| | | | | |  | | By David Lim and Katherine Ellen Foley | Presented by Pharmaceutical Care Management Association | With Megan R. Wilson
| | |  The House E&C Committee could be facing stormy weather in its effort to advance a bipartisan health package. | J. Scott Applewhite/AP Photo | E&C QUIBBLE OVER HEALTH PACKAGE — Top lawmakers on the House Energy and Commerce Committee are pushing to advance a sweeping package of bills and discussion drafts aiming to address transparency and competition issues in health care, but there could be choppy seas ahead. The sticking points in the otherwise bipartisan effort involve certain discussion drafts Democrats say were added to a legislative hearing docket “at the last minute,” a Democratic committee staffer granted anonymity to discuss sensitive discussions told POLITICO. “We need to work together hand in hand on drafting legislation and coming to policy consensus together, and that’s not what happened in this case,” the committee aide said. “This was rolled out as bipartisan, and that’s just not where we’re at.” An E&C Republican spokesperson said lawmakers are working in a bipartisan fashion and it is a priority to achieve bills that lower health care costs for patients. The Health Subcommittee will consider 17 bills and discussion drafts during its April 26 hearing that cover proposed measures, including ones intended to increase transparency around health care costs and the ownership structures of hospitals and doctors groups. IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Our condolences to those in D.C. battling historically high tree pollen. Send news, tips and unused handkerchiefs to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with Maggie Miller, who reports on the breach of DC Health Link, uncovered last month, which involved the theft of more than 50,000 customers, including at least 17 House members and almost 600 House staffers.
| | A message from Pharmaceutical Care Management Association: Don’t let their smoke and mirrors fool you: high drug costs start and end with big drug companies. While pharmacy benefit companies are lowering costs, drug companies are busy blaming everyone in the supply chain but themselves to avoid culpability for the affordability challenge some patients face. Without more competition and accountability, big drug companies will continue to abuse the patent system and block affordable alternatives – making life-saving medications unaffordable for American families. Learn more. | | | | | | | | HELP HEARING SET ON INSULIN, PBMs — Senate HELP Committee Chair Bernie Sanders (I-Vt.) is summoning executives from top insulin makers and pharmacy benefit managers as part of his efforts to rein in drug prices, Megan reports. The hearing, slated for May 10, comes after major drugmakers Eli Lilly, Novo Nordisk and Sanofi announced they would be slashing insulin prices. It will feature testimony from those CEOs, plus executives from the three largest PBMs, which negotiate discounts on drugs like insulin with drugmakers and decide which medicines insurance plans will cover. Sanders tells Megan the announcements to reduce prices are “an important step forward,” but there’s more to do on drug pricing, adding the U.S. “cannot continue to pay, by far, the highest prices in the world for prescription drugs while drug companies and PBMs make billions in profits.” While PBMs argue they lower drug costs by using bargaining power to obtain drug discounts, critics have countered that drugmakers raise their prices to give larger rebates to the PBMs and receive preferential placement on insurance formularies. “Recent price cuts on insulin clearly demonstrate that drug companies alone have the ability and discretion to set, raise and lower their prices,” said Katie Payne, a spokesperson for the Pharmaceutical Care Management Association, a PBM industry group.
|  PhRMA doesn't expect drug pricing provisions in the IRA to be changed in the near future. | M. Scott Mahaskey/POLITICO | M. Scott Mahaskey/POLITICO | QUICK IRA REPEAL, TWEAKS NOT IN THE CARDS — The top drug lobby acknowledges that legislative changes to the Inflation Reduction Act’s drug pricing provisions will not happen anytime soon. “We recognize that’s probably not a short-term proposition,” PhRMA COO Lori Reilly told reporters. “I don’t believe that President Biden would likely sign changes into law.” The decision by top House Republicans not to float revisions to Medicare drug pricing negotiations in their debt ceiling proposal unveiled Wednesday underscores the political durability of the IRA — and suggests the GOP is reticent to attempt a repeal to the law after years of failed efforts to claw back the Affordable Care Act. “I don’t think Republicans support having the government negotiate drug prices, but there's not a lot to gain by taking on a very popular provision with an election coming up,” said Larry Levitt, KFF executive vice president for health policy. “PhRMA’s influence only goes so far.” For now, the drug industry is focusing its fire on pharmacy middlemen — and pushing CMS to loosen proposed restrictions on publicly disclosing drug price negotiation details. PhRMA said it is exploring “every potential avenue to fight” back against the IRA when asked whether the push to loosen information about the negotiation process is an attempt to discern whether CMS’ methodological approach to drug selection and negotiation could potentially open a legal challenge in the future. “That's certainly one angle,” said Lauren Neves, PhRMA deputy vice president of policy and research. “I don't think we've made any decisions at this time, but it's certainly something we're looking into.” FINANCE BIPARTISAN PBM BOOGIE — Senate Finance Committee leaders, Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho), have outlined a bipartisan roadmap for action on pharmacy benefit managers, Megan reports. The agreement on policy principles — including compelling more transparency from the industry, modernizing Medicare’s “Any Willing Pharmacy” requirements and looking at rebates PBMs receive from drugmakers — comes as other congressional panels are putting PBMs in the crosshairs. Wyden, who has long been critical of PBMs, said he’s aiming to introduce legislation this summer.
| | | | GO INSIDE THE 2023 MILKEN INSTITUTE GLOBAL CONFERENCE: POLITICO is proud to partner with the Milken Institute to produce a special edition "Global Insider" newsletter featuring exclusive coverage, insider nuggets and unparalleled insights from the 2023 Global Conference, which will convene leaders in health, finance, politics, philanthropy and entertainment from April 30-May 3. This year’s theme, Advancing a Thriving World, will challenge and inspire attendees to lean into building an optimistic coalition capable of tackling the issues and inequities we collectively face. Don’t miss a thing — subscribe today for a front row seat. | | | | | | | | | EMERGENT BIOSOLUTIONS PRICES OTC NARCAN — On Thursday, the maker of the first nonprescription opioid overdose reversal drug said it plans to charge $50 for a two-pack of the 4-milligram naloxone nasal spray, Katherine reports. Narcan, made by Emergent BioSolutions, is available by prescription only and costs roughly $70 for a two-pack, though cost varies by insurance coverage. The company said retailers will determine the sales price of over-the-counter Narcan. It’s unclear whether insurance plans will cover it; most don’t cover nonprescription products. Public health experts fear that at $50 for a two-pack, OTC Narcan will remain inaccessible for people most at risk of an overdose. “It’s kind of like the country-club naloxone,” Nabarun Dasgupta, an innovation fellow for the school of public health at UNC-Chapel Hill, told Prescription Pulse. Dasgupta is also board chair of the Remedy Alliance, a nonprofit that distributes free naloxone. “This idea that you’re going to have it in every gas station is so nice, but if you go into a gas station, do you see any products that are $50?” he added, noting that he suspects it most likely will be sold in vape and hemp shops. The FDA is considering another nonprescription nasal naloxone from Harm Reduction Therapeutics, a nonprofit with funding from Purdue Pharma, opioid Oxycontin’s maker. HRT’s product contains 3 milligrams of naloxone, and the company pledges to charge just over $36 for a two-pack if approved. Emergent attributes the price difference to the higher dose of naloxone in its product. Michael Hufford, HRT’s president and co-founder, disagreed. Naloxone costs pennies to produce, he said. “It’s not dimes, it’s not nickels — pennies is the actual cost of the naloxone in any intranasal spray,” Hufford said.
| | | | A message from Pharmaceutical Care Management Association:   | | | | | CDC STREAMLINES COVID VAX SCHEDULE — The CDC said late Wednesday that most adults will be considered up to date on Covid vaccinations if they have received one bivalent mRNA shot, Katherine reports. It also recommended that adults over 65 and those with compromised immune systems receive one more bivalent booster now ahead of a potential updated fall shot. The CDC changes follow the FDA’s Tuesday authorization updates to mRNA Covid vaccines from Pfizer-BioNTech and Moderna. Authorizations for Novavax and Johnson & Johnson Covid shots remain unchanged. The FDA plans to decide on the composition of new Covid boosters for the fall after its independent advisory committee meeting in June.
| | Emily Weeks has joined tobacco giant R.J. Reynolds as a senior manager for corporate communications. The White House plans to nominate Monica Bertagnolli to run the National Institutes of Health, two people familiar with the matter told POLITICO’s Adam Cancryn.
| | | | STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today. | | | | | | | | | The lofty price tags of novel therapies are at odds with Europe’s goal of providing affordable medications for everyone, Helen Collis writes for POLITICO.
| | On Wednesday, the FDA published draft guidance for manufacturers developing therapies for acute radiation syndrome.
| | A message from Pharmaceutical Care Management Association: Big drug companies choose to set unaffordable prices for many Americans – then add insult to injury by blocking competition in the prescription drug market to maximize their profit, and drive drug costs higher at the expense of patients.
Rather than limiting choice for employers and restricting options for achieving savings, Congress should act to strengthen competition in the market, and end big drug companies’ egregious abuse of the patent system that blocks affordable alternatives – such as generics and biosimilars – from entering the prescription drug market.
Patent thickets on five of the 10 top-selling drugs in the U.S. resulted in more than $500 billion in additional sales, and patent abuse blocking biosimilars from the market alone will cost patients an estimated $30 billion over the next decade.
While big drug companies are focused on profits, pharmacy benefit companies are driving costs down and securing savings for patients, employers, and taxpayers. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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