Washington Week: Drugmakers, PBMs Hammered Over High Drug Prices



WASHINGTON -- Members of Congress blamed and shamed key players in the pharmaceutical market for high drug prices, while also asking for their help; and the Trump administration quietly advanced its block grant strategy for Medicaid.

Drugmakers, PBMs Run the Gauntlet at House Hearing

No punches were thrown, but tensions were high during a House hearing on Wednesday, as witnesses representing drug companies and pharmacy benefit managers (PBMs) fought to shield themselves from blame for high insulin prices, and desperate and dying patients.

Members of the House Oversight and Investigations Subcommittee, mostly Democrats, leveled a number of threats around price-fixing, and turning PBMs into utilities or getting rid of them entirely.

"You're in trouble ... If you think you can out-talk us without any transparency, without any accountability, I just want you to know your days are numbered," said Rep. Jan Schakowsky (D-Ill.) to drugmakers after highlighting how "curiously close in price" each one's product was -- in the range of $270-$280.

In the Senate, PBMs Plead Innocent

Senators chastised pharmacy benefit managers (PBMs) for using backdoor tactics and secret schemes that make drugs costlier to patients than they otherwise would be, during a Senate Finance Committee hearing on Tuesday.

PBMs negotiate drug prices with drugmakers and pharmacies to lower drug prices on behalf of their health-insurer clients. In theory that should lower prices, but in practice, critics have argued that patients end up paying more.

"The current system is so opaque that it's easy to see why there are many questions about PBMs' motives and practices. One question we must ask is whether PBMs prefer a high-cost drug with big rebates over a cheaper drug," said committee chair Chuck Grassley (R-Iowa).

"Some even argue that PBMs force drug companies to raise their list price," he said.

FDA OKs First 2-Drug HIV Combo for Tx-Naive Patients

The first two-drug complete regimen for treatment-naive HIV patients was approved on Monday, the FDA announced.

Dovato (ViiV Healthcare) is a combination of integrase inhibitor dolutegravir (Tivicay) and lamivudine (3TC). It is a two-drug, fixed-dose complete regimen for the treatment of HIV infection in adults who have no antiretroviral therapy (ART) history and no known or suspected resistance to the individual components of the drug.

"Currently, the standard of care for patients who have never been treated is a three-drug regimen. With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug," said Debra Birnkrant, MD, director of the FDA's Division of Antiviral Products in a statement.

Trump Administration Revs Up Push for Medicaid Block Grants

The Trump administration's message is clear: in Medicaid, block grants are the way to go.

"The budget ... proposes to give states additional flexibility over their Medicaid programs by transferring control of Medicaid transformation efforts locally where it belongs," the White House said in its message accompanying its fiscal year 2020 budget proposal. "The administration recognizes that the only way to reform Medicaid and set it on a sound fiscal path is by putting states on equal footing with the federal government to implement comprehensive Medicaid financing reform through a per-capita cap or block grant."

The block-grant proposal isn't likely to get approved by Congress, given that the House is under Democratic control, but the administration also has other ways of pursuing its block-grant agenda. The Centers for Medicare & Medicaid Services (CMS) is reportedly working on a plan to encourage states to apply for what's known as Section 1115 waiver authority to implement their own Medicaid block grants.

FDA Loosens Alcohol Warning for Addyi

Drinking alcohol with the female libido booster flibanserin (Addyi) appears somewhat less dangerous than initially thought and the FDA has ordered a label change to reflect the new data -- over the manufacturer's objection.

Drugmaker Sprout Pharmaceuticals wanted the warnings removed altogether, the agency explained. When negotiations over the label change broke down, the FDA said it decided to order Sprout to use the agency's preferred language.

When flibanserin was approved, it came with a boxed warning about hypotension and syncope in women taking the drug after drinking alcohol, which had been seen in the product's clinical trials. "Alcohol use is contraindicated," the current label states flatly.

But according to the FDA's announcement Thursday, post-marketing data indicate that risk of such events is low when at least two hours elapse between an alcoholic drink and taking the flibanserin pill.

PBM Rep Has the Solution to High Drug Prices

A top official at the trade group representing pharmacy benefit managers (PBMs) said the solution to high drug prices is simple: "Increase competition."

That was the chief message from Kristin Bass, chief policy and external affairs officer of the Pharmaceutical Care Management Association (PCMA), addressing the American Hospital Association's (AHA) annual membership meeting here on Monday.

"Our industry doesn't sleep at night because of specialty [drugs]," said Bass.

But despite some outliers -- Turing Pharmaceuticals' Daraprim is one example (its price shot up from $13.50 to $750 literally overnight in 2015) -- Bass said that, broadly speaking, generic competition is strong.

New Postmenopausal Osteoporosis Drug OK'd

The FDA approved romosozumab (Evenity) for osteoporosis in postmenopausal women at high risk for fracture, the agency announced Tuesday.

One dose of the bone anabolic agent, a monoclonal antibody targeting the protein sclerostin to support new bone formation, would be administered in two back-to-back injections each month. Due to a treatment plateau seen after a year of therapy in the drug's trials, no more than 12 doses are recommended.

This approval doesn't come as much of a surprise, after members of the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 18-1 in favor of the treatment's approval in January.

However, cardiovascular safety concerns with the drug were identified during the trials, mainly increased incidence of MI and stroke.

Next Week

On Monday, The National Alliance Against Disparities in Patient Health will explore health disparities as a national crisis.

On Wednesday, the Council for Affordable Health Coverage will examine Medicare Part B.

And the Alliance for Health Policy will host a congressional briefing focused on the role of comparative effectiveness research.

Congress is on recess.

Source: https://www.medpagetoday.com/washington-watch/washington-watch/79190

Washington Week: Drugmakers, PBMs Hammered Over High Drug



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