA CEO Stephen Ubl said that the new members will help as the lobby strives to “address costs holistically.” More from Sarah.
CMS WEIGHS IN ON VALUE-BASED DRUG PURCHASING AGREEMENTS … KIND OF — In guidance released late last week CMS said that value-based purchasing arrangements developed between drug companies and payers could affect the calculation of a drug’s “best price” for Medicaid. Drug companies are required to offer Medicaid the lowest price on a drug offered on the private market. Companies, have been worried value or outcomes-based purchasing agreements could lower their best price and serve as a disincentive to create these arrangements with private payers.
CMS didn’t offer specifics on what kind of agreements would affect the calculations but said companies can submit questions on a particular arrangement to its CMCS Division of Pharmacy. Based on these inquiries it plans to generalize lessons learned and produce additional guidance. CMS is also encouraging state Medicaid programs to use value-based purchasing.. http://bit.ly/29ZuX2F
E&C APPROVES NEW PRIORITY REVIEW VOUCHER PROGRAM — The House Energy and Commerce Committee approved a bill last week that would reward companies that get a “medical countermeasure” approved with a priority review voucher for a six-month review of a future drug application. Medical countermeasures are drugs that would treat or prevent harm from biological, chemical, radiological or nuclear threats. That could include treatments for Zika or pandemic flu, for instance. Drug companies can sell their vouchers. To refresh your memory, vouchers rewarded as part of other priority review programs, such as for rare pediatric disease, have sold for hundreds of millions of dollars -- the chance to get a drug to market just a few months faster is extremely valuable for companies. The bill also sets up a user fee program for companies that use a priority review voucher. http://bit.ly/29HUdrS
…BIO applauded the bill’s advancement through committee. Similar legislation has been passed out of Senate HELP. The FDA, however, hasn’t been a huge fan of priority review voucher programs, saying they often force the agency to prioritize drugs that don’t necessarily deserve a faster review. BIO’s statement: http://bit.ly/29ADVpw
ICER LOOKS FOR INPUT; PLANS NEW REPORT — The Institute of Clinical and Economic Review, which has been giving drug makers heart burn with its frequently unflattering estimates of their products economic value, is accepting public input before a planned update next year on how it can improve value assessments. How to submit your two cents here.
… ICER also announced that it will report on the comparative effectiveness and value of new drug treatments for rheumatoid arthritis, and possibly psoriatic arthritis. More here.
— PhRMA and doctor groups appear to be working together to push back on CMS’s Medicare Part B demo, USA Today reports. http://usat.ly/29WqttY
— Scott Gottlieb and Kavita Patel propose an approach to drug prices including indication and outcomes-based pricing and reducing regulatory burdens. http://bit.ly/29WquhS
— Avik Roy at Forbes criticizes the GOP for not taking on high drug prices. The conservative writer briefly outlines several policy options for market-based reforms, including equal tax treatment of health insurance, expanded accelerated approvals and more. http://bit.ly/2a4C78X
— Former Republican Majority Leader Bill Frist and Democratic Rep. Bart Gordon argue for the use of “real-world data” to accelerate drug and device approvals at US News & World Report. http://bit.ly/29Jp7lv
— Gilead, in the spotlight for its high cost breakthrough hepatitis C treatments, avoided paying $10 billion in U.S. taxes by moving some of its assets to Ireland, according to a new report by Americans for Tax Fairness, detailed in the Washington Post. http://wapo.st/29J9FKn
… Rep. Lloyd Doggett blasted the company in a statement: “Gilead excels at tax dodging and price gouging. While a chief exporter of drug patents and profits to Ireland, it refuses to charge Americans the much lower drug prices of Ireland.”
— Insurers could reduce drug prices, but policymakers are making it harder to them to do so, according to an op-ed in Health Affairs. http://bit.ly/29UFSMY
— A new survey finds two-thirds of chronic pain sufferers say getting opioid prescriptions has become more difficult in the past year, the Boston Globe reports.
— Race is the most significant factor influencing NIH grant awards, and new policies are need to address the gap, a new study out of the University of Kansas finds. http://bit.ly/2ag9Qsi
CHOOSING WISELY CAMPAIGN SAYS: USE CHEAPER EFFECTIVE DRUGS — The American College of Preventive Medicine issued several new recommendations last week, including that doctors should use the cheaper alternative among equally effective medications. They also advised against taking a multivitamin, vitamin E or beta carotene to prevent heart disease or cancer. The new recommendations.
AHRQ FUNDS OPIOID ABUSE TREATMENT IN RURAL PRACTICES — AHRQ is making about $9 million in grants over three years to help rural primary care practices provide medication-assisted treatment to more than 20,000 patients. Details here.
CIGAR TRADE GROUPS SUE FDA OVER DEEMING REG — A lawsuit filed Friday by cigar interests is the latest legal challenge to FDA’s deeming rule released in May which asserts the agency’s authority to regulate e-cigarettes, hookahs, cigars, pipe tobacco and other products under the Tobacco Control Act. The premium cigar industry had lobbied hard but did not get an exemption from pre-market review to which new tobacco products will be subjected. The lawsuit was brought by Cigar Rights of America, the International Premium Cigars & Pipe Retailers Association and the Cigar Association of America, and alleges that FDA incorrectly subjects new products to stricter regulation that those that were already on the market and effectively imposes a tax on cigars by charging user fees for FDA review, among other complaints. Some companies in the vaping industry have already sued.
— Francis de Souza is taking the helm as the new CEO at Illumina after serving as president. http://bit.ly/29IXgG7
— From POLITICO Influence: James Stansel, former acting HHS general council, will become PhRMA’s general counsel after serving as co-head of Sidley Austin’s global life sciences team.
… Michael Spira, former chief of staff for Rep. Carolyn McCarthy (D-N.Y.), joins the American Pharmacists Association as vice president.
… Joseph Devaney was named VP of government affairs and policy, Americas, for Astellas.
— From Playbook: Caitlin Carroll joins the communications team at PhRMA from the Republican Study Committee.
— Cybele Bjorklund joins Sanofi as head of policy where she’ll focus on pricing, affordability, access, science policy and other issues. She spent 14 years a staffer on the House Ways & Means Committee and nearly four years as a health policy adviser for Sen. Ted Kennedy.
CATCHING OUR ATTENTION: PUSHBACK ON DRUG PRICES HASN’T KEPT PHARMA COMPANIES DOWN — Most of the largest drug companies said that increasing prices boosted sales of some or most of their top products in the first quarter of this year, the Wall Street Journal reports based on a review of corporate filings and conference call transcripts. Despite slow economic growth, pharma is proving more able than most other industries to boost prices and the increases have grown in “magnitude and frequency” in recent years. From May 2015 to May 2016, pharmaceutical prices received by manufacturers grew 9.8 percent – the second biggest increase tracked by the Bureau of Labor Statistics’ Producer Price index in the largest products and services category, behind investment services. While drug makers often divert attention away from list prices, citing negotiated discounts, their financial disclosures show how prices continue to rise. “The industry sort of hiding behind that is really a diversionary tactic,” said Geoffrey Porges, a Leerink Partners LLC biotech analyst.