Democratic divide on drug pricing likely in House Presented by the Partnership for America's Health Care Future

With help from Adam Cancryn

THE DEMOCRATIC DIVIDE: DOGGETT AND ESHOO WOULD BRING DIVERGENT PHARMA RECORDS TO LEADERSHIP ROLES — Congressional Democrats’ united front on curbing drug prices may soon change: A pair of senior lawmakers who’ve disagreed in the past on the pharmaceutical industry are in line to chair key health subcommittees in the next Congress.

Rep. Anna Eshoo, on Energy and Commerce, is a biotech champion from the Silicon Valley and the second-biggest recipient of drug and health product industry contributions in Congress. Rep. Lloyd Doggett, on Ways and Means, is a Texas progressive who once urged President Donald Trump to curb the industry’s patent rights. The health subcommittees they're set to lead will steer the legislative policies addressing the surging costs of medicines. Together, they will serve as a barometer for Democratic unity as the party tries to make good on health policy promises that dominated the midterms.

“If you look at Anna Eshoo versus Lloyd Doggett I think you have a pretty solid showdown,” said Alex Lawson, executive director of Social Security Works, a left-leaning group that works to safeguard Social Security and is pushing drug pricing reform. “Eshoo is very much unabashedly cozy with pharma, while Lloyd Doggett is doing everything he can” to take on the industry.

Doggett is co-chairman of the House Democrats’ Affordable Prescription Drug Task Force and lead sponsor of four drug pricing bills in this Congress. Contrast that with Eshoo, who hasn’t lent her support to most recent drug pricing bills — even those with bipartisan backing like price transparency proposals. Instead, she’s backed bills that would extend drug company marketing protections.

Pros can read the full dissection of their records here.

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A message from the Partnership for America's Health Care Future: A new poll found lowering costs is voters’ top priority when it comes to health care, but the public option could force the average worker to pay $2,300 a year in new taxes even if they like their current coverage and care. Get the facts.

POLITICO Pro DataPoint just published a series of biographies on the 116th House and Senate freshman class. The collection of graphics includes vital information about the members-elect — careers prior to being elected to serve on the Hill, campaign platform promises, key support and endorsements.

HOUSE TACKS MEDICAID OVERCHARGE ONTO HEALTH SPENDING VOTE — The House is expected to vote this week on legislation aimed at cracking down on drug companies that overcharge Medicaid, The Hill’s Peter Sullivan first reported. The overcharge language — from draft text in the Right Rebate Act of 2018, introduced by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) as S. 3702 (115) — will likely be rolled into legislation intended to help offset higher health care costs expected from the IMPROVE Act, H.R. 7217 (115), Pro's Adam Cancryn confirmed. IMPROVE, sponsored by Rep. Joe Barton (R-Texas), includes Medicaid extenders for children with complex conditions.

Suffering from bill overload? Here’s what you need to know: The expected language would let HHS fine drug companies that knowingly misclassify drugs to pay lower rebates — such as the instance in which Mylan intentionally classified EpiPen as a generic. More on the Grassley-Wyden bill here.

FDA WINS IN DRAFT LAB TEST BILL — Lawmakers on Thursday unveiled the latest draft of a bill to regulate diagnostic kits and laboratory-developed tests, largely hewing to FDA’s August recommendations that give the agency definitive oversight. The bipartisan VALID Act from Reps. Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.) is the latest in the pair’s effort to clarify regulations around lab tests that are typically developed by research universities and providers for their own use — leaving them outside the usual FDA approval process.

The newest version of what was formerly dubbed the Diagnostic Accuracy and Innovation Act would give FDA power to approve the highest-risk diagnostic tests, pull those it deems unsafe from the market and grandfather in requirements for lower-risk tests.

The draft’s release came just hours after senior FDA officials called for expanded regulatory authority in a blog post that argued the current system leaves questions around LDTs’ accuracy and reliability, particularly as diagnostic tests for cancer mutations become more complex.

Next steps: There will be another round of meetings with regulators, industry and patient groups to finalize details like how provisional approval for new tests might work, according to a Bucshon staffer. The lawmakers hope to introduce the bill in the House by next summer.

SUPREME COURT SETS ARGUMENTS IN MERCK DRUG LABELING CASE — The high court will hear arguments Jan. 7 in Merck v. Albrecht, a case that could have wide-ranging implications for when drugmakers are protected from consumer lawsuits alleging harm, because FDA, not drug companies have final say in the content of warning labels. The court last week also agreed to let the acting solicitor general participate in oral arguments. This could help Merck, considering that the Trump administration submitted an amicus brief in favor of the drug company. Attorneys general from 22 states and the District of Columbia submitted an amicus brief on the opposing side.

The case centers around a series of state lawsuits against Merck that argued the labeling of its osteoporosis drug didn’t adequately convey the risk of fractures. Merck maintained the lawsuits were pre-empted by the FDA because the drugmaker was rebuffed in efforts to strengthen warnings on the label.

At issue is the 3rd Circuit Court of Appeals’ interpretation of a landmark Supreme Court ruling in Wyeth v. Levine. The Supreme Court held in 2009 that FDA’s approval of a drug label does not insulate manufacturers from failure-to-warn lawsuits under state law because pharmaceutical companies have a responsibility to constantly monitor their products and provide updated information to the agency.

LONG-TERM CAR-T RESULTS RAISE COST QUESTIONS — CAR-T cell therapies have been billed as one-time, potentially curative treatments for aggressive blood cancers, a narrative that has helped rationalize the $373,000 price tag for Gilead’s Yescarta. But a recent study showed that just 39 percent of B-cell lymphoma patients treated with Yescarta were still cancer-free two years later — and the median response was just over 11 months.

“This is in stark contrast with the rhetoric and hype in this space,” vocal drug industry critic Vinay Prasad told Prescription PULSE. The oncologist has previously recommended a three-year money-back guarantee for patients whose cancers return.

Not everyone agrees. The Institute for Clinical and Economic Review released a report earlier this year that concluded Yescarta fell within its typical cost-effectiveness thresholds for patients with this type of lymphoma. ICER spokesperson David Whitrap said the latest data are in line with the assumptions that ICER used for its assessment — meaning Gilead’s latest findings wouldn’t necessarily change the institute’s conclusion.

CMS, meanwhile, is conducting a national coverage analysis to determine how to reimburse providers for CAR-T therapy — and duration of response has come up in its meetings on the topic as well. The agency’s coverage plan is expected in May.

CRS REPORT SUGGESTS RIGHT-TO-TRY TWEAKS — The nonpartisan Congressional Research Service offers a slew of proposed tweaks to the Right to Try Act, S. 204 (115), if Congress decides to revisit it. The law, which garnered widespread support despite objections from bioethicists as well as drugmakers, lets patients skirt the FDA and request access to experimental medicines directly from pharmaceutical companies. Among CRS’ suggestions:

Patient eligibility: The report recommends a narrower definition than in the current law, which permits a person diagnosed with a “life-threatening disease or condition” to use the right-to-try process. This could include patients with life-threatening chronic conditions that are manageable with current treatment. It is a broader population than what supporters typically described when trying to get the legislation passed. They usually focused on people very close to death with no options remaining — those whose limited options and life expectancy would make them willing to risk taking an unapproved drug that might hasten their death.

Informed consent: CRS proposes a more “explicit” informed consent requirement to ensure that desperate patients are adequately informed about risks and less likely to become prey for unscrupulous actors. The existing law does not specify what informed consent must include, and thus may provide weaker protections than FDA’s compassionate use process.

Adverse events: CRS recommends requiring that data on safety events be provided to the FDA faster.

More: Read the full report here.





New York opioid tax case goes to court — Oral arguments in the wholesaler lobby’s challenge to the state’s opioid tax take place today in federal district court for the Southern District of New York. The Healthcare Distribution Alliance said in its July filing that the state’s Opioid Stewardship Act — which aims to fund addiction centers through charges to opioid manufacturers and distributors — is unconstitutional and would cost the companies $600 million over six years. They argue it is a punitive surcharge that tries to legislatively adjudicate issues that are the subject of ongoing state and city investigations into companies’ practices. The lobby also maintains distributors play no role in prescribing or dispensing the addictive drugs and shouldn't be subject to a law that seeks to punish those who fueled the opioid epidemic. But the state responded last month that the law is a tax measure intended to raise revenue for critical public health programs.

Walling off opioids: Mallinckrodt will, Insys hopes to — Beleaguered drugmaker Mallinckrodt is splitting the company after failed attempts to sell its generics business — which includes opioids — and hundreds of lawsuits related to their sales. That segment will stay in St. Louis under the Mallinckrodt name, while branded products will become a yet-unnamed business. And an even more beleaguered opioid maker — Insys Therapeutics, the target of multiple civil and criminal lawsuits alleging fraud — is desperate to sell its super-potent fentanyl Subsys, which until last year was its only marketed product and responsible for 100 percent of its profits. So far there are no takers, Bloomberg reports.

Is America ready for prescription heroin? — The possibility was raised in a Rand Corporation analysis that advised heroin-assisted treatment in measured doses under supervision for longtime users who failed to respond to other treatments, NPR’s Elana Gordon reports. But the idea, long-accepted in some European countries, would face many hurdles here: There are already challenges to medication-assisted treatments containing far milder opioids that were approved many years ago, experts said. More here.

Could naloxone reimbursement now mean life insurance denials later? — Public health leaders say broad access to the opioid overdose reversal medication saves lives. Their recommendations that people at risk carry it have been widely adopted, “standing” prescriptions are common and many insurers cover it. But submitting it for reimbursement — the consumer brands Narcan and Evzio are pricey — could lead to coverage denials because of assumptions attached to the prescription, WBUR’s Martha Bebinger reports. More here.

The next pill delivery service at your door — Walgreens and FedEx announced a partnership to launch next-day prescription deliveries, joining the ranks of mail-order pharmacy services like Express Scripts — recently bought by Cigna — and PillPack, one of Amazon’s latest acquisitions. Walgreens says it will have the edge by being the “fastest choice,” writes Forbes’ Bruce Japsen.

Biosimilar makers join Pfizer in marketing fight — The Biosimilars Forum sent FDA a letter two weeks ago backing Pfizer’s August plea for the agency to take action on branded drugmakers’ “misleading” claims over their cheaper rivals’ safety and effectiveness, writes Biocentury’s Mark Zipkin. Pfizer’s earlier citizen’s petition named Amgen and Roche’s Genentech as sowing doubt over drugs that the FDA has deemed biologically equivalent to their own.

FDA’s CDER named Peter Stein permanent director of its Office of New Drugs. Stein was previously OND deputy director and a vice president for Merck Research Laboratories.

CDER also appointed Robert Temple to the new position of senior adviser within OND, to advise on “medical decisions that are controversial, complex or critical in nature” and sign off on OND-level appeals. Temple previously served as acting deputy director of the Office of Drug Evaluation I.

HHS Office of Inspector General submitted its semi-annual report to Congress.

HHS OIG released a report finding that Medicare improperly paid for durable medical equipment, prosthetics, orthotics and other supplies provided during inpatient hospital stays.

The Institute for Clinical and Economic Review released a final report on the comparative clinical effectiveness and value of extended-release medicines to treat opioid use disorder.

ICER is seeking nominations for new members to join its evidence review groups.

FDA officials wrote a blog post on how the agency’s device center engages with patients, providers and industry to accomplish its work.

The Coalition for Affordable Prescription Drugs released a framework for evaluating proposals that address drug pricing.

Generics’ prices predictive of shortages — Lower-priced generics are significantly more likely than expensive ones to experience a shortage, a new study in Value In Health found. Those with prices considered medium or high were 30 percent to 40 percent less likely to go through a shortage. The authors, from Harvard and the University of Utah, hypothesized that generic drugmakers may prioritize the continued production of more profitable products — and be more likely to cut corners with cheaper drugs in ways that compromise production quality and predispose them to FDA regulatory scrutiny and shortages. More from Zachary Brennan at RAPS here.

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