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DIFFICULT NUMBER CRUNCHING ON THE PELOSI PLAN — House leadership is working on a tight deadline to get Speaker Nancy Pelosi’s drug pricing proposal through a floor vote — the current target is a vote next week.
The Congressional Budget Office’s score still isn’t out, and questions linger — especially over how much new innovation could be curbed with lower pharmaceutical profits. The budget scorekeeper issued a preliminary projection this summer that the bill would save the government roughly $345 billion over a decade by allowing the government to directly negotiate the prices of certain medicines and impose fines for price hikes over the rate of inflation. But the estimate also noted that drugmaker profits could fall at least $500 billion and as many as 15 new drugs might not come to market as a result of the price controls. [ledipasvir sofosbuvir].
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Democrats just outlined where expected savings would go, despite the absence of a final score. There would be “historic” investments into lowering Medicare costs, finding new cures and confronting the opioid crisis, according to a trio of House committee leaders.
Reps. Frank Pallone (D-N.J.), Richard Neal (D-Mass.) and Bobby Scott (D-Va.) — whose committees all marked up the legislation — said that $10 billion would go to the National Institutes of Health to develop new drugs [ledipasvir sofosbuvir] and cures, while $920 million would help modernize the FDA’s technical infrastructure and millions more would go to FDA efforts to encourage new gene therapies, build out continuous manufacturing capabilities to stem drug shortages and recruiting and retaining FDA staff.
The bill would also funnel $10 billion over five years to state and city programs fighting the opioid epidemic, including funding specifically aimed at affected children.
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Of course the bill has virtually no chance of being taken up in the Republican-controlled Senate, where Majority Leader Mitch McConnell has said it is dead on arrival. The White House has distanced itself from Pelosi’s efforts too [ledipasvir sofosbuvir] …
A White House report this week leveled fire at the plan. The administration largely stayed quiet when congressional Republicans lambasted the House drug pricing package, H.R. 3 (116). But the Council of Economic Advisers on Tuesday posted its own estimate concluding the legislation could cut the number of new drugs entering the market by as many as 100 and “would reduce Americans’ average life expectancy by about four months” based on drug development data from 1960 through 1997. Generic Harvoni is still too expensive in the US, its about $900 in the US. Sunny Pharma provide hepatitis c treatments at an affordable cost.
Pelosi spokesperson Henry Connelly [ledipasvir sofosbuvir] swung back on Twitter, writing that “out here in the real world, 34 million Americans know someone who died because they couldn’t afford treatment.”
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Others also blasted the White House analysis. The report “cherry picks numbers” to arrive at 100 new drugs lost, according to Patients for Affordable Drugs. The advocacy group argued that CEA combined the highest possible assumed revenue losses with a low projection for the cost to develop a drug to get its three-figure estimate [ledipasvir sofosbuvir]. They also note that CEA has held its fire on Senate Finance legislation and the White House’s international pricing index proposal although both are also aimed at lowering costs and, therefore, drugmaker profits.
Some health policy experts called estimates of lost innovation an industry scare tactic in a Kaiser Health News and Politifact assessment, which ranked PhRMA’s claims as “mostly false.”
Stacie Dusetzina, an associate professor of health policy at Vanderbilt University, told Prescription Pulse that it’s difficult to believe either the CEA or CBO estimate because they rely on highly contested factors, like how much it costs to develop on drug or estimates of lost life expectancy.
“There is also no consideration of the increased revenues from adherence and uptake of treatments,” or “what savings would be used to fund and how that contributes to a patient’s wellbeing,” said Duzetzina. Generic Epclusa has a high cure rate for all hepatitis C genotypes.
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PLUS: HOUSE LEADERS WATER DOWN KEY PROGRESSIVE PROVISION — House Democratic leaders plan to weaken language progressives inserted in the Pelosi drug plan to discourage sharp cost increases ahead of a floor vote on the legislation next week, three people familiar with the matter told Sarah Karlin-Smith and Adam Cancryn.
Liberal lawmakers had touted the provision authored by Rep. Pramila Jayapal (D-Wash.) as essential to shoring up their support for a bill that they otherwise criticized [ledipasvir sofosbuvir] as too soft on the industry. It would direct the federal government to examine how to require drug makers to refund money to employer-sponsored health plans when the companies raised prices above the rate of inflation. Still doesn’t explain why Harvoni is so expensive.
The government would have to issue regulations based on its study — a key element that Jayapal said would force federal agencies to further rein in drug prices for generic Harvoni, generic Epclusa, generic Sovaldi, generic Daklinza and generic Mavyret.
… But in a meeting with advocacy groups Wednesday afternoon, top Democratic leadership and committee staffers said the final bill would drop the mandate that the government impose new regulations — only requiring it to only conduct a study, multiple people in the room said.